المؤلفون: Méndez Vidal Mj, Torres Borrego J, Peña Rosa Mj, Beaudoin Perron A, García Martínez E

المصدر: Anales de Pediatría, Vol 61, Iss 1, Pp 69-73 (2004)

مصطلحات موضوعية: Thorax, medicine.medical_specialty, Spontaneous regression, business.industry, Incidence (epidemiology), Histology, Pericardial Mesothelioma, Clinical manifestation, medicine.disease, Pericardial effusion, Pediatrics, RJ1-570, Pediatrics, Perinatology and Child Health, medicine, Pericardial tumours, Radiology, Teratomas, Differential diagnosis, business, Cardiac Tumors

الوصف: Los tumores cardíacos son neoplasias infrecuentes, con una incidencia de 0,027 casos/100. Hasta un 90% son tumores benignos, si bien debido a su localización pueden ser letales, con independencia de la histología. Afectan fundamentalmente a menores de un añoLos teratomas, relativamente frecuentes en niñas, se ubican preferentemente en ovario, sacrocóccix, tórax y retroperitoneo, siendo la localización intrapericárdica menos frecuente. En esta localización, la sintomatología se debe a la compresión de estructuras vecinas y determina la actitud terapéutica en cada caso. El diagnóstico definitivo, tras la aproximación con las pruebas de imagen, se obtiene tras su resección quirúrgica, que es el tratamiento de elecciónEl diagnóstico diferencial de los tumores pericárdicos incluye fundamentalmente con los tumores del mediastino anterior, hipertrofia tímica, derrame pericárdico y lesiones cardíacas primarias como mesoteliomas pericárdicos, malformación de Ebstein y quistes broncogénicos intrapericárdicosSe presentan 2 pacientes pediátricos diagnosticados en el primer año de vida en nuestro hospital; ambos desarrollaron tumores de localización pericárdica. En uno de los casos la masa involucionó hasta desaparecer; en el otro, de diagnóstico más tardío, fue necesario el tratamiento quirúrgico : Cardiac tumors are rare neoplasms with an incidence of 0.027 cases per 100. Up to 90% of these tumors are benign but, because of their location, they can be lethal, despite their histology. Most appear in infants aged less than 1 yearTeratomas, which are relatively frequent in the pediatric age group, are usually located in the ovaries, sacrococcygeal area, thorax, and retroperitoneal area. Intrapericar-dial location is less frequent. In this localization, the clinical manifestation depends on compression of adjacent structures and determines the therapeutic attitude in each case. Imaging studies should be performed and the definitive diagnosis is obtained after surgical resection, which is the treatment of choiceThe differential diagnosis should include other tumors of the anterior mediastinum, thymus hypertrophy, pericardial effusion and primary cardiac disorders such as pericardial mesothelioma, Ebstein malformation, and intrapericardial bronchogenic cystsWe present two patients who were diagnosed in the first year of life in our hospital. Both children developed pericardial tumours. In one patient, the mass decreased and disappeared while in the other, who received a later diagnosis, surgical treatment was required

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a6989b8f27f25801a193fb034780456a
http://www.sciencedirect.com/science/article/pii/S1695403304783563

المؤلفون: Joan Carles, Teresa Alonso-Gordoa, Begoña Mellado, María J. Méndez-Vidal, Sergio Vázquez, Aránzazu González-del-Alba, Josep M. Piulats, Pablo Borrega, Enrique Gallardo, Rafael Morales-Barrera, Pilar Paredes, Oscar Reig, Carmen Garcías de España, Ricardo Collado, Teresa Bonfill, Cristina Suárez, Miguel Sampayo-Cordero, Andrea Malfettone, Javier Garde

المساهمون: Institut Català de la Salut, [Carles J] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Medica Scientia Innovation Research (MEDSIR), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Alonso-Gordoa T] Medical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain. [Mellado B] Medical Oncology Department, Hospital Clínic Barcelona, Barcelona, Spain. Translational Genomics and Targeted Therapeutics in Solid Tumors Lab, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. [Méndez-Vidal MJ] Maimonides Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, Spain. Reina Sofía University Hospital (HURS), Córdoba, Spain. [Vázquez S] Lucus Augusti University Hospital, Lugo, Spain. [González-del-Alba A] Puerta de Hierro-Majadahonda University Hospital, Madrid, Spain. [Morales-Barrera R] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain, Vall d'Hebron Barcelona Hospital Campus

المصدر: Scientia

مصطلحات موضوعية: Male, Cancer Research, Antiandrògens - Ús terapèutic, Hormones, Hormone Substitutes, and Hormone Antagonists::Hormone Antagonists::Androgen Antagonists [CHEMICALS AND DRUGS], Abiraterone Acetate, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Androgen Antagonists, Bone Neoplasms, Pròstata - Càncer - Tractament, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms, Male::Prostatic Neoplasms::Prostatic Neoplasms, Castration-Resistant [DISEASES], Prostatic Neoplasms, Castration-Resistant, hormonas, sustitutos de hormonas y antagonistas de hormonas::antagonistas de hormonas::antagonistas de andrógenos [COMPUESTOS QUÍMICOS Y DROGAS], Oncology, Receptors, Androgen, neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales masculinos::neoplasias de la próstata::neoplasias prostáticas resistentes a la castración [ENFERMEDADES], Benzamides, Nitriles, Phenylthiohydantoin, Avaluació de resultats (Assistència sanitària), Humans, Radium

الوصف: Bone metastases; Metastatic castration-resistant prostate cancer Metástasis óseas; Cáncer de próstata metastásico resistente a la castración Metàstasis òssies; Càncer de pròstata resistent a la castració metastàtic Purpose The paper aims to evaluate the efficacy and safety of 223Ra in patients who progressed after first-line androgen deprivation therapy. Patients and methods EXCAAPE (NCT03002220) was a multicentre, single-arm, open-label, non-controlled phase IIa trial in 52 patients with metastatic castration-resistant prostate cancer and asymptomatic bone metastases who have progressed on abiraterone acetate or enzalutamide, up to six doses of 223Ra (55 kBq/kg of body weight per month). The primary end-point was radiographic progression-free survival (rPFS). Secondary end-points included rPFS based on androgen receptor splice variant 7 (AR-V7) expression in circulating tumour cells (CTCs), overall survival, and safety. Results Median rPFS was 5.5 months (95% CI 5.3–5.5). Median rPFS of patients with AR-V7(−) CTCs was longer than that of patients with AR-V7(+) CTCs (5.5 versus 2.2 months, respectively; P = 0.056). Median overall survival was 14.8 months (95% CI 11.2–not reached) and was significantly greater for AR-V7(−) patients than for AR-V7(+) patients (14.8 months versus 3.5 months, respectively; P < 0.01). 223Ra was well tolerated; anaemia and thrombocytopenia were the most common grade 3/4 adverse events (5.8% and 11.5%, respectively). Conclusions 223Ra seems to be a reasonable treatment for patients with metastatic castration-resistant prostate cancer and asymptomatic bone metastases progressing on novel hormonal therapy and had an acceptable safety profile. The study was conceived and designed by Joan Carles in collaboration with Medica Scientia Innovation Research (MEDSIR). MEDSIR, as legal sponsor of the study, is responsible for compliance with all clinical and regulatory procedures and adherence to the study protocol. MEDSIR had a role in study design, collection, management, analysis, and interpretation of the data and writing of the report. Bayer Inc. funded the study and provided 223Ra. The funder of the study had no role in data collection, management, data analysis, data interpretation, writing of the report, or decision to submit the manuscript for publication. All authors had full access to the data used to prepare the manuscript and participated in writing, editing, and/or critically reviewing the manuscript. The manuscript was written with editorial support from a medical writer, funded by MEDSIR. The corresponding author had final responsibility for the decision to submit for publication.

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9578fe4d02c1c74477e8b12ba44cee24
https://doi.org/10.1016/j.ejca.2022.06.057

المؤلفون: Climent MÁ; Valencian Institute of Oncology, Valencia, Spain., Álvarez C; Hospital Universitario Central de Asturias, Oviedo, Spain., Morales R; Vall d'Hebron University Hospital, Barcelona, Spain., Maroto P; Hospital Universitari de La Santa Creu I Sant Pau, Barcelona, Spain., Rodríguez-Vida A; Hospital del Mar-CIBERONC, IMIM Research Institute, Barcelona, Spain., Méndez-Vidal MJ; Maimonides Institute for Biomedical Research of Cordoba (IMIBIC), Reina Sofia University Hospital (HURS), Cordoba, Spain., Del Muro XG; Catalan Institute of Oncology, Barcelona, Spain., Puente J; Hospital Universitario Clínico San Carlos, Madrid, Spain., Láinez N; University Hospital of Navarra, Pamplona, Spain., Vázquez S; Hospital Universitario Lucus Augusti, Lugo, Spain., Castellano D; Hospital 12 de Octubre, Madrid, Spain., Lang CG; Merck S.L.U., an Affiliate of Merck KGaA, Madrid, Spain., Wang J; Pfizer, Cambridge, MA, USA., di Pietro A; Pfizer Srl, Milan, Italy., Davis C; Pfizer Translational Oncology, La Jolla, CA, USA., Sanz-Castillo B; Pfizer Oncology, Madrid, Spain., Bolós MV; Pfizer Oncology, Madrid, Spain., Valderrama BP; Virgen del Rocío University Hospital, Seville, Spain. bpvalderrama@gmail.com.

المصدر: Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico [Clin Transl Oncol] 2024 Jun; Vol. 26 (6), pp. 1532-1538. Date of Electronic Publication: 2023 Dec 15.

نوع المنشور: Journal Article; Randomized Controlled Trial; Clinical Trial, Phase III

بيانات الدورية: Publisher: Country of Publication: Italy NLM ID: 101247119 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1699-3055 (Electronic) Linking ISSN: 1699048X NLM ISO Abbreviation: Clin Transl Oncol Subsets: MEDLINE

مواضيع طبية MeSH: B7-H1 Antigen*/metabolism , Antibodies, Monoclonal, Humanized*/therapeutic use , Urinary Bladder Neoplasms*/drug therapy , Urinary Bladder Neoplasms*/metabolism , Urinary Bladder Neoplasms*/pathology , Urinary Bladder Neoplasms*/mortality , Carcinoma, Transitional Cell*/drug therapy , Carcinoma, Transitional Cell*/metabolism , Carcinoma, Transitional Cell*/pathology, Humans ; Progression-Free Survival ; Female ; Male ; Antineoplastic Agents, Immunological/therapeutic use ; Aged ; Middle Aged ; Maintenance Chemotherapy ; Survival Rate

مستخلص: Purpose: Post hoc analysis of the JAVELIN Bladder 100 trial of avelumab maintenance in locally advanced/metastatic urothelial carcinoma (la/mUC) to determine the interaction by programmed death ligand 1 (PD-L1) status for overall survival (OS), and additional analyses of survival per a different PD-L1 expression cutoff of ≥ 1% in tumor cells or immune cells (TC/IC).
Methods: JAVELIN Bladder 100 data were used for the analysis of the interaction by PD-L1 status (per cutoff used in the trial) for OS and, additionally, OS and progression-free survival (PFS) analyses per a different ≥ 1% TC/IC PD-L1 expression cutoff (Ventana SP263 assay).
Results: No significant interaction between treatment and PD-L1 status was observed for OS. Clinically meaningful and robust survival data were observed in favor of avelumab using the different ≥ 1% TC/IC PD-L1 expression cutoff.
Conclusions: These results demonstrate the benefit of avelumab maintenance in la/mUC regardless of PD-L1 expression, consistent with approved labels.
(© 2023. The Author(s).)

المؤلفون: Motzer RJ; Memorial Sloan Kettering Cancer Center, New York, NY., Porta C; University of Bari 'A. Moro,' Bari, Italy.; University of Pavia, Pavia, Italy., Eto M; Kyushu University, Fukuoka, Japan., Powles T; The Royal Free NHS Trust, London, United Kingdom., Grünwald V; University Hospital Essen, Essen, Germany., Hutson TE; Texas Oncology, Dallas, TX., Alekseev B; P.A. Herzen Moscow Oncological Research Institute, Moscow, Russia., Rha SY; Yonsei Cancer Center, Yonsei University Health System, Seoul, South Korea., Merchan J; University of Miami Sylvester Comprehensive Cancer Center, Miami, FL., Goh JC; ICON Research, South Brisbane & Queensland University of Technology, Brisbane, Queensland, Australia., Lalani AA; Juravinski Cancer Centre, McMaster University, Hamilton, Ontario, Canada., De Giorgi U; IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Italy., Melichar B; Palacky University, and University Hospital Olomouc, Olomouc, Czech Republic., Hong SH; Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, South Korea., Gurney H; Macquarie University, Sydney, NSW, Australia., Méndez-Vidal MJ; Maimonides Institute for Biomedical research of Cordoba (IMIBIC) Hospital Universitario Reina Sofía, Medical Oncology Department, Córdoba, Spain., Kopyltsov E; State Institution of Healthcare 'Regional Clinical Oncology Dispensary,' Omsk, Russia., Tjulandin S; N N Blokhin National Medical Research Center for Oncology, Ministry of Health of the Russian Federation, Moscow, Russia., Gordoa TA; Hospital Universitario Ramón y Cajal, Madrid, Spain., Kozlov V; State budgetary Health Care Institution 'Novosibirsk Regional Clinical Oncology Dispensary,' Novosibirsk, Russia., Alyasova A; Prevoljskiy Region Medical Centre, Novgorod, Russia., Winquist E; Western University, London, Ontario, Canada., Maroto P; Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Kim M; Seoul National University Hospital, Seoul, South Korea., Peer A; Rambam Health Care Campus, Haifa, Israel., Procopio G; Fondazione IRCCS Istituto Nazionale Tumori Milano, Milan, Italy., Takagi T; Tokyo Women's Medical University, Tokyo, Japan., Wong S; Western Health, Melbourne, Victoria, Australia., Bedke J; Department of Urology and Transplantation Surgery, Klinikum Stuttgart, Stuttgart, Germany., Schmidinger M; Department of Urology, Medical University of Vienna, Vienna, Austria., Rodriguez-Lopez K; Merck & Co, Inc, Rahway, NJ., Burgents J; Merck & Co, Inc, Kenilworth, NJ., He C; Eisai Inc, Nutley, NJ., Okpara CE; Eisai Ltd, Hatfield, UK., McKenzie J; Eisai Inc, Nutley, NJ., Choueiri TK; Dana-Farber Cancer Institute, Boston, MA.

مؤلفون مشاركون: CLEAR Trial Investigators

المصدر: Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 Apr 10; Vol. 42 (11), pp. 1222-1228. Date of Electronic Publication: 2024 Jan 16.

نوع المنشور: Randomized Controlled Trial; Clinical Trial, Phase III; Journal Article

بيانات الدورية: Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-7755 (Electronic) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE

مواضيع طبية MeSH: Carcinoma, Renal Cell*/pathology , Kidney Neoplasms*/pathology , Phenylurea Compounds* , Quinolines* , Antibodies, Monoclonal, Humanized*, Humans ; Sunitinib/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Survival Analysis

مستخلص: Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical trial updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. We present the final prespecified overall survival (OS) analysis of the open-label, phase III CLEAR study in treatment-naïve patients with advanced renal cell carcinoma (aRCC). With an additional follow-up of 23 months from the primary analysis, we report results from the lenvatinib plus pembrolizumab versus sunitinib comparison of CLEAR. Treatment-naïve patients with aRCC were randomly assigned to receive lenvatinib (20 mg orally once daily in 21-day cycles) plus pembrolizumab (200 mg intravenously once every 3 weeks) or sunitinib (50 mg orally once daily [4 weeks on/2 weeks off]). At this data cutoff date (July 31, 2022), the OS hazard ratio (HR) was 0.79 (95% CI, 0.63 to 0.99). The median OS (95% CI) was 53.7 months (95% CI, 48.7 to not estimable [NE]) with lenvatinib plus pembrolizumab versus 54.3 months (95% CI, 40.9 to NE) with sunitinib; 36-month OS rates (95% CI) were 66.4% (95% CI, 61.1 to 71.2) and 60.2% (95% CI, 54.6 to 65.2), respectively. The median progression-free survival (95% CI) was 23.9 months (95% CI, 20.8 to 27.7) with lenvatinib plus pembrolizumab and 9.2 months (95% CI, 6.0 to 11.0) with sunitinib (HR, 0.47 [95% CI, 0.38 to 0.57]). Objective response rate also favored the combination over sunitinib (71.3% v 36.7%; relative risk 1.94 [95% CI, 1.67 to 2.26]). Treatment-emergent adverse events occurred in >90% of patients who received either treatment. In conclusion, lenvatinib plus pembrolizumab achieved consistent, durable benefit with a manageable safety profile in treatment-naïve patients with aRCC.

المؤلفون: Grünwald V; Clinic for Medical Oncology and Clinic for Urology, University Hospital Essen, Essen, Germany., Powles T; Barts Cancer Institute and the Royal Free Hospital, Queen Mary University of London, London, United Kingdom., Eto M; Department of Urology, Kyushu University, Fukuoka, Japan., Kopyltsov E; State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia., Rha SY; Department of Internal Medicine, Yonsei Cancer Center, Yonsei University Health System, Seoul, Republic of Korea., Porta C; Department of Biomedical Sciences and Human Oncology, University of Bari 'A. Moro', Bari, Italy., Motzer R; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States., Hutson TE; Medical Oncology, Texas Oncology, Dallas, TX, United States., Méndez-Vidal MJ; Department of Oncology, Maimonides Institute for Biomedical Research of Córdoba (IMIBIC) Hospital Universitario Reina Sofía, Córdoba, Spain., Hong SH; Department of Urology, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea., Winquist E; Department of Oncology, University of Western Ontario, London, ON, Canada., Goh JC; ICON Research, South Brisbane & University of Queensland, St Lucia, QLD, Australia., Maroto P; Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Buchler T; Department of Oncology, Charles University and Thomayer University Hospital, Prague, Czechia., Takagi T; Department of Urology, Tokyo Women's Medical University, Tokyo, Japan., Burgents JE; Global Clinical Development, Merck & Co., Inc., Rahway, NJ, United States., Perini R; Clinical Research, Merck & Co., Inc., Rahway, NJ, United States., He C; Biostatistics, Eisai Inc., Nutley, NJ, United States., Okpara CE; Clinical Research, Eisai Ltd., Hatfield, United Kingdom., McKenzie J; Clinical Research, Eisai Inc., Nutley, NJ, United States., Choueiri TK; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.

المصدر: Frontiers in oncology [Front Oncol] 2024 Mar 01; Vol. 13, pp. 1343027. Date of Electronic Publication: 2024 Mar 01 (Print Publication: 2023).

نوع المنشور: Published Erratum

بيانات الدورية: Publisher: Frontiers Research Foundation] Country of Publication: Switzerland NLM ID: 101568867 Publication Model: eCollection Cited Medium: Print ISSN: 2234-943X (Print) Linking ISSN: 2234943X NLM ISO Abbreviation: Front Oncol Subsets: PubMed not MEDLINE

مستخلص: [This corrects the article DOI: 10.3389/fonc.2023.1223282.].
(Copyright © 2024 Grünwald, Powles, Eto, Kopyltsov, Rha, Porta, Motzer, Hutson, Méndez-Vidal, Hong, Winquist, Goh, Maroto, Buchler, Takagi, Burgents, Perini, He, Okpara, McKenzie and Choueiri.)

المؤلفون: Méndez-Vidal MJ; Medical Oncology Department, Maimonides Institute for Biomedical Research of Cordoba (IMIBIC), Hospital Universitario Reina Sofía, Córdoba, Spain. mariajose.mendezvidal@gmail.com., Lázaro Quintela M; Medical Oncology Department, Hospital Alvaro Cunqueiro-Complejo Hospitalario Universitario de Vigo, Pontevedra, Spain., Lainez-Milagro N; Medical Oncology Department, Hospital Universitario de Navarra (HUN), Pamplona, Spain., Perez-Valderrama B; Medical Oncology Department, Hospital Universitario Virgen del Rocío, Seville, Spain., Suárez Rodriguez C; Medical Oncology Department, Hospital Universitario Vall D'Hebron, Barcelona, Spain., Arranz Arija JÁ; Medical Oncology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Peláez Fernández I; Medical Oncology Department, Hospital de Cabueñes, Gijón, Spain., Gallardo Díaz E; Medical Oncology Department, Corporació Sanitària Parc Taulì, Barcelona, Spain., Lambea Sorrosal J; Medical Oncology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain., González-Del-Alba A; Medical Oncology Department, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.

المصدر: Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico [Clin Transl Oncol] 2023 Sep; Vol. 25 (9), pp. 2732-2748. Date of Electronic Publication: 2023 Aug 09.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Country of Publication: Italy NLM ID: 101247119 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1699-3055 (Electronic) Linking ISSN: 1699048X NLM ISO Abbreviation: Clin Transl Oncol Subsets: MEDLINE

مواضيع طبية MeSH: Carcinoma, Renal Cell*/therapy , Carcinoma, Renal Cell*/drug therapy , Kidney Neoplasms*/therapy , Kidney Neoplasms*/drug therapy, Male ; Humans ; Female ; Sunitinib/adverse effects ; Nivolumab/therapeutic use ; Quality of Life ; Tyrosine/therapeutic use

مستخلص: Renal cancer is the seventh most common cancer in men and the tenth in women. The aim of this article is to review the diagnosis, treatment, and follow-up of renal carcinoma accompanied by recommendations with new evidence and treatment algorithms. A new pathologic classification of RCC by the World Health Organization (WHO) was published in 2022 and this classification would be considered a "bridge" to a future molecular classification. For patients with localized disease, surgery is the treatment of choice with nephron-sparing surgery recommended when feasible. Adjuvant treatment with pembrolizumab is an option for intermediate-or high-risk cases, as well as patients after complete resection of metastatic disease. More data are needed in the future, including positive overall survival data. Clinical prognostic classification, preferably IMDC, should be used for treatment decision making in mRCC. Cytoreductive nephrectomy should not be deemed mandatory in individuals with intermediate-poor IMDC/MSKCC risk who require systemic therapy. Metastasectomy can be contemplated in selected subjects with a limited number of metastases or long metachronous disease-free interval. For the population of patients with metastatic ccRCC as a whole, the combination of pembrolizumab-axitinib, nivolumab-cabozantinib, or pembrolizumab-lenvatinib can be considered as the first option based on the benefit obtained in OS versus sunitinib. In cases that have an intermediate IMDC and poor prognosis, the combination of ipilimumab and nivolumab has demonstrated superior OS compared to sunitinib. As for individuals with advanced RCC previously treated with one or two antiangiogenic tyrosine-kinase inhibitors, nivolumab and cabozantinib are the options of choice. When there is progression following initial immunotherapy-based treatment, we recommend treatment with an antiangiogenic tyrosine-kinase inhibitor. While no clear sequence can be advocated, medical oncologists and patients should be aware of the recent advances and new strategies that improve survival and quality of life in the setting of metastatic RC.
(© 2023. The Author(s).)

المؤلفون: Grünwald V; Clinic for Medical Oncology and Clinic for Urology, University Hospital Essen, Essen, Germany., Powles T; Barts Cancer Institute and the Royal Free Hospital, Queen Mary University of London, London, United Kingdom., Eto M; Department of Urology, Kyushu University, Fukuoka, Japan., Kopyltsov E; State Institution of Healthcare Regional Clinical Oncology Dispensary, Omsk, Russia., Rha SY; Department of Internal Medicine, Yonsei Cancer Center, Yonsei University Health System, Seoul, Republic of Korea., Porta C; Department of Biomedical Sciences and Human Oncology, University of Bari 'A. Moro', Bari, Italy., Motzer R; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, United States., Hutson TE; Medical Oncology, Texas Oncology, Dallas, TX, United States., Méndez-Vidal MJ; Department of Oncology, Maimonides Institute for Biomedical Research of Córdoba (IMIBIC) Hospital Universitario Reina Sofía, Córdoba, Spain., Hong SH; Department of Urology, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea., Winquist E; Department of Oncology, University of Western Ontario, London, ON, Canada., Goh JC; ICON Research, South Brisbane & University of Queensland, St Lucia, QLD, Australia., Maroto P; Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Buchler T; Department of Oncology, Charles University and Thomayer University Hospital, Prague, Czechia., Takagi T; Department of Urology, Tokyo Women's Medical University, Tokyo, Japan., Burgents JE; Global Clinical Development, Merck & Co., Inc., Rahway, NJ, United States., Perini R; Clinical Research, Merck & Co., Inc., Rahway, NJ, United States., He C; Biostatistics, Eisai Inc., Nutley, NJ, United States., Okpara CE; Clinical Research, Eisai Ltd., Hatfield, United Kingdom., McKenzie J; Clinical Research, Eisai Inc., Nutley, NJ, United States., Choueiri TK; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, United States.

المصدر: Frontiers in oncology [Front Oncol] 2023 Aug 16; Vol. 13, pp. 1223282. Date of Electronic Publication: 2023 Aug 16 (Print Publication: 2023).

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Frontiers Research Foundation] Country of Publication: Switzerland NLM ID: 101568867 Publication Model: eCollection Cited Medium: Print ISSN: 2234-943X (Print) Linking ISSN: 2234943X NLM ISO Abbreviation: Front Oncol Subsets: PubMed not MEDLINE

مستخلص: Introduction: The phase 3 CLEAR study demonstrated that lenvatinib plus pembrolizumab significantly improved efficacy versus sunitinib as first-line treatment for patients with advanced renal cell carcinoma (RCC). Prognostic features including presence and/or site of baseline metastases, prior nephrectomy, and sarcomatoid features have been associated with disease and treatment success. This subsequent analysis explores outcomes in patients with or without specific prognostic features.
Methods: In CLEAR, patients with clear cell RCC were randomly assigned (1:1:1) to receive either lenvatinib (20 mg/day) plus pembrolizumab (200 mg every 3 weeks), lenvatinib (18 mg/day) plus everolimus (5 mg/day), or sunitinib alone (50 mg/day, 4 weeks on, 2 weeks off). In this report, progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) were all assessed in the lenvatinib-plus-pembrolizumab and the sunitinib arms, based on baseline features: lung metastases, bone metastases, liver metastases, prior nephrectomy, and sarcomatoid histology.
Results: In all the assessed subgroups, median PFS was longer with lenvatinib-plus-pembrolizumab than with sunitinib treatment, notably among patients with baseline bone metastases (HR 0.33, 95% CI 0.21-0.52) and patients with sarcomatoid features (HR 0.39, 95% CI 0.18-0.84). Median OS favored lenvatinib plus pembrolizumab over sunitinib irrespective of metastatic lesions at baseline, prior nephrectomy, and sarcomatoid features. Of interest, among patients with baseline bone metastases the HR for survival was 0.50 (95% CI 0.30-0.83) and among patients with sarcomatoid features the HR for survival was 0.91 (95% CI 0.32-2.58); though for many groups, median OS was not reached. ORR also favored lenvatinib plus pembrolizumab over sunitinib across all subgroups; similarly, complete responses also followed this pattern.
Conclusion: Efficacy outcomes improved following treatment with lenvatinib-plus-pembrolizumab versus sunitinib in patients with RCC-irrespective of the presence or absence of baseline lung metastases, baseline bone metastases, baseline liver metastases, prior nephrectomy, or sarcomatoid features. These findings corroborate those of the primary CLEAR study analysis in the overall population and support lenvatinib plus pembrolizumab as a standard of care in 1L treatment for patients with advanced RCC.
Clinical Trial Registration: ClinicalTrials.gov, identifier NCT02811861.
Competing Interests: VG: Invited Speaker: AstraZeneca, Astellas, BMS, EISAI, Ipsen, Janssen-Cilag, Merck, MSD, Pfizer, ONO Pharmaceutical, Novartis/AAA; Advisory Board: Apogepha, BMS, EISAI, EUSA Pharm, Cureteq, Debiopharm, Gilead, Janssen-Cilag, Merck, MSD, Pfizer, Novartis, Oncorena, PCI Biotech; Stocks/Shares: AstraZeneca, BMS, MSD, SeaGen; Steering Committee Member: BMS, EISAI, Ipsen, Novartis, PharmaMar; Travel support: AstraZeneca, Ipsen, Merck, Janssen, Pfizer. Non-Financial Interests: Membership: ASCO, ESMO, German medical Oncology and Hematology Society; Advisory role: German Cancer Society; Leadership role: Working Group medical oncology (AIO). TP: reports research funding from Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Ipsen, Johnson & Johnson, Merck, Merck Serono, MSD, Novartis, Pfizer, Roche, and Seattle Genetics; consulting fees from Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Incyte, Ipsen, Johnson & Johnson, Merck, Merck Serono, MSD, Novartis, Pfizer, Roche, and Seattle Genetics; support for attending meetings or travel from Astra Zeneca, Ipsen, MSD, Pfizer, and Roche. ME: reports research funding from Kissei, Sanofi, Astellas, ONO, Takeda, and Bayer; and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from MSD, ONO, Chugai, Novartis, Pfizer, Bristol Myers Squibb, Takeda, Janssen, and Merck. SYR: reports grants or contracts from Amgen, Merck, Bristol Myers Squibb, MSD, Lilly, Daiichi Sankyo, Beigene, Eisai, and AstraZeneca; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Amgen, Lilly, Bristol Myers Squibb, MSD, and Eisai; and participation on a data safety monitoring board or advisory board from Amgen, MSD, Bristol Myers Squibb, Merck, Indivumed, Beigene, Eisai, and Daiichi Sankyo. CP: reports consulting fees from Angelini Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, Ipsen, and MSD; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Angelini Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, General Electric, Ipsen, and MSD; and participation on a data safety monitoring board or advisory board for Bristol Myers Squibb, Eisai, MSD, the European Society of Medical Oncology, and the Italian Association for Medical Oncology. RM: reports research funding, paid to their institution from Bristol Myers Squibb, Eisai, Exelixis, Genentech/Roche, Merck, Pfizer, and Aveo Pharmaceuticals and consulting fees from AstraZeneca, Aveo Pharmaceuticals, Eisai, EMD Serono, Exelixis, Genentech/Roche, Incyte, Lilly, Merck, Novartis, Pfizer, and Takeda. TEH: reports grants or contracts, paid to their institution, from Bristol Myers Squibb, Eisai, Exelixis, Johnson & Johnson, and Pfizer; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Astellas Pharma, Bristol Myers Squibb, Eisai, Exelixis, Johnson & Johnson, and Pfizer; and participation on a data safety monitoring board or advisory board for Astellas Pharma, Bayer/Onyx, Bristol Myers Squibb, Exelixis, Johnson & Johnson, Novartis, and Pfizer. MJM-V: reports consulting fees from Astellas Pharma, Bristol Myers Squibb, EUSA Pharma, Ipsen, Eisai, Janssen-Cilag, Novartis, Pfizer, Roche, and Sanofi; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Astellas Pharma, Bristol Myers Squibb, Ipsen, EUSA Pharma, Janssen-Cilag, Pfizer, and Roche; and support for attending meetings or travel from Astellas Pharma, Bristol Myers Squibb, Ipsen, Janssen-Cilag, Pfizer, and Roche. EW: reports research support, paid to their institution from Ayala Pharmaceuticals, Eisai, Merck, Pfizer, and Roche/Genentech; honoraria from Amgen, Bayer, Eisai, Merck, and Roche. JCG: reports consulting fees for an advisory board meeting from MSD Australia, Bristol Myers Squibb, and GlaxoSmithKline; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Janssen–Cilag, Ipsen, MSD Australia, and AstraZeneca Australia; and support for attending meetings or travel from AstraZeneca Australia, GlaxoSmithKline, and Pfizer. PM: reports research support, paid to their institution from Roche. TB: reports institutional research support from AstraZeneca, Roche, Bristol Myers Squibb, Exelixis, Merck, and Novartis; consulting fees from Bristol Myers Squibb, Astellas, Janssen, and Sanofi/Aventis; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Ipsen, Bristol Myers Squibb, Servier, and Pfizer; and institutional receipt of equipment, materials, drugs, medical writing, gifts, or other services from Bristol Myers Squibb, AstraZeneca, Roche, and Servier. TT: reports honoraria from Bristol Myers Squibb, Eisai, and Ono Pharmaceutical. JEB: employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. RP: employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. CH: employee of Eisai Inc. CO: employee of Eisai Ltd. JM: employee of Eisai Inc. TKC: reports institutional and/or personal, paid and/or unpaid support for research, advisory boards, consultancy, and honoraria from: Alkermes, AstraZeneca, Aravive, Aveo, Bayer, Bristol Myers Squibb, Calithera, Circle Pharma, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, Gilead, IQVA, Infinity, Ipsen, Jansen, Kanaph, Lilly, Merck, Nikang, Nuscan, Novartis, Pfizer, Roche, Sanofi/Aventis, Scholar Rock, Surface Oncology, Takeda, Tempest, Up-To-Date, CME events Peerview, OncLive, MJH and others, outside the submitted work. Institutional patents filed on molecular alterations and immunotherapy response/toxicity, and ctDNA. Equity: Tempest, Pionyr, Osel, Precede Bio, CureResponse. Committees: NCCN, GU Steering Committee, ASCO/ESMO, ACCRU, KidneyCan. Medical writing and editorial assistance support may have been funded by Communications companies in part. No speaker’s bureau. Mentored several non-US citizens on research projects with potential funding in part from non-US sources/Foreign Components. The institution Dana-Farber Cancer Institute may have received additional independent funding of drug companies or/and royalties potentially involved in research around the subject matter. TKC is supported in part by the Dana-Farber/Harvard Cancer Center Kidney SPORE 2P50CA101942-16 and Program 5P30CA006516-56, the Kohlberg Chair at Harvard Medical School and the Trust Family, Michael Brigham, Pan Mass Challenge, Hinda and Arthur Marcus Fund and Loker Pinard Funds for Kidney Cancer Research at DFCI. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
(Copyright © 2023 Grünwald, Powles, Eto, Kopyltsov, Rha, Porta, Motzer, Hutson, Méndez-Vidal, Hong, Winquist, Goh, Maroto, Buchler, Takagi, Burgents, Perini, He, Okpara, McKenzie and Choueiri.)

المؤلفون: de Velasco G; Department of Medical Oncology, Madrid, Spain. Electronic address: Gdvelasco.gdv@gmail.com., Alonso-Gordoa T; Department of Medical Oncology and Department of Genitourinary, Germ cell and Endocrine Tumors, Ramón y Cajal University Hospital and Ramón y Cajal Health Research Institute (IRYCIS), Madrid, Spain., Rodríguez-Vida A; Department of Medical Oncology, Hospital del Mar-CIBERONC, IMIM Research Institute, Barcelona, Spain., Anguera G; Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain., Campayo M; Department of Medical Oncology, Hospital Universitari Mutua Terrassa, Terrassa, Barcelona, Spain., Pinto Á; Department of Medical Oncology, University Hospital La Paz, Madrid, Spain., Ortega EM; Department of Medical Oncology, University Hospital of Jaén, Jaén, Spain., Gallardo E; Department of Medical Oncology, University Hospital Parc Taulí, Institut d'Investigació i Innovació Parc Taulí, Sabadell, Spain., Núñez NF; Department of Medical Oncology, University Hospital Lucus Augusti, Lugo, Spain., García-Carbonero I; Department of Medical Oncology, University Hospital of Toledo, Toledo, Spain., Reig O; Department of Medical Oncology, Hospital Clínic and Translational Genomics and Targeted Therapeutics in Solid Tumors Group (IDIBAPS), Barcelona, Spain., Méndez-Vidal MJ; Department of Medical Oncology, University Hospital Reina Sofía, Maimónides Institute for Biomedical research of Córdoba (IMIBIC), Córdoba, Spain., Fernández-Calvo O; Department of Medical Oncology, University Hospital of Ourense, Ourense, Spain., Cassinello NV; Department of Medical Oncology, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), CIBERONC, Madrid, Spain., Torregrosa D; Department of Medical Oncology, University Hospital Dr. Peset, Valencia, Spain., López-Martín A; Medical Oncology Department, University Hospital Severo Ochoa, Madrid, Spain., Rosero A; Department of Medical Oncology, University Hospital Infanta Cristina, Parla, Madrid, Spain., Valiente PG; Department of Medical Oncology, University Hospital Marqués de Valdecilla, Santander, Spain., de España CG; Department of Medical Oncology, University Hospital Son Espases, Palma de Mallorca, Spain., Climent MA; Department of Medical Oncology, Fundación Instituto Valenciano de Oncología, Valencia, Spain., Santasusana MD; Department of Medical Oncology, Hospital Althaia, Manresa, Spain., Sánchez ÁR; Department of Medical Oncology, University Hospital of León, León, Spain., González IC; Department of Medical Oncology, Hospital Clínico Universitario, INCLIVA, University of Valencia, Valencia, Spain., Afonso R; Department of Medical Oncology, University Hospital Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain., García Del Muro X; Genitourinary Cancer and Sarcoma Unit, Institut Català d'Oncologia, Hospitalet, Barcelona, Spain., Casinello J; Department of Medical Oncology, University Hospital of Guadalajara, Guadalajara, Spain., Fernández-Parra EM; Department of Medical Oncology, University Hospital Valme, Sevilla, Spain., García Sánchez L; Department of Medical Oncology, University Hospital of Segovia, Segovia, Spain., Afonso J; Department of Medical Oncology, University Hospital of Ferrol, A Coruña, Spain., Polo SH; Department of Medical Oncology, University Hospital Fundación Alcorcón, Madrid, Spain., Asensio Ú; Medical Department, Pfizer Oncology, Madrid, Spain.

المصدر: Clinical genitourinary cancer [Clin Genitourin Cancer] 2023 Jun; Vol. 21 (3), pp. e166-e174. Date of Electronic Publication: 2022 Dec 05.

نوع المنشور: Observational Study; Journal Article; Research Support, Non-U.S. Gov't

بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 101260955 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1938-0682 (Electronic) Linking ISSN: 15587673 NLM ISO Abbreviation: Clin Genitourin Cancer Subsets: MEDLINE

مواضيع طبية MeSH: Carcinoma, Renal Cell*/drug therapy , Carcinoma, Renal Cell*/secondary , Antineoplastic Agents*/therapeutic use , Kidney Neoplasms*/drug therapy , Kidney Neoplasms*/pathology, Humans ; Middle Aged ; Sunitinib/therapeutic use ; Retrospective Studies ; Indoles/therapeutic use ; Pyrroles/therapeutic use

مستخلص: Introduction: The long-term clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) and a complete response (CR) to the tyrosine kinase inhibitor (TKI) sunitinib are poorly known. The characteristics of these patients could reveal previously undetected associations with clinical variables.
Patients and Methods: This observational, retrospective study (ATILA) used data from a registry of patients with mRCC who had received first-line sunitinib and had achieved CR from 2007 to 2018 in Spain.
Results: Sixty-two patients with CR were included; 48 patients (77.4%) received sunitinib in monotherapy and 14 (22.6%) combined with or followed by local treatment. Median age was 58.5 years (range, 32-81). Most patients (79.0%) had clear cell histology and had undergone previous nephrectomy (90.3%). The majority (70.2%) had an intermediate IMDC prognosis, 23% favorable and 7.0% poor. The median time on treatment with sunitinib was 28.2 months (IQR, 16.7-41.0) and the median time to CR was 10.9 months (IQR, 7.2-19.3). After a median follow-up of 8 years (range, 3-13 years), the median PFS was not reached. The overall median duration of complete response was 64.1 months (IQR, 32.2-99.4). The tolerance and safety profile of sunitinib was consistent with previous reports.
Conclusion: Durable CR to sunitinib was observed in patients regardless the prognosis group, metastasis site or histology type, with 75% of patients remaining in CR after 10 years.
Clinicaltrials: gov: NCT03916458.
Competing Interests: Disclosures G.d.V. received research grants from Pfizer, Roche, and Ipsen; consulting or honoraria fees from Ipsen, Pfizer, Roche, Bayer, Astellas, BMS, MSD and Merck. T.A.G. received research grants from Pfizer, Roche, and Ipsen; consulting fees from Ipsen, Pfizer, Roche, Sanofi, Bayer, Astellas, Janssen-Cilag, BMS, and EISAI; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Ipsen, Pfizer, Eisai, and Merck; and support for attending meetings and/or travel from Pfizer, Sanofi, BMS, and IPSEN. A.R.-V. served in advisory boards for MSD, Pfizer, BMS, Astellas, Janssen, Bayer, Clovis and Roche; received honoraria or travel expenses from Pfizer, MSD, Astellas, BMS, Janssen, Astra Zeneca, Roche, Bayer, and Sanofi Aventis; and research funding from Takeda, Pfizer, and Merck. G.A.P. served in speaker bureaus for Ipsen, BMS, Roche, and Janssen. M.C. served in advisory or consultancy roles for AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, EUSA Pharma, Lilly, Roche; received honoraria for lectures for Abbot, Bristol-Myers Squibb, EUSA Pharma, Ipsen, Novartis, Pfizer, Pierre Fabre, Roche; holds institutional financial interests in Astra Zeneca, Merck, Pfizer, Roche, and received travel expenses from Ipsen, Lilly, Merck, Pfizer, and Pierre Fabre. A.P. received research grants from Pfizer and BMS; advisory boards/speaker fees from Pfizer, BMS, Ipsen, Roche, Merck, MSD, Janssen, Astellas, Bayer, Sanofi; and travel expenses from Pfizer, BMS, Janssen and Roche. E.G. received grant support from Astellas, Janssen, Sanofi, Bayer, Ipsen, Ferrer, Pfizer, Roche, GSK and BMS; consulting fees from Sanofi, Janssen, Astellas, Bayer, Ipsen, Pfizer, Roche, Novartis, Eisai, EUSA Pharma, BMS, AstraZeneca, Merck, Rovi, Daiichi Sankyo and Techdow; payment or honoraria for lectures, presentations, speakers’ bureaus, man-uscript writing, or educational events from Astellas, Janssen, Sanofi, Bayer, Ipsen, Pfizer, Roche, BMS, Rovi, Daiichi Sankyo, Leo Pharma, Menarini, Eisai, MSD, Boehringer Ingelheim, Merck, EUSA Pharma and Novartis; support for attending meetings and/or travel from As-tellas, Janssen, Sanofi, BMS, Bayer, Ipsen, Roche, Novartis, Pierre Fabre, Pfizer and Eisai. N.F.N. received support from Roche, BMS, Boehringuer, Sanofi, Bayer, Astra Zeneca, Janssen, MSD, Lilly, Pfizer and IPSEN. I.C.-G. participated in advisory boards of Pfizer, EISAI and BMS. O.R. had consulting or advisory roles with BMS, EISAI, Ipsen; received travel and accommodations support from Ipsen and Pfizer. M.J.M. received honoraria and /or travel support from Janssen-Cilag, Bayer healthcare, Sanofi Aventis, Astellas Medivation, Roche, Ipsen, EISAI, Novartis and Pfizer; advisory boards and speaking for: Pfizer, Astellas, Roche, Ipsen, BMS, Eusa Pharma, Sanofi, Novartis, Janssen andPierre Fabre. N.V.C. received consultant fees from Janssen; speaking fees from Sanofi, Astra Zeneca, Astellas, Janssen, Roche, MSD, Ipsen; and travel support from Pfizer, Pierre Fabre, BMS. A.L.M. received support for attending meetings from Roche and MSD. C.G.d.E. has held consultant or advisory roles with Janssen, Sanofi, Bayer, Astellas; speaking roles from Janssen, Sanofi, Bayer, Astellas, Roche, Ipsen, Pfizer; and other support from Janssen, Sanofi and Roche. M.A.C. has held consulting or advisory role with BMS, MSD, Bayer, EUNSA, Pfizer, Roche, Janssen, Pierre Fabre, Ipsen; received travel expenses from Janssen, Astellas, Roche, Ipsen, and MSD. A.R.S. held consulting or advisory roles for Roche, Bristol, Sanofi, Merck, Ipsen and Eisai. I.C.G. has served as consultant or advisory board to Pzifer, Bristol-Myers Squibb, Ipsen, Roche and EusaPharma; has served as speaker to Pfizer, Bristol-Myers Squibb and Ipsen; and received travel and/or accommodation grants from Pfizer. R.A. has participated in advisory boards for Pfizer, Roche, Sanofi and Servier. X.G.d.M. has participated in advisory boards or as invited speaker for Astellas, BMS, Ipsen, Roche, Eusa Pharma, Eisai, Pfizer and Pharmamar. J.C. reports support from Janssen, Roche, AstraZéneca, Astellas, BMS, Pfizer, Sanofi, and Novartis. J.A. received advisory boards/speaker fees from Novartis, Pfizer, Merck, Roche, BMS; and travel and accommodations from AstraZeneca, BMS, Pfizer, Astellas and Sanofi. S.H.P. participated in advisory boards and as speaker for GSK, Clovis, Astra-Zeneca/MSD and Pfizer. Ú.A. is an employee of Pfizer. All other authors report no conflicts of interests.
(Copyright © 2022 Elsevier Inc. All rights reserved.)

المؤلفون: Fernandez-Perez MP; Department of Haematology and Medical Oncology, Hospital Universitario Morales Meseguer, IMIB, Murcia, Spain., Perez-Navarro E; Department of Medical Oncology, Instituto de Investigación, Hospital Universitario 12 de Octubre, Madrid, Spain., Alonso-Gordoa T; Department of Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain., Conteduca V; Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) 'Dino Amadori' IRCCS, Meldola, Italy., Font A; Department of Medical Oncology, Catalan Institute of Oncology, Badalona Applied Research Group in Oncology (BARGO), Badalona, Spain., Vázquez-Estévez S; Department of Medical Oncology, H. Universitario Lucus Augusti, Lugo, Spain., González-Del-Alba A; Department of Medical Oncology, H.U. Son Espases, Palma de Mallorca, Spain., Wetterskog D; University College London Cancer Institute, Paul O'Gorman Building, London, UK., Antonarakis ES; Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., Mellado B; Department of Medical Oncology, IDIBAPS, Hospital Clinic, Universidad de Barcelona, Barcelona, Spain., Fernandez-Calvo O; Department of Medical Oncology, Complejo Hospitalario Universitario Ourense, Orense, Spain., Méndez-Vidal MJ; Department of Medical Oncology, Hospital Universitario Reina Sofía (HURS), Maimonides Institute for biomedical research of Córdoba (IMIBIC), Córdoba, Spain., Climent MA; Servicio de Oncología Médica, Instituto Valenciano de Oncología, Valencia, Spain., Duran I; Instituto de Biomedicina de Sevilla, IBiS/Hospital Universitario Virgen del Rocío/CSIC/Universidad de Sevilla, Seville, Spain., Gallardo E; Department of Medical Oncology, Servicio de Oncología Médica, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Sabadell, Spain., Rodriguez Sanchez A; Department of Medical Oncology, Hospital Universitario de León, León, Spain., Santander C; Department of Medical Oncology, Hospital Universitario Miguel Servet, Zaragoza, Spain., Sáez MI; Medical Oncology Intercenter Unit, Regional and Virgen de la Victoria University Hospitals, IBIMA, Málaga, Spain., Puente J; Department of Medical Oncology, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), CIBERONC, Madrid, Spain., Tudela J; Department of Pathology, Hospital Morales Meseguer, Murcia, Spain., Martínez A; Biobanco de la región de Murcia, IMIB, Nodo 3, Murcia, Spain., López-Andreo MJ; Department of Molecular Biology, SAI-IMIB-Universidad de Murcia, Murcia, Spain., Padilla J; Department of Haematology and Medical Oncology, Hospital Universitario Morales Meseguer, IMIB, Murcia, Spain., Lozano R; Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre, Madrid, Spain.; Genitourinary Translational Research Group, Instituto de Investigación Biomédica de Málaga, Málaga, Spain., Hervas D; Data Science Unit, Instituto de Investigación Sanitaria La Fe, Valencia, Spain., Luo J; Department of Urology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA., de Giorgi U; Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) 'Dino Amadori' IRCCS, Meldola, Italy., Castellano D; Department of Medical Oncology, Instituto de Investigación, Hospital Universitario 12 de Octubre, Madrid, Spain., Attard G; University College London Cancer Institute, Paul O'Gorman Building, London, UK., Grande E; MD Anderson Cancer Center Madrid, Madrid, Spain., Gonzalez-Billalabeitia E; Department of Haematology and Medical Oncology, Hospital Universitario Morales Meseguer, IMIB, Murcia, Spain.; Department of Medical Oncology, Instituto de Investigación, Hospital Universitario 12 de Octubre, Madrid, Spain.; Universidad Católica San Antonio de Murcia-UCAM, Murcia, Spain.

المصدر: The Prostate [Prostate] 2023 Mar; Vol. 83 (4), pp. 376-384. Date of Electronic Publication: 2022 Dec 23.

نوع المنشور: Clinical Trial, Phase II; Journal Article

بيانات الدورية: Publisher: Wiley-Liss Country of Publication: United States NLM ID: 8101368 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-0045 (Electronic) Linking ISSN: 02704137 NLM ISO Abbreviation: Prostate Subsets: MEDLINE

مواضيع طبية MeSH: Neoplastic Cells, Circulating*/pathology , Prostatic Neoplasms, Castration-Resistant*/drug therapy , Prostatic Neoplasms, Castration-Resistant*/genetics , Prostatic Neoplasms, Castration-Resistant*/pathology, Humans ; Male ; Biomarkers, Tumor/genetics ; Nitriles/therapeutic use ; Prognosis ; Prostate-Specific Antigen ; Receptors, Androgen/genetics

مستخلص: Background: There is a considerable need to incorporate biomarkers of resistance to new antiandrogen agents in the management of castration-resistant prostate cancer (CRPC).
Methods: We conducted a phase II trial of enzalutamide in first-line chemo-naïve asymptomatic or minimally symptomatic mCRPC and analyzed the prognostic value of TMPRSS2-ERG and other biomarkers, including circulating tumor cells (CTCs), androgen receptor splice variant (AR-V7) in CTCs and plasma Androgen Receptor copy number gain (AR-gain). These biomarkers were correlated with treatment response and survival outcomes and developed a clinical-molecular prognostic model using penalized cox-proportional hazard model. This model was validated in an independent cohort.
Results: Ninety-eight patients were included. TMPRSS2-ERG fusion gene was detected in 32 patients with no differences observed in efficacy outcomes. CTC detection was associated with worse outcome and AR-V7 in CTCs was associated with increased rate of progression as best response. Plasma AR gain was strongly associated with an adverse outcome, with worse median prostate specific antigen (PSA)-PFS (4.2 vs. 14.7 m; p < 0.0001), rad-PFS (4.5 vs. 27.6 m; p < 0.0001), and OS (12.7 vs. 38.1 m; p < 0.0001). The clinical prognostic model developed in PREVAIL was validated (C-Index 0.70) and the addition of plasma AR (C-Index 0.79; p < 0.001) increased its prognostic ability. We generated a parsimonious model including alkaline phosphatase (ALP); PSA and AR gain (C-index 0.78) that was validated in an independent cohort.
Conclusions: TMPRSS2-ERG detection did not correlate with differential activity of enzalutamide in first-line mCRPC. However, we observed that CTCs and plasma AR gain were the most relevant biomarkers.
(© 2022 The Authors. The Prostate published by Wiley Periodicals LLC.)

المؤلفون: Choueiri TK; Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA. Electronic address: toni_choueiri@dfci.harvard.edu., Eto M; Department of Urology, Kyushu University, Fukuoka, Japan., Motzer R; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA., De Giorgi U; Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola, Italy., Buchler T; Department of Oncology, First Faculty of Medicine, Charles University and Thomayer University Hospital, Prague, Czech Republic., Basappa NS; Department of Medical Oncology, Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada., Méndez-Vidal MJ; Department of Medical Oncology, Hospital Universitario Reina Sofía, Maimonides Institute for Biomedical Research of Córdoba, Córdoba, Spain., Tjulandin S; Department of Clinical Pharmacology and Chemotherapy, N N Blokhin National Medical Research Center for Oncology, Ministry of Health of the Russian Federation, Moscow, Russia., Hoon Park S; Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea., Melichar B; Department of Oncology, Palacký University Medical School and Teaching Hospital, Olomouc, Czech Republic., Hutson T; Department of Medical Oncology, Texas Oncology-Baylor Charles A Sammons Cancer Center, Dallas, TX, USA., Alemany C; Department of Hematology and Oncology, AdventHealth Cancer Institute, Orlando, FL, USA., McGregor B; Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA., Powles T; Department of Oncology, The Royal Free NHS Trust, London, England, UK; Department of Oncology, Barts Cancer Institute, Queen Mary Institute of London, London, UK., Grünwald V; Clinic for Urology and Clinic for Medical Oncology, University Hospital Essen, Essen, Germany., Alekseev B; Department of Onco-urology, P A Hertsen Moscow Cancer Research Institute, Moscow, Russia., Rha SY; Department of Medical Oncology, Yonsei Cancer Center, Yonsei University Health System, Seoul, South Korea., Kopyltsov E; State Institution of Healthcare 'Regional Clinical Oncology Dispensary', Omsk, Russia., Kapoor A; Division of Urology, Department of Surgery, Juravinski Cancer Centre, McMaster University, Hamilton, ON, Canada., Alonso Gordoa T; Medical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain., Goh JC; ICON Research, South Brisbane, QLD, Australia; Department of BioMedical Sciences, Queensland University of Technology, Brisbane, QLD, Australia., Staehler M; Department of Urology, University Hospital, Ludwig Maximilian University of Munich, Munich, Germany., Merchan JR; Department of Medicine, University of Miami Sylvester Comprehensive Cancer Center, Miami, FL, USA., Xie R; Biostatistics, Eisai, Nutley, NJ, USA., Perini RF; Clinical Research, Merck, Rahway, NJ, USA., Mody K; Clinical Research, Eisai, Nutley, NJ, USA., McKenzie J; Clinical Research, Eisai, Nutley, NJ, USA., Porta CG; Interdisciplinary Department of Medicine, University of Bari 'A Moro', Bari, Italy.

المصدر: The Lancet. Oncology [Lancet Oncol] 2023 Mar; Vol. 24 (3), pp. 228-238.

نوع المنشور: Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

بيانات الدورية: Publisher: Lancet Pub. Group Country of Publication: England NLM ID: 100957246 Publication Model: Print Cited Medium: Internet ISSN: 1474-5488 (Electronic) Linking ISSN: 14702045 NLM ISO Abbreviation: Lancet Oncol Subsets: MEDLINE

مواضيع طبية MeSH: Carcinoma, Renal Cell* , Kidney Neoplasms*, Female ; Humans ; Male ; Middle Aged ; Everolimus ; Follow-Up Studies ; Sunitinib

مستخلص: Background: In the primary analysis of the CLEAR study, lenvatinib plus pembrolizumab significantly improved progression-free survival and overall survival versus sunitinib in patients with advanced renal cell carcinoma (data cutoff Aug 28, 2020). We aimed to assess overall survival based on 7 months of additional follow-up.
Methods: This is a protocol-prespecified updated overall survival analysis (data cutoff March 31, 2021) of the open-label, phase 3, randomised CLEAR trial. Patients with clear-cell advanced renal cell carcinoma who had not received any systemic anticancer therapy for renal cell carcinoma, including anti-vascular endothelial growth factor therapy, or any systemic investigational anticancer drug, were eligible for inclusion from 200 sites (hospitals and cancer centres) across 20 countries. Patients were randomly assigned (1:1:1) to receive lenvatinib (20 mg per day orally in 21-day cycles) plus pembrolizumab (200 mg intravenously every 21 days; lenvatinib plus pembrolizumab group), lenvatinib (18 mg per day orally) plus everolimus (5 mg per day orally; lenvatinib plus everolimus group [not reported in this updated analysis]) in 21-day cycles, or sunitinib (50 mg per day orally, 4 weeks on and 2 weeks off; sunitinib group). Eligible patients were at least 18 years old with a Karnofsky performance status of 70 or higher. A computer-generated randomisation scheme was used, and stratification factors were geographical region and Memorial Sloan Kettering Cancer Center prognostic groups. The primary endpoint was progression-free survival assessed by independent imaging review according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). In this Article, extended follow-up analyses for progression-free survival and protocol-specified updated overall survival data are reported for the intention-to-treat population. No safety analyses were done at this follow-up. This study is closed to new participants and is registered with ClinicalTrials.gov, NCT02811861.
Findings: Between Oct 13, 2016, and July 24, 2019, 1417 patients were screened for inclusion in the CLEAR trial, of whom 1069 (75%; 273 [26%] female, 796 [74%] male; median age 62 years [IQR 55-69]) were randomly assigned: 355 (33%) patients (255 [72%] male and 100 [28%] female) to the lenvatinib plus pembrolizumab group, 357 (33%) patients (275 [77%] male and 82 [23%] female) to the sunitinib group, and 357 (33%) patients to the lenvatinib plus everolimus group (not reported in this updated analysis). Median follow-up for progression-free survival was 27·8 months (IQR 20·3-33·8) in the lenvatinib plus pembrolizumab group and 19·4 months (5·5-32·5) in the sunitinib group. Median progression-free survival was 23·3 months (95% CI 20·8-27·7) in the lenvatinib plus pembrolizumab group and 9·2 months (6·0-11·0) in the sunitinib group (stratified hazard ratio [HR] 0·42 [95% CI 0·34-0·52]). Median overall survival follow-up was 33·7 months (IQR 27·4-36·9) in the lenvatinib plus pembrolizumab group and 33·4 months (26·7-36·8) in the sunitinib group. Overall survival was improved with lenvatinib plus pembrolizumab (median not reached [95% CI 41·5-not estimable]) versus sunitinib (median not reached [38·4-not estimable]; HR 0·72 [95% CI 0·55-0·93]).
Interpretation: Efficacy benefits of lenvatinib plus pembrolizumab over sunitinib were durable and clinically meaningful with extended follow-up. These results support the use of lenvatinib plus pembrolizumab as a first-line therapy for patients with advanced renal cell carcinoma.
Funding: Eisai and Merck Sharp & Dohme.
Competing Interests: Declaration of interests TKC reports research funding, paid to their institution, from AstraZeneca, Aveo, Bayer, Bristol-Myers Squibb, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, Lilly, Merck, Nikang, Novartis, Pfizer, Roche, Sanofi/Aventis, and Takeda; consulting fees from AstraZeneca, Aravive, Aveo, Bayer, Bristol-Myers Squibb, Circle Pharma, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, IQVA, Infiniti, Ipsen, Kanaph, Lilly, Merck, Nikang, Novartis, Nuscan, Pfizer, Roche, Sanofi/Aventis, Surface Oncology, Takeda, Tempest, Up-To-Date, and CME events; payment or honoraria for lectures, presentations, manuscript writing, or educational events from AstraZeneca, Aravive, Aveo, Bayer, Bristol-Myers Squibb, Eisai, EMD Serono, Exelixis, GlaxoSmithKline, IQVA, Infiniti, Ipsen, Kanaph, Lilly, Merck, Nikang, Novartis, Pfizer, Roche, Sanofi/Aventis, Takeda, Tempest, Up-To-Date, and CME events; support for attending meetings or travel from Eisai, Merck, Exelixis, and Pfizer; patents planned, issued, or pending related to ctDNA and biomarkers of response to immune checkpoint inhibitors (no royalties as of April 12, 2022); participated on a data safety monitoring board or advisory board for Aravive; a leadership or fiduciary role in other board, society, committee, or advocacy group, for KidneyCan (unpaid), committees for American Society of Clinical Oncology, European Society for Medical Oncology, National Comprehensive Cancer Network®, and Genitourinary Steering Committee of the National Cancer Institute; stock or stock options from Pionyr, Tempest, Precede Bio, and Osel; and salary and research support from Dana-Farber and Harvard Cancer Center Kidney SPORE (2P50CA101942-16) and Program 5P30CA006516-56, the Kohlberg Chair at Harvard Medical School, and the Trust Family, Michael Brigham, and Loker Pinard Funds for Kidney Cancer Research at Dana-Farber Cancer Institute. ME reports research funding from Kissei, Sanofi, Astellas, ONO, Takeda, and Bayer; and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from MSD, ONO, Chugai, Novartis, Pfizer, Bristol Myers Squibb, Takeda, Janssen, and Merck. RM reports research funding, paid to their institution from Bristol Myers Squibb, Eisai, Exelixis, Genentech/Roche, Merck, Pfizer, and Aveo Pharmaceuticals and consulting fees from AstraZeneca, Aveo Pharmaceuticals, Eisai, EMD Serono, Exelixis, Genentech/Roche, Incyte, Lilly, Merck, Novartis, Pfizer, and Takeda. UDG reports payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Clovis oncology, Eisai, Janssen, MSD, Pfizer, Ipsen, and Roche and support for attending meetings or travel from Janssen, Bristol-Myers Squibb, and Ipsen. TB reports research support, paid to their institution from AstraZeneca, Roche, Bristol Myers Squibb, Exelixis, Merck, and Novartis; consulting fees from Bristol Myers Squibb, Astellas, Janssen, and Sanofi/Aventis; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Ipsen, Bristol-Myers Squibb, Servier, and Pfizer; and receipt of equipment, materials, drugs, medical writing, gifts, or other services, paid to their institution from Bristol-Myers Squibb, AstraZeneca, Roche, and Servier. NSB reports consulting fees from Bristol-Myers Squibb, Ipsen, Eisai, Janssen, Pfizer, Roche, Merck, EMD Serono, AstraZeneca, and Bayer; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events (personal) from Bristol-Myers Squibb, Ipsen, and Merck; and support for attending meetings or travel from Eisai and Janssen. MJM-V reports consulting fees from Astellas Pharma, Bristol-Myers Squibb, EUSA Pharma, Ipsen, Eisai, Janssen-Cilag, Novartis, Pfizer, Roche, and Sanofi; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Astellas Pharma, Bristol-Myers Squibb, Ipsen, EUSA Pharma, Janssen-Cilag, Pfizer, and Roche; and support for attending meetings or travel from Astellas Pharma, Bristol-Myers Squibb, Ipsen, Janssen-Cilag, Pfizer, and Roche. BM reports payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Roche, Pfizer, Bristol-Myers Squibb, Astellas, Novartis, Bayer, MSD, Merck Serono, Sanofi, Servier, AstraZeneca, Amgen, Janssen, Eisai, E Lilly, and Pierre Farbre; support for attending meetings or travel from Bristol-Myers Squibb and Merck Serono; and participation on a data safety monitoring board or advisory board for Roche, Pfizer, Bristol-Myers Squibb, Astellas, Novartis, Bayer, MSD, Merck Serono, Sanofi, Servier, AstraZeneca, Amgen, Janssen, Eisai, E Lilly, and Pierre Farbre. TH reports grants or contracts, paid to their institution, from Bristol-Myers Squibb, Eisai, Exelixis, Johnson & Johnson, and Pfizer; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Astellas Pharma, Bristol-Myers Squibb, Eisai, Exelixis, Johnson & Johnson, and Pfizer; and participation on a data safety monitoring board or advisory board for Astellas Pharma, Bayer/Onyx, Bristol Myers Squibb, Exelixis, Johnson & Johnson, Novartis, and Pfizer. BMcG reports grants or contracts, paid to their institution from Exelixis, SeaGen, Pfizer, Bristol Myers Squibb and consulting fees from Astellas, Bristol-Myers Squibb, Calithera, Eisai, Exelixis, Pfizer, and SeaGen. TP reports research funding from Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Ipsen, Johnson & Johnson, Merck, Merck Serono, MSD, Novartis, Pfizer, Roche, and Seattle Genetics; consulting fees from Astellas Pharma, AstraZeneca, Bristol-Myers Squibb, Eisai, Exelixis, Incyte, Ipsen, Johnson & Johnson, Merck, Merck Serono, MSD, Novartis, Pfizer, Roche, and Seattle Genetics; support for attending meetings or travel Astra Zeneca, Ipsen, MSD, Pfizer, and Roche. VG reports grants or contracts, paid to their institution, from AstraZeneca, Bristol-Myers Squibb, MSD, Pfizer, Ipsen; consulting fees from Bristol-Myers Squibb, Pfizer, Roche, MSD, Oncorena, PCI Biotech, Nanobiotix, Merck Serono, EUSA Pharm, Debiopharm, Eisai, and Apogepha; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Bristol Myers Squibb, Eisai, Ipsen, Janssen-Cilag, Merck Serono, MSD, Novartis, Pfizer, Roche, AstraZeneca, and Astellas; support for attending meetings or travel from Pfizer and Merck; participation on a data safety monitoring board or advisory board for Bristol-Myers Squibb, Ipsen, Eisai, PharmaMar, and PharmaMar; leadership or fiduciary role in other board, society, committee, or advocacy group from National Working Group AIO (Working Group on Internal Oncology in the German Cancer Society), German Cancer Society; and stock or stock options in AstraZeneca, Bristol-Myers Squibb, MSD, and SeaGen. BA reports grants or contracts from Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Ipsen, Janssen, Merck, MSD, Pfizer, and Roche; consulting fees from Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen, Janssen, Merck, MSD, Pfizer, and Roche; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events: Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen, Janssen, Merck, MSD, Pfizer, Roche; payment for expert testimony from Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen, Janssen, Merck, MSD, Pfizer, and Roche; and support for attending meetings or travel from Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Ipsen, Janssen, Merck, MSD, Pfizer, and Roche. SYR reports grants or contracts from Amgen, Merck, Bristol-Myers Squibb, MSD, Lilly, Daiichi Sankyo, Beigene, Eisai, and AstraZeneca; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Amgen, Lilly, Bristol-Myers Squibb, MSD, and Eisai; and participation on a data safety monitoring board or advisory board from Amgen, MSD, Bristol-Myers Squibb, Merck, Indivumed, Beigene, Eisai, and Daiichi Sankyo. AK reports payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Merck, Bristol-Myers Squibb, Ipsen, Eisai, Janssen, AbbVie; leadership or fiduciary role in for Kidney Cancer Canada; and stock in Verity Pharma. TAG reports grants or contracts from Pfizer, Roche, and Ipsen; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Ipsen, Lilly, Pfizer, Roche, Bristol-Myers Squibb, MSD, Eisai, Bayer, Janssen, Sanofi, and Astellas. JCG reports consulting fees for an advisory board meeting from Merck Sharp & Dohme (Australia), Bristol-Myers Squibb, and GlaxoSmithKline; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Janssen–Cilag, Ipsen, Merck Sharp and Dohme (Australia), and AstraZeneca (Australia); and support for attending meetings or travel AstraZeneca (Australia), GlaxoSmithKline, and MSD. MS reports grants or contracts from Pfizer, GlaxoSmithKline, AVEO, Bristol Myers Squibb, Novartis, Bayer, Roche/Genentech, Immatics, Wilex, Ipsen, Exelixis, and Eisai; consulting fees from Pfizer, GlaxoSmithKline, Novartis, Bayer, Roche, Aveo, EUSA Pharm, Astellas, Ipsen, Exelixis, Pelloton, Eisai, Bristol-Myers Squibb, MSD, Apogepha, and Oncorena; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Pfizer, GlaxoSmithKline, AVEO, Novartis, Bayer, EUSA Pharma, Astellas, Ipsen, Exelixis, Pelloton, Eisai, Bristol-Myers Squibb, MSD, and Apogepha; and support for attending meetings or travel from Pfizer, EUSAPharm, Ipsen, Eisai, Bristol-Myers Squibb, MSD, and Apogepha. JRM reports grants or contracts, paid to their institution from Corvus Pharmaceuticals, Eisai, Genentech/Roche, Lilly, Merck, Novartis, Peloton Therapeutics, Pfizer, Replimune, Seattle Genetics/Astellas, Sillajen, Tizona Therapeutics, Tocagen, and Vyriad, and consulting fees from Exelixis. RX, KM, and JMcK are employees of Eisai. RFP is an employee of and holds stock in Merck, Rahway, NJ, USA. CGP reports consulting fees from Angelini Pharma, AstraZeneca, Bristol-Myers Squibb, Eisai, Ipsen, and MSD; payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Angelini Pharma, AstraZeneca, Bristol-Myers Squibb, Eisai, General Electric, Ipsen, and MSD; and participation on a data safety monitoring board or advisory board for Bristol-Myers Squibb, Eisai, MSD, the European Society of Medical Oncology, and the Italian Association for Medical Oncology. All other authors declare no competing interests.
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