دورية أكاديمية
IELSG30 phase 2 trial: intravenous and intrathecal CNS prophylaxis in primary testicular diffuse large B-cell lymphoma.
| العنوان: | IELSG30 phase 2 trial: intravenous and intrathecal CNS prophylaxis in primary testicular diffuse large B-cell lymphoma. |
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| المؤلفون: | Conconi A; Division of Hematology, Ospedale degli Infermi, Biella, Italy., Chiappella A; Haematology Unit, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy., Ferreri AJM; Lymphoma Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy., Stathis A; Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.; Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland., Botto B; SC Ematologia, AOU Città della Salute e della Scienza di Torino, Turin, Italy., Sassone M; Lymphoma Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy., Gaidano G; SCDU Ematologia, Department of Translational Medicine, University of Eastern Piedmont and AOU Maggiore della Carità, Novara, Italy., Balzarotti M; UO Ematologia, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy., Merli F; Hematology Unit, Azienda USL-IRCCS of Reggio Emilia, Reggio Emilia, Italy., Tucci A; Division of Hematology, ASST Spedali Civili di Brescia, Brescia, Italy., Vanazzi A; Division of Clinical Haemato-Oncology, European Institute of Oncology IRCCS, Milan, Italy., Tani M; UO Ematologia, Dipartimento Oncologia ed Ematologia, Ospedale Santa Maria delle Croci, Ravenna, Italy., Bruna R; Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland., Orsucci L; Lymphoma Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy., Cabras MG; Ospedale Oncologico, Ematologia e CTMO, Cagliari, Italy., Celli M; Ospedale degli Infermi, Hematology Unit, Rimini, Italy., Annibali O; Area Ematologia Medicina Trasfusionale e Terapia cellulare Policlinico Universitario Campus Bio-Medico, Rome, Italy., Liberati AM; SC Oncoematologia, Azienda Ospedaliera Santa Maria, Università degli studi di Perugia, Terni, Italy., Zanni M; Antonio e Biagio e Cesare Arrigo Hospital, Hematology Unit, Alessandria, Italy., Ghiggi C; IRCCS Ospedale Policlinico San Martino UO Ematologia e Terapie Cellulari, Genoa, Italy., Pisani F; Hematology and Stem Cell Transplantation Unit, IRCCS Istituto Nazionale dei Tumori Regina Elena, Rome, Italy., Pinotti G; Ospedale di Circolo, Oncologia Medica, Varese, Italy., Dore F; AOU di Sassari, Sassari, Italy., Esposito F; Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland., Pirosa MC; Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.; Institute of Oncology Research, Bellinzona, Switzerland., Cesaretti M; Fondazione Italiana Linfomi ONLUS, Modena, Italy., Bonomini L; Institute of Oncology Research, Bellinzona, Switzerland., Vitolo U; Medical Oncology, Candiolo Cancer Institute, Fondazione del Piemonte per l'Oncologia-IRCCS, Candiolo, Turin, Italy., Zucca E; Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.; Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland.; Institute of Oncology Research, Bellinzona, Switzerland. |
| المصدر: | Blood advances [Blood Adv] 2024 Mar 26; Vol. 8 (6), pp. 1541-1549. |
| نوع المنشور: | Clinical Trial, Phase II; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Society of Hematology Country of Publication: United States NLM ID: 101698425 Publication Model: Print Cited Medium: Internet ISSN: 2473-9537 (Electronic) Linking ISSN: 24739529 NLM ISO Abbreviation: Blood Adv Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Washington, DC : American Society of Hematology, [2016]- |
| مواضيع طبية MeSH: | Neoplasm Recurrence, Local*/prevention & control , Neoplasm Recurrence, Local*/drug therapy , Lymphoma, Large B-Cell, Diffuse*/drug therapy , Lymphoma, Large B-Cell, Diffuse*/pathology, Male ; Adult ; Humans ; Aged ; Antibodies, Monoclonal, Murine-Derived ; Rituximab/therapeutic use ; Methotrexate/therapeutic use ; Cytarabine/adverse effects ; Recurrence |
| مستخلص: | Abstract: Primary testicular diffuse large B-cell lymphoma (PTL) is characterized by high risk of contralateral testis and central nervous system (CNS) relapse. Chemoimmunotherapy with intrathecal (IT) CNS prophylaxis and contralateral testis irradiation eliminates contralateral recurrences and reduces CNS relapses. The IELSG30 phase 2 study investigated feasibility and activity of an intensified IT and IV CNS prophylaxis. Patients with stage I/II PTL who had not received treatment received 2 cycles of IV high-dose methotrexate (MTX) (1.5 g/m2) after 6 cycles of the R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, every 21 days). IT liposomal cytarabine was administered on day 0 of cycles 2 to 5 of 21-day R-CHOP regimen. Contralateral testis radiotherapy (25-30 Gy) was recommended. Fifty-four patients (median age: 66 years) with stage I (n = 32) or II (n = 22) disease were treated with R-CHOP, 53 received at least 3 doses of IT cytarabine, 48 received at least 1 dose of IV MTX, and 50 received prophylactic radiotherapy. No unexpected toxicity occurred. At a median follow-up of 6 years, there was no CNS relapse; 7 patients progressed, and 8 died, with 5-year progression-free and overall survival rates of 91% (95% confidence interval [CI], 79-96) and 92% (95% CI, 81-97), respectively. Extranodal recurrence was documented in 6 patients (in 2 without nodal involvement). In 4 cases, the relapse occurred >6 years after treatment. Causes of death were lymphoma (n = 4), second primary malignancy (n = 1), cerebral vasculopathy (n = 1), unknown (n = 2). Intensive prophylaxis was feasible and effective in preventing CNS relapses. Late relapses, mainly at extranodal sites, represented the most relevant pattern of failure. This trial was registered at www.clinicaltrials.gov as #NCT00945724. (© 2024 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.) |
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| سلسلة جزيئية: | ClinicalTrials.gov NCT00945724 |
| المشرفين على المادة: | 0 (Antibodies, Monoclonal, Murine-Derived) 4F4X42SYQ6 (Rituximab) YL5FZ2Y5U1 (Methotrexate) 04079A1RDZ (Cytarabine) |
| تواريخ الأحداث: | Date Created: 20240105 Date Completed: 20240319 Latest Revision: 20240329 |
| رمز التحديث: | 20240329 |
| مُعرف محوري في PubMed: | PMC10966164 |
| DOI: | 10.1182/bloodadvances.2023011251 |
| PMID: | 38181782 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 2473-9537 |
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| DOI: | 10.1182/bloodadvances.2023011251 |