دورية أكاديمية
Real-world dosing patterns of regorafenib for patients with metastatic colorectal cancer in Spain: the RE-SEARCH study.
| العنوان: | Real-world dosing patterns of regorafenib for patients with metastatic colorectal cancer in Spain: the RE-SEARCH study. |
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| المؤلفون: | López Muñoz AM; Medical Oncology, Hospital Universitario de Burgos, Avenida Islas Baleares S/N, 09006, Burgos, Spain. alopezmu@saludcastillayleon.es., González Flores E; Medical Oncology, Hospital Universitario Virgen de Las Nieves, Granada, Spain., Carral Maseda A; Medical Oncology, Hospital Universitario Lucus Augusti, Lugo, Spain., Pimentel Cáceres P; Medical Oncology, Hospital General Universitario Santa Lucia, Cartagena, Spain., Afonso Gómez R; Medical Oncology, Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain., López López C; Medical Oncology, Hospital Universitario Marqués de Valdecilla IDIVAL, UNICAN, Santander, Spain., Jimeno Maté R; Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander, Spain., Reina Zoilo JJ; Medical Oncology, Hospital Universitario Virgen Macarena, Sevilla, Spain., Castañón López C; Medical Oncology, Complejo Asistencial Universitario de León, León, Spain., Salgado Fernández M; Medical Oncology, Complejo Hospitalario Universitario Ourense, Ourense, Spain., Aparicio Urtasun J; Medical Oncology, Hospital Universitario y Politécnico la Fe, Valencia, Spain., Asensio Martínez E; Medical Oncology, Hospital General Universitario de Elche, Elche, Spain., Martín Gómez T; Medical Oncology, Hospital Universitario Salamanca, Salamanca, 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] 2024 Aug 11. Date of Electronic Publication: 2024 Aug 11. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| 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 |
| أسماء مطبوعة: | Publication: <2010- >: Milan : Springer Italia Original Publication: Barcelona, Spain : Doyma, c2005- |
| مستخلص: | Purpose: To describe the dosing patterns of regorafenib in a real-world population of patients with metastatic colorectal cancer (mCRC) in a routine clinical practice setting in Spain, focusing on the starting dose of regorafenib. Methods: An observational, retrospective, multicenter study that included patients ≥ 18 years old who had histologically documented mCRC and who had initiated treatment with regorafenib since January 2017. Post hoc categorization of dosing patterns revealed the following: initial dose < 160 mg and dose escalation, initial dose < 160 mg and maintenance, initial dose equal to 160 mg and maintenance, and initial dose equal to 160 mg and dose reduction. Results: Most patients (152/241, 63.8%) initiated treatment with regorafenib at doses < 160 mg. There was large variation in the starting dose of regorafenib over time: in 2017, most patients (59%) initiated regorafenib at a dose of 160 mg, this proportion decreased to 6% in 2021. There were no significant differences in the median progression-free survival according to the regorafenib dose patterns during the first two cycles. The proportion of patients who reported at least one adverse event (AE), had a grade 3-4 AE or had an AE leading to dose reduction was greater in the group of patients who received an initial dose equal to 160 and reduction. Conclusions: Our results indicate that physicians in Spain have gradually adopted a dose-escalation approach during cycle 1, which is a common practice for starting treatment with a reduced dose (< 160 mg/day), a strategy that seems to improve tolerability while maintaining efficacy. Trial Registration: Not applicable. (© 2024. The Author(s), under exclusive licence to Federación de Sociedades Españolas de Oncología (FESEO).) |
| References: | European Medicines Agency. Stivarga. Summary of product characteristics. 2022. https://www.ema.europa.eu/en/documents/product-information/stivarga-epar-product-information_en.pdf . Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouché O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D. Regorafenib monotherapy for previously treated metastatic colorectal cancer (correct): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013;381:303–12. https://doi.org/10.1016/s0140-6736(12)61900-x . (PMID: 10.1016/s0140-6736(12)61900-x23177514) Li J, Qin S, Xu R, Yau TC, Ma B, Pan H, Xu J, Bai Y, Chi Y, Wang L, Yeh KH, Bi F, Cheng Y, Le AT, Lin JK, Liu T, Ma D, Kappeler C, Kalmus J, Kim TW. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015;16:619–29. https://doi.org/10.1016/s1470-2045(15)70156-7 . (PMID: 10.1016/s1470-2045(15)70156-725981818) Grothey A, Cutsem EV, Sobrero AF, Siena S, Falcone A, Ychou M, Humblet Y, Bouche O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz H-J, Goldberg RM, Sargent DJ, Cihon F, Wagner A, Laurent D, Cupit L. Time course of regorafenib-associated adverse events in the phase III CORRECT study. J Clin Oncol. 2013;31:467. https://doi.org/10.1200/jco.2013.31.4_suppl.467 . (PMID: 10.1200/jco.2013.31.4_suppl.467) Ducreux M, Petersen LN, Öhler L, Bergamo F, Metges JP, De Groot JW, Wang JY, García Paredes B, Dochy E, Fiala-Buskies S, Cervantes A, O’Connor JM, Falcone A. Safety and effectiveness of regorafenib in patients with metastatic colorectal cancer in routine clinical practice in the prospective, observational correlate study. Eur J Cancer. 2019;123:146–54. https://doi.org/10.1016/j.ejca.2019.09.015 . (PMID: 10.1016/j.ejca.2019.09.01531698328) Gotfrit J, Vickers M, Sud S, Asmis T, Cripps C, Goel R, Hsu T, Jonker D, Goodwin R. Real-life treatment of metastatic colorectal cancer with regorafenib: a single-centre review. Curr Oncol. 2017;24:234–9. https://doi.org/10.3747/co.24.3562 . (PMID: 10.3747/co.24.3562288748915576459) Lam KO, Lee KC, Chiu J, Lee VH, Leung R, Choy TS, Yau T. The real-world use of regorafenib for metastatic colorectal cancer: multicentre analysis of treatment pattern and outcomes in Hong Kong. Postgrad Med J. 2017;93:395–400. https://doi.org/10.1136/postgradmedj-2016-134547 . (PMID: 10.1136/postgradmedj-2016-13454727836933) Bekaii-Saab TS, Ou FS, Ahn DH, Boland PM, Ciombor KK, Heying EN, Dockter TJ, Jacobs NL, Pasche BC, Cleary JM, Meyers JP, Desnoyers RJ, McCune JS, Pedersen K, Barzi A, Chiorean EG, Sloan J, Lacouture ME, Lenz HJ, Grothey A. Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study. Lancet Oncol. 2019;20:1070–82. https://doi.org/10.1016/s1470-2045(19)30272-4 . (PMID: 10.1016/s1470-2045(19)30272-4312626579187307) Argilés G, Mulet N, Valladares-Ayerbes M, Viéitez JM, Grávalos C, García-Alfonso P, Santos C, Tobeña M, García-Paredes B, Benavides M, Cano MT, Loupakis F, Rodríguez-Garrote M, Rivera F, Goldberg RM, Cremolini C, Bennouna J, Ciardiello F, Tabernero JM, Aranda E, Argilés G, Tabernero J. A randomised phase 2 study comparing different dose approaches of induction treatment of regorafenib in previously treated metastatic colorectal cancer patients (REARRANGE trial). Eur J Cancer. 2022;177:154–63. https://doi.org/10.1016/j.ejca.2022.09.037 . (PMID: 10.1016/j.ejca.2022.09.03736335783) Kudo T, Kato T, Kagawa Y, Sakai D, Satoh T, Doki Y, Mori M. Phase II dose titration study of regorafenib for patients with unresectable metastatic colorectal cancer that progressed after standard chemotherapy. J Clin Oncol. 2018;36:821. https://doi.org/10.1200/JCO.2018.36.4_suppl.821 . (PMID: 10.1200/JCO.2018.36.4_suppl.821) Suzuki T, Sukawa Y, Imamura CK, Masuishi T, Satake H, Kumekawa Y, Funakoshi S, Kotaka M, Horie Y, Kawai S, Okuda H, Terazawa T, Kondoh C, Kato K, Yoshimura K, Ishikawa H, Hamamoto Y, Boku N, Takaishi H, Kanai T. A phase ii study of regorafenib with a lower starting dose in patients with metastatic colorectal cancer: exposure-toxicity analysis of unbound regorafenib and its active metabolites (RESET Trial). Clin Colorectal Cancer. 2020;19:13-21.e3. https://doi.org/10.1016/j.clcc.2019.10.004 . (PMID: 10.1016/j.clcc.2019.10.00431732439) National Comprehensive Cancer Network. NCCN guidelines. Colon cancer. 2023. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf . Accessed April 25 2023. Paredes BG, Maseda AC, Luengo JM, García TG, Hernández IB, Urtasun JA, Plazas JG, Flores EG, Báez L, Cervantes A (2019) [Safety and effectiveness of regorafenib in patients with metastatic colorectal cancer (mCRC) in daily clinical practice: data from the Spanish cohort of the prospective international observational CORRELATE study]. Poster presented at the congress of the Sociedad Española de Oncología Médica (SEOM), 23–25 October 2019; Pamplona, Spain. Van Cutsem E, Martinelli E, Cascinu S, Sobrero A, Banzi M, Seitz JF, Barone C, Ychou M, Peeters M, Brenner B, Hofheinz RD, Maiello E, André T, Spallanzani A, Garcia-Carbonero R, Arriaga YE, Verma U, Grothey A, Kappeler C, Miriyala A, Kalmus J, Falcone A, Zaniboni A. Regorafenib for patients with metastatic colorectal cancer who progressed after standard therapy: results of the large, single-arm, open-label phase IIIb consign study. Oncologist. 2019;24:185–92. https://doi.org/10.1634/theoncologist.2018-0072 . (PMID: 10.1634/theoncologist.2018-007230190299) Adenis A, De La Fouchardiere C, Paule B, Burtin P, Tougeron D, Wallet J, Dourthe LM, Etienne PL, Mineur L, Clisant S, Phelip JM, Kramar A, Andre T. Survival, safety, and prognostic factors for outcome with regorafenib in patients with metastatic colorectal cancer refractory to standard therapies: results from a multicenter study (REBECCA) nested within a compassionate use program. BMC Cancer. 2016;16:412. https://doi.org/10.1186/s12885-016-2440-9 . (PMID: 10.1186/s12885-016-2440-9273895644936193) Yamaguchi K, Komatsu Y, Satoh T, Uetake H, Yoshino T, Nishida T, Yamazaki N, Takikawa H, Morimoto T, Chosa M, Sunaya T, Hamada Y, Muro K, Sugihara K. Large-scale, prospective observational study of regorafenib in Japanese patients with metastatic colorectal cancer in a real-world clinical setting. Oncologist. 2019;24:e450–7. https://doi.org/10.1634/theoncologist.2018-0377 . (PMID: 10.1634/theoncologist.2018-0377306068856656456) Schulz H, Janssen J, Strauss UP, Langen M, Dworschak KU, Fiala-Buskies S, Bokemeyer C. Clinical efficacy and safety of regorafenib (REG) in the treatment of metastatic colorectal cancer (mCRC) in daily practice in Germany: final results of the prospective multicentre non-interventional RECORA study. J Clin Oncol. 2018;36:748. https://doi.org/10.1200/JCO.2018.36.4_suppl.748 . (PMID: 10.1200/JCO.2018.36.4_suppl.748) |
| فهرسة مساهمة: | Keywords: Dosing patterns; Metastatic colorectal cancer; Regorafenib |
| تواريخ الأحداث: | Date Created: 20240811 Latest Revision: 20240811 |
| رمز التحديث: | 20240812 |
| DOI: | 10.1007/s12094-024-03630-1 |
| PMID: | 39127984 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 1699-3055 |
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| DOI: | 10.1007/s12094-024-03630-1 |