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Subgroup analysis in RAISE : a randomized, double-blind phase III study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab or placebo in patients with metastatic colorectal carcinoma progression
Obermannová, R. (Masaryk Memorial Cancer Institute (Czech Republic))
Van Cutsem, E. (KU Leuven. University Hospitals Leuven (Belgium))
Yoshino, T. (National Cancer Center Hospital East (Japan))
Bodoky, G. (St László Hospital (Hungary))
Prausová, J. (Charles University. Onocology Clinic (Czech Republic))
Garcia-Carbonero, R. (Hospital Universitario Doce de Octubre)
Ciuleanu, T. (Institutul Oncologic Ion Chiricuta and UMF (Romania))
Garcia Alfonso, P. (Hospital General Universitario Gregorio Maraňón)
Portnoy, D. (The University of Tennessee. Health Science Center (USA))
Cohn, A. (Rocky Mountain Cancer Center (USA))
Yamazaki, K. (Shizouka Cancer Center (Japan))
Clingan, P. (Southern Medical Day Care Centre (Australia))
Lonardi, S. (Istituto Oncologico Veneto-IRCCS (Italy))
Kim, T. W. (University of Ulsan College of Medicine. Asan Medical Center (South Corea))
Yang, L. (Eli Lilly and Company (USA))
Nasroulah, F. (Eli Lilly and Company (República Argentina))
Tabernero Caturla, Josep (Institut d'Oncologia de la Vall Hebron (VHIO))
Universitat Autònoma de Barcelona

Fecha: 2016
Resumen: The RAISE phase III trial demonstrated ramucirumab + FOLFIRI improved survival compared with placebo + FOLFIRI for second-line metastatic colorectal carcinoma patients previously treated with first-line bevacizumab, oxaliplatin, and a fluoropyrimidine. Analyses reported here found similar efficacy and safety in patients regardless of KRAS mutational status, time to first-line progression, and age. The RAISE phase III clinical trial demonstrated that ramucirumab + FOLFIRI improved overall survival (OS) [hazard ratio (HR) = 0. 844, P = 0. 0219] and progression-free survival (PFS) (HR = 0. 793, P < 0. 0005) compared with placebo + FOLFIRI for second-line metastatic colorectal carcinoma (mCRC) patients previously treated with first-line bevacizumab, oxaliplatin, and a fluoropyrimidine. Since some patient or disease characteristics could be associated with differential efficacy or safety, prespecified subgroup analyses were undertaken. This report focuses on three of the most relevant ones: KRAS status (wild-type versus mutant), age (<65 versus ≥65 years), and time to progression (TTP) on first-line therapy (<6 versus ≥6 months). OS and PFS were evaluated by the Kaplan–Meier analysis, with HR determined by the Cox proportional hazards model. Treatment-by-subgroup interaction was tested to determine whether treatment effect was consistent between subgroup pairs. Patients with both wild-type and mutant KRAS benefited from ramucirumab + FOLFIRI treatment over placebo + FOLFIRI (interaction P = 0. 526); although numerically, wild-type KRAS patients benefited more (wild-type KRAS : median OS = 14. 4 versus 11. 9 months, HR = 0. 82, P = 0. 049; mutant KRAS : median OS = 12. 7 versus 11. 3 months, HR = 0. 89, P = 0. 263). Patients with both longer and shorter first-line TTP benefited from ramucirumab (interaction P = 0. 9434), although TTP <6 months was associated with poorer OS (TTP ≥6 months: median OS = 14. 3 versus 12. 5 months, HR = 0. 86, P = 0. 061; TTP <6 months: median OS = 10. 4 versus 8. 0 months, HR = 0. 86, P = 0. 276). The subgroups of patients ≥65 versus <65 years also derived a similar ramucirumab survival benefit (interaction P = 0. 9521) (≥65 years: median OS = 13. 8 versus 11. 7 months, HR = 0. 85, P = 0. 156; <65 years: median OS = 13. 1 versus 11. 9 months, HR = 0. 86, P = 0. 098). The safety profile of ramucirumab + FOLFIRI was similar across subgroups. These analyses revealed similar efficacy and safety among patient subgroups with differing KRAS mutation status, longer or shorter first-line TTP, and age. Ramucirumab is a beneficial addition to second-line FOLFIRI treatment for a wide range of patients with mCRC. ClinicalTrials. gov, NCT01183780.
Derechos: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. Creative Commons
Lengua: Anglès.
Documento: article ; recerca ; publishedVersion
Materia: Ramucirumab ; Metastatic colorectal carcinoma ; CRC ; VEGFR-2 ; RAISE ; Phase III clinical trial
Publicado en: Annals of Oncology, Vol. 27, Issue 11 (November 2016) , p. 2082-2090, ISSN 1569-8041

PMID: 27573561
DOI: 10.1093/annonc/mdw402

8 p, 412.5 KB

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