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(aEuro)

J 2016

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(aEuro)

OBERMANNOVÁ, Radka; E. VAN CUTSEM; T. YOSHINO; G. BODOKY; J. PRAUSOVA et al.

Základní údaje

Originální název

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(aEuro)

Autoři

Vydání

Annals of Oncology, AMSTERDAM, ELSEVIER, 2016, 0923-7534

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30204 Oncology

Stát vydavatele

Nizozemské království

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 11.855

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/16:00124642

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

ramucirumab; metastatic colorectal carcinoma; CRC; VEGFR-2; RAISE; phase III clinical trial

Štítky

rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 20. 5. 2022 10:14, Mgr. Tereza Miškechová

Anotace

V originále

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.

Citovat

OBERMANNOVÁ, Radka; E. VAN CUTSEM; T. YOSHINO; G. BODOKY; J. PRAUSOVA; R. GARCIA-CARBONERO; T. CIULEANU; Alfonso P. GARCIA; D. PORTNOY; A. COHN; K. YAMAZAKI; P. CLINGAN; S. LONARDI; T. W. KIM; L. YANG; F. NASROULAH a J. TABERNERO. 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(aEuro). Annals of Oncology. AMSTERDAM: ELSEVIER, 2016, roč. 27, č. 11, s. 2082-2089. ISSN 0923-7534. Dostupné z: https://doi.org/10.1093/annonc/mdw402.

@article{1854523,
   author = {Obermannová, Radka and Van Cutsem, E. and Yoshino, T. and Bodoky, G. and Prausova, J. and GarciaandCarbonero, R. and Ciuleanu, T. and Garcia, Alfonso P. and Portnoy, D. and Cohn, A. and Yamazaki, K. and Clingan, P. and Lonardi, S. and Kim, T. W. and Yang, L. and Nasroulah, F. and Tabernero, J.},
   article_location = {AMSTERDAM},
   article_number = {11},
   doi = {https://doi.org/10.1093/annonc/mdw402},
   keywords = {ramucirumab; metastatic colorectal carcinoma; CRC; VEGFR-2; RAISE; phase III clinical trial},
   language = {eng},
   issn = {0923-7534},
   journal = {Annals of Oncology},
   title = {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(aEuro)},
   url = {https://www.sciencedirect.com/science/article/pii/S0923753419358429?via%3Dihub},
   volume = {27},
   year = {2016}
}

TY  - JOUR
ID  - 1854523
AU  - Obermannová, Radka - Van Cutsem, E. - Yoshino, T. - Bodoky, G. - Prausova, J. - Garcia-Carbonero, R. - Ciuleanu, T. - Garcia, Alfonso P. - Portnoy, D. - Cohn, A. - Yamazaki, K. - Clingan, P. - Lonardi, S. - Kim, T. W. - Yang, L. - Nasroulah, F. - Tabernero, J.
PY  - 2016
TI  - 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(aEuro)
JF  - Annals of Oncology
VL  - 27
IS  - 11
SP  - 2082-2089
EP  - 2082-2089
PB  - ELSEVIER
SN  - 09237534
KW  - ramucirumab
KW  - metastatic colorectal carcinoma
KW  - CRC
KW  - VEGFR-2
KW  - RAISE
KW  - phase III clinical trial
UR  - https://www.sciencedirect.com/science/article/pii/S0923753419358429?via%3Dihub
N2  - 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.
ER  -

OBERMANNOVÁ, Radka; E. VAN CUTSEM; T. YOSHINO; G. BODOKY; J. PRAUSOVA; R. GARCIA-CARBONERO; T. CIULEANU; Alfonso P. GARCIA; D. PORTNOY; A. COHN; K. YAMAZAKI; P. CLINGAN; S. LONARDI; T. W. KIM; L. YANG; F. NASROULAH a J. TABERNERO. 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(aEuro). \textit{Annals of Oncology}. AMSTERDAM: ELSEVIER, 2016, roč.~27, č.~11, s.~2082-2089. ISSN~0923-7534. Dostupné z: https://doi.org/10.1093/annonc/mdw402.

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