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, Radka; Cutsem, Éric Van; Yoshino, Takayuki; Bodoky, G.; Prausová, Jana; Garcia-Carbonero, Rocío; Ciuleanu, Tudor-Eliade; Alfonso, Pilar; Portnoy, David C.; Cohn, Allen Lee; Yamazaki, Kentaro; Clingan, P.; Lonardi, Sara; Kim, T. W.; Yang, Lifen; Nasroulah, Federico; Tabernero, Josep

doi:10.1093/annonc/mdw402

Cited by 65 publications

(65 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Predefined analyses examined RAISE subgroups based on stratification factors and known prognostic and disease factors [6]. Within each subgroup, a consistent OS and PFS benefit for ramucirumab þ FOLFIRI over the placebo þ FOLFIRI arm was observed.…”

Section: Introductionmentioning

confidence: 99%

“…Within each subgroup, a consistent OS and PFS benefit for ramucirumab þ FOLFIRI over the placebo þ FOLFIRI arm was observed. Additionally, there was no difference in safety profile for subgroups based on age, KRAS status (mutant versus wild type, where KRAS is the human homolog of the Kirsten rat sarcoma-2 virus oncogene), and time-to-progression on first-line therapy (TTP) [6].…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Baseline carcinoembryonic antigen as a predictive factor of ramucirumab efficacy in RAISE, a second-line metastatic colorectal carcinoma phase III trial

Yoshino

Obermannová

Bodoky

et al. 2017

European Journal of Cancer

View full text Add to dashboard Cite

show abstract

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Baseline carcinoembryonic antigen as a predictive factor of ramucirumab efficacy in RAISE, a second-line metastatic colorectal carcinoma phase III trial

Yoshino

Obermannová

Bodoky

et al. 2017

European Journal of Cancer

View full text Add to dashboard Cite

show abstract

“…The efficacy of irinotecan-containing combination therapy was comparable in patients < 70 and > 70 years [17, 32 -34], but with higher toxicity in elderly patients in 2 of these studies [32,34]. Comparative studies in patients < 65 and > 65 years revealed similar efficacy of bevacizumab monotherapy [35,36] or ramucirumab-5-FU-irinotecan combinations [37]. Increased toxicity, especially thrombembolic disease or other nonhematological side effects, was observed more often in patients > 65 years in 1 study [35].…”

Section: Discussionmentioning

confidence: 98%

Efficacy of palliative chemotherapy in elderly patients with colorectal cancer

Bohle

Pachlhofer

2019

Z Gastroenterol

View full text Add to dashboard Cite

Background The number of old patients suffering from colorectal cancer rises. In clinical trials, old patients are underrepresented, and chemotherapy is significantly less often performed in elderly patients. We analyzed the impact of elder age for palliative chemotherapy in patients suffering from metastatic colorectal cancer, according to therapeutic drugs used, intensity of treatment performed, and therapeutic results. Materials and methods We analyzed consecutive patients with metastatic colorectal cancer treated in palliative intention in our department. Assessed data included age (</> 75 years), sex, comorbidity, site of primary tumor, k-ras-status, site and amount of metastasis, number and kind of chemotherapeutic agents used, number of consecutive therapy lines performed, dose intensity, toxicity, time between start and end of palliative chemotherapy, and overall survival. Prognostic variables were tested in uni- and multivariate analysis. Results Ninety-seven patients (69 < 75, 18 > 75 years) were included. Age groups were well balanced according to site of primary tumor, k-ras-mutational status, localization, and number of metastatic sites. Cardial and renal comorbidity was more frequent in elderly patients. The median number of chemotherapeutic drugs used and lines of therapy performed did not differ between age groups, except of oxaliplatin, which was significantly less often used in old patients. Median survival did not differ between age groups (23.4 vs. 23.5 months). In multivariate analysis, only left-sided primary tumor and more than 3 lines of therapy performed were prognostic positive variables. Conclusion Old patients can profit from palliative chemotherapy to the same extent as younger ones.

show abstract

“…О р и г и н а л ь н ы е и с с л е д о в а н и я медиана продолжительности жизни в группе с раму-цирумабом составила 12,7 мес, а в группе химиотера-пии -11,3 мес (ОР 0,89; 95 % ДИ 0,73-1,09; р for interaction = 0,51) [6].…”

Section: Kew Words: Colon Cancer Anti-angiogenic Therapy Chemotheraunclassified

Efficacy of continuing anti-angiogenic agents in the second-line treatment for metastatic colon cancer depending on the KRAS mutation status: a meta-analysis

Федянин¹,

Трякин²,

Тюляндин³

2018

Onkol. koloproktol.

View full text Add to dashboard Cite

Objective: to assess the efficacy of anti-angiogenic agents incorporated into second-line chemotherapeutic regimens for metastatic colon cancer depending on the KRAS gene mutation status.Materials and methods. We selected completed prospective randomized controlled phase III clinical trials evaluating the efficacy of antiangiogenic agents (bevacizumab, ramucirumab and aflibercept) added to second-line chemotherapy for metastatic colon cancer with subanalysis of treatment efficacy depending on the KRAS gene mutation status. Meta-analysis was performed using the ReviewManager (RevMan) v. 5.3 (The Cochrane Collaboration, Denmark).Results. Three studies (ML18147, RAISE, VELOUR) involving 2165 patients (1137 with KRAS wild-type tumors and 1028 with KRAS-mutant tumors) met the inclusion criteria and were included into this meta-analysis. The majority of patients (84 %) received bevacizumab in the first-line treatment. The results of our meta-analysis suggest that adding an anti-angiogenic drug to chemotherapy in patients with KRAS wildtype colon cancer significantly improved both progression-free survival (hazard ratio (HR) 0.71; 95 % confidence interval (CI) 0.62–0.80; р<0.00001; I2 = 22 %, p = 0.21) and overall survival (HR 0.76; 95 % CI 0.66–0.88; р= 0.0001; I2 = 0, p = 0.59). In patients with KRASmutant colon cancer, incorporation of an anti-angiogenic drug into the treatment regimen was not associated with better overall survival (ОР0.9; 95 % CI 0.79–1.03; р= 0.11; I2 = 0, p = 0.98), although improved progression-free survival (HR 0.78; 95 % CI 0.68–0.89; р= 0.0002; I2 = 0, p = 0.46). Conclusion. Continuation of anti-angiogenic therapy in the second-line treatment for metastatic colon cancer is most effective in patients with KRAS wild-type tumors. In individuals with KRAS-mutant tumors, continuation of bevacizumab or switch to another anti-angiogenic agent in the second-line treatment improves progression-free survival and has a statistically insignificant effect on overall survival.

show abstract

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

Cited by 65 publications

References 17 publications

Baseline carcinoembryonic antigen as a predictive factor of ramucirumab efficacy in RAISE, a second-line metastatic colorectal carcinoma phase III trial

Baseline carcinoembryonic antigen as a predictive factor of ramucirumab efficacy in RAISE, a second-line metastatic colorectal carcinoma phase III trial

Efficacy of palliative chemotherapy in elderly patients with colorectal cancer

Efficacy of continuing anti-angiogenic agents in the second-line treatment for metastatic colon cancer depending on the KRAS mutation status: a meta-analysis

Contact Info

Product

Resources

About