Bevacizumab in Combination With Either FOLFOX-4 or XELOX-2 in First-line Treatment of Patients With Metastatic Colorectal Cancer: A Multicenter Randomized Phase II Trial of the Gruppo Oncologico dell'Italia Meridionale (GOIM 2802)
| Autor: | Saverio Cinieri, Antonio Rinaldi, Massimo Di Maio, Roberto Bordonaro, Gabriele Di Maggio, Giuseppe Colucci, D. Rizzi, Michele Aieta, Salvatore Pisconti, Antonio Rossi, Tiziana Latiano, Francesco Giuliani, Antonio Febbraro, Stefano Cordio, Evaristo Maiello |
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| Rok vydání: | 2019 |
| Předmět: |
Oncology
Adult Male medicine.medical_specialty Non-comparative Neutropenia Bevacizumab Organoplatinum Compounds Oxaloacetates Leucovorin Phases of clinical research Severity of Illness Index Capecitabine 03 medical and health sciences 0302 clinical medicine Elderly Frail FOLFOX Internal medicine Antineoplastic Combined Chemotherapy Protocols Medicine Humans Progression-free survival Aged business.industry Hazard ratio Gastroenterology Nausea Middle Aged medicine.disease digestive system diseases Progression-Free Survival Oxaliplatin Fluoropyrimidine 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology Female Fluorouracil business Colorectal Neoplasms Febrile neutropenia medicine.drug |
| Zdroj: | Clinical colorectal cancer. 19(2) |
| ISSN: | 1938-0674 |
| Popis: | Introduction Biweekly schedule of XELOX-2 (capecitabine plus oxaliplatin) showed interesting results in first-line therapy of patients with metastatic colorectal cancer (mCRC). Bevacizumab plus FOLFOX-4 (oxaliplatin, folinic acid, and infusional 5-fluorouracil) is among standard first-line treatment options in this setting. We performed a phase II randomized trial in order to evaluate the activity of bevacizumab plus either FOLFOX-4 or XELOX-2 in first-line therapy of patients with mCRC. Materials and Methods Patients with mCRC were randomized, in a 1:2 ratio, to first-line bevacizumab plus either FOLFOX-4 (Arm A), as calibration arm, or XELOX-2 (Arm B), up to 12 cycles. Patients without progression were further randomized to maintenance bevacizumab alone or with the same induction fluoropyrimidine. The primary endpoint was objective response rate (ORR); secondary endpoints included progression-free survival, overall survival, and toxicity. The study design was formally non-comparative, but exploratory comparison was performed. Results Forty-five patients were randomized in arm A and 87 in arm B with an ORR of 55.6% versus 48.3% (P = .43), respectively. After a median follow-up of 47.2 months, progression-free survival was 10.0 versus 9.9 months (hazard ratio, 0.96; 95% confidence interval, 0.65-1.41; P = .84) and overall survival was 29.8 versus 25.0 months (hazard ratio, 1.21; 95% confidence interval, 0.77-1.92; P = .41), respectively. The main grade 3 to 4 toxicities (% A/B) were: neutropenia 15/3 and nausea 9/5. Conclusion This exploratory analysis showed that biweekly XELOX-2 plus bevacizumab has a comparable ORR with FOLFOX-4 plus bevacizumab in patients with mCRC. |
| Databáze: | OpenAIRE |
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