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): Clinical Colorectal Cancer

E. Maiello, G. Di Maggio, S. Cordio, S. Cinieri, F. Giuliani, S. Pisconti, A. Rinaldi, A. Febbraro, T.P. Latiano, M. Aieta, A. Rossi, D. Rizzi, M. Di Maio, G. Colucci, R. Bordonaro

Research output: Contribution to journalArticlepeer-review

Abstract

Bevacizumab plus either FOLFOX-4 (oxaliplatin, folinic acid, and infusional 5-fluorouracil) or XELOX-2 (capecitabine plus oxaliplatin) is among standard first-line treatment options in patients with metastatic colorectal cancer. This phase II randomized non-comparative trial evaluated the first-line combination of bevacizumab with either FOLFOX-4 or biweekly XELOX-2 in patients with metastatic colorectal cancer. Comparable response and a better tolerability for bevacizumab plus XELOX-2 was reported. © 2020 Elsevier Inc. 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. © 2020 Elsevier Inc.
Original languageEnglish
Pages (from-to)109-115
Number of pages7
JournalClin. Colorectal Cancer
Volume19
Issue number2
DOIs
Publication statusPublished - 2020

Keywords

  • Capecitabine
  • Elderly
  • Fluoropyrimidine
  • Frail
  • Non-comparative
  • bevacizumab
  • capecitabine
  • fluoropyrimidine
  • fluorouracil
  • folinic acid
  • oxaliplatin
  • adult
  • aged
  • anemia
  • Article
  • bleeding
  • bone pain
  • cancer combination chemotherapy
  • cancer growth
  • cancer patient
  • clinical outcome
  • comparative study
  • controlled study
  • diarrhea
  • drug tolerability
  • dysgeusia
  • epistasis
  • febrile neutropenia
  • female
  • fever
  • follow up
  • human
  • hypertension
  • kidney disease
  • leukopenia
  • liver disease
  • maintenance chemotherapy
  • major clinical study
  • male
  • medication compliance
  • metastatic colorectal cancer
  • motor neuropathy
  • mucosa inflammation
  • multiple cycle treatment
  • nausea
  • neurotoxicity
  • neutropenia
  • overall survival
  • patient compliance
  • phase 2 clinical trial
  • progression free survival
  • proteinuria
  • randomized controlled trial
  • sensory neuropathy
  • sepsis
  • side effect
  • skin disease
  • thrombocytopenia
  • treatment response
  • urinary tract infection
  • vomiting

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