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Bevacizumab Effective in Elderly Patients with Advanced Colorectal Cancer

Summary and Comment |
November 15, 2013

Bevacizumab Effective in Elderly Patients with Advanced Colorectal Cancer

  1. David H. Ilson, MD, PhD

Adding bevacizumab to capecitabine significantly improved progression-free survival and response.

  1. David H. Ilson, MD, PhD

Elderly patients with colorectal cancer (CRC) may have diminished tolerance for combination chemotherapy. But, prospective data are lacking regarding the safety and efficacy of chemotherapy or targeted agents for these patients.

Now, investigators have conducted an industry-sponsored, international, randomized, open-label, phase III trial (AVEX) of capecitabine chemotherapy with or without the vascular endothelial growth factor (VEGF)–targeted agent bevacizumab in 280 elderly CRC patients (median age, 76; range, 70–87). Eligible patients had previously untreated, unresectable, metastatic disease deemed unsuitable for multiagent chemotherapy. Patients received capecitabine (1000 mg/m2 twice daily for 14 days) alone or in combination with bevacizumab (7.5 mg/kg on day 1) every 3 weeks. Most patients had liver metastases (68% and 63% in the monotherapy and combination therapy groups, respectively) and colonic primary tumors (54% and 58%), and few had received prior adjuvant therapy (19% and 32%).

Progression-free survival (PFS; the primary endpoint) was superior with combination therapy versus monotherapy (median 9.1 vs. 5.1 months; hazard ratio, 0.53; P<0.0001). This PFS benefit was seen in all age ranges, including patients >80. The response rate was also superior with combination therapy (19% vs. 10%; P=0.04), and overall survival trended longer with combination therapy (16.8 vs. 20.7 months; HR 0.79; P=0.18). Treatment-related adverse events were more common with combination therapy (14% vs. 8%). Grade 3 or higher events were similar in both groups, except that grade 3 or higher venous thromboembolism was more common with combination therapy.

Comment

The AVEX trial is one of the first to prospectively address chemotherapy treatment for elderly patients with colorectal cancer. The study supports the safety and efficacy of capecitabine plus bevacizumab versus capecitabine alone, demonstrating that the combination improves progression-free survival and response and trends toward improvement in overall survival. The data also reinforce a benefit for bevacizumab even with 5-fluorouracil monotherapy, not just with combination chemotherapy, and indicate that bevacizumab plus fluorinated pyrimidine monotherapy is a viable therapy option in the elderly.

  • Disclosures for David H. Ilson, MD, PhD at time of publication Consultant / Advisory board Clovis; Eli-Lilly; ImClone Speaker's bureau Genentech Grant / research support Bayer Editorial boards HemOnc Today; Journal of Clinical Oncology

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