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Maintenance therapy with bevacizumab, capecitabine extended survival in HER-2–negative breast cancer

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Patients with HER-2–negative metastatic breast cancer who underwent maintenance therapy with bevacizumab and capecitabine demonstrated significantly longer PFS and OS than those who received bevacizumab alone, according to results of a randomized phase 3 trial presented at the European Society for Medical Oncology Annual Congress in Madrid.

The analysis — conducted at 54 hospitals across Brazil, China, Egypt, France, Hong Kong, India, Italy, Poland, Spain and Turkey — initially included 284 patients with HER-2–negative, metastatic breast cancer who underwent three to six cycles of first-line bevacizumab (Avastin, Genentech) 15 m/kg and docetaxel chemotherapy 75 mg/m2 to 100 mg/m2 every 3 weeks.

Joseph Gligorov, MD, of the Francilian Breast Intergroup and University Cancer Institute-Pierre & Marie Curie at Sorbonne University in Paris, and colleagues randomly assigned 185 patients who were progression-free after first-line treatment to maintenance therapy with bevacizumab plus capecitabine (n=91) or bevacizumab alone (n=94).

Patients received bevacizumab 15 mg/kg on day 1, and capecitabine 1,000 mg/m2 twice daily on days 1-14. Treatment was administered in 3-week cycles until progression.

PFS in the intention-to-treat population served as primary outcome.  Enrollment was terminated prematurely.

Gligorov and colleagues reported significantly longer median PFS (11.9 months vs. 4.3 months; HR=0.38; 95% CI, 0.27-0.55) and median OS (39 months vs. 23.7 months; HR=0.43; 95% CI, 0.26-0.69) among patients assigned bevacizumab plus capecitabine. Researchers also observed a higher objective response rate (86% vs. 77%) and clinical benefit rate (99% vs. 98%) in the combination arm.

Ten patients (11%) assigned bevacizumab plus capecitabine and seven patients (8%) assigned bevacizumab alone experienced serious adverse events.

Overall, grade ≥3 adverse events during the maintenance phase were more common among patients assigned the combination than bevacizumab alone (49% vs. 27%). These events included hand–foot syndrome (31% vs. 0%) and hypertension (9% vs. 3%). Grade ≥3 proteinuria was more common among those assigned bevacizumab alone (4% vs. 3%).

“Despite prematurely terminated accrual and lack of information about post-progression treatment, both PFS and OS were significantly improved with bevacizumab and capecitabine compared with bevacizumab alone as a maintenance treatment,” Gligorov and colleagues wrote. “These results might inform future maintenance trials and current first-line treatment strategies for HER-2–negative metastatic breast cancer.”

For more information:

• Gligorov J. Abstract #352O. Presented at: European Society for Medical Oncology Annual Congress; Sept. 26-30, 2014; Madrid.
• Gligorov J. Lancet Oncol. 2014;doi:10.1016/S1470-2045(14)70444-9.

Disclosure: The researchers report funding, honoraria and travel support from, consultant roles with, personal feels and non-financial support from, stock ownership in and employment relationships with AstraZeneca, Bristol-Myers Squibb, Eisai, Genomic Health, GlaxoSmithKline, Merck Sharp & Dohme, Roche, Sanofi and Teva.