Phase II Study of Bevacizumab in Combination with Trastuzumab and Capecitabine as First-Line Treatment for HER-2-positive Locally Recurrent or Metastatic Breast Cancer Full Text
The Oncologist, 04/26/2012
Martin M et al. – The combination of bevacizumab, trastuzumab, and capecitabine was clinically active as first–line therapy for patients with human epidermal growth factor receptor (HER)–2–positive metastatic breast cancer (MBC), with an acceptable safety profile and no unexpected toxicities.Methods
- Patients were aged ≥18years with confirmed breast adenocarcinoma, measurable LR/MBC and documented HER-2-positive disease.
- Patients received bevacizumab (15mg/kg on day 1) plus trastuzumab (8mg/kg on day 1 of cycle 1, 6mg/kg on day 1 of each subsequent cycle) plus capecitabine (1,000mg/m2 twice daily, days 1-14) every 3weeks until disease progression, unacceptable toxicity, or consent withdrawal.
- Eighty-eight patients were enrolled; 40 (46%) are still on study treatment.
- The median follow-up was 8.8 months (range, 0.9-17.1months).
- The overall response rate, the primary endpoint, was 73% (95% confidence interval [CI], 62%-82%), comprising 7% complete and 66% partial responses.
- The median progression-free survival interval was 14.4months (95% CI, 10.4months to not reached [NR]), with 35 events.
- The median time to progression was 14.5months (95% CI, 10.5months to NR), with 33 events.
- Treatment was well tolerated; main side effects were grade 3 hand–foot syndrome (22%), grade ≥3 diarrhea (9%), and grade ≥3 hypertension (7%).
- Overall, 44% of patients experienced grade ≥3 treatment-related adverse events and 13 patients discontinued capecitabine because of toxicity, but continued with bevacizumab and trastuzumab.
- Heart failure was seen in two patients.