A randomized phase II study of paclitaxel and bevacizumab with and without gemcitabine as first-line treatment for metastatic breast cancer

Adam Brufsky, Karen Hoelzer, Thaddeus Beck, Robert Whorf, Mark Keaton, Padma Nadella, Elisa Krill-Jackson, Joan Kroener, Edward Middleman, Michael Frontiera, Devchand Paul, Timothy Panella, Jane Bromund, Luping Zhao, Mauro Orlando, Fritz Tai, Martin D. Marciniak, Coleman Obasaju, John Hainsworth

Research output: Contribution to journalArticlepeer-review

27 Scopus citations


Background: The addition of bevacizumab to paclitaxel improved progression-free survival (PFS) of patients with metastatic breast cancer (MBC). We examined the efficacy and safety of adding gemcitabine to paclitaxel/bevacizumab (PB). Patients and Methods: In this multicenter, open-label, randomized phase II trial, women with locally advanced or MBC were randomly assigned to receive paclitaxel 90 mg/m2 (days 1, 8, 15) and bevacizumab 10 mg/kg (days 1, 15) with or without gemcitabine 1500 mg/m 2 (days 1, 15) in 28-day cycles. Patients with prior cytotoxic therapy for MBC were ineligible. The primary endpoint was investigator-assessed overall response rate (ORR); secondary endpoints were PFS, overall survival (OS), safety, and quality of life. Results: Ninety-four patients received PB, and 93 received paclitaxel/bevacizumab/gemcitabine (PB+G). The ORRs were 48.9% (95% confidence interval [CI], 38.5%-59.5%) and 58.7% (95% CI, 47.9%-68.9%; P =.117) with PB and PB+G, respectively. The median PFS was 8.8 months (95% CI, 8.1-10.4 months) and 11.3 months (95% CI, 9.7-12.7 months; P =.247; hazard ratio, 0.82); the median OS was 25.0 months (95% CI, 18.8-not assessable [N/A] months) and 24.3 months (95% CI, 20.3-N/A months; P =.475; hazard ratio, 0.84), with PB and PB+G, respectively. There was significantly more grade 3-4 neutropenia (P =.001) and dyspnea (P =.014) with PB+G. Patients treated with PB experienced more improvement in total FACT-B (Functional Assessment of Cancer Therapy-Breast) (P =.021), FACT-B Social/Family Well-being (P =.041), and Breast Cancer-Additional Concerns (P =.008) scores than patients treated with PB+G. Conclusion: The addition of gemcitabine to PB was not associated with a statistically significant improvement in ORR. Treatment with PB+G increased the incidence of severe neutropenia and dyspnea, although the regimen generally was well tolerated.

Original languageEnglish (US)
Pages (from-to)211-220
Number of pages10
JournalClinical breast cancer
Issue number4
StatePublished - Aug 2011
Externally publishedYes


  • Bevacizumab
  • Gemcitabine
  • Metastatic breast cancer
  • Paclitaxel
  • Phase II

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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