Final results of a phase II study of nab-paclitaxel, bevacizumab, and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer

Christopher Lobo, Gilberto Lopes, Odalys Baez, Aurelio Castrellon, Annapoorna Ferrell, Connie Higgins, Erin Hurley, Judith Hurley, Isildinha Reis, Stephen P Richman, Pearl H Seo, Orlando Silva, Joyce M Slingerland, Keleni Tukia, Catherine Welsh, Stefan Glück

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Abstract

In order to examine the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-P) in combination with bevacizumab (B) and gemcitabine (G) for the first-line treatment of patients with HER2-negative metastatic breast cancer (MBC). In this single-center, open-label phase II trial, patients with HER2-negative MBC received gemcitabine 1500 mg/m2, nab-paclitaxel 150 mg/m2, and bevacizumab 10 mg/kg (each administered intravenously) on days 1 and 15 of a 28-day cycle. The primary end point was progression free survival (PFS); secondary end points were overall response rate (ORR), complete (CR) and partial (PR) response rates, clinical benefit (ORR + stable disease), overall survival (OS), and safety. Thirty patients were enrolled. One patient was ineligible and was not included in analysis. Median PFS was 10.4 months (95% CI: 5.6-15.2 months). ORR was 75.9%, comprising eight (27.6%) CRs and 14 (48.3%) PRs; five patients had stable disease (SD) and two patients (6.9%) had progressive disease (PD) as their best response. The clinical benefit rate was 93.1% (27/29) in the overall group and 84.6% in the triple-negative cohort (11/13). The 18-month survival rate was 77.2% (95% CI: 51.1-90.5%). Eight (27.6%) patients experienced grade 3 or 4 toxicity: grade 4 neutropenic fever (n = 1) and grade 3 infection (n = 6), leukopenia, thrombocytopenia, peripheral neuropathy, seizure, shortness of breath, hematuria, and cardiac tamponade (one each). First-line therapy with nab-P, B, and G demonstrated a median PFS of 10.4 months and a 75.9% ORR with acceptable toxicity; this novel combination warrants investigation in a randomized study.

Original languageEnglish
Pages (from-to)427-435
Number of pages9
JournalBreast Cancer Research and Treatment
Volume123
Issue number2
DOIs
StatePublished - Sep 1 2010

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gemcitabine
Breast Neoplasms
Disease-Free Survival
Nanoparticles
Therapeutics
Safety
Cardiac Tamponade
Leukopenia
Peripheral Nervous System Diseases
Hematuria
130-nm albumin-bound paclitaxel
Bevacizumab
Thrombocytopenia
Dyspnea
Seizures
Fever
Survival Rate

Keywords

  • Bevacizumab
  • First-line therapy
  • Gemcitabine
  • HER2-negative metastatic breast cancer
  • Nab-paclitaxel

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Final results of a phase II study of nab-paclitaxel, bevacizumab, and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer. / Lobo, Christopher; Lopes, Gilberto; Baez, Odalys; Castrellon, Aurelio; Ferrell, Annapoorna; Higgins, Connie; Hurley, Erin; Hurley, Judith; Reis, Isildinha; Richman, Stephen P; Seo, Pearl H; Silva, Orlando; Slingerland, Joyce M; Tukia, Keleni; Welsh, Catherine; Glück, Stefan.

In: Breast Cancer Research and Treatment, Vol. 123, No. 2, 01.09.2010, p. 427-435.

Research output: Contribution to journalArticle

Lobo, Christopher ; Lopes, Gilberto ; Baez, Odalys ; Castrellon, Aurelio ; Ferrell, Annapoorna ; Higgins, Connie ; Hurley, Erin ; Hurley, Judith ; Reis, Isildinha ; Richman, Stephen P ; Seo, Pearl H ; Silva, Orlando ; Slingerland, Joyce M ; Tukia, Keleni ; Welsh, Catherine ; Glück, Stefan. / Final results of a phase II study of nab-paclitaxel, bevacizumab, and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer. In: Breast Cancer Research and Treatment. 2010 ; Vol. 123, No. 2. pp. 427-435.
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