Phase II trial of nab-paclitaxel compared with docetaxel as first-line chemotherapy in patients with metastatic breast cancer: Final analysis of overall survival

William J. Gradishar*, Dimitry Krasnojon, Sergey Cheporov, Anatoly N. Makhson, Georgiy M. Manikhas, Alicia Clawson, Paul Bhar, John R. McGuire, Jose Iglesias

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

83 Scopus citations

Abstract

Background: A randomized phase II study in first-line MBC demonstrated superior efficacy and safety of weekly nab-paclitaxel compared with docetaxel. Final survival analyses and updated safety results are reported. Patients and Methods: Three hundred two patients with no previous chemotherapy for MBC were randomized to receive nab-paclitaxel 300 mg/m2 q3w, nab-paclitaxel 100 mg/m2 or 150 mg/m2 the first 3 of 4 weeks (qw 3/4), or docetaxel 100 mg/m2 q3w. The trial was powered for analyses of antitumor activity and safety. Results: Treatment with nab-paclitaxel 150 mg/m2 qw 3/4 resulted in a median overall survival (OS) of 33.8 months compared with 22.2, 27.7, and 26.6 months for nab-paclitaxel 100 mg/m2 qw 3/4, nab-paclitaxel 300 mg/m2 q3w, and docetaxel, respectively (overall P =.047). Patients receiving 150 mg/m2 nab-paclitaxel had prolonged median OS compared with those in the 100 mg/m 2 nab-paclitaxel arm (hazard ratio, 0.575; P =.008). A trend toward a longer OS was noted in the 150 mg/m2 nab-paclitaxel arm versus docetaxel arm (hazard ratio, 0.688). Grade 3 or 4 fatigue, neutropenia, and febrile neutropenia were less frequent in all nab-paclitaxel arms compared with docetaxel. Conclusions: Consistent with previously published efficacy results, these data suggest that 150 mg/m2 qw 3/4 may represent the most clinically efficacious nab-paclitaxel dosing regimen for patients with no previous chemotherapy for MBC. A phase III trial confirming these results would be necessary and prudent before widespread adoption of the 150 mg/m2 dose in clinical practice.

Original languageEnglish (US)
Pages (from-to)313-321
Number of pages9
JournalClinical breast cancer
Volume12
Issue number5
DOIs
StatePublished - Oct 2012

Keywords

  • Dose
  • Schedule
  • Solvent
  • Taxane
  • Treatment-naive

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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