Bi-weekly docetaxel and gemcitabine regimen in her-2-negative and anthracycline-pretreated metastatic breast cancer patients: A multicenter phase II trial

R. Murialdo, F. Bertolotti, G. Pastorino, M. Mencoboni, M. Bergaglio, U. Folco, N. Cinzia, F. Vaira, C. Simoni, L. Canobbio, M. Parodi, Fulvio Brema, Alberto Ballestrero

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: Bi-weekly gemcitabine (G) in combination with docetaxel (D) is an effective treatment for metastatic breast cancer (MBC) previously treated with adjuvant/neoadjuvant anthracyclines containing regimens with a good toxicity profile. In the present phase II study, we investigated the activity of the same regimen as first-line treatment. Methods: Women with breast cancer pretreated in adjuvant/neoadjuvant setting with anthracyclines received bi-weekly G (1,250 mg/m2 days 1, 15) and D (50 mg/m2 days 1, 15) every 28 days with restaging after 3 and 6 cycles. Results: Overall 42 patients were enrolled. Median age is 48 years (range, 31-71 years). Eight patients (19%) achieved complete responses, 18 (43%) partial responses for an overall response rate (ORR) of 62%; five patients (12%) obtained stable disease (SD), and 8 (19%) patients had progressive disease (PD). After a median 17-month follow-up, the median time to disease progression was 12 months (95% CI, 3-26 months) and the median survival time was 27 months (95% CI, 4-57 months). No grade 4 toxicity was seen except in one patient who developed a grade 4 neutropenia. Grade 3 toxicities were leukopenia (2%), neutropenia (14%), anemia (2%), nausea and vomiting (2%), diarrhea (2%), asthenia (2%), and skin toxicity (12%). Conclusion: The GD bi-weekly regimen is well tolerated and active as first line in anthracyclines-pretreated women with MBC. It appears as an interesting alternative compared to a 3-week schedule whenever hematological toxicity is the main clinical concern.

Original languageEnglish
Pages (from-to)1009-1016
Number of pages8
JournalCancer Chemotherapy and Pharmacology
Volume68
Issue number4
DOIs
Publication statusPublished - Oct 2011

Keywords

  • Bi-weekly
  • Chemotherapy
  • Docetaxel
  • Gemcitabine
  • Metastatic breast cancer
  • Phase II

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Toxicology

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