N0332 phase 2 trial of weekly irinotecan hydrochloride and docetaxel in refractory metastatic breast cancer: A North Central Cancer Treatment Group (NCCTG) Trial

W. W. Tan, D. W. Hillman, M. Salim, D. W. Northfelt, D. M. Anderson, P. J. Stella, R. Niedringhaus, A. M. Bernath, S. S. Gamini, F. Palmieri, E. A. Perez

Research output: Contribution to journalArticle

Abstract

Background: Because of the single-agent activity of irinotecan hydrochloride, combination of irinotecan and docetaxel treatment against metastatic breast cancer (MBC) should be evaluated. Patients and methods: Single-stage phase 2 study of irinotecan and docetaxel to evaluate tumor response, toxicity, time to progression, and overall survival was carried out. Regimen of docetaxel (25 mg/m2) and irinotecan (70 mg/m2) was administered on days 1 and 8 of each 3-week cycle. Patients had histologically confirmed breast adenocarcinoma and metastatic cancer measurable with RECIST. Results: Of 70 patients enrolled, 64 were assessable. Prior treatment with an anthracycline and a taxane was required. Eighteen (28%) patients [95% confidence interval (CI) 15% to 31%] had tumor response, plus four patients had stable disease (less than 30% decrease in sum of longest diameter and less than 20% increase) for >6 months. The clinical benefit rate was 34% overall. Median duration of tumor response was 6.7 months (95% CI 4.2-37.7 months); median follow-up was 18.6 months (range 8.5-37.7 months). The most common severe adverse events included fatigue [n = 16 (25%)] and neutropenia [n = 13 (20%)]. Conclusions: Weekly dosing of combination of irinotecan and docetaxel is active against MBC. However, the response rate to our regimen was not significantly better than single-agent docetaxel. Other schedules of irinotecan plus docetaxel should be considered for future studies.

Original languageEnglish (US)
Pages (from-to)493-497
Number of pages5
JournalAnnals of Oncology
Volume21
Issue number3
DOIs
StatePublished - Jul 22 2009

Keywords

  • Adenocarcinoma
  • Breast neoplasms
  • Drug therapy
  • Neoplasm metastasis

ASJC Scopus subject areas

  • Hematology
  • Oncology

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    Tan, W. W., Hillman, D. W., Salim, M., Northfelt, D. W., Anderson, D. M., Stella, P. J., Niedringhaus, R., Bernath, A. M., Gamini, S. S., Palmieri, F., & Perez, E. A. (2009). N0332 phase 2 trial of weekly irinotecan hydrochloride and docetaxel in refractory metastatic breast cancer: A North Central Cancer Treatment Group (NCCTG) Trial. Annals of Oncology, 21(3), 493-497. https://doi.org/10.1093/annonc/mdp328