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

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

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9 Scopus citations

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)
Article numbermdp328
Pages (from-to)493-497
Number of pages5
JournalAnnals of Oncology
Volume21
Issue number3
DOIs
StatePublished - Jul 22 2009

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Keywords

  • Adenocarcinoma
  • Breast neoplasms
  • Drug therapy
  • Neoplasm metastasis

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Tan, 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. [mdp328]. https://doi.org/10.1093/annonc/mdp328