A phase II trial of a combination of pemetrexed and gemcitabine in patients with metastatic breast cancer: An NCCTG study

C. X. Ma, P. Steen, K. M. Rowland, R. D. Niedringhaus, T. R. Fitch, J. W. Kugler, D. W. Hillman, E. A. Perez, J. N. Ingle, Alex A. Adjei

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17 Scopus citations

Abstract

Purpose: This phase II study was undertaken to define the efficacy and toxicity of pemetrexed in combination with gemcitabine in patients with metastatic breast cancer. Patients and methods: Patients with measurable metastatic breast cancer who had previously received an anthracycline and a taxane in either the adjuvant or metastatic setting were treated with gemcitabine 1250 mg/ m2 (intravenous; days 1 and 8) and pemetrexed 500 mg/m2 (intravenous; day 8) every 21 days. Results: Fifty-nine patients received a median of five cycles (range one to 22) of treatment and were followed until death or for a median of 28 months (range 19.4-36.6) among living patients. Fourteen partial responses for an overall response rate of 24% [95% confidence interval (CI) 16% to 39%] were documented. Nine (15%; CI 5% to 32%) patients had stable disease for >6 months. The median survival time was 10.3 months (95% CI 8.3-18.9) and the 1 year survival rate was 49% (95% CI 38% to 64%). The median time to progression was estimated to be 3.7 months (95% CI 2.3-5.3). The most common grade 3 or 4 toxicities were neutropenia and thrombocytopenia in 83% and 27% of patients, respectively. Fourteen percent of patients experienced febrile neutropenia. Other common grade 3 or 4 non-hematological toxicities included fatigue (17%), dyspnea (15%), rash (7%) and anorexia (5%). Conclusions: The combination of pemetrexed and gemcitabine is clinically active, with an overall response rate of 24% in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane. Myelosuppression (66% grade 4 neutropenia and 14% febrile neutropenia) was the major treatment-related toxicity observed for this combination.

Original languageEnglish (US)
Pages (from-to)226-231
Number of pages6
JournalAnnals of Oncology
Volume17
Issue number2
DOIs
StatePublished - Feb 2006

Keywords

  • Clinical Trial
  • Gemcitabine
  • Metastatic Breast Cancer
  • Pemetrexed

ASJC Scopus subject areas

  • Hematology
  • Oncology

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    Ma, C. X., Steen, P., Rowland, K. M., Niedringhaus, R. D., Fitch, T. R., Kugler, J. W., Hillman, D. W., Perez, E. A., Ingle, J. N., & Adjei, A. A. (2006). A phase II trial of a combination of pemetrexed and gemcitabine in patients with metastatic breast cancer: An NCCTG study. Annals of Oncology, 17(2), 226-231. https://doi.org/10.1093/annonc/mdj054