Annals of Oncology Advance Access originally published online on November 22, 2005
Annals of Oncology 2006 17(2):226-231; doi:10.1093/annonc/mdj054
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© 2005 European Society for Medical Oncology
A phase II trial of a combination of pemetrexed and gemcitabine in patients with metastatic breast cancer: an NCCTG study
1 Mayo Clinic and Foundation, Department of Oncology and Medicine, Rochester, MN; 2 Roger Maris Cancer Center, Fargo, ND; 3 Carle Clinic Association, Champaign, IL; 4 Duluth Clinic, Duluth, MN; 5 Scottsdale CCOP, Scottsdale, AZ; 6 Oncology Hematology Association, Peoria, IL; 7 Mayo Clinic Jacksonville, Jacksonville, FL, USA
* Correspondence to: Dr A. A. Adjei, Division of Medical Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. Tel: +1-507-538-0548; Fax: +1-507-284-1803; E-mail: adjei.alex{at}mayo.edu
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.
Key words: clinical trial, gemcitabine, metastatic breast cancer, pemetrexed
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