Annals of Oncology 14:1246-1252, 2003
© 2003 European Society for Medical Oncology
Original Paper |
Phase II study of pemetrexed in breast cancer patients pretreated with anthracyclines
1 Hospital Universitario San Carlos, Madrid, Spain; 2 Institut Gustave Roussy, Villejuif, France; 3 Centre Antoine Lacassagne, Nice, France; 4 St Vicentius Krankenhaeuser, Karlsruhe, Germany; 5 Klinik fur Tumorbiologie, Freiburg, Germany; 6 University of Hull School of Medicine, Hull, UK; 7 Fakultni Nemocnice S Poliklinikou, Ostrava-Prouba, Czech Republic; 8 University of Newcastle Upon Tyne, Newcastle Upon Tyne, UK; 9 Hospital Clínico Universitario, Valencia, Spain; 10 Eli Lilly & Co., Madrid, Spain; 11 Eli Lilly & Co., Suresnes, France; 12 University Hospital, Vienna, Austria
Received 20 November 2002; revised 31 March 2003; accepted 15 April 2003
Background:
To assess antitumor activity and toxicity of pemetrexed in metastatic breast cancer (MBC) patients previously treated with anthracyclines.
Patients and methods:
Seventy-seven MBC patients from 12 European institutions were entered into the study. Seventy-two patients were considered evaluable for response and toxicity. Forty-two patients were classified as anthracycline-failure (relapse >30 days after completion of a prior anthracycline regimen) and 30 as anthracycline-refractory (progression within 30 days after anthracycline therapy). Pemetrexed 600 mg/m2 was administered intravenously every 3 weeks until progressive disease or unacceptable toxicity.
Results:
There were three complete and 12 partial responders [response rate 21% (95% confidence interval 12%)]. Response rates in the anthracycline-failure and anthracycline-refractory groups were 24% and 17%, respectively. A subset of 31 patients pretreated with anthracyclines and taxanes had a response rate of 26%. Median duration of response and median survival were 5.5 and 10.7 months, respectively (13 months in the failure group and 5.7 months for refractory). Grade 3/4 toxicities included neutropenia and thrombocytopenia in 56% and 19% of patients, respectively. Nine patients (12%) experienced neutropenic fever. Grade 3/4 non-hematological toxicities included skin rash (10%), nausea (12%), fatigue (10%) and stomatitis (5%).
Conclusion:
Our trial demonstrates pemetrexed to be active in breast cancer, with manageable toxicity. Activity of pemetrexed did not appear to be adversely affected by prior taxane, 5-fluorouracil or endocrine treatments.
Key words: anthracyclines, breast cancer, pemetrexed, taxanes
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