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Phase II study of pemetrexed in breast cancer patients pretreated with anthracyclines

Lookup NU author(s): Professor Alan Calvert

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Abstract

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.


Publication metadata

Author(s): Martin, M., Spielmann, M., Namer, M., duBois, A., Unger, C., Dodwell, D., Vodvarka, P., Lind, M., Calvert, A. H., Casado, A., Zelek, L., Lluch, A., Carrasco, E., Kayitalire, L., Zielinski, C.

Publication type: Article

Publication status: Published

Journal: Annals of Oncology

Year: 2003

Volume: 14

Issue: 8

Pages: 1246-1252

Print publication date: 01/08/2003

ISSN (print): 0923-7534

ISSN (electronic): 1569-8041

URL: http://dx.doi.org/10.1093/annonc/mdg339

DOI: 10.1093/annonc/mdg339

PubMed id: 12881387


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