Gemcitabine/cyclophosphamide/5-fluorouracil/folinic acid triplet combination in anthracycline- and taxane-refractory breast cancer patients: A southern Italy Cooperative Oncology Group phase I/II study

G. Frasci, G. D'Aiuto, P. Comella, R. Thomas, I. Capasso, G. Botti, G. R. Cortino, V. De Rosa, G. Comella

Research output: Contribution to journalArticle

Abstract

We sought to define the recommended dose of cyclophosphamide (CTX) for subsequent phase II assessment when combined with fixed doses of gemcitabine (Gemzar; Eli Lilly and Company, Indianapolis, IN) and 5-fluorouracil/folinic acid in metastatic breast cancer patients previously treated with anthracyclines and taxanes. Patients age 70 or less, with an Eastern Cooperative Oncology Group performance status 0 to 2, were enrolled. Patients received gemcitabine 1,000 mg/m2, 5-fluorouracil 425 mg/m2, folinic acid 100 mg/m2, and escalating doses of CTX (in 100-mg/m2 increments), starting at 500 mg/m2, on days 1 and 8 every 3 weeks. Since March 1999, 46 patients, with a median age of 51 years (range, 38 to 74 years), entered the trial in seven cohorts. Cyclophosphamide dose escalation was stopped at 600 mg/m2 when three of six patients experienced dose-limiting toxicity (one each with grade 3 thrombocytopenia, grade 3 neutropenia, and persistent grade 2 neutropenia), and then continued with granulocyte colony-stimulating factor support. The CTX dose of 800 mg/m2 was proven safe and was chosen for phase II study. Two complete and 15 partial responses provided an overall response rate of 37% (95% confidence interval, 23% to 51%). Gemcitabine/CTX/5-fluorouracil/folinic acid is well tolerated by metastatic breast cancer patients pretreated with anthracyclines/taxanes, up to a CTX dose of 800 mg/m2. The phase II study is ongoing.

Original languageEnglish
Pages (from-to)50-56
Number of pages7
JournalSeminars in Oncology
Volume28
Issue number3 SUPPL. 10
Publication statusPublished - 2001

ASJC Scopus subject areas

  • Oncology

Fingerprint Dive into the research topics of 'Gemcitabine/cyclophosphamide/5-fluorouracil/folinic acid triplet combination in anthracycline- and taxane-refractory breast cancer patients: A southern Italy Cooperative Oncology Group phase I/II study'. Together they form a unique fingerprint.

  • Cite this