Phase II trial of paclitaxel and uracil--tegafur in metastatic breast cancer. TEGATAX trial

This Phase II trial investigated the combination paclitaxel (P) and uracil-tegafur (UFT) in patients with metastatic breast cancer (MBC).

Methods

Main eligibility criteria included HER-2 negative MBC, ECOG performance status of 0-2, exposure to 1-2 prior chemotherapy regimen in the metastatic setting, previous exposure to an anthracycline containing regimen either at metastatic or adjuvant setting. Each 35-day cycle consisted of P at 80 mg/m² by intravenous infusion on days 1, 8, 15, 22 and 29 and oral UFT at 300 mg/m² TID (three time a day) from days 1-28 and oral folinic acid at 90 mg QD (one a day).

Results

Between March 2003 and December 2007, 31 patients were enrolled. Median age was 66 years (range 44-78). All tumours were HER-2 negative and 7% were triple negative (ER, PgR, HER-2). The majority of patients had visceral disease (81%). All patients had received an anthracycline containing regimen and 74% had a previous docetaxel containing treatment. Median of 4 and 3 cycles of P and UFT were administered with a relative dose intensity of 85.3% and 94.3%, respectively. Twelve (40%)(95% CI: 22.5-57.5) confirmed ORR were observed. Stable and progression disease were reported in 43% and 17% of cases. Median Response duration was 8.4 month (95% CI: 4.9-11.7), median Time to progression was 9.5 months (95% CI: 6.6-13.8) and median Overall Survival was 23.5 months (95% CI: 16.8-37.2). Thirteen pts (43%) experienced a grade 3 or 4 adverse events (AEs): One death occurred related to the study drugs (febrile neutropenia). Chemotherapy was discontinued due to toxicity in 30% of pts

Conclusions

Accrual was closed in January 2008 due to concerns regarding the degree and accumulative nature of AEs. Nonetheless, the ORR is encouraging and warranted further studies with adapted doses and schedules.