Phase II Study of Compliance and Morbidity with 4 Cycles of Taxotere Followed by 4 of Doxorubicin-Cyclophosphamide for Adjuvant Treatment of Operable Breast Cancer Patients.

BACKGROUND: In the adjuvant treatment of breast cancer, anthracycline and taxane based regimens can be used concomitantly or sequentially. The best order in the sequential regimens has yet to be well established. This study evaluated the feasibility of 4 cycles of adjuvant taxotere (100mg/m2) every 3 weeks followed by 4 cycles of doxorubicin (60 mg/m2) and cyclophosphamide (600mg/m2) every 3 weeks. The primary outcome was the safety profile. Secondary outcomes were disease free survival (DFS) and overall survival (OS).

MATERIALS AND METHODS: This non-randomized prospective phase II study was performed at Jordan University of Science and Technology and its affiliated King Abdulla Teaching Hospital between July 2009 and August 2010. Data collection was closed on May 31th, 2015, giving a median follow up period of 62 months. The study was approved by the institutional review board and written informed consent was obtained for each patient.

RESULTS: Fifty patients were enrolled. The median age was 53.1 years (range 34-76). One patient (2%) had stage I disease, 17 (34%) stage II, and 32 (64.0%) stage III. Forty-six patients were evaluable for efficacy analysis. The completion rate was 95.7%. No dose modifications were needed. The incidences of grade 3-4 neutropenia and febrile neutropenia were 14% and 10%. No grade 3-4 non-hematological adverse events were encountered. At a median follow up time of 62 months the OS and the DFS rates were 76.1% and 56.5%. Those for stages I and II combined were 100% and 75%.

CONCLUSIONS: Taxotere first followed by doxorubicin-cyclophosphamide appears a feasible regimen as evidenced by an acceptable completion rate, a satisfactory safety profile, and OS and DFS rates comparable to other studies.