To analyze the safety, efficacy, and toxicity profile of ixabepilone and capecitabine combination in metastatic breast cancer patients in Indian population.

Abstract

e11513 Background: With the increasing use of anthracyclines and taxanes in the adjuvant setting, improved survival of patients with breast cancer, there is an unmet need of developing second-line chemotherapeutic agents which can be used specially in the subset of HER2-negative patients. Methods: Patients had to have histologically proven breast cancer, at least one measurable disease, age >18 years, ECOG scale 0-2. Patients with CNS metastasis deranged LFT, estimated life survival less than three months were excluded. Ixabepilone was administered as 40 mg/m2 q 3 weekly and capecitabine as 850 mg/m2 bd for 14 days. Prophylactic growth factor support was not given. Patients were evaluated before treatment and subsequently every 3 cycles until progression. The primary end point was to assess time-to-tumor progression, toxicity profile, and quality of life. Results: 25 patients were analyzed. The median number of cycles received was 5. 15 patients had partial response whereas 2 patients achieved complete response. 5 patients had stable disease whereas 3 patients had progressive disease. 3 patients could not tolerate the combination therapy and had to discontinue treatment. The median time-to-tumor progression was 5.8 months. Grade 3 or 4 toxicities included neutropenia (22%), fatigue (33%), anorexia (22%), and neuropathy (41%). The incidence of hand foot syndrome was 30%. The most distressing symptom was neuropathy and hand foot syndrome. Conclusions: The combination of ixabepilone and capecitabine, though effective, is associated with significant neuropathy and hematological toxicity. A lot of research needs to be done to develop new chemotherapeutic agents that are equally efficacious, cost effective, and maintain a good quality of life for the patients. No significant financial relationships to disclose.