Survival and safety analysis of eribulin in Indian patients with metastatic breast cancer: A real world clinical experience.

e13002 Background: Eribulin is a synthetic non-taxane anti-microtubule agent approved in India for the second line of treatment of locally advanced or metastatic breast cancer. Eribulin has shown to improve overall survival (OS) in various subgroups of patients with metastatic breast cancer (MBC) who were pretreated with an anthracycline and taxane. However, efficacy and safety data for eribulin in Indian patients with MBC is limited. Therefore, this real world study assessed the clinical outcomes of eribulin in heavily pre-treated MBC Indian females. Methods: Histologically confirmed adult MBC patients who received eribulin over several lines of therapy were retrospectively analysed. Socio-demographic, clinical, pathology, imaging, and therapy records were reviewed. The progression-free survival (PFS), overall survival (OS), tumor response and safety were evaluated. Results: A total of 189 patients were included and out of these patients 145 patients were analysed. The median age of patients was 52 years (range: 28-71). Eribulin was used as a 2 nd , 3 rd , 4 th and ≥ 5 th line chemotherapy agent in 17 (11.72%), 27 (18.62%), 44 (30.34%) and 57(39.31%) of MBC patients, respectively. In the overall population, the objective response rate (ORR) was 7.58%, while the clinical benefit rate (CBR) was 15.48%. The median PFS and OS were 3.86 (95% CI: 3.18-4.54) and 11.56 (95% CI: 8.72-14.40) months respectively. There was positive correlation between the number of eribulin cycles and the outcomes of survival, with patients getting more than 3 cycles having significantly superior OS and PFS. On subgroup analysis, there was no significant difference in the outcomes of survival on the basis of hormone receptor and her-2 status, however the patients who had more than 3 metastatic sites had significantly lower survival outcomes. The anthracycline and taxane refractory (progression within 6 months after their last anthracycline/taxane dose) patients had significantly (p<0.001) lower median PFS as compared to anthracycline and taxane sensitive patients (2.96 months vs 5.23 months) and (2.86 months vs 4.46 months) respectively. Among the grade ≥3 toxicities, neutropenia was 26.21%, anemia was 13.10%, thrombocytopenia was 6.21% and mucositis was 8.97%. The grade ≥2 peripheral neuropathy was seen in 28.97% patients and 21.38% patients had gastro-intestinal symptoms. Conclusions: This study confirms that Eribulin is effective and has manageable toxicity in patients with MBC. It should be considered as the strategy of several chemotherapy lines in MBC.