e12031 Background: Eribulin (E) is a nontaxane microtubule inhibitor currently indicated for third-line chemotherapy (CHT) of MBC. To evaluate its tolerability and impact on QoL and symptoms improvement in MBC pts, from April 2012, we conducted a prospective observational study. Methods: Pts pretreated with anthracycline (A) and taxane (T) who has received 2 CHT lines for MBC, scheduled to be treated with E were considered eligible. Pts complete the Edmonton Symptoms Assessment Scale (ESAS) at each cycle and the Functional Assessment of Cancer Therapy-Breast (FACT-B) every 2 cycles. Outcome of QoL included the FACT-B total score, FACT-General (FACT-G) score and the Trial Outcome Index (TOI) score. Groups of data were analyzed using ANOVA and the Friedman test. Kaplan-Meier method was used for survival calculation. Overall Survival was calculated by the Kaplan-Meier product-limit method. Results: 25 consecutive MBC pts entered the study. Median age 65 (range 31-77), PS (ECOG) 0-1 96%, 24% had triple-negative MBC, 70% ER/PgR positive and 5% HER2 positive. All pts were pretreated with A and T, 19 (76%) also with capecitabine. Median cycles 6 (range 3-13), 36% received more than 6 cycles. Five pts are to early for evaluation. Of the 20 evaluable pts main toxicity were: alopecia G1 58% and G2 42%, asthenia G2 40% peripheral neuropathy G2 25% neutropenia G2 0% and G3-G4 10%.At a median follow-up of 6 months 16% of pts achieved partial response (PR) 44% stable disease (SD) and 20% progressive disease; disease control rate (PR+SD ≥ 6 m) occurred in 40% of pts. Median PFS is 5 m (95% CI, 4-6) currently 70% of pts are alive. Data of ESAS and QoL are reported in table. Conclusions: Our preliminary results shows that treatment with E is associated with a significant improvement of ESAS scores (p=0.03) mainly in responders pts (p=0.02) and with a good maintenance of QoL with expected and manageable toxicities. Data collection is ongoing and update results will be presented. [Table: see text]
Impact of equilibration duration during oocyte vitrification protocol: preliminary results of a prospective observational study
