6533b854fe1ef96bd12ae819

RESEARCH PRODUCT

Effects of erybuline/capecitabine (EC) treatment in very elderly women (VEW) with MBC.

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e12508 Background: Eribuline mesylate, is widely prescribed for MBC pts alone or in combination with Capecitabine in patients pretreated with at least 1-2 lines of chemotherapy, including anthracyclines and taxanes (A&T). Elderly Patients (EP) develop rapid and sometimes fatal toxicity during treatments due to pharmacokinetic features of these drugs.A combination schedule (E+C) to evaluate its suitability for VEW with MBC patients ,was used in this study. Methods: Treatment plan: E 0.96 mg/sqm IV on d1 every 21d - C 900 mg/sqm bid d1-14 every 28d (Dose-adjustement if necessary was according to Kintzel-Dorr’s formula for elderly), schedule administration continued until progression or intolerable toxicity . Eligibility criteria: histologically confirmed diagnosis of BC, 1 or more measurable lesion,(bone or visceral ) not brain mts, age > 75 years, failure of previous treatment with A or T , Comprehensive Geriatric Assessment evaluation (CGA) permissive for chemotherapy, adequate renal (CCl evaluation), bone marrow and liver function. Charlson's Score Comorbidity Scale was also considered. Evaluations tools: Clinical Benefit (CB) as Stable Disease + Objective Response Rates according to ESMO CB scale v.2a, Toxicity Profile using CTCAE v3.0 Criteria and Quality of Life (QoL) score through EORTC QLQ-C30 questionnaires V.3. Results: From 2014 jan to 2016 dec ,39 metastatic VEW, mean age 83.5 were treated and 37 are still under maintenance therapy (2 pts discontinued treatment for personal reasons). A total of 659 cycles were delivered to the 37 pts without any G4 toxicity. No delay in therapy delivery was needed. QoL score shows no worsening with improvement in about 79% after treatment in comparison with baseline. Clinical Benefit was evaluated about 80%. Conclusions: A further period of monitoring allowed to confirm our previous report in this setting with this combination schedule. It appears more fit with comorbidity or frailty than other chemotherapy regimens for MBC. The analysis of preliminary data shows a non-inferiority vs other usual treatments ,more suitability for very elderly women. An enlarged polycentric study is ongoing in order to confirm these outcomes.