University of Palermo, Palermo, Italy
Ignazio Ugo Carreca , Giuseppe Bronte , Anna Paola Carreca , Viviana Bazan , Dario Cova , Antonio Russo
Background: E mesylate, a nontaxane microtubule dynamics inhibitor is widely prescribed for MBC pts 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 standard treatments because of their pharmacokinetic features. We designed a new combination schedule (E+C) to evaluate its suitability for elderly MBC patients. 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 EP), schedule would be continued until progression or intolerable toxicity. Eligibility criteria: histologically confirmed diagnosis of MBC, written informed consent, at least 1 measurable lesion, at least 1 site of visceral mts (not brain mts), age > 70 years, previous treatment with A&T, Comprehensive Geriatric Assessment evaluation (CGA) permissive for chemotherapy, adequate renal, 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 WHO criteria, toxicity profile using NCI-CTC v2.0 and Quality of Life (QoL) score through EORTC QLQ-C30 questionnaires. Results: From 2013 jan to 2014 dec 39 metastatic EP, mean age 80.5 (range 71 - 90) were treated and 37 are still under maintenance therapy (2 pts discontinued treatment for personal reasons). A total of 599 cycles were delivered to the 37 pts without G4 toxicity. No delay in therapy delivery was needed. QoL score shows no worsening with improvement in about 55% (72-78 y/o group) after treatment in comparison with baseline. Total CB was 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 standard chemotherapy regimens for MBC. In this updated analysis this schedule has showed non-inferiority vs standard treatments and more suitability for older EP. This study will be extended to confirm these outcomes in order to validate a schedule devoted to EP.
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