345P Optimal Dose of Eribulin As First Line Treatment in Elderly Patients ≥ 70 Years with Advanced Breast Cancer: A Multicenter Phase II Trial [SAKK 25/14]
Annals of oncology(2020)
Abstract
In elderly patients (pts) with metastatic breast cancer (mBC), there is no generally accepted 1st line chemotherapy (CT) and only scarce data on any CT regimen. Eribulin mesylate (1.4 mg/m2) in first line mBC achieved a clinical benefit rate (CBR; CR, PR or SD ≥ 6 months (mts)), of 26 - 52%. Less than 10% of pts in the registration-trial were ≥ 70 years (y); dose reductions were frequent in the elderly. We hypothesized: a reduced dose with less toxicity will lead to longer treatment duration and comparable CBR to the standard dose. Single-arm 2-stage phase II trial investigating a reduced starting-dose of eribulin mesylate 1.1 mg/m2 d1+8 q3wk in pts ≥ 70y with CT-naïve mBC. Disease control rate at 6 mts (CBR) was the primary endpoint. A Simon’s optimal single arm two-stage design to test H0 (CBR ≤ 35%) against H1 (CBR ≥ 50%) with a type-I error of 0.05 and power of 80% required 77 pts. Patient reported on neuropathy (FACT/GOG-Ntx) at the start of each cycle. From Aug 2015 to Feb 2019, 77 pts were accrued. Median (m) age was 76y (70-89); PS 0-1 in 90%, PS 2 in 10%; 64% had co-morbidities; 45% liver metastases, 3% bone-only disease. CBR was 40% (90% CI 31-50), ORR 22% (95%CI 13-33), mPFS 5.4 mts (95% CI 4.5-7.7) and mOS 16.1 mts (95% CI 13.5-26.9). The median number of cycles was 6 (1-24); dose modifications were necessary in 35% of pts; median dose per cycle was 2.1 mg/m2 (1.1-2.3). In 9 pts, >15 cycles were given. Main reasons for treatment discontinuation were progressive disease (57%), patient refusal (14%) and unacceptable toxicity (11%). Neutropenia G3 occurred in 10%, G4 in 12% of pts. Two pts (3%) suffered febrile neutropenia. Sensory neuropathy in 23% was usually mild (12% G1, 5% G2, 6% G3), median patient-reported neuropathy scores remained stable for at least 15 cycles. We report the first prospective data on treatment with 1st line Eribulin in elderly pts. A reduced starting dose of 1.1 mg/m2 is safe and the efficacy as expected, although the lower boundary of the 90% CI crossed the predefined threshold. A relevant subgroup of pts had prolonged disease control and tolerated this long time treatment without worsening of patient-reported neuropathy.
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