Safety And Efficacy Of Eltrombopag (Epag) Vs Placebo (Pbo) For Treatment Of Chemotherapy (Ctx)-Induced Thrombocytopenia (Tcp) In Patients (Pts) With Solid Tumors Receiving Gemcitabine (Gem)-Based Ctx: A Phase 2 Study

9602 Background: A phase 1 EPAG study showed favorable results for the treatment of CTx-induced TCP in pts receiving GEM-based CTx. Methods: This was a phase 2, blinded, PBO-controlled, multicenter study in adults with solid tumors and TCP receiving ≤6 cycles of CTx. Pts received GEM on days 1 and 8 (every 21 days) and cisplatin on day 1 (or divided dose on days 1 and 8) or carboplatin on day 1, or received GEM alone on days 1, 8, and 15 (every 28 days). Pts were randomized (2:1) to EPAG 100 mg or PBO daily for 5 days before and after day 1 of CTx. Results: We report early results of 44 pts randomized to EPAG (n = 31) or PBO (n = 13). Data review with an external, independent physician after ≥ 2 cycles showed no safety concerns. Myelosuppression was the most common adverse event (AE), with lower rates of anemia, neutropenia, and TCP seen with EPAG versus PBO (Table). In the EPAG arm, 23% of patients developed TCP (all grade 3/4) vs 46% (31% grade 3/4) of PBO patients. Proportionately fewer serious AEs (SA...