In Reply We appreciate the thoughtful comments from Dr Tomao and colleagues regarding our recently published phase 1/2 trial of combination alisertib with paclitaxel.1 As described in our Methods section, patients underwent restaging imaging every 2 cycles (because each cycle was 28 days, imaging was performed every 56 days). Efficacy assessment with imaging was performed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, which included either computed tomography or magnetic resonance imaging, according to the judgment of the investigator.2 We requested that the same imaging modality be used throughout disease assessment in an individual patient. Efficacy assessment with CA-125 was performed every cycle (28 days) and followed the modified Gynecologic Cancer Intergroup CA-125 criteria.3 Comparison of the 2 groups using these efficacy metrics is therefore consistent with methodology from previously reported multicenter randomized clinical trials.4,5
Falchook G, Coleman RL, Schilder RJ. Paclitaxel and Alisertib in Recurrent Ovarian Cancer—In Reply. JAMA Oncol. Published online April 25, 20195(6):910–911. doi:10.1001/jamaoncol.2019.0562
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