To the Editor A phase 1/2 trial investigating the combination of alisertib with paclitaxel in patients with advanced breast cancer or recurrent ovarian cancer was recently published in JAMA Oncology.1 In our opinion, the phase 2 part of the study investigating this novel combination in ovarian cancer (OC) deserves a critical discussion. Alisertib is an aurora A kinase inhibitor that demonstrates a synthetic lethality interaction when associated with checkpoint kinase 1 and increased sensitivity to taxanes and platinum agents.2 In a phase 2 study exploring the activity of alisertib in platinum-resistant OC, modest single-agent activity was observed.3 These dated results indicate that alsertib should be combined with other drugs. In the study by Falchook et al,1 142 patients were randomized to alisertib plus weekly paclitaxel or weekly paclitaxel alone in the phase 2 part of the study. Progression-free survival, complete response, partial response, duration of response, and time to progression were evaluated with RECIST version 1.1 criteria and CA-125 analysis. However, the authors did not specify which imaging techniques were used (computed tomography, nuclear magnetic resonance, positron emission tomography) or the timing. Moreover, we do not know at which interval CA-125 was tested. Therefore, it seems risky to compare the outcome data of patients, considering the high number of centers (33) from 3 different countries that participated in the study.
Tomao F, Benedetti Panici P, Tomao S. Paclitaxel and Alisertib in Recurrent Ovarian Cancer. JAMA Oncol. Published online April 25, 20195(6):909–910. doi:10.1001/jamaoncol.2019.0559
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