AI Article Synopsis
- Recurrent gynecological tumors like endometrial and ovarian cancers lack effective treatments, prompting research into the PTEN-AKT-PI3K pathway as a target, with alpelisib being a notable PI3K inhibitor.
- A study involving 36 patients with PIK3CA-mutated advanced gynecological cancers showed an overall objective response rate (ORR) of 28% and a disease control rate (DCR) of 61%, with the best results in endometrial cancer patients.
- The findings suggest that alpelisib could be a promising treatment option for these patients and highlight the importance of further clinical trials focusing on biomarker-driven approaches for PI3K inhibitors in gynecological cancers
Article Abstract
Objective: Recurrent gynecological tumors (e.g., endometrial, and ovarian cancers) are incurable diseases; therefore, new treatment options are urgently needed. The PTEN-AKT-PI3K pathway is frequently altered in these tumors, representing a potential treatment target. Alpelisib is an α-specific PI3K inhibitor approved in PIK3CA-mutated advanced breast cancer. We report outcomes from a large series of patients with PIK3CA-mutated gynecological cancers prospectively treated with alpelisib within a controlled program.
Methods: From April 2021 to December 2022, 36 patients with PIK3CA-mutated advanced gynecological cancers received alpelisib 300 mg orally once daily. Objective response (ORR) and disease control (DCR) rates provided measure of the antitumor activity of alpelisib, the primary objective of the study.
Results: Included patients had endometrial (17/36 [47%]), ovarian (10/36 [28%]), or other gynecological cancers (9/36 [25%]). Most patients had received 2-3 prior systemic treatments (endometrial, 47·2%; ovarian, 60%; other, 56%), and presented with visceral metastases at baseline (82%, 70%, and 56%, respectively). Overall, 17 different PIK3CA mutations were found, including 53% in the kinase domain (most commonly H1047R) and 36% in the helical domain (most commonly E545K). Overall, the ORR was 28% and DCR was 61%, with the greatest benefit observed in patients with endometrial cancer (35% and 71%, respectively).
Conclusion: Alpelisib represents an active treatment option in patients with recurrent gynecological cancers harboring a PIK3CA mutation. These findings support the need of biomarker-driven randomized trials of PI3K inhibitors in gynecological cancers.
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| http://dx.doi.org/10.1016/j.ygyno.2024.02.029 | DOI Listing |
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