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The efficacy and safety of Capivasertib (azd5363) in the treatment of patients with solid tumor. A systematic review and meta-analysis of randomized clinical trials

Expert Opin Drug Saf. 2023 May 24. doi: 10.1080/14740338.2023.2218085. Online ahead of print.

ABSTRACT

OBJECTIVE: To evaluate the clinical efficacy and safety of Capivasertib on patients with solid tumors.

METHODS: Data from four RCTs were pooled to create a systematic review and meta-analysis with a focus on Capivasertib treated patients with solid tumors. Progression-free survival (PFS) and adverse events (AE) were the primary outcomes.

RESULTS: A total of 540 individuals from four RCTs were included. The analysis showed that Capivasertib improved PFS for ITT population with an HR of 0.75 (95% CI = 0.62-0.90, p = 0.002), whereas it did not show improvement in PFS of the PI3K/AKT/PTEN-altered group with an HR = 0.61 (95% CI = 0.32-1.16, p = 0.13). The analysis also showed that Capivasertib improved OS for ITT population with an HR = 0.61 (95% CI = 0.47-0.78, p = 0.0001). For safety, 4 studies were included, Statistical differences between capivasertib and placebo were found in discontinuation of capivasertib due to toxicity or AE (RR = 2.37 (95% CI = 1.37-4.10, p = 0.002).

CONCLUSION: Capivasertib and chemotherapy combination shown promising antitumor efficacy and a manageable safety profile in the treatment of individuals with solid tumors.

PMID:37224269 | DOI:10.1080/14740338.2023.2218085

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