The oncologist · 2026
Prevalence of adverse events following T-cell redirecting therapies in patients with metastatic castration-resistant prostate cancer: a pooled analysis.
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Saxena Abhiraj, Yorker Marc, Zorko Nicholas A, Narayan Vivek, Siddiqui Bilal A, Saraiya Biren, Tester William J, Mille Patrick J, Shaver Amy L, Nikita Nikita, Lu-Yao Grace L, Kelly William Kevin, Zarrabi Kevin K
Аннотация
BACKGROUND: T-cell redirecting therapies, including T-cell engagers (TCEs) and Chimeric Antigen Receptor T-cell (CAR-T), are under investigation in metastatic castration-resistant prostate cancer (mCRPC). Despite their promising therapeutic potential, these therapies remain in early stages of development due to treatment-related adverse events (TRAEs). This study aims to quantify the frequency and severity of adverse events in clinical trials with a pooled analysis.
MATERIALS AND METHODS: A systematic search of PubMed, CINHAL, Scopus, and Ovid was conducted to identify clinical trials evaluating TCEs or CAR-T in patients with mCRPC. Types and frequencies of TRAEs were collected and analyzed using a random-effects model.
RESULTS: Thirteen TCEs trials involving 861 patients and 5 CAR-T trials involving 55 patients were identified. Cytokine release syndrome occurred in 59% (95% confidence interval: 25, 86) and 43% (28, 59) with TCEs and CAR-T, respectively. Neurologic TRAEs occurred in 39% (22, 60) with CAR-T compared to 9% (4, 17) with TCEs (P < 0.0001). Hematologic and hepatic TRAEs occurred in 34% (8, 75) and 25% (12, 44) with CAR-T, compared to 23% (7, 56) and 33% (12, 64) with TCEs, respectively. Musculoskeletal/dermatologic TRAEs occurred in 33% (24, 42) and 29% (8, 58) with TCEs and CAR-T, respectively. Renal and gastrointestinal TRAEs occurred in 21% (5, 51) and 14% (2, 43) with CAR-T, compared to 15% (8, 25) and 21% (12, 36) with TCEs, respectively.
CONCLUSIONS: These data underscore the TRAE profiles associated with these therapies and emphasize the importance of differentiating off-target toxicities from immune effector cell-toxicities to inform the development of effective TRAE mitigation strategies.
MATERIALS AND METHODS: A systematic search of PubMed, CINHAL, Scopus, and Ovid was conducted to identify clinical trials evaluating TCEs or CAR-T in patients with mCRPC. Types and frequencies of TRAEs were collected and analyzed using a random-effects model.
RESULTS: Thirteen TCEs trials involving 861 patients and 5 CAR-T trials involving 55 patients were identified. Cytokine release syndrome occurred in 59% (95% confidence interval: 25, 86) and 43% (28, 59) with TCEs and CAR-T, respectively. Neurologic TRAEs occurred in 39% (22, 60) with CAR-T compared to 9% (4, 17) with TCEs (P < 0.0001). Hematologic and hepatic TRAEs occurred in 34% (8, 75) and 25% (12, 44) with CAR-T, compared to 23% (7, 56) and 33% (12, 64) with TCEs, respectively. Musculoskeletal/dermatologic TRAEs occurred in 33% (24, 42) and 29% (8, 58) with TCEs and CAR-T, respectively. Renal and gastrointestinal TRAEs occurred in 21% (5, 51) and 14% (2, 43) with CAR-T, compared to 15% (8, 25) and 21% (12, 36) with TCEs, respectively.
CONCLUSIONS: These data underscore the TRAE profiles associated with these therapies and emphasize the importance of differentiating off-target toxicities from immune effector cell-toxicities to inform the development of effective TRAE mitigation strategies.