Comparative adverse event profiles of triplet therapy versus docetaxel-based therapy in patients with metastatic...

To compare adverse event (AE) profiles between patients with prostate cancer receiving triplet therapy (docetaxel, androgen receptor signaling inhibitors [ARSIs], and androgen deprivation therapy [ADT]) and those receiving docetaxel-based therapy (docetaxel and ADT). Additionally, we sought to identify risk factors for severe AEs associated with these treatment regimens.

In this retrospective, multicenter study, we included 359 patients diagnosed with metastatic castration-sensitive prostate cancer (mCSPC) or metastatic castration-resistant prostate cancer (mCRPC) who were treated with docetaxel. We analyzed patient demographics, hematologic and non-hematologic AEs, and risk factors for severe AEs. Logistic regression models were used to assess risk factors.

There were no significant differences in the incidence of ≥ grade 3 neutropenia or febrile neutropenia (FN) between the triplet and docetaxel-based therapy groups when stratified by the use of primary prophylaxis. Non-hematologic AEs, especially fatigue, were more frequent in the mCRPC group compared to the triplet therapy group. Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) significantly reduced the risk of severe neutropenia (odds ratio [OR] 0.092, P < 0.001) and FN (OR 0.13, P = 0.007).

This study represents the first real-world analysis comparing the adverse event profiles of triplet therapy and docetaxel-based therapy in Japanese patients with mCSPC, as well as docetaxel-based therapy in those with mCRPC. No significant difference in severe AEs was observed between the therapies. Primary prophylaxis with G-CSF proved critical in reducing severe neutropenia and FN, underscoring its importance in enhancing the safety and efficacy of docetaxel-based therapies.