Abstract 1649P
Background
The CHART trial demonstrated significant improvements in radiographic PFS and OS with Rez + ADT compared to bicalutamide (Bic) + ADT in high-volume mHSPC (Gu et al., Lancet Oncol 2022). This post-hoc analysis assessed the impact of concomitant medications on safety profile of these patients.
Methods
Patients aged ≥18 years with high-volume mHSPC and no prior history of chemotherapy or localized treatment for prostate cancer were randomized 1:1 to receive Rez (240 mg) + ADT or Bic (50 mg) + ADT orally once daily. The post-hoc analysis was conducted in patients receiving concomitant medications and assessed the impact of three common concomitant drugs that may potentially interact with Rez, including concomitant antithrombotics, gastric acid disorder-related drugs, and lipid-modifying drugs, on safety in both treatment groups.
Results
Of the 654 patients included in the study, 323 patients in the Rez + ADT group and 319 patients in the Bic + ADT group received concomitant medications, with a generally comparable use of each specific concomitant drug between the two groups. In patients receiving concomitant antithrombotics, gastric acid disorder-related drugs, or lipid-modifying drugs, the incidence of toxicities was either comparable or slightly higher in the Rez + ADT group than in the Bic + ADT group (Table), which may partially be attributed to the longer exposure duration to Rez + ADT treatment than Bic + ADT treatment (1.7–2.0 times). Table: 1649P
Safety results with the use of concomitant medications
| Antithrombotics | Gastric acid disorder-related drugs | Lipid-modifying drugs | ||||
| Rez+ADT (N=56) | Bic+ADT (N=49) | Rez+ADT (N=74) | Bic+ADT (N=61) | Rez+ADT (N=75) | Bic+ADT (N=36) | |
| AE | 56 (100) | 49 (100) | 74 (100) | 61 (100) | 75 (100) | 36 (100) |
| Grade ≥3 AE | 42 (75.0) | 32 (65.3) | 54 (73.0) | 42 (68.9) | 55 (73.3) | 21 (58.3) |
| SAE | 34 (60.7) | 28 (57.1) | 48 (64.9) | 29 (47.5) | 39 (52.0) | 13 (36.1) |
| TRAE | 48 (85.7) | 41 (83.7) | 61 (82.4) | 52 (85.2) | 66 (88.0) | 31 (86.1) |
| Grade ≥3 TRAE | 13 (23.2) | 10 (20.4) | 20 (27.0) | 16 (26.2) | 25 (33.3) | 8 (22.2) |
| TRSAE | 7 (12.5) | 4 (8.2) | 7 (9.5) | 4 (6.6) | 6 (8.0) | 3 (8.3) |
AE, adverse event; TRAE, treatment-related AE; SAE, serious AE; TRSAE, treatment-related serious AE.
Conclusions
The concomitant use of antithrombotics, gastric acid disorder-related drugs, and lipid-modifying drugs during Rez + ADT treatment has either no or minimal impact on the safety profile of patients with high-volume mHSPC, supporting the safe use of these concomitant medications when clinically indicated.
Clinical trial identification
NCT03520478.
Editorial acknowledgement
Legal entity responsible for the study
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
X. Yang, J. Lian, W. Wang: Other, Personal, Full or part-time Employment: Jiangsu Hengrui Pharmaceuticals Co., Ltd. All other authors have declared no conflicts of interest.
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