Abstract 1788P
Background
CHART trial has demonstrated the survival benefit of rezvilutamide plus androgen deprivation therapy (ADT) over bicalutamide plus ADT in treating patients with high-volume, metastatic hormone-sensitive prostate cancer (mHSPC). This post-hoc analysis aimed to evaluate the association between achievement of deep PSA decline with survival outcomes in patients with high-volume mHSPC in the CHART trial.
Methods
Patients with high-volume mHSPC were randomly assigned (1:1) to receive ADT plus either rezvilutamide or bicalutamide. PSA kinetics and the association between deep PSA decline (≤0.2 ng/ml) and radiographic progression-free survival (rPFS) and overall survival (OS) in two groups were evaluated.
Results
A total of 654 patients were included in the analysis, with 326 patients in the rezvilutamide plus ADT group, and 328 patients in the bicalutamide plus ADT group. The median PSA nadir levels were 0.02 ng/ml, and 0.68 ng/ml in two groups, respectively. At 6-month, 170 (52.15%) and 90 (27.44%) patients achieved a deep PSA decline, respectively. With a median follow-up of 29.3 months, patients who achieved a deep PSA decline at 6-month had longer rPFS (HR=0.359, 95%CI 0.238, 0.543, P<0.001) and OS (HR=0.339, 95%CI 0.212, 0.540, P<0.001) than those who did not achieve it in the rezvilutamide plus ADT group. Significantly, rezvilutamide plus ADT was found to significantly prolong rPFS compared to bicalutamide plus ADT, regardless of whether patients achieved deep PSA decline at 6-month (HR=0.462, 95%CI 0.283, 0.754, P=0.002) or not (HR=0.587, 95%CI 0.428, 0.804, P<0.001). Table: 1788P
PSA kinetics in CHART trial
| Variables | Rezvilutamide plus ADT (n=326) | Bicalutamide plus ADT (n=328) |
| PSA baseline (ng/ml), median (Q1, Q3) | 78.79 (12.82, 314.80) | 51.32 (8.08, 236.63) |
| PSA nadir (ng/ml), median (Q1, Q3) | 0.02 (0.00, 0.41) | 0.68 (0.08, 3.16) |
| Time to PSA nadir, day, median (Q1, Q3) | 308.0 (169.0, 634.8) | 167.0 (85.0, 281.0) |
| PSA nadir ≤0.2 ng/ml, n (%) | 224 (68.7) | 109 (33.2) |
| Time to PSA ≤0.2 ng/ml, day, median (Q1, Q3) | 392.0 (222.3, 671.0) | 238.0 (141.0, 393.0) |
| PSA ≤0.2 ng/ml at 3-month, n (%) | 125 (38.34) | 58 (17.68) |
| PSA ≤0.2 ng/ml at 6-month, n (%) | 170 (52.15) | 90 (27.44) |
| PSA ≤0.2 ng/ml at 12-month, n (%) | 201 (61.66) | 108 (32.93) |
Conclusions
Rezvilutamide plus ADT resulted in a deep PSA decline, which was associated with improved long-term survival in patients with high-volume mHSPC.
Clinical trial identification
NCT03520478.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Disclosure
J. Lian, Q. Shi: Financial Interests, Personal, Full or part-time Employment: Jiangsu Hengrui Pharmaceuticals. All other authors have declared no conflicts of interest.
Resources from the same session
1250P - Assessing lung carcinoma: A retrospective study on volume evaluation, consolidation and infiltration using chest OMX
Presenter: Swarnambiga Ayyachamy
Session: Poster session 14
1251P - Development of a deep learning algorithm for lung cancer diagnosis using methylation and fragment size profiles of cfDNA
Presenter: Jiyoung Huh
Session: Poster session 14
1252P - Quantitative cell signaling activity profiling of solid tumors to support personalized treatment in the FINPROVE basket trial: Presentation of skin tumor data
Presenter: Diederick Keizer
Session: Poster session 14
1253P - Analytic validation and implementation of OncoDEEP: A pan-cancer comprehensive genomic profiling NGS assay for assessing homologous recombination deficiency (HRD)
Presenter: Marcel Trautmann
Session: Poster session 14
1254P - Retrospective analysis of brain OMX: Diagnostic tool for structural (T1) and functional connectome (RS-FMRI) analysis of brain
Presenter: Swarnambiga Ayyachamy
Session: Poster session 14
1255P - Evaluating GPT-4 as an academic support tool for clinicians: A comparative analysis of case records from the literature
Presenter: Marcos Aurelio Fonseca Magalhaes Filho
Session: Poster session 14
1256P - Value of detection of peripheral blood circRNA based on digital PCR in the diagnosis of lung adenocarcinoma
Presenter: Jihong Zhou
Session: Poster session 14
1257P - Double heterozygous prevalence in hereditary cancer syndromes in Northern Mexico population
Presenter: Carlos Burciaga Flores
Session: Poster session 14
1258P - Does FDG PET-based radiomics have an added value for prediction of overall survival in non-small cell lung cancer?
Presenter: Andrea Ciarmiello
Session: Poster session 14
1260TiP - Enhancing lung nodule discrimination with a novel cfDNA test: The cancer signature ensemble (CSE) approach
Presenter: Young-Chul Kim
Session: Poster session 14