The Prostate · 2026
Evaluation of Time to Metastasis After Prostatectomy as a Prognostic Factor in Patients With Metachronous mHSPC: A Secondary Analysis of the SWOG-1216 Phase 3 Trial.
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Sayegh Nicolas, Jo Yeonjung, Swami Umang, Nandakumar Varun, Gebrael Georges, Ozay Zeynep Irem, Li Haoran, Goel Krishnam, Maughan Benjamin L, Plets Melissa, Hussain Maha H A, Dorff Tanya B, Lara Primo N, Goldkorn Amir, Lerner Seth P, Agarwal Neeraj
Аннотация
BACKGROUND: The prognostic significance of time to metastasis (TTM) following radical prostatectomy in patients with metachronous metastatic hormone-sensitive prostate cancer (mHSPC) remains uncertain. We performed a secondary analysis of patient-level data from the phase 3 SWOG 1216 randomized clinical trial to evaluate whether TTM is associated with progression-free survival (PFS) or overall survival (OS).
METHODS: Among 1279 trial participants, 301 patients with metachronous mHSPC who had previously undergone prostatectomy were included. Participants were randomized to androgen deprivation therapy (ADT) plus orteronel or ADT plus bicalutamide and followed through 2023. TTM was analyzed as both a continuous variable and using categorical thresholds ranging from 1 to 10 years. Multivariable Cox proportional hazards models adjusted for treatment arm, disease burden, Gleason score, performance status, prostate-specific antigen, age, and prior ADT.
RESULTS: Of the included patients, 161 received ADT plus orteronel and 140 received ADT plus bicalutamide; 38% had extensive disease. TTM was not associated with PFS when analyzed continuously (hazard ratio [HR], 1.0; p = 0.30) or categorically across any threshold. Similarly, TTM was not associated with OS (continuous HR, 1.0; p = 0.14), with consistent findings across treatment arms.
CONCLUSIONS: In the secondary analysis of SWOG 1216, TTM was not independently associated with survival outcomes in the multivariable analysis. These findings suggest that TTM alone may not provide sufficient prognostic information to guide patient counseling, and treatment decisions after metastatic recurrence.
METHODS: Among 1279 trial participants, 301 patients with metachronous mHSPC who had previously undergone prostatectomy were included. Participants were randomized to androgen deprivation therapy (ADT) plus orteronel or ADT plus bicalutamide and followed through 2023. TTM was analyzed as both a continuous variable and using categorical thresholds ranging from 1 to 10 years. Multivariable Cox proportional hazards models adjusted for treatment arm, disease burden, Gleason score, performance status, prostate-specific antigen, age, and prior ADT.
RESULTS: Of the included patients, 161 received ADT plus orteronel and 140 received ADT plus bicalutamide; 38% had extensive disease. TTM was not associated with PFS when analyzed continuously (hazard ratio [HR], 1.0; p = 0.30) or categorically across any threshold. Similarly, TTM was not associated with OS (continuous HR, 1.0; p = 0.14), with consistent findings across treatment arms.
CONCLUSIONS: In the secondary analysis of SWOG 1216, TTM was not independently associated with survival outcomes in the multivariable analysis. These findings suggest that TTM alone may not provide sufficient prognostic information to guide patient counseling, and treatment decisions after metastatic recurrence.