This IPD meta-analysis of 5 randomized phase 3 trials (n=4,781) evaluated whether the number of adverse pathologic features (grade group 4–5, seminal vesicle invasion, positive surgical margins, extracapsular extension; scored 0–4) modifies the OS or MFS benefit of adding hormonal therapy (HT) to postoperative radiotherapy in recurrent prostate cancer patients with pre-RT PSA ≤0.5 ng/mL, over a median follow-up of 9.1 years.
Adverse feature count (AFC) was independently prognostic for OS and MFS, but did not significantly modify the OS benefit of HT (interaction HR 0.93, 95% CI 0.79–1.10; p=0.4) or MFS benefit (interaction HR 0.88, 95% CI 0.77–1.01; p=0.08); results were consistent across categorical AFC analyses, high-risk subsets, and a restricted score (GG4–5 + seminal vesicle invasion only).
- Analysis limited to patients with pre-RT PSA ≤0.5 ng/mL, restricting generalizability to higher PSA subgroups. - AFC components were not uniformly reported or centrally reviewed across all five trials. - Interaction p-values, while non-significant, do not rule out a modest predictive effect given confidence interval widths.
Adverse pathologic features (high grade, seminal vesicle invasion, positive margins, extracapsular extension) should not be used alone to select or exclude patients from HT when adding it to post-prostatectomy salvage radiotherapy — they are prognostic but not predictive of HT benefit at PSA ≤0.5 ng/mL. Clinicians should weigh other factors (e.g., HT toxicity, comorbidities) rather than tumor pathology when deciding on HT in this setting.
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