Rana R McKay1, Bruce Montgomery2, Wanling Xie3, Zhenwei Zhang4, Glenn J Bubley5, David W Lin6, Mark A Preston7, Quoc-Dien Trinh7, Peter Chang8, Andrew A Wagner8, Elahe A Mostaghel2, Philip W Kantoff9, Peter S Nelson2, Adam S Kibel7, Mary-Ellen Taplin10. 1. Department of Medicine, Division of Hematology/Oncology, University of California San Diego, San Diego, CA, USA. 2. Department of Medicine, Division of Oncology, University of Washington, Seattle, WA, USA. 3. Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA. 4. Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. 5. Department of Medicine, Division of Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA. 6. Department of Urology, University of Washington, Seattle, WA, USA. 7. Department of Surgery, Division of Urology, Dana Farber/Brigham and Women's Cancer Center, Boston, MA, USA. 8. Department of Urology, Beth Israel Deaconess Medical Center, Boston, MA, USA. 9. Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. 10. Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. Mary_Taplin@DFCI.harvard.edu.
Abstract
BACKGROUND: Patients with high-risk prostate cancer have an increased likelihood of experiencing a relapse following radical prostatectomy (RP). We previously conducted three neoadjuvant androgen-deprivation therapy (ADT) trials prior to RP in unfavorable intermediate and high-risk disease. METHODS: In this analysis, we report on the post-RP outcomes of a subset of patients enrolled on these studies. We conducted a pooled analysis of patients with available follow-up data treated on three neoadjuvant trials at three institutions. All patients received intense ADT prior to RP. The primary endpoint was time to biochemical recurrence (BCR). BCR was defined as a PSA ≥ 0.2 ng/mL or treatment with radiation or androgen-deprivation therapy for a rising PSA < 0.2 ng/mL. RESULTS: Overall, 72 patients were included of whom the majority had a Gleason score ≥ 8 (n = 46, 63.9%). Following neoadjuvant therapy, 55.7% of patients (n = 39/70) had pT3 disease, 40% (n = 28) had seminal vesicle invasion, 12.9% (n = 9) had positive margins, and 11.4% (n = 8) had lymph node involvement. Overall, 11 (15.7%) had tumor measuring ≤ 0.5 cm, which included four patients (5.7%) with a pathologic complete response and seven (10.0%) with residual tumor measuring 0.1-0.5 cm. Compared to pretreatment clinical staging, 10 patients (14.3%) had pathologic T downstaging at RP. The median follow-up was 3.4 years. Overall, the 3-year BCR-free rate was 70% (95% CI 57%, 90%). Of the 15 patients with either residual tumor ≤ 0.5 cm or pathologic T downstaging, no patient experienced a recurrence. CONCLUSION: In this exploratory pooled clinical trials analysis, we highlight that neoadjuvant therapy prior to RP in unfavorable intermediate and high-risk patients may potentially have a positive impact on recurrence rates. Larger studies with longer follow-up periods are warranted to evaluate the impact of neoadjuvant hormone therapy on pathologic and long-term outcomes.
BACKGROUND:Patients with high-risk prostate cancer have an increased likelihood of experiencing a relapse following radical prostatectomy (RP). We previously conducted three neoadjuvant androgen-deprivation therapy (ADT) trials prior to RP in unfavorable intermediate and high-risk disease. METHODS: In this analysis, we report on the post-RP outcomes of a subset of patients enrolled on these studies. We conducted a pooled analysis of patients with available follow-up data treated on three neoadjuvant trials at three institutions. All patients received intense ADT prior to RP. The primary endpoint was time to biochemical recurrence (BCR). BCR was defined as a PSA ≥ 0.2 ng/mL or treatment with radiation or androgen-deprivation therapy for a rising PSA < 0.2 ng/mL. RESULTS: Overall, 72 patients were included of whom the majority had a Gleason score ≥ 8 (n = 46, 63.9%). Following neoadjuvant therapy, 55.7% of patients (n = 39/70) had pT3 disease, 40% (n = 28) had seminal vesicle invasion, 12.9% (n = 9) had positive margins, and 11.4% (n = 8) had lymph node involvement. Overall, 11 (15.7%) had tumor measuring ≤ 0.5 cm, which included four patients (5.7%) with a pathologic complete response and seven (10.0%) with residual tumor measuring 0.1-0.5 cm. Compared to pretreatment clinical staging, 10 patients (14.3%) had pathologic T downstaging at RP. The median follow-up was 3.4 years. Overall, the 3-year BCR-free rate was 70% (95% CI 57%, 90%). Of the 15 patients with either residual tumor ≤ 0.5 cm or pathologic T downstaging, no patient experienced a recurrence. CONCLUSION: In this exploratory pooled clinical trials analysis, we highlight that neoadjuvant therapy prior to RP in unfavorable intermediate and high-risk patients may potentially have a positive impact on recurrence rates. Larger studies with longer follow-up periods are warranted to evaluate the impact of neoadjuvant hormone therapy on pathologic and long-term outcomes.
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