OLIGOPELVIS GETUG P07, a Multicenter Phase II Trial of Combined High-dose Salvage Radiotherapy and Hormone Therapy in Oligorecurrent Pelvic Node Relapses in Prostate Cancer.

Abstract

BACKGROUND:

Oligorecurrent pelvic nodal relapse in prostatic cancer is a challenge for regional salvage treatments. Androgen depriving therapies (ADTs) are a mainstay in metastatic prostate cancer, and salvage pelvic radiotherapy may offer long ADT-free intervals for patients harboring regional nodal relapses.

OBJECTIVE:

To assess the efficacy of the combination of ADT and salvage radiotherapy in men with oligorecurrent pelvic node relapses of prostate cancer.

DESIGN, SETTING, AND PARTICIPANTS:

We performed an open-label, phase II trial of combined high-dose intensity-modulated radiotherapy and ADT (6 mo) in oligorecurrent (five or fewer) pelvic node relapses in prostate cancer, detected by fluorocholine positron-emission tomography computed tomography imaging.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:

The primary endpoint was 2-yr progression-free survival defined as two consecutive prostate-specific antigen levels above the level at inclusion and/or clinical evidence of progression as per RECIST 1.1 and/or death from any cause.

RESULTS AND LIMITATIONS:

Between August 2014 and July 2016, 67 patients were recruited in 15 centers. Half of the patients had received prior prostatic irradiation. The median age was 67.7 yr. After a median follow-up of 49.4 mo, 2- and 3-yr progression-free survival rates were 81% and 58%, respectively. Median progression-free survival was 45.3 mo. The median biochemical relapse-free survival (BRFS) was 25.9 mo. At 2 and 3 yr, the BRFS rates were 58% and 46%, respectively. Grade 2 + 2-yr genitourinary and gastrointestinal toxicities were 10% and 2%, respectively.

CONCLUSIONS:

Combined high-dose salvage pelvic radiotherapy and ADT appeared to prolong tumor control in oligorecurrent pelvic node relapses in prostate cancer with limited toxicity. After 3 yr, nearly half of patients were in complete remission. Our study showed initial evidence of benefit, but a randomized trial is required to confirm this result.

PATIENT SUMMARY:

In this report, we looked at the outcomes of combined high-dose salvage pelvic radiotherapy and 6-mo-long hormone therapy in oligorecurrent pelvic nodal relapse in prostatic cancer. We found that 46% of patients presenting with oligorecurrent pelvic node relapses in prostate cancer were in complete remission after 3 yr following combined treatment at the cost of limited toxicity.

• Authors: Stéphane Supiot, Loig Vaugier, David Pasquier, Xavier Buthaud, Nicolas Magné, Didier Peiffert, Paul Sargos, Gilles Crehange, Pascal Pommier, Genevieve Loos, Ali Hasbini, Igor Latorzeff, Marlon Silva, Fabrice Denis, Jean-Léon Lagrange, Cyrille Morvan, Loic Campion, Audrey Blanc-Lapierre
• Journal: European urology (Eur Urol) Vol. 80 Issue 4 Pg. 405-414 (10 2021) ISSN: 1873-7560 [Electronic] Switzerland
• PMID: 34247896 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2021. Published by Elsevier B.V.

Chemical References

• Androgen Antagonists
• Hormones
• Prostate-Specific Antigen

Topics

• Aged
• Androgen Antagonists
• Hormones
• Humans
• Lymphatic Metastasis
• Male
• Neoplasm Recurrence, Local (therapy)
• Prostate-Specific Antigen
• Prostatic Neoplasms (therapy)
• Salvage Therapy