EAU 2020: Late Toxicity and Quality of Life from GETUG-AFU 22 Study: A Randomised Phase II Trial Comparing 6 Months of Degarelix in Combination with Radiotherapy to Radiotherapy Alone for Patients with Detectable PSA After Radical Prostatectomy

(UroToday.com) The best abstract oncology session at the virtual EAU 2020 meeting featured second place winner Dr. Paul Sargos discussing late toxicity and quality of life from the GETUG-AFU 22 study. Currently, no recommendations exist for patients with immediate detectable prostate specific antigen (PSA) after radical prostatectomy. The purpose of the GETUG-AFU 22 study was to compare the toxicity and quality of life results in adding hormone therapy to radiotherapy for patients with detectable PSA after radical prostatectomy.

Patients with localized prostate cancer, treated by radical prostatectomy (R0 or R1), with a PSA-level post-radical prostatectomy ≥0.2 ng/mL and ≤2 ng/mL at randomization and N0 M0 on imaging were included. Patients were randomized (1:1) to radiotherapy alone or 6 months of degarelix hormone therapy plus radiotherapy. The trial schema is as follows:

GETUG_AFU22_StudySchema.png

Radiotherapy consisted of pelvic irradiation (46 Gy in 23 fractions) with a boost on the prostate bed (66 Gy in 33 fractions). The primary endpoint was event-free survival, and acute and late toxicities were evaluated as secondary endpoints and scored using CTCAE v4.0. Quality of life was assessed with QLQ-C30 and QLQ-PR25 questionnaires at 12 and 24 months. Late toxicity was reported at 24 months.

From January 2013 to September 2015, 125 patients were included (radiotherapy arm: 64 patients; hormone therapy plus radiotherapy arm: 61 patients). Median follow up was 38.1 months (95% CI 31.4-44.1), and the baseline characteristics were well-balanced between both arms: median age was 66 years (50-77), 92% of patients had a performance status of ECOG 0, median Gleason score was 7 (range 3-9), median PSA level was 0.3 ng/mL (range 0.09-1.82) post-radical prostatectomy and 0.6 ng/mL (range 0.12-3.65) at randomization. All patients received 33 fractions of radiotherapy. In the hormone therapy with radiotherapy arm, 98.4% of patients received the 6 months of hormone therapy planned. At 24 months, there was no difference in late genitourinary or gastrointestinal toxicity observed between both arms (p=0.145). Grade 3 late toxicities were reported for 15/125 patients (12%): 8/64 (6.5%) in the radiotherapy arm and 7/61 (5.5%) in the hormone therapy with radiotherapy arm (not significant); no toxicity grade >3 was observed. Quality of life was evaluated at 12 months of follow up in 80% of patients in the radiotherapy arm, and 89% in hormone therapy with radiotherapy arm, and at 24 months for 59% and 77% of patients, respectively. At 12 months, hormone therapy-related symptoms were more important in hormone therapy with radiotherapy arm (p=0.04). At 24 months, no difference in QLQC-30 or QLQ-PR25 analysis was reported.

Dr. Sargos concluded his presentation of GETUG-AFU 22 with the following remarks:

  • This is the only randomized phase II trial comparing radiotherapy versus hormone therapy with radiotherapy in a very selected postoperative population (median pre-radiotherapy PSA was 0.6 ng/mL)
  • Late toxicity by physicians was low and no difference was noted between the two arms at two years for genitourinary/gastrointestinal or maximal toxicity
  • Quality of life assessed with questionnaires showed an impact of ADT related symptoms at one year, but there was no difference with longer follow-up
  • Final results for efficacy are still pending and should be available for next year
Presented by: Paul Sargos, MD, Institut Bergonie, Comprehensive Cancer Center, Bordeaux, France

Written by: Zachary Klaassen, MD, MSc – Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, Twitter: @zklaassen_md at the Virtual 2020 EAU Annual Meeting #EAU20, July 17-19, 2020
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