Dr. Paul Sargos (Institute Bergonie, Bordeaux, France) presented the first results of the GETUG-AFU 22 study and won the second prize in the EAU20 Best Abstract Awards for Oncology1.
The GETUG-AFU 22 study, a multicentre randomized phase-2 trial, compared 6 months of degarelix short-term androgen deprivation therapy (STADT) in combination with radiotherapy (RT) and with RT alone as salvage treatment for patients with detectable prostate-specific antigen (PSA) levels after radical prostatectomy (RP). The primary efficacy endpoint was event-free survival, which will be reported later this year. Key secondary endpoints were toxicity (as measured by CTCAE V4.0) and quality of life (QLQ-C30 and QLQ-PR25) results.
Dr. Sargos presented the key secondary endpoints in 125 patients with localized prostate cancer, treated by RP, with a PSA level post-RP ≥ 0.2 ng/mL and ≤ 2 ng/mL at randomization and N0 M0 on imaging were included. Median PSA level was 0.3 ng/mL (0.09-1.82) post-RP and 0.6 ng/mL (0.12-3.65) at randomisation.
With a median follow-up of 38 months, the 2-years toxicity showed no differences in late genitourinary or gastrointestinal toxicity between the 2 arms (P=0.145). No difference was seen between the 2 arms for erectile dysfunction, while 2 patients in each arm reported grade-3 cardiovascular events (in the RT-alone arm, tight coronary stenosis, and femoral arteritis; in the RT + STADT arm, pulmonary embolism, and cardiac arrhythmia). The number of second cancers was not significantly different between the arms.
Quality of life was evaluated in 59% of patients in the RT arm and 77% in the RT + STADT arm. At 12 months, QLQ-PR25 related symptoms were significantly higher in the RT + STADT arm (P=0.04), but these data normalized by 24 months when no significant difference in QLQC-30 or QLQ-PR25 outcomes was reported. This study highlights the good tolerance of postoperative radiotherapy.
Reference:
1. Sargos P, et al. Late toxicity and quality of life from GETUG-AFU 22 study: A randomized phase ii trial comparing 6 months of degarelix in combination with radiotherapy to radiotherapy alone for patients with detectable PSA after radical prostatectomy. 2020 European Association of Urology Virtual Congress. July 17-26, 2020 Abstract PT925.