Based on 10 years of trial follow-up data, docetaxel should not be used to treat high-risk localized prostate cancer, investigators report.
Oliver Sartor, MD, of Tulane University Health Services Center in New Orleans, Louisiana, and colleagues presented 10.4 years of median follow-up data from the phase 3 NRG Oncology/RTOG 0521 trial testing androgen deprivation therapy (ADT) plus external beam radiation therapy (EBRT) with or without 6 cycles of docetaxel chemotherapy in 612 men with high-risk prostate cancer. This modified intent-to-treat analysis included 563 men. Most patients (53%) had Gleason score 9-10 cancers. Another 21% had Gleason 8 disease, PSA levels less than 20 ng/mL, and cT2 or higher tumors based on conventional imaging); 10% had Gleason 8 and PSA levels exceeding 20 ng/mL; and 16% had Gleason 7 and PSA levels higher than 20 ng/mL.
Survival at 10 years was 64% for the ADT + EBRT group and 69% for the ADT + EBRT + docetaxel group – a nonsignificant difference, Dr Sartor’s team reported in European Urology. The restricted mean survival time at 12 years did not differ significantly between groups.
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The investigators also found no differences between groups in disease-free survival, distant metastasis, or PSA recurrence risk.
Docetaxel chemotherapy, however, contributed to grade 5 toxicity in 2 patients.
“While the original publication reported a survival benefit of docetaxel after a median follow-up of 5.7 yr, with the longer follow-up (a median follow-up of 10.4 yr) in this report, the data no longer provide a compelling case for the use of docetaxel for patients with high-risk clinically localized prostate cancer when combined with EBRT and ADT,” Dr Sartor’s team wrote.
The investigators added that PSMA PET, artificial intelligence, and genomic markers may allow more precise identification of the highest-risk patients with localized disease who may benefit from treatment intensification strategies.
Disclosure: This research was partly supported by Sanofi. Please see the original reference for a full list of disclosures.
Reference
Sartor O, Karrison TG, Sandler HM, et al. Androgen deprivation and radiotherapy with or without docetaxel for localized high-risk prostate cancer: long-term follow-up from the randomized NRG Oncology RTOG 0521 trial. Eur Urol. 2023 Aug;84(2):156-163. doi:10.1016/j.eururo.2023.04.024