Docetaxel Versus Surveillance After Radical Radiotherapy for Intermediate- or High-risk Prostate Cancer-Results from the Prospective, Randomised, Open-label Phase III SPCG-13 Trial
| Autor: | Lars Franzén, Lennart Åström, Teppo Huttunen, Marie Hjälm-Eriksson, Camilla Thellenberg-Karlsson, Mihalj Zeke, Pirkko-Liisa Kellokumpu-Lehtinen, Claes Ginman, Markku J Leskinen, Ann-Sofie Fransson |
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| Rok vydání: | 2019 |
| Předmět: |
Male
medicine.medical_specialty Urology 030232 urology & nephrology Antineoplastic Agents Docetaxel urologic and male genital diseases Risk Assessment Disease-Free Survival Androgen deprivation therapy 03 medical and health sciences Prostate cancer 0302 clinical medicine Prednisone medicine Clinical endpoint Humans Prospective Studies Watchful Waiting Aged business.industry Hazard ratio Prostatic Neoplasms Androgen Antagonists Middle Aged medicine.disease Combined Modality Therapy Confidence interval 030220 oncology & carcinogenesis business Febrile neutropenia medicine.drug |
| Zdroj: | European urology. 76(6) |
| ISSN: | 1873-7560 |
| Popis: | Background Docetaxel combined with androgen deprivation therapy (ADT) has improved patient survival for advanced prostate cancer (PCa). Objective This randomised trial aimed to evaluate whether six courses of docetaxel improved biochemical disease–free survival (BDFS) after radical radiotherapy (RT) for intermediate- or high-risk PCa patients. Design, setting, and participants A total of 376 patients were randomised in this multinational phase III study, and received either six cycles of adjuvant docetaxel 75 mg/m2 every 3 wk without continuous prednisone (arm A, n = 188) or surveillance (arm B, n = 188) after RT (NTC006653848). Neoadjuvant/adjuvant ADT was mandatory for all the patients. The primary endpoint was rising prostate-specific antigen (PSA) ≥2 ng/ml above the nadir PSA value. Intermediate- or high-risk PCa was defined as T2 with a Gleason score (GS) of 4 + 3, PSA > 10; T2, GS 8–10, ≤ 70 ng/ml; or any T3. The patients were followed for 5 yr by assessing PSA levels every 3 mo for 2 yr and every 6 mo thereafter. Outcome measurements and statistical analysis The study power was 89% to detect a difference in BDFS between groups, and the sample size calculation accounted for the T2/T3 distribution, where a 12%/15% difference in BDFS was assumed for the T2/T3 patients. Results and limitations All six cycles were completed in 147 (78%) of the patients in arm A. The median age was 67 yr in both treatment groups, 75% had T3 disease, and 47% had GS 8–10. The median follow-up was 59 mo (range 1–111 mo). The primary endpoint was observed for 58 patients in arm A (docetaxel) and for 57 patients in arm B (surveillance). The Kaplan-Meier analysis showed no difference in the BDFS curves (p = 0.6) between the treatment groups. The 5-yr estimated biochemical progression rates were 31% for arm A and 28% for arm B. Febrile neutropenia occurred in 16% of the docetaxel patients. No deaths were related to the docetaxel treatment. There were 43 deaths during the trial, including 20 in arm A and 23 in arm B, of which nine and seven, respectively, were due to PCa. The hazard ratio from Cox multivariate analysis for PSA progression of arm A (docetaxel) versus arm B (surveillance) was 1.14 (95% confidence interval 0.79–1.64, p = 0.5). Conclusions Adjuvant docetaxel without prednisone did not improve BDFS after radical RT with ADT for intermediate- or high-risk PCa. Patient summary We compared six cycles of adjuvant docetaxel given after radical external radiotherapy plus androgen deprivation therapy to surveillance in intermediate- and high-risk localised prostate cancer. We found no overall benefit in this setting. |
| Databáze: | OpenAIRE |
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