Surveillance or Metastasis-Directed Therapy for Oligometastatic Prostate Cancer Recurrence: A Prospective, Randomized, Multicenter Phase II Trial

医学 四分位间距 前列腺癌 雄激素剥夺疗法 危险系数 临床终点 生化复发 放射治疗 转移 内科学 无进展生存期 无症状的 随机对照试验 外科 前列腺特异性抗原 肿瘤科 癌症 化疗 前列腺切除术 置信区间
作者
Piet Ost,Dries Reynders,Karel Decaestecker,Valérie Fonteyne,Nicolaas Lumen,Aurélie De Bruycker,Bieke Lambert,Louke Delrue,Renée Bultijnck,Tom Claeys,Els Goetghebeur,Geert Villeirs,Kathia De Man,Filip Ameye,Ignace Billiet,Steven Joniau,Friedl Vanhaverbeke,Gert De Meerleer
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:36 (5): 446-453 被引量:1169
标识
DOI:10.1200/jco.2017.75.4853
摘要

Purpose Retrospective studies suggest that metastasis-directed therapy (MDT) for oligorecurrent prostate cancer (PCa) improves progression-free survival. We aimed to assess the benefit of MDT in a randomized phase II trial. Patients and Methods In this multicenter, randomized, phase II study, patients with asymptomatic PCa were eligible if they had had a biochemical recurrence after primary PCa treatment with curative intent, three or fewer extracranial metastatic lesions on choline positron emission tomography-computed tomography, and serum testosterone levels > 50 ng/mL. Patients were randomly assigned (1:1) to either surveillance or MDT of all detected lesions (surgery or stereotactic body radiotherapy). Surveillance was performed with prostate-specific antigen (PSA) follow-up every 3 months, with repeated imaging at PSA progression or clinical suspicion for progression. Random assignment was balanced dynamically on the basis of two factors: PSA doubling time (≤ 3 v > 3 months) and nodal versus non-nodal metastases. The primary end point was androgen deprivation therapy (ADT)-free survival. ADT was started at symptomatic progression, progression to more than three metastases, or local progression of known metastases. Results Between August 2012 and August 2015, 62 patients were enrolled. At a median follow-up time of 3 years (interquartile range, 2.3-3.75 years), the median ADT-free survival was 13 months (80% CI, 12 to 17 months) for the surveillance group and 21 months (80% CI, 14 to 29 months) for the MDT group (hazard ratio, 0.60 [80% CI, 0.40 to 0.90]; log-rank P = .11). Quality of life was similar between arms at baseline and remained comparable at 3-month and 1-year follow-up. Six patients developed grade 1 toxicity in the MDT arm. No grade 2 to 5 toxicity was observed. Conclusion ADT-free survival was longer with MDT than with surveillance alone for oligorecurrent PCa, suggesting that MDT should be explored further in phase III trials.
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