Short-Term Androgen Deprivation Therapy and High-Dose Radiotherapy in Intermediate- and High-Risk Localized Prostate Cancer: Results from the GETUG 14 Randomized Phase III Trial

IF 6.4 1区医学 Q1 ONCOLOGY

International Journal of Radiation Oncology Biology Physics Pub Date : 2024-10-01 DOI:10.1016/j.ijrobp.2024.08.017

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引用次数: 0

Abstract

Purpose/Objective(s)

Few studies compared short-term androgen deprivation (STADT) with high-dose radiotherapy (STADT-RT) versus high-dose radiotherapy (RT) alone in localized prostate cancer.

Materials/Methods

The GETUG 14 study randomized 376 patients between RT (n=191) and STADT-RT (n=179). RT dose was 80 Gy in both arms and STADT was monthly triptorelin and daily flutamide for a total duration of 4 months, starting 2 months before irradiation. Disease-free survival (DFS) was the primary endpoint. Secondary endpoints were overall survival (OS), biochemical failure (BF), metastasis failure (MF), toxicity and quality of life.

Results

With a median follow-up of 84 months, five-year DFS was 76% in RT arm versus 84% in STADT-RT arm (hazard ratio [HR] = 0.64; [95% CI 0.43 - 0.89]; P = .02). ADT decreased BF (HR = 0.45; P = .001) and MF (HR = 0.5; P = .09) but not OS (HR = 1.22; P = .54). No difference was found in terms of gastrointestinal (26% of grade ≥2 in both arm, P = .97) and genito-urinary acute toxicity (39% for RT and 42% for STADT-RT, P = .55). Similarly, no difference was found in late toxicity and quality of life.

Conclusion

STADT improves disease-free survival in intermediate and high-risk prostate cancer patients receiving high dose (80 Gy) RT, without any deterioration in the safety profile.

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中高危局部前列腺癌的短期雄激素剥夺疗法和大剂量放疗：GETUG 14 随机 III 期试验的结果

材料/方法 GETUG 14研究将376名患者随机分为RT组（191人）和STADT-RT组（179人）。两组患者的 RT 剂量均为 80 Gy，STADT 为每月一次曲普瑞林和每天一次氟他胺，总疗程为 4 个月，从照射前 2 个月开始。无病生存期（DFS）是主要终点。结果中位随访84个月，RT治疗组的五年无病生存率为76%，STADT-RT治疗组为84%（危险比[HR] = 0.64；[95% CI 0.43 - 0.89]；P = .02）。ADT降低了BF（HR = 0.45；P = .001）和MF（HR = 0.5；P = .09），但没有降低OS（HR = 1.22；P = .54）。在胃肠道急性毒性（两组均有26%≥2级，P = .97）和泌尿生殖系统急性毒性（RT为39%，STADT-RT为42%，P = .55）方面未发现差异。结论STADT能提高接受大剂量（80 Gy）RT治疗的中高危前列腺癌患者的无病生存率，但安全性没有任何下降。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Radiation Oncology Biology Physics 医学-核医学

CiteScore

11.00

自引率

7.10%

发文量

2538

审稿时长

6.6 weeks

期刊介绍： International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field. This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.