Preliminary results of a randomized radiotherapy dose-escalation study comparing 70 Gy with 78 Gy for prostate cancer
Preliminary results of a randomized radiotherapy dose-escalation study comparing 70 Gy with 78 Gy for prostate cancer
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DOI：
10.1200/jco.2000.18.23.3904
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发表时间：
2000-12-01
影响因子：
45.3
通讯作者：
Rosen, I
中科院分区：
文献类型：
--
作者：
Pollack, A;Zagars, GK;Rosen, I
目的：确定放射疗法剂量对第三阶段试验中的前列腺癌患者结局和活检阳性的影响。患者和方法：随机分配总共305阶段T1至T3患者接受70 OY或78 GY外束放射治疗在1993年至1998年之间。其中301个是可以评估的。分层基于预处理前列腺特异性抗原水平（PSA）。剂量以每分分数为2 Gy处方，AII患者进行了计划骨盆计算机断层扫描扫描以确认前列腺位置。治疗失败被定义为连续三次随访或抢救治疗的PSA增加。中位随访时间为40个月。分辨率：一百五十名患者被随机分为70-GY ARM和151 TA 78-GY ARM。 70-GY和78-GY组的生化和/或疾病失败（FFF）的自由度分别为69％和79％，在5年时至少显着（log-rank p =，.058） ，多种旋转的COX比例危害回归表明，该研究随机分组是FFF的独立相关性，以及预处理PSA，Gleasan评分和阶段，受益最大的患者从8GY剂量升级中的是那些具有超过10 ng/ml的预处理PSA的剂量。 70-GY和78-GY臂的5年FFF率分别为48％和75％（p = .011）。当治疗PSA小于或等于10 ng/ml时，手臂之间没有差异（类似于80％的5年FFF）。结论：使用保形放射疗法增加8 Gy的剂量增加了8 Gy预处理PSA的患者的前列腺癌FFF发生率超过10 ng/ml，有发现证明了中间至中等前列腺癌的局部持续性当使用70 OY或更少的剂量时，高危患者是一个主要问题。 （c）2000年美国临床肿瘤学会。
Purpose: To determine the effect of radiotherapy dose on prostate cancer patient outcome and biopsy positivity in a phase III trial.Patients and Methods: A total of 305 stage T1 through T3 patients were randomized to receive 70 Oy or 78 Gy of external-beam radiotherapy between 1993 and 1998. Of these, 301 were assessable; stratification was based on pretreatment prostate-specific antigen level (PSA). Dose was prescribed to the isocenter at 2 Gy per fraction, AII patients underwent planning pelvic computed tomography scan to confirm prostate position. Treatment failure was defined as an increasing PSA on three consecutive follow-up visits or the initiation of salvage treatment. Median follow-up was 40 months.Results: One hundred fifty patients were randomized to the 70-Gy arm and 151 ta the 78-Gy arm. The difference in freedom from biochemical and/or disease failure (FFF) rates of 69% and 79% for the 70-Gy and 78-Gy groups, respectively, at 5 years was marginally significant (log-rank P =, .058), Multiple-covariate Cox proportional hazards regression showed that the study randomization was an independent correlate of FFF, along with pretreatment PSA, Gleasan score, and stage, The patients who benefited most from the 8-Gy dose escalation were those with a pretreatment PSA of more than 10 ng/ml; 5-year FFF rates were 48% and 75% (P = .011) for the 70-Gy and 78-Gy arms, respectively. There was no difference between the arms (similar to 80% 5-year FFF) when the pretreatment PSA was less than or equal to 10 ng/mL.Conclusion: A modest dose increase of 8 Gy using conformal radiotherapy resulted in a substantial improvement in prostate cancer FFF rates for patients with a pretreatment PSA of more than 10 ng/mL, There findings document that local persistence of prostate cancer in intermediate- to high-risk patients is a major problem when doses of 70 Oy or less are used. (C) 2000 by American Society of Clinical Oncology.