Prostate cancer radiation dose response: Results of the M. D. Anderson phase III randomized trial
Prostate cancer radiation dose response: Results of the M. D. Anderson phase III randomized trial
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DOI：
10.1016/s0360-3016(02)02829-8
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发表时间：
2002-08-01
影响因子：
7
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：在1993年至1998年之间进行了一项随机放疗剂量升级试验，以比较70 vs. 78 Gy在控制前列腺癌中的疗效。方法和材料：总共305阶段T1-T3患者被纳入该试验，并具有，及其，且材料。可以评估这些301个中位随访的中位随访。在301例患者中，有150例在70 GY臂中，151例在78 Gy臂中。主要终点是免于失败（FFF），包括生化衰竭，该衰竭定义为前列腺特异性抗原（PSA）水平的3升。根据放射疗法的完成计算了Kaplan-Meier生存分析。对数秩检验用于比较组。 COX比例危害回归分析用于检查多变量分析中研究随机化的独立性。分析：通过随机组和阶段，格里森评分和预处理PSA水平，患者的分布均匀。 6年时70和78 Gy臂的FFF率分别为64％和70％（p = 0.03）。剂量升级到78 Gy优先使经过预处理psa> 10 ng/ml的人受益； 78 GY臂的FFF率为62％，而接受70 Gy的人（p = 0.01）的FFF率为43％。对于预处理PSA小于或等于10 ng/mL的患者，未发现明显的剂量反应，平均6年FFF率约为75％。尽管总体存活率没有差异，但对PSA水平> 10 ng/ml的远处转移率的自由度较高，而接受治疗为78 Gy的人（6年时为98％vs. 88％，P = 0.056）。 78 GY组的直肠副作用也明显更大。 70 Gy和78 Gy臂的6年级或更高级别的毒性率分别为12％和26％（p = 0.001）。 2级或更高的膀胱并发症相似，为10％。对于78 GY组中的患者，2级或更高的直肠毒性与治疗为> 70 Gy的直肠的比例高度相关。结论：增加8 Gy导致中等到中间患者的FFF高度显着改善高风险，尽管直肠反应也增加了。限制接收到大于或等于70 Gy的直肠体积的剂量升级技术
Purpose: A randomized radiotherapy dose escalation trial was undertaken between 1993 and 1998 to compare the efficacy of 70 vs. 78 Gy in controlling prostate cancer.Methods and Materials: A total of 305 Stage T1-T3 patients were entered into the trial and, of these, 301 with a median follow-up of 60 months, were assessable. Of the 301 patients, 150 were in the 70 Gy arm and 151 were in the 78 Gy arm. The primary end point was freedom from failure (FFF), including biochemical failure, which was defined as 3 rises in the prostate-specific antigen (PSA) level. Kaplan-Meier survival analyses were calculated from the completion of radiotherapy. The log-rank test was used to compare the groups. Cox proportional hazard regression analysis was used to examine the independence of study randomization in multivariate analysis.Results: There was an even distribution of patients by randomization arm and stage, Gleason score, and pretreatment PSA level. The FFF rates for the 70- and 78 Gy arms at 6 years were 64% and 70%, respectively (p = 0.03). Dose escalation to 78 Gy preferentially benefited those with a pretreatment PSA > 10 ng/mL; the FFF rate was 62% for the 78 Gy arm vs. 43% for those who received 70 Gy (P = 0.01). For patients with a pretreatment PSA less than or equal to10 ng/mL, no significant dose response was found, with an average 6-year FFF rate of about 75%. Although no difference occurred in overall survival, the freedom from distant metastasis rate was higher for those with PSA levels > 10 ng/mL who were treated to 78 Gy (98% vs. 88% at 6 years, p = 0.056). Rectal side effects were also significantly greater in the 78 Gy group. Grade 2 or higher toxicity rates at 6 years were 12% and 26% for the 70 Gy and 78 Gy arms, respectively (p = 0.001). Grade 2 or higher bladder complications were similar at 10%. For patients in the 78 Gy arm, Grade 2 or higher rectal toxicity correlated highly with the proportion of the rectum treated to >70 Gy.Conclusion: An increase of 8 Gy resulted in a highly significant improvement in FFF for patients at intermediate-to-high risk, although the rectal reactions were also increased. Dose escalation techniques that limit the rectal volume that receives greater than or equal to70 Gy to