POSTOPERATIVE ADJUVANT CHEMOTHERAPY OR RADIATION-THERAPY FOR RECTAL-CANCER - RESULTS FROM NSABP PROTOCOL R-01
POSTOPERATIVE ADJUVANT CHEMOTHERAPY OR RADIATION-THERAPY FOR RECTAL-CANCER - RESULTS FROM NSABP PROTOCOL R-01
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DOI：
10.1093/jnci/80.1.21
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发表时间：
1988-03-02
影响因子：
10.3
通讯作者：
ROBIDOUX, A
中科院分区：
文献类型：
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作者：
FISHER, B;WOLMARK, N;ROBIDOUX, A
资料来自于1977年11月至1986年10月期间参加国家外科辅助乳腺和肠道项目（NSABP）R-01方案的555例Dukes B和C直肠癌根治性切除术患者。他们的平均学习时间为64.1个月。患者被随机分配至不接受进一步治疗（184例患者）、术后5-氟尿嘧啶、司莫司汀和长春新碱（MOF）辅助化疗（187例患者）或术后放疗（184例患者）。与单纯手术治疗组相比，化疗组的无病生存率（P = 0.006）和生存率（P = 0.05）总体上有所改善。采用比例风险模型，使用全局检验确定是否存在治疗相互作用。分层变量的调查表明，性别，在较小程度上年龄和杜克斯状态，作出个人贡献的无病生存期和生存受益于化疗。当根据性别进行评估时，化疗的5年无病生存率（29% vs. 47%; P <0.001;相对优势2.00）和生存率（37% vs. 60%; P = 0.001;相对优势1.93）仅限于男性。当使用逻辑回归分析测试男性的年龄趋势时，发现化疗在年轻患者中更有利。当接受术后放疗组（4，600 - 4，700 rad，分26-27次;会阴最大5，100 - 5，300 rad）与仅接受手术治疗组相比时，局部区域复发率总体上从25%降至16%（P = 0.06）。使用放射治疗对总体无病生存率（P = 0.4）或生存率（P = 0.7）没有显著的益处。确定患者亚组内放射反应异质性的相互作用的总体检验不显著。总之，这项研究表明，辅助化疗（MOF）的直肠癌管理的好处。观察到的优势仅限于男性。术后放射治疗降低了局部区域复发的发生率，但未能影响总体无病生存率和生存率。
Information is presented from 555 patients with Dukes B and C rectal cancers treated by curative resection who were entered into the National Surgical Adjuvant Breast and Bowel Project (NSABP) protocol R-01 between November 1977 and October 1986. Their average time on study was 64.1 months. The patients were randomized to receive no further treatment (184 patients), postoperative adjuvant chemotherapy with 5-fluorouracil, semustine, and vincristine (MOF) (187 patients), or postoperative radiation therapy (184 patients). The chemotherapy group, when compared with the group treated by surgery alone, demonstrated an overall improvement in disease-free survival (P = .006) and in survival (P = .05). Employing the proportional hazards model, a global test was used to determine the presence of treatment interactions. Investigation of stratification variables employed in this study indicated that sex, and to a lesser extent age and Dukes state, made individual contributions to the disease-free survival and the survival benefit from chemotherapy. When evaluated according to sex, the benefit for chemotherapy at 5 years, both in disease-free survival (29% vs. 47%; P < .001; relative odds, 2.00) and in survival (37% vs. 60%; P = .001; relative odds, 1.93), was restricted to males. When males were tested for age trend with the use of a logistic regression analysis, chemotherapy was found to be more advantageous in younger patients. When the group receiving post-operative radiation (4,600-4,700 rad in 26-27 fractions; 5,100-5,300 rad maximum at the perineum) was compared to the group treated only by surgery, there was on overall reduction in local-regional recurrence from 25% to 16% (P = .06). No significant benefit in overall disease-free survival (P = .4) or survival (P = .7) from the use of radiation has been demonstrated. The global test for interaction to identify heterogeneity of response to radiation within subsets of patients was not significant. In conclusion, this investigation has demonstrated a benefit from adjuvant chemotherapy (MOF) for the management of rectal cancer. The observed advantage was restricted to males. Postoperative radiation therapy reduced the incidence of local-regional recurrence, but it failed to affect overall disease-free survival and survival.