Bujko K, Glimelius B, Valentini V, Michalski W, Spalek M
Department of Radiotherapy II, M. Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland.
Department of Radiology, Oncology, and Radiation Science, Uppsala University, Uppsala, Sweden.
Eur J Surg Oncol. 2015 Jun;41(6):713-23. doi: 10.1016/j.ejso.2015.03.233. Epub 2015 Apr 13.
There is no consensus on the role of postoperative chemotherapy in patients with rectal cancer who have received preoperative radio(chemo)therapy.
A systematic review and meta-analysis were performed of trials that used preoperative radio(chemo)therapy and randomized patients either between postoperative chemotherapy and observation or between a fluoropyrimidine only (FU-only) and a fluoropyrimidine with oxaliplatin (FU-OXA) as postoperative chemotherapy.
Five randomized studies compared postoperative chemotherapy with observation in a total of 2398 patients. None of these trials demonstrated a statistically significant benefit of chemotherapy for OS and DFS. The pooled differences in OS and DFS did not differ statistically significantly between the chemotherapy group and the observation group. The hazard ratios (HRs) and 95% confidence intervals (CIs) were 0.95 (CI: 0.82-1.10), P = 0.49 and 0.92 (CI: 0.80-1.04), P = 0.19, respectively. In the subgroup of trials in which randomization was performed after surgery (n = 753), a statistically significant positive pooled chemotherapy effect was observed for DFS (HR = 0.79, 95% CI: 0.62-1.00, P = 0.047), but not for OS (P = 0.39). Four randomized trials compared adjuvant FU-OXA with adjuvant FU-only in 2710 patients. In two trials, the difference in DFS between groups was statistically significant in favour of FU-OXA, and in the other two trials, the difference was not significant. The pooled difference in DFS between the FU-OXA group and the FU-only group was not statistically significant: HR = 0.84 (CI: 0.66-1.06), P = 0.15.
The use of postoperative chemotherapy in patients with rectal cancer receiving preoperative radio(chemo)therapy is not based on strong scientific evidence.
对于接受术前放（化）疗的直肠癌患者，术后化疗的作用尚无共识。
对使用术前放（化）疗的试验进行了系统评价和荟萃分析，将患者随机分为术后化疗组与观察组，或术后化疗仅使用氟尿嘧啶（单纯氟尿嘧啶组）与氟尿嘧啶联合奥沙利铂（氟尿嘧啶 - 奥沙利铂组）。
五项随机研究对总共2398例患者比较了术后化疗与观察。这些试验均未显示化疗对总生存期（OS）和无病生存期（DFS）有统计学显著益处。化疗组与观察组在OS和DFS方面的合并差异无统计学显著差异。风险比（HR）及95%置信区间（CI）分别为0.95（CI：0.82 - 1.10），P = 0.49和0.92（CI：0.80 - 1.04），P = 0.19。在术后进行随机分组的试验亚组（n = 753）中，观察到化疗对DFS有统计学显著的阳性合并效应（HR = 0.79，95%CI：0.62 - 1.00，P = 0.047），但对OS无此效应（P = 0.39）。四项随机试验对2710例患者比较了辅助性氟尿嘧啶 - 奥沙利铂与单纯辅助性氟尿嘧啶。在两项试验中，两组间DFS差异有统计学显著意义，有利于氟尿嘧啶 - 奥沙利铂组，而在另外两项试验中差异不显著。氟尿嘧啶 - 奥沙利铂组与单纯氟尿嘧啶组在DFS方面的合并差异无统计学显著意义：HR = 0.84（CI：0.66 - 1.06），P = 0.15。
对于接受术前放（化）疗的直肠癌患者，使用术后化疗并非基于有力的科学证据。
