Comparative efficacy of adjuvant chemotherapy in patients with Dukes' B versus Dukes' c colon cancer: Results from four national surgical adjuvant breast and bowel project adjuvant studies (C-01, C-02, C-03, and C-04)
Comparative efficacy of adjuvant chemotherapy in patients with Dukes' B versus Dukes' c colon cancer: Results from four national surgical adjuvant breast and bowel project adjuvant studies (C-01, C-02, C-03, and C-04)
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DOI：
10.1200/jco.1999.17.5.1349
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发表时间：
1999-05-01
影响因子：
45.3
通讯作者：
Rockette, H
中科院分区：
文献类型：
--
作者：
Mamounas, E;Wieand, S;Rockette, H
目的：虽然辅助化疗在Dukes‘C结肠癌患者中的益处已经明确，但在Dykes’B病患者中，这种益处一直受到质疑。为了确定Dukes‘B病患者是否从辅助化疗中受益，并评估其益处的大小，与观察到的Dukes’C患者相比，我们在四个国家外科辅助乳房和Dowel项目序贯试验(C-01、C-02、C-03和C-04)中，根据Dukes‘分期来检验辅助化疗的相对疗效，这些试验相互比较不同的辅助化疗方案或不进行辅助治疗。所有四个试验的资格标准和后续要求是相似的。C-01方案比较佐剂司莫司汀、长春新碱和氟尿嘧啶(5-FU)(MOF方案)与单纯手术治疗的疗效。C-02方案比较了门静脉输注5-FU与单纯手术的围手术期给药。C-03方案比较佐剂5-FU和亚叶酸钙(LV)与佐剂MOF。C-04方案比较佐剂5-FU和LV与5-FU和左旋咪唑(LEV)以及5-FU、LV和LEV的组合。结果：4个试验中41%的患者切除了Dykes‘B肿瘤。在所有四项研究中，所有患者的总体、无病和无复发生存率的改善在Dukes‘B和Dykes’C患者中都是明显的。当检查化疗的相对疗效时，无论Dukes‘s分期，死亡率、复发或无病生存事件总是有观察到的下降，在大多数情况下，Dykes’B级患者的下降幅度与Dykes‘C级患者相同或更大。当对所有四项试验的数据进行联合分析时，Dukes‘B级患者的死亡率降低了30%，而Dykes’C级患者的死亡率下降了18%。无论是否存在不利的预后因素，Dukes‘B期结肠癌患者的死亡率均有所降低。结论：Dukes’B期结肠癌患者受益于辅助化疗，应提供这种治疗方案。不管是否存在其他临床预后因素，Dukes‘B期患者似乎都能从化疗中受益。J Clin Oncol17：1349-1355。(C)1999年，由美国临床肿瘤学会主办。
Purpose: Although the benefit from adjuvant chemotherapy has been clearly established in patients with Dukes' C colon cancer, such benefit has been questioned in patients with Dykes' B disease. To determine whether patients with Dukes' B disease benefit from adjuvant chemotherapy and to evaluate the magnitude of the benefit, compared with that observed in Dukes' C patients, we examined the relative efficacy of adjuvant chemotherapy according to Dukes' stage in four sequential National Surgical Adjuvant Breast and Dowel Project trials (C-01,C-02, C-03, and C-04) that compared different adjuvant chemotherapy regimens with each other or with no adjuvant treatment.Patients and Methods: The four trials included Dukes' B and C patients and were conducted between 1977 and 1990. The eligibility criteria and follow-up requirements were similar for all four trials. Protocol C-01 compared adjuvant semustine, vincristine, and fluorouracil(5-FU) (MOF regimen) with operation alone. Protocol C-02 compared the perioperative administration of a portal venous infusion of 5-FU with operation alone. Protocol C-03 compared adjuvant 5-FU and leucovorin (LV) with adjuvant MOF. Protocol C-04 compared adjuvant 5-FU and LV with 5-FU and levamisole (LEV) and with the combination of 5-FU, LV,and LEV.Results: Forty-one percent of the patients included in these four trials had resected Dykes' B tumors. In all four studies, the overall, disease-free, and recurrence-free survival improvement noted for all patients was evident in both Dukes' B and Dykes' C patients. When the relative efficacy of chemotherapy was examined, there was always an observed reduction in mortality, recurrence, or disease-free survival event, irrespective of Dukes' stage, and in most instances, the reduction was as great or greater for Dykes' B patients as for Dykes' C patients. When data from all four trials were examined in a combined analysis, the mortality reduction was 30% for Dukes' B patients versus 18% for Dykes' C patients. The mortality reduction in Dukes' B patients occurred irrespective of the presence or absence of adverse prognostic factors.Conclusion: Patients with Dukes' B colon cancer benefit from adjuvant chemotherapy and should be presented with this treatment option. Regardless of the presence or absence of other clinical prognostic factors, Dukes' B patients seem to benefit from chemotherapy administration. J Clin Oncol 17:1349-1355. (C) 1999 by American Society of Clinical Oncology.