Wolmark N, Colangelo L, Wieand S
National Surgical Adjuvant Breast and Bowel Project Operations Center, Pittsburgh, PA 15212, USA.
Semin Oncol. 2001 Feb;28(1 Suppl 1):9-13. doi: 10.1016/s0093-7754(01)90245-3.
During the last decade, the National Surgical Adjuvant Breast and Bowel Project (NSABP) has completed six adjuvant chemotherapy trials comparing different adjuvant therapy regimens or adjuvant therapy versus surgery alone. A seventh trial is ongoing. These trials have contributed to defining the role of adjuvant therapy in colon cancer. Patients eligible for inclusion in NSABP trials had been diagnosed as having stage II or III colon cancer with no evidence of gross residual or metastatic disease. The follow-up strategies were similar in the reported trials with follow-up every 3 months for the first 2 years, then every 6 months for the next 3 to 5 years, and annually thereafter. The NSABP C-01 protocol was a three-arm trial comparing an adjuvant semustine/vincristine/5-fluorouracil (5-FU) regimen (MOF) to a Bacille Calmette-Guerin treatment, and to surgery alone. The C-02 protocol investigated whether portal vein infusion of 5-FU improved survival outcome compared with surgery alone. Protocol C-03 compared a semustine/vincristine/5-FU regimen to a 5-FU plus leucovorin (LV) (5-FU/LV) regimen. The NSABP C-04 protocol was a three-arm trial comparing 5-FU/LV, 5-FU plus levamisole, and 5-FU/LV plus levamisole. The NSABP C-05 trial compared 5-FU/LV to 5-FU/LV plus alpha-interferon. Results of NSABP C-01, C-02, C-03, C-04, and C-05 trials are summarized in this report. Patient accrual has completed in the NSABP C-06 trial comparing 5-FU/LV with oral tegafur and plus uracil leucovorin. The NSABP is currently conducting another trial (C-07) comparing 5-FU/LV with 5-FU/LV plus oxaliplatin. The role of adjuvant chemotherapy in stage II colon cancer is also discussed in this report. A recent pooled analysis of studies C-01, C-02, C-03, and C-04 has indicated that the relative treatment benefit in stage II disease is at least equal to the benefit in stage III colon cancers, and concluded that adjuvant chemotherapy also should be considered as the standard of care for stage II colon cancer patients.
在过去十年间，美国国家乳腺与肠道外科辅助治疗项目（NSABP）已完成六项辅助化疗试验，比较不同的辅助治疗方案，或辅助治疗与单纯手术治疗的效果。第七项试验正在进行中。这些试验有助于明确辅助治疗在结肠癌中的作用。符合NSABP试验纳入标准的患者被诊断为患有II期或III期结肠癌，且无肉眼可见的残留或转移病灶。在已报道的试验中，随访策略相似，前两年每3个月随访一次，接下来3至5年每6个月随访一次，此后每年随访一次。NSABP C - 01方案是一项三臂试验，比较辅助性司莫司汀/长春新碱/5 - 氟尿嘧啶（5 - FU）方案（MOF）、卡介苗治疗和单纯手术治疗。C - 02方案研究了与单纯手术相比，门静脉输注5 - FU是否能改善生存结局。C - 03方案比较了司莫司汀/长春新碱/5 - FU方案与5 - FU加亚叶酸（LV）（5 - FU/LV）方案。NSABP C - 04方案是一项三臂试验，比较5 - FU/LV、5 - FU加左旋咪唑和5 - FU/LV加左旋咪唑。NSABP C - 05试验比较了5 - FU/LV与5 - FU/LV加α - 干扰素。本报告总结了NSABP C - 01、C - 02、C - 03、C - 04和C - 05试验的结果。NSABP C - 06试验已完成患者招募，该试验比较5 - FU/LV与口服替加氟加尿嘧啶亚叶酸。NSABP目前正在进行另一项试验（C - 07），比较5 - FU/LV与5 - FU/LV加奥沙利铂。本报告还讨论了辅助化疗在II期结肠癌中的作用。最近对C - 01、C - 02、C - 03和C - 04研究的汇总分析表明，II期疾病的相对治疗益处至少与III期结肠癌的益处相当，并得出结论，辅助化疗也应被视为II期结肠癌患者的标准治疗方法。
