Irinotecan fluorouracil plus leucovorin is not superior to fluorouracil plus leucovorin alone as adjuvant treatment for stage III colon cancer: Results of CALGB 89803
Irinotecan fluorouracil plus leucovorin is not superior to fluorouracil plus leucovorin alone as adjuvant treatment for stage III colon cancer: Results of CALGB 89803
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DOI：
10.1200/jco.2007.11.2144
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发表时间：
2007-08-10
影响因子：
45.3
通讯作者：
Mayer, Robert J.
中科院分区：
文献类型：
--
作者：
Saltz, Leonard B.;Niedzwiecki, Donna;Mayer, Robert J.
目的：随机对照研究表明，伊立替康（CPT- 11）二线治疗和加用氟尿嘧啶（FU）+亚叶酸钙（LV）一线治疗转移性结直肠癌可延长患者的生存期。当这项研究开始时，FU加LV是III期结肠癌的标准辅助治疗。我们评估的有效性和安全性，每周推注CPT-11加FU加LV在治疗完全切除的III期结肠癌患者。方法共1,264例患者被随机分配到接受标准的每周推注FU加LV方案或每周推注CPT-11加FU加LV。研究的主要终点是总生存期（OS）和无病生存期（DFS）。两个治疗组之间的DFS或OS无差异。毒性，包括致死性毒性，是显着较高的CPT-11加FU加LV arm.Conclusion除了CPT-11每周推注FU加LV没有改善DFS或OS在III期疾病，但增加了致命性和非致命性毒性。该试验表明，转移性疾病治疗的进展并不一定转化为辅助治疗的进展，并且它强化了随机对照辅助研究的必要性。
Purpose Randomized studies have shown that irinotecan (CPT- 11) extends survival in metastatic colorectal cancer patients when administered in second-line and when added to fluorouracil (FU) plus leucovorin (LV) in first-line therapy of metastatic colorectal cancer. When this study was initiated, FU plus LV was standard adjuvant treatment for stage III colon cancer. We evaluated the efficacy and safety of weekly bolus CPT-11 plus FU plus LV in the treatment of patients with completely resected stage III colon cancer.Methods A total of 1,264 patients were randomly assigned to receive either standard weekly bolus FU plus LV regimen or weekly bolus CPT-11 plus FU plus LV. The primary end points of the study were overall survival (OS) and disease- free survival (DFS).Results Treatment arms were well-balanced for patient characteristics and prognostic variables. There were no differences in either DFS or OS between the two treatment arms. Toxicity, including lethal toxicity, was significantly higher on the CPT-11 plus FU plus LV arm.Conclusion The addition of CPT-11 to weekly bolus FU plus LV did not result in improvement in DFS or OS in stage III disease, but did increase both lethal and nonlethal toxicity. This trial demonstrates that advances in the treatment of metastatic disease do not necessarily translate into advances in adjuvant treatment, and it reinforces the need for randomized controlled adjuvant studies.