The efficacy of oxalipatin (Ox) when added to 5-flurorouracil/leucovorin (FU/L) in stage II colon cancer
发布日期：2011-07-13 15:54 文章来源：互联网
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Background: The use of adjuvant chemotherapy in patients (pts) with stage II colon cancer who lack “high-risk” features ([HiR] perforation, T4 disease and/or less than 12 lymph nodes examined [LNEx]) is highly controversial. We investigated the addition of Ox to FU/L in pts with stage II colon cancer as well as in subsets without HiR (“low/intermediate-risk” [LoR]) and those with HiR. Methods: Our analysis includes 4,883 pts with stage II and III colon cancer (2009 with stage II disease) treated using FU/L regimens, and 3,788 pts with stage II and III colon cancer (991 with stage II disease) treated with FU/L Ox. Pts from 4 NSABP trials were included: C-05, C-06, C-07, C-08. Only in C-07 was there random assignment to Ox. Analyses controlled for stage, race, age, gender, LNEx, T-stage, bevacizumab (bev) treatment, and the bev-time interaction as appropriate. Results: Overall, there was a highly significant benefit of Ox for DFS and OS in pts with stage II and III disease combined. A test for a stage-Ox interaction was not significant for DFS (p0.20) or OS (p0.38), suggesting that the relative effect of Ox did not differ by stage. The effect of Ox remained significant for DFS and OS in stage III. For stage II, Ox did not significantly improve outcomes. A further exploratory analysis in LoR and HiR stage II disease demonstrates 5-year DFS of 0.80 for LoR pts treated without Ox, and 0.83 for those treated with Ox (3% absolute difference). For pts with HiR features these same estimates were 0.76 without Ox and 0.81 for those treated with Ox (5% absolute difference). 5-year OS estimates for the LoR group were 0.89 and 0.91, and for the HiR pts, 0.87 and 0.90 treated without and with Ox, respectively. Conclusions: Regardless of risk status, we were unable to show a statistically significant benefit for the addition of Ox to FU/L in 3,000 pts with stage II colon cancer participating in NSABP clinical trials in this exploratory pooled analysis. The observed 2-3% increase in 5-year OS with Ox for LoR and HiR stage II colon cancer may not outweigh the substantial risk of adverse events including persistent neuropathy. Funded by grants U10-CA-37377, U10-CA-69974, U10-CA-12027, U10-CA-69651, with support from Brystol-Myers Squibb, sanofi-aventis, and Genentech.
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