Abstract
BackgroundThe National Comprehensive Cancer Network (NCCN) guidelines have recommended tailored chemotherapy for stage III high-risk (T4 and/or N2) and low-risk (T1-T3 and N1) colon cancer since 2018. Studies have investigated the effect of relative dose intensity (RDI) of FOLFOX on stage III colon cancer survival, however, none has performed a stratified analysis by risk profiles. This study aims to identify the FOLFOX optimal RDI for high-risk and low-risk stage III colon cancer patients. MethodsData on 407 eligible patients, diagnosed with stage III colon cancer in 2011 who received FOLFOX, were collected by 8 population-based cancer registries. Multivariable Cox model and Fine-Gray competing risks model were employed to explore Optimal RDI defined as the lowest RDI administered without significant differences in either overall or cause-specific death. ResultsAmong the 168 high-risk patients, the optimal RDI cut-off was 70% (HR = 1.59 with 95% CI: 0.69-3.66 in overall mortality; HR = 1.24 with 95% CI: 0.42-3.64 in cause-specific mortality when RDI < 70% vs. RDI ≥ 70%). Among the 239 low-risk patients, none of the evaluated cut-offs were associated with significant differences in risk of death between comparison groups. The lowest assessed RDI was 45%, HR = 0.80; 95% CI: 0.24 to 2.73 for overall mortality and HR = 0.53; 95% CI: 0.06 to 4.95 for cause-specific mortality, when RDI <45% versus RDI ≥45%. ConclusionsThere is no significant harm on the risk of death when reducing RDI by <30% for high-risk patients. For the low-risk patients, we found that RDI as low as 45% did not significantly affect the risk of death.
Highlights
Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer, and the second leading cause of cancer death for males and females combined in the United States (US).[1]
Non-Hispanic whites (67%), and privately insured (56%). 60% of patients resided in urban areas, 71% lived in low poverty areas, 78% were in high education areas, 51% were in high married census tracts, and more than 70% were from the states of Florida, Louisiana, and North Carolina
Our results found that the optimal cut-off point of relative dose intensity (RDI) was 70% in the high-risk stage III colon cancer patients, which implied for patients who need dose reductions due to toxicities, a 70% of the preplanned dose does not seem to impact survival outcomes; we didn’t find significant differences in risk of death at predefined RDI cutoff points of 45%, 50%, 55%, 60%, 65%, and 70% for low-risk stage III colon cancer
Summary
Colorectal cancer (CRC) is the fourth most commonly diagnosed cancer, and the second leading cause of cancer death for males and females combined in the United States (US).[1]. The meta-analysis of these trials showed that for stage III colon cancer patients, 3-month FOLFOX therapy resulted in a lower disease-free survival rate, for the high-risk subgroup (patients with T4, N2, or both) (definitions of T and N are in Appendix 1), whereas among patients with low-risk cancers (T1, T2, or T3 and N1), the noninferiority with the 3-month chemotherapy use was not proven.[10]
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