Objective To explore the independent prognosis factors of long-term survival for patients of advanced duodenal cancer and evaluate the efficacy and safety of its first-line chemotherapy. Methods From June 2008 to January 2016, a total of 40 advanced duodenal cancer patients were analyzed. Only 31 patients received chemotherapy, including 13 patients of GEMOX regimen, 13 patients of FOLFOX regimen, 2 patients of capecitabine regimen and 3 patients of gemcitabine regimen. The efficacy and safety were evaluated by RECIST 1.1 and NCI-CTC 4.0 criteria. Survival analysis was performed by using Kaplan-Meier method. Univariate analysis of prognosis was made by Log-rank method. Multivariable analysis of prognosis was used by Cox proportional hazard regression model. Results The total treatment cycle of chemotherapy was 146, and the median treatment cycle was 4(2-12 cycles). CR was not observed. For GEMOX regimen, 1 case of PR and 10 cases of SD and 2 cases of PD were observed with disease control rate (DCR) of84.6％. For FOLFOX regimen, 6 cases of SD and 7 cases of PD were observed with DCR of 46.2％. For capecitabine and gemcitabine regimen, 3 cases of SD and 2 cases of PD were observed with DCR of 60.0％. The median overall survival (OS) of chemotherapy and non-chemotherapy were 15.7 months and 4.4 months(P<0.001). The median OS of GEMOX, FOLFOX regimen and single drug group were 27.9 months, 15.2 months and 15.2 months(P=0.656). The median progression-free survival (PFS) of GEMOX, FOLFOX regimen and single drug group were 7.8 months, 4.0 months and 5.1 months(P=0.053). The major treatment-related side effects including leucopenia, neutropenia, anemia, fatigue, nausea and etc, were mainly in grade 1-2. In univariate analysis, depth of invasion, degree of differentiation, liver metastasis and chemotherapy correlated with the prognosis of the patients of advanced duodenal cancer(P<0.05). Multivariable analysis revealed that degree of differentiation, liver metastasis and chemotherapy were independent risk factors of prognosis. Conclusion GEMOX, FOLFOX, capecitabine and gemcitabine regimen were effective and well-tolerated in first-line chemotherapy. GEMOX regimen may have a longer OS and PFS in first-line chemotherapy. Degree of differentiation, liver metastasis and chemotherapy may serve as dependent prognostic factors with advanced duodenal cancer, which can be used to guide the choice and practice of the therapy for advanced duodenal cancer.%目的探讨晚期十二指肠癌患者一线化疗方案的疗效与安全性以及影响预后的因素.方法回顾分析本院2008年6月至2016年1月收治的晚期十二指肠癌患者40例,9例未接受化疗,31例接受化疗,其中GEMOX方案13例、 FOLFOX方案13例、卡培他滨单药2例和吉西他滨单药3例.采用RECIST 1.1版与NCI-CTC 4.0版标准评价化疗的近期疗效和不良反应.生存分析采用Kaplan-Meier法并行Log-rank检验,多因素分析采用Cox比例风险回归模型.结果31例化疗患者均可评价疗效和不良反应,共完成化疗146个周期,中位化疗4个周期(2～12个周期).GEMOX方案组获PR 1例、SD 10例、PD 2例,疾病控制率(DCR)为84.6％;FOLFOX方案组获SD 6例、PD 7例,DCR为46.2％;单药组:卡培他滨获SD 2例,吉西他滨获SD 1例、PD2例,DCR为60.0％.31例化疗患者的中位生存期(OS)为15.7个月,9例未化疗患者的中位OS为4.4个月,差异有统计学意义(P<0.001).GEMOX方案组的中位OS为27.9个月,FOLFOX方案组为15.2个月,单药组为15.2个月,差异无统计学意义(P=0.656). GEMOX方案组的中位无进展生存期(PFS)为7.8个月,FOLFOX方案组为4.0个月,单药组为5.1个月,差异无统计学意义(P=0.053).常见不良反应多为1～2级,主要为白细胞减少、中性粒细胞减少、贫血、乏力及恶心等.单因素分析显示,浸润深度、分化程度、是否肝转移及是否化疗与晚期十二指肠癌的预后有关(P<0.05).Cox多因素分析显示,分化程度、是否肝转移及是否化疗是影响晚期十二指肠癌患者预后的独立因素.结论GEMOX方案、FOL-FOX方案、卡培他滨单药及吉西他滨单药一线化疗均对晚期十二指肠癌有效,且耐受性良好;其中GEMOX方案可能有更好的生存获益.分化程度、是否肝转移及是否化疗可能是影响晚期十二指肠癌患者的预后因素,临床上可作参考.
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