Abstract: Objective We conducted a multicenter observational study comparing the FOLFIRINOX regimen and the AG regimen as the first-line treatment in advanced pancreatic cancer, and summarized experience to guide clinical practice. Methods Participants of this study were retrospectively recruited from the Guangdong Provincial People′s Hospital, Sun Yat-sen Memorial Hospital of Sun Yat-Sen University, the First Affiliated Hospital of Sun Yat-sen University, the First Affiliated Hospital of Guangdong Pharmaceutical University, and the Zhongshan People′s Hospital between January 2016 and June 2020. All these patients were diagnosed with advanced pancreatic cancer. They all received FOLFIRINOX regimen or AG regimen as the first-line treatment, and all had complete survival data. The last follow-up time was October 31, 2020. The primary endpoint was OS. The survival analysis was performed by the Kaplan-Meier method. A two-tailed P-value of less than 0.05 was considered as statistically significant. Results The five centers included a total of 62 patients who met the inclusion and exclusion criteria. According to the first-line chemotherapy regimen, 26 patients were included in the FOLFIRINOX （FFX） regimen group, and the remaining 36 patients were included in the AG regimen group. The median OS of the FFX regimen group and the AG regimen group were 13 months and 11 months, respectively （P=0.202）. And the median PFS were 10 months and 11 months the FFX regimen group and the AG regimen group, respectively（P=0.132）. There was no statistically significant difference in OS and PFS between the two groups. There were 5 patients receiving FFX regimen as the first-line treatment but AG regimen as the second-line, and 6 patients receiving AG regimen as the first-line treatment but FFX regimen as the second-line treatment. A total of 11 patients were included in the analysis. The median OS was 13 months and 11 months, respectively. When the CA199 level increased abnormally, especially 59 times higher than the normal value, the median OS of the AG group （10.21 months） was numerically longer than the FFX group （3.5 months）. Due to the lack of data, statistical analysis of Objective efficiency and adverse reactions was abandoned. Conclusion There were no significant differences in the efficacy between the FOLFIRINOX regimen group and the AG regimen group as the first-line treatment for advanced pancreatic cancer. It seemed that the order of medication didn′t affect the efficacy. The use of CA199 level to predict the efficacy of different treatments may be helpful, and it deserves further exploration.

Key words: advanced pancreatic cancer, FOLFIRINOX regimen, AG regimen, multicenter observational study

摘要： 目的 开展FOLFIRINOX方案和AG方案一线治疗晚期胰腺癌的多中心观察性研究,总结经验指导临床实践。方法 选取2016年1月~2020年6月,在广东省人民医院、中山大学孙逸仙纪念医院、中山大学附属第一院、广东药科大学附属第一医院以及中山市人民医院住院治疗的病理确诊的晚期胰腺癌患者,一线接受FOLFIRINOX方案或AG方案治疗,有完整生存资料。末次随访时间为2020年10月31日。主要终点指标为OS。生存资料检验采用K-M法,以P≤0.05为有统计学意义。结果 五个中心共纳入符合纳入标准和排除标准病例62例,按一线化疗方案分为FOLFIRINOX方案组26例和AG方案组36例,FOLFIRINOX方案组与AG方案组中位OS分别为13个月和11个月（P=0.202）、PFS分别为10个月和11个月（P=0.132）,两组差别均无统计学意义。一线FOLFIRINOX方案序贯二线AG方案化疗5例,反之有6例,中位OS分别为13个月和11个月。CA199高于正常值59倍或以上,AG组OS中位数10.21个月,数值上似长于FOLFIRINOX组的3.5个月。客观有效率、不良反应等缺漏较多,放弃统计分析。结论 FOLFIRINOX方案和AG方案一线治疗晚期胰腺癌疗效相似;用药顺序似不影响疗效;CA199水平用于预测不同方案的疗效可能有一定帮助,值得进一步探讨。

关键词: 晚期胰腺癌, FOLFIRINOX方案, AG方案, 多中心研究