The appropriate first-line chemotherapy regimen for incurable pancreatic cancer in clinical practice: A consideration of patients’ overall survival and quality of life

<b>Purpose</b>: For incurable pancreatic cancer, the therapeutic goal is to prolong survival and maintain the quality of life (QOL). Unexpected outpatient consultation (OCT) and emergency hospitalization lead to the deterioration of QOL. The National Comprehensive Cancer Network (NCCN) guidelines recommend FOLFIRINOX and nabPTX+GEM as the preferred first-line regimens. Japanese clinical practice guidelines further recommend GEM and S-1. At present, no treatment strategy considers QOL during patients’ entire clinical course. <b>Methods</b>: In this study, hospital-free survival (HFS), defined as the period without hospitalization and OCT, was introduced as a new indicator of the qualitative aspect of overall survival (OS). We compared OS, length of hospitalization (LOH), OCT, and HFS for the four first-line chemotherapy groups. <b>Results</b>: No significant difference was observed in the median OS and HFS, nor was there a strong correlation between OS and LOH, based on the four first-line chemotherapy groups. There were strong correlations between OS and OCT, and OS and HFS, in all first-line chemotherapy groups. The ratio of OCT to OS was similar for mFOLFIRINOX and nabPTX+GEM. S-1 had the lowest OCT-to-OS ratio. The ratio of HFS to OS declined from S-1, nabPTX+GEM, mFOLFIRINOX, and GEM, from highest to lowest. <b>Conclusion</b>: The appropriate first-line chemotherapy for incurable pancreatic cancer, ensuring OS and QOL, may be S-1, nabPTX+GEM, mFOLFIRINOX, and GEM, in that order; although, a bias for the elderly exists among S-1 group patients. In the future, when conducting clinical trials on chemotherapy, it may be necessary to examine QOL during the entire clinical course.The ethics committee of the Miyagi Cancer Center approved this study (approval number: 4). All procedures were performed according to the ethical standards of the institutional and national research committees, and the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.<b><i></i></b> According to the local ethics policy for the retrospective analysis of our own anonymized clinical data, informed consent, with an opt-out option, was obtained from all patients.<br>

**研究目的**：针对不可治愈性胰腺癌，治疗目标为延长患者生存时间并维持生活质量（Quality of Life, QOL）。意外门诊就诊（Outpatient Consultation, OCT）与急诊住院会导致生活质量下降。美国国家综合癌症网络（National Comprehensive Cancer Network, NCCN）指南推荐FOLFIRINOX方案与nabPTX+GEM方案作为一线优选化疗方案；日本临床实践指南则进一步推荐吉西他滨（GEM）与S-1方案。目前尚无治疗策略在患者全临床病程中兼顾生活质量。**研究方法**：本研究引入无住院与门诊就诊生存期（Hospital-free Survival, HFS）——定义为未发生住院与意外门诊就诊的时间段——作为总生存期（Overall Survival, OS）质量维度的新型评价指标。本研究针对4种一线化疗方案组，比较了总生存期、住院时长（Length of Hospitalization, LOH）、门诊就诊情况及无住院与门诊就诊生存期。**研究结果**：基于4种一线化疗方案组，中位总生存期与中位无住院与门诊就诊生存期均无显著差异，且总生存期与住院时长未呈现强相关性。在所有一线化疗方案组中，总生存期与门诊就诊情况、总生存期与无住院与门诊就诊生存期均呈现强相关性。mFOLFIRINOX方案与nabPTX+GEM方案的门诊就诊占总生存期比例相近；S-1方案的该比例最低。无住院与门诊就诊生存期占总生存期的比例从高到低依次为S-1、nabPTX+GEM、mFOLFIRINOX与吉西他滨。**研究结论**：兼顾总生存期与生活质量的不可治愈性胰腺癌一线化疗方案优选顺序依次为S-1、nabPTX+GEM、mFOLFIRINOX与吉西他滨；但S-1方案组患者存在老年人群偏倚。未来开展化疗相关临床试验时，有必要在患者全临床病程中评估生活质量。本研究经宫城县癌症中心伦理委员会批准（批准编号：4）。所有研究操作均符合机构及国家研究委员会的伦理标准，以及1964年《赫尔辛基宣言》及其后续修订版或同类伦理标准。根据本院匿名回顾性临床数据分析的当地伦理政策，所有患者均已签署知情同意书，且提供了退出选择权。