Su Yung-Yeh, Chiang Nai-Jung, Yang Yi-Hsin, Yen Chia-Jui, Bai Li-Yuan, Chiu Chang-Fang, Chuang Shih-Chang, Yang Shih-Hung, Chou Wen-Chi, Chen Jen-Shi, Chiu Tai-Jan, Chen Yen-Yang, Chan De-Chuan, Peng Cheng-Ming, Chiu Sz-Chi, Li Chung-Pin, Shan Yan-Shen, Chen Li-Tzong
National Institute of Cancer Research, National Health Research Institutes, Tainan 704016, Taiwan.
Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704302, Taiwan.
Cancers (Basel). 2023 Feb 5;15(4):1008. doi: 10.3390/cancers15041008.
The nomogram derived from the pivotal phase III NAPOLI-1 study demonstrated a significant ability to predict median overall survival (OS) in gemcitabine-refractory metastatic pancreatic ductal adenocarcinoma (PDAC) treated with liposomal irinotecan plus fluorouracil and leucovorin (nal-IRI+5-FU/LV). However, the NAPOLI-1 nomogram has not been validated in a real-world setting and therefore the applicability of the NAPOLI-1 nomogram in daily practice remains unknown. This study aims to evaluate the NAPOLI-1 nomogram in a multicenter real-world cohort.
The NAPOLI-1 nomogram was applied to a previously established cohort of metastatic PDAC patients treated with nal-IRI+5-FU/LV in nine participating centers in Taiwan. Patients were divided into three risk groups according to the NAPOLI-1 nomogram. The survival impact of relative dose intensity at 6 weeks (RDI at 6 weeks) in different risk groups was also investigated.
Of the 473 included patients, the median OSs of patients classified as low ( = 156), medium ( = 186), and high ( = 131) risk were 10.9, 6.3, and 4.3 months, respectively ( < 0.0001). The survival impact of RDI at 6 weeks remained significant after stratification by risk groups, adjustment with Cox regression, inverse probability weighting, or propensity score matching.
Our results support the usefulness of the NAPOLI-1 nomogram for risk stratification in gemcitabine-refractory metastatic PDAC treated with nal-IRI+5-FU/LV in daily practice. We further showed that the RDI at 6 weeks is an independent prognostic factor beyond the NAPOLI-1 nomogram.
源自关键的III期NAPOLI-1研究的列线图显示，对于接受脂质体伊立替康联合氟尿嘧啶和亚叶酸钙（nal-IRI+5-FU/LV）治疗的吉西他滨难治性转移性胰腺导管腺癌（PDAC）患者，该列线图在预测中位总生存期（OS）方面具有显著能力。然而，NAPOLI-1列线图尚未在真实世界环境中得到验证，因此其在日常实践中的适用性仍然未知。本研究旨在评估NAPOLI-1列线图在多中心真实世界队列中的情况。
将NAPOLI-1列线图应用于台湾9个参与中心先前建立的接受nal-IRI+5-FU/LV治疗的转移性PDAC患者队列。根据NAPOLI-1列线图将患者分为三个风险组。还研究了不同风险组中6周相对剂量强度（6周RDI）对生存的影响。
在纳入的473例患者中，分类为低风险（n = 156）、中风险（n = 186）和高风险（n = 131）的患者中位OS分别为10.9个月、6.3个月和4.3个月（P < 0.0001）。在按风险组分层、通过Cox回归调整、逆概率加权或倾向评分匹配后，6周RDI对生存的影响仍然显著。
我们的结果支持NAPOLI-1列线图在日常实践中对接受nal-IRI+5-FU/LV治疗的吉西他滨难治性转移性PDAC进行风险分层的有用性。我们进一步表明，6周RDI是超出NAPOLI-1列线图的独立预后因素。
