Real-World Data Validation of NAPOLI-1 Nomogram for the Prediction of Overall Survival in Metastatic Pancreatic Cancer

Yung-Yeh Su; Nai-Jung Chiang; Yi-Hsin Yang; Chia-Jui Yen; Li-Yuan Bai; Chang-Fang Chiu; Shih-Chang Chuang; Shih-Hung Yang; Wen-Chi Chou; Jen-Shi Chen; Tai-Jan Chiu; Yen-Yang Chen; De-Chuan Chan; Cheng-Ming Peng; Sz-Chi Chiu; Chung-Pin Li; Yan-Shen Shan; Li-Tzong Chen

doi:10.3390/cancers15041008

Real-World Data Validation of NAPOLI-1 Nomogram for the Prediction of Overall Survival in Metastatic Pancreatic Cancer

Cancers (Basel). 2023 Feb 5;15(4):1008. doi: 10.3390/cancers15041008.

Authors

Yung-Yeh Su^{1

2

3

4}, Nai-Jung Chiang^{1

5

6}, Yi-Hsin Yang¹, Chia-Jui Yen², Li-Yuan Bai^{7

8}, Chang-Fang Chiu^{7

8

9}, Shih-Chang Chuang^{10

11}, Shih-Hung Yang¹², Wen-Chi Chou^{13

14}, Jen-Shi Chen^{13

14}, Tai-Jan Chiu^{14

15}, Yen-Yang Chen^{14

15}, De-Chuan Chan¹⁶, Cheng-Ming Peng¹⁷, Sz-Chi Chiu¹⁸, Chung-Pin Li^{6

19

20}, Yan-Shen Shan^{3

21}, Li-Tzong Chen^{1

2

4

22}

Affiliations

¹ National Institute of Cancer Research, National Health Research Institutes, Tainan 704016, Taiwan.
² Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704302, Taiwan.
³ Institute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan 704017, Taiwan.
⁴ Center for Cancer Research, Kaohsiung Medical University, Kaohsiung 807377, Taiwan.
⁵ Department of Oncology, Taipei Veterans General Hospital, Taipei 112201, Taiwan.
⁶ School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei 112304, Taiwan.
⁷ Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung 404327, Taiwan.
⁸ School of Medicine, College of Medicine, China Medical University, Taichung 404328, Taiwan.
⁹ Cancer Center, China Medical University Hospital, China Medical University, Taichung 404327, Taiwan.
¹⁰ Division of General and Digestive Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung 807377, Taiwan.
¹¹ Department of Surgery, Faculty of Medicine, Kaohsiung Medical University, Kaohsiung 807378, Taiwan.
¹² Department of Oncology, National Taiwan University Hospital, Taipei 100229, Taiwan.
¹³ Division of Hematology-Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan 333423, Taiwan.
¹⁴ College of Medicine, Chang Gung University, Taoyuan 33302, Taiwan.
¹⁵ Division of Hematology-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 833401, Taiwan.
¹⁶ Division of General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei 114202, Taiwan.
¹⁷ Department of Surgery, Chung Shan Medical University Hospital, Chung Shan Medical University, Taichung 402306, Taiwan.
¹⁸ PharmaEngine, Inc., Taipei 104511, Taiwan.
¹⁹ Division of Clinical Skills Training, Department of Medical Education, Taipei Veterans General Hospital, Taipei 112201, Taiwan.
²⁰ Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei 112201, Taiwan.
²¹ Division of General Surgery, Department of Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704302, Taiwan.
²² Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung 807377, Taiwan.

Abstract

Background: 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.

Methods: 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.

Results: Of the 473 included patients, the median OSs of patients classified as low (n = 156), medium (n = 186), and high (n = 131) risk were 10.9, 6.3, and 4.3 months, respectively (p < 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.

Conclusions: 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.

Keywords: nal-IRI; nomogram; pancreatic cancer; real-world.

Grants and funding

This research received no external funding.