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

Cancers (Feb 2023)

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

Affiliations

Yung-Yeh Su: National Institute of Cancer Research, National Health Research Institutes, Tainan 704016, Taiwan
Nai-Jung Chiang: National Institute of Cancer Research, National Health Research Institutes, Tainan 704016, Taiwan
Yi-Hsin Yang: National Institute of Cancer Research, National Health Research Institutes, Tainan 704016, Taiwan
Chia-Jui Yen: Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan 704302, Taiwan
Li-Yuan Bai: Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung 404327, Taiwan
Chang-Fang Chiu: Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, China Medical University, Taichung 404327, Taiwan
Shih-Chang Chuang: Division of General and Digestive Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung 807377, Taiwan
Shih-Hung Yang: Department of Oncology, National Taiwan University Hospital, Taipei 100229, Taiwan
Wen-Chi Chou: Division of Hematology-Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan 333423, Taiwan
Jen-Shi Chen: Division of Hematology-Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan 333423, Taiwan
Tai-Jan Chiu: College of Medicine, Chang Gung University, Taoyuan 33302, Taiwan
Yen-Yang Chen: College of Medicine, Chang Gung University, Taoyuan 33302, Taiwan
De-Chuan Chan: Division of General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei 114202, Taiwan
Cheng-Ming Peng: Department of Surgery, Chung Shan Medical University Hospital, Chung Shan Medical University, Taichung 402306, Taiwan
Sz-Chi Chiu: PharmaEngine, Inc., Taipei 104511, Taiwan
Chung-Pin Li: School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei 112304, Taiwan
Yan-Shen Shan: Institute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan 704017, Taiwan
Li-Tzong Chen: National Institute of Cancer Research, National Health Research Institutes, Tainan 704016, Taiwan

DOI: https://doi.org/10.3390/cancers15041008
Journal volume & issue: Vol. 15, no. 4
p. 1008

Abstract

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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.

Published in Cancers

ISSN: 2072-6694 (Online)
Publisher: MDPI AG
Country of publisher: Switzerland
LCC subjects: Medicine: Internal medicine: Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Website: https://www.mdpi.com/journal/cancers/

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