Real-World Data Validation of NAPOLI-1 Nomogram for the Prediction of Overall Survival in Metastatic Pancreatic Cancer-Reference-Cited by-同舟云学术

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

Published:2023-02-05 Issue:4 Volume:15 Page:1008
ISSN:2072-6694
Container-title:Cancers
language:en
Short-container-title:Cancers

Author:

Su Yung-Yeh¹²³⁴^ORCID,Chiang Nai-Jung¹⁵⁶,Yang Yi-Hsin¹^ORCID,Yen Chia-Jui²,Bai Li-Yuan⁷⁸,Chiu Chang-Fang⁷⁸⁹,Chuang Shih-Chang¹⁰¹¹,Yang Shih-Hung¹²,Chou Wen-Chi¹³¹⁴^ORCID,Chen Jen-Shi¹³¹⁴^ORCID,Chiu Tai-Jan¹⁴¹⁵^ORCID,Chen Yen-Yang¹⁴¹⁵,Chan De-Chuan¹⁶,Peng Cheng-Ming¹⁷,Chiu Sz-Chi¹⁸,Li Chung-Pin⁶¹⁹²⁰^ORCID,Shan Yan-Shen³²¹^ORCID,Chen Li-Tzong¹²⁴²²

Affiliation:

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.

Publisher

MDPI AG

Subject

Cancer Research,Oncology

Link

https://www.mdpi.com/2072-6694/15/4/1008/pdf

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