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

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

^*Corresponding author for this work

School of Medicine

National Cheng Kung University
Kaohsiung Medical University
Veterans General Hospital-Taipei
National Yang Ming Chiao Tung University
China Medical University Taichung
National Taiwan University
Chang Gung Memorial Hospital
Chang Gung University
Triservice General Hospital Taiwan
Chung Shan Medical University
PharmaEngine, Inc

Research output: Contribution to journal › Journal Article › peer-review

8 Scopus citations

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.

Original language	English
Article number	1008
Journal	Cancers
Volume	15
Issue number	4
DOIs	https://doi.org/10.3390/cancers15041008
State	Published - 05 02 2023

Bibliographical note

Publisher Copyright:
© 2023 by the authors.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

nal-IRI
nomogram
pancreatic cancer
real-world

Access to Document

10.3390/cancers15041008

Cite this

Su, Y. Y., Chiang, N. J., Yang, Y. H., Yen, C. J., Bai, L. Y., Chiu, C. F., Chuang, S. C., Yang, S. H., Chou, W. C., Chen, J. S., Chiu, T. J., Chen, Y. Y., Chan, D. C., Peng, C. M., Chiu, S. C., Li, C. P., Shan, Y. S., & Chen, L. T. (2023). Real-World Data Validation of NAPOLI-1 Nomogram for the Prediction of Overall Survival in Metastatic Pancreatic Cancer. Cancers, 15(4), Article 1008. https://doi.org/10.3390/cancers15041008

@article{2e434725a7844bdda47198841ff9c74b,

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

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",

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

note = "Publisher Copyright: {\textcopyright} 2023 by the authors.",

year = "2023",

month = feb,

day = "5",

doi = "10.3390/cancers15041008",

language = "英语",

volume = "15",

journal = "Cancers",

issn = "2072-6694",

publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",

number = "4",

}

Su, YY, Chiang, NJ, Yang, YH, Yen, CJ, Bai, LY, Chiu, CF, Chuang, SC, Yang, SH, Chou, WC, Chen, JS, Chiu, TJ, Chen, YY, Chan, DC, Peng, CM, Chiu, SC, Li, CP, Shan, YS & Chen, LT 2023, 'Real-World Data Validation of NAPOLI-1 Nomogram for the Prediction of Overall Survival in Metastatic Pancreatic Cancer', Cancers, vol. 15, no. 4, 1008. https://doi.org/10.3390/cancers15041008

TY - JOUR

T1 - Real-World Data Validation of NAPOLI-1 Nomogram for the Prediction of Overall Survival in Metastatic Pancreatic Cancer

AU - Su, Yung Yeh

AU - Chiang, Nai Jung

AU - Yang, Yi Hsin

AU - Yen, Chia Jui

AU - Bai, Li Yuan

AU - Chiu, Chang Fang

AU - Chuang, Shih Chang

AU - Yang, Shih Hung

AU - Chou, Wen Chi

AU - Chen, Jen Shi

AU - Chiu, Tai Jan

AU - Chen, Yen Yang

AU - Chan, De Chuan

AU - Peng, Cheng Ming

AU - Chiu, Sz Chi

AU - Li, Chung Pin

AU - Shan, Yan Shen

AU - Chen, Li Tzong

PY - 2023/2/5

Y1 - 2023/2/5

N2 - 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.

AB - 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.

KW - nal-IRI

KW - nomogram

KW - pancreatic cancer

KW - real-world

UR - https://www.scopus.com/pages/publications/85149117119

U2 - 10.3390/cancers15041008

DO - 10.3390/cancers15041008

M3 - 文章

C2 - 36831353

AN - SCOPUS:85149117119

SN - 2072-6694

VL - 15

JO - Cancers

JF - Cancers

IS - 4

M1 - 1008

ER -

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

Abstract

Bibliographical note

UN SDGs

Keywords

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