Dosing Pattern and Early Cumulative Dose of Liposomal Irinotecan in Metastatic Pancreatic Cancer: A Real-World Multicenter Study

IntroductionThis multicenter, real-world cohort study aimed to evaluate the effectiveness of early cumulative dose administration and dosing pattern of liposomal irinotecan plus fluorouracil/leucovorin (nal-IRI+5-FU/LV) in patients with gemcitabine-refractory metastatic pancreatic ductal adenocarcin...

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Main Authors: Yung-Yeh Su, Nai-Jung Chiang, Chung-Pin Li, Chia-Jui Yen, Shih-Hung Yang, Wen-Chi Chou, Jen-Shi Chen, Tai-Jan Chiu, Yen-Yang Chen, Shih-Chang Chuang, Li-Yuan Bai, Chang-Fang Chiu, Cheng-Ming Peng, De-Chuan Chan, Sz-Chi Chiu, Yi-Hsin Yang, Yan-Shen Shan, Li‐Tzong Chen
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-06-01
Series:Frontiers in Oncology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fonc.2022.800842/full
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author Yung-Yeh Su
Yung-Yeh Su
Yung-Yeh Su
Nai-Jung Chiang
Nai-Jung Chiang
Nai-Jung Chiang
Chung-Pin Li
Chung-Pin Li
Chung-Pin Li
Chia-Jui Yen
Shih-Hung Yang
Wen-Chi Chou
Jen-Shi Chen
Tai-Jan Chiu
Yen-Yang Chen
Shih-Chang Chuang
Shih-Chang Chuang
Li-Yuan Bai
Li-Yuan Bai
Chang-Fang Chiu
Chang-Fang Chiu
Chang-Fang Chiu
Cheng-Ming Peng
De-Chuan Chan
Sz-Chi Chiu
Yi-Hsin Yang
Yan-Shen Shan
Yan-Shen Shan
Li‐Tzong Chen
Li‐Tzong Chen
Li‐Tzong Chen
Li‐Tzong Chen
author_facet Yung-Yeh Su
Yung-Yeh Su
Yung-Yeh Su
Nai-Jung Chiang
Nai-Jung Chiang
Nai-Jung Chiang
Chung-Pin Li
Chung-Pin Li
Chung-Pin Li
Chia-Jui Yen
Shih-Hung Yang
Wen-Chi Chou
Jen-Shi Chen
Tai-Jan Chiu
Yen-Yang Chen
Shih-Chang Chuang
Shih-Chang Chuang
Li-Yuan Bai
Li-Yuan Bai
Chang-Fang Chiu
Chang-Fang Chiu
Chang-Fang Chiu
Cheng-Ming Peng
De-Chuan Chan
Sz-Chi Chiu
Yi-Hsin Yang
Yan-Shen Shan
Yan-Shen Shan
Li‐Tzong Chen
Li‐Tzong Chen
Li‐Tzong Chen
Li‐Tzong Chen
author_sort Yung-Yeh Su
collection DOAJ
description IntroductionThis multicenter, real-world cohort study aimed to evaluate the effectiveness of early cumulative dose administration and dosing pattern of liposomal irinotecan plus fluorouracil/leucovorin (nal-IRI+5-FU/LV) in patients with gemcitabine-refractory metastatic pancreatic ductal adenocarcinoma (mPDAC).Material and MethodsThe electronic medical records of mPDAC patients treated with nal-IRI+5-FU/LV in nine participating centers were manually reviewed. To accommodate to the NAPOLI-1 study population, only patients with an Eastern Cooperative Oncology Group Performance Score of 0–1 were included. The survival impact of the relative 6-week cumulative dose and dosing pattern (standard vs. reduced starting dose, with and without further dose modification) were investigated.ResultsOf the 473 included patients, their median overall survival (mOS) was 6.8 [95% CI, 6.2–7.7] months. The mOS of patients who received a relative 6-week cumulative dose of >80%, 60%–80%, and <60% were 7.9, 8.2, and 4.3 months, respectively (p<0.0001). Their survival impact remained significant after covariate adjustment using Cox regression. The mOS was 8.0–8.2 months in patients with a standard starting dose with and without early dose modification, and 9.3 and 6.7 months in those who had a reduced starting dose with and without escalation in the subsequent treatment, respectively. The incidence of grade 3–4 neutropenia and diarrhea was 23.3% and 2.7%, respectively.ConclusionOur results support the use of nal-IRI+5-FU/LV in gemcitabine-refractory mPDAC and suggest that a lower starting dose followed by a re-escalation strategy could achieve clinical outcomes comparable to those with standard starting doses in real-world practice.
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spelling doaj.art-ae5f896e6042415b809ccdd1fe10f2362022-12-22T02:39:36ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2022-06-011210.3389/fonc.2022.800842800842Dosing Pattern and Early Cumulative Dose of Liposomal Irinotecan in Metastatic Pancreatic Cancer: A Real-World Multicenter StudyYung-Yeh Su0Yung-Yeh Su1Yung-Yeh Su2Nai-Jung Chiang3Nai-Jung Chiang4Nai-Jung Chiang5Chung-Pin Li6Chung-Pin Li7Chung-Pin Li8Chia-Jui Yen9Shih-Hung Yang10Wen-Chi Chou11Jen-Shi Chen12Tai-Jan Chiu13Yen-Yang Chen14Shih-Chang Chuang15Shih-Chang Chuang16Li-Yuan Bai17Li-Yuan Bai18Chang-Fang Chiu19Chang-Fang Chiu20Chang-Fang Chiu21Cheng-Ming Peng22De-Chuan Chan23Sz-Chi Chiu24Yi-Hsin Yang25Yan-Shen Shan26Yan-Shen Shan27Li‐Tzong Chen28Li‐Tzong Chen29Li‐Tzong Chen30Li‐Tzong Chen31National Institute of Cancer Research, National Health Research Institutes, Tainan, TaiwanDepartment of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, TaiwanInstitute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, TaiwanNational Institute of Cancer Research, National Health Research Institutes, Tainan, TaiwanDepartment of Oncology, Taipei Veterans General Hospital, Taipei, TaiwanSchool of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, TaiwanSchool of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, TaiwanDivision of Clinical Skills Training, Department of Medical Education, Taipei Veterans General Hospital, Taipei, TaiwanDivision of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, TaiwanDepartment of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, TaiwanDepartment of Oncology, National Taiwan University Hospital, Taipei, TaiwanDivision of Hematology-Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, TaiwanDivision of Hematology-Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital and Chang Gung University, Taoyuan, Taiwan0Division of Hematology-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, Kaohsiung, Taiwan0Division of Hematology-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University, Kaohsiung, Taiwan1Division of General and Digestive Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan2Department of Surgery, Faculty of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan3Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, and China Medical University, Taichung, Taiwan4College of Medicine, School of Medicine, China Medical University, Taichung, Taiwan3Division of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, and China Medical University, Taichung, Taiwan4College of Medicine, School of Medicine, China Medical University, Taichung, Taiwan5Cancer Center, China Medical University Hospital, Taichung, Taiwan6Department of Surgery, Chung Shan Medical University Hospital and Chung Shan Medical University, Taichung, Taiwan7Division of General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan8Department of Sales and Marketing, PharmaEngine, Inc., Taipei, TaiwanNational Institute of Cancer Research, National Health Research Institutes, Tainan, TaiwanInstitute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan9Division of General Surgery, Department of Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, TaiwanNational Institute of Cancer Research, National Health Research Institutes, Tainan, TaiwanDepartment of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan0Department of Internal Medicine, Kaohsiung Medical University Hospital, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan1Center for Cancer Research, Kaohsiung Medical University, Kaohsiung, TaiwanIntroductionThis multicenter, real-world cohort study aimed to evaluate the effectiveness of early cumulative dose administration and dosing pattern of liposomal irinotecan plus fluorouracil/leucovorin (nal-IRI+5-FU/LV) in patients with gemcitabine-refractory metastatic pancreatic ductal adenocarcinoma (mPDAC).Material and MethodsThe electronic medical records of mPDAC patients treated with nal-IRI+5-FU/LV in nine participating centers were manually reviewed. To accommodate to the NAPOLI-1 study population, only patients with an Eastern Cooperative Oncology Group Performance Score of 0–1 were included. The survival impact of the relative 6-week cumulative dose and dosing pattern (standard vs. reduced starting dose, with and without further dose modification) were investigated.ResultsOf the 473 included patients, their median overall survival (mOS) was 6.8 [95% CI, 6.2–7.7] months. The mOS of patients who received a relative 6-week cumulative dose of >80%, 60%–80%, and <60% were 7.9, 8.2, and 4.3 months, respectively (p<0.0001). Their survival impact remained significant after covariate adjustment using Cox regression. The mOS was 8.0–8.2 months in patients with a standard starting dose with and without early dose modification, and 9.3 and 6.7 months in those who had a reduced starting dose with and without escalation in the subsequent treatment, respectively. The incidence of grade 3–4 neutropenia and diarrhea was 23.3% and 2.7%, respectively.ConclusionOur results support the use of nal-IRI+5-FU/LV in gemcitabine-refractory mPDAC and suggest that a lower starting dose followed by a re-escalation strategy could achieve clinical outcomes comparable to those with standard starting doses in real-world practice.https://www.frontiersin.org/articles/10.3389/fonc.2022.800842/fullpancreatic cancernal-IRIdose intensitydose escalation strategyreal world
spellingShingle Yung-Yeh Su
Yung-Yeh Su
Yung-Yeh Su
Nai-Jung Chiang
Nai-Jung Chiang
Nai-Jung Chiang
Chung-Pin Li
Chung-Pin Li
Chung-Pin Li
Chia-Jui Yen
Shih-Hung Yang
Wen-Chi Chou
Jen-Shi Chen
Tai-Jan Chiu
Yen-Yang Chen
Shih-Chang Chuang
Shih-Chang Chuang
Li-Yuan Bai
Li-Yuan Bai
Chang-Fang Chiu
Chang-Fang Chiu
Chang-Fang Chiu
Cheng-Ming Peng
De-Chuan Chan
Sz-Chi Chiu
Yi-Hsin Yang
Yan-Shen Shan
Yan-Shen Shan
Li‐Tzong Chen
Li‐Tzong Chen
Li‐Tzong Chen
Li‐Tzong Chen
Dosing Pattern and Early Cumulative Dose of Liposomal Irinotecan in Metastatic Pancreatic Cancer: A Real-World Multicenter Study
Frontiers in Oncology
pancreatic cancer
nal-IRI
dose intensity
dose escalation strategy
real world
title Dosing Pattern and Early Cumulative Dose of Liposomal Irinotecan in Metastatic Pancreatic Cancer: A Real-World Multicenter Study
title_full Dosing Pattern and Early Cumulative Dose of Liposomal Irinotecan in Metastatic Pancreatic Cancer: A Real-World Multicenter Study
title_fullStr Dosing Pattern and Early Cumulative Dose of Liposomal Irinotecan in Metastatic Pancreatic Cancer: A Real-World Multicenter Study
title_full_unstemmed Dosing Pattern and Early Cumulative Dose of Liposomal Irinotecan in Metastatic Pancreatic Cancer: A Real-World Multicenter Study
title_short Dosing Pattern and Early Cumulative Dose of Liposomal Irinotecan in Metastatic Pancreatic Cancer: A Real-World Multicenter Study
title_sort dosing pattern and early cumulative dose of liposomal irinotecan in metastatic pancreatic cancer a real world multicenter study
topic pancreatic cancer
nal-IRI
dose intensity
dose escalation strategy
real world
url https://www.frontiersin.org/articles/10.3389/fonc.2022.800842/full
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