Liposomal irinotecan pre-emptive dose reduction in patients with pancreatic ductal adenocarcinoma: 667 patients’ experience within a population-based study

Background: Liposomal irinotecan (nal-IRI) plus 5-fluorouracil and leucovorin (5-FU/LV) is currently the standard second-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC) after previous failed gemcitabine-based therapy. This population-based study aimed to evaluate the efficac...

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Autores principales:	Tai-Jan Chiu, Yung-Yeh Su, Shih-Hung Yang, Chung-Pin Li, Li-Yuan Bai, Nai-Jung Chiang, Shih-Chang Chuang, Yan-Shen Shan, De-Chuan Chan, Li-Tzong Chen, Chia-Jui Yen, Cheng-Ming Peng, Yen-Yang Chen, Jen-Shi Chen, Wen-Chi Chou
Formato:	article
Lenguaje:	EN
Publicado:	SAGE Publishing 2021
Materias:	Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/4f0d6e13c91c49d18e9d3d1591cc40a2
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spelling	oai:doaj.org-article:4f0d6e13c91c49d18e9d3d1591cc40a22021-11-21T02:03:21ZLiposomal irinotecan pre-emptive dose reduction in patients with pancreatic ductal adenocarcinoma: 667 patients’ experience within a population-based study1758-835910.1177/17588359211058255https://doaj.org/article/4f0d6e13c91c49d18e9d3d1591cc40a22021-11-01T00:00:00Zhttps://doi.org/10.1177/17588359211058255https://doaj.org/toc/1758-8359Background: Liposomal irinotecan (nal-IRI) plus 5-fluorouracil and leucovorin (5-FU/LV) is currently the standard second-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC) after previous failed gemcitabine-based therapy. This population-based study aimed to evaluate the efficacy and safety of nal-IRI + 5-FU/LV and the association of pre-emptive nal-IRI dosing with treatment outcomes in patients with PDAC. Methods: We retrospectively enrolled a total of 667 consecutive patients with PDAC who received nal-IRI plus 5-FU/LV treatment between August 2018 and November 2020 at 9 medical centers in Taiwan. Patients were allocated into groups according to pre-emptive nal-IRI dosing (⩾75%, 50–74%, <50%) for comparison of treatment efficacy and safety. Results: The median overall survival (OS) and time to treatment failure (TTF) were 5.9 months [95% confidence interval (CI), 5.3–6.5] and 2.8 months (95% CI, 2.6–3.0), respectively. The median OS was 6.5 months (95% CI, 5.7–6.7), 5.0 months (95% CI, 3.4–6.5), and 4.1 months (95% CI, 2.7–5.6), respectively, among the ⩾75%, 50–74%, and <50% pre-emptive nal-IRI dosing groups, whereas the median TTF of the three groups was 3.0 months (95% CI, 2.6–3.4), 2.6 months (95% CI, 2.3–2.9), and 1.9 months (95% CI, 1.6–2.2), respectively. Pre-emptive nal-IRI dosing <50% was an independent negative prognostic factor for OS and TTF in multivariate analyses. The most common severe adverse events were neutropenia (22.9%), anemia (21.1%), and hypokalemia (15.4%). Patients in the <50% pre-emptive nal-IRI dosing group had a significantly lower incidence of neutropenia and non-neutropenic infection than those in the other groups. Conclusion: Our results support the use of nal-IRI + 5-FU/LV as standard clinical practice for treating patients with PDAC based on this large population-based study. Our findings encourage physicians to provide adequate doses of nal-IRI in order to achieve better outcomes without compromising safety profiles.Tai-Jan ChiuYung-Yeh SuShih-Hung YangChung-Pin LiLi-Yuan BaiNai-Jung ChiangShih-Chang ChuangYan-Shen ShanDe-Chuan ChanLi-Tzong ChenChia-Jui YenCheng-Ming PengYen-Yang ChenJen-Shi ChenWen-Chi ChouSAGE PublishingarticleNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENTherapeutic Advances in Medical Oncology, Vol 13 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Tai-Jan Chiu Yung-Yeh Su Shih-Hung Yang Chung-Pin Li Li-Yuan Bai Nai-Jung Chiang Shih-Chang Chuang Yan-Shen Shan De-Chuan Chan Li-Tzong Chen Chia-Jui Yen Cheng-Ming Peng Yen-Yang Chen Jen-Shi Chen Wen-Chi Chou Liposomal irinotecan pre-emptive dose reduction in patients with pancreatic ductal adenocarcinoma: 667 patients’ experience within a population-based study
description	Background: Liposomal irinotecan (nal-IRI) plus 5-fluorouracil and leucovorin (5-FU/LV) is currently the standard second-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC) after previous failed gemcitabine-based therapy. This population-based study aimed to evaluate the efficacy and safety of nal-IRI + 5-FU/LV and the association of pre-emptive nal-IRI dosing with treatment outcomes in patients with PDAC. Methods: We retrospectively enrolled a total of 667 consecutive patients with PDAC who received nal-IRI plus 5-FU/LV treatment between August 2018 and November 2020 at 9 medical centers in Taiwan. Patients were allocated into groups according to pre-emptive nal-IRI dosing (⩾75%, 50–74%, <50%) for comparison of treatment efficacy and safety. Results: The median overall survival (OS) and time to treatment failure (TTF) were 5.9 months [95% confidence interval (CI), 5.3–6.5] and 2.8 months (95% CI, 2.6–3.0), respectively. The median OS was 6.5 months (95% CI, 5.7–6.7), 5.0 months (95% CI, 3.4–6.5), and 4.1 months (95% CI, 2.7–5.6), respectively, among the ⩾75%, 50–74%, and <50% pre-emptive nal-IRI dosing groups, whereas the median TTF of the three groups was 3.0 months (95% CI, 2.6–3.4), 2.6 months (95% CI, 2.3–2.9), and 1.9 months (95% CI, 1.6–2.2), respectively. Pre-emptive nal-IRI dosing <50% was an independent negative prognostic factor for OS and TTF in multivariate analyses. The most common severe adverse events were neutropenia (22.9%), anemia (21.1%), and hypokalemia (15.4%). Patients in the <50% pre-emptive nal-IRI dosing group had a significantly lower incidence of neutropenia and non-neutropenic infection than those in the other groups. Conclusion: Our results support the use of nal-IRI + 5-FU/LV as standard clinical practice for treating patients with PDAC based on this large population-based study. Our findings encourage physicians to provide adequate doses of nal-IRI in order to achieve better outcomes without compromising safety profiles.
format	article
author	Tai-Jan Chiu Yung-Yeh Su Shih-Hung Yang Chung-Pin Li Li-Yuan Bai Nai-Jung Chiang Shih-Chang Chuang Yan-Shen Shan De-Chuan Chan Li-Tzong Chen Chia-Jui Yen Cheng-Ming Peng Yen-Yang Chen Jen-Shi Chen Wen-Chi Chou
author_facet	Tai-Jan Chiu Yung-Yeh Su Shih-Hung Yang Chung-Pin Li Li-Yuan Bai Nai-Jung Chiang Shih-Chang Chuang Yan-Shen Shan De-Chuan Chan Li-Tzong Chen Chia-Jui Yen Cheng-Ming Peng Yen-Yang Chen Jen-Shi Chen Wen-Chi Chou
author_sort	Tai-Jan Chiu
title	Liposomal irinotecan pre-emptive dose reduction in patients with pancreatic ductal adenocarcinoma: 667 patients’ experience within a population-based study
title_short	Liposomal irinotecan pre-emptive dose reduction in patients with pancreatic ductal adenocarcinoma: 667 patients’ experience within a population-based study
title_full	Liposomal irinotecan pre-emptive dose reduction in patients with pancreatic ductal adenocarcinoma: 667 patients’ experience within a population-based study
title_fullStr	Liposomal irinotecan pre-emptive dose reduction in patients with pancreatic ductal adenocarcinoma: 667 patients’ experience within a population-based study
title_full_unstemmed	Liposomal irinotecan pre-emptive dose reduction in patients with pancreatic ductal adenocarcinoma: 667 patients’ experience within a population-based study
title_sort	liposomal irinotecan pre-emptive dose reduction in patients with pancreatic ductal adenocarcinoma: 667 patients’ experience within a population-based study
publisher	SAGE Publishing
publishDate	2021
url	https://doaj.org/article/4f0d6e13c91c49d18e9d3d1591cc40a2
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Liposomal irinotecan pre-emptive dose reduction in patients with pancreatic ductal adenocarcinoma: 667 patients’ experience within a population-based study

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