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. 2021 Nov 20:13:17588359211058255.
doi: 10.1177/17588359211058255. eCollection 2021.

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

Tai-Jan Chiu  1 , Yung-Yeh Su  2 , Shih-Hung Yang  3 , Chung-Pin Li  4 , Li-Yuan Bai  5 , Nai-Jung Chiang  2 , Shih-Chang Chuang  6 , Yan-Shen Shan  7 , De-Chuan Chan  8 , Li-Tzong Chen  2 , Chia-Jui Yen  9 , Cheng-Ming Peng  10 , Yen-Yang Chen  1 , Jen-Shi Chen  11 , Wen-Chi Chou  12
Affiliations

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

Tai-Jan Chiu et al. Ther Adv Med Oncol. .

Abstract

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.

Keywords: dose reduction; liposomal irinotecan; outcome; pancreatic cancer; toxicity.

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Conflict of interest statement

Conflict of interest statement: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Overall survival and time to treatment failure curves.
Figure 2.
Figure 2.
Kaplan–Meier estimates of overall survival (a) and time to treatment failure (b) among three pre-emptive nal-IRI dosing groups.
Figure 3.
Figure 3.
Best tumor responses to nal-IRI + 5-FU/LV treatment among the entire cohort and among the three pre-emptive nal-IRI dosing groups.
See this image and copyright information in PMC

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