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

Abstract

Introduction:

This 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 Methods:

The 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.

Results:

Of 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.

Conclusion:

Our 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.

• 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
• Journal: Frontiers in oncology (Front Oncol) Vol. 12 Pg. 800842 ( 2022) ISSN: 2234-943X [Print] Switzerland
• PMID: 35814374 (Publication Type: Journal Article)
• Copyright: Copyright © 2022 Su, Chiang, Li, Yen, Yang, Chou, Chen, Chiu, Chen, Chuang, Bai, Chiu, Peng, Chan, Chiu, Yang, Shan and Chen.