Safety and efficacy of S-IROX (S-1, irinotecan and oxaliplatin combination therapy) in patients with advanced pancreatic cancer: A multicenter phase 1b dose-escalation and dose-expansion clinical trial.
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Camptothecin
/ adverse effects
Clinical Trials, Phase I as Topic
Clinical Trials, Phase II as Topic
Fluorouracil
/ adverse effects
Humans
Irinotecan
/ adverse effects
Multicenter Studies as Topic
Organoplatinum Compounds
/ adverse effects
Oxaliplatin
/ adverse effects
Pancreatic Neoplasms
/ drug therapy
Pancreatic Neoplasms
Irinotecan
Oxaliplatin
Pancreatic cancer
S-1
Journal
European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373
Informations de publication
Date de publication:
Oct 2022
Oct 2022
Historique:
received:
06
03
2022
revised:
27
05
2022
accepted:
02
06
2022
pubmed:
16
8
2022
medline:
21
9
2022
entrez:
15
8
2022
Statut:
ppublish
Résumé
This phase 1b trial evaluated the toxicity and efficacy of S-1, irinotecan, and oxaliplatin combination therapy (S-IROX) as first-line chemotherapy in patients with advanced pancreatic cancer (APC). Patients aged 20-75 years with APC and an Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible to receive escalating doses of S-1 (60 or 80 mg m Approximately 47 patients were enrolled, of whom 45 were eligible for the analysis. The MTD was not determined, but the RD was determined to be dose level 1 based on a review of data from each level. Among the 45 patients, the ORR was 51.1% [95% confidence interval (CI), 35.8-66.3%]. The median progression-free survival and median overall survival was 6.9 months (95% CI, 5.1-8.8 months) and 15.8 months (95% CI, 9.8-20.8 months), respectively. Common adverse events included neutropenia, elevated liver enzyme levels, diarrhoea, and nausea. The S-IROX regimen showed promising efficacy with manageable toxicities in Japanese patients with APC. A randomised phase 2/3 trial comparing S-IROX, mFOLFIRINOX, and gemcitabine plus nab-paclitaxel is currently ongoing (jRCTs031190009).
Sections du résumé
BACKGROUND
This phase 1b trial evaluated the toxicity and efficacy of S-1, irinotecan, and oxaliplatin combination therapy (S-IROX) as first-line chemotherapy in patients with advanced pancreatic cancer (APC).
METHODS
Patients aged 20-75 years with APC and an Eastern Cooperative Oncology Group performance status of 0 or 1 were eligible to receive escalating doses of S-1 (60 or 80 mg m
RESULTS
Approximately 47 patients were enrolled, of whom 45 were eligible for the analysis. The MTD was not determined, but the RD was determined to be dose level 1 based on a review of data from each level. Among the 45 patients, the ORR was 51.1% [95% confidence interval (CI), 35.8-66.3%]. The median progression-free survival and median overall survival was 6.9 months (95% CI, 5.1-8.8 months) and 15.8 months (95% CI, 9.8-20.8 months), respectively. Common adverse events included neutropenia, elevated liver enzyme levels, diarrhoea, and nausea.
CONCLUSIONS
The S-IROX regimen showed promising efficacy with manageable toxicities in Japanese patients with APC. A randomised phase 2/3 trial comparing S-IROX, mFOLFIRINOX, and gemcitabine plus nab-paclitaxel is currently ongoing (jRCTs031190009).
Identifiants
pubmed: 35970035
pii: S0959-8049(22)00361-6
doi: 10.1016/j.ejca.2022.06.010
pii:
doi:
Substances chimiques
Organoplatinum Compounds
0
Oxaliplatin
04ZR38536J
Irinotecan
7673326042
Fluorouracil
U3P01618RT
Camptothecin
XT3Z54Z28A
Types de publication
Clinical Trial, Phase I
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
40-47Informations de copyright
Copyright © 2022 Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. A.O. has received honoraria from Yakult and Taiho. N.O. has received honorarium from Taiho. F.M. has received research funding from Yakult, Taiho, and Daiichi Sankyo, honoraria from Yakult, Taiho, and Daiichi Sankyo. M.S. has received honorarium from Yakult. H.I. has received honorarium from Yakult. C.M. has received research funding from Yakult, Taiho, and Daiichi Sankyo, honoraria from Yakult and Taiho. M.O. has received honorarium from Yakult. M.I. has received research funding from Yakult, honoraria from Yakult and Taiho. J.F. has received research funding from Yakult, Taiho, and Daiichi Sankyo, honoraria from Yakult, Taiho, and Daiichi Sankyo. T.O. has received honoraria from Yakult, Taiho, and Daiichi Sankyo. All remaining authors have declared no conflicts of interest.