Differences in disease status between patients with progression after first-line chemotherapy versus early relapse after adjuvant chemotherapy who undergo second-line chemotherapy for gastric cancer: Exploratory analysis of the randomized phase III TRICS trial.
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Chemotherapy, Adjuvant
/ mortality
Cisplatin
/ administration & dosage
Female
Follow-Up Studies
Humans
Irinotecan
/ administration & dosage
Male
Middle Aged
Neoplasm Recurrence, Local
/ drug therapy
Prognosis
Stomach Neoplasms
/ drug therapy
Survival Rate
Advanced gastric cancer
Early relapse
Irinotecan-based chemotherapy
S-1 adjuvant therapy
Second-line chemotherapy
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:
06 2020
06 2020
Historique:
received:
17
11
2019
revised:
20
03
2020
accepted:
28
03
2020
pubmed:
8
5
2020
medline:
11
11
2020
entrez:
8
5
2020
Statut:
ppublish
Résumé
Second-line chemotherapy (SLC) improves survival in advanced gastric cancer (AGC). Patients receiving SLC are categorized into two disease status groups: tumour progression after first-line chemotherapy and early recurrence after adjuvant chemotherapy. Differences between these groups have not yet been clarified. A total of 163 eligible patients registered in the randomized phase III TRICS trial evaluating SLC for patients with AGC was classified into the progressive disease (PD) group (n = 55) or the early relapse (ER) group (n = 108). We compared overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and safety. Adjusted OS and adjusted PFS were estimated using inverse probability of treatment weighting (IPTW). The ER group had a lower median age than the PD group (66 vs. 72 years; P = 0.016), performance status (PS) 0 was more frequently seen in the ER group (87% vs. 71%; P = 0.012). The adjusted median OS was 13.7 months in the ER group and 13.6 months in the PD group (IPTW hazard ratio [HR]: 1.023; P = 0.854). The adjusted median PFS was 4.9 months in the ER group and 4.4 months in the PD group (IPTW HR: 0.707; P = 0.004). ORR was significantly better in the ER group than the PD group (21.3% vs. 4.9%; P = 0.020). No significant differences were observed in the incidence of adverse events. ER was associated with improved PFS and better ORR than PD, although no difference in survival was demonstrated. From the viewpoint of treatment outcome, it seems appropriate to treat patients with ER in the same way as patients with PD. UMIN 000002571.
Sections du résumé
BACKGROUND
Second-line chemotherapy (SLC) improves survival in advanced gastric cancer (AGC). Patients receiving SLC are categorized into two disease status groups: tumour progression after first-line chemotherapy and early recurrence after adjuvant chemotherapy. Differences between these groups have not yet been clarified.
PATIENTS AND METHODS
A total of 163 eligible patients registered in the randomized phase III TRICS trial evaluating SLC for patients with AGC was classified into the progressive disease (PD) group (n = 55) or the early relapse (ER) group (n = 108). We compared overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and safety. Adjusted OS and adjusted PFS were estimated using inverse probability of treatment weighting (IPTW).
RESULTS
The ER group had a lower median age than the PD group (66 vs. 72 years; P = 0.016), performance status (PS) 0 was more frequently seen in the ER group (87% vs. 71%; P = 0.012). The adjusted median OS was 13.7 months in the ER group and 13.6 months in the PD group (IPTW hazard ratio [HR]: 1.023; P = 0.854). The adjusted median PFS was 4.9 months in the ER group and 4.4 months in the PD group (IPTW HR: 0.707; P = 0.004). ORR was significantly better in the ER group than the PD group (21.3% vs. 4.9%; P = 0.020). No significant differences were observed in the incidence of adverse events.
CONCLUSIONS
ER was associated with improved PFS and better ORR than PD, although no difference in survival was demonstrated. From the viewpoint of treatment outcome, it seems appropriate to treat patients with ER in the same way as patients with PD.
CLINICAL TRIAL REGISTRATION
UMIN 000002571.
Identifiants
pubmed: 32380427
pii: S0959-8049(20)30177-5
doi: 10.1016/j.ejca.2020.03.027
pii:
doi:
Substances chimiques
Irinotecan
7673326042
Cisplatin
Q20Q21Q62J
Types de publication
Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
159-167Informations de copyright
Copyright © 2020 Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Conflict of interest statement Kazuhiro Nishikawa has received honoraria from Chugai, Taiho, Yakult, Eli Lilly, Tsumura, and EA Pharma, as well as research funding from Yakult and Taiho unrelated to the submitted work. T.Y. has received lecture fees from Chugai, Taiho, Yakult, Eli Lilly, and Ono, as well as fees for advisory work for Ono and MSD unrelated to the submitted work. M.N. has received honoraria from Chugai, Taiho, Merk, Takeda, Yakult, Eli Lilly, Bayer, Ono, and Otsuka Pharma unrelated to the submitted work. S.M. has received honoraria from Chugai and Taiho unrelated to the submitted work. J.S. has received consultant fees from Takeda and honoraria from Tsumura, Nihon Kayaku, and Chugai unrelated to the submitted work. All remaining authors have no conflicts of interest to declare.