Meta-analysis of two randomized phase III trials (TCOG GI-0801 and ECRIN TRICS) of biweekly irinotecan plus cisplatin versus irinotecan alone as second-line treatment for advanced gastric cancer.
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Cisplatin
/ administration & dosage
Clinical Trials, Phase III as Topic
Female
Humans
Irinotecan
/ administration & dosage
Male
Middle Aged
Randomized Controlled Trials as Topic
Stomach Neoplasms
/ drug therapy
Treatment Outcome
Advanced gastric cancer
Biweekly irinotecan plus cisplatin
Irinotecan
Meta-analysis
Second-line chemotherapy
Journal
Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association
ISSN: 1436-3305
Titre abrégé: Gastric Cancer
Pays: Japan
ID NLM: 100886238
Informations de publication
Date de publication:
01 2020
01 2020
Historique:
received:
16
04
2019
accepted:
06
07
2019
pubmed:
17
7
2019
medline:
30
5
2020
entrez:
17
7
2019
Statut:
ppublish
Résumé
Biweekly irinotecan (CPT-11) plus cisplatin (CDDP) combination (BIRIP) and CPT-11 alone are both expectable options for treating advanced gastric cancer (AGC) in a second-line setting. We conducted a meta-analysis to compare the efficacy and safety of these two regimens in patients enrolled two randomized phase III trials. Individual patient-level data from two randomized phase III trials were collected for this study. In both trials, patients with AGC refractory to S-1-based chemotherapy were randomly allocated to BIRIP (CPT-11, 60 mg/m Cumulative data from 290 eligible patients were evaluated. The OS was 12.3 months [95% confidence interval (CI) 10.5-14.1] in the BIRIP group and 11.3 months (95% CI 10.0-13.2) in the CPT-11 group (hazard ratio 0.87; 95% CI 0.68-1.12, P = 0.272), while PFS was significantly longer in the BIRIP group (4.3 months [95% CI 3.5-5.1]) than in the CPT-11 group (3.3 months [2.9-4.1]; HR 0.77; 95% CI 0.61-0.98, P = 0.035). The response rate was 20.5% in the BIRIP group and 16.0% in the CPT-11 group (P = 0.361). However, the disease control rate was significantly better in the BIRIP group (72.1%) than in the CPT-11 group (59.2%) (P = 0.032). The two groups did not differ significantly in the incidences of grade 3 or worse adverse events. Both BIRIP and CPT-11 may be good therapeutic options for patients with AGC as second-line treatment. UMIN 000025367.
Sections du résumé
BACKGROUND
Biweekly irinotecan (CPT-11) plus cisplatin (CDDP) combination (BIRIP) and CPT-11 alone are both expectable options for treating advanced gastric cancer (AGC) in a second-line setting. We conducted a meta-analysis to compare the efficacy and safety of these two regimens in patients enrolled two randomized phase III trials.
PATIENTS AND METHODS
Individual patient-level data from two randomized phase III trials were collected for this study. In both trials, patients with AGC refractory to S-1-based chemotherapy were randomly allocated to BIRIP (CPT-11, 60 mg/m
RESULTS
Cumulative data from 290 eligible patients were evaluated. The OS was 12.3 months [95% confidence interval (CI) 10.5-14.1] in the BIRIP group and 11.3 months (95% CI 10.0-13.2) in the CPT-11 group (hazard ratio 0.87; 95% CI 0.68-1.12, P = 0.272), while PFS was significantly longer in the BIRIP group (4.3 months [95% CI 3.5-5.1]) than in the CPT-11 group (3.3 months [2.9-4.1]; HR 0.77; 95% CI 0.61-0.98, P = 0.035). The response rate was 20.5% in the BIRIP group and 16.0% in the CPT-11 group (P = 0.361). However, the disease control rate was significantly better in the BIRIP group (72.1%) than in the CPT-11 group (59.2%) (P = 0.032). The two groups did not differ significantly in the incidences of grade 3 or worse adverse events.
CONCLUSIONS
Both BIRIP and CPT-11 may be good therapeutic options for patients with AGC as second-line treatment.
CLINICAL TRIAL REGISTRATION
UMIN 000025367.
Identifiants
pubmed: 31309387
doi: 10.1007/s10120-019-00990-4
pii: 10.1007/s10120-019-00990-4
doi:
Substances chimiques
Irinotecan
7673326042
Cisplatin
Q20Q21Q62J
Types de publication
Journal Article
Meta-Analysis
Langues
eng
Sous-ensembles de citation
IM
Pagination
160-167Références
Gastric Cancer. 2015 Oct;18(4):824-32
pubmed: 25185971
Ann Oncol. 2013 Nov;24(11):2850-4
pubmed: 23942775
J Clin Oncol. 2006 Jun 20;24(18):2903-9
pubmed: 16782930
Eur J Cancer. 2014 May;50(8):1437-45
pubmed: 24560487
J Clin Oncol. 2012 May 1;30(13):1513-8
pubmed: 22412140
Eur J Cancer. 2015 May;51(7):808-16
pubmed: 25797356
Lancet Oncol. 2014 Jan;15(1):78-86
pubmed: 24332238
J Clin Oncol. 2011 Nov 20;29(33):4387-93
pubmed: 22010012
Cancer Chemother Pharmacol. 2001 May;47(5):380-4
pubmed: 11391851
J Clin Oncol. 2019 May 20;37(15):1296-1304
pubmed: 30925125
J Clin Oncol. 2013 Dec 10;31(35):4438-44
pubmed: 24190112
Eur J Cancer. 2011 Oct;47(15):2306-14
pubmed: 21742485
Int J Cancer. 2015 Mar 1;136(5):E359-86
pubmed: 25220842
Oncologist. 2019 Jan;24(1):18-e24
pubmed: 30126861
Gastric Cancer. 2011 Jun;14(2):155-60
pubmed: 21340668
J Clin Oncol. 2004 Apr 1;22(7):1209-14
pubmed: 15051767
Cancer Res. 1991 Aug 15;51(16):4187-91
pubmed: 1651156
Cancer Chemother Pharmacol. 2013 Feb;71(2):481-8
pubmed: 23192279
Ann Oncol. 2015 Sep;26(9):1916-22
pubmed: 26109630
J Clin Invest. 1998 Feb 15;101(4):847-54
pubmed: 9466980
Anticancer Res. 2005 Mar-Apr;25(2B):1257-62
pubmed: 15865075
Lancet Oncol. 2014 Oct;15(11):1224-35
pubmed: 25240821
JAMA. 2015 Apr 28;313(16):1657-65
pubmed: 25919529
Gastric Cancer. 2017 Mar;20(2):332-340
pubmed: 26956689
Ann Oncol. 2013 Jun;24(6):1567-73
pubmed: 23406728
Cancer Res. 1994 Jul 15;54(14):3723-5
pubmed: 8033091
BMC Cancer. 2018 Apr 20;18(1):449
pubmed: 29678146
J Clin Oncol. 2004 Apr 15;22(8):1382-8
pubmed: 15007088
Lancet. 2012 Jan 28;379(9813):315-21
pubmed: 22226517