A Phase II Study of Perioperative Capecitabine plus Oxaliplatin Therapy for Clinical SS/SE N1-3 M0 Gastric Cancer (OGSG 1601).
Journal
The oncologist
ISSN: 1549-490X
Titre abrégé: Oncologist
Pays: England
ID NLM: 9607837
Informations de publication
Date de publication:
02 2020
02 2020
Historique:
received:
15
05
2019
accepted:
05
08
2019
entrez:
12
2
2020
pubmed:
12
2
2020
medline:
22
6
2021
Statut:
ppublish
Résumé
Perioperative capecitabine and oxaliplatin (CapeOx) therapy showed favorable efficacy with sufficient pathological response. Small sample size limited the statistical power of this result. Perioperative CapeOx therapy showed good feasibility. Further studies with larger sample size are required to validate this novel approach. D2 gastrectomy followed by adjuvant S-1 is the standard therapy for patients (pts) with stage III gastric cancer (GC) in Japan; however, the outcome is not satisfactory. We examined the efficacy of perioperative capecitabine and oxaliplatin (CapeOx) in pts with GC. The eligibility criteria included confirmed clinical T3(SS)/T4a(SE) N1-3 M0 GC according to the Japanese Classification (JCGC; 3rd English Edition). Three cycles of neoadjuvant CapeOx (NAC; capecitabine, 2,000 mg/m Thirty-seven pts were enrolled on CapeOx. An R0 resection rate of 78.4% (n = 29) and a pRR of 54.1% (n = 20, p = .058; 90% confidence interval [CI], 39.4-68.2) were demonstrated. Among 27 pts who initiated AC, 21 (63.6%) completed the treatment. Grade 3-4 toxicities during NAC included neutropenia (8%), thrombocytopenia (8%), and anorexia (8%) and during AC included neutropenia (37%), diarrhea (4%), and anorexia (4%). Perioperative CapeOx showed good feasibility and favorable efficacy with sufficient pathological response, although statistical significance at .058 did not reach the commonly accepted cutoff of .05. The data obtained using this novel approach warrant further investigations.
Sections du résumé
LESSONS LEARNED
Perioperative capecitabine and oxaliplatin (CapeOx) therapy showed favorable efficacy with sufficient pathological response. Small sample size limited the statistical power of this result. Perioperative CapeOx therapy showed good feasibility. Further studies with larger sample size are required to validate this novel approach.
BACKGROUND
D2 gastrectomy followed by adjuvant S-1 is the standard therapy for patients (pts) with stage III gastric cancer (GC) in Japan; however, the outcome is not satisfactory. We examined the efficacy of perioperative capecitabine and oxaliplatin (CapeOx) in pts with GC.
METHODS
The eligibility criteria included confirmed clinical T3(SS)/T4a(SE) N1-3 M0 GC according to the Japanese Classification (JCGC; 3rd English Edition). Three cycles of neoadjuvant CapeOx (NAC; capecitabine, 2,000 mg/m
RESULTS
Thirty-seven pts were enrolled on CapeOx. An R0 resection rate of 78.4% (n = 29) and a pRR of 54.1% (n = 20, p = .058; 90% confidence interval [CI], 39.4-68.2) were demonstrated. Among 27 pts who initiated AC, 21 (63.6%) completed the treatment. Grade 3-4 toxicities during NAC included neutropenia (8%), thrombocytopenia (8%), and anorexia (8%) and during AC included neutropenia (37%), diarrhea (4%), and anorexia (4%).
CONCLUSION
Perioperative CapeOx showed good feasibility and favorable efficacy with sufficient pathological response, although statistical significance at .058 did not reach the commonly accepted cutoff of .05. The data obtained using this novel approach warrant further investigations.
Identifiants
pubmed: 32043772
doi: 10.1634/theoncologist.2019-0601
pmc: PMC8696956
doi:
Substances chimiques
Organoplatinum Compounds
0
Oxaliplatin
04ZR38536J
Capecitabine
6804DJ8Z9U
Types de publication
Clinical Trial, Phase II
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
119-e208Informations de copyright
© AlphaMed Press; the data published online to support this summary are the property of the authors.
Références
Gastric Cancer. 2011 Jun;14(2):101-12
pubmed: 21573743
Ann Oncol. 2013 Oct;24 Suppl 6:vi57-63
pubmed: 24078663
Gastric Cancer. 2018 Jan;21(1):68-73
pubmed: 28194522
Jpn J Clin Oncol. 2014 Jan;44(1):36-41
pubmed: 24218520
Gastric Cancer. 2014;17(3):514-21
pubmed: 23999869
Anticancer Drugs. 2008 Sep;19(8):819-24
pubmed: 18690094
J Clin Oncol. 2004 Jul 15;22(14):2767-73
pubmed: 15199090
J Clin Oncol. 2011 Nov 20;29(33):4387-93
pubmed: 22010012
N Engl J Med. 2006 Jul 6;355(1):11-20
pubmed: 16822992
J Natl Cancer Inst. 2008 Mar 19;100(6):388-98
pubmed: 18334706
J Clin Oncol. 2019 May 20;37(15):1296-1304
pubmed: 30925125
Surg Today. 2016 Sep;46(9):1076-82
pubmed: 26563224
Ann Surg Oncol. 2014 Jan;21(1):213-9
pubmed: 23838904
J Natl Cancer Inst. 2007 Apr 18;99(8):601-7
pubmed: 17440161
Cancer. 2003 Oct 1;98(7):1521-30
pubmed: 14508841
Cancer Chemother Pharmacol. 2013 Oct;72(4):815-23
pubmed: 23921575
J Natl Cancer Inst. 2000 Feb 2;92(3):205-16
pubmed: 10655437
Lancet Oncol. 2016 Dec;17(12):1697-1708
pubmed: 27776843
Gastric Cancer. 2017 Mar;20(2):332-340
pubmed: 26956689
Lancet. 2012 Jan 28;379(9813):315-21
pubmed: 22226517
CA Cancer J Clin. 2018 Nov;68(6):394-424
pubmed: 30207593
Gastric Cancer. 2010 Aug;13(3):197-203
pubmed: 20820990
Br J Surg. 2014 May;101(6):653-60
pubmed: 24668391
Br J Surg. 2013 Jan;100(1):83-94
pubmed: 23180474
Lancet Oncol. 2014 Nov;15(12):1389-96
pubmed: 25439693
Gastric Cancer. 1998 Dec;1(1):10-24
pubmed: 11957040
Gastric Cancer. 2015 Jul;18(3):597-604
pubmed: 24968818