A prospective feasibility study of one-year administration of adjuvant S-1 therapy for resected biliary tract cancer in a multi-institutional trial (Tokyo Study Group for Biliary Cancer: TOSBIC01).
Administration, Oral
Adult
Aged
Aged, 80 and over
Ampulla of Vater
Bile Duct Neoplasms
/ drug therapy
Carcinoma
/ drug therapy
Cholangiocarcinoma
/ drug therapy
Disease-Free Survival
Drug Administration Schedule
Drug Combinations
Feasibility Studies
Female
Gallbladder Neoplasms
/ drug therapy
Humans
Male
Middle Aged
Oxonic Acid
/ administration & dosage
Prospective Studies
Tegafur
/ administration & dosage
Treatment Outcome
1-year administration of S-1
Adjuvant chemotherapy
Biliary tract cancer
Feasibility study
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
23 Jul 2020
23 Jul 2020
Historique:
received:
12
04
2020
accepted:
15
07
2020
entrez:
25
7
2020
pubmed:
25
7
2020
medline:
7
2
2021
Statut:
epublish
Résumé
Although surgery is the definitive curative treatment for biliary tract cancer (BTC), outcomes after surgery alone have not been satisfactory. Adjuvant therapy with S-1 may improve survival in patients with BTC. This study examined the safety and efficacy of 1 year adjuvant S-1 therapy for BTC in a multi-institutional trial. The inclusion criteria were as follows: histologically proven BTC, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, R0 or R1 surgery performed, cancer classified as Stage IB to III. Within 10 weeks post-surgery, a 42-day cycle of treatment with S-1 (80 mg/m Forty-six patients met the inclusion criteria of whom 19 had extrahepatic cholangiocarcinoma, 10 had gallbladder carcinoma, 9 had ampullary carcinoma, and 8 had intrahepatic cholangiocarcinoma. Overall, 25 patients completed adjuvant chemotherapy, with a 54.3% completion rate while the completion rate without recurrence during the 1 year administration was 62.5%. Seven patients (15%) experienced adverse events (grade 3/4). The median number of courses administered was 7.5. Thirteen patients needed dose reduction or temporary therapy withdrawal. OS and DFS rates at 1/2 years were 91.2/80.0% and 84.3/77.2%, respectively. Among patients who were administered more than 3 courses of S-1, only one patient discontinued because of adverse events. One-year administration of adjuvant S-1 therapy for resected BTC was feasible and may be a promising treatment for those with resected BTC. Now, a randomized trial to determine the optimal duration of S-1 is ongoing. UMIN-CTR, UMIN000009029. Registered 5 October 2012-Retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009347.
Sections du résumé
BACKGROUND
BACKGROUND
Although surgery is the definitive curative treatment for biliary tract cancer (BTC), outcomes after surgery alone have not been satisfactory. Adjuvant therapy with S-1 may improve survival in patients with BTC. This study examined the safety and efficacy of 1 year adjuvant S-1 therapy for BTC in a multi-institutional trial.
METHODS
METHODS
The inclusion criteria were as follows: histologically proven BTC, Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, R0 or R1 surgery performed, cancer classified as Stage IB to III. Within 10 weeks post-surgery, a 42-day cycle of treatment with S-1 (80 mg/m
RESULTS
RESULTS
Forty-six patients met the inclusion criteria of whom 19 had extrahepatic cholangiocarcinoma, 10 had gallbladder carcinoma, 9 had ampullary carcinoma, and 8 had intrahepatic cholangiocarcinoma. Overall, 25 patients completed adjuvant chemotherapy, with a 54.3% completion rate while the completion rate without recurrence during the 1 year administration was 62.5%. Seven patients (15%) experienced adverse events (grade 3/4). The median number of courses administered was 7.5. Thirteen patients needed dose reduction or temporary therapy withdrawal. OS and DFS rates at 1/2 years were 91.2/80.0% and 84.3/77.2%, respectively. Among patients who were administered more than 3 courses of S-1, only one patient discontinued because of adverse events.
CONCLUSIONS
CONCLUSIONS
One-year administration of adjuvant S-1 therapy for resected BTC was feasible and may be a promising treatment for those with resected BTC. Now, a randomized trial to determine the optimal duration of S-1 is ongoing.
TRIAL REGISTRATION
BACKGROUND
UMIN-CTR, UMIN000009029. Registered 5 October 2012-Retrospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009347.
Identifiants
pubmed: 32703191
doi: 10.1186/s12885-020-07185-6
pii: 10.1186/s12885-020-07185-6
pmc: PMC7379785
doi:
Substances chimiques
Drug Combinations
0
S 1 (combination)
150863-82-4
Tegafur
1548R74NSZ
Oxonic Acid
5VT6420TIG
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
688Références
Br J Surg. 2018 Feb;105(3):192-202
pubmed: 29405274
Gastric Cancer. 2004;7(2):104-9
pubmed: 15224197
J Hepatobiliary Pancreat Sci. 2016 Mar;23(3):149-57
pubmed: 26699688
BMC Cancer. 2002 May 03;2:10
pubmed: 11991810
Ann Surg. 2019 Aug;270(2):230-237
pubmed: 30339627
Lancet Oncol. 2019 May;20(5):663-673
pubmed: 30922733
Hepatol Res. 2016 Mar;46(5):372-90
pubmed: 26970231
CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90
pubmed: 21296855
Hepatogastroenterology. 1998 Nov-Dec;45(24):2020-6
pubmed: 9951857
Lancet. 2016 Jul 16;388(10041):248-57
pubmed: 27265347
JAMA. 2012 Jul 11;308(2):147-56
pubmed: 22782416
Surg Today. 2020 Apr 2;:
pubmed: 32240378
ESMO Open. 2018 Oct 7;3(6):e000428
pubmed: 30425843
N Engl J Med. 2007 Nov 1;357(18):1810-20
pubmed: 17978289
JAMA Oncol. 2018 Nov 1;4(11):1553-1568
pubmed: 29860482
Lancet Gastroenterol Hepatol. 2019 Mar;4(3):208-216
pubmed: 30679107
Front Oncol. 2019 Apr 17;9:294
pubmed: 31058092
J Clin Oncol. 2012 Jun 1;30(16):1934-40
pubmed: 22529261
Cancer Chemother Pharmacol. 2008 Oct;62(5):849-55
pubmed: 18214482
Int J Clin Oncol. 2018 Oct;23(5):894-899
pubmed: 29705976
Jpn J Clin Oncol. 2018 Apr 1;48(4):392-395
pubmed: 29462482