trialsTrialPositive

ASCOT (JCOG1202)

In Japan, six months of the oral chemotherapy S-1 after surgery for bile duct, gallbladder or ampullary cancer improved three-year survival from 68 to 77 percent. S-1 is not licensed for this use in the UK or Europe, so the result cannot be applied directly to NHS patients.

Also called: ASCOTJCOG1202

ASCOT (JCOG1202, UMIN000011688) randomised 440 patients between 2013 and 2018 (218 to S-1, 222 to observation) after resection of biliary tract cancer, including gallbladder carcinoma, with no or only microscopic residual tumour. S-1 (tegafur, gimeracil and oteracil) was given at 40 to 60 mg twice daily for four weeks of every six for four cycles. At a median follow-up of 45.4 months, three-year overall survival was 77.1 percent with S-1 versus 67.6 percent with observation (adjusted hazard ratio 0.69, 95 percent confidence interval 0.51 to 0.94, one-sided p 0.0080), meeting the primary endpoint; three-year relapse-free survival was 62.4 versus 50.9 percent (hazard ratio 0.80, 0.61 to 1.04). Grade 3 to 4 neutropenia occurred in 14 percent and biliary tract infection in 7 percent of the S-1 group. The trial makes S-1 the Japanese adjuvant standard alongside capecitabine from BILCAP; the two have not been compared. In Europe S-1 (Teysuno) is licensed only for gastric cancer, and it is not commissioned for biliary cancer in the UK, so capecitabine remains the NHS adjuvant drug. Gallbladder carcinoma was an eligible site and a stratification factor (primary tumour site), but a gallbladder-specific effect is not reported in the abstract.

Setting

Adjuvant S-1 for four cycles versus observation after resection of extrahepatic cholangiocarcinoma, gallbladder carcinoma, ampullary carcinoma or intrahepatic cholangiocarcinoma (R0 or R1), 38 Japanese hospitals

Phase

Phase 3

Sponsor

Japan Clinical Oncology Group

Headline result

3-year overall survival 77.1% vs 67.6%, adjusted HR 0.69 (0.51 to 0.94), one-sided p=0.0080.

Reported

2023

Enrolled

440 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

440 enrolled

3-year overall survivalprimarysurvival endpoint

77.1 vs 67.6 out of 100 alive at 3 years with S-1 compared with Observation; 9.5 more per 100.
Roughly one extra person helped for every 11 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Put another way, the treated group had about 31 percent lower chance of the event at any given time (hazard ratio 0.69, likely range 0.51 to 0.94).

Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

3-year relapse-free survivalsurrogate endpoint

62.4 vs 50.9 out of 100 alive without the cancer coming back at 3 years with S-1 compared with Observation; 11.5 more per 100.
Roughly one extra person helped for every 9 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Put another way, the treated group had about 20 percent lower chance of the event at any given time (hazard ratio 0.8, likely range 0.61 to 1.04).

The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Caveats

These results apply to the people the trial enrolled: Adjuvant S-1 for four cycles versus observation after resection of extrahepatic cholangiocarcinoma, gallbladder carcinoma, ampullary carcinoma or intrahepatic cholangiocarcinoma (R0 or R1), 38 Japanese hospitals. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

440 enrolled.

3-year overall survivalprimary

HR 0.69 (0.51 to 0.94) · p = 0.0080 (one-sided)

S-177.1 of 100

n = 218

Observation67.6 of 100

n = 222

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3-year relapse-free survival

HR 0.8 (0.61 to 1.04) · p = 0.088

S-162.4 of 100

n = 218

Observation50.9 of 100

n = 222

Download

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
3-year overall survivalprimary	S-1	218	77.1%	0.69 (0.51 to 0.94)	0.0080 (one-sided)	link
3-year overall survivalprimary	Observation	222	67.6%	0.69 (0.51 to 0.94)	0.0080 (one-sided)	link
3-year relapse-free survival	S-1	218	62.4%	0.8 (0.61 to 1.04)	0.088	link
3-year relapse-free survival	Observation	222	50.9%	0.8 (0.61 to 1.04)	0.088	link

Notes

Registered with the UMIN Clinical Trials Registry as UMIN000011688; no ClinicalTrials.gov entry.

Connected

Similar pages

cancers

Ampullary cancer (ampulla of Vater)Biliary tract cancer (all types)Biliary tract cancer (cholangiocarcinoma)Extrahepatic cholangiocarcinoma (perihilar and distal)Gallbladder cancer Intrahepatic cholangiocarcinoma

technologies

Cytotoxic chemotherapy

drugs

ApprovedOral fluoropyrimidine combination (antimetabolite)

Tegafur, gimeracil and oteracil (S-1) · Teysuno

companies

Japan Clinical Oncology Group (JCOG)

terms

Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)