ACTS-GC: trial | Bending the Curve: Trial by Trial

ACTS-GC

Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine

Population

Patients in Japan with stage II or III gastric cancer who underwent gastrectomy with extended (D2) lymph-node dissection.

Design

Randomised trial in Japan: surgery followed by adjuvant S-1 for one year (6-week cycles: 80 mg/m2/day for 4 weeks, 2 weeks off) or surgery only, after D2 gastrectomy for stage II or III gastric cancer. 529 and 530 patients were randomised between October 2001 and December 2004; the trial was stopped at the first interim analysis on the data monitoring committee's recommendation. The ClinicalTrials.gov record lists an estimated enrolment of 1000, which differs from the 529 plus 530 patients randomised in the paper.

Primary endpoint

Arms

Surgery only (control, n = 530): D2 gastrectomy with no adjuvant treatment
Surgery plus adjuvant S-1 (experimental, n = 529): S-1 for one year after D2 gastrectomy

People

Sakuramoto S, senior author ACTS-GC Group

OSHR 0.68 (95% CI 0.52–0.87)Δ 36-month OS+10 pointsOSHR 0.669 (95% CI 0.540–0.828)Δ 60-month OS+10.6 pointsRFSHR 0.653 (95% CI 0.537–0.793)Δ 60-month RFS+12.3 points

Show the numbers

Results reported for ACTS-GC
Endpoint	Analysis	Surgery plus adjuvant S-1	Surgery only	Effect
OSRandomised patients (529 S-1, 530 surgery only)	interimSakuramoto 2007	80.1% at 3 y	70.1% at 3 y	HR 0.68 (95% CI 0.52–0.87)P=0.003The trial was stopped on the recommendation of the independent data and safety monitoring committee after the first interim analysis.
OSRandomised patients	long term-updateSasako 2011	71.7% at 5 y	61.1% at 5 y	HR 0.669 (95% CI 0.540–0.828)
RFSRandomised patients	long term-updateSasako 2011	65.4% at 5 y	53.1% at 5 y	HR 0.653 (95% CI 0.537–0.793)Relapse-free survival was a secondary endpoint.

Results reported for ACTS-GC
Endpoint	Analysis	Surgery plus adjuvant S-1	Surgery only	Effect
OSRandomised patients (529 S-1, 530 surgery only)	interimSakuramoto 2007	80.1% at 3 y	70.1% at 3 y	HR 0.68 (95% CI 0.52–0.87)P=0.003The trial was stopped on the recommendation of the independent data and safety monitoring committee after the first interim analysis.
OSRandomised patients	long term-updateSasako 2011	71.7% at 5 y	61.1% at 5 y	HR 0.669 (95% CI 0.540–0.828)
RFSRandomised patients	long term-updateSasako 2011	65.4% at 5 y	53.1% at 5 y	HR 0.653 (95% CI 0.537–0.793)Relapse-free survival was a secondary endpoint.

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
OS	0.68	0.52–0.87
OS	0.669	0.54–0.828
RFS	0.653	0.537–0.793

Appears in

2007 Adjuvant S-1 (ACTS-GC) and capecitabine-oxaliplatin (CLASSIC) after D2

Sources

Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, et al. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007;357(18):1810-20.
PubMed DOI
Sasako M, Sakuramoto S, Katai H, Kinoshita T, Furukawa H, Yamaguchi T, et al. Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. J Clin Oncol. 2011;29(33):4387-93.
PubMed DOI