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Complementary chemotherapy and/or chemotherapy is one of the standard treatments for stomach cancer (GC).
Gastric Tumor Assisted Chemotherapy (ARTER)2 trial compared the prognostics of treatment with two complementary chemotherapy options and a course of chemotherapy for patients with stage D2, Stage II or Stage III lymph node-positive gastric cancer.
in this trial, the subjects were randomly divided into three groups (1:1:1) and accepted: S-1 (40-60 mg, oral, 2 times/day, with 4 weeks/stop 2 weeks) for 1 Year; S-1 (with 2 weeks/stop 1 week) and O'Sullivan platinum (130 mg/m2, 1 time/3 weeks, SOX) for 6 months; SOX plus radiotherapy (45Gy, SOXRT).
are layered according to the type of surgery (full or secondary total gastric excision), pathological station (II or III), and Lauren histological classification (diffuse or intestinal/mixed).
end of the disease is 3 years disease-free survival (DFS), and a 33% reduction in the risk ratio (HR) of SOX or SOXRT treatment to DFS is considered clinically significant compared to S-1.
February 2013-January 2018, 546 patients were recruited, with 182, 181 and 183 patients in the S-1, SOX and SOXRT groups, respectively.
followed for 47 months and observed 178 DFS events.
3-year disease-free survival rates in the S-1, SOX and SOXRT groups were estimated at 64.8%, 74.3% and 72.8%, respectively.
control group (S-1) DFS HR is shorter than SOX group and SOXRT group: S-1 group vs SOX group is 0.692 (P-0.042), S-1 group vs SOXRT group is 0.724 (P-0.074).
the DFS differences between the SOX group and the SOXRT group are not statistically significant (HR 0.971, P=0.879).
adverse reactions in all groups of patients were expected and generally well-toned and controlled.
SOX or SOX/RT-assisted therapy can effectively extend DFS compared to S-1 single therapy in GC patients with D2 excision, stage II/III, and positive lymph nodes.
addition of radiotherapy to the SOX programme did not further significantly reduce the recurrence rate of patients after D2 gastric excision.