Validation of the JCOG prognostic index in advanced gastric cancer of the SPIRITS and G-SOX trials, using individual patient data.

Authors

null

Daisuke Takahari

Department of Gastroenterology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan

Daisuke Takahari , Junki Mizusawa , Wasaburo Koizumi , Ichinosuke Hyodo , Narikazu Boku

Organizations

Department of Gastroenterology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan, Biostatistics Division, National Cancer Center, Tokyo, Japan, Department of Gastroenterology, School of Medicine, Kitasato University, Sagamihara, Japan, Division of Gastroenterology,University of Tsukuba, Tsukuba, Japan, Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan

Research Funding

Other

Background: While the Royal Marsden Hospital (RMH) prognostic model had been established in Western patients with advanced gastric cancer(AGC) (Chau, JCO, 2004), we identified four risk factors; performance status (PS) ≥ 1, number of metastatic sites ≥ 2, no prior gastrectomy, and serum alkaline phosphatase (ALP) > normal range, and proposed Japan Clinical Oncology Group (JCOG) prognostic index based on the number of these factors (good risk 0,1; moderate risk 2,3; poor risk 4) in the JCOG9912 trial (Takahari, Oncologist, 2014). Methods: To validate our JCOG prognostic index, it was applied to the combined cohort of other two Japanese phase III trials for AGC; SPIRITS trial comparing between S-1 and S-1 + Cisplatin (SP) (Koizumi, Lancet Oncol., 2008) and G-SOX trial comparing between SP and S-1 + Oxaliplatin (SOX) (Yamada, Ann. Oncol., 2015). Results: 936 (94.5%) out of the totally 990 patients randomized in these trials, whose complete data were available for multivariate analyses, were included in the present study (S-1 n=150, SP n=470, SOX n=316). The median survival time (MST) for all patients was 13.2 months, and each risk factor of the JCOG index remained a significant prognostic factor (Table). Three risk groups categorized by the JCOG prognostic index identified highly significant survival differences (compared with good risk group [n=338]; HR, [95%CI];1.71[1.46-2.01], p<0.001 in moderate risk group [n=537] and 3.32[2.47-4.46], p<0.001 in poor risk group [n=61]), associated with MST of 17.2, 12.0 and 7.8 months, respectively. Good and moderate risk groups categorized by RMH index showed no significant survival differences (compared with good [n=314]; HR, [95%CI];1.10[0.94-1.28], P =0.23 in moderate [n=598] and 1.98[1.27-3.10], P =0.003 in poor [n=24]), associated with MST of 14.9, 13.0 and 6.9 months, respectively. Conclusions: JCOG prognostic index was validated and can be used for patient stratification in the future clinical trials.

FactorHazard Ratio95% CIP value
PS ≥ 1 (vs. 0)1.441.23-1.67<0.0001
No. of metastatic sites >2 (vs. <2)1.451.24-1.71<0.0001
Prior gastrectomy(-) (vs. (+))1.551.31-1.84<0.0001
ALP >(vs. < normal range)1.191.02-1.380.03

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Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Citation

J Clin Oncol 34, 2016 (suppl; abstr 4026)

DOI

10.1200/JCO.2016.34.15_suppl.4026

Abstract #

4026

Poster Bd #

18

Abstract Disclosures

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