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• W2264754673 abstract "6638 Background: JCOG9912 phase III trial demonstrated the treatment effect of irinotecan plus cisplatin (CP) regimen or S-1 regimen compared with 5-FU regimen for advanced gastric cancer (ASCO2007 Abs#LBA4513). As written in international statistical guideline (ICH-E9), it is important to examine the variations among hospitals in the baseline risks of standard 5-FU regimen for standardization of cancer treatment and also in the treatment effects of experimental CP or S-1 regimen for evaluating the generalizability of the outcomes of JCOG9912 trial. Methods: Mixed effect models were applied to data of survival and adverse events (AE) for 658 (5-FU: 218, CP: 221, S-1: 219) patients from 22 Japanese hospitals. After adjustment with nine prognostic factors, the baseline risk of 5-FU regimen and the treatment effect of CP or S-1 regimen were estimated at each hospital. Spearman's correlation coefficients between the estimated differences and hospital factors were also estimated. Results: In the baseline risks of 5-FU regimen, the median OS and PFS were estimated at 8.3 to 13.3 months and 2.4 to 3.4 months, respectively. The treatment effect of CP or S-1 regimen was estimated as shown in Table. As for the hospital factors correlated with estimated differences, physician's experience in oncology and AE in CP regimen (r=-0.46) and the number of physicians and AE in S-1 regimen (r=-0.48) were significantly correlated. There were no significant correlations with hospital factors other than these two factors. Conclusions: The hospitals participated in JCOG9912 phase III trial had some variation in the baseline risks of 5- FU regimen. The final result of JCOG9912 trial seemed to be generalizable to the target populations, because there was little heterogeneity in the treatment effect of CP or S-1 regimen. The ranges of estimated relative risks of CP or S-1 regimen to 5-FU regimen among 22 hospitals Regimen Hazard ratio for OS (Extension of median OS) Hazard ratio for PFS (Extension of median PFS) Risk ratio for AE (Increase of AE proportion) CP 0.81 to 0.91 (+1.1 to +2.5 mo) 0.62 to 0.82 (+0.6 to +1.7 mo) 1.90 to 1.94 (+38.8 to +40.5%) S-1 0.75 to 0.80 (+2.7 to +3.6 mo) 0.77 to 0.90 (+0.3 to +0.8 mo) 0.94 to 0.96 (-2.6 to -1.7%) No significant financial relationships to disclose." @default.
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• W2264754673 date "2008-05-20" @default.
• W2264754673 modified "2023-10-16" @default.
• W2264754673 title "Evaluation of heterogeneities in baseline risks and treatment effects among hospitals: Additional result of JCOG9912 phase III trial for advanced gastric cancer" @default.
• W2264754673 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.6638" @default.
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