Cancer Res Treat. 2023 May 25. doi: 10.4143/crt.2023.333. Online ahead of print.
ABSTRACT
PURPOSE: This study evaluated whether combination therapy is more effective than monotherapy in elderly patients with metastatic or recurrent gastric cancer (MRGC) as first-line chemotherapy.
MATERIALS AND METHODS: Elderly (≥70 years) chemo-naïve patients with MRGC were allocated to receive either combination therapy (group A: 5-FU/oxaliplatin, capecitabine/oxaliplatin, capecitabine/cisplatin, or S-1/cisplatin) or monotherapy (group B; 5-FU, capecitabine, or S-1). In group A, starting doses were 80% of standard doses, and they could be escalated to 100% at the discretion of the investigator. Primary endpoint was to confirm superior overall survival (OS) of combination therapy vs monotherapy.
RESULTS: After 111 of the planned 238 patients were randomized, enrollment was terminated due to poor accrual. In the full-analysis population [group A (n=53) and group B (n=51)], median OS of combination therapy vs. monotherapy was 11.5 vs. 7.5 months [hazard ratio (HR), 0.86; 95% confidence interval (CI), 0.56-1.30; p=0.231]. Median progression-free survival (PFS) was 5.6 vs. 3.7 months (HR, 0.53; 95% CI, 0.34-0.83; p=0.005). In subgroup analyses, patients aged 70-74 years tended to have superior OS with combination therapy [15.9 vs. 7.2 months (p=0.056)]. Treatment-related adverse events (TRAEs) occurred more frequently in group A vs. group B. However, among severe TRAEs (≥grade 3), there were no TRAEs with a frequency difference of > 5%.
CONCLUSION: Combination therapy was associated with numerically improved OS, although statistically insignificant, and a significant PFS benefit compared with monotherapy. Although combination therapy showed more frequent TRAEs, there was no difference in the frequency of severe TRAEs.
PMID:37232070 | DOI:10.4143/crt.2023.333
