Cancer Res Treat.  2023 Oct;55(4):1250-1260. 10.4143/crt.2023.333.

A Phase 3 Randomized Clinical Trial to Compare Efficacy and Safety between Combination Therapy and Monotherapy in Elderly Patients with Advanced Gastric Cancer (KCSG ST13-10)

• Lee KW
• Zang DY
• Ryu MH
• Han HS
• Kim KH
• Kim MJ
• Koh SA
• Lee SS
• Koo DH
• Ko YH
• Sohn BS
• Kim JW
• Park JH
• Nam BH
• Choi IS

• KMID: 2547799
• DOI: http://doi.org/10.4143/crt.2023.333

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-fluorouracil [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 to 1.30; p=0.231). Median progression-free survival (PFS) was 5.6 vs. 3.7 months (HR, 0.53; 95% CI, 0.34 to 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.

Keyword

Stomach neoplasms; Metastatic; Elderly; Drug therapy; First-line

Figure

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  Fig. 1 CONSORT diagram. FAS, full-analysis set; FL, 5-fluorouracil/leucovorin; FOLFOX, 5-fluorouracil, leucovorin and oxaliplatin; IP, investigational product; PPS, per-protocol set.

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  Fig. 2 Survival curves in full-analysis set: (A) overall survival and (B) progression-free survival. CI, confidence interval.

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  Fig. 3 Subgroup analysis (overall survival). CAPOX, capecitabine/oxaliplatin; ECOG, Eastern Cooperative Oncology Group; FOLFOX, 5-fluorouracil, leucovorin and oxaliplatin.

Reference

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