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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).

Authors :
Keun-Wook Lee
Dae Young Zang
Min-Hee Ryu
Hye Sook Han
Ki Hyang Kim
Mi-Jung Kim
Sung Ae Koh
Sung Sook Lee
Dong-Hoe Koo
Yoon Ho Ko
Byeong Seok Sohn
Jin Won Kim
Jin Hyun Park
Byung-Ho Nam
In Sil Choi
Source :
Cancer Research & Treatment. Oct2023, Vol. 55 Issue 4, p1250-1260. 11p.
Publication Year :
2023

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. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
15982998
Volume :
55
Issue :
4
Database :
Academic Search Index
Journal :
Cancer Research & Treatment
Publication Type :
Academic Journal
Accession number :
173541390
Full Text :
https://doi.org/10.4143/crt.2023.333