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)
Year: 2022
Type: article
Study design: Clinical Trial
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.
Source: Cancer Research and Treatment
DOI: 10.4143/crt.2023.333
Institutions: Seoul National University, Seoul National University Bundang Hospital, Hallym University, Hallym University Sacred Heart Hospital, Asan Medical Center, University of Ulsan, Chungbuk National University, Chungbuk National University Hospital, Inje University, Inje University Busan Paik Hospital, National Cancer Center, Catholic Kwandong University International St. Mary's Hospital, Catholic Kwandong University, Yeungnam University Medical Center, Inje University Haeundae Paik Hospital, Kangbuk Samsung Hospital, Sungkyunkwan University, The Catholic University of Korea Eunpyeong St. Mary's Hospital, Catholic University of Korea, Inje University Sanggye Paik Hospital, SNUH SMG-SNU Boramae Medical Center
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
Funder: Ministry of Health and Welfare
Award: G189999912
OpenAlex ID: W4378348017