KEY TAKEAWAYS
- The phase II trial aimed to assess the safety and early efficacy of ACT with SOX for locally advanced or metastatic gastric/gastroesophageal adenocarcinoma
- The primary endpoint was to measure AEs. Secondary endpoints were PFS, OS, ORR, and DCR.
- The study found that ACT-SOX was safe and showed long-term survival benefits in first-line advanced gastric/gastroesophageal adenocarcinoma.
Researchers aimed to evaluate the safety and early efficacy of adoptive cell therapy (ACT) with SOX for locally advanced or metastatic gastric/gastroesophageal adenocarcinoma.
Patients(pts) with confirmed advanced gastric or gastroesophageal adenocarcinoma were randomly split into two groups, one receiving a combination treatment of ACT with S-1 and oxaliplatin (SOX) and the other receiving SOX alone. The primary endpoint was to assess the occurrence of adverse events (AEs), while secondary endpoints included measuring progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR).
About 59 pts participated in the study. Of these, 31 received ACT combined with SOX (ACT-SOX), and 28 received SOX alone. Both groups’ most common AEs included gastrointestinal issues, blood-related problems, and liver function abnormalities, with higher rates in the SOX group. Median progression-free survival (PFS) for ACT-SOX was 6.9 months and 4.9 months for SOX alone, with no significant difference. Median overall survival (OS) was 17.8 months for ACT-SOX and 9.75 months for SOX alone, without a significant difference. Pts who received more than 3 specific lymphocyte subset injections benefited more from combination therapy. Tumor metastasis to more than two organs was a significant risk factor for PFS and OS in univariate and multivariate analyses. Among pts with measurable lesions, the objective response rate (ORR) was 55.2% for ACT-SOX and 32.0% for SOX alone, and the disease control rate (DCR) was 93.1% for ACT-SOX and 88.0% for SOX alone.
The study found that ACT-SOX is safe and shows long-term survival benefits in first-line advanced gastric/gastroesophageal adenocarcinoma.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.4037
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02504229
Xiaoting Ma and Lin Yang. DOI: 10.1200/JCO.2023.41.16_suppl.4037 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 4037-4037.
