Abstract / Summary
Purpose: To compare the efficacy and safety of doublet (capecitabine + cisplatin) and triplet (capecitabine + cisplatin + docetaxel) neoadjuvant chemotherapy (NACT) regimens in patients with locally advanced gastric cancer at a regional oncology center in Kazakhstan.
Methods: A prospective stratified randomized study included 107 patients with locally advanced gastric cancer. Patients were stratified by age, tumor location, and histological type/differentiation grade and then randomized in a 1:1 ratio to receive either capecitabine plus cisplatin or capecitabine plus cisplatin plus docetaxel. Tumor response was assessed using RECIST 1.1, pathological response was assessed in resected specimens, and toxicity was graded according to CTCAE v5.0.
Results: The triplet regimen was associated with numerically higher rates of radiological partial response according to RECIST 1.1 (68.0% vs. 59.3%, p=0.423) and radical surgery among patients with partial response (91.7% vs. 78.1%, p=0.172). Pathological response was assessed in 58 patients who underwent radical gastrectomy. Pathological complete response (ypT0N0/TRG 1a) was observed in 2 patients in the triplet group and in none of the patients in the doublet group (0% vs. 6.1%, p=0.501). Favorable pathological regression (TRG 1a-1b) was more frequent after triplet therapy than after doublet therapy (24.2% vs. 12.0%, p=0.320). Grade III-IV neutropenia was more frequent in the triplet group (24.5% vs. 9.3%, p=0.041).
Conclusions: The triplet regimen showed a numerical efficacy advantage but was associated with increased hematologic toxicity, requiring careful monitoring. Treatment personalization based on histology and comorbidities is critical.
Limitations: Small sample size, lack of survival data, and the need for multicenter validation.