Abstract
BACKGROUND: The superiority of paclitaxel/ramucirumab over alternative therapeutic regimens in patients with gastric cancer has yet to be defined. Our aim was to evaluate whether second-line treatment with paclitaxel/ramucirumab is superior compared with other therapies. PATIENTS AND METHODS: Retrospective real-world data from patients with advanced adenocarcinoma of the stomach, gastroesophageal junction, or distal esophagus, treated at Departments of Medical Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG), were collected. All patients had received at least 2 months of second-line treatment. The primary endpoint was progression-free survival 1 (PFS1). RESULTS: From March 2015 to March 2023, 179 patients received second-line treatment (median age 61.3 years). Of those, 77 (43%) received paclitaxel/ramucirumab, 21 (11.7%) irinotecan/5-fluorouracil (5-FU)/leucovorin, 16 (8.9%) docetaxel, and 65 (36.3%) other treatments. The efficacy of paclitaxel/ramucirumab was assessed by histological subtype: diffuse, intestinal, and mixed. For diffuse histology, the adjusted hazard ratio (aHR) for PFS1 was 1.03 [95% confidence interval (CI) 0.50-2.16] and for overall survival (OS) was 1.71 (95% CI 0.79-3.68). For intestinal histology, the aHR for PFS1 was 0.53 (95% CI 0.28-1.01) and for OS was 0.44 (95% CI 0.22-0.88), indicating a statistically significant OS benefit. Mixed histology showed no significant differences in PFS1 (aHR 1.00, 95% CI 0.23-4.37) or OS (aHR 1.10, 95% CI 0.32-3.82). Toxicity, dose reduction, and discontinuation rates were similar between paclitaxel/ramucirumab and other regimens. CONCLUSIONS: Second-line treatment with paclitaxel/ramucirumab was independently associated with OS compared with other regimens in patients with advanced intestinal-type gastric cancer. Identification of the most effective treatment for advanced gastric cancer remains a challenge.