Paclitaxel oral solution versus paclitaxel injection as second-line therapy for advanced gastric cancer: a multicenter, open-label, randomized phase III trial.

BACKGROUND: Paclitaxel is widely used in various cancers. This study aimed to evaluate paclitaxel oral solution versus paclitaxel injection in the second line of gastric cancer. PATIENTS AND METHODS: Patients with unresectable, recurrent, or metastatic disease who have progressed after fluoropyrimidine-based first-line therapy were randomly assigned 1:1 (stratified by gastrectomy, Eastern Cooperative Oncology Group performance status and prior chemotherapy) to receive paclitaxel oral solution (200 mg/m2 twice daily on days 1, 8, and 15 of a 28-day cycle) or paclitaxel injection (175 mg/m2 on day 1 of a 21-day cycle). Dual primary endpoints included progression-free survival (PFS), assessed by a blind independent review committee, and overall survival (OS), with the noninferiority margin of the hazard ratio (HR) of 1.18 for PFS and 1.16 for OS. RESULTS: A total of 536 patients were randomly assigned into two groups (n = 268 each). Compared with paclitaxel injection, paclitaxel oral solution demonstrated a statistically significant and clinically meaningful improvement in OS [9.13 versus 6.54 months; HR 0.770, 95.5% confidence interval (CI) 0.635-0.934, P = 0.006], and was noninferior to paclitaxel injection in PFS (3.02 versus 2.89 months; HR 0.894, 95% CI 0.719-1.112, P = 0.311), along with a favorable and manageable safety profile. Paclitaxel oral solution showed a lower incidence of neuropathy, hypersensitivity reactions, alopecia, and musculoskeletal and connective tissue disorders. Treatment-related fatal adverse events were rare in both groups [four (1.5%) versus three (1.1%)]. CONCLUSIONS: These findings support the use of paclitaxel oral solution as a viable alternative second-line option for gastric cancer.