A phase II trial of ramucirumab and docetaxel as second-line treatment for patients with advanced gastric cancer (HGCSG 1903).

BACKGROUND

Ramucirumab has shown efficacy in combination with paclitaxel in the second-line treatment of advanced gastric cancer (AGC). The efficacy and safety regarding the combination therapy of ramucirumab and docetaxel have not been reported. This treatment could reduce the incidence of neuropathy and patients' hospital visits.

METHODS

This was a multicenter, single-arm phase II trial. Patients with AGC who were refractory or intolerant to primary treatment were eligible. Patients received ramucirumab at a dose of 8 mg/kg on day1 and 15, and docetaxel at a dose of 60 mg/m2 on day1 of a 28-day cycle. The primary endpoint was overall response rate (ORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), relative dose intensity, and safety.

RESULTS

A final analysis of efficacy and safety was performed in 35 patients. ORR was 25.7% (90% confidence interval [CI] 14.1-40.6) and disease control rate was 74.3% (90%CI 59.4-85.9). Median PFS and OS were 3.1 months (95%CI 2.1-4.2) and 11.5 months (95%CI 9.2-13.9), respectively. Grade 3 or higher adverse events that occurred in more than 10% of patients were neutropenia, leucopenia, febrile neutropenia, hypertension, and anorexia. The study protocol was amended to allow primary granulocyte-colony stimulating factor (G-CSF) prophylaxis during study period. There was no one incident febrile neutropenia after the protocol amendment. Peripheral sensory neuropathy occurred in 65.7% of all grades, with no incidence of grade 3 or higher.

CONCLUSIONS

The combination therapy of ramucirumab and docetaxel demonstrated some efficacy for AGC. Caution is required regarding the occurrence of febrile neutropenia. This treatment might be considered as an option for second-line treatment of patients with AGC.