Ramucirumab Plus Docetaxel Shows Phase II Activity in Gastric Cancer
Key Takeaways
- The combination was associated with measurable activity, with disease control reported in nearly three quarters of patients.
- The findings came from a multicenter, single-arm phase II trial of 35 patients who were refractory or intolerant to primary treatment.
- Grade 3 or higher febrile neutropenia was among adverse events seen in more than 10% of patients, and no further cases were reported after the protocol amendment allowing primary G-CSF prophylaxis during the study period.
This multicenter, single-arm phase II trial enrolled patients with advanced gastric cancer who were refractory or intolerant to primary treatment. Patients received ramucirumab 8 mg/kg on days 1 and 15 plus docetaxel 60 mg/m2 on day 1 of a 28-day cycle. The schedule paired twice-monthly ramucirumab with day-1 docetaxel throughout each 28-day treatment cycle. Overall response rate was the primary endpoint, while progression-free survival, overall survival, relative dose intensity, and safety were secondary endpoints. The final efficacy and safety analysis included 35 patients.
In the final analysis, overall response rate was 25.7% with a 90% CI of 14.1 to 40.6, and disease control rate was 74.3%. The 90% CI for disease control was 59.4 to 85.9 in the 35-patient cohort. Median progression-free survival was 3.1 months with a 95% CI of 2.1 to 4.2. Median overall survival was 11.5 months with a 95% CI of 9.2 to 13.9. These findings completed the efficacy profile within the study's single-arm design and remained descriptive rather than comparative.
Grade 3 or higher neutropenia, leucopenia, febrile neutropenia, hypertension, and anorexia each occurred in more than 10% of patients. During the study, the protocol was amended to allow primary G-CSF prophylaxis during the study period. No incident febrile neutropenia was reported after that amendment. Peripheral sensory neuropathy occurred in 65.7% across all grades, and no grade 3 or higher cases were observed. Febrile neutropenia nevertheless remained the central cautionary feature in the regimen's safety profile overall.
Investigators characterized the combination as showing some efficacy in advanced gastric cancer in this setting. They also indicated it might be considered as a second-line option, while continuing to emphasize caution about febrile neutropenia. That interpretation was tempered by the reported febrile neutropenia signal and the broader hematologic toxicity pattern seen during treatment. The interpretation remained limited to this regimen and the enrolled study population. Reported activity and safety concerns remained closely linked in the study's closing message.