Abstract
The current approval is based on the results of the RAISE study, a phase 3 trial that compared Ramucirumab (Rmab) plus FOLFIRI to placebo plus FOLFIRI in patients with metastatic colorectal cancer who experienced disease progression after prior therapy. Rmab is a vascular endothelial growth factor receptor 2 antagonist and is seen as a successor to the first angiogenesis inhibitor, bevacizumab (Bmab). We have been reporting that safety and efficacy of FOLFIRI combined Rmab for metastatic colorectal cancer as 2nd line. Methods:Between June 2017 and January 2018, we investigated to safety and efficacy of FOLFIRI combined Rmab for metastatic colorectal cancer as 2nd line. Eligible patients had confirmed colorectal adenocarcinoma: had a treatment history of Bmab combined chemotherapy. Patients have measurable lesions have an Eastern Cooperative Oncology Group performance status (PS) of between 0 and 2: and have adequate bone-marrow, hepatic, renal functions and under 2 plus proteinuria within 7 days of enrolment. Patients characteristics. Patients received either intravenous ramucirumab 8 mg/kg or placebo every 2 weeks until disease progression, unacceptable toxicity, or death. Results. Patient characteristics as follow; twelve patients enrolled, gender. male were 8 and female were 4, median age was 73 years, PS was 1, the response rate and disease control rate were 50% and 83%, respectively. The overall survival has still been investigating. Hematological adverse events as follows; 54% of leukopenia, 55% of anemia, 28% of thrombocytopenia. Non-hematological adverse events as follows 62% of proteinuria and 25% of leg edema. However we do not have any grade4 adverse events. The safety and efficacy in clinical situation of Rmab as 2nd line chemotherapy was demonstrated. Conclusion: Rmab has promising efficacy and a tolerable safety profile in patients with metastatic colorectal cancer who are refractory or intolerant to Bmab combined chemotherapies.
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