In a nutshell
The authors assessed the safety and efficacy of ramucirumab (Cyramza) for patients with metastatic colorectal cancer (cancer that has spread from the colon or rectum to distant sites) that has progressed despite treatment.
Some background
Ramucirumab has recently been approved for the treatment of metastatic colorectal cancer. Like bevacizumab (Avastin), ramucirumab blocks the formation of new blood vessels that are needed for cancer to grow and spread. Bevacizumab plus chemotherapy is currently the standard treatment for metastatic colorectal cancer. However, the cancer can continue to grow despite this treatment. For these patients, ramucirumab may slow down the cancers growth (progression) and increase patient survival.
Methods & findings
This study assessed the safety and efficacy of ramucirumab for metastatic colorectal cancer. It included 1072 patients whose cancer had progressed during or after bevacizumab plus chemotherapy treatment. Patients were divided into two groups. 536 patients in Group 1 received 8 mg/kg of ramucirumab plus chemotherapy every two weeks. 536 patients in Group 2 received a placebo (substance with no effect on the body used for comparison) plus chemotherapy every two weeks. The chemotherapy included 5-fluorouracil (Efudex), leucovorin and irinotecan (Camptosar). Patient survival time and adverse events were recorded.
Patients in Group 1 survived for an average of 13.3 months compared to 11.7 months for patients in Group 2. It also took longer for the cancer to progress in patients from Group 1, 5.7 months compared to 4.5 months for Group 2.
The rate of serious adverse events was similar for patients in both groups. The most common adverse events included high blood pressure, diarrhea, fatigue, and neutropenia (an abnormally low count of neutrophils, a type of white blood cell, the cells needed to fight infections). 38% of Group 1 had severe neutropenia compared to 23% of Group 2. 11% of Group 1 had severe high blood pressure compared to 3% of Group 2. 11% of Group 1 had severe diarrhea compared to 10% of Group 2. 12% of patients in Group 1 had severe fatigue compared to 8% of Group 2.
The bottom line
The authors concluded that ramucirumab prolonged survival and slowed cancer progression in patients who had already received bevacizumab and chemotherapy.
The fine print
This study was funded by Eli Lilly, the manufacturers of ramucirumab.
Published By :
The Lancet. Oncology
Date :
Apr 10, 2015
