Adding cetuximab (Erbitux) to brivanib alaniate (BMS-582664) does not improve patient quality of life

The study investigated whether cetuximab (Erbitux) and brivanib alaniate (BMS-582664) can improve the quality of life of patients with chemotherapy-refractory metastatic colorectal cancer.

Some patients with colorectal cancer have chemotherapy-refractory metastatic cancer (the cancer does not respond to chemotherapy and has spread beyond the bowel). Average life expectancy is significantly shorter for these patients. Therefore, an important aim of treatment is to maintain patient quality of life (general wellbeing).

Two new antitumor drugs cetuximab and brivanib alaniate may hold the key to extending survival while maintaining quality of life for patients with chemotherapy-refractory cancer. These drugs block proteins that are involved in cancer cell growth and invasion (spread). As a result of this they can slow the growth and spread of cancer. 

745 patients with wild-type KRAS (normal KRAS gene) and chemotherapy-refractory metastatic cancer were included in the study. The patients were randomly divided into two groups. The 372 patients in group 1 received a combination of cetuximab and brivanib alaniate. The 373 patients in group 2 received cetuximab and a placebo (a substance with no effect on the body used as a comparison).

Quality of life was assessed for patients at the beginning of the study and after 2, 4, 6, 8, 12, 16 and 24 weeks. Unexpectedly, adding brivanib alaniate to the cetuximab treatment did not improve quality of life for patients. In fact quality of life deteriorated more quickly in patients from group 1 than in patients from group 2.

No difference in overall survival was observed between group 1 (average survival of 8.8 months) and group 2 (average survival of 8.1 months). However, the disease progression (increased growth speed and spread) was slower for patients in group 1 (average of 5.4 months) compared to group 2 (3.4 months).

Patients receiving both cetuximab and brivanib alaniate had a higher incidence of severe adverse events. 78% of patients in group 1 suffered from severe adverse events compared to 53% of patients in group 2. These adverse events included fatigue, rash, high blood pressure, abdominal pain, diarrhea, dehydration, and anorexia.

The authors concluded that quality of life was worse for patients who received cetuximab plus brivanib alaniate compared to patients who received cetuximab and placebo. This may be due to the increased numbers of severe adverse events experienced following cetuximab and brivanib alaniate.