A prospective study of efficacy and safety of conventional chemotherapy vs targeted therapy plus chemotherapy in recurrent and metastatic colorectal malignancies

Colorectal cancer (CRC) is an important health problem both globally and in India. It is the third most common malignant tumor and the fourth most common cause of cancer death in the World. In Indian population, there is paucity of literature on efficacy and toxicity profile of conventional vs targeted therapy plus chemotherapy in recurrent and metastatic colorectal malignancies. Present study was prospective study done to evaluate the Response rate and Progression free survival of conventional chemotherapy compared to that of Targeted therapy plus chemotherapy in first line setting in cases of recurrent or metastatic colorectal malignancies and also to assess the toxicity profile and overall survival on these drug combinations. Patients were enrolled from September 2013 to August 2014 and the date of last follow up was 20th June, 2015. Histologically or radiologically proven patients of recurrent and metastatic colorectal malignancies were enrolled for the study. A total of 70 patients were then enrolled into the study arm which received targeted therapy plus chemotherapy. 70 patients of similar demographic profile and disease status were randomly selected who received chemotherapy alone. The median PFS was 4 months and mean PFS was 5.51 months in the chemotherapy arm. The median PFS was 8 months and mean PFS was 7.21 months in the targeted therapy plus chemotherapy arm (p=0.001). The median OS was 19 months and mean OS was 18.03 months in the targeted therapy plus chemotherapy arm (p value <0.001). The overall response rate was 42.85% in chemotherapy arm and 62.85% in targeted therapy plus chemotherapy arm which was statistically significant. The rates of grade III and IV hematological adverse effects was comparable in both arms. There was 27.14% neutropenia, 12.85% thrombocytopenia, 14.28% anemia requiring transfusion and 14.28% cases of febrile neutropenia in chemotherapy arm. There was 30% neutropenia, 10% thrombocytopenia, 17.14% anemia requiring transfusion and 12.85% cases of febrile neutropenia in targeted therapy plus chemotherapy arm. The differences were not statistically significant.