A PHARMACOVIGILANCE STUDY ON CANCER PATIENTS UNDERGOING THERAPY WITH MONOCLONAL ANTIBODIES IN A TEACHING HOSPITAL OF CENTRAL INDIA.

Abstract

ADR related to Anti cancer drugs are important in view of mortality and morbidity. So
the current work is targeted to detection, assessment and reporting of Adverse Drug
Events (ADEs) in cancer patients undergoing therapy for cancer and treated with
Monoclonal Antibodies in a teaching hospital of central india. It was a hospital based
prospective observational study with follow up during the study period. Patient
Proforma and CDSCO adverse drug event reporting form were used for data
collections. ADEs observed with Bevacizumab therapy includes nausea, vomiting,
diarrhea, muscular stiffness, fever, chills, anemia and aggravation of burning pain of
pre-existing hemorrhoids. ADEs observed with Cetuximab therapy includes dyspepsia
& regurgitation, vomiting, acneiform rash, backache, mouth ulcer and anemia. ADEs
observed with Nimotuzumab therapy includes vomiting, dysphagia/ odynophagia,
constipation, taste perversion, decreased appetite, weakness, insomnia, chills,
backache, headache and mucositis. ADEs observed with Rituximab therapy includes
dyspnoea, headache, weakness, anemia, nausea and vomiting. ADEs observed with
Rituximab therapy includes dyspnoea, headache, weakness, anemia, nausea and
vomiting. Overall 79.2% ADEs were found to be mild grade and 20.8% ADEs were of
moderate grade in severity. No ADEs of severe grade was reported. In conclusion,
this study suggests that the use of monoclonal antibody for cancers therapy is well
tolerated and associated with less or minor adverse reactions that can be managed
easily by supportive treatment.