Study of Impact of Adverse Drug Reaction of Chemotherapy on Treatment Outcome, Overall Morbidity and Mortality of Oral Cavity Squamous Cell Carcinoma: A Prospective Longitudinal Study

摘要

Evaluation of impact of adverse drug reactions of chemotherapy for treatment of oral cavity squamous cell carcinoma. A prospective longitudinal study was conducted by enrolling all newly diagnosed patients of oral cavity squamous cell carcinoma (OCSCC), who were to receive chemotherapy. After getting informed written consent, according to clinical criteria, patients were divided into Concurrent Chemo-Radiation (CTRT) and Neo-Adjuvant Chemotherapy (NACT) group. Patients- baseline demographic, clinical and hematological profiles were noted during enrollment and they were followed up for development of any adverse drug reaction (ADR) by analysis of history and investigations. Causality of ADRs were assessed and the impact of ADR was evaluated by the treatment outcome in the form of severity, mortality, morbidity and loss to follow up of the standard treatment. In this observational study, out of total 67 eligible patients, 63 patients consented to participate in the study, while total 41 patients completed the treatment. There were total 5 (7.93%) deaths during follow up, while 22 (34.92%) patients were noncompliant with the treatment. All the patients had developed one or more ADRs, which further deteriorated treatment outcome. On causality assessment, 73% adverse drug reactions were classified under possible group. Moreover, majority of ADRs were moderate in severity and half of the ADRs were not preventable. In short, in spite of giving prophylactic measure during chemotherapy of OCSCC, the outcome of treatment of OCSCC remains poor due to the disease itself and treatment related ADRs.