Pharmacovigilance Study on Platinum-based Chemotherapeutic Regimens in Oral Cancer Patients: A Prospective Cohort Study

Abstract

Platinum-based chemotherapy is one of the most common therapies employed in oral cancer treat-ment. This is a prospective cohort study to analyse the pattern and incidence of adverse drug reac-tions to platinum based chemotherapeutic regimens in oral cancer patients. Pharmacovigilance studies are still unexplored in oral cancer patients in Bihar (India). Oral cancer patients who received platinum-based cancer chemotherapy were monitored for adverse drug reactions. The collected re-ports analysed for demographic, causality, preventability and severity of adverse drug reactions. Causality was assessed by the World Health Organization causality assessment scale. Preventability and severity of adverse drug reactions assessed by modified Schumock and Thornton scale, modified Hartwig and Siegel scale respectively. Incidence rate, relative risk and attributable risk were evaluat-ed among the regimens. Out of 120 patients, 108 (90%) patients were males. 105 patients (87.5%) developed a total of 247 adverse drug reactions. World Health Organization UMC causality scale showed 82% of adverse drug reactions were “certain”, 15% were “probable” and 3% were “possi-ble”. Modified Hartwig and Siegel severity scale showed 89% of adverse drug reactions were “mild” and 11% were “moderate” type. Schumock and Thornton preventability scale showed 93% of ad-verse drug reactions were “not preventable” and 20% were “probably preventable”. Paclitax-el+carboplatin regimen showed lowest values in terms of adverse drug reactions. Platinum-based chemotherapy was used in the treatment of oral cancer. From this study it is evident that paclitax-el+carboplatin regimen reported least incidence rate of adverse drug reactions among platinum regi-mens. Incidence rate was more reported in cisplatin regimen.