290 Comparative Study of Efficacy and Toxicity of Different Doses of Gemcitabine In Head, Neck and Cervical Cancer

Wednesday, April 25, 2012
Abay Poster Exhibition and Hall (Millennium Hall)
Jegan RS, BPharm Semler Research Ltd, India
Deepak Jose Medispan Ltd, India
Habeeb Ibrahim Abdul Razack Accenture Pharmaceutical Services, India
Brief outline of context: This study was carried among head, neck and cervical cancer patients in oncology department, Meenakshi Mission Hospital, Madurai, Tamilnadu, India to know the dose effect of drug Gemcitabine. Strategy for change: The head & neck cancer patients were diagnosed by CT Scans & biopsy and Cervical cancer patients were diagnosed by Pap smear, ultra sound abdomen, urine examination and biopsy. The patients in stage III cancer were given Gemcitabine 200mg/week. Stage I & II cancer were given Gemcitabine 100mg/week as radio sensitizer and all these patients received radio therapy. All the patients were scheduled to receive 6 cycles. The size of the tumor was observed every week to assess the response of treatment. Patients were also observed for ADR to drug such as Vomiting, Skin rashes, Diarrhoea, leucopenia, and Mucositis. Measurement of improvement: Out of 51 patients, 35 received 100mg (group I), 16 received 200mg (group II). Where group1 completed schedule, but group II completed only 2 cycles due to severe toxicity. In group I 26% showed complete response and 74% showed partial response. In group II 86% achieved complete response and 12% partial response. Patients receiving 200mg of Gemcitabine showed high level of toxicity than the patients receiving 100mg Gemcitabine. Effects of changes: This study concludes that Gemcitabine 200mg was comparatively more toxic than Gemcitabine 100mg, where as efficacy was more for Gemcitabine 200mg with complete response in 87% in two cycle itself. So for mild cases 100mg drug is enough but for the patients with severe disease have to go for 200mg of dose.

Learning Objectives: By this study, we were able to reduce the side effects and increase the therapeutic efficacy of the patients receiving Gemcitabine. As the adverse events are reported for 100mg dose itself, it is preferred to use <100mg.