Background: Management of advanced head and neck carcinoma is a
challenging proposition. Presently concomitant chemo-irradiation has
become the standard of care in such patients. Many chemotherapeutic
drugs have shown radio-sensitising effects when used concomitantly
along with radiation. The present study was carried out with the
objective of assessing the feasibility and efficacy of low dose
gemcitabine as radiosensitizer when used during radical
radiotherapeutic management of patients with locally advanced head and
neck carcinomas. Patients and methods: From November 2000 to March
2003, Eighty histopathologically proven cases of squamous cell head and
neck carcinoma were included in this trial, 40 patients were randomly
assigned to receive radiotherapy alone and 40 patients to receive
gemcitabine along with radiotherapy. Results: All patients were
assessable for toxicity and response. Severe mucositis (WHO level 5
reactions were observed in 67% patients in the CT/RT group vs 16%
patients in the RT only group. No severe hematological toxicity was
seen. The rates of complete and partial responses were 42.5% &
57.5% respectively for RT only and 62.5% & 37.5%, respectively for
CT/RT group. There was no significant difference in the response rates
at the end of treatment but disease free survival at three years was
better in the CT/RT group (63.3% vs 20%). Nine of the 17 patients with
complete response in the radiation only group developed relapse while
no relapses were seen in CT/RT group. Conclusion: In the present
study the combination of gemcitabine and radiotherapy has not shown any
statistical difference in locoregional control but survival advantage
was seen as compared to radiotherapy alone. At the same time more
mucosal and skin toxicity was encountered when Gemcitabine is given
concurrently with radiation