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Abstract This study was carried out at Clinical Oncology and Nuclear Medicine Departement at Sohag faculty of medicine during the period from July 2008 to December 2010. It aimed to compare the outcome (response, survival and toxicity profile) of low dose gemcitabine based chemoirradiation with cisplatin based chemoirradiation. Sixty patients with locally advanced HNSCC were enrolled. The patients were treated in two equal groups. Seven patients were excluded from the study, Four from group A (tested regimen) and three from group B (standard regimen). one of them – from group A – died from cerebral infarction developed at week 4 of treatment and the others discontinued treatment between week 4 and 6 of treatment and refused follow up and to receive an alternative line of treatment. All patients had histopathologically confirmed diagnosis of SCC, all of them were not treated befor against HNSCC. Our patients had adequate medical condition with adequate hepatic and renal functions and a written informed consent was given by each patient. Patients in group A received radical dose of RT (70 GY) concurrent with weekly 50 mg/m2 gemcitabine for 7 weeks and in group B, they received the same dose of RT concurrent with cisplatin 100 mg/m2 every 3 weeks (day 1, 22 and 43). At the end of treatment 53 patients were eligible for evaluation, 26 from group A and 27 from group B. PDF created with pdfFactory Pro trial version www.pdffactory.com Summary, conclusion and recommendations ١٥٩ The most frequent primary tumor site was laryngeal primary in both groups. There was no statistically significant difference between two groups as regard patient’s characteristics. There was statistically signifcant difference between the lymph node staging distribution and pathological grades in the two groups. Gemcitabine based chemoirradiation offered the same overall response rate as that of cisplatin based one which was 100% objective response rate (≈ 77% CR and ≈ 23% PR in both groups). No statistically signifcant effect of any of the patient’s or tumor’s prognostic factors on response. However, there was a trend for better response in patients of group A with T2 or pathological grade II and a trend for better response in patients of group B with laryngeal cancer. At a median follow-up time of 24 months in both groups, the 2- year overall survival (OS) was 53.84% and 51.85% in group A and B respectively. The 2-year progression-free survival (PFS) was 46.15% and 48.14% in group A and B respectively. The 2-year disease-free survival (DFS) was 38.46% and 44.44% in group A and B respectively. No statistically significant difference between group A and B as regards to overall survival, progression-free survival and disease-free survival. PDF created with pdfFactory Pro trial version www.pdffactory.com Summary, conclusion and recommendations ١٦٠ There was no statistically significant effect of primary tumor site, disease stage, nodal status or response on survival in group A patients. There was a statistically significant effect of primary tumor site on survival in group B patients. This was evident in laryngeal cancer patients who showed better survival than those with other primaries. This effect was abolished when adjusted for other factors affecting survival. Response had a statistically significant effect on survival in group B patients. This was evident in patients who attained partial response (PR) and showed a lower survival than those with (CR). However, this effect was abolished when adjusted for other factors affecting survival. Disease stage, nodal status had no statistically significant effect on survival in group B patients. The major acute toxicity encountered was acute mucositis and there was a statistically signifcant difference between the two groups as regard this, where high grade mucositis was frequently experienced in group A (77%) versus 7.5% in group B. The major chronic toxicities encountered were chronic mucosal toxicity and xerostomia. There was a statistically signifcant difference between the two groups as regard this, where high grade chronic mucosal toxicity and xerostomia were experienced in group A. |