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Abstract Summary &Conclusion This is a prospective phase II study that included sixty patients with locally advanced SCCHN presented to Kasr Eleiny clinical oncology centre from March 2010 till June 2011,to evaluate overall response rate (PR+CR), Progression free survival (PFS) ,Overall survival (OAS) and Safety profile after treatment with (gemcitabine 50 mg/m2/week) in comparison to the control arm treated with ( cisplatin30 mg / m2/week ) , both arms concomitant with radiotherapy 70 GY/35 fractions/7 weeks . Four to six weeks after concurrent chemoradiotherapy ; the ORR (CR,PR) was 83% in both arms , and only the stage was correlated with the response rate in both arms (57% vs 26 % in arm A, while 53% vs 30% in arm B) in stage III & IV respectively . At a median follow-up of 13 months (range 6-21), the one year PFS , in Arm A was 33.3% with a Mean PFS 9.9 ±0.7 months (95% CI 8.6-11.3) (median 9 mo) compared to Arm B with one year progression free survival 21.7% with a mean PFS 10.4± 0.5 months (95% CI 9.3-11.4) (median 11mo) (p= 0.8) with a hazard ratio of 0.08 (95% CI 0.005 – 1.47). Acute radiation reactions in form of skin toxicity (erethema and desquamation), nausea, vomiting, mucositis and weight loss were equally distributed in the treatment arms. Dysphagia and fatigue were markedly higher in Arm B. While infection and and neutropenia requiring hospitalization, IVantibiotics were slightly higher in Arm A compared to Arm B. Regarding the late radiation induced reactions , G III-IV xerostomia affected (70%) of patients in arm A and (80 %) of patients in arm B . Grade III skin lesions affected (20%) of patients in arm A and (16.7%) of patients in arm B. Mucositis grade III/IV affects (10%) of patients in arm A and (16.7%) of patients in arm B. Conclusion and Recommendations : 1. Weekly gemcitabine concurrent with radiotherapy is quite effective in the treatment of locally advanced HNSCC. 2. Weekly gemcitabine concurrent with radiotherapy has manageable toxicities comparable with those receiving cisplatin concurrent with radiotherapy . 3. Weekly gemcitabine concurrent with radiotherapy can be used instead of cisplatin concurrent with radiotherapy in the treatment of locally advanced HNSCC in patients who cannot tolerate cisplatin either due to old age or poor renal function. 4. The weekly dose of cisplatin with radiation in the treatment of locally advanced HNSCC can be increased safely to 40 mg/m2 instead of 30 mg/m2 especially with the use of more sophisticated technique (3DCRT) and(IMRT). 5. An effort to further estimate this treatment protocol in further randomized studies with larger number of patients and longer follow up are needed. |