Shaharyar, Abrar Ahmed Javed, Ijaz Hussain Shah, Tariq Nadeem Ansari, Shahid Rasool, Muhammad Faheem, Humera Mehmood, Mazher Ali Shah, Muhammad Saleem Khan, Muhammad Ali Afridi.
A phase II study of Gemcitabine concurrent with radiation in locally advanced Squamous Cell Carcinoma of head and neck: A trial of the Cancer Research Group Pakistan.
Pak J Med Sci Jan ;22(3):258-64.

Objective: To evaluate the efficacy and toxicity of weekly gemcitabine as a radiosensitizer concurrent with radical radiotherapy in locally advanced carcinoma of head and neck. Patients and Methods: From August 2001 to January 2002, thirty-nine patients with stage III or IV B inoperable carcinoma of head and neck were enrolled. Patients with histopathologically confirmed squamous cell carcinoma with at least one bidimensionally measurable lesion, no prior chemotherapy or radiotherapy, and a KPS of 60 or above were included. Patients with nasopharyngeal, glottic or sub-glottic cancer were excluded. Gemcitabine 150mg/m2 or a total dose not exceeding 200 mg was given on day 1, 8, 15, 22, 29, and 36 during radiation treatment. Radiation was delivered with conventional fractionation to a total dose of 66-70Gy. Miller`s criteria was used for response evaluation. RTOG/EORTC acute radiation (and chemotherapy) morbidity scoring system and WHO grading of acute and sub acute toxicity criteria were used for documentation of toxicity. Results: All 39 patients were evaluable for toxicity but only 35 patients were evaluable for response. An overall response rate of 94.3% ( 95% CI; 80.8-99.3) was seen with a partial response rate of 71.4% and complete response rate of 22.9 % (95 %CI; 10.4- 40.1). Grade 3 mucositis was seen in 28 patients (71.8%). Grade 4 mucositis was seen in 2 patients (5.1 %). Pharyngeal toxicity was the second-most common toxicity. Grade 2 toxicity was seen in 12 patients (30.8%) and grade 3 in 6 patients (15.4%). Despite vigorous symptomatic and supportive care acute toxicities led to treatment interruption in 40% of patients. Conclusion: A high overall response rate and a high rate of acute toxicity are seen at a weekly gemcitabine dose of 150mg/m2 concurrent with radiation. This shows that gemcitabine is a potent radiosensitizer with a marked tumor and normal tissue radio sensitization.

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