The current treatment of head and neck squamous cell carcinoma (HNSCC) has high toxicity rate, so an alternate protocol is necessary to increase the chance of disease control. The rationale of the present study is to assess the response rate, disease free survival and median survival of concomitant chemoradiation using gemcitabine in locally advanced HNSCC.
Eighty three (83) patients with locally advanced HNSCC were enrolled. Gemcitabine in a dose of 100 mg/m2 was given once weekly during external beam radiotherapy (ERT). ERT was delivered using 60Co upto 66 Gy, 2 Gy/fraction/day limiting spinal cord dose to 44 Gy. Response was assessed by computed tomography at six weeks. Response to therapy was assessed through clinical examination and computed tomography (CT) at two months from start of treatment. The primary endpoint was to assess disease-free survival (DFS) and overall survival (OS).
Complete response (CR) was seen in 44 (53%), partial response (PR) in 29 (35%), stable disease (SD) in 5 (6%) patients and progressive disease in 5 (6%) patients. There was no statistically significant difference in combined CR and PR between male (84%) and female (89%), and according to age. There was significant difference (P-value < 0.05) in combined CR and PR between stage III (93%) and IV patients (79%). Four year DFS and OS were 38% and 51%, respectively. Mean and median DFS (year) were 2.17 Â± 0.16 (95% confidence interval [CI] 1.86 to 2.48) and 1.70 Â± 0.24 (95% CI 1.23 to 2.17), respectively. Mean and median OS (year) were 2.97 Â± 0.16 (95% CI 2.66 to 3.28) and 3.01 Â± 0.19 (95% CI 2.82 to 3.26), respectively.
This study showed that concomitant chemoradiation using gemcitabine has a high response rate and fairly good DFS and OS even in advanced HNSCC, especially in stage III patients.
Clinical trial identification
All authors have declared no conflicts of interest.