Activity of combined gemcitabine therapy on treatment of planocellular carcinoma: A pilot study

BACKGROUND: Drug-orientated, pilot study was conducted to estimate the activity of gemcitabine on treatment of head and neck and lung planocellular carcinoma in combination with either radiotherapy or chemotherapy. METHODS There were 22 patients treated with gemcitabine for planocellular carcinoma of head and neck (9 patients) and lung (13 patients). Combined gemcitabine-radiotherapy was applied in 10 patients while gemcitabine-chemotherapy in 12 patients. Eligible and evaluable patients (22) were with either locally advanced (14 patients) or metastatic (8 patients) stage of the disease. In gemcitabine-radiotherapy group, gemcitabine was given IV, 1000 mg/ m2, on day 1, 8, and 15 during the radiotherapy course as radiopotentiator (65 Gy in 32 fractions for head and neck, and 55 Gy in 20 fractions, split course one month for lung cancer patients). In gemcitabine-chemotherapy group the same dose of gemcitabine was given (4-week schedule) in combination with platinum based cytotoxic drugs. We analyzed response rate and toxicity. RESULTS: Among patients treated for head and neck planocellular carcinoma, there were 67% complete responders while there was 15% complete responders treated for lung cancer. Also, 80% of patients treated in gemcitabine-radiotherapy group had complete response while 50% of those treated in gemc- itabine-chemotherapy group. Actuarial survival as function of tumor control was 52% for lung and 88% for head and neck cancer 12 months after the initiation of treatment. In gemcitabine-radiotherapy group of patients treated for head and neck carcinoma, the radiation mucositis grade III was observed in 80% while in gemcitabine - chemotherapy group of patients the most common side effect (60% of patients) was neutropenia grade II (40%)/III (20%). CONCLUSION: There was no statistically significant difference regarding response rate between two groups of patients (head and neck vs. lung cancer, and gemcitabine- radiotherapy vs. gemcitabine - chemotherapy). However, better clinical results were achieved for head and neck cancer patients, particularly in gemcitabine - radiotherapy group but with significant toxicity due to high gemcitabine dose