A Prospective Phase III Open Label Study Comparing Low Dose Paclitaxel Versus Cisplatin as Weekly Regimen with Concurrent Radiation in Locally Advanced Head and Neck Cancer

A prospective randomized study was done to determine the comparative effectiveness and safety of low dose weekly paclitaxel versus weekly cisplatin with concurrent radiation in the treatment of locally advanced head and neck cancer. Material and Method: The prospective single centered study was conducted on 122 patients in the department of radiation oncology in a tertiary care hospital from October 2010 to November 2011. All patients were histopathologically proved squamous cell carcinoma. Previously untreated one hundred eight randomly selected and patients were divided into two groups by computer generated programme. The study group received injection Paclitaxel 20 mg/m² while control group received injection Cisplatin 30 mg/m². All patients had received 66-70 Gy concurrent radiation at the rate of 2 Gy/day, 5 #/week, in 6-7 weeks by cobalt-60 Theratron -780 E/780C Teletherapy units. Result: Out of 122, 112 patients were men and 10 were women with a median age of 51 years range (30 - 65). 63 versus 59 patients were distributed on the basis of computer generated programme in Cisplatin and Paclitaxsel arm. There was no statistically significant difference in DFS in CDDP arm and Paclitaxel arm (Χ²= 0.072; p value 0.789) at the 24 months. There was no statistically significant difference in OS in CDDP arm and Paclitaxel arm (Χ²= 0.006; p value: 0.936) at the 24 months. The common adverse effect both in the CDDP arm and Paclitaxsel arm was oral mucosits. There was no significant difference in the incidence of mucositis and dermatitis between CDDP and Paclitaxsel arm. Conclusion: Low dose Paclitaxel weekly schedule is comparable to Cisplatin in locally advanced head and neck squamous cell carcinoma both in form of survival and toxicity.