Low Dose Weekly Paclitaxel Versus Low Dose Weekly Cisplatin with Concomitant Radiation in Locally Advanced Head and Neck Cancers

Purpose: The purpose of this prospective phase III study was to compare the role of concomitant chemoradiation using paclitaxel versus cisplatin in locally advanced head and neck cancers. Patients and methods: 52 patients were randomly assigned to one of the two concomitant chemoradiation arms: arm I (n=26) and arm II (n= 26) who received injection of paclitaxel 20 mg/m2 I/V 1 hour infusion before radiation, repeated weekly for 6 cycles, and cisplatin 30 mg/m2 I/V 1 hour infusion before radiation, repeated weekly for 6 cycles, respectively. The planned radiotherapy dose was 66-70 Gy, 1.8-2 Gy/day, 5#/Week in 6-7 weeks. Results: Response rates were 76 and 69.2% in arm I and arm II, respectively (P = 0.53). The hematological toxicity was generally mild. On the contrary, non-hematologic toxicities were severe. Grade III mucositis occurred in 32% in arm I and in 23.1% in arm II (P = 0.04). Moreover, grade III dermatitis were encountered in 28% in arm I and 11.5% in arm II (P = 0.03). The 2-year local-regional control figures were 60 and 57.1% in arm I and arm II, respectively(P=0.52) ; however the 2-year progression-free survival figures were 36.8 and 33.3% in arm I and arm II, respectively(P=0.43), while the 2-year overall survival figures were 56 and 50% in arm I and arm II, respectively (P = 0.68). Conclusion: Both concomitant chemoradiotherapy regimens were easily given in the outpatient clinic. The regimen based on paclitaxel was more effective; however, the difference was insignificant.