Hyperfractionated radiation therapy with or without concurrent low-dose daily cisplatin in locally advanced squamous cell carcinoma of the head and neck: A prospective randomized trial

Purpose: To investigate whether the addition of cisplatin (CDDP) to hyperfr actionation (Hfx) radiation therapy (RT) offers an advantage over the same Hfx RT given alone in locally advanced (stages III and IV) squamous cell ca rcinoma of the head and neck. Patients and Methods: One hundred thirty patients were randomized to receiv e either Hfx RT alone to a tumor dose of 77 Gy in 70 fractions in 35 treatm ent days over 7 weeks (group I, n = 65) or the same Hfx RT and concurrent l ow-dose (6 mg/m(2)) daily CDDP (group II, n = 65). Results: Hfx RT/chemotherapy offered significantly higher survival rates th an Hfx RT alone (68% v 49% at 2 years and 46% v 25% at 5 years; P = .0075). It also offered higher progression-free survival (46% v 25% at 5 years; P = .0068), higher locoregional progression-free survival (LRPFS) (50% v 36% at 5 years; P = .041), and higher distant metastasis-free survival (DMFS) ( 86% v 57% or 5 years; P = .0013). However, there was no difference between the two treatment groups in the incidence of either acute or late high-grad e RT-induced toxicity. Hematologic high-grade toxicity was more frequent in group II patients. Conclusion: As compared with Hfx RT alone, Hfx RT and concurrent low-dose d aily CDDP offered a survival advantage, as well as improved LRPFS and DMFS. (C) 2000 by American Society of Clinical Oncology.