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Journal of Clinical Oncology, Vol 18, Issue 7 (April), 2000: 1458-1464
© 2000 American Society for Clinical Oncology

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

By Branislav Jeremic, Yuta Shibamoto, Biljana Milicic, Nebojsa Nikolic, Aleksandar Dagovic, Jasna Aleksandrovic, Zeljko Vaskovic, Ljiljana Tadic

From the Departments of Oncology, and Otorhynolaryngology, University Hospital, Kragujevac, Yugoslavia, and Department of Oncology, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan.

Address reprint requests to Branislav Jeremic, MD, PhD, Department of Radiotherapy, University Hospital, Hoppe-Seyler-Strasse 3, D-72076 Tuebingen, Germany; email bjeremic{at}med.uni-tuebingen.de

PURPOSE: To investigate whether the addition of cisplatin (CDDP) to hyperfractionation (Hfx) radiation therapy (RT) offers an advantage over the same Hfx RT given alone in locally advanced (stages III and IV) squamous cell carcinoma of the head and neck.

PATIENTS AND METHODS: One hundred thirty patients were randomized to receive either Hfx RT alone to a tumor dose of 77 Gy in 70 fractions in 35 treatment days over 7 weeks (group I, n = 65) or the same Hfx RT and concurrent low-dose (6 mg/m2) daily CDDP (group II, n = 65).

RESULTS: Hfx RT/chemotherapy offered significantly higher survival rates than 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% at 5 years; P = .0013). However, there was no difference between the two treatment groups in the incidence of either acute or late high-grade 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 daily CDDP offered a survival advantage, as well as improved LRPFS and DMFS.


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