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Hyperfractionated Irradiation with or without Concurrent Chemotherapy for Locally Advanced Head and Neck Cancer
Reviewer: Roberto Santiago, MD
Abramson Cancer Center of the University of Pennsylvania
Last Modified: April 11, 2003
Source: The New England Journal of Medicine Vol 338(25): 1798-1804, 1998
Author: Brizel, David M. et al
Affiliation: Departments of Radiation Oncology, Duke Comprehensive Cancer Center, Duke University Medical Center, Durham, N.C.
Background
- Cure of locally advanced carcinoma of the head and neck is uncommon, and most patients die with progressive local disease.
- Accelerated fractionation and hyperfractionation can improve disease control by about 20%, as compared with conventional radiation, without an increase in long-term toxicity.
- Several randomized studies have shown improved overall survival or disease-free survival when radiation therapy (RT) was combined with concurrent chemotherapy as compared to sequential chemotherapy plus RT or RT alone.
- This study tests the hypothesis that hyperfractionated RT plus concurrent chemotherapy followed by additional chemotherapy leads to better locoregional control, relapse-free survival, and overall survival than accelerated hyperfractionation alone.
Methods
- Multicenter randomized study (6/1990-12/1995) of 116 patients with advanced head and neck carcinoma treated either with:
- 3-Field, hyperfractionated radiation therapy (RT) alone (4-6 MV photons, 125 cGy twice a day (BID), at least 6 hours apart, to 7500 cGy)
- 3-Field, hyperfractionated RT (4-6 MV photons, 125 cGy BID, at least 6 hours apart, to 7000 cGy) plus 5 days of cisplatin plus 5FU (12mg/m2/d plus 600mg/m2/d) during weeks 1 and 6 of irradiation followed by 2 more courses of the two drugs.
- Eligibile patients had previously untreated squamous-cell carcinoma of the head and neck region stages T3-T4, N0-N3, M0 (T2N0 Base of tongue were eligible) with good renal and hematologic function
- Primary tumors were classified and stratified as resectable or unresectable as well as low (< 12 g/dL) or normal hemoglobin.
- CT or MRI was repeated 4-6 weeks after treatment to assess response.
- Patients with stage N0-N1 were treated only with RT or RT plus chemotherapy.
- Patients with N2-N3 were evaluated after RT and elective neck dissection was planned for complete responders.
- The primary outcome measures were:
- Rate of complete response at the primary site
- Rate of locoregional control



