Does concurrent postoperative radiotherapy and chemotherapy in head and neck cancer improve patient outcome?
11/13/2004 Sue S Yom and David I Rosenthal Nature Clinical Practice Oncology (2004) 1, 14-15 Background: Patients with advanced high-risk squamous-cell carcinoma of the head and neck frequently have a recurrence in the original tumor bed. Following tumor resection, radiotherapy can be effective in improving cancer control. This study assessed whether the addition of cisplatin to postoperative radiotherapy could improve local and regional control rates in head and neck cancer patients. Design: This phase III, multicenter, randomized, stratified study enrolled men and women with squamous-cell carcinoma, who were at high risk of disease, had undergone tumor resection, and who could tolerate chemotherapy. Patients were included if they were aged 18 years or more with a minimum Karnofsky Performance Status score of 60, and on the basis of particular clinical laboratory results. Intervention: Radiotherapy began not later than 8 weeks after surgery; patients were stratified according to age (>70 years vs <70 years), surgical margin, and tumor status. Patients were randomly assigned to receive 60 Gy radiosurgery in 30 fractions over 6 weeks, with or without 6 Gy boosts in 3 fractions over a 3-day period. Patients in the combined therapy group also received intravenous cisplatin at 100 mg/m2 of body-surface area on days 1, 22, and 43. Patients were examined weekly during treatment, and post-treatment evaluations were carried out after 9 weeks, then every 3 months for the first year, twice in the second and third years, and annually thereafter. Outcome Measures: Local and regional tumor control was the primary [...]