Preliminary Results of Radiation Therapy Oncology Group 97-03: A Randomized Phase II Trial of Concurrent Radiation and Chemotherapy for Advanced Squamous Cell Carcinomas of the Head and Neck

• Published in: Journal of clinical oncology Vol. 22; no. 14; pp. 2856 - 2864
• Main Authors: GARDEN, A. S, HARRIS, J, DEMAS, W, GORE, E, VOKES, E. E, FORASTIERE, A. A, RIDGE, J. A, JONES, C, HORWITZ, E. M, GLISSON, B. S, NABELL, L, COOPER, J. S
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Baltimore, MD American Society of Clinical Oncology 15-07-2004; Lippincott Williams & Wilkins
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - pathology; Carcinoma, Squamous Cell - radiotherapy; Cisplatin - administration & dosage; Combined Modality Therapy; Feasibility Studies; Female; Fluorouracil - administration & dosage; Head and Neck Neoplasms - drug therapy; Head and Neck Neoplasms - pathology; Head and Neck Neoplasms - radiotherapy; Humans; Hydroxyurea - administration & dosage; Male; Medical sciences; Middle Aged; Neoplasm Staging; Paclitaxel - administration & dosage; Radiotherapy Dosage; Survival Analysis; Treatment Outcome; Tumors; Antineoplastic agent; Squamous cell carcinoma; Chemotherapy; Cancerology; Treatment; Concurrent; Phase II trial; Head and neck; Clinical trial; Advanced stage; Malignant tumor
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2004.12.012

To define further the role of concurrent chemoradiotherapy for patients with advanced squamous carcinoma of the head and neck.
The Radiation Therapy Oncology Group developed this three-arm randomized phase II trial. Patients with stage III or IV squamous carcinoma of the oral cavity, oropharynx, or hypopharynx were eligible. Each of three arms proposed a radiation schedule of 70 Gy in 35 fractions. Patients on arm 1 were to receive cisplatin 10 mg/m(2) daily and fluorouracil (FU) 400 mg/m(2) continuous infusion (CI) daily for the final 10 days of treatment. Treatment on arm 2 consisted of hydroxyurea 1 g every 12 hours and FU 800 mg/m(2)/d CI delivered with each fraction of radiation. Arm 3 patients were to receive weekly paclitaxel 30 mg/m(2) and cisplatin 20 mg/m(2). Patients randomly assigned to arms 1 and 3 were to receive their treatments every week; patients on arm 2 were to receive their therapy every other week.
Between 1997 and 1999, 241 patients were entered onto study; 231 were analyzable. Ninety-two percent, 79%, and 83% of patients on arms 1, 2, and 3, respectively, were able to complete their radiation as planned or with an acceptable variation. Fewer than 10% of patients had unacceptable deviations or incomplete chemotherapy in the three arms. Estimated 2-year disease-free and overall survival rates were 38.2% and 57.4% for arm 1, 48.6% and 69.4% for arm 2, and 51.3% and 66.6% for arm 3.
We have demonstrated that three different approaches of concurrent multiagent chemotherapy and radiation were feasible and could be delivered to patients in a multi-institutional setting with high compliance rates.