Randomized study of adjuvant chemotherapy for head and neck cancer. Otolaryngol Head Neck Surg 1985 Dec;93(6):712-7
Date
12/01/1985Pubmed ID
2418400DOI
10.1177/019459988509300604Scopus ID
2-s2.0-0022211391 (requires institutional sign-in at Scopus site) 46 CitationsAbstract
The ability of surgery and radiotherapy to control advanced squamous cell carcinoma of the head and neck has reached its maximal potential. We initiated a randomized, prospective, stratified study of adjuvant chemotherapy. Patients with stage II disease of the pyriform sinus and stage II and IV disease of the oral cavity, larynx, hypopharynx, oropharynx, nasopharynx, and paranasal sinuses were eligible. Patients were randomized to receive either standard therapy alone or two courses of 5-fluorouracil (B-CMF) chemotherapy prior to and two courses after the completion of standard therapy. Standard therapy consisted of preoperative irradiation followed by radical surgery. Of 133 patients with advanced disease, 83 were included in the study--43 in the chemotherapy group and 40 in the control group. Rates of residual and recurrent disease, as well as distant metastases, were similar for the two groups. The survival rates of patients without persistent disease at the end of treatment showed no significant difference for the two groups. The study has been discontinued because statistical analysis indicated that the addition of more patients would not materially increase the statistical significance of the study.
Author List
Holoye PY, Grossman TW, Toohill RJ, Kun LE, Byhardt RW, Duncavage JA, Teplin RW, Ritch PS, Hoffman RG, Malin TCMESH terms used to index this publication - Major topics in bold
Antineoplastic Combined Chemotherapy ProtocolsBleomycin
Carcinoma, Squamous Cell
Clinical Trials as Topic
Combined Modality Therapy
Cyclophosphamide
Drug Administration Schedule
Fluorouracil
Head and Neck Neoplasms
Humans
Methotrexate
Prognosis
Prospective Studies
Random Allocation
