Document Detail

Intensification regimen 2 for advanced head and neck squamous cell carcinomas.
MedLine Citation:
PMID:  10604408     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To determine the feasibility, toxicity, and compliance of an intense treatment regimen for patients with advanced, previously untreated, resectable head and neck squamous cell carcinomas. DESIGN: Prospective, nonrandomized, controlled (phase 1 or 2) clinical trial; median time at risk, 25 months (range, 7 days to 36 months). SETTING: Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Columbus. PATIENTS: Forty-three patients (median age, 59 years; range, 32-76 years) with resectable, previously untreated stage III or IV squamous cell carcinomas of the oral cavity, oropharynx, or hypopharynx or stage II squamous cell carcinomas of the hypopharynx (referred sample of patients). INTERVENTIONS: Days 1 to 4, perioperative, slightly accelerated, hyperfractionated radiotherapy (9.1 Gy) to off cord fields; days 1 to 3, cisplatin, 30 mg/m2 per day; day 4, surgical resection and intraoperative radiotherapy boost (7.5 Gy); days 45 to 52, postoperative radiotherapy (40 Gy to the primary site and upper neck and 45 Gy to the supraclavicular areas); days 24, 45, and 66, paclitaxel, 135 mg/m2 per 24 hours, with routine granulocyte colony-stimulating factor support; and days 25 and 46, cisplatin, 100 mg/m2. MAIN OUTCOME MEASURES: Toxicity, compliance, local control, and distant metastatic rates. RESULTS: Patient compliance was 91% (39 of 43 patients), but protocol compliance was only 58% (25 of 43 patients), reflecting increased toxicity of the systemic regimen (2 [5%] of the 43 patients experienced grade 5 hematologic toxicity due to the regimen; 16 [37%], grade 4; and 10 [23%], grade 3). Local-regional control was 92% (23 of 25 patients), and the distant metastatic rate was 8% (2 of 25) in patients completing treatment per protocol. One patient had surgical salvage of a second primary tumor. CONCLUSIONS: Local control and patient compliance were encouraging, but systemic toxicity was unacceptable. Thus, the paclitaxel was changed to a weekly regimen.
J C Grecula; D E Schuller; C A Rhoades; J L Au; S Nag; C J Bauer; A Agrawal; R Martinez-Monge; A Johnson; D Young; R A Gahbauer
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Publication Detail:
Type:  Clinical Trial; Controlled Clinical Trial; Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Archives of otolaryngology--head & neck surgery     Volume:  125     ISSN:  0886-4470     ISO Abbreviation:  Arch. Otolaryngol. Head Neck Surg.     Publication Date:  1999 Dec 
Date Detail:
Created Date:  2000-01-05     Completed Date:  2000-01-05     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  8603209     Medline TA:  Arch Otolaryngol Head Neck Surg     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1313-8     Citation Subset:  AIM; IM    
Division of Radiation Oncology, Arthur G. James Cancer Hospital, The Ohio State University Comprehensive Cancer Center, Columbus 43210, USA.
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MeSH Terms
Antineoplastic Agents / adverse effects,  therapeutic use*
Carcinoma, Squamous Cell / drug therapy,  pathology,  radiotherapy*,  surgery
Cisplatin / adverse effects,  therapeutic use*
Combined Modality Therapy
Dose-Response Relationship, Radiation
Feasibility Studies
Head and Neck Neoplasms / drug therapy,  pathology,  radiotherapy*,  surgery
Middle Aged
Neoplasm Staging
Paclitaxel / adverse effects,  therapeutic use*
Patient Compliance
Survival Rate
Grant Support
Reg. No./Substance:
0/Antineoplastic Agents; 15663-27-1/Cisplatin; 33069-62-4/Paclitaxel

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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