Multimodal intensification therapy for previously untreated advanced resectable squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx.
BACKGROUND
An intensified treatment regimen for previously untreated Stage III and IV resectable oral cavity, oropharyngeal, or hypopharyngeal squamous cell carcinoma was analyzed to assess disease control, patient compliance, and toxicity.


METHODS
Forty three patients with previously untreated, advanced, resectable squamous cell carcinoma of the oral cavity, oropharynx, or hypopharynx were enrolled in a prospective Phase II institutional clinical trial at a tertiary care comprehensive cancer center. This regimen was a continuum of multimodal treatment in a contracted time interval. It included preoperative slightly accelerated hyperfractionated radiotherapy with concurrent cisplatin, followed immediately with surgery and intraoperative radiotherapy, and completed with early postoperative weekly paclitaxel (beginning on Day 6 after surgery), two additional cisplatin cycles, and concurrent once daily radiotherapy beginning on Day 28 after surgery.


RESULTS
The current trial was designed to reduce the toxicity of the systemic therapy while maintaining or improving locoregional/distant disease control and patient compliance. There were 43 patients enrolled, and the range of time at risk was 2.6 to 24.7 months (median, 14.6 months). Of the 43 registered patients, 43 were evaluable. The locoregional (100%) and systemic (93%) disease control rates were excellent, with low rates of patient noncompliance (21%) and reduced levels of toxicity.


CONCLUSIONS
An intensive treatment regimen that improves disease control and treatment compliance is clearly feasible for this patient population. Future plans include modifications to continue to reduce toxicity and expansion to a multi-center Phase II trial to determine if the single institutional results can be duplicated.
Department of Otolaryngology, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Ohio State University, Columbus, Ohio 43210, USA. schuller-1@medctr.osu.edu
David E
DE
Schuller
John C
JC
Grecula
Amit
A
Agrawal
Chris A
CA
Rhoades
Debra A
DA
Orr
Donn C
DC
Young
James P
JP
Malone
Meredith
M
Merz
D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007012:Hypopharyngeal Neoplasms / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000401:mortality / Q000628:therapy*; D009362:Neoplasm Metastasis; D009959:Oropharyngeal Neoplasms / Q000401:mortality / Q000628:therapy*; D010349:Patient Compliance; D011446:Prospective Studies; D020521:Stroke / Q000209:etiology