Intensification regimen for advanced-stage resectable hypopharyngeal carcinoma.
OBJECTIVE
To determine feasibility, compliance, long-term survival, and disease control rates in the intensification regimen for advanced resectable hypopharyngeal carcinoma.


METHODS
Prospective, nonrandomized, controlled phase 2 trial with a median follow-up period of 89 months (range, 3.4-140.0 months).


METHODS
Cancer center at a state university.


METHODS
Thirty-two patients (age range, 44-79 years; median age, 59 years) with advanced (69% stage IV, 31% stage III) resectable hypopharyngeal carcinoma.


METHODS
Combination of surgery, radiation therapy, and chemotherapy (cisplatin and paclitaxel) along with intraoperative radiation therapy.


METHODS
Compliance, long-term survival, and locoregional and systemic disease control rates and functional outcome.


RESULTS
The protocol compliance rate was 62% (20 of 32 patients), and the overall 5-year survival rate was 56%. Local recurrence occurred in 3 patients (9%). The systemic disease control rate was 91% (29 of 32 patients). Total laryngectomy was required in 15 patients (47%); preservation of the larynx was possible in 17 patients (53%). Only 3 (13%) of 6 patients were percutaneous endoscopic gastrostomy tube dependent in the long-term follow-up.


CONCLUSIONS
The intensification regimen described in this study accomplished excellent long-term survival and disease control rates in patients with advanced resectable hypopharyngeal carcinoma. The future plan is to proceed with a phase 3 trial if the single-institutional experience at The Ohio State University can be duplicated in a multi-institutional phase 2 study.
Ozer
Enver
E
Department of Otolaryngology-Head and Neck Surgery, The Ohio State University, Columbus, OH 43210, USA. ozer-1@medctr.osu.edu
Grecula
John C
JC
Agrawal
Amit
A
Rhoades
Chris A
CA
Schuller
David E
DE
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007012:Hypopharyngeal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D007825:Laryngectomy; D008297:Male; D008875:Middle Aged; D009820:Ohio / Q000453:epidemiology; D017239:Paclitaxel / Q000008:administration & dosage; D010349:Patient Compliance; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome
D017239:Paclitaxel; D002945:Cisplatin