A prospective phase II trial of concomitant chemotherapy and radiotherapy with delayed accelerated fractionation in unresectable tumors of the head and neck.
BACKGROUND
Our study is a prospective evaluation of unresectable malignant cancers of the head and neck treated with concomitant chemotherapy and radiotherapy (RT) using delayed accelerated fractionation (concomitant boost).


METHODS
Between January 1988 and March 1995, 82 patients with unresectable cancers of the head and neck were enrolled in this phase II study. Of these, 52 patients were treated and followed for a minimum of 3 years and are the subject of this analysis. All patients had T4 lesions and were stage IV according to the American Joint Committee on Staging Criteria (AJCC). Patients received RT with accelerated fractionation to a total of 70 Gy in 6 weeks using a concomitant-boost technique. Concomitant cis platin (100 mg/M2) was given on days 1 and 22 of RT. Twenty-seven patients received mitomycin-C (7.5 mg/M2) on days 1 and 22, and 1 patient received mitomycin-C on day 1. In addition, 27 patients received adjuvant chemotherapy with cis platin and vinblastine. The mean follow-up was 45 months (range, 36-72 months). The minimum follow-up for surviving patients in 3 years.


RESULTS
At 3 years, the local control rate was 58%. Three-year local control rates for paranasal sinus, nasopharynx, oropharynx, and larynx/hypopharynx were 78%, 78%, 64%, and 100%, respectively. For all patients, the distant-metastasis-free survival was 56%, and the overall survival rate was 36%. Patients with oral cavity cancers experienced worse overall survival versus other sites, 0% versus 47% (p = .03). Salivary cancers also showed worse survival versus other sites, 0% versus 47%, but was not statistically significant. Severe acute complications occurred in 34% of patients. Treatment-related toxicity also resulted in the death of 2 patients. Severe late complications occurred in 7% of patients.


CONCLUSIONS
Treatment of this poor prognostic group of patients with aggressive chemotherapy and RT produced surprisingly good local control and survival.
Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
L B
LB
Harrison
A
A
Raben
D G
DG
Pfister
M
M
Zelefsky
E
E
Strong
J P
JP
Shah
R H
RH
Spiro
A
A
Shaha
D H
DH
Kraus
S P
SP
Schantz
E
E
Carper
B
B
Bodansky
C
C
White
G
G
Bosl
D000293:Adolescent; D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008937:Mitomycins / Q000008:administration & dosage; D009367:Neoplasm Staging; D010166:Palliative Care / Q000379:methods*; D010865:Pilot Projects; D011446:Prospective Studies; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage; D015996:Survival Rate; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; D008937:Mitomycins; D011838:Radiation-Sensitizing Agents; D002945:Cisplatin