70215
document
Hyperfractionated accelerated radiation therapy ( HART ) of 70.6 Gy with concurrent 5-FU/Mitomycin C is superior to HART of 77.6 Gy alone in locally advanced head and neck cancer : long-term results of the ARO 95-06 randomized phase III trial . PURPOSE To report the long-term results of the ARO 95-06 randomized trial comparing hyperfractionated accelerated chemoradiation with mitomycin C/5-fluorouracil ( C-HART ) with hyperfractionated accelerated radiation therapy ( HART ) alone in locally advanced head and neck cancer . PATIENTS AND METHODS The primary endpoint was locoregional control ( LRC ) . Three hundred eighty-four patients with stage III ( 6 % ) and IV ( 94 % ) oropharyngeal ( 59.4 % ) , hypopharyngeal ( 32.3 % ) , and oral cavity ( 8.3 % ) cancer were randomly assigned to 30 Gy/2 Gy daily followed by twice-daily 1.4 Gy to a total of 70.6 Gy concurrently with mitomycin C/5-FU ( C-HART ) or 16 Gy/2 Gy daily followed by twice-daily 1.4 Gy to a total dose of 77.6 Gy alone ( HART ) . Statistical analyses were done with the log-rank test and univariate and multivariate Cox regression analyses . RESULTS The median follow-up time was 8.7 years ( 95 % confidence interval [ CI ] : 7.8-9.7 years ) . At 10 years , the LRC rates were 38.0 % ( C-HART ) versus 26.0 % ( HART , P=.002 ) . The cancer-specific survival and overall survival rates were 39 % and 10 % ( C-HART ) versus 30.0 % and 9 % ( HART , P=.042 and P=.049 ) , respectively . According to multivariate Cox regression analysis , the combined treatment was associated with improved LRC ( hazard ratio [ HR ] : 0.6 [ 95 % CI : 0.5-0.8 ; P=.002 ] ) . The association between combined treatment arm and increased LRC appeared to be limited to oropharyngeal cancer ( P=.003 ) as compared with hypopharyngeal or oral cavity cancer ( P=.264 ) . CONCLUSIONS C-HART remains superior to HART in terms of LRC . However , this effect may be limited to oropharyngeal cancer patients .
70216
Intervention_Pharmacological
Hyperfractionated accelerated radiation therapy ( HART
70217
Intervention_Pharmacological
5-FU/Mitomycin C
70218
Intervention_Physical
HART
70219
Intervention_Pharmacological
mitomycin C/5-fluorouracil ( C-HART )
70220
Intervention_Control
hyperfractionated accelerated radiation therapy ( HART ) alone
70221
Outcome_Other
RESULTS The median follow-up
70222
Outcome_Other
10 years , the
70223
Outcome_Other
P=.002
70224
Outcome_Mortality
The cancer-specific survival and overall survival
70225
Outcome_Physical
associated with improved
70226
Outcome_Physical
and increased
70227
Outcome_Other
in terms
70228
Participant_Condition
locally advanced head and neck cancer
70229
Participant_Condition
locally advanced head and neck cancer
70230
Participant_Sample-size
Three hundred eighty-four patients with stage III
70231
Participant_Condition
limited to oropharyngeal cancer