21393
document
Phase III study of the Eastern Cooperative Oncology Group ( ECOG 2597 ) : induction chemotherapy followed by either standard thoracic radiotherapy or hyperfractionated accelerated radiotherapy for patients with unresectable stage IIIA and B non-small-cell lung cancer . PURPOSE To compare once-daily radiation therapy ( qdRT ) with hyperfractionated accelerated radiation therapy ( HART ) after two cycles of induction chemotherapy . PATIENTS AND METHODS Eligible patients were treatment naive , and had stage IIIA and B unresectable non-small-cell lung cancer , Eastern Cooperative Oncology Group performance status 0/1 , and normal organ function . Induction chemotherapy consisted of two cycles of carboplatin area under time-concentration curve 6 mg/mL . min plus paclitaxel 225 mg/m2 on day 1 . RT consisted of arm 1 ( qdRT ) , 64 Gy ( 2 Gy/d ) , versus arm 2 ( HART ) , 57.6 Gy ( 1.5 Gy tid for 2.5 weeks ) . A total of 388 patients were needed to detect a 50 % increase in median survival from 14 months of qdRT to 21 months of HART ; accrual was not achieved and the study closed prematurely . RESULTS Of 141 patients enrolled , 83 % were randomly assigned after chemotherapy to qdRT ( n = 59 ) or HART ( n = 60 ) . Median survival was 20.3 and 14.9 months for HART and qdRT , respectively ( P = .28 ) . Overall response was 25 % and 22 % for HART and qdRT , respectively ( P = .69 ) . Two- and 3-year survival was 44 % and 34 % for HART , and 24 % and 14 % for qdRT , respectively . Grade > or = 3 toxicities included esophagitis in 14 v nine patients , and pneumonitis in 0 v 6 patients for HART and qdRT , respectively . Any subsequent trials of the HART regimen must address the issues that led to early closure , including slow accrual , logistics of HART , mucosal toxicity , and the fact that concurrent chemoradiotherapy now seems more effective than sequential treatment . CONCLUSION After two cycles of induction chemotherapy with carboplatin-paclitaxel , HART is feasible with an acceptable toxicity profile . Although statistical significance was not achieved and the study closed early , there was a positive statistical trend suggesting a survival advantage with the HART regimen .
21394
Intervention_Physical
induction chemotherapy
21395
Intervention_Physical
standard thoracic radiotherapy
21396
Intervention_Physical
hyperfractionated accelerated radiotherapy
21397
Intervention_Physical
once-daily radiation therapy ( qdRT )
21398
Intervention_Physical
hyperfractionated accelerated radiation therapy ( HART )
21399
Intervention_Physical
induction chemotherapy
21400
Intervention_Pharmacological
Induction chemotherapy
21401
Intervention_Pharmacological
carboplatin
21402
Intervention_Pharmacological
paclitaxel
21403
Intervention_Physical
qdRT
21404
Intervention_Physical
HART
21405
Intervention_Physical
qdRT
21406
Intervention_Physical
HART
21407
Intervention_Physical
HART
21408
Intervention_Physical
qdRT
21409
Intervention_Physical
HART
21410
Intervention_Physical
qdRT
21411
Intervention_Physical
HART
21412
Intervention_Physical
qdRT
21413
Intervention_Physical
HART
21414
Intervention_Physical
qdRT
21415
Intervention_Physical
HART
21416
Intervention_Physical
HART
21417
Intervention_Physical
induction chemotherapy
21418
Intervention_Pharmacological
carboplatin-paclitaxel , HART
21419
Intervention_Physical
HART
21420
Outcome_Mortality
Median survival
21421
Outcome_Other
Overall response
21422
Outcome_Mortality
Two- and 3-year survival
21423
Outcome_Adverse-effects
Grade > or = 3 toxicities
21424
Outcome_Physical
slow accrual , logistics of HART , mucosal toxicity