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The addition of amifostine to carboplatin and paclitaxel based chemoradiation in locally advanced non-small cell lung cancer : long-term follow-up of Radiation Therapy Oncology Group ( RTOG ) randomized trial 9801 . INTRODUCTION We report the long-term results of RTOG 9801 , a randomized trial investigating the ability of amifostine , a radioprotector , to reduce chemoradiation-induced esophagitis . METHODS Patients with stages II and IIIA/B non-small-cell lung cancer received induction paclitaxel 225 mg/m2 intravenously ( IV ) and carboplatin area under the curve ( AUC ) 6 both days 1 and 22 , followed by concurrent weekly paclitaxel ( 50 mg/m2 ) and carboplatin ( AUC 2 ) , with hyperfractionated radiation therapy ( 69.6 Gy at 1.2 Gy BID ) . Patients were randomly assigned to amifostine ( AM ) 500 mg IV four times per week or no-AM during chemoradiotherapy . Stratification factors included age ( < 70 vs. ≥70 years ) , stage and performance status . RESULTS 243 patients ( pts ) were enrolled ; 120 received AM , 123 received no-AM . Two pts on each arm were found ineligible . Overall , 85 % of patients were ≤70 years ; 75 % had a KPS ≥90 . 34 % had squamous histology . With median follow-up of 96.3 months ( for patients still alive ) , overall survival was identical ( hazard ratio 1.03 ( 0.79-1.34 ) , NS ) : five-year survival 17 % in both arms . The incidence of late grade 3-5 toxicities was 16 % in the AM arm and 19 % in the control arm ( hazard ratio 1.24 ( 0.66-2.32 ) , NS ) . There was no significant difference between the arms regarding overall survival , disease-free survival or long-term toxicity . CONCLUSION The chemoradiation regimen of carboplatin and paclitaxel produced long-term results in the multi-institutional setting comparable to other regimens . Amifostine did not appear to compromise survival . As done in RTOG 9801 , more consistent reporting of long term toxicity is needed for comparison of different chemoradiation regimens .
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Intervention_Pharmacological
amifostine
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Intervention_Pharmacological
carboplatin
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Intervention_Pharmacological
paclitaxel
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Intervention_Physical
chemoradiation
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Intervention_Pharmacological
amifostine
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Intervention_Pharmacological
paclitaxel
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Intervention_Pharmacological
carboplatin
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Intervention_Pharmacological
paclitaxel
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Intervention_Pharmacological
carboplatin
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Intervention_Pharmacological
hyperfractionated radiation therapy
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Intervention_Pharmacological
amifostine
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Outcome_Mortality
overall survival
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Outcome_Mortality
five-year survival
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Outcome_Adverse-effects
incidence of late grade 3-5 toxicities
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Outcome_Mortality
disease-free survival
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Outcome_Other
long term toxicity
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Participant_Condition
locally advanced non-small cell lung cancer :
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Participant_Condition
Patients with stages II and IIIA/B non-small-cell lung cancer