Abstract | 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: 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.
|
Authors | Yaacov Richard Lawrence, Rebecca Paulus, Corey Langer, Maria Werner-Wasik, Mark K Buyyounouski, Ritsuko Komaki, Mitchell Machtay, Colum Smith, Rita S Axelrod, Todd Wasserman, Jeffrey D Bradley, Benjamin Movsas |
Journal | Lung cancer (Amsterdam, Netherlands)
(Lung Cancer)
Vol. 80
Issue 3
Pg. 298-305
(Jun 2013)
ISSN: 1872-8332 [Electronic] Ireland |
PMID | 23477890
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
|
Copyright | Copyright © 2013 Elsevier Ireland Ltd. All rights reserved. |
Chemical References |
- Carboplatin
- Amifostine
- Paclitaxel
|
Topics |
- Adult
- Aged
- Aged, 80 and over
- Amifostine
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
- Carboplatin
(administration & dosage)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, pathology, radiotherapy)
- Chemoradiotherapy
- Disease-Free Survival
- Drug-Related Side Effects and Adverse Reactions
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Neoplasm Recurrence, Local
(drug therapy, pathology, radiotherapy)
- Neoplasm Staging
- Paclitaxel
(administration & dosage)
|