TY - JOUR
T1 - The addition of amifostine to carboplatin and paclitaxel based chemoradiation in locally advanced non-small cell lung cancer
T2 - Long-term follow-up of Radiation Therapy Oncology Group (RTOG) randomized trial 9801
AU - Lawrence, Yaacov Richard
AU - Paulus, Rebecca
AU - Langer, Corey
AU - Werner-Wasik, Maria
AU - Buyyounouski, Mark K.
AU - Komaki, Ritsuko
AU - Machtay, Mitchell
AU - Smith, Colum
AU - Axelrod, Rita S.
AU - Wasserman, Todd
AU - Bradley, Jeffrey D.
AU - Movsas, Benjamin
N1 - Funding Information:
This trial was conducted by the RTOG and was supported by RTOG grant U10 CA21661 , CCOP grant U10 CA37422 , and Stat grant U10 CA32115 from the National Cancer Institute (NCI) and by Medimmune Oncology. This manuscript's contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCI. Medimmune played no role in the study design, in the collection, analysis and interpretation of data; in the writing of the manuscript; or in the decision to submit the manuscript for publication.
PY - 2013/6
Y1 - 2013/6
N2 - 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 225mg/m2 intravenously (IV) and carboplatin area under the curve (AUC) 6 both days 1 and 22, followed by concurrent weekly paclitaxel (50mg/m2) and carboplatin (AUC 2), with hyperfractionated radiation therapy (69.6Gy at 1.2Gy BID). Patients were randomly assigned to amifostine (AM) 500mg IV four times per week or no-AM during chemoradiotherapy. Stratification factors included age (<70 vs. ≥70years), 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.
AB - 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 225mg/m2 intravenously (IV) and carboplatin area under the curve (AUC) 6 both days 1 and 22, followed by concurrent weekly paclitaxel (50mg/m2) and carboplatin (AUC 2), with hyperfractionated radiation therapy (69.6Gy at 1.2Gy BID). Patients were randomly assigned to amifostine (AM) 500mg IV four times per week or no-AM during chemoradiotherapy. Stratification factors included age (<70 vs. ≥70years), 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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U2 - 10.1016/j.lungcan.2013.02.008
DO - 10.1016/j.lungcan.2013.02.008
M3 - Article
C2 - 23477890
AN - SCOPUS:84877148192
SN - 0169-5002
VL - 80
SP - 298
EP - 305
JO - Lung Cancer
JF - Lung Cancer
IS - 3
ER -
