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.
RCT Entities:
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.
Authors: B Jeremic; Y Shibamoto; L Acimovic; B Milicic; S Milisavljevic; N Nikolic; A Dagovic; J Aleksandrovic; G Radosavljevic-Asic Journal: Int J Radiat Oncol Biol Phys Date: 2001-05-01 Impact factor: 7.038
Authors: Joan H Schiller; David Harrington; Chandra P Belani; Corey Langer; Alan Sandler; James Krook; Junming Zhu; David H Johnson Journal: N Engl J Med Date: 2002-01-10 Impact factor: 91.245
Authors: K Furuse; M Fukuoka; M Kawahara; H Nishikawa; Y Takada; S Kudoh; N Katagami; Y Ariyoshi Journal: J Clin Oncol Date: 1999-09 Impact factor: 44.544
Authors: Everett E Vokes; James E Herndon; Jeffrey Crawford; Kenneth A Leopold; Michael C Perry; Antonius A Miller; Mark R Green Journal: J Clin Oncol Date: 2002-10-15 Impact factor: 44.544
Authors: D Antonadou; N Coliarakis; M Synodinou; H Athanassiou; A Kouveli; C Verigos; G Georgakopoulos; K Panoussaki; P Karageorgis; N Throuvalas Journal: Int J Radiat Oncol Biol Phys Date: 2001-11-15 Impact factor: 7.038
Authors: Audrey Mauguen; Cécile Le Péchoux; Michele I Saunders; Steven E Schild; Andrew T Turrisi; Michael Baumann; William T Sause; David Ball; Chandra P Belani; James A Bonner; Aleksander Zajusz; Suzanne E Dahlberg; Matthew Nankivell; Sumithra J Mandrekar; Rebecca Paulus; Katarzyna Behrendt; Rainer Koch; James F Bishop; Stanley Dische; Rodrigo Arriagada; Dirk De Ruysscher; Jean-Pierre Pignon Journal: J Clin Oncol Date: 2012-07-02 Impact factor: 44.544
Authors: B Movsas; J Moughan; R Komaki; H Choy; R Byhardt; C Langer; M Goldberg; M Graham; D Ettinger; D Johnstone; R Abrams; R Munden; G Starkschall; J Owen Journal: J Clin Oncol Date: 2003-11-03 Impact factor: 44.544
Authors: Steven E Schild; Philip J Stella; Susan M Geyer; James A Bonner; Randolph S Marks; William L McGinnis; Steven P Goetz; Steven A Kuross; James A Mailliard; John W Kugler; Paul L Schaefer; James R Jett Journal: Int J Radiat Oncol Biol Phys Date: 2002-10-01 Impact factor: 7.038
Authors: Peter Paximadis; Matthew Schipper; Martha Matuszak; Mary Feng; Shruti Jolly; Thomas Boike; Inga Grills; Larry Kestin; Benjamin Movsas; Kent Griffith; Gregory Gustafson; Jean Moran; Teamour Nurushev; Jeffrey Radawski; Lori Pierce; James Hayman Journal: Pract Radiat Oncol Date: 2017-07-19