PURPOSE: Clinical trials demonstrated the efficacy and safety of intravenous (i.v.) or subcutaneous (s.c.) amifostine for reducing xerostomia and mucositis after radiotherapy or radiochemotherapyfor head-and-neck cancer. This randomized, double-blinded, placebo-controlled, phase III study evaluated the efficacy and safety of i.v. amifostine during radiochemotherapyfor head-and-neck cancer. METHODS AND MATERIALS: Patients from European and American study centers receivedi.v. amifostine 300 mg/m2 (n = 67) or placebo (n = 65) before carboplatin 70 mg/m2 and radiotherapy on Days 1 to 5 and 21 to 25, and i.v. amifostine 200 mg/m2 or placebo before radiotherapy on other days. RESULTS:Toxicity incidences were (amifostine, placebo, p value): Grade 2 or higher acute xerostomia (39%, 34%, 0.715), Grade 3 or higher acute mucositis (39%, 22%, 0.055), Grade 2 or higher late xerostomia (37%, 24%, 0.235), and Grade 3 or higher treatment-related adverse events (42%, 20%, 0.008). One-year rates of locoregional failure, progression-free survival, and overall survival were not significantly different between treatments. CONCLUSIONS: The used amifostine doses were not able to reduce the toxicity of simultaneous radiochemotherapyfor head-and-neck cancer. The safety of amifostine and the lack of tumor protection were consistent with previous studies.
RCT Entities:
PURPOSE: Clinical trials demonstrated the efficacy and safety of intravenous (i.v.) or subcutaneous (s.c.) amifostine for reducing xerostomia and mucositis after radiotherapy or radiochemotherapy for head-and-neck cancer. This randomized, double-blinded, placebo-controlled, phase III study evaluated the efficacy and safety of i.v. amifostine during radiochemotherapy for head-and-neck cancer. METHODS AND MATERIALS: Patients from European and American study centers received i.v. amifostine 300 mg/m2 (n = 67) or placebo (n = 65) before carboplatin 70 mg/m2 and radiotherapy on Days 1 to 5 and 21 to 25, and i.v. amifostine 200 mg/m2 or placebo before radiotherapy on other days. RESULTS:Toxicity incidences were (amifostine, placebo, p value): Grade 2 or higher acute xerostomia (39%, 34%, 0.715), Grade 3 or higher acute mucositis (39%, 22%, 0.055), Grade 2 or higher late xerostomia (37%, 24%, 0.235), and Grade 3 or higher treatment-related adverse events (42%, 20%, 0.008). One-year rates of locoregional failure, progression-free survival, and overall survival were not significantly different between treatments. CONCLUSIONS: The used amifostine doses were not able to reduce the toxicity of simultaneous radiochemotherapy for head-and-neck cancer. The safety of amifostine and the lack of tumor protection were consistent with previous studies.
Authors: S B Jensen; A M L Pedersen; A Vissink; E Andersen; C G Brown; A N Davies; J Dutilh; J S Fulton; L Jankovic; N N F Lopes; A L S Mello; L V Muniz; C A Murdoch-Kinch; R G Nair; J J Napeñas; A Nogueira-Rodrigues; D Saunders; B Stirling; I von Bültzingslöwen; D S Weikel; L S Elting; F K L Spijkervet; M T Brennan Journal: Support Care Cancer Date: 2010-03-25 Impact factor: 3.603
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Authors: Ana P Cotrim; Masanobu Yoshikawa; Abraham N Sunshine; Changyu Zheng; Anastasia L Sowers; Angela D Thetford; John A Cook; James B Mitchell; Bruce J Baum Journal: Int J Radiat Oncol Biol Phys Date: 2011-12-22 Impact factor: 7.038
Authors: Naresh Jha; Jonathan Harris; Hadi Seikaly; John R Jacobs; A J B McEwan; K Thomas Robbins; John Grecula; Anand K Sharma; K Kian Ang Journal: Int J Radiat Oncol Biol Phys Date: 2012-04-27 Impact factor: 7.038
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 Date: 2013-03-07 Impact factor: 5.705