Phase II: trial of twice weekly amifostine in patients with non-small cell lung cancer treated with chemoradiotherapy.
Twenty-four patients with non-small cell lung cancer received induction chemotherapy (paclitaxel, carboplatin) followed by concurrent thoracic irradiation (RT) and weekly paclitaxel. Acute esophagitis was scored weekly. Amifostine (AMI), 500 mg intravenously twice weekly, was added to the regimen in the second cohort of 12 patients. AMI was well tolerated. The incidence of grade 3 esophagitis was 18% in the initial 11 patients versus 9% in the AMI-treated patients. Mean esophagitis index (EI) was numerically lower in the AMI-treated patients than in the initial group (5.1 v 11.6, P =.14). The length of esophagus in the RT field was similar in both groups. Median survival time for all patients was 12.4 months. The EI, a novel measure of the severity and duration of acute esophagitis, may be reduced in lung cancer patients receiving AMI twice weekly with thoracic RT and paclitaxel. The effect of AMI was not caused by the shorter irradiated esophageal length. A phase III randomized trial is now open to assess the effect of AMI on esophagitis.
Werner-Wasik
Maria
M
Kimmel Cancer Center of Jefferson Medical College, Philadelphia, PA, USA.
Axelrod
Rita S
RS
Friedland
David P
DP
Hauck
Walter
W
Rose
Lewis J
LJ
Chapman
Andrew E
AE
Grubbs
S
S
Deshields
M
M
Curran
Walter J
WJ
D000208:Acute Disease; D000368:Aged; D004999:Amifostine / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D004941:Esophagitis / Q000209:etiology / Q000473:pathology; D004947:Esophagus / Q000473:pathology / Q000528:radiation effects; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D011832:Radiation Injuries / Q000473:pathology; D011837:Radiation-Protective Agents / Q000008:administration & dosage*; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage; D015996:Survival Rate
D011837:Radiation-Protective Agents; D011838:Radiation-Sensitizing Agents; D016190:Carboplatin; D004999:Amifostine; D017239:Paclitaxel