A phase III randomized evaluation of amifostine in stage IIIA/IIIB non-small cell lung cancer patients receiving concurrent carboplatin, paclitaxel, and radiation therapy followed by gemcitabine and cisplatin intensification: preliminary findings.

Author(s): Senzer N

Affiliation(s): Department of Radiation Oncology, Sammons Cancer Center, US Oncology, Dallas, TX 75246, USA.

Publication date & source: 2002-12, Semin Oncol., 29(6 Suppl 19):38-41.

Publication type: Clinical Trial; Clinical Trial, Phase III; Randomized Controlled Trial

Despite the progress in pharmaceutical therapeutics and the hardware and software advances supporting radiation oncology, the major advance in the treatment of locally advanced nonmetastatic non-small cell lung cancer during the previous decade has been the adoption of integrated combined-modality therapy. This has resulted in an appreciation of the associated increase in treatment-related morbidity that has fostered new efforts to maximize the therapeutic index, including evaluation of cytoprotective agents. This report presents the preliminary data from a prospective randomized phase III trial of radiation therapy (64.8 Gy) administered concurrently with paclitaxel and carboplatin with posterior consolidation with cisplatin and gemcitabine with or without amifostine. The data to date do not support a cytoprotective advantage to the use of intravenous amifostine targeting esophagitis at 200 mg/m2/d before radiation. Further efforts to assess the role and potential of amifostine in the treatment of patients with non-small cell lung cancer are recommended. Copyright 2002, Elsevier Science (USA). All rights reserved.