Journal of Clinical Oncology, Vol 15, 2850-2857, Copyright © 1997 by American Society of Clinical Oncology
Effect of amifostine on toxicities associated with sequential chemotherapy and radiation therapy for unresectable non-small-cell lung cancer: results of a phase II trial
SP Tannehill, MP Mehta, M Larson, B Storer, J Pellet, TJ Kinsella and JH Schiller
Department of Human Oncology, University of Wisconsin Medical School, Madison 53792-0600, USA.
PURPOSE: To determine the effect of amifostine on the safety and efficacy
of induction chemotherapy with high-dose cisplatin and vinblastine followed
by large-field thoracic irradiation to 60 Gy in patients with stage IIIA or
IIIB non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Twenty-six
patients with unresectable stage IIIA or IIIB NSCLC were entered onto the
study between May 1991 and November 1994. Patients received amifostine (740
or 910 mg/m2) followed by cisplatin (120 mg/m2) on days 1 and 29.
Vinblastine (5 mg/m2) was given weekly for 5 weeks with no amifostine
pretreatment. Following chemotherapy, patients received amifostine (340
mg/m2 4 days a week for 5 weeks, or 200 mg/m2 5 days a week for 6 weeks) 15
minutes before definitive thoracic radiation therapy to a total dose of 60
Gy in 6 weeks. RESULTS: Twenty-five patients were assessable for response
and survival. The objective response rate was 60%. One-, 2-, and 3-year
survival rates were 55%, 23%, and 23%. There was no grade 3 or greater
renal toxicity during chemotherapy or grade 3 or greater esophagitis during
radiation therapy. Neutropenia (secondary to vinblastine use) was the only
grade 4 toxicity. There were no treatment-related deaths. CONCLUSION:
Amifostine can be administered safely with high-dose cisplatin,
vinblastine, and radiation therapy for NSCLC. The response rate and
survival data provide no evidence that amifostine impairs response to
treatment. Amifostine appears to reduce cisplatin-related nephrotoxicity
and radiation-induced esophagitis.
