Study of cisplatin-vinblastine plus amifostine in patients with locally advanced or metastatic non-small cell lung cancer.

ABSTRACT

OBJECTIVE: To determine whether pretreatment with amifostine would reduce the toxicity of cisplatin with no reduction in antitumor efficacy in patients with advanced non-small lung cancer PATIENTS AND METHOD: Patients with locally advanced or metastatic non-small cell lung cancer, aged less than 75 years, with an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 were enrolled in the study. Amifostine was administered at a dose of 740 mg/m2 before chemotherapy. Then cisplatin at 100 mg/m2 was administered on day 1 and vinblastine 5 mg/m2 given on days 1, 8 and 15 in a 28 day cycle. RESULTS: Forty one patients were enrolled Baseline characteristics included; a median age of 58 years (range, 28-72); 23 males and 18 females; performance status of 0 (1 patient), 1 (38 patients) and 2 (2 patients); stage IIIa (1 patient), stage IIIb (10 patients) and stage IV (30 patients). The predominant histology was adenocarcinoma (60.97%). A median of 4 cycles (range, 1-6) were administered Thirty six cases out of forty one patients were assessable for response. The response rate was 38%. All those responding gave partial response. The median survival time was 33 weeks. One and two years survival were 23.9% and 9% respectively. Grade 3/4 toxicity was primarily hematologic. Grade 3/4 leukopenia occurred in 12.4%. Grade 3/4 thrombocytopenia occurred in 1.2%. Anemia grade 3/4 occurred in 7.5%. The observed grade 3/4 nonhematological toxicities were hypertension, hypocalcemia, nausea and vomiting and sensory neuropathy. Other toxicities were grade 2 or below. CONCLUSION: This study demonstrated that amifostine has the potential to be a broad spectrum cytoprotectant of normal tissues from toxicity caused by chemotherapy and no effect on therapeutic outcome in lung cancer patients.