A randomized trial comparing vindesine and cisplatinum to vindesine and methotrexate in advanced non small cell lung carcinoma.

Combination chemotherapy using vindesine and cisplatinum has been reported to be active in non-small cell lung carcinoma (NSCLC). In an attempt to reduce the potential neurotoxicity of this combination, and to assess the role of cisplatinum, a randomized trial has compared vindesine and cisplatinum to vindesine and methotrexate in 48 patients with advanced symptomatic NSCLC. Patient characteristics were similar in the two treatment arms. Objective tumour response and survival were similar for both treatments. No complete response occurred. Four patients receiving vindesine/cisplatinum (16%) and three patients receiving vindesine/methotrexate (13%) had a partial response. All responses occurred in patients with a performance status of 70% or more and no response was seen in patients with squamous cell carcinoma. Median survival for both regimens was 16 weeks. Toxicity was considerable and only six patients (12.5%) felt better on treatment. Nausea and vomiting were more frequent in the vindesine/cisplatinum arm, but mild neurotoxicity was more common in the vindesine/methotrexate arm. The low response rates, short survival and significant toxicity suggest that the role of combination chemotherapy in NSCLC remains to be established.

RCT Entities:   Population Interventions Outcomes