RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF CISPLATIN AND ETOPOSIDE PLUS MEGESTROL-ACETATE PLACEBO IN EXTENSIVE-STAGE SMALL-CELL LUNG-CANCER - A NORTH CENTRAL CANCER-TREATMENT GROUP-STUDY

Purpose: Megestrol acetate has been reported to improve appetite and q uality of life and to decrease nausea and vomiting in patients with ca ncer anorexia/cachexia. The present trial was formulated to evaluate t he impact of megestrol acetate on quality of life, toxicity, response, and survival in individuals with extensive-stage small-cell lung canc er who received concomitant chemotherapy. Patients end Methods: Patien ts were randomized to receive megestrol acetate 800 mg/d orally or pla cebo. In addition, all patients were scheduled to receive a max imum o f four cycles of cisplatin and etoposide chemotherapy. Quality of life was self-assessed at entry onto study, with every cycle of chemothera py, and 4 months thereafter with a linear visual analog scale. Toxicit y was evaluated by patient questionnaire and investigator reports. Res ults: A total of 243 eligible patients were randomized. Those who rece ived megestrol acetate had increased nonfluid weight gain (P=.004) and significantly less nausea (P=.0002) and vomiting (P=.02). Significant thromboembolic pheonomena occurred more often in patients who receive d megestrol acetate versus placebo (9% v2%, P=.01). Patients who recei ved megestrol acetate had more edema (30% v 20%, P=.002), an inferior response rate to chemotherapy (68% v 80%, P .03), and a trend for infe rior survival duration (median, 8.2 v 10.0 months, P =.49). These find ings may have been influenced by a poorer quality of life of the meges trol acetate group at study initiation. There were no significant chan ges in quality of life scores over time between either of the study ar ms. Conclusion: Megestrol acetate cannot be routinely recommended for all patients with small-cell lung cancer at the time of chemotherapy i nitiation. Rather, its therapeutic ratio may be more favorable for pat ients with problematic cancer anorexia/cachexia. (C) 1996 by American Society of Clinical Oncology.