PHASE-II RANDOMIZED STUDY OF CISPLATIN PLUS ETOPOSIDE PHOSPHATE OR ETOPOSIDE IN THE TREATMENT OF SMALL-CELL LUNG-CANCER

Purpose: This randomized phase II study evaluated the efficacy toxicit y of etoposide phosphate when used in combination with cisplatin in th e treatment of smalt-cell lung cancer. Patients and Methods: Patients with previously untreated small-cell lung cancer were randomized to re ceive cisplatin in combination With either etoposide or etoposide phos phate. Molar-equivalent doses of etoposide and etoposide phosphate wer e used, Response rate, time to progression, survival, and toxicity wer e compared, Results: Major response rates with etoposide phosphate and etoposide were 61% (95% confidence interval, 55% to 67%) and 58% (95% confidence interval, 52% to 64%), respectively (P = .85). No signific ant differences in median time to progression or survival were Observe d in patients who recieved etoposide phosphate versus etoposide. Grade 3 and 4 leukopenia occurred in 63% of patients who received etoposide phosphate compared with 77% who received etoposide (P = .16). Conclus ion: The combination of etoposide phosphate and cisplatin is effective in the treatment of small-cell lung cancer, and can be administered w ith acceptable toxicity. Although this study was not designed to be a formal comparative trial, the efficacy and toxicity observed with this regimen were found to be similar to a standard etoposide/cisplatin re gimen, using molar-equivalent etoposide doses. Because of its greater ease of administration, etoposide phosphate is preferrable to etoposid e for routine clinical use. (C) 1995 by American Society of Clinical O ncology.