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Phase II Study of Area Under the Plasma-Concentration-Versus-Time Curve–Based Carboplatin Plus Standard-Dose Intravenous Etoposide in Elderly Patients With Small-Cell Lung Cancer

From the Yokohama Municipal Citizen's Hospital, Yokohama; National Cancer Center Hospital East, Kashiwa; Tochigi Cancer Center, Tochigi; Niigata Cancer Center, Niigata; Cancer Institute, Tokyo; Nihon University School of Medicine, Tokyo; Toranomon Hospital, Tokyo; National Nishi-Gunma Hospital, Shibukawa; National Sapporo Hospital, Sapporo; and National Cancer Center, Tokyo; Japan.

Address reprint requests to Hiroaki Okamoto, MD, Division of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa 240-0062, Japan; email scyooka{at}alles.or.jp

PURPOSE: The target area under the plasma-concentration-versus-time curve (AUC)–based dosing of carboplatin using Calvert's formula is expected to result in more acceptable toxicity and greater efficacy in elderly patients with small-cell lung cancer (SCLC) than the body surface area–based dosing strategy. This phase II study was designed to determine the toxicity and efficacy of carboplatin based on Calvert's formula plus the standard dose of intravenous etoposide for elderly patients with SCLC.

PATIENTS AND METHODS: Carboplatin, dosed to a target AUC of 5 x (24-hour creatinine clearance + 25), was given intravenously on day 1 and etoposide 100 mg/m² was given intravenously on days 1, 2, and 3. Patients aged 70 years old with a performance status of 0 to 2 were eligible.

RESULTS: Thirty-six patients were enrolled onto the study. The patient characteristics were as follows: median age, 73 years; limited disease (LD), 16 patients; and extensive disease (ED), 20 patients. Grades 3 and 4 leukopenia occurred in 57% and 3% of patients, and grades 3 and 4 thrombocytopenia occurred in 40% and 11% of patients, respectively. There was one treatment-related death due to hemoptysis. Other toxicities were relatively mild. There were two complete responses and 25 partial responses, for a response rate of 75%. The median survival time was 10.8 months (LD, 11.6 months; ED, 10.1 months), and the 1-year survival rate was 47%.

CONCLUSION: This carboplatin/etoposide combination chemotherapy is an active and relatively nontoxic regimen in elderly patients with SCLC, which suggests that the combination may be suitable for randomized controlled trials.

Presented in part at the Thirty-Fourth Annual Meeting of the American Society of Clinical Oncology, Los Angeles, CA, May 16-19, 1998.

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