1. ¹Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa 240-8555, Japan
2. ²Niigata Cancer Center Hospital, Niigata-city, Japan
3. ³Osaka City University Medical School, Osaka-city, Japan
4. ⁴National Cancer Center, Tokyo, Japan
5. ⁵National Cancer Center Hospital, Tokyo, Japan
6. ⁶National Cancer Center East Hospital, Kashiwa, Japan

Correspondence: Dr H Okamoto, E-mail address: scyooka@alles.or.jp

Received 18 October 2006; Revised 25 April 2007; Accepted 26 April 2007; Published online 19 June 2007.

Abstract

We compared the efficacy and the safety of a carboplatin plus etoposide regimen (CE) vs split doses of cisplatin plus etoposide (SPE) in elderly or poor-risk patients with extensive disease small-cell lung cancer (ED-SCLC). Eligibility criteria included: untreated ED-SCLC; age 70 and performance status 0–2, or age <70 and PS 3. The CE arm received carboplatin area under the curve of five intravenously (IV) on day 1 and etoposide 80 mg m^-2 IV on days 1–3. The SPE arm received cisplatin 25 mg m^-2 IV on days 1–3 and etoposide 80 mg m^-2 IV on days 1–3. Both regimens were given with granulocyte colony-stimulating factor support in a 21–28 day cycle for four courses. A total of 220 patients were randomised. Median age was 74 years and 74% had a PS of 0 or 1. Major grade 3–4 toxicities were (%CE/%SPE): leucopenia 54/51, neutropenia 95/90, thrombocytopenia 56/16, infection 7/6. There was no significant difference (CE/SPE) in the response rate (73/73%) and overall survival (median 10.6/9.9 mo; P=0.54). Palliation scores were very similar between the arms. Although the SPE regimen is still considered to be the standard treatment in elderly or poor-risk patients with ED-SCLC, the CE regimen can be an alternative for this population considering the risk–benefit balance.