Randomised phase III trial of carboplatin plus etoposide vs split doses of cisplatin plus etoposide in elderly or poor-risk patients with extensive disease small-cell lung cancer: JCOG 9702

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 EDSCLC; 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 mgm(-2) IV on days 1-3. The SPE arm received cisplatin 25 mgm(-2) IV on days 1-3 and etoposide 80 mgm(-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.