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Clinical Trial
. 2007 Jul 16;97(2):162-9.
doi: 10.1038/sj.bjc.6603810. Epub 2007 Jun 19.

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

H Okamoto  1 , K Watanabe, H Kunikane, A Yokoyama, S Kudoh, T Asakawa, T Shibata, H Kunitoh, T Tamura, N Saijo
Affiliations
Clinical Trial

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

H Okamoto et al. Br J Cancer. .

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.

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Figures

Figure 1
Figure 1
Flow diagram of randomised phase III trial of CE vs SPE in elderly or poor-risk patients with extensive disease SCLC.
Figure 2
Figure 2
(A) PFS curves (n=220). (B) OS curves (n=220). (C) Survival curves of the patients ⩾70 years of age with a PS of 0–2 (n=202).
See this image and copyright information in PMC

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