Phase III study of cyclophosphamide, doxorubicin, and etoposide compared with carboplatin and paclitaxel in patients with extensive disease small-cell lung cancer☆☆☆

Received 26 May 2007; received in revised form 13 July 2007; accepted 31 July 2007. published online 10 September 2007.

Abstract

The progression-free survival (PFS) of cyclophosphamide/doxorubicin/etoposide (CDE) and carboplatin/paclitaxel (CP) was compared in chemonaive patients with extensive disease small-cell lung cancer (ED-SCLC). A total of 203 patients were randomised to three-weekly CDE (n=102) or CP (n=101) for five cycles. Tumour response rates in CDE and CP were 60% and 61%. PFS of CP was 5.2 months, PFS of CDE 4.9 months (p=0.60). The major difference in toxicity between CDE and CP was grade 4 leukocytopaenia in 64% and 9% of the patients (p<0.0001), leading to febrile neutropaenia in 30% and 4% of the patients (p<0.0001), respectively. This was the reason for differences in the total number of hospital admissions (63 for CDE and 40 for CP, p=0.0025).

This study failed to demonstrate any benefit in PFS with CP compared with CDE. CP was associated with significantly less haematological toxicity, leading to 37% less hospital admissions for febrile neutropaenia.

Keywords: Small-cell lung cancer, Chemotherapy, Extensive disease, Phase III study

a Department of Pulmonology, University Medical Center Groningen, University of Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands

b Department of Pulmonology, Academy Medical Center, Amsterdam, The Netherlands

c Department of Pulmonology, Jeroen Bosch Hospital, ‘s-Hertogenbosch, The Netherlands

d Department of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands

e Department of Pulmonology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

f Department of Medicine, Zaans Medisch Centrum, Zaandam, The Netherlands

g Comprehensive Cancer Center Amsterdam, Amsterdam, The Netherlands

h Department of Pulmonology, Vrije Universiteit Medical Center, Amsterdam, The Netherlands

Corresponding author: Tel.: +31 (0)50 3616161; fax: +31 (0)50 3619320.

☆ This study was presented in part at the 41st Annual meeting of the American Society of Clinical Oncology, Orlando, FL, May 13–17, 2005, and at the 11th World Conference on Lung Cancer, Barcelona, Spain, July 3–6, 2005.

☆☆ Registered at www.clinicaltrials.gov, NCT00003696.

PII: S0959-8049(07)00587-4

doi:10.1016/j.ejca.2007.07.029

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