title: Phase III study of cyclophosphamide, doxorubicin, and etoposide compared with carboplatin and paclitaxel in patients with extensive disease small-cell lung cancer.
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.
authors.affiliation: Department of Pulmonology, University Medical Center Groningen, University of Groningen, P.O. Box 30.001, 9700 RB Groningen, The Netherlands.
authors.forename: Wouter K
authors.initials: WK
authors.lastname: de Jong
authors.forename: Harry J M
authors.initials: HJ
authors.lastname: Groen
authors.forename: Mia G J
authors.initials: MG
authors.lastname: Koolen
authors.forename: Bonne
authors.initials: B
authors.lastname: Biesma
authors.forename: Luuk N A
authors.initials: LN
authors.lastname: Willems
authors.forename: Hian-Bie
authors.initials: HB
authors.lastname: Kwa
authors.forename: Aart
authors.initials: A
authors.lastname: van Bochove
authors.forename: Harm
authors.initials: H
authors.lastname: van Tinteren
authors.forename: Egbert F
authors.initials: EF
authors.lastname: Smit
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D002423:Cause of Death; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004351:Drug Resistance; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D016019:Survival Analysis