Publication
Title
Randomised phase II study of amrubicin as single agent or in combination with cisplatin versus cisplatin etoposide as first-line treatment in patients with extensive stage small cell lung cancer - EORTC 08062
Author
Abstract
Purpose: The EORTC 08062 phase II randomised trial investigated the activity and safety of single agent amrubicin, cisplatin combined with amrubicin, and cisplatin combined with etoposide as first line treatment in extensive disease (ED) small cell lung cancer (SCLC). Patients and methods: Eligible patients with previously untreated ED-SCLC, WHO performance status (PS) 0-2 and measurable disease were randomised to 3 weekly cycles of either amrubicin alone 45 mg/m(2) i.v. day(d) 1-3 (A), cisplatin 60 mg/m(2) iv. d1 and amrubicin 40 mg/m(2) i.v. d1-3 (PA), or cisplatin 75 mg/m(2) iv. d1 and etoposide 100 mg/m(2) d1, d2-3 i.v./po (PE). The primary end-point was overall response rate (ORR) as assessed by local investigators (RECIST1.0 criteria). Secondary end-points were treatment toxicity, progression-free survival and overall survival. Results: The number of randomised/eligible patients who started treatment was 33/28 in A, 33/30 in PA and 33/30 in PE, respectively. Grade (G) >= 3 haematological toxicity in A, PA and PE was neutropenia (73%, 73%, 69%); thrombocytopenia (17%, 15%, 9.4%), anaemia (10%, 15%, 3.1%) and febrile neutropenia (13%, 18%, 6%). Early deaths, including treatment related, occurred in 1, 3 and 3 patients in A, PA and PE arms, respectively. Cardiac toxicity did not differ among the 3 arms. Out of 88 eligible patients who started treatment, ORR was 61%, (90% 1-sided confidence intervals [CI] 47-100%), 77% (CI 64-100%) and 63%, (CI 50-100%) for A, PA and PE respectively. Conclusion: All regimens were active and PA met the criteria for further investigation, despite slightly higher haematological toxicity. (C) 2011 Elsevier Ltd. All rights reserved.
Language
English
Source (journal)
European journal of cancer
Publication
2011
ISSN
0959-8049
1879-0852
Volume/pages
47:15(2011), p. 2322-2330
ISI
000296393700010
Full text (Publisher's DOI)
Full text (publisher's version - intranet only)
UAntwerpen
Faculty/Department
Publication type
Subject
External links
Web of Science
Record
Identification
Creation 18.11.2014
Last edited 19.06.2017