Universität zu Köln

Elter, Thomas, Gercheva-Kyuchukova, Liana, Pylylpenko, Halyna, Robak, Tadesuz, Jaksic, Branimir, Rekhtman, Grigoriy, Kyrcz-Krzemien, Slawomira, Vatutin, Mykola, Wu, Jingyang, Sirard, Cynthia, Hallek, Michael and Engert, Andreas (2011). Fludarabine plus alemtuzumab versus fludarabine alone in patients with previously treated chronic lymphocytic leukaemia: a randomised phase 3 trial. Lancet Oncol., 12 (13). S. 1204 - 1214. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1474-5488

Full text not available from this repository.

Abstract

Background Chronic lymphocytic leukaemia (CLL) is an incurable and chronic disorder, with worsening prognosis for patients as their disease progresses. We compared the efficacy and safety of the combination of fludarabine and alemtuzumab with fludarabine monotherapy in previously treated patients with relapsed or refractory CLL. Methods Patients (aged >= 18 years) with CLL Binet stage A, B, or C or Rai stages I-IV were randomly assigned in a 1: 1 ratio according to a computer-generated allocation schedule to open-label combination treatment (fludarabine 30 mg/m(2) per day and alemtuzumab 30 mg per day on days 1-3) or monotherapy (fludarabine 25 mg/m(2) on days 1-5) by use of an interactive voice response system. Both regimens were given intravenously for a maximum of six 28-day cycles. The primary endpoint was progression-free survival (PFS). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00086580. Findings Fludarabine plus alemtuzumab (n=168) resulted in better PFS than did fludarabine monotherapy (n=167; median 23.7 months [95% CI 19.2-28.4] vs 16.5 months [12.5-21.2]; hazard ratio 0.61 [95% CI 0.47-0.80]; p=0.0003) and overall survival (median not reached vs 52.9 months [40.9-not reached]; 0.65 [0.45-0.94]; p=0.021) compared with fludarabine alone. All-cause adverse events occurred in 161 (98%) of 164 patients in the combination treatment group and 149 (90%) of 165 in the fludarabine alone group. Patients in the fludarabine plus alemtuzumab group had more cytomegalovirus events (23 [14%] vs one [<1%]) and grade 1 or 2 potentially alemtuzumab infusion-related adverse reactions (102 [62%] vs 22 [13%]). Grade 3 or 4 toxicities in the combination treatment and monotherapy groups were leucopenia (121 [74%] of 164 vs 55 [34%] of 164), lymphopenia (149 [94%] of 158 vs 53 [33%] of 161), neutropenia (93 [59%] of 157 vs 110 [68%] of 161), thrombocytopenia (18 [11%] of 164 vs 27 [17%] of 163), and anaemia (14 [9%] of 163 vs 28 [17%] of 164). The incidence of serious adverse events was higher in the combination treatment group (54 [33%] of 164 vs 41 [25%] of 165); deaths due to adverse events were similar between the two groups (ten [6%] vs 12 [7%]). Interpretation The combination of fludarabine and alemtuzumab is another treatment option for patients with previously treated CLL.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Elter, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Gercheva-Kyuchukova, Liana UNSPECIFIED UNSPECIFIED UNSPECIFIED Pylylpenko, Halyna UNSPECIFIED UNSPECIFIED UNSPECIFIED Robak, Tadesuz UNSPECIFIED UNSPECIFIED UNSPECIFIED Jaksic, Branimir UNSPECIFIED UNSPECIFIED UNSPECIFIED Rekhtman, Grigoriy UNSPECIFIED UNSPECIFIED UNSPECIFIED Kyrcz-Krzemien, Slawomira UNSPECIFIED UNSPECIFIED UNSPECIFIED Vatutin, Mykola UNSPECIFIED UNSPECIFIED UNSPECIFIED Wu, Jingyang UNSPECIFIED UNSPECIFIED UNSPECIFIED Sirard, Cynthia UNSPECIFIED UNSPECIFIED UNSPECIFIED Hallek, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Engert, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-484113
DOI:	10.1016/S1470-2045(11)70242-X
Journal or Publication Title:	Lancet Oncol.
Volume:	12
Number:	13
Page Range:	S. 1204 - 1214
Date:	2011
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1474-5488
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language CYCLOPHOSPHAMIDE; COMBINATION; CAMPATH-1H; DIAGNOSIS; SURVIVAL; THERAPY Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/48411