Universität zu Köln

Stadler, Nicolas ORCID: 0000-0001-8212-7459, Shang, Aijing, Bosch, Francesc ORCID: 0000-0001-9241-2886, Briggs, Andrew ORCID: 0000-0002-0777-1997, Goede, Valentin, Berthier, Aurelien, Renaudin, Corinne and Leblond, Veronique (2016). A Systematic Review and Network Meta-Analysis to Evaluate the Comparative Efficacy of Interventions for Unfit Patients with Chronic Lymphocytic Leukemia. Adv. Ther., 33 (10). S. 1814 - 1831. NEW YORK: SPRINGER. ISSN 1865-8652

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Abstract

Rituximab plus fludarabine and cyclophosphamide (RFC) is the standard of care for fit patients with untreated chronic lymphocytic leukemia (CLL); however, its use is limited in 'unfit' (co-morbid and/or full-dose F-ineligible) patients due to its toxicity profile. We conducted a systematic review and Bayesian network meta-analysis (NMA) to determine the relative efficacy of commercially available interventions for the first-line treatment of unfit CLL patients. For inclusion in the NMA, studies had to be linked via common treatment comparators, report progression-free survival (PFS), and/or overall survival (OS), and meet at least one of the five inclusion criteria: median cumulative illness score > 6, median creatinine clearance aecurrency sign70 mL/min, existing co-morbidities, median age aeyen70 years, and no full-dose F in the comparator arm. A manual review, validated by external experts, of all studies that met at least one of these criteria was also performed to confirm that they evaluated first-line therapeutic options for unfit patients with CLL. In unfit patients, the main NMA (five studies for PFS and four for OS) demonstrated clear preference in terms of PFS for obinutuzumab + chlorambucil (G-Clb) versus rituximab + chlorambucil (R-Clb), ofatumumab + chlorambucil (O-Clb), fludarabine and chlorambucil (median hazard ratios [HRs] 0.43, 0.33, 0.20, and 0.19, respectively), and a trend for better efficacy versus rituximab + bendamustine (R-Benda) and RFC-Lite (median HR 0.81 and 0.88, respectively). OS results were generally consistent with PFS data, (median HR 0.48, 0.53, and 0.81, respectively) for G-Clb versus Clb, O-Clb, and R-Clb 0.35 and 0.81 versus F and R-Benda, respectively); however, the OS findings were associated with higher uncertainty. Treatment ranking reflected improved PFS and OS with G-Clb over other treatment strategies (median rank of one for both endpoints). G-Clb is likely to show superior efficacy to other treatment options selected in our NMA for unfit treatment-na < ve patients with CLL. F. Hoffmann-La Roche Ltd.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Stadler, Nicolas UNSPECIFIED orcid.org/0000-0001-8212-7459 UNSPECIFIED Shang, Aijing UNSPECIFIED UNSPECIFIED UNSPECIFIED Bosch, Francesc UNSPECIFIED orcid.org/0000-0001-9241-2886 UNSPECIFIED Briggs, Andrew UNSPECIFIED orcid.org/0000-0002-0777-1997 UNSPECIFIED Goede, Valentin UNSPECIFIED UNSPECIFIED UNSPECIFIED Berthier, Aurelien UNSPECIFIED UNSPECIFIED UNSPECIFIED Renaudin, Corinne UNSPECIFIED UNSPECIFIED UNSPECIFIED Leblond, Veronique UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-261223
DOI:	10.1007/s12325-016-0398-2
Journal or Publication Title:	Adv. Ther.
Volume:	33
Number:	10
Page Range:	S. 1814 - 1831
Date:	2016
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1865-8652
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PREVIOUSLY UNTREATED PATIENTS; CLINICAL-PRACTICE GUIDELINES; INITIAL THERAPY; DOSE FLUDARABINE; PLUS RITUXIMAB; OPEN-LABEL; CHLORAMBUCIL; CYCLOPHOSPHAMIDE; CHEMOIMMUNOTHERAPY; OUTCOMES Multiple languages Medicine, Research & Experimental; Pharmacology & Pharmacy Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/26122