We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Daratumumab-based therapies in transplant-ineligible patients with untreated multiple myeloma and hepatic dysfunction: A systematic review of subgroup analyses.
- Authors
Gil-Sierra, Manuel David; Briceño-Casado, Maria del Pilar; Fénix-Caballero, Silvia; Alegre-Del Rey, Emilio Jesús; de la Lastra-Romero, Catalina Alarcón; Sánchez-Hidalgo, Marina
- Abstract
Introduction: There is subgroup analysis suggesting a lack of benefit of daratumumab use in multiple myeloma (MM) and hepatic disease (HD). The objectives of this study were to conduct a systematic review and interpretation of daratumumab-based regimen efficacy in transplant-ineligible patients with untreated MM and HD. Methods: A systematic search in Pubmed® database about randomized clinical trials (RCTs) with subgroup analysis regarding hepatic function for overall survival (OS) or progression-free survival (PFS) were developed. Two methodologies were applied. One of them considered statistical interaction, prespecification, biological support and consistency of subgroup results. Second methodology was two-part validated tool: preliminary questions to reject subset analysis without minimal relevance, and a checklist relating a recommendation for applicability in clinical practice. Results: It was included three records. About first methodology, statistical interaction among subgroups was found for PFS in one RCT. Subsets were prespecified in all RCTs. Biological support of efficacy differences could be reasonable. Inconsistent results were found. Second methology directly rejected applicability of subset analysis in two records. Checklist recommended "null" application of results in the remaining RCT. Conclusions: No consistent heterogeneity for daratumumab-based regimen efficacy was observed among subgroups regarding hepatic function in transplant-ineligible patients with untreated MM. Patients with normal hepatic function and HD could benefit from these treatments.
- Subjects
THERAPEUTIC use of monoclonal antibodies; ONLINE information services; SYSTEMATIC reviews; LIVER diseases; QUALITY assurance; DESCRIPTIVE statistics; MULTIPLE myeloma; MEDLINE; PROGRESSION-free survival; DECISION making in clinical medicine
- Publication
Journal of Oncology Pharmacy Practice, 2023, Vol 29, Issue 1, p155
- ISSN
1078-1552
- Publication type
Article
- DOI
10.1177/10781552211062144