Daratumumab-based therapies in transplant-ineligible patients with untreated multiple myeloma and hepatic dysfunction: A systematic review of subgroup analyses
| Autor: | Silvia Fénix-Caballero, Manuel David Gil-Sierra, María Del Pilar Briceño-Casado, Marina Sánchez-Hidalgo, Catalina Alarcón de la Lastra-Romero, Emilio Jesús Alegre-Del Rey |
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| Rok vydání: | 2021 |
| Předmět: |
Oncology
medicine.medical_specialty business.industry Daratumumab Subgroup analysis Disease medicine.disease Transplant ineligible Progression-Free Survival Clinical decision making Internal medicine Antineoplastic Combined Chemotherapy Protocols Monoclonal Humans Medicine Pharmacology (medical) Multiple Myeloma Hepatic dysfunction business Multiple myeloma |
| Zdroj: | Journal of Oncology Pharmacy Practice. 29:155-161 |
| ISSN: | 1477-092X 1078-1552 |
| DOI: | 10.1177/10781552211062144 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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