Systematic Literature Review to Characterize the Burden and Unmet Needs Associated with Cremophor EL
Brixner D1, McKinley K2, Gelder M2, Oak B3, Dehipawala S4, Hadker N4
1University of Utah College of Pharmacy, Salt Lake City, UT, USA, 2Elevar Therapeutics, Salt Lake City, UT, USA, 3Trinity Life Sciences, Arlington, MA, USA, 4Trinity Life Sciences, Waltham, MA, USA
OBJECTIVES: Cremophor EL (CrEL) is an additive (excipient) used to improve the solubility of hydrophobic drugs including certain anti-cancer drugs, like paclitaxel. Although the potential toxicities associated with CrEL are well known, the burden of CrEL-containing therapy is not well defined in the published scientific literature. METHODS: This systematic literature review (SLR) summarized current evidence on the clinical, economic, and humanistic burden related to anti-cancer therapy containing CrEL in specific cancer types, including ovarian cancer. A systematic search for English publications across the years 2016-2020 was conducted across Embase and PubMed. Two independent reviewers conducted screening and data extraction with validation of all extracted data. RESULTS: Database searches identified 377 records across Embase and PubMed; 292 were eligible for screening upon deduplication. Upon comprehensive title and abstract review, 66 records were selected for full-text review, including 5 hand-searched articles. From those records, this SLR included 31 studies for qualitative synthesis. Three studies reported on the burden of CrEL-containing therapy, while 22 studies reported on burden of paclitaxel therapy (assumed to contain CrEL). Safety/tolerability of CrEL included hypersensitivity reactions (HSRs), peripheral sensory/motor neuropathy and other all-grade adverse events leading to treatment discontinuation/intubation in one study. Six studies reported that most patients received premedication with steroids, antihistamines, anti-emetics, or antacids as prophylaxis before receiving CrEL-containing therapy. Eleven studies reported on quality of life (QOL) with overall QOL being negatively impacted in one study post-CrEL-containing therapy. Three studies reported on healthcare costs and resource-utilization (HCRU) with patients requiring inpatient and intensive care stays due to HSRs resulting from CrEL-containing therapy. CONCLUSIONS: Anti-cancer therapy with CrEL is associated with clinical burden as reported extensively in published literature. Comparatively, fewer studies report on the significant QOL, HCRU and economic burden of CrEL. Further research is needed to understand the clinical, economic and humanistic benefit of non-CrEL containing therapy.
Conference/Value in Health Info
2021-05, ISPOR 2021, Montreal, Canada
Value in Health, Volume 24, Issue 5, S1 (May 2021)
Patient-reported Outcomes & Quality of Life Outcomes