PMID- 33215562 OWN - NLM STAT- MEDLINE DCOM- 20210426 LR - 20210426 IS - 1477-092X (Electronic) IS - 1078-1552 (Print) IS - 1078-1552 (Linking) VI - 27 IP - 3 DP - 2021 Apr TI - Glasdegib plus low-dose cytarabine for acute myeloid leukemia: Practical considerations from advanced practitioners and pharmacists. PG - 658-672 LID - 10.1177/1078155220973737 [doi] AB - OBJECTIVE: Acute myeloid leukemia (AML) is primarily a disease of older adults. These patients may not be candidates for intensive treatment, and there has been an ongoing need for treatment options for this group. We review the use of glasdegib, a hedgehog-pathway inhibitor available for use in combination with low-dose cytarabine (LDAC).Data Sources: PubMed and relevant congress abstracts were searched using the term "glasdegib". In addition, based on our experience with glasdegib, we considered treatment aspects of particular relevance to pharmacists and advanced practitioners.Data Summary: In a randomized phase II study, the combination of glasdegib plus LDAC demonstrated superior overall survival versus LDAC alone (hazard ratio 0.51, 80% confidence interval 0.39-0.67, p = 0.0004). The trial reported adverse events (AEs) of special relevance for older patients, such as hematologic events, gastrointestinal toxicity, and fatigue, as well as AEs associated with Hh-pathway inhibitors (alopecia, muscle spasms, dysgeusia). Educating patients about typical AEs can facilitate adherence as well as early AE identification and proactive management. For LDAC, which is a long-established therapy in AML, various stages of delivery need consideration, with attention to individual circumstances. Practical measures such as dispensing a longer supply can reduce the number of return clinic visits, providing a meaningful difference for many patients. CONCLUSIONS: Pharmacists and advanced practitioners play important roles in treatment with glasdegib plus LDAC. Ultimately, framing plans for treatment delivery within the individual circumstances of each patient may enable them to stay on therapy longer, giving them the greatest potential to achieve benefit. FAU - Relias, Valerie AU - Relias V AUID- ORCID: 0000-0002-1476-5747 AD - Division of Hematology/Oncology, Tufts Medical Center, Boston, MA, USA. FAU - McBride, Ali AU - McBride A AD - Department of Pharmacy, The University of Arizona Cancer Center, Tucson, AZ, USA. FAU - Newman, Matthew J AU - Newman MJ AUID- ORCID: 0000-0002-1402-5554 AD - The Johns Hopkins Hospital Department of Pharmacy, Baltimore, MD, USA. FAU - Paul, Shilpa AU - Paul S AD - Department of Pharmacy at the University of Texas MD Anderson Cancer Center, Houston, TX, USA. FAU - Saneeymehri, Seyyedeh AU - Saneeymehri S AD - Emory University Hospital/Winship Cancer Institute, Atlanta, GA, USA. FAU - Stanislaus, Genique AU - Stanislaus G AD - John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA. FAU - Tobin, Jennifer AU - Tobin J AD - Blood Disorders Center, University of Colorado Hospital, Aurora, CO, USA. FAU - Hoang, Caroline J AU - Hoang CJ AD - Pfizer Oncology, Pfizer Inc., New York, NY, USA. FAU - Ryan, Joanne C AU - Ryan JC AD - Pfizer Oncology, Pfizer Inc., New York, NY, USA. FAU - Galinsky, Ilene AU - Galinsky I AD - Department of Leukemia, Dana-Farber Cancer Institute, Boston, MA, USA. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Randomized Controlled Trial DEP - 20201120 PL - England TA - J Oncol Pharm Pract JT - Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners JID - 9511372 RN - 0 (Antimetabolites, Antineoplastic) RN - 0 (Benzimidazoles) RN - 0 (Phenylurea Compounds) RN - 04079A1RDZ (Cytarabine) RN - K673DMO5H9 (glasdegib) SB - IM MH - Aged MH - Aged, 80 and over MH - Antimetabolites, Antineoplastic/administration & dosage/adverse effects MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse effects MH - Benzimidazoles/*administration & dosage/adverse effects MH - Cytarabine/*administration & dosage/adverse effects MH - Drug Interactions/physiology MH - Female MH - Gastrointestinal Diseases/chemically induced MH - Hematologic Diseases/chemically induced MH - Humans MH - Leukemia, Myeloid, Acute/diagnosis/*drug therapy MH - Male MH - Pharmacists/*standards MH - Phenylurea Compounds/*administration & dosage/adverse effects MH - Physicians/*standards PMC - PMC8008421 OTO - NOTNLM OT - Acute myeloid leukemia OT - elderly OT - glasdegib OT - hedgehog pathway inhibitor OT - low-dose cytarabine COIS- Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Relias serves on Speakers Bureau for AbbVie and Genentech. Dr McBride is a consultant for Sandoz, Sanofi Genzyme, and Teva. Dr Newman has no potential disclosures to report. Dr Paul has no potential disclosures to report. Dr Saneeymehri has no potential disclosures to report. Ms Stanislaus discloses potential conflicts of interest with Celgene, Jazz, Novartis, and Takeda. Dr Tobin is a consultant for KaryoPharm. Drs Hoang and Ryan are employees of Pfizer. Ms Galinsky is a consultant/advisory board member for AbbVie, Merus Pharmaceuticals, and Pfizer. EDAT- 2020/11/21 06:00 MHDA- 2021/04/27 06:00 PMCR- 2021/03/30 CRDT- 2020/11/20 08:39 PHST- 2020/11/21 06:00 [pubmed] PHST- 2021/04/27 06:00 [medline] PHST- 2020/11/20 08:39 [entrez] PHST- 2021/03/30 00:00 [pmc-release] AID - 10.1177_1078155220973737 [pii] AID - 10.1177/1078155220973737 [doi] PST - ppublish SO - J Oncol Pharm Pract. 2021 Apr;27(3):658-672. doi: 10.1177/1078155220973737. Epub 2020 Nov 20.