Hematology Oncology Research: The Leading Edge

The variety of ongoing research in cancer has never been more dynamic. Increased understanding into the pathogenesis of cancers, intriguing research into the development of new treatments, the establishment of advanced methods of identifying actionable targets for treatment, and improved strategies for managing adverse events occurring with therapy are among the up-to-the-minute topics in the field.

This new feature in The Oncology Pharmacist is a compendium of pioneering work by established and up-and-coming hematology oncology pharmacists and other healthcare providers working in a variety of oncology settings who published abstracts in the March issue of the Journal of Hematology Oncology Pharmacy. We aim to highlight this important research and follow up with our readers when it is published as a full article.

HOPA Annual Conference 2024 Platform Presentations

Post-Transplant Cyclophosphamide, Tacrolimus, and Mycophenolate vs Tacrolimus and Methotrexate as GVHD Prevention Following Allogeneic Stem Cell Transplant With Myeloablative Conditioning

Presenting Authors: Mary C. Cash, PharmD, BCOP, and Erin M. Eberwein, PharmD, BCOP, Duke University Hospital, Durham, NC

Co-Authors: Elizabeth R. Eubanks, PharmD, MPH, BCPS, BCOP, and Daniel Schrum, PharmD, BCOP, Duke University Hospital, Durham, NC; Joshua Burrows, MS, and Hui-Jie Lee, PhD, Duke University School of Medicine, Department of Biostatistics and Bioinformatics, Durham, NC

BACKGROUND: The use of post-transplant cyclophosphamide, tacrolimus, and mycophenolate (PTCy-Tac-MMF) has gained popularity for the prevention of graft-versus-host disease (GVHD) following hematopoietic stem cell transplant (HSCT) with an HLA-matched related donor (MRD) or an HLA-matched unrelated donor (MUD) donor. Although the results of BMT-CTN 1703 solidified the role of PTCy-Tac-MMF as standard of care following reduced-intensity conditioning, limited data exist evaluating its use following myeloablative conditioning.

OBJECTIVE: The purpose of this study is to compare the efficacy and safety of PTCy-Tac-MMF and tacrolimus and methotrexate (Tac-MTX) as GVHD prevention among patients who underwent HSCT from a MRD or MUD following myeloablative conditioning.

Remote Outpatient Temperature Monitoring for Early Detection of Febrile Neutropenia After High-Dose Cytarabine Consolidation Chemotherapy (the REMEDY Trial)

Presenting Authors: Emily Behren Ketchum, PharmD, BCOP, Wellstar-MCG Health Georgia Cancer Center, Augusta, GA; Amber B. Clemmons, PharmD, BCOP, FHOPA, University of Georgia College of Pharmacy, Augusta, GA

Co-Authors: Stephanie Daniels, PA-C, and Sarah Jimenez, DNP, APN-BC, AGACNP, AOCNP, Wellstar-MCG Health Georgia Cancer Center, Augusta, GA; Mohammad Mian, MD, PhD, MPH, and Locke J. Bryan, MD, Department of Medicine, Hematology and Oncology, Wellstar-MCG Health Georgia Cancer Center, Augusta, GA

BACKGROUND: Febrile neutropenia (FN) is a common and potentially life-threatening complication of high-dose cytarabine (HiDAC) consolidation for patients with acute myeloid leukemia (AML). Early detection may limit negative sequelae. Although continuous temperature monitoring via commercially available remote temperature monitoring transdermal patch (RTM-patch) is reported to detect FN earlier than intermittent manual monitoring in hospitalized patients, evaluation in the outpatient oncology setting is lacking.

OBJECTIVE: To examine the feasibility and effectiveness of a remote continuous temperature monitoring device for early detection of FN after HiDAC.

Survey of PGY-2 Oncology Residency Program Directors to Assess Current Resources and Effects on Burnout

Presenting Author: Eugene R. Przespolewski, PharmD, BCOP, DPLA, Roswell Park Comprehensive Cancer Center, Buffalo, NY

Co-Authors: Alharith Abdel-Arazzaq, University at Buffalo School of Pharmacy and Pharmaceutical Sciences, Buffalo, NY; Sarah Mullin Falls, MS PhD, and Grazyna Riebandt, PharmD BCOP, DPLA, Roswell Park Comprehensive Cancer Center, Buffalo, NY

BACKGROUND: Many hematology-oncology pharmacists have reported high burnout levels for reasons including increased hours worked and administrative requirements in a recently completed survey. This has resulted in challenges in recruiting and retaining hematology-oncology pharmacists in addition to already demanding clinical responsibilities. Oncology PGY-2 residency program directors (OPGY-2 RPDs) are particularly vulnerable with voluminous regulations and administrative requirements to conduct a residency program in addition to clinical responsibilities. Neither the well-being of OPGY-2 RPDs nor the implementation and impact of additional resources have been described.

OBJECTIVES: The goal is to describe the status, structure, support for RPDs, and time requirements of OPGY-2 across the country, and to provide a well-being assessment of these RPDs to capture the level of burnout.

Predictive Factors of Dose Reduction Among Patients Treated With Palbociclib for Advanced or Metastatic Breast Cancer in a Real-World Setting

Presenting Authors: Sandra Savignac, PharmD, MSc, CIUSSS de l’Est-de-l’Île-de-Montréal, Quebec, Canada; Marianne Boyer, BPharm, MSc, BCOP, Centre hospitalier de l’Université de Montréal, Quebec, Canada

Co-Authors: Christine Messier, BPharm, MSc, BCOP, and Marie-Lawrence Monfette, PharmD, MSc, BCOP, Centre hospitalier de l’Université de Montréal, Quebec, Canada; Nathalie Letarte, PharmD, MSc, BCOP, Faculté de pharmacie, Université de Montréal, Centre hospitalier de l’Université de Montréal, Quebec, Canada

BACKGROUND: The Canadian palbociclib monograph recommends a starting dose of 125 mg/day and subsequent dose reductions during treatment if adverse events occur. However, in practice, clinicians sometimes choose to initiate palbociclib at a lower dose to prevent the occurrence of adverse events in patients who are considered more likely to have them.

OBJECTIVES: This study aimed to identify baseline patient characteristics that may predict the need for palbociclib dose reduction during treatment. The secondary objectives were to describe treatment patterns and clinical outcomes, including progression-free survival (PFS), in patients treated with palbociclib at the Centre hospitalier de l’Université de Montréal (CHUM). The study also aimed to identify the frequency and type of interventions carried out by oncology pharmacists for these patients.

Additional Abstracts of Note

Biodistribution and Shedding Analysis Following RP1 Oncolytic Immunotherapy Dosing in Patients From the IGNYTE Clinical Trial: Implications for Oncology Pharmacists

Presenting Author: Christina Davis, PharmD, BCOP, University of Colorado Hospital, Aurora, CO

Co-Authors: Praveen K. Bommareddy, PhD, BPharm, MS, and Alina Monteagudo, PhD, Replimune, Woburn, MA; Mohammed M. Milhem, MD, Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA; Joseph J. Sacco, MD, The Clatterbridge Centre and University of Liverpool, Liverpool, England; Tawnya Lynn Bowles, MD, Intermountain Medical Center, Murray, UT; Katy K. Tsai, MD, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; Gino K. In, MD, MPH, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Eva Muñoz-Couselo, MD, PhD, Vall d’Hebron Institute of Oncology and Vall d’Hebron Hospital Medical Oncology Department, Barcelona, Spain; Ari M. VanderWalde, MD, FACP, MA, MPH, West Cancer Center and Research Institute, Germantown, TN; Jason Alan Chesney, MD, PhD, James Graham Brown Cancer Center, University of Louisville, Louisville, KY; Judith Michels, MD, PhD, Gustave Roussy, Département de Médecine Oncologique, Villejuif, France; Adel Samson, PhD, MBChB, MRCP, BSc, Leeds Institute of Medical Research at St. James’s, University of Leeds, Leeds, England; Georgia M. Beasley, MD, Duke Cancer Institute, Duke University, Durham, NC; Trisha M. Wise-Draper, MD, PhD, University of Cincinnati, Cincinnati, OH; Dirk Schadendorf, MD, West German Cancer Center, University Hospital Essen, Essen, Germany; Fade Mahmoud, MD, The T.W. Lewis Melanoma Center of Excellence, Banner MD Anderson Cancer Center at Banner Gateway Medical Center, Gilbert, AZ; Michael K. Wong, MD, PhD, The University of Texas MD Anderson Cancer Center, Houston, TX; Marcus Viana, MD, Jeannie W. Hou, MD, Aaron Clack, PhD, and Robert S. Coffin, PhD, Replimune, Woburn, MA; Mark R. Middleton, PhD, FRCP, Churchill Hospital and the University of Oxford, Oxford, England; Bartosz Chmielowski, MD, PhD, Jonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, CA

BACKGROUND: RP1 is an HSV-1–based tumor-directed oncolytic immunotherapy modified to enhance safety and increase oncolytic potential that is administered via intratumoral injection. To date, RP1 plus nivolumab has demonstrated clinical activity with an acceptable safety profile in a variety of cancers.

OBJECTIVE: To assess biodistribution and shedding data from 87 patients enrolled in the phase 1 dose expansion (n=14) and phase 2 (n=73) cohorts from the ongoing IGNYTE clinical trial (NCT03767348).

Characterizing Second Line and Beyond Treatments for Primary Central Nervous System Lymphomas

Presenting Authors: Erin K. Yeung, PharmD, BCPS, BCOP, and Brian Primeaux, PharmD, BCOP, University of Texas MD Anderson Cancer Center, Houston, TX

Co-Authors: Chelsea Luo, PharmD, BCOP, Caitlin Linger, PharmD, BCOP, Sheree Chen, PharmD, BCOP, and Bryan Do, PharmD, BCOP, University of Texas MD Anderson Cancer Center Houston, TX

BACKGROUND: Primary central nervous system lymphoma (PCNSL) is a rare and aggressive lymphoma that affects the CNS in the absence of other systemic involvement. High-dose methotrexate (HD-MTX)–based regimens are recommended as frontline treatment, followed by consolidation with high-dose chemotherapy regimens, whole brain radiation therapy (WBRT) with or without temozolomide (TMZ), or autologous stem-cell transplant (autoSCT). Despite treatment advancements with the introduction of HD-MTX and rituximab, up to half of patients will have disease relapse, 10% to 15% may have primary refractory disease, and the median survival is approximately 2 months without additional intervention. Treatment for relapsed or refractory disease can widely vary because preferred regimens in this setting are not well-established.

OBJECTIVE: The primary objective was to characterize the therapies used in relapsed or refractory PCNSL. The secondary objective was to characterize the consolidation methods used after frontline treatment.

Dosing, Safety, and Pharmacokinetics of Combination Therapy With Darolutamide, Androgen-Deprivation Therapy, and Docetaxel for Metastatic Hormone-Sensitive Prostate Cancer in the ARASENS Study

Presenting Author: Ji Sun, PharmD, PhD, BCNSP, BCOP, University of California San Diego, La Jolla, CA

Co-Authors: Matthew R. Smith, MD, PhD, Massachusetts General Hospital Cancer Center, Boston, MA; Bertrand Tombal, MD, PhD, Division of Urology, IREC, Cliniques Universitaires Saint Luc, UCLouvain, Brussels, Belgium; Maha Hussain, MD, Northwestern University, Feinberg School of Medicine, Chicago, IL; Fred Saad, MD, University of Montreal Hospital Center, Montreal, Quebec, Canada; Karim Fizazi, MD, PhD, Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France; Cora N. Sternberg, MD, Englander Institute for Precision Medicine, Weill Cornell Department of Medicine, Meyer Cancer Center, New York-Presbyterian Hospital, New York, NY; E. David Crawford, MD, UC San Diego School of Medicine, San Diego, CA; Natasha Littleton, Bayer Ltd., Dublin, Ireland; Yuan Wang, Weijiang Zhang, and Rui Li, Bayer HealthCare Pharmaceuticals, Whippany, NJ; Arash Rezazadeh Kalebasty, MD, University of California, Irvine, Orange, CA

BACKGROUND: In the ARASENS study (NCT02799602), darolutamide (DARO) plus androgen-deprivation therapy (ADT) and docetaxel (DOC) significantly reduced the risk for death by 32.5% (hazard ratio, 0.68; 95% confidence interval, 0.57-0.80; P<.001) versus placebo (PBO) plus ADT and DOC in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The incidences of treatment-emergent adverse events (TEAEs) were similar between the treatment groups.

OBJECTIVE: To report the dosing, safety, and pharmacokinetics (PK) of the coadministration of DARO plus ADT and DOC.