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Lisa Dwyer Orr,1 Dee Lin,1 Bingcao Wu,1 Thomas W LeBlanc,2 Beth Faiman,3 Jenny Ahlstrom,4 Margaret Yung,5 Kathleen L Deering,5 Victoria Kulbokas,5 Joshua L Feldman,6 Erika Kline,6 Noa Biran7 1Janssen Scientific Affairs LLC, Titusville, NJ, USA; 2Duke Cancer Institute, Duke University School of Medicine, Durham, NC, USA; 3Cleveland Clinic, Taussig Cancer Institute, Cleveland, OH, USA; 4HealthTree Foundation, Draper, UT, USA; 5EPI-Q Inc, Chicago, IL, USA; 6Inspire Insights, Arlington, VA, USA; 7Hackensack Meridian Health, John Theurer Cancer Center, Hackensack, NJ, USACorrespondence: Lisa Dwyer Orr, Janssen Scientific Affairs LLC, Titusville, NJ, USA, Tel +1 561 290-9901, Email LDwyer2@ITS.JNJ.comIntroduction: Treatment decision-making for multiple myeloma (MM) is complex. Individuals involved in decision-making may value treatment attributes differently based on their role as a patient, care partner, or physician. This study describes those attributes, and what is most important by role.Methods: We conducted a cross-sectional online survey with consenting adult patients with MM, MM care partners, and physicians treating MM. Respondents were recruited from US panels (Inspire and M3 Global Research) between September and December 2022. Survey items were informed by a targeted literature review, qualitative interviews, and a steering committee comprising clinical experts, a patient advocate, patient, and care partner. Descriptive statistics were generated and reported in aggregate.Results: Email invitations were sent to 8071 Inspire members interested in or posting about MM. Of these, 4427 viewed the invitation, 941 responded, and 156 patients and care partners completed the survey (17% of respondents). For physicians, 5588 were invited via Email by M3 Global Research, with 761 viewing the invitation, 214 accessing the survey link, and 137 completing the survey (64% of respondents). Duration of response, side effects, and patients’ quality-of-life (QoL) were the top three treatment attributes selected across the three cohorts; alignment of these attributes was consistent among patients regardless of disease severity. Separately, patients rated QoL and the amount of caregiving needed during/after treatment as the most important factors for future treatment decisions. If more effective MM treatments were offered, care partners were more willing to assume greater family burden (77%) compared to patients (49%), and patients were more accepting of potential serious side effects (50%) than were care partners (34%).Conclusion: Patients with MM, care partners, and physicians consider and value various treatment decision-making factors. Recognizing and addressing these differences is critical to meeting patients’ preferences, needs, and optimizing patient outcomes.Keywords: Decision-making, treatment choice, cross-sectional survey, multiple myeloma

Hannah Le,1 Kellie Ryan,1 Svea K Wahlstrom,2 Martine C Maculaitis,3 Oliver Will,4 Emily Mulvihill,5 Thomas W LeBlanc6 1US Medical Affairs, AstraZeneca, Gaithersburg, MD, USA; 2US Patient Safety, AstraZeneca, Wilmington, DE, USA; 3Kantar, Health Division, New York, NY, USA; 4Kantar, Health Division, Horsham, PA, USA; 5Kantar, Health Division, St. Louis, MO, USA; 6Division of Hematologic Malignancies and Cellular Therapy, Duke University, Durham, NC, USACorrespondence: Martine C Maculaitis Email Martine.Maculaitis@kantar.comPurpose: Treatment for chronic lymphocytic leukemia (CLL) has changed dramatically with the approval of novel agents. Information regarding how patients and oncologists make trade-offs across attributes of novel therapies is limited. The purpose of this study was to understand how variations in attributes impact treatment choice among patients and oncologists.Patients and Methods: In this study, 371 participants (patients [n=220] and oncologists [n=151]) completed an online discrete choice experiment (DCE) to quantify preferences for first-line (1L) CLL treatment with novel agents; participants chose between hypothetical treatment profiles consisting of eight attributes with varying levels taken from published literature. Hierarchical Bayesian models were used to estimate attribute level preference weights. The weights were used to compute relative importance, a measure of how influential an attribute is to treatment choice.Results: Increasing 2-year progression-free survival (PFS) from 75% to 95% had the greatest impact on preferences in 1L CLL treatment, accounting for 40% and 30% of the variation in preferences among patients and oncologists, respectively. Risk differences in atrial fibrillation (AF), infection, and discontinuation due to adverse events (AEs) were also important to patients and oncologists. Among both groups, risk differences in tumor lysis syndrome (TLS) and bleeding were least influential in treatment choice. Oncologists required 2– 4 times higher increases in 2-year PFS than patients to accept increased risks of AF, discontinuation due to AEs, bleeding, TLS, and arthralgia/myalgia.Conclusion: Patient–oncologist communication may be improved by a more focused discussion on the risks of AEs, relative to treatment outcomes, with patient goals in mind.Keywords: leukemia, lymphocytic, chronic, B-cell, progression-free survival, tumor lysis syndrome, oncologists

Limited data exist on factors associated with early quality of life (QOL) response to palliative care (PC) in patients undergoing hematopoietic cell transplantation (HCT). We conducted a secondary analysis from two randomized clinical trials of PC versus usual care in adults with hematologic malignancies undergoing HCT. We measured patient-reported QOL, physical and psychological symptoms, and coping (categorized as approach-oriented and avoidant) at time of HCT admission, 2-weeks, 3- and 6- months post-HCT. PC clinicians completed weekly surveys documenting PC domains addressed. We defined early QOL response to PC as change in FACT-BMT Total score from HCT admission to week 2 and used the median split to define "high" responders. 252 participants were included in analyses. The median change in QOL from HCT admission to week 2 was -10.7 (range: -77.0, +52.0). Minoritized race (OR=3.2, CI=[1.7,6.3], p<0.001), lower baseline QOL (OR=0.97, CI=[0.96,0.99], p<0.001), higher physical (OR=1.02, CI=[1.0,1.04], p=0.004) and PTSD symptoms (OR=1.04, CI=[1.01,1.07], p=0.008) were associated with being a high PC responder. High PC responders reported greater use of approach-oriented coping at week 2 (D=2.5, CI=[0.9,4.1], p=0.002), 3 months (D=1.7, CI=[0.1,3.3], p=0.04), and 6 months post-HCT (D=2.6, CI=[0.8,4.4], p=0.003). Based on PC clinician surveys during HCT, high responders' PC visits focused on coping, illness/HCT education, and symptom education, compared to low responders' visits which focused on symptom management. These findings provide insights into factors associated with early QOL response to PC in HCT and help identify those most likely to benefit in real world practice. The clinical trial were registered at clinicaltrials.gov (NCT02207322, NCT03641378)., (Copyright © 2025 American Society of Hematology.)

Chimeric Antigen Receptor T-Cell (CAR-T) therapy is an effective therapy and promising frontier in the treatment of hematologic malignancies. However, this revolutionary treatment has led to new challenges for patients, caregivers, and the healthcare system. In this review article, we discuss the various difficulties patients face both in the acute and long-term period following CAR-T infusion. We highlight the various ways these difficulties are addressed, as well as further areas of research and support needed to improve patient experience. Additionally, we consider the difficulties and burdens placed on caregivers and healthcare systems, as well as barriers to accessing CAR-T therapy. Finally, we address future directions of research and intervention development to meet patient and caregiver needs and improve equitable access. We pose early integration of specialty palliative care for individuals and their caregivers undergoing CAR-T therapy as one promising strategy to help improve patient experience and meet their needs.

Objectives: In cancer studies, assessment of patients' physical function can provide insight into cancer-related symptoms and the side effects of treatment. Physical function can be assessed using patient-reported outcome measures (PROMs), which may or may not include a recall period-the amount of time the questionnaire asks the respondent to think back to answer the questions. More understanding is needed about how patients interpret and respond to items posed with different recall periods, and which recall period they actually use., Study Design and Setting: We conducted a qualitative study with 72 adults diagnosed with cancer to describe response processes when answering PROM items about physical function., Results: When describing their physical function during concept elicitation interviews, most participants recalled their functioning over 1 month or more. When presented with PROM items with no recall period, the most used period was more than 4 weeks. When presented with a 7-day recall, the most used period was 7 days. However, almost 30% of responses used recall periods greater than 1 week., Conclusion: Including a 7-day recall period improves recall consistency for patients when answering physical function PROM items, but there is still room for improvement. The inaccuracy of recall for PROMs in clinical trials influences the ability to calculate the change in treatment outcomes over time and may conceal or emphasize actual treatment effects., Competing Interests: Declarations. Conflict of interest: TC has research funding from Merck and Pfizer; a prior consulting agreement with Regenxbio; and received a speaking honorarium from ISPOR. CA was a fellow at Duke (2021–2023) funded by AstraZeneca and is now an employee at AstraZeneca (2023-present). CRG is a consultant for Stryker and Medtronic. BBR had a consulting role with Novartis. TWL has received honoraria for consulting/advisory boards from AbbVie, Agilix, Agios/Servier, Apellis, Astellas, AstraZeneca, BlueNote, BMS/Celgene, Genentech, GSK, Lilly, Meter Health, Novartis, and Pfizer; speaking related honoraria from AbbVie, Agios, Astellas, BMS/Celgene, Incyte, and Rigel; equity interest in Dosentrx (stock options in a privately-held company); royalties from UpToDate; research funding from the AbbVie, American Cancer Society, AstraZeneca, BMS, Deverra Therapeutics, Duke University, GSK, Jazz Pharmaceuticals, and Seattle Genetics. TWL is a Scholar in Clinical Research of the Leukemia & Lymphoma Society. BBR has received honoraria for participating in a meeting with Novartis. All other authors have no disclosures., (© 2024. The Author(s).)

Context: Prognostication challenges contribute to delays in advance care planning (ACP) for patients with cancer near the end of life (EOL)., Objectives: Examine a quality improvement mortality prediction algorithm intervention's impact on ACP documentation and EOL care., Methods: We implemented a validated mortality risk prediction machine learning model for solid malignancy patients admitted from the emergency department (ED) to a dedicated solid malignancy unit at Duke University Hospital. Clinicians received an email when a patient was identified as high-risk. We compared ACP documentation and EOL care outcomes before and after the notification intervention. We excluded patients with intensive care unit (ICU) admission in the first 24 hours. Comparisons involved chi-square/Fisher's exact tests and Wilcoxon rank sum tests; comparisons stratified by physician specialty employ Cochran-Mantel-Haenszel tests., Results: Preintervention and postintervention cohorts comprised 88 and 77 patients, respectively. Most were White, non-Hispanic/Latino, and married. ACP conversations were documented for 2.3% of hospitalizations preintervention vs. 80.5% postintervention (P<0.001), and if the attending physician notified was a palliative care specialist (4.1% vs. 84.6%) or oncologist (0% vs. 76.3%) (P<0.001). There were no differences between groups in length of stay (LOS), hospice referral, code status change, ICU admissions or LOS, 30-day readmissions, 30-day ED visits, and inpatient and 30-day deaths., Conclusion: Identifying patients with cancer and high mortality risk via machine learning elicited a substantial increase in documented ACP conversations but did not impact EOL care. Our intervention showed promise in changing clinician behavior. Further integration of this model in clinical practice is ongoing., (Published by Elsevier Inc.)

Language discordance between clinicians and families in pediatrics has been associated with adverse events and lower quality of care. We aimed to summarize the existing literature evaluating the impact of language discordance among healthcare professionals and families within pediatric oncology by conducting a systematic review. Of 8364 studies, 43 studies met eligibility for inclusion in this review. These studies highlight the impact of language discordance on pediatric cancer care outcomes, including communication challenges, obstacles to research participation, and potentially higher risk disease features at presentation. Healthcare professionals endorsed inconsistent professional interpreter use and lack of formal training on communicating via interpreters. Interventions to address barriers to language-appropriate care are sparse. Further research is warranted to design and implement interventions promoting language justice and provision of high-quality, equitable pediatric cancer care for all families., (© 2024 Wiley Periodicals LLC.)

Gemtuzumab ozogamicin (GO) is a CD33-targeting antibody-drug conjugate approved for the treatment of CD33-positive de novo and relapsed and refractory acute myeloid leukemia (AML). Subset analyses have demonstrated improved clinical outcomes in patients with favorable-risk disease. It is unclear whether the addition of GO to cytarabine and anthracycline chemotherapy (7+3) improves clinical outcomes compared with other conventional regimens for AML. We evaluated the real-world experience with GO added to 7+3 chemotherapy for patients with favorable risk AML. This retrospective analysis included 174 patients with de novo favorable risk AML undergoing induction chemotherapy between 2010 and 2020. The primary outcome was overall survival (OS) and secondary outcomes included rates of remission, measurable residual disease (MRD), and toxicity. Eighteen patients received GO, 37 received a high-dose (HD) anthracycline, and 119 received an intermediate-dose anthracycline. Composite complete remission was achieved in 162 patients (93.1%). Among the 54 patients who were assessed for MRD at remission, 66.7% were undetectable. An improvement in OS was seen for patients who received GO and those treated with HD anthracycline, which was better explained by differences in patient performance status and comorbidities. Patients who received GO did not show increased toxicity., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Limited data are available on the impact of specialist palliative care on end-of-life care quality for patients with hematologic malignancies. This study aims to analyze the quality of end-of-life care in patients with hematological malignancies, comparing those who receive palliative care with those who do not., Methods: Observational, single center retrospective study. This study was conducted at the National Cancer Institute (INCan) in Mexico City, a tertiary care hospital, between January 2016 and June 2021. This study included deceased patients with hematological malignancies who were hospitalized or patients who were hospitalized and receiving home palliative care, with follow-up from the palliative care service. End-of-life care quality was assessed using the ASCO/NQF instrument., Results: Three hundred sixty deceased patients with hematological malignancies were included in the analysis; 51.4% were men, with a median age of 52 years. The most common diagnosis was non-Hodgkin lymphoma (41.4%); 37.8% of patients were referred to palliative care, with an average referral time from admission to INCan of 99.5 days. Patients without palliative care referral showed worse quality of death indicators (71.6% vs. 28.4%). Survival analysis revealed a median survival of 5.29 months for patients with up to 3 worse quality of death indicators and 3.65 months for those with ≥ 4 worse quality of death indicators at the end-of-life (p < 0.001)., Conclusion: Patients with hematologic malignancies who did not receive palliative care experienced more intensive end-of-life interventions and had lower overall survival rates. Early integration of palliative care is crucial to promote compassionate approaches near death and ensure quality end-of-life care., Competing Interests: Declarations. Ethics approval: This observational study was performed in line with the principles of the Declaration of Helsinki. The research protocol was reviewed and approved by the Ethics Committee of the National Institute of Cancerology in Mexico. The approval was granted under protocol number 2021/50. Consent to participate: As this study was a retrospective analysis of previously collected data, informed consent was not required from individual patients. The data used in this study were anonymized, and the ethical guidelines of our institution were followed to ensure patient confidentiality and data protection. Competing interests: The authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Patients with multiple myeloma (MM) experience significant symptom burden. We used a symptom monitoring app to longitudinally characterize the MM treatment experience in detail based on line of therapy (LOT)., Methods: Adults with MM on active treatment completed weekly symptom monitoring surveys. Patients on their 4th LOT or greater were considered heavily pretreated. We characterized moderate to very severe (MOD-VS) symptom prevalence, weekly symptom burden, symptom bother (FACT-GP5), and health-related quality of life (HR-QoL) (EORTC QLQ-C30 Item 30) per LOT., Results: We considered 109 patients on LOT < 4 and 47 on LOT ≥ 4. The top MOD-VS symptoms were fatigue (71.6% of patients), muscle pain (59.8%), general pain (51.6%), numbness/tingling (48.4%), and insomnia (47.6%). More patients on LOT ≥ 4 experienced numbness/tingling (66.7% vs. 41.3%; OR 2.84, 95% CI 1.27-6.37; p = 0.0098) and fatigue (83.3% vs. 65.6%; OR 2.60, 95% CI 0.96-7.09; p = 0.0557). Some symptoms (fatigue, muscle pain, anxiety) persisted for months among patients on LOT ≥ 4, but patients on LOT < 4 also had unmet longitudinal needs (numbness/tingling, dyspnea). Patients on LOT ≥ 4 had more weeks with ≥ 3 MOD-VS symptoms (27.1% of weeks vs. 15.7%; OR 2.56, 95% CI 1.07-6.08; p = 0.0337) and experienced high symptom bother more often (39.1% of surveys vs. 30.0%; OR 4.23, 95% CI 1.37-13.10; p = 0.0123). HR-QoL was similar between groups., Conclusion: Heavily pretreated patients experienced greater symptom burden and bother, but patients at earlier LOTs also had unmet needs. Interventions are needed to improve symptom management in MM regardless of LOT, but most pressingly for heavily pretreated patients., Competing Interests: Declarations Ethics approval This study was performed in accordance with the Declaration of Helsinki. This study utilized a prospectively collected database of electronic patient-reported outcomes; we obtained approval from the Institutional Review Board at Duke University Medical Center for analysis of these data (Pro00108428). Consent to participate Informed consent was obtained from all individual participants included in the study. Competing interests Mihir N. Patel has received royalties from Prepped Health (Agreement #012617, HOPE). Suzanne Johnson and Julie Scott are employees of and hold stock or stock options in Carevive Systems, Inc. Thomas W. LeBlanc has received honoraria for consulting/advisory boards from AbbVie, Agilix, Agios/Servier, Apellis, Astellas, AstraZeneca, Beigene, BlueNote, BMS/Celgene, Genentech, GSK, Lilly, Meter Health, Novartis, and Pfizer; speaking related honoraria from AbbVie, Agios, Astellas, BMS/Celgene, GSK, Incyte, and Rigel; equity interest in Dosentrx and ThymeCare (stock options in a privately-held company); royalties from UpToDate; research funding from AbbVie, American Cancer Society, AstraZeneca, BMS, Deverra Therapeutics, Duke University, GSK, Jazz Pharmaceuticals, the Leukemia and Lymphoma Society, the National Institute of Nursing Research/ National Institutes of Health, and Seattle Genetics. All other authors have no relevant financial or non-financial interests to disclose., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Older people with acute myeloid leukaemia (AML) have a poor prognosis, reduced health-related quality of life (HRQoL) and require substantial healthcare resources. The objectives of this systematic review were to determine what health state utility values (HSUVs) are reported in the literature that can be used in economic evaluations of interventions for older people with AML, identify research gaps, and discuss directions for future research., Methods: The following databases were searched for studies published from inception until Feb 2023: PubMed, EMBASE, CINAHL, PsycINFO, Cochrane, and EconLit. Studies were included if they reported on HSUVs of people with AML >60 years, or HRQoL data that could be mapped to HSUVs using currently published algorithms., Results: Of 532 studies identified, 7 met inclusion (4 full studies and 3 conference abstracts). Twenty-eight potentially eligible studies were excluded as they did not report HRQoL measures in sufficient detail to be mapped to utility values. Included studies reported on health states of newly diagnosed disease (n=4 studies), intensive therapy (n=1 study), controlled remission (n=3 studies), and relapsed or refractory disease (n=2 studies). No studies reported on low intensity therapy or supportive care health states. Utility values were largely reported via the EuroQol and ranged from 0.535 (intensive therapy) to 0.834 (controlled remission)., Conclusion: There are gaps in knowledge on HSUVs for older people with AML, particularly for certain treatment-related health states. Future articles should publish comprehensive HRQoL outcomes to enable use in economic evaluation., (© 2024. The Author(s).)

Context: Early specialist palliative care (PC) involvement in metastatic non-small cell lung cancer (mNSCLC) is associated with improved quality of life, less aggressive end of life (EoL) care, and longer survival. As treatment paradigms for NSCLC have evolved, PC utilization remains low., Objectives: This work examines how the timing and extent of PC involvement impacts outcomes and the patient experience in mNSCLC in the era of immunotherapy., Methods: This retrospective review analyzed patients with mNSCLC who initiated first-line treatment with chemotherapy, immunotherapy, or combined chemoimmunotherapy at Duke University between March 2015 and July 2019. PC consultation and outcomes data were abstracted through November 2022. EoL care variables were analyzed using descriptive statistics., Results: 152 patients were stratified based on whether PC was consulted during their disease course. 80 patients (53%) never saw PC, while the 72 patients (47%) who saw PC were further stratified by time to first PC encounter and total number of PC visits. 31% were seen within two months of diagnosis (early), 33% between two and six months (intermediate), and 36% after 6 months (late). Patients who received early PC had longer median time on hospice (35 days), had lower rates of aggressive EoL care (43%), and experienced less frequent in-hospital death (14%) compared to other groups., Conclusion: This real-world study reveals that referrals to PC still occur late or not at all in mNSCLC despite demonstrated benefits of early PC integration. Early outpatient PC referrals resulted in longer time on hospice, lower frequency of aggressive EoL care, and lower rates of in-hospital death., (Copyright © 2024 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Purpose: Historically, patients with hematologic malignancies are referred to palliative care less often and later in the disease trajectory than those with solid tumors. Recent evidence demonstrates the benefit of early, integrated inpatient palliative care (PC) for patients with acute myeloid leukemia (AML) receiving chemotherapy at academic centers. The current study evaluated the feasibility of implementing standardized early palliative care services (PCS) during hospitalization for AML treatment in a community setting., Methods: Starting June 2018, automated consultations for PCS were incorporated into clinical pathways to encourage early, integrated services for patients receiving chemotherapy for AML with an expected hospital stay of 4-6 weeks. Expectations were established that consultations would be performed within 72 hours of request; patients would have two visits per week by a palliative care clinician and at least one visit by a member of the interdisciplinary team. To measure the feasibility of this intervention, data on number of patients who received palliative care consultation and time to palliative care consultation were compared with institutional historical controls., Results: On the basis of retrospective chart review, the postintervention group (n = 21) had greater PCS compared with historical controls (n = 28; 95% v 36%). The average number of PC team member visits per patient was significantly greater after the intervention: PC clinicians (1.04-8.05, P < .001), chaplains (1.3-3.3, P = .0085), and social workers (1.0-4.3, P < .001). Of those patients who received PCS, 74% had their initial palliative medicine consultation within 3 days of a clinician's order and 100% within 4 days., Conclusion: We have demonstrated the feasibility of implementing standardized integration of PCS for patients with AML hospitalized for treatment in a community setting.

Purpose: Performance status is an important concept in oncology, but is typically clinician-reported. Efforts are underway to include patient-reported measures in cancer care, which may improve patient symptoms, quality of life and overall survival. The purpose of this study was to gain a preliminary understanding of how patients determined their physical performance status based on a novel patient-reported version of the Eastern Cooperative Oncology Group Performance Status (ECOG) scale., Methods: We conducted qualitative interviews, including concept elicitation and cognitive interviewing as part of the Patient Reports of Physical Functioning Study (PROPS) to investigate how participants selected their answers to a novel patient-reported ECOG. Participants were administered the patient-reported ECOG and asked to describe devices and modifications used to keep up with daily activities., Results: Participants generally understood the ECOG as intended. Participants with recent changes in status had some difficulty selecting an answer. Most participants used modifications and assistive devices in their daily lives but did not incorporate these into their rational for the ECOG., Conclusion: The potential benefits of a patient-reported ECOG are numerous and this study demonstrates that participants were able to understand and answer the patient-reported ECOG as intended. We recommend future evaluation for the most-appropriate recall period, whether to include modifications in the ECOG instructions, and if increasing the number of response options to the patient-reported ECOG may improve confidence when providing an answer., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objectives: Patients with hematologic cancer experience severe symptoms (i.e. insomnia, fatigue, pain, distress). Few interventions addressing insomnia and other symptoms exist for this population. Mindfulness-Based Therapy for Insomnia (MBTI) may be appropriate but has only been tested in healthy outpatients. This study aimed to develop and test an adapted MBTI protocol for hematologic cancer patients., Methods: Patient ( n  = 3) and clinician ( n  = 1) focus groups, and user-testing ( N  = 5) informed adaptation of Mindful Night-to-Day (MBTI+). A single-arm pilot trial ( N  = 32) evaluated feasibility (accrual, attrition, adherence), acceptability (intervention satisfaction), and changes to insomnia symptom severity (Insomnia Severity Index; primary outcome) and secondary outcomes (fatigue, pain, distress, pre-sleep arousal, mindfulness, symptom management self-efficacy) at baseline, post-intervention, and 1-month post-intervention. Descriptive statistics and paired sample t-tests were conducted., Results: Qualitative feedback informed MBTI+ content, format, and delivery. Mindfulness was used to increase symptom awareness (sleepiness vs. fatigue). Meditations and behavioral skills were applied to inpatient treatment. MBTI+ met feasibility ( N  = 32/12 months; 8.1% attrition; 83.8% adherence) and acceptability ( M  = 3.52/4.00) benchmarks. Insomnia symptom severity decreased (d = 1.20) from baseline to post-intervention, as did most secondary outcomes., Conclusions: MBTI+ was feasible, acceptable, and showed promise for benefits throughout inpatient and outpatient treatment. Findings warrant further evaluation in a randomized trial.

Myeloproliferative neoplasms (MPNs) are a group of rare chronic progressive blood cancers that vary widely in clinical presentation, yet all patients have a risk of disease progression and thrombotic complications. Diseases include primary myelofibrosis, polycythemia vera, and essential thrombocythemia. With current treatment approaches, most patients live a prolonged life, but many experience a complex of symptoms that negatively influence their functional status and quality of life. Although significant advances have been made in preventing arterial and venous complications while mitigating inflammatory processes, comprehensive palliative care can help address unmet complex physical and psychosocial needs on a long-term basis. This article, created by a multidisciplinary group of providers, offers an overview of MPNs so palliative care clinicians can better support patients with these hematologic cancers.

Importance: Despite the evidence for early palliative care improving outcomes, it has not been widely implemented in part due to palliative care workforce limitations., Objective: To evaluate a stepped-care model to deliver less resource-intensive and more patient-centered palliative care for patients with advanced cancer., Design, Setting, and Participants: Randomized, nonblinded, noninferiority trial of stepped vs early palliative care conducted between February 12, 2018, and December 15, 2022, at 3 academic medical centers in Boston, Massachusetts, Philadelphia, Pennsylvania, and Durham, North Carolina, among 507 patients who had been diagnosed with advanced lung cancer within the past 12 weeks., Intervention: Step 1 of the intervention was an initial palliative care visit within 4 weeks of enrollment and subsequent visits only at the time of a change in cancer treatment or after a hospitalization. During step 1, patients completed a measure of quality of life (QOL; Functional Assessment of Cancer Therapy-Lung [FACT-L]; range, 0-136, with higher scores indicating better QOL) every 6 weeks, and those with a 10-point or greater decrease from baseline were stepped up to meet with the palliative care clinician every 4 weeks (intervention step 2). Patients assigned to early palliative care had palliative care visits every 4 weeks after enrollment., Main Outcomes and Measures: Noninferiority (margin = -4.5) of the effect of stepped vs early palliative care on patient-reported QOL on the FACT-L at week 24., Results: The sample (n = 507) mostly included patients with advanced non-small cell lung cancer (78.3%; mean age, 66.5 years; 51.4% female; 84.6% White). The mean number of palliative care visits by week 24 was 2.4 for stepped palliative care and 4.7 for early palliative care (adjusted mean difference, -2.3; P < .001). FACT-L scores at week 24 for the stepped palliative care group were noninferior to scores among those receiving early palliative care (adjusted FACT-L mean score, 100.6 vs 97.8, respectively; difference, 2.9; lower 1-sided 95% confidence limit, -0.1; P < .001 for noninferiority). Although the rate of end-of-life care communication was also noninferior between groups, noninferiority was not demonstrated for days in hospice (adjusted mean, 19.5 with stepped palliative care vs 34.6 with early palliative care; P = .91)., Conclusions and Relevance: A stepped-care model, with palliative care visits occurring only at key points in patients' cancer trajectories and using a decrement in QOL to trigger more intensive palliative care exposure, resulted in fewer palliative care visits without diminishing the benefits for patients' QOL. While stepped palliative care was associated with fewer days in hospice, it is a more scalable way to deliver early palliative care to enhance patient-reported outcomes., Trial Registration: ClinicalTrials.gov Identifier: NCT03337399.

Purpose: The U.S. Food & Drug Administration has identified physical functioning (PF) as a core patient-reported outcome (PRO) in cancer clinical trials. The purpose of this study was to identify PF PRO measures (PROMs) in adult cancer populations and classify the PROMs by content covered (facets of PF) in each measure., Methods: As part of the Patient Reports of Physical Functioning Study (PROPS) research program, we conducted a targeted literature review to identify PROMs that could be used in clinical trials to evaluate PF from the patient perspective. Next, we convened an advisory panel to conduct a modified, reactive, Delphi study to reach consensus on which PF facets are assessed by PROMs identified in the review. The panel engaged in a "card sort" activity to classify PROM items by PF facets. Consensus was reached when 80% of panel members agreed that at least one facet was being measured by each PROM item., Results: The literature review identified 13 PROMs that met inclusion criteria. Eight facets of PF were identified for classification in the Delphi study: ability, completion, difficulty, limitation, quality, frequency, bother, and satisfaction. Through two rounds, the panel documented and classified conceptual approaches for each PRO item presented. The most prevalent PF facets were ability, difficulty, and limitation., Conclusion: Classifying PF PROMs by PF facets will promote more consistent communication regarding the aspects of PF represented in each PROM, helping researchers prioritize measures for inclusion in cancer clinical trials., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Purpose: Successful patient-focused drug development involves selecting and measuring outcomes in clinical trials that are important to patients. The U.S. Food & Drug Administration's definition of clinical benefit includes how patients feel, function, or survive. Patients are considered the experts in describing how they feel and function. In cancer trials, patient-reported measures of physical function provide insight into how patients function at baseline, benefit from the interventions being studied, and the impact of treatment side effects. We conducted a qualitative study with adults diagnosed with cancer to describe facets of physical function from their perspective and to identify which facets are most important to this patient population., Methods: Using concept elicitation and cognitive interviewing techniques, we conducted semi-structured interviews with 72 adults ≥ 22 years of age with cancer who received treatment with an anticancer drug or biologic within six months of the interview. We selected participants using purposive sampling with the aim to elicit diverse experiences regarding how they may interpret and respond to questions related to physical function. Participants were presented with patient-reported outcome (PRO) items representative of PRO measures used in cancer and general populations., Results: Five facets of how physical function relates to activities were defined from the patient perspective: ability, difficulty, limitation, satisfaction, and completion. More than half of the participants indicated that ability was the most important facet of physical function. The next most important were satisfaction (18.3%), limitation (14.1%), difficulty (5.6%), and completion (2.8%)., Conclusion: This study demonstrates that we must be more specific about the facets of physical function that we set out to assess when we use PRO measures to describe the patient experience. These results have implications for the specificity of physical function facets when measured in cancer clinical trials., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Acute myeloid leukemia (AML) is the most common form of acute leukemia in adults. Rapidly proliferating leukemic cells cause symptoms and increase the risk of infection. While individuals may initially benefit from supportive measures, disease-directed therapy may ultimately be required for symptom management, even at the end of life, although this may also inadvertently increase symptom burden. This unpredictable illness trajectory complicates prognostic uncertainty and the timing of hospice referral, which may prohibit access to palliative therapies and lead to recurrent hospitalizations. However, emerging evidence demonstrates that early palliative care (PC) integration with standard leukemia care results in improved quality of life, psychological outcomes, and greater participation in advance care planning. To orient PC clinicians asked to care for patients with AML, this article highlights 10 salient considerations.

Background: Allogeneic hematopoietic stem cell transplantation (HSCT) survivors experience significant psychological distress and low levels of positive psychological well-being, which can undermine patient-reported outcomes (PROs), such as quality of life (QoL). Hence, we conducted a pilot randomized clinical trial to assess the feasibility and preliminary efficacy of a telephone-delivered positive psychology intervention (Positive Affect for the Transplantation of Hematopoietic stem cells intervention [PATH]) for improving well-being in HSCT survivors., Methods: HSCT survivors who were 100 days post-HSCT for hematologic malignancy at an academic institution were randomly assigned to either PATH or usual care. PATH, delivered by a behavioral health expert, entailed 9 weekly phone sessions on gratitude, personal strengths, and meaning. We defined feasibility a priori as >60% of eligible participants enrolling in the study and >75% of PATH participants completing ≥6 of 9 sessions. At baseline and 9 and 18 weeks, patients self-reported gratitude, positive affect, life satisfaction, optimism, anxiety, depression, posttraumatic stress disorder (PTSD), QoL, physical function, and fatigue. We used repeated measures regression models and estimates of effect size (Cohen's d) to explore the preliminary effects of PATH on outcomes., Results: We enrolled 68.6% (72/105) of eligible patients (mean age, 57 years; 50% female). Of those randomized to PATH, 91% completed all sessions and reported positive psychology exercises as easy to complete and subjectively useful. Compared with usual care, PATH participants reported greater improvements in gratitude (β = 1.38; d = 0.32), anxiety (β = -1.43; d = -0.40), and physical function (β = 2.15; d = 0.23) at 9 weeks and gratitude (β = 0.97; d = 0.22), positive affect (β = 2.02; d = 0.27), life satisfaction (β = 1.82; d = 0.24), optimism (β = 2.70; d = 0.49), anxiety (β = -1.62; d = -0.46), depression (β = -1.04; d = -0.33), PTSD (β = -2.50; d = -0.29), QoL (β = 7.70; d = 0.41), physical function (β = 5.21; d = 0.56), and fatigue (β = -2.54; d = -0.33) at 18 weeks., Conclusions: PATH is feasible, with promising signals for improving psychological well-being, QoL, physical function, and fatigue in HSCT survivors. Future multisite trials that investigate PATH's efficacy are needed to establish its effects on PROs in this population.

For patients with triple-class exposed/refractory multiple myeloma (TCE/RMM), where effective treatments options are limited, B-cell maturation antigen and CD3-directed bispecific antibodies offer a promising new approach. Teclistamab gained conditional approval in Europe and accelerated Food and Drug Administration (FDA) approval based on the MajesTEC-1 trial (NCT03145181). Elranatamab, approved by the FDA demonstrated its safety and efficacy in the MagnetisMM-3 trial (NCT04649359). Given the absence of head-to-head trials, an unanchored matching-adjusted indirect comparison (MAIC) was conducted to assess their relative efficacy. Key baseline characteristics were adjusted to be comparable between the two trials. In the MAIC, elranatamab demonstrated significantly better objective response rate and progression-free survival (PFS) than teclistamab, and numerically better complete response, duration of response, and overall survival (OS). These results suggest that elranatamab is an efficacious option for treating patients with TCE/R MM.

Objective: We describe the impact of acute myeloid leukemia (AML) diagnosis on workplace absenteeism and disability days among patients and their caregivers., Methods: This retrospective study included adults with newly diagnosed AML (2009-2019) and adult caregivers of patients with newly diagnosed AML, identified from the US Merative™ MarketScan® Commercial Database. The Merative MarketScan Health and Productivity Management Database provided linked patient-level records of workplace absence and short-term (STD) and long-term disability (LTD) data. Endpoints included workplace absence, STD and LTD for patients and caregivers during 12 months pre-AML (baseline) and ≤3 years' follow-up, and corresponding cost of work loss., Results: Patient workplace absence decreased in the months post-AML diagnosis, but the number of STD and LTD leave days claimed increased significantly by sixfold and fourfold, respectively. The proportion of patients making STD leave claims increased within 4-5 months of diagnosis, while the proportion making LTD leave claims increased significantly starting from month 5. Caregiver workplace absence peaked in the first 2 months post-diagnosis and remained elevated versus baseline throughout the study., Conclusion: AML diagnosis leads to workplace absenteeism and increased economic burden for patients with AML and their caregivers.

Background: Invasive fungal infection (IFI) prophylaxis is recommended in patients with acute myeloid leukemia (AML) during induction chemotherapy. Posaconazole (POSA) is the recommended agent of choice; however, this medication can be associated with QTc prolongation, hepatotoxicity, and drug-drug interactions. Furthermore, there is conflicting evidence for the role of isavuconazole (ISAV) in this setting as an alternative to POSA., Objective: The primary objective of this study was to evaluate the use of ISAV prophylaxis for primary IFI prevention in patients with AML undergoing induction. Additionally, the study investigated the use of ISAV trough concentration monitoring and compared these results to the efficacy of POSA therapeutic drug monitoring (TDM). Other secondary objectives included assessing the rates of toxicities associated with either prophylactic agent. This study analyzed the impact these toxicities had on patient outcomes by examining the need to hold or discontinue therapy. The final endpoint considered the efficacy associated with multiple dosing strategies employed at the study institution. Specifically, this included the use of loading doses or foregoing these when initiating prophylaxis., Methods: This was a retrospective, single-center, cohort study. Patients included in this study were adults with AML admitted to Duke University Hospital between June 30, 2016 and June 30, 2021, who received induction chemotherapy and primary IFI prophylaxis for at least 7 days. Exclusion criteria included patients who received concomitant antifungal agents and patients who received antifungal agents as secondary prophylaxis., Results: 241 patients met inclusion criteria with 12 (4.98%) participants in the ISAV group and 229 (95.02%) participants in the POSA group. The IFI incidence in the POSA group was 14.5%, while the ISAV group did not have any occurrences of IFI. No significant difference was found in the rate of IFI occurrence between the two treatment groups (p  =  0.3805). Furthermore, it was demonstrated that the use of a loading dose when initiating prophylaxis could impact rates of IFI for this patient population., Conclusion: Due to no difference in incidence, patient specific factors such as concomitant medications and baseline QTc should influence the choice between prophylactic agent., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Thomas LeBlanc, MD, MA has received payments and support to attend meetings from AbbVie, Astellas, AstraZeneca, Agios, BMS/Celgene, Flatiron, GSK, Genentech, Pfizer, and Novartis.

Abstract: Patients undergoing hematopoietic cell transplantation (HCT) must cope with physical and psychological symptoms. Yet, studies examining pre-HCT coping are limited. We aimed to characterize pre-HCT coping, evaluate the association of coping with baseline quality of life (QOL) and psychological distress, and identify sociodemographic factors associated with pre-HCT coping. We conducted a cross-sectional analysis of baseline data from a multisite randomized supportive care intervention trial among patients with hematologic malignancies undergoing allogeneic or autologous HCT. We assessed patient-reported QOL, psychological distress, and coping within 72 hours of admission for HCT. We used the median split method to dichotomize coping and multivariate regression analyses to characterize the association of coping with psychological distress and QOL. Of patients awaiting HCT (n = 360; mean age, 55.4 years; 49.7% autologous), 43.5% were high users of approach-oriented coping, whereas 31.3% were high users of avoidant coping. Patients reported high use of emotional support (60.9%), acceptance (51.2%), self-blame (33%), and denial (31.3%). Older age (≥65 years) was associated with less frequent use of avoidant coping (odds ratio, 0.5; P = .01). Approach-oriented coping was associated with better pre-HCT QOL (Beta(B) = 6.7; P = .001), and lower depression (B = -1.1; P = .001) and anxiety (B = -0.9; P = .02) symptoms. Avoidant coping was associated with worse pre-HCT QOL (B = -13.3; P < .001) and symptoms of depression (B = 1.9; P < .001), anxiety (B = 3.1; P < .001), and posttraumatic stress disorder (B = 8.1; P < .001). Pre-HCT coping is strongly associated with psychological distress and QOL. These data support the need for interventions to address coping during HCT hospitalization. This clinical trial was registered at www.clinicaltrials.gov as #NCT03641378., (© 2024 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)

Background: Opioids are a key component of pain management among patients with metastatic cancer pain. However, the evidence base available to guide opioid-related decision-making in individuals with advanced cancer is limited. Patients with advanced cancer or cancer that is unlikely to be cured frequently experience pain. Opioids are a key component of pain management among patients with metastatic cancer pain. Many individuals with advanced cancer are now living long enough to experience opioid-related harm. Emerging evidence from chronic noncancer pain literature suggests that longer-term opioid therapy may have limited benefits for pain and function, and opioid-related harms are also a major concern. However, whether these benefits and harms of opioids apply to patients with cancer-related pain is unknown., Objective: This manuscript outlines the protocol for the "Opioid Therapy for Pain in Individuals With Metastatic Cancer: The Benefits, Harms, and Stakeholder Perspectives (BEST) Study." The study aims to better understand opioid decision-making in patients with advanced cancer, along with opioid benefits and harms, through prospective examination of patients' pain experiences and opioid side effects and understanding the decision-making by patients, care partners, and clinicians., Methods: This is a multicenter, prospective cohort study that aims to enroll 630 patients with advanced cancer, 20 care partners, and 20 clinicians (670 total participants). Patient participants must have an advanced solid cancer diagnosis, defined by the American Cancer Society as cancer that is unlikely to be cured. We will recruit patient participants within 12 weeks after diagnosis so that we can understand opioid benefits, harms, and perspectives on opioid decision-making throughout the course of their advanced cancer (up to 2 years). We will also specifically elicit information regarding long-term opioid use (ie, opioids for ≥90 consecutive days) and exclude patients on long-term opioid therapy before an advanced cancer diagnosis. Lived-experience perspectives related to opioid use in those with advanced cancer will be captured by qualitative interviews with a subset of patients, clinicians, and care partners. Our data collection will be grounded in a behavioral decision research approach that will allow us to develop future interventions to inform opioid-related decision-making for patients with metastatic cancer., Results: Data collection began in October 2022 and is anticipated to end by November 2024., Conclusions: Upon successful execution of our study protocol, we anticipate the development of a comprehensive evidence base on opioid therapy in individuals with advanced cancer guided by the behavioral decision research framework. The information gained from this study will be used to guide interventions to facilitate opioid decisions among patients, clinicians, and care partners. Given the limited evidence base about opioid therapy in people with cancer, we envision this study will have significant real-world implications for cancer-related pain management and opioid-related clinical decision-making., International Registered Report Identifier (irrid): DERR1-10.2196/54953., (©Katie Fitzgerald Jones, Gretchen White, Antonia Bennett, Hailey Bulls, Paula Escott, Sarah Orris, Elizabeth Escott, Stacy Fischer, Megan Hamm, Tamar Krishnamurti, Risa Wong, Thomas W LeBlanc, Jane Liebschutz, Salimah Meghani, Cardinale Smith, Jennifer Temel, Christine Ritchie, Jessica S Merlin. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.03.2024.)

Background: Patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT) commonly experience debilitating physical and psychological symptoms during a 3-4-week-hospitalization. During hospitalization, caregivers (i.e., family and friends) also endure immense emotional stress as they witness their loved one struggle with HSCT toxicities. Yet interventions to improve quality of life (QOL) and reduce psychological distress during HSCT are limited., Methods: We are conducting a multi-site randomized controlled trial of inpatient integrated palliative and transplant care versus usual care in 360 patients hospitalized for HSCT and their caregivers at three academic centers. Intervention participants meet with a palliative care clinician at least twice weekly during the HSCT hospitalization to address their physical and psychological symptoms. Patients assigned to usual care receive all supportive care measures provided by the HSCT team and could be seen by palliative care upon request. We assess patient QOL (Functional Assessment of Cancer Therapy (FACT) - Bone Marrow Transplant), depression and anxiety symptoms (Hospital Anxiety and Depression Scale), post-traumatic stress (PTSD) symptoms (PTSD checklist), symptom burden (Edmonton Symptom Assessment Scale), and fatigue (FACT-Fatigue) as well as caregiver-reported outcomes at baseline, 2 weeks, 3-months, 6-months, and 12-months post-HSCT. The primary endpoint is to compare QOL at week-2 during HSCT hospitalization between the two groups when patients typically experience their QOL nadir during HSCT., Conclusions: This multi-site trial will define the role of palliative care for improving QOL and care for patients with hematologic malignancies undergoing HSCT and their caregivers., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:, (Copyright © 2023. Published by Elsevier Inc.)

Introduction: For patients with triple-class exposed/refractory multiple myeloma (TCE/R MM), prognosis is poor and effective treatment options are limited. Elranatamab is a novel B-cell maturation antigen (BCMA)- and CD3-directed bispecific antibody which was approved by the US Food and Drug Administration in August 2023 and demonstrated safety and efficacy in patients with TCE/R MM in the phase 2, single-arm MagnetisMM-3 trial (NCT04649359). To compare the effectiveness of elranatamab vs physician's choice of treatment (PCT) in the absence of head-to-head comparative data, a matching-adjusted indirect comparison (MAIC) was conducted., Methods: Individual patient data from MagnetisMM-3 (Cohort A [BCMA-naïve] N  = 123, 14.7 months of follow-up) were reweighted to match published summary data from two real-world studies of PCT in patients with TCE/R MM (LocoMMotion and MAMMOTH) using a propensity score-type logistic regression. Unanchored MAIC analyses were conducted according to National Institute for Health and Care Excellence (NICE) Decision Support Unit (DSU) 18 guidance., Results: Compared with PCT in LocoMMotion, elranatamab was associated with a significantly higher objective response rate (ORR rate difference: 37.52; 95% CI 26.20-48.83; odds ratio: 4.85; 95% CI 2.85-8.23) and complete or stringent complete response rate (≥CR rate difference: 42.29; 95% CI 31.84-52.74; odds ratio: 184.01; 95% CI 24.66-1372.86), longer progression-free survival (PFS HR 0.32; 95% CI 0.20-0.49), and overall survival (OS HR 0.62; 95% CI 0.40-0.94). Compared with PCT in MAMMOTH, elranatamab was associated with significantly higher ORR (rate difference: 28.14; 95% CI 16.77-39.52; odds ratio: 3.24; 95% CI 1.98-5.32) and ≥ CR (rate difference: 26.22; 95% CI 16.40-36.05; odds ratio: 5.48; 95% CI 2.88-10.44), as well as longer PFS (HR 0.25; 95% CI 0.17-0.37) and OS (HR 0.49; 95% CI 0.33-0.71). Sensitivity analysis results were consistent with the base case., Conclusion: In the MAIC, elranatamab was consistently associated with improved rates and depth of response and significantly longer PFS and OS versus PCT in LocoMMotion and MAMMOTH.

Context: Palliative Care (PC) is poorly understood by laypersons. However, little is known about what ambulatory patients with cancer understand about PC or what barriers to access exist., Methods: Outpatients undergoing cancer treatment completed a survey evaluating their familiarity and knowledge of PC, Palliative Care Knowledge Scale (PaCKS), feelings towards PC (before and after reading a definition of PC), barriers to PC, and prognostic understanding. We summarized responses descriptively and used logistic regression models to examine variables associated with familiarity and interest., Results: The survey response rate was 32%. Of 151 participants, 58.9% reported familiarity with PC. The average PaCKs score was 11.9 out of 13 (standard deviation, 1.4), with 46.4% receiving a perfect score, indicating high knowledge of PC. Patients diagnosed more than one year ago had significantly increased odds of being familiar with PC (OR 2.93; 95% CI 1.37-6.25). More participants reported future interest in PC compared to current interest (74.2% vs 44.4%, respectively). Patients with stage III or IV cancer had significantly increased odds of having a current interest in receiving PC compared to patients with stage I or II disease (OR 2.66; 95% CI: 1.05, 6.76). Participants reported feeling significantly less anxious and more reassured after reading a standardized definition of PC (P < 0.05)., Conclusion: Outpatients with cancer who are being treated at a large academic cancer center exhibit high awareness and knowledge of PC, but anxiety toward PC persists. Factors beyond knowledge may perpetuate the delayed or lack of involvement with PC., Key Message: In this cross-sectional study of outpatients with cancer, findings suggest that high knowledge of PC may co-exist with a lingering uneasiness towards the service. Additionally, factors beyond knowledge, such as logistic barriers, anxiety, and oncologists' preference may be perpetuating the delay or lack of involvement in PC., Competing Interests: Disclosures and Acknowledgments Dr. LeBlanc's work on palliative care and patient experience issues in hematology is supported in part by a scholar in Clinical Research Award from the Leukemia and Lymphoma Society. Ms. Schlichte's effort was supported by the Snydermann/Moore scholars in health care scholarship offered to Duke School of medicine students. The statements presented in this article are solely the responsibility of the author(s) and do not necessarily represent the views of the Snydermann/Moore Scholars in health care scholarship committee. TWL has received honoraria for consulting/advisory boards from AbbVie, Agilix, Agios/Servier, Astellas, AstraZeneca, Beigene, BlueNote, BMS/Celgene, CareVive, Flatiron, Genentech, GSK, Lilly, Meter Health, Novartis, and Pfizer; speaking related honoraria from AbbVie, Agios, Astellas, BMS/Celgene, and Incyte; equity interest in Dosentrx; research funding from the AbbVie, American Cancer Society, AstraZeneca, BMS, Deverra Therapeutics, Duke University, Jazz Pharmaceuticals, the Leukemia and Lymphoma Society, the National Institute of Nursing Research/ National Institutes of Health, and Seattle Genetics. LMS, JH, SW, KWH, and JDT all declare no conflicts of interest., (Copyright © 2023 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Elranatamab efficacy in the single-arm, registrational MagnetisMM-3 trial (NCT04649359) was compared with that of physician's choice of treatment (PCT) for triple-class refractory multiple myeloma. MagnestisMM-3 eligibility criteria were applied to two USA-based oncology electronic health record databases, COTA and Flatiron Health (FH), to identify cohorts for this study (NCT05932290). Applied statistical techniques accounted for cohort imbalances. MagnetisMM-3 (BCMA-naive; n = 123) outcomes were compared with those from COTA (n = 239) and FH (n = 152). Elranatamab was associated with a significantly higher objective response rate (risk ratios, 1.88-2.25), significantly longer progression-free survival (hazard ratios [HRs], 0.37-0.57), and, across most analyses, significantly longer overall survival (HRs, 0.46-0.66) versus PCT. BCMA-naive patients who were treated with elranatamab exhibited significantly better outcomes than patients treated in real-world clinical practice.