Multi-Site Randomized Trial of Integrated Palliative and Oncology Care for Patients with Acute Myeloid Leukemia (AML)
Authors: El-Jawahri Areej , Leblanc Thomas W. , Kavanaugh Alison R. , Webb Jason A. , Jackson Vicki , Campbell Toby , O'Connor Nina R. , Luger Selina M. , Gafford Ellin , Gustin Jillian , Bhatnagar Bhavana , Fathi Amir T. , Hobbs Gabriela S. , Nicholson Showly , Davis Debra , Temel Jennifer S. 
Published: November 2020

Background: Patients with AML receiving intensive chemotherapy experience substantial decline in their quality of life (QOL) and mood during their hospitalization for induction chemotherapy and often receive aggressive care at the end of life (EOL). We sought to examine the effect of integrated palliative and oncology care on QOL, mood, post-traumatic stress (PTSD) symptoms, and EOL outcomes in patients with AML.
Methods: We conducted a multi-center randomized trial of integrated palliative and oncology care (n=86) versus usual oncology care (n=74) for patients with AML undergoing intensive chemotherapy. Patients assigned to the intervention were seen by palliative care clinicians at least twice per week during their hospitalization for induction chemotherapy and all subsequent hospitalizations. Patients completed the Functional Assessment of Cancer Therapy-Leukemia, the Hospital Anxiety and Depression Scale, and the PTSD Checklist to assess their QOL, mood, and PTSD symptoms at baseline, weeks 2, 4, 12, and 24. The primary endpoint was QOL at week-2. We used analysis of covariance and mixed linear effect models, controlling for baseline scores, to assess the effect of the intervention on patient-reported outcomes.
Results: Between 1/2017 and 7/2019, we enrolled 160/235 (68.1%) of eligible patients. Compared to those receiving usual care, intervention patients reported better QOL (107.59 vs. 116.45, P=0.039) and lower depression (7.20 vs. 5.68, P=0.021), anxiety (5.94 vs. 4.53, P=0.018), and PTSD symptoms (31.69 vs. 27.79, P=0.009) at week 2. Intervention effects were sustained up to week 24 for QOL (B=2.35, P=0.048), depression (B=-0.42, P=0.039), anxiety (B=-0.38, P=0.042), and PTSD symptoms (B=-1.43, P=0.002). Among deceased participants, those receiving the intervention were more likely to report discussing their EOL care preferences with their clinicians (75.0% vs. 40.0%, P=0.009) and less likely to receive chemotherapy in the last 30 days of life (34.9% vs. 65.9%, P=0.008). There was no difference in hospice utilization or hospitalization at the EOL.
Conclusion: The integrated palliative and oncology care model for patients with AML receiving intensive chemotherapy led to substantial improvements in patients' QOL, psychological distress, and EOL care. Thus, palliative care should be considered a new standard of care for patients with AML.

Disclosures
Leblanc: UpToDate: Patents & Royalties: Royalties; Agios, AbbVie, and Bristol Myers Squibb/Celgene: Speakers Bureau; American Cancer Society, BMS, Duke University, NINR/NIH, Jazz Pharmaceuticals, Seattle Genetics: Research Funding; AbbVie, Agios, Amgen, AstraZeneca, CareVive, BMS/Celgene, Daiichi-Sankyo, Flatiron, Helsinn, Heron, Otsuka, Medtronic, Pfizer, Seattle Genetics, Welvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Research Funding. Luger:Acceleron: Honoraria; Agios: Honoraria; Loxo Oncology: Honoraria; Onconova: Research Funding; Kura: Research Funding; Hoffman La Roche: Research Funding; Ariad: Research Funding; Biosight: Research Funding; Daiichi-Sankyo: Honoraria; Pfizer: Honoraria; Bristol-Myers Squibb: Honoraria. Bhatnagar:Cell Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Astellas: Membership on an entity's Board of Directors or advisory committees; Pfizer: Membership on an entity's Board of Directors or advisory committees; KITE: Membership on an entity's Board of Directors or advisory committees; KaryoPharm Therapuetics: Research Funding; Novartis: Membership on an entity's Board of Directors or advisory committees. Fathi:TrovaGene: Consultancy; Forty Seven: Consultancy; Pfizer: Consultancy; Amgen: Consultancy; Bristol-Myers Squibb: Consultancy, Research Funding; Blue Print Oncology: Consultancy; Boston Biomedical: Consultancy; Kura: Consultancy; Novartis: Consultancy; NewLink Genetics: Consultancy, Honoraria; Kite: Consultancy, Honoraria; Amphivena: Consultancy, Honoraria; AbbVie: Consultancy; Agios: Consultancy, Research Funding; PTC Therapeutics: Consultancy; Trillium: Consultancy; Takeda: Consultancy; Jazz: Consultancy, Honoraria; Daiichi Sankyo: Consultancy; Celgene: Consultancy, Research Funding; Astellas: Consultancy; Seattle Genetics: Consultancy, Research Funding. Hobbs:Novartis: Honoraria; Bayer: Research Funding; Incyte: Research Funding; Merck: Research Funding; Celgene/BMS: Honoraria; Constellation: Honoraria, Research Funding; Jazz: Honoraria.