Patient-Reported Symptom and Functioning Status during the First 12 Months after Chimeric Antigen Receptor T Cell Therapy for Hematologic Malignancies.

Chimeric antigen receptor (CAR) T cell therapy is being increasingly used to treat patients with advanced hematologic malignancies; however, the symptoms related to standard of care CAR T cell therapy during the first year after treatment have not been assessed using patient-reported outcome (PRO) measurements. This study aimed to quantify patients' perspectives of symptom burden and functional status using PROs during the first year after CAR T cell therapy for hematologic malignancies, especially in patients who experienced grade 2-4 toxicities. Sixty patients were enrolled in this observational cross-sectional study at any time during their first 12 months post-treatment. All 60 had received CAR T cell therapy as standard of care at MD Anderson Cancer Center in 2019. PROs were measured using the MD Anderson Symptom Inventory (MDASI), the PROs Measurement Information System 29 (PROMIS-29), the global health tool EQ5D-5L, and the single-item health-related quality of life scale (HRQoL). Twenty-two additional symptoms related to CAR T cell therapy, as identified by an expert panel, were also evaluated. CAR T cell therapy-related toxicities were rated according to the ASTCT consensus grading criteria. The majority of patients (52 of 60; 87%) received axicabtagene ciloleucel (Yescarta). One-third of the patients developed grade 2-4 cytokine release syndrome or neurotoxicity. The first 90 days after infusion represented the most symptomatic period, in which >10% of patients rated 18 symptoms as severe (ie, MDASI symptom score of 7 to 10 on scale of 0 to 10), strongly indicating the need for effective symptom management. Physical functioning, measured by interference on the "general activity" item on the MDASI and this domain on the PROMIS-29, were significantly worse in patients who underwent therapy during the first 30 days compared with those who underwent therapy over 90 days (all P < .05 with the Hochberg step-up procedure), whereas the EQ5D-5L and single-item HRQoL did not detect such differences. Compared with patients who had mild cytokine release syndrome or neurotoxicity (grade 0-1), patients who developed grade 2-4 toxicities persistently reported multiple severe symptoms after 30 days following therapy (all P < .05). Furthermore, although using a different recall period, patient-reported scores on several PROMIS-29 domains were significantly correlated with the scores of corresponding MDASI symptom items. This real-world quantitative PRO symptoms study provides evidence of unique profiles of the physical, psychological, and cognitive symptom burden in patients undergoing CAR T cell therapy that varies within the first year after infusion and demonstrates differences among PRO measurement scales. These results support the need for validation of fit-for-purpose PRO measurements for routinely monitoring symptom and toxicity burdens in CAR T cell therapy care settings.

Affective tone in medical encounters and its relationship with treatment adherence in a multiethnic cohort of patients with rheumatoid arthritis.

BACKGROUND: Tone of voice in communication between patients and rheumatologists may offer insight into problems of treatment adherence in patients with rheumatoid arthritis. OBJECTIVE: The aim of this study was to evaluate physician-patient affective vocal tone within the medical encounter and its relationship to treatment adherence in ethnically diverse patients with rheumatoid arthritis. METHODS: The consultations of 174 patients with rheumatoid arthritis were audio recorded at a baseline visit. Of these, 135 completed follow-up adherence measures at 3 months. The positive and negative affective tones of patients, physicians, and interpreters (and distressed tones of patients and interpreters) were assessed using the Roter Interaction Analysis System affective communication scale. Treatment adherence was evaluated at baseline and at 3 months using the Compliance Questionnaire Rheumatology. RESULTS: A total of 117 baseline consultations were in English (n = 42, 36, and 39 white, African American, and Hispanic patients, respectively), 24 in Spanish, and 33 with an interpreter (total = 174). Patients reporting poorer adherence were rated as having more distressed affect and less positive affect than patients reporting greater adherence. Physicians expressed more positive affect to more educated patients. Physicians and patients reciprocated one another's positive and negative affect. Controlling for baseline adherence, physician negative affect predicted greater adherence at 3 months for Hispanic patients, regardless of language choice, compared with white patients. CONCLUSIONS: Patients' affective tones offer clues to problems patients may have with treatment adherence and well-being. More research is needed regarding why physicians' expression of negative affect may facilitate adherence for some groups of patients.