|The following article features coverage from the American Society of Hematology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
According to results of a study presented at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida, adult patients with hematologic cancers treated with stem cell transplantation (SCT) reported worse quality of life (QoL) at week 2 compared with those treated with chimeric antigen receptor T-cell (CAR-T) therapy.
Approaches to capturing the experiences of patients enrolled in clinical trials include assessments of QoL, as well as patient self-reports of symptomatic adverse events using the patient-reported outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (CTCAE). In addition, the longitudinal “toxicity over time” approach has been used to facilitate an understanding of the trajectory of adverse events in a clinical trial as assessed by PRO-CTCAE.2
This prospective study involved recruitment of 3 cohorts of patients with hematologic cancers: those who were scheduled to receive CAR-T therapy, autologous SCT, or allogeneic SCT.
The primary study end point was longitudinal QoL as evaluated using the Functional Assessment of Cancer Therapy–General (FACT-G) questionnaire, with secondary end points including assessments of memory and cognition using the NeuroQoL v2 questionnaire; symptomatic AEs assessed using a composite PRO-CTCAE score incorporating the frequency, severity, and interference of each assessed symptom; and the “toxicity over time” approach to the assessment of PRO-CTCAEs.
Questionnaires were completed by patients at baseline, 2 weeks, and then once a month for a total of 6 months.
Of the 101 patients enrolled in the study, 27, 37, and 37 underwent treatment with CAR-T therapy, autologous SCT, and allogeneic SCT, respectively. The median patient age ranged from 60 to 62 years, depending on patient treatment group.
At baseline, assessments of QoL, cognition, and performance status were similar in all 3 groups.
A key finding of an interim analysis covering the period up to 3 months following treatment was a statistically significant worsening in overall QoL in the autologous SCT (P =.003) and allogeneic SCT cohorts (P <.001) compared with the CAR-T group at 2 weeks. Although most pronounced at 2 weeks, a significant difference was still evident through month 2 for patients in the allogeneic SCT cohort, but not the autologous SCT cohort, although a gradual return to baseline QoL was observed in both groups.
Cognitive function was significantly worse in the allogeneic SCT group compared with the CAR-T group at 2 weeks only (P =.02), but no significant differences were observed between the autologous SCT and CAR-T groups at any other time point. However, significant differences existed in QoL scores representing physical and functional well-being, as well as performance status, between the CAR-T and allogeneic SCT groups, and these differences persisted at 3 month follow-up.
Regarding PRO-CTCAE, the most common symptomatic adverse events reported by patients were decreased appetite, diarrhea, and fatigue. While the difference in the mean PRO-CTCAE composite scores for these symptoms was not significant when patients in the CAR-T group were compared with those in the autologous SCT group, a comparison of the CAR-T group with the allogeneic SCT group showed significantly higher mean PRO-CTCAE composite scores for the following adverse events in the latter group: mouth or throat sores (30% vs 79%; P <.001); decreased appetite (65% vs 97%; P =.002); diarrhea (48% vs 85%; P =.007); pain (39% vs 91%; P <.001); fatigue (50% vs 91%; P =.001); and sad feelings (23% vs 56%; P =.03).
Toxicity over time analyses of PRO-CTCAE revealed the mean PRO-CTCAE composite scores for mouth sores, fatigue, diarrhea, and decreased appetite were highest at week 2 in all 3 groups, with mouth sores particularly notable at 2 weeks following allogeneic SCT.
In summarizing the results of this study, the presenting study author, Surbhi Sidana, MD, of the Mayo Clinic, mentioned that study limitations included the heterogeneity of the underlying diagnoses of patients included in the study, the use of different CAR-T constructs, as well as some missing data, particularly for patients in the CAR-T cohort.
Disclosure: Some of the authors disclosed financial relationships with the pharmaceutical industry. For a full list of disclosures, please refer to the original abstract.
Read more of Cancer Therapy Advisor‘s coverage of ASH’s annual meeting by visiting the conference page.
- Sidana S, Thanarajasingam G, Griffin J, et al. Patient experience of chimeric antigen receptor (CAR)-T cell therapy vs. stem cell transplant: longitudinal patient reported adverse events, cognition and quality of life. Presented at: 61st American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2019; Orlando, FL. Abstract 794.
- Thanarajasingam G, Atherton PJ, Novotny PJ, et al. Longitudinal adverse event assessment in oncology clinical trials: The Toxicity Over Time (ToxT) analysis of Alliance Trials NCCTG N9741 and 979254. Lancet Oncol. 2016;17:663-670.