Mycosis Fungoides and Sézary Syndrome, Subtypes of Cutaneous T-Cell Lymphoma, Compromise Health-Related Quality of Life in Patients

Author(s):

Luke Halpern, Assistant Editor

Key Takeaways

HRQL is notably compromised in advanced MF and SS, impacting treatment decisions and patient goals.
Mogamulizumab showed superior HRQL improvements over vorinostat in the MAVORIC study, especially for severe symptom burden.
Skindex-29, ItchyQol, and FACT-G assessments revealed significant HRQL impairments, notably in females, younger individuals, and Black patients.
Incorporating HRQL measures in clinical research and routine care is crucial for managing MF/SS effectively.

Comprising most cases of this rare form of lymphoma, it is essential that pharmacists and treatment providers are aware of the health-related burdens patients with these subtypes consistently face.

Health-related quality of life (HRQL) was generally compromised in patients with symptoms of advanced mycosis fungoides (MF) and sézary syndrome (SS), common subtypes of cutaneous T-cell lymphoma (CTCL), indicating that choice of therapy and patient treatment goals should be guided by an individual’s disease burden.¹

It is important to note the burdens that patients with lymphoma face due to their symptoms or treatment. | Image Credit: © Dr_Microbe | stock.adobe.com

Often, patients are saddled with the burdens associated with MF/SS for many years as they battle the disease. CTCL presents itself as plaques, patches, or tumors, and can be associated with severe pruritus and visible lesions. This significant symptom burden can impact HRQL, defined as a patient’s subjective perception of the impact of disease and treatment on daily life.¹

In the phase 3 MAVORIC study (NCT01728805), researchers analyzed the efficacy of mogamulizumab, an anti-CCR4 monoclonal antibody, compared with vorinostat in patients with relapsed or refractory MF or SS. Positive results regarding mogamulizumab were reported in 2018, with the treatment being associated in greater improvements in HRQL at 6 months. Furthermore, patients with the greatest symptom burden and impairment had the largest improvements in HRQL.^2,3

Although the reported data were positive, the analysis focused on the impact of treatment on HRQL, rather than the HRQL themselves. Based on pre-treatment MAVORIC data and the large, well-defined cohort of patients available, the investigators aimed to develop a greater understanding of HRQL and describe the burden these patients consistently face.^1,2

Three HRQL instruments were included in the MAVORIC study to evaluate the data. Skindex-29 was used to evaluate the effect of skin disease on HRQL over the prior 4 weeks, ItchyQol measures the impact of pruritus on HRQL over the previous week, and FACT-G measures HRQL for individuals with cancer.¹

Regarding Skindex-29 responses, all items had subjects reporting the greatest level of impairment. For 6 items, over half of the respondents reported response options of “often” or “all the time.” The items included worry that their skin condition may worsen, worry that their skin condition may be serious, and general skin itches. Interestingly, worsen Skindex-29-associated HRQL was more often found in females and younger individuals.¹

Data regarding baseline ItchyQol were available for 369 subjects. Impairment was seen across all domains, with the greatest impact observed on functioning. All items in the questionnaire had subjects report the highest level of impairment. Some items included “need to scratch skin,” “skin affects how well I sleep,” “frustrated by skin,” and others. Once more, being female and younger age were associated with worse ItchyQol HRQL, in addition to race—there were worse scores for Black patients, according to the study authors.¹

About the Trial

Trial Name: Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL

ClinicalTrials.gov ID: NCT01728805

Sponsor: Kyowa Kirin, Inc.

Completion Date: February 17, 2021

Lastly, FACT-G data were examined. Compared with the general population in the United States, impairment was seen across all domains and total scores, the investigators reported. The greatest impact of MF/SS was seen in the functional and emotional well-being domains. Some items that individuals reported concerns around included satisfaction with sex life, sleeping well, and worry that the condition was getting worse.¹

Some limitations of the analysis were reported. Patients previously treated for their MF or SS that had failed to respond to at least 1 systemic therapy were the focus of the analysis, which makes the findings not generalizable to earlier disease. Additionally, the HRQL questionnaires have not been validated specifically for patients with CTCL.¹

Important differences in HRQL based on age, race, and sex were identified. “Awareness of these differences will be important to inform decision-making and the management of MF/SS,” the study authors wrote.¹

“The authors call for HRQL measures to be incorporated into both clinical research (including clinical trials) and routine care for patients living with MF/SS.”¹

REFERENCES

1. Ortiz Romero PL, Kim YH, Molloy K, et al. Health-related quality of life in cutaneous T-cell lymphoma: A post hoc analysis of a phase 3 trial in mycosis fungoides and Sézary syndrome. J Eur Acad Dermatol Venereol. 2024;00:1-13. doi:10.1111/jdv.20357

2. Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): An international, open-label, randomized, controlled phase 3 trial. Lancet. 2018;19(9):1192-1204. doi:10.1016/S1470-2045(18)30379-6

3. ClinicalTrials.gov. Study of KW-0761 versus vorinostat in relapsed/refractory CTCL. National Library of Medicine. Last updated April 25, 2024. Accessed October 18, 2024.