The efficacy of combination bexarotene and photochemotherapy for Japanese patients with cutaneous T-cell lymphoma (CTCL) was supported by study data published in the Journal of Dermatology. Although international treatment guidelines recommend combination bexarotene and photochemotherapy for TCTL, they were developed based on European patient data. This study represents the first effort to assess safety and efficacy in Japanese patients.
Investigators conducted a 24-week, single-arm, confirmatory, open-label clinical study of adult (≥20 years) patients with CTCL. Study treatment was administered at 2 sites: Nagoya City University and Osaka City University. Bexarotene was administered orally once daily after meals at a dose of 300 mg/m2 body surface area. After bexarotene dose, patients received 1 of 2 types of ultraviolet (UV) irradiation: bath-psoralen plus UV-A (PUVA) or narrowband UV-B. Irradiation dosing was gradually increased at each session at the discretion of study investigators. Treatment response was evaluated using the Severity-Weighted Assessment Tool (mSWAT) and the Physical Assessment of Clinical Condition (PGA) at weeks 1, 2, 3, 4, 8, 12, and 24. Serum blood samples were taken to assess changes in CTCL biomarkers, including thymus and activation-regulated chemokine (TARC). Adverse events were monitored throughout the trial.
A total of 25 patients completed 24 weeks of study treatment. Mean age was 69.1 ± 13.2 years, and 14 patients (56.0%) were women. At baseline, disease stage was IA to IB in 12 patients (48.0%), IIA or higher in 12 patients (48.0%), and unable to be assessed in 1 patient (4.0%). By week 24, overall response rate was 80.0% per mSWAT criteria and 84.0% per PGA criteria. Time to mSWAT response was 20.7 ± 9.62 days; mean duration of response was 117 ± 43.0 days; and mean time to stage progression was 163.6 ± 28.8 days. Overall response rate, time to response, duration of response, and time to disease progression did not differ significantly by disease stage. Biomarker analyses revealed significant reductions in TARC values from baseline to weeks 12 (P =.004) and 24 (P =.001). Adverse events occurred with high incidence, with a total of 151 reported across all patients. The most commonly observed adverse events were triglyceridemia, hypothyroidism, neutropenia, hypocholesterolemia, anemia, and nasopharyngitis and burns. Severe adverse events included sepsis (n=1), anemia (n=1), congestive cardiac insufficiency (n=1), pyrexia (n=1), and fracture around an artificial joint (n=1).
In line with existing international guidelines, these data support the efficacy of combination bexarotene and PUVA therapy for CTCL.
Disclosure: This research was funded by Minophagen Pharmaceutical, Tokyo, Japan.
Please see the original reference for a full list of authors’ disclosures.
Morita A, Tateishi C, Muramatsu S, et al. Efficacy and safety of bexarotene combined with photo (chemo)therapy for cutaneous T-cell lymphoma [published online March 18, 2020]. J Dermatol. doi: 10.1111/1346-8138.15310