Case series of cutaneous T‐cell lymphomas treated with bexarotene‐based therapy

Abstract

Bexarotene is useful for both early and advanced cutaneous T-cell lymphoma (CTCL), and is sometimes applied to ultraviolet-tolerant early CTCL patients as one of the first-line therapies in the real world. However, continuous administration of bexarotene is sometimes difficult because of its adverse events (AE). Development of an appropriate protocol for bexarotene that can induce a consistent response for CTCL without severe AE (SAE) is needed. We retrospectively investigated 29 Japanese cases of CTCL and evaluated the efficacy of treatment and incident ratios of all AE and SAE. Objective response rate (ORR) for the overall cohort was 65.5%. ORR of the 300 mg/m 2 cohort (conventional dose) was 76.2%, while that of the 150-300 mg/body (low dose) with narrowband ultraviolet B light (NBUVB) cohort was 37.5%. Mean event-free survival was 10.0 months for all patients, 6.7 months for the bexarotene conventional-dose cohort and 19.1 months for the low-dose with NBUVB cohort. The incident ratio of total SAE for all patients was 20.7%. The incident ratio of total SAE was 23.8% for the conventional-dose cohort and 12.5% for the low-dose with NBUVB cohort. Our present study suggests that low-dose bexarotene plus NBUVB therapy is well-tolerated and could be one of the optimal therapies for advanced CTCL.

Safety and efficacy of bexarotene for Japanese patients with cutaneous T‐cell lymphoma: Real‐world experience from post‐marketing surveillance

“…SAE (grade 3 and 4) developed in 23.8% of the regular‐dose cohort and 12.5% of the low‐dose cohort. Mean event‐free survival of the low‐dose cohort was prolonged compared with the regular‐dose cohort (19.1 months [95% CI, 8.7–29.5] vs. 6.7 months [95% CI, 3.6–9.7]) 16 . Consequently, these results suggest that a combination of low‐dose bexarotene plus NBUVB therapy provides a promising therapeutic option for safety reasons 16 …”

Comparison of the Efficacy and Safety of Bexarotene and Photo(Chemo)Therapy Combination Therapy and Bexarotene Monotherapy for Cutaneous T-Cell Lymphoma

“…The subjects in this study had a high proportion of early-stage MF and high response rates by mSWAT and PGA evaluation after 8 weeks, suggesting that early diagnosis and early treatment are necessary for CTCL treatment. A case series study performed by Fujimura et al indicated that a low initial dose of bexarotene (150-300 mg/body) combined with narrowband UVB could be an optimal treatment for advanced-stage CTCL [18]. These findings The results of the mSWAT and PGA evaluations after 8 weeks did not differ significantly between the two groups.…”

Topical and Systemic Formulation Options for Cutaneous T Cell Lymphomas

“…The incidences of SAEs ranged from 20.7 to 25.0% [54,63]. Overall, bexarotene is effective and well-tolerated for the treatment of patients with early-and advanced-stage CTCLs [54,60,62,63].…”

“…The most frequent drug-related AEs were hypothyroidism (93.8-96.6%), hyperlipidemia (81.3-93.1%), and leukopenia (31.0-68.8%) [11,62]. The incidences of SAEs ranged from 20.7 to 25.0% [54,63]. Overall, bexarotene is effective and well-tolerated for the treatment of patients with early-and advanced-stage CTCLs [54,60,62,63].…”

“…Among these reagents, IFN and bexarotene recently have been investigated for their immunomodulatory effects on the CTCL tumor microenvironment [12,28,[47][48][49]. These reports suggest the possible utility of combination therapies for CTCL, such as IFN-α2a in combination with psoralen with ultraviolet light A (PUVA), low-dose methotrexate, or retinoid [50][51][52], or bexarotene plus phototherapy [53,54]. Preclinical findings suggest that more immunomodulatory reagent-based combination therapies will be established in the future.…”