Clinical Outcomes of Single-Agent Chemotherapy in a Diverse Cohort of Patients with Recalcitrant Cutaneous T-Cell Lymphoma

Introduction: Pegylated liposomal doxorubicin and gemcitabine are frequently used as single agent chemotherapies for advanced cutaneous T-cell lymphoma (CTCL). Initial small clinical trials on these chemotherapies were conducted 1-2 decades ago, and there is limited updated data on their real-world efficacy. This study examines the efficacy and tolerability of these chemotherapies in a large and diverse cohort of patients with CTCL.

Objectives: Evaluate the safety and efficacy of doxorubicin and gemcitabine as single-agent chemotherapy for CTCL.

Methods: Patients with confirmed CTCL who were treated with single-agent doxorubicin or gemcitabine at Johns Hopkins Hospital from January 1st, 2011 to June 1st, 2022 were identified by retrospective chart review. Response to treatment was evaluated with the criteria from the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organization for Research and Treatment of Cancer. Adverse events were graded with the Common Terminology Criteria for Adverse Events version 5.0.

Results: Of 508 total patients, 28 were treated with doxorubicin (stage IB-IVB at treatment start) and 12 were treated with gemcitabine (stage IB-IVA at treatment start). Overall response rates were 41.4% (n=12) for doxorubicin and 27.3% (n=3) for gemcitabine. There was no difference in response rate between Black and White patients for either chemotherapy (doxorubicin: 40% vs. 46.2%, p=1; gemcitabine: 25% vs. 28.6%, p=1). Patients received a median of 3 systemic treatments (range 0-6) prior to doxorubicin and 3 (range 1-8) prior to gemcitabine. Overall survival was 51.7% (n=15) for doxorubicin and 41.7% (n=5) for gemcitabine. Median follow-up time was 15.9 months for doxorubicin and 8.8 months for gemcitabine. Median time to next treatment was 6.9 months for doxorubicin and 3.7 months for gemcitabine.

The most common toxicities for doxorubicin were fatigue (n=13), peripheral edema (n=8), anemia (n=6) and hand-foot syndrome (n=4). Only one patient developed heart failure. Two patients had sepsis due to skin infection. Higher doses of gemcitabine were associated with more grade 3 adverse events (p=0.04). The most common toxicities for gemcitabine were neutropenia (n=3) and anemia (n=2). One patient developed pneumonia and a heart failure exacerbation after the first dose of gemcitabine, which was discontinued.

Conclusion: To our knowledge, this study includes the largest cohort of Black patients with CTCL who received single agent chemotherapy at a tertiary cancer center. Our findings demonstrate the tolerability of single-agent chemotherapy in this patient population. The overall response rates were lower than the early clinical trials, and we are investigating outcome-related clinical characteristics in this cohort. These observations should be further investigated through multicenter studies of diverse cohorts of patients.

No relevant conflicts of interest to declare.

Pegylated liposomal doxorubicin for cutaneous T-Cell lymphoma