Multicenter study of pegylated liposomal doxorubicin in patients with cutaneous T‐cell lymphoma

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Abstract
BACKGROUND In single center studies and case reports, it was shown that pegylated liposomal doxorubicin (PEG‐DOXO) was effective as second‐line therapy for patients with cutaneous T‐cell lymphoma (CTCL). The objective of this study was to evaluate the efficacy and toxicity of single‐agent PEG‐DOXO as second‐line chemotherapy in patients with CTCL. METHODS A retrospective, multicenter study was performed evaluating 34 patients (31 male patients and 3 female patients). Twenty‐seven patients received PEG‐DOXO 20 mg/m2, 5 patients received PEG‐DOXO 20–30 mg/m2, and 2 patients received PEG‐DOXO 40 mg/m2. PEG‐DOXO was administered intravenously every 2 weeks in 6 patients, every 2–3 weeks in 4 patients, and every 4 weeks in 23 patients. One patient received only a single course of PEG‐DOXO. Outcomes were evaluated, and adverse effects were recorded. RESULTS Thirty‐four patients received at least 1 cycle of PEG‐DOXO. Disease was classified as mycosis fungoides in 28 patients, mycosis fungoides with follicular mucinosis in 2 patients, small or medium‐sized pleomorphic CTCL in 2 patients, Sèzary syndrome in 1 patient, and CD30 positive CTCL in 1 patient. Fifteen patients achieved a complete response (CR), including patients who achieved a CR and patients who achieved a CR defined by clinical criteria only with no biopsy (CRu), and 15 patients achieved a partial response (PR), resulting in a response rate (CRs, CRus, and PRs) of 88.2%. Two patients dropped out: one patient after a single PEG‐DOXO infusion because of Grade 3 capillary leakage syndrome and one patient after two cycles because of a suicide attempt that was not related to treatment or to CTCL. All other patients received at least four cycles of PEG‐DOXO. Overall survival was 17.8 months ± 10.5 months (n = 33 patients), event‐free survival was 12.0 months ± 9.5 months, and disease‐free survival was 13.3 ± 10.5 months (n = 16 patients). Adverse effects were seen in 14 of 34 patients (41.2%); they were temporary and generally mild. Only 6 patients had Grade 3 or 4 adverse effects. CONCLUSIONS This multicenter study provided evidence of high efficacy of PEG‐DOXO monotherapy with a low rate of severe adverse effects compared with other chemotherapy protocols in patients with CTCL. Cancer 2003;98:993–1001. © 2003 American Cancer Society. DOI 10.1002/cncr.11593