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

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

Pegylated liposomal doxorubicin in the treatment of primary cutaneous T-cell lymphomas

“…Stage was not found to be significantly associated with PFS. This study confirms previous reports [5][6][7] which demonstrate that PegDoxo is a well tolerated, safe and effective drug in the treatment of advanced and relapsed CTCLs, often refractory to standard therapies. Adverse events were observed in 26% patients, yet grade III-IV in only 11%.…”

“…4 Experience with PegDoxo in this group of patients is encouraging but still limited to studies of single cases of groups of a maximum of 34 patients in the largest series. [5][6][7] This led therefore to the present prospective study on advanced, relapsed and refractory primary CTCLs using Peg-Doxo as single agent. Results are compared with previous experiences with this drug and other chemotherapeutic options reported in literature.…”

EORTC consensus recommendations for the treatment of mycosis fungoides/Sézary syndrome

“…103 Wollina and colleagues evaluated the efficacy of single-agent pegylated liposomal doxorubicin as second-line chemotherapy in patients with CTCL. 122 Of 34 patients treated with pegylated liposomal doxorubicin, 15 achieved a CR and 15 a PR, with an ORR of 88.2%. Overall survival was 17.8 ± 10.5 months, event-free survival was 12 ± 9.5 months and disease-free survival was 13.3 ± 10.5 months.…”

“…Overall survival was 17.8 ± 10.5 months, event-free survival was 12 ± 9.5 months and disease-free survival was 13.3 ± 10.5 months. 122 12.3.2.3. Denileukin diftitox.…”

Cutaneous T‐cell lymphoma: 2011 update on diagnosis, risk‐stratification, and management

“…For example, overall response rates of 58-76% (and 41% complete response rate) have been observed in patients with MF/SS treated with low-dose, oral methotrexate [336][337][338][339]. In contrast, for patients with an adequate performance status, single-agent gemcitabine [340][341][342][343][344], pegylated liposomal doxorubicin [345][346][347][348] and pentostatin [349][350][351][352][353][354][355] are frequently utilized (Table VI). Gemcitabine, a pyrimidine nucleoside analog, is associated with overall and complete response rates of 50-70% and 10-20%, respectively, but is associated with neutropenia and nonhematologic toxicities [356].…”