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Efficacy and safety of pegylated liposomal doxorubicin in primary cutaneous B-cell lymphomas and comparison with the commonly used therapies

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Abstract Objectives: 

The therapy of advanced, relapsed or refractory primary cutaneous lymphomas is often unsatisfactory. Recent data indicate a favourable pharmacokynetic, pharmacodynamic and toxicity profile of pegylated liposomal doxorubicin (Peg-Doxo) in primary cutaneous T-cell lymphomas, while in primary cutaneous B-cell lymphomas (PCBCLs), the drug efficacy has never been assessed so far. Methods: 

We performed a prospective phase II pilot clinical trial of Peg-Doxo monotherapy (20 mg/m2) in PCBCLs. One patient had a marginal zone B-cell lymphoma and four were affected by diffuse large B-cell lymphoma-leg type, all with widespread nodular lesions. Results: 

All the patients achieved a complete response (CR = 100%) in a short period of time (median 3 months), even when pretreated with radio-chemotherapy. Two experienced a relapse. At follow-up, one patient died for progressive disease; four are in CR after 5, 52, 63 and 69 months. As concerning the toxicity profile, the treatment was well-tolerated, no one decreased or delayed the dose. The haematological toxicity was mild with only one case of grade III neutropenia; a patient showed a grade I neurotoxicity. Dermatological toxicity, in particular the palmar–plantar erythrodysesthesia, did not occurred, probably because of both the low dosages of Peg-Doxo monotherapy and the oral prophylaxis with pyridoxine. Conclusions: 

In spite of the small number of patients, it emerges that monochemotherapy with Peg-Doxo has a significantly high clinical activity and a good safety profile in PCBCLs, even in aggressive forms, compared with other therapeutic regimens, which are completely reviewed. It suggests the need of further investigations in this field.
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Keywords: monochemotherapy; pegylated liposomal doxorubicin; primary cutaneous B-cell lymphomas; primary cutaneous lymphomas

Document Type: Research Article

Affiliations: 1: Clinical Hematology, Department of Hematology, ‘Spirito Santo’ Civic Hospital, Pescara, Italy 2: Clinic of Hematology, Polytechnic University of Marche, Ancona, Italy 3: Institute of Pathology, Polytechnic University of Marche, Ancona, Italy 4: Department of Dermatological Sciences, University of Florence, Florence, Italy 5: Department of Hematology, University of Florence, Florence, Italy 6: Division of Dermatology, Macerata, Italy 7: Division of Internal Medicine, Civitanova Marche, Italy

Publication date: March 1, 2009

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