Originally published as JCO Early Release 10.1200/JCO.2007.11.4207 on August 20 2007

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Phase II Trial of Proteasome Inhibitor Bortezomib in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma

Pier Luigi Zinzani, Gerardo Musuraca, Monica Tani, Vittorio Stefoni, Enrica Marchi, Mariapaola Fina, Cinzia Pellegrini, Lapo Alinari, Enrico Derenzini, Antonio de Vivo, Elena Sabattini, Stefano Pileri, Michele Baccarani

From the Institute of Hematology and Medical Oncology "L. & A. Seràgnoli", University of Bologna, Bologna, Italy

Address reprint requests to Pier Luigi Zinzani, MD, Institute of Hematology and Oncology "L. & A. Seràgnoli", Via Massarenti 9, 40138 Bologna, Italy; e-mail: plzinzo{at}med.unibo.it

Purpose: To determine the antitumor activity of the proteasome inhibitor bortezomib in patients with cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma unspecified (PTCLU) with isolated skin involvement.

Patients and Methods: From May 2005 to June 2006 at our institute, we treated patients with previously pretreated CTCL or PTCLU using bortezomib as a single agent, at a dose of 1.3 mg/m² intravenously on days 1, 4, 8, and 11, every 21 days for a total of six cycles.

Results: Fifteen patients were registered, of whom 12 (10 CTCL, all mycosis fungoides, and two PTCLU with isolated skin involvement) were assessable. The overall response rate was 67%, with two (17%) complete remissions and six (50%) partial remissions. The remaining four patients had disease progression. Histologically, the responder patients were seven with CTCL and one with PTCLU with isolated skin involvement. All responses were durable, lasting from 7 to 14 or more months. Overall, the drug was well tolerated, with no grade 4 toxicity. The most common grade 3 toxicities were neutropenia (n = 2), thrombocytopenia (n = 2), and sensory neuropathy (n = 2).

Conclusion: This study suggests that bortezomib was well tolerated and has significant single-agent activity in patients with cutaneous T-cell lymphoma.

published online ahead of print at www.jco.org on August 20, 2007.

Supported in part by Sezione di Bologna dell’Associazione Italiana contro le leucemie, linformi e mieloma (BolognAIL).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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