Alemtuzumab in Patients with Advanced Mycosis Fungoids: First Interim Report.

Objectives: Alemtuzumab (Campath®/Mabcampath®, a humanized anti-CD52 monoclonal antibody) has shown to be effective in the treatment of diverse hematological malignancies, including B-cell chronic lymphocytic leukemia and T-cell prolymphocytic leukemia. Mycosis fungoids (MF) is a low grade T-cell cutaneous lymphoma with indolent course and good prognosis while response to chemotherapy is achieved. We started a prospective phase II study in refractory relapse MF cases (advanced disease) treated with i.v. Alemtuzumab (ClinicalTrial.gov Identifier: NCT 00157274)

Methods: From July 2005 to April 2006 a total of eight patients were recruited from 2 centers in Lima-Perú with hystopathological diagnosed of advanced refractory relapse MF. Inclusion criteria include: above 18 years old, ECOG status 0–2, no active infections, no more than 3 previous chemotherapy or radiotherapy, HTLV-1 negative, HIV negative, normal renal or hepatic function and written informed consent. Median age 64 years old (range: 36–72). Five were male. Median number of previous therapies was 2 (range: 2–3). Original treatment scheduled was planed as Alemtuzumab 30 mg i.v. tiw per 12 weeks with a gradually escalated doses during the first week (3, 10, 30 mg). Trimethoprim/sulphamethoxazole and acyclovir prophylaxis was given as regular. Median Alemtuzumab total dose was 283 mg (range: 123–706) over a median of 5 weeks of treatment (range: 3–15). The first four patients (pts.) received the programmed dosification and due toxicity the subsequent 2 pts. received Alemtuzumab 30 mg i.v. tiw for 4 weeks and then 30 mg i.v. weekly and the last 2 recruited pts. received Alemtuzumab 10 mg i.v. tiw for 4 weeks them 10 mg i.v. biw and finally 10 mg i.v. weekly. CMV monitoring with pp65 was performed in the first five pts. and qualitative PCR in the last 3 pts.

Results: Seven patients were evaluated for response, overall response rate (ORR) was 57% (4/7), with two pts. achieving complete remission (CR), two pts. with partial response (PR) and three pts. progressive disease (PD) during treatment. Response duration and follow-up and CMV status is described in table 1. Median Pruritus Analogue Scale was reduced from 4 to 1. Grade 1 neutropenia in one pt. and grade 1 thrombocytopenia in one pt. One patient developed urosepsis caused by E. Coli. No cardiac toxicity was reported. Kaposi’s sarcoma was discovered in a CR pt. (pt 4, table 1)

Conclusions: Alemtuzumab shows promising clinical activity in patients with advanced MF previously treated. Alemtuzumab s.c. as maintenance therapy or in combination with other agents should be explored in advanced MF.