Tre-P-17 - Single-center experience of using pegylated liposomal doxorubicin as maintenance therapy in mycosis fungoides

Abstract

Primary cutaneous T-cell lymphomas (CTCL) are characterized by a clonal accumulation of T cells in the skin. Mycosis fungoides (MF) is the most common subtype. Most part of patients has early stage at the time of the diagnosis (70%), and the risk for progression at 5 years is relatively low. However, advanced forms of MF lead to a decrease of the patients 5-year overall survivor. Consequently, more aggressive systemic therapies are needed for a better control of advanced disease. Available treatments usually provide partial responses (PR) of limited duration. Considering the high rates or morbidity and mortality of advanced MF, the need of maintenance strategies seems to be mandatory. Doxorubicin is an anthracycline with antineoplastic activity in patients with non-Hodgkin lymphoma. We report our experience using pegilated-doxorubicin (Caelyx®) as a maintenance strategy for advanced-stage MF, describing 18 patients from our center. 18 patients (12 men, 6 women) with a mean age of 57 years were treated with Caelyx® 20 mg/m². All the patients were previously treated with at least one systemic therapy due to advanced MF. An overall response in skin was achieved in 14 patients (77%): 5 patients presented complete response (CR) and 9 partial responses (PR). Skin disease progression (PD) was observed in 1 patient, and the other 3 patients remained with stable disease (SD). From the 9 patients with nodal involvement, the responses observed were SD (n=4), CR (n=3) and PD (n=2). Blood disease expression was present in 5 patients at doxorubicin initiation (B2): PR was observed in 3 patients, achieving the other two only SD. Only one patient presented M1 stage (pulmonary metastasis), with PR of the lung lesions. No PD was observed in blood or metastatic disease. All the patients received at least 14 cycles of Caelyx® (6 months), ranging from 14 to 37 cycles. The interval between infusions was typically 2 weeks. The mean rates of time to response (TTR), response duration (RD) and time to new treatment (TTNT) were 14.4, 48.5 and 91.7 weeks. The overall survival since doxorubicin initiation was 31.3 months. Lymphopenia was the most common adverse effect (n=8). Doxorubicin discontinuation was made in 15 patients, due to decease (n=1), adverse effects (n=1), PD (n=7), no response (n=1), persistent CR (n=4) and other complications (melanoma progression in one patient). We report our real-world experience with doxorubicin as a maintenance treatment for patients with CTCL. Doxorubicin was well tolerated, with no severe adverse effects except one case of refractory lymphopenia. One patient passed away due to an infectious complication. Moreover, no cardiac adverse effects were observed. OR was better in skin and blood (77% and 66%). Interestingly, 7 patients have been on treatment for more than 1 year. In four of them doxorubicin was finally discontinued. The other 3 patients remain with active treatment and good disease control.