Clinical Trial of High-Dose Pegylated-Interferon-Alfa-2b Combined With Phototherapy in Advanced Stage Mycosis Fungoides

March 2021 | Volume 20 | Issue 3 | Editorials | 349 | Copyright © March 2021


Published online February 3, 2021

Christina J Walker MDa, Maria L Espinosa BSb, Neha Mehta-Shah MD MSCId, Barbara Pro MDb, Joan Guitart MDa, Timothy Kuzel MDc

aDepartment of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL
bDivision of Hematology/Oncology, Northwestern University Feinberg School of Medicine, Chicago, IL
cDivision of Hematology/Oncology, Rush Medical College, Chicago, IL
dDivision of Oncology, Department of Medicine, Washington University School of Medicine, St. Louis, MO

Abstract
The combination of Interferon-α-2b (IFN-α-2b) and phototherapy is highly effective in treating mycosis fungoides (MF) but side effects often lead to discontinuation of therapy.1
The combination of Interferon-α-2b (IFN-α-2b) and phototherapy is highly effective in treating mycosis fungoides (MF) but side effects often lead to discontinuation of therapy.1 The development of pegylated interferon-α-2b (PEG-IFN-α-2b), a modified interferon with a polyethylene glycol (PEG) chain with 10-fold longer plasma halflife in comparison to IFN-α-2b, showed better tolerability with fewer dose-limiting toxicities than conventional IFN-α-2b. A case report of PEG-IFN-α-2b successfully treating a patient with MF and hepatitis C prompted us to explore the combination of PEG-IFN-α-2b and phototherapy in MF.2 Consistent with this hypothesis, Huesken et al demonstrated high response and increased survival in treatment group with PEG-IFN-α-2b (1.5 μg/kg weekly) plus psoralen with UVA (PUVA) versus IFN-α-2b (9 MIU 3×/week) plus PUVA.3

An open label pilot study was conducted between 2008–2011 in patients with advanced stage MF/SS (stage IIB-IVB) who had ECOG ≤1 and no previous interferon therapy. Five patients with MF [IIB (4/7), IIIB (1/7)] and 2 with Sézary Syndrome (SS) were enrolled with a median age of 58 years (range, 38–79) (Table1). They received PEG-IFN-α-2b at a starting dose of 1.5 μg/kg, administered subcutaneously once weekly with dose escalation up to 9 μg/kg or maximum tolerated dose. PUVA treatment or narrow-band UVB was scheduled three times weekly following the institutional standard protocol. Primary end point was to