| Autor: |
Mitsunaga, Keila, Bagot, Martine, Ram-Wolff, Caroline, Guenova, Emmanuella, Gugelberg, Christina von, Hodak, Emmilia, Amitay-Laish, Iris, Papadavid, Evangelia, Jonak, Constanze, Porkert, Stefanie, Scarisbrick, Julia, Applewaite, Rona, Beylot-Barry, Marie, Nicolay, Jan, Quaglino, Pietro, Sanches, José Antonio, Cury-Martins, Jade, Lora-Pablos, David, Ortiz, Pablo |
| Předmět: |
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| Zdroj: |
British Journal of Dermatology; Sep2024, Vol. 191 Issue 3, p419-427, 9p |
| Abstrakt: |
Background Mycosis fungoides (MF) and Sézary syndrome (SS) are chronic malignant diseases that typically necessitate diverse strategies to achieve remission. Systemic interferon (IFN)-α (subtypes 2a and 2b) has been used to treat MF/SS since 1984; however, its production was recently stopped. The recombinant pegylated (PEG) form of IFN-α-2a remains the only alternative IFN treatment, although it has not been approved for use in MF/SS. Objectives To assess the effectiveness and safety of PEG-IFN-α-2a in monotherapy and in combination with other treatments using time to next treatment (TTNT) as a measure of clinical therapeutic benefit in a real-world setting. Methods We conducted an international, multicentre retrospective study of patients with MF and SS (of any stage) treated with PEG-IFN-α-2a from July 2012 to February 2022. Patients were included across 11 centres in 10 countries. The primary endpoints were to determine the TTNT of PEG-IFN-α-2a and adverse events (AEs) in MF/SS. Results In total, 105 patients were included [mean (SD) age 61 (13.1) years]; 42 (40.0%) had stage IA–IIA and 63 (60.0%) had stage IIB–IVB disease. PEG-IFN-α-2a was combined with other therapies in 67 (63.8%) patients, most commonly with extracorporeal photopheresis (36%) and bexarotene (22%). Patients with stage I–IIA disease achieved an overall response rate (ORR) of 57%; the ORR in those with stage IIB–IVB disease was 51%. Combination treatment resulted in a median TTNT of 10.4 months (range 0.6–50.7) vs. 7.0 months (range 0.7–52.4) for those who received monotherapy (P < 0.01). Overall, the mean (SD) TTNT was 9.2 (10.6) months and the ORR was 53.3% (n = 56). A complete response was seen in 13% of patients and a partial response in 40%. AEs were described in 68.6% (n = 72) of patients. Flu-like symptoms (n = 28; 26.7%), lymphopenia (n = 24; 22.9%) and elevated liver function (n = 10; 9.5%) were the most frequently reported. Grade 3–4 AEs were reported in 23 (21.9%) patients, mostly related to myelosuppression. Conclusions PEG-IFN-α-2a for MF/SS resulted in an ORR of 53.3% and a mean (SD) TTNT of 9.2 (10.6) months. Combination regimens were superior to monotherapy and doses of 180 µg PEG-IFN-α-2a weekly were related to a higher ORR. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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