Abstract
Introduction: Patients with early stage Cutaneous T cell Lymphoma (CTCL) usually have a benign and chronic disease course. Refractoriness under skin directed therapies and/or more extensive disease pose some therapeutic changes. Using the combination of psoralen plus ultraviolet A irradiation (PUVA) and low-dose Interferon-α (INF), the principal treatment goal is to keep confined the disease to the skin, preventing disease progression.
Methods: We carry out a prospective data on 87 patients with early stage IA to IIA MF treated with low-dose IFN-α2b and PUVA, enrolled from 1997 to 2010. We collected data regarding clinical characteristics of MF, efficacy and outcome. Subcutaneous IFN-α2b was administered 1.5 MU/day during the first week; in the second week the dose was increased to 3MU/day. PUVA irradiation was started on the 3th week with IFN-α2b 3 MU 3 times weekly until CR, of for a maximum of 2 months. During maintenance therapy, IFN-α2b was scheduled for 3 MU 3 times weekly for 2 months and subsequently 3 MU 2 times weekly for 10 months and PUVA was gradually reduced every 2 months over a period of 12 months. Diagnostic, risk and response assignments were according to EORTC criteria.
Results: Patient characteristics at time diagnosis, staging, response rates and overall outcome are shown in Table 1. Among the 87 patients, overall response rate (ORR) was 97.8% (n=85) and included complete remission (CR) in 70 patients (80.5%), very good partial remission in 5 patients (5.8%) and partial remission (PR) in another 10 (11.5%). The best response to therapy was seen after a median of 5 months (range, 1-30) and the 74.3% of patients who achieved a CR after induction therapy kept the complete response at the last follow up. Among the responders, 40 (47.1%) relapsed with minor event with in median time of 21 months (range, 0-71) and 7(8.2%) relapsed with major event in a median time of 6 months (range, 1-81).
After a median follow up of 207 months (range, 6-295), 25 (28.7) patients died, only 1 for progressive disease. Median overall survival (OS) for our cohort was not reached (95% CI; 235-NR months) and median time to next treatment (TTNT) was 38.5 months (95% CI, 33-46 months). Moreover, disease free survival (DFS) in CR patients was 210 months (95% CI; 200-226 months).
Conclusions: The long follow up of this study verifies our preliminary results and confirms the efficacy of INF-PUVA combination therapy in a real world setting, according conventional (OS and DFS) and emerging (TTNT) clinical endpoints of treatment efficacy.
Figure 1 Figure 1.
Disclosures
No relevant conflicts of interest to declare.
Long-Term Efficacy of Psoralen Plus Ultraviolet a Irradiation and Low-Dose Interferon-Alpha Therapy According to Conventional and Emerging Clinical Endopoints of Early Stage Cutaneous T Cell Lymphoma