Journal of Clinical Oncology, Vol 10, 1907-1913, Copyright © 1992 by American Society of Clinical Oncology
Phase II study of pentostatin and intermittent high-dose recombinant interferon alfa-2a in advanced mycosis fungoides/Sezary syndrome
FM Foss, DC Ihde, DL Breneman, RM Phelps, AB Fischmann, GP Schechter, I Linnoila, JC Breneman, JD Cotelingam and BC Ghosh
National Cancer Institute, National Institutes of Health, Bethesda, MD.
PURPOSE: This phase II study was undertaken to assess the efficacy and
toxicity of alternating administration of pentostatin (deoxycoformycin
[DCF]) and interferon alfa-2a (IFN) in patients with advanced or refractory
mycosis fungoides (MF) or the Sezary syndrome (SS). PATIENTS AND METHODS:
Forty-one patients underwent therapy with alternating cycles of DCF 4 mg/m2
intravenously (IV) days 1 through 3 and IFN 10 million U/m2 intramuscularly
(IM) day 22, and 50 million U/m2 intramuscularly (IM) days 23 through 26.
Twenty-nine patients had not responded to prior chemotherapy or total-skin
electron-beam irradiation (TSEB), six had not responded to topical
therapies, and six had no previous treatment. RESULTS: Two patients
achieved a complete response (CR) and 15 achieved a partial response (PR),
for an overall response rate of 41% (95% confidence interval, 26% to 58%).
No responses were observed in the seven patients with visceral involvement.
The median progression-free survival of patients who responded was 13.1
months. IFN-related constitutional symptoms were reported in 39% of
patients; severe toxicities included cardiomyopathy in one patient, acute
and chronic pulmonary dysfunction in four, and reversible mental status
changes in two. Seven patients developed herpes zoster during therapy and
six had staphylococcal bacteremia. CONCLUSION: These results suggest that
the combination of DCF and IFN is an active regimen in MF patients without
visceral involvement.