Denileukin diftitox for the treatment of CD25 low-expression mycosis fungoides and Sézary syndrome.
In a placebo-controlled study, denileukin diftitox (DD) was effective against cutaneous T-cell lymphoma (CTCL) expressing CD25. An open-label companion study examined the efficacy and safety of DD in 36 patients with skin biopsies containing < 20% CD25 cells by immunohistochemistry staining (CD25 low expression). Patients received DD 18 μg/kg/day for 5 consecutive days every 3 weeks for up to eight courses. The primary endpoint, overall response rate, was 30.6% (95% confidence interval: 16.3, 48.1), 33.3% for stage IIA or lower disease, and 26.7% for stage IIB or greater disease. Median progression-free survival (PFS) was > 487 days, and median time to treatment failure was 68.5 days. No difference in PFS by disease stage was observed. The safety profile of DD in CD25 low-expression disease was similar to that in CD25+ disease. These findings suggest that CD25 low expression does not preclude a meaningful clinical response to DD in patients with CTCL.
Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia. miles.prince@petermac.org
H Miles
HM
Prince
Ann G
AG
Martin
Elise A
EA
Olsen
David P
DP
Fivenson
Madeleine
M
Duvic
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004167:Diphtheria Toxin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D053645:Interleukin-2 Receptor alpha Subunit / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D009182:Mycosis Fungoides / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012751:Sezary Syndrome / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D004167:Diphtheria Toxin; D007376:Interleukin-2; D053645:Interleukin-2 Receptor alpha Subunit; D011993:Recombinant Fusion Proteins; C078456:denileukin diftitox