{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T02:51:48Z","timestamp":1793242308743,"version":"4.5.0"},"reference-count":31,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2010,4,10]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>\n                      This phase III, placebo-controlled, randomized trial was designed to investigate efficacy and safety of two doses of denileukin diftitox (DD; DAB\n                      <jats:sub>389<\/jats:sub>\n                      \u2013interleukin-2 [IL-2]), a recombinant fusion protein targeting IL-2 receptor\u2013expressing malignant T lymphocytes, in patients with stage IA to III, CD25 assay\u2013positive cutaneous T-cell lymphoma (CTCL), including the mycosis fungoides and S\u00e9zary syndrome forms of the disease, who had received up to three prior therapies. The primary end point was overall response rate (ORR).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>Patients (N = 144) with biopsy-confirmed, CD25 assay\u2013positive CTCL were randomly assigned to DD 9 \u03bcg\/kg\/d (n = 45), DD 18 \u03bcg\/kg\/d (n = 55), or placebo infusions (n = 44), administered for 5 consecutive days every 3 weeks for up to eight cycles. Patients were monitored for drug efficacy, clinical benefit, and safety of DD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>ORR was 44% for all participants treated with DD (n = 100; 10% complete response [CR] and 34% partial response [PR]) compared with 15.9% for placebo-treated patients (2% CR and 13.6% PR). ORR was higher in the 18 \u03bcg\/kg\/d group versus the 9 \u03bcg\/kg\/d group (49.1% v 37.8%, respectively), and both doses were significantly superior to placebo. Progression-free survival (PFS) was significantly longer (median, &gt; 2 years) for both DD doses compared with placebo (median, 124 days; P &lt; .001). Rates of moderately severe and severe adverse events (AEs) were slightly higher in the DD groups, whereas moderate and mild AEs were similar to placebo. No statistical differences were observed for drug-related serious AEs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>DD had a significant and durable effect on ORR and PFS with an acceptable safety profile in patients with early- and late-stage CTCL.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.2009.26.2386","type":"journal-article","created":{"date-parts":[[2010,3,9]],"date-time":"2010-03-09T00:29:26Z","timestamp":1268094566000},"page":"1870-1877","source":"Crossref","is-referenced-by-count":206,"title":["Phase III Placebo-Controlled Trial of Denileukin Diftitox for Patients With Cutaneous T-Cell Lymphoma"],"prefix":"10.1200","volume":"28","author":[{"given":"H. Miles","family":"Prince","sequence":"first","affiliation":[{"name":"From the Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Victoria, Australia; Skin Cancer Center Charit\u00e9, Universit\u00e4tsmedizin, Berlin; Department of Dermatology, HELIOS Klinikum Krefeld, Krefeld, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; Washington University School of Medicine, St Louis, MO; Eisai, Woodcliff Lake, NJ; Memorial Sloan-Kettering Cancer Center, New York, NY; and TransMed Institute, Washington, DC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madeleine","family":"Duvic","sequence":"additional","affiliation":[{"name":"From the Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Victoria, Australia; Skin Cancer Center Charit\u00e9, Universit\u00e4tsmedizin, Berlin; Department of Dermatology, HELIOS Klinikum Krefeld, Krefeld, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; Washington University School of Medicine, St Louis, MO; Eisai, Woodcliff Lake, NJ; Memorial Sloan-Kettering Cancer Center, New York, NY; and TransMed Institute, Washington, DC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann","family":"Martin","sequence":"additional","affiliation":[{"name":"From the Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Victoria, Australia; Skin Cancer Center Charit\u00e9, Universit\u00e4tsmedizin, Berlin; Department of Dermatology, HELIOS Klinikum Krefeld, Krefeld, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; Washington University School of Medicine, St Louis, MO; Eisai, Woodcliff Lake, NJ; Memorial Sloan-Kettering Cancer Center, New York, NY; and TransMed Institute, Washington, DC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wolfram","family":"Sterry","sequence":"additional","affiliation":[{"name":"From the Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Victoria, Australia; Skin Cancer Center Charit\u00e9, Universit\u00e4tsmedizin, Berlin; Department of Dermatology, HELIOS Klinikum Krefeld, Krefeld, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; Washington University School of Medicine, St Louis, MO; Eisai, Woodcliff Lake, NJ; Memorial Sloan-Kettering Cancer Center, New York, NY; and TransMed Institute, Washington, DC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chalid","family":"Assaf","sequence":"additional","affiliation":[{"name":"From the Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Victoria, Australia; Skin Cancer Center Charit\u00e9, Universit\u00e4tsmedizin, Berlin; Department of Dermatology, HELIOS Klinikum Krefeld, Krefeld, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; Washington University School of Medicine, St Louis, MO; Eisai, Woodcliff Lake, NJ; Memorial Sloan-Kettering Cancer Center, New York, NY; and TransMed Institute, Washington, DC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yijun","family":"Sun","sequence":"additional","affiliation":[{"name":"From the Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Victoria, Australia; Skin Cancer Center Charit\u00e9, Universit\u00e4tsmedizin, Berlin; Department of Dermatology, HELIOS Klinikum Krefeld, Krefeld, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; Washington University School of Medicine, St Louis, MO; Eisai, Woodcliff Lake, NJ; Memorial Sloan-Kettering Cancer Center, New York, NY; and TransMed Institute, Washington, DC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Straus","sequence":"additional","affiliation":[{"name":"From the Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Victoria, Australia; Skin Cancer Center Charit\u00e9, Universit\u00e4tsmedizin, Berlin; Department of Dermatology, HELIOS Klinikum Krefeld, Krefeld, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; Washington University School of Medicine, St Louis, MO; Eisai, Woodcliff Lake, NJ; Memorial Sloan-Kettering Cancer Center, New York, NY; and TransMed Institute, Washington, DC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Acosta","sequence":"additional","affiliation":[{"name":"From the Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Victoria, Australia; Skin Cancer Center Charit\u00e9, Universit\u00e4tsmedizin, Berlin; Department of Dermatology, HELIOS Klinikum Krefeld, Krefeld, Germany; The University of Texas M.D. Anderson Cancer Center, Houston, TX; Washington University School of Medicine, St Louis, MO; Eisai, Woodcliff Lake, NJ; Memorial Sloan-Kettering Cancer Center, New York, NY; and TransMed Institute, Washington, DC."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andres","family":"Negro-Vilar","sequence":"additional","affiliation":[{"name":"From the Peter MacCallum Cancer Centre; University of Melbourne, Melbourne, Victoria, Australia; Skin Cancer Center Charit\u00e9, Universit\u00e4tsmedizin, Berlin; Department of Dermatology, HELIOS Klinikum Krefeld, Krefeld, Germany; 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