Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Dummer, R; Quaglino, P; Becker, JC; Hasan, B; Karrasch, M; Whittaker, S; Morris, S; Weichenthal, M; Stadler, R; Bagot, M; Cozzio, A; Bernengo, MG; Knobler, R; .
Prospective International Multicenter Phase II Trial of Intravenous Pegylated Liposomal Doxorubicin Monochemotherapy in Patients With Stage IIB, IVA, or IVB Advanced Mycosis Fungoides: Final Results From EORTC 21012.
J CLIN ONCOL. 2012; 30(33): 4091-4097.
Doi: 10.1200/JCO.2011.39.8065
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- Co-Autor*innen der Med Uni Graz
- Becker Jürgen Christian
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- Abstract:
- Purpose Mycosis fungoides (MF) is the most common primary cutaneous T-cell lymphoma. There is a need for multicenter trials involving defined patient populations using rigorous assessment criteria. We have investigated pegylated liposomal doxorubicin (PLD) in a clearly defined patient population with advanced MF. Patients and Methods Eligible patients had stage IIB, IVA, or IVB MF, refractory or recurrent after at least two previous systemic therapies. Patients were registered to receive a maximum of six cycles of PLD 20 mg/m(2) on days 1 and 15, every 28 days (one cycle). The primary end point was response rate (RR). Results Nine centers recruited 49 eligible patients. The median number of chemotherapy cycles received was five. There were no grade 3 to 4 hematologic toxicities. Grade 3 or 4 nonhematologic/nonbiochemical toxicities included cardiac symptom (2%), allergy/hypersensitivity (2%), constitutional symptom (4%), hand and foot reaction (2%), other dermatologic toxicity (6%), other GI toxicity (4%), infection (4%), pulmonary embolism (2%), and cardiac ischemia (2%). Of 49 patients, 20 (40.8%) were responders (complete clinical response [CCR] or partial response [PR] as overall response): three (6.1%) experienced CCRs, and 17 (34.7%) experienced PRs. A 50% or greater reduction of cutaneous manifestations was observed in 26 (60.5%) of 43 assessable patients. Two early deaths were reported, resulting from related cardiovascular toxicity and disease progression. The lower limit of the one-sided 90% CI for RR was 31.2%. Median time to progression and median duration of response were 7.4 and 6 months, respectively. Conclusion PLD has an acceptable safety profile in patients with advanced MF. The efficacy of PLD seems promising.
- Find related publications in this database (using NLM MeSH Indexing)
- Administration, Intravenous -
- Adult -
- Aged -
- Aged, 80 and over -
- Dose-Response Relationship, Drug -
- Doxorubicin - administration & dosage
- Humans -
- Middle Aged -
- Mycosis Fungoides - drug therapy
- Neoplasm Staging -
- Polyethylene Glycols - administration & dosage
- Prospective Studies -
- Remission Induction -
- Skin Neoplasms - drug therapy
- Treatment Outcome -