Panobinostat activity in both bexarotene-exposed and -naïve patients with refractory cutaneous T-cell lymphoma: Results of a phase II trial

European Journal of Cancer - Tập 49 - Trang 386-394 - 2013
Madeleine Duvic1, Reinhard Dummer2, Jürgen C. Becker3, Nicolas Poulalhon4, Pablo Ortiz Romero5, Maria Grazia Bernengo6, Celeste Lebbé7, Chalid Assaf8,9, Margaret Squier10, Denise Williams10, Miriam Marshood10, Feng Tai10, H. Miles Prince11
1MD Anderson Cancer Center, Houston, TX, USA
2University Hospital Zurich, Department of Dermatology, Zurich, Switzerland
3Medical University of Graz, Graz, Austria
4Centre hospitalier Lyon Sud, Pierre-Bénite, France
5Instituto i+12 del Hospital 12 de Octubre, Facultad de Medicina, Universidad Complutense, Madrid, Spain
6University of Turin, Department of Biomedical Science and Human Oncology, Turin, Italy
7AP-HP Hôpital Saint-Louis, Department of Dermatology and Center of Clinical Investigation, Université Paris Diderot, Paris, France
8HELIOS Klinikum Krefeld, Department of Dermatology, Krefeld, Germany
9Skin Cancer Center Charité, Department of Dermatology and Allergology, Charité-Universitätsmedizin Berlin, Berlin, Germany
10Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
11Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Australia

Tài liệu tham khảo

Willemze, 2005, WHO–EORTC classification for cutaneous lymphomas, Blood, 105, 3768, 10.1182/blood-2004-09-3502 Jenni, 2011, Primary cutaneous lymphoma: two-decade comparison in a population of 263 cases from a Swiss tertiary referral centre, Br J Dermatol, 164, 1071, 10.1111/j.1365-2133.2010.10143.x Kiessling, 2011, High-throughput mutation profiling of CTCL samples reveals KRAS and NRAS mutations sensitizing tumors toward inhibition of the RAS/RAF/MEK signaling cascade, Blood, 117, 2433, 10.1182/blood-2010-09-305128 Dummer R, Dreyling M; ESMO Guidelines Working Group. Primary cutaneous lymphoma: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 2008;19 (Suppl. 2):ii72–6. Zhang, 2006, Treatment of cutaneous T-cell lymphoma with retinoids, Dermatol Ther, 19, 264, 10.1111/j.1529-8019.2006.00083.x Duvic, 2001, Bexarotene is effective and safe for treatment of refractory advanced-stage cutaneous T-cell lymphoma: multinational phase II–III trial results, J Clin Oncol, 19, 2456, 10.1200/JCO.2001.19.9.2456 Heald, 2003, Topical bexarotene therapy for patients with refractory or persistent early-stage cutaneous T-cell lymphoma: results of the phase III clinical trial, J Am Acad Dermatol, 49, 801, 10.1016/S0190-9622(03)01475-0 Olsen, 2003, Interferon in the treatment of cutaneous T-cell lymphoma, Dermatol Ther, 16, 311, 10.1111/j.1396-0296.2003.01643.x Kaplan, 1990, Phase II study of recombinant human interferon gamma for treatment of cutaneous T-cell lymphoma, J Natl Cancer Inst, 82, 208, 10.1093/jnci/82.3.208 Edelson, 1987, Treatment of cutaneous T-cell lymphoma by extracorporeal photochemotherapy. Preliminary results, N Engl J Med, 316, 297, 10.1056/NEJM198702053160603 Olsen, 2001, Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma, J Clin Oncol, 19, 376, 10.1200/JCO.2001.19.2.376 Prince, 2010, Phase III placebo-controlled trial of denileukin diftitox for patients with cutaneous T-cell lymphoma, J Clin Oncol, 28, 1870, 10.1200/JCO.2009.26.2386 Zackheim, 1996, Low-dose methotrexate to treat erythrodermic cutaneous T-cell lymphoma: results in twenty-nine patients, J Am Acad Dermatol, 34, 626, 10.1016/S0190-9622(96)80062-4 Duvic, 2006, Phase II evaluation of gemcitabine monotherapy for cutaneous T-cell lymphoma, Clin Lymphoma Myeloma, 7, 51, 10.3816/CLM.2006.n.039 Horwitz, 2009, Pralatrexate is active in cutaneous T-cell lymphoma (CTCL): results of a multicenter, dose-finding trial, ASH Annu Meet Abstr, 114, 919 Zinzani, 2007, Phase II trial of proteasome inhibitor bortezomib in patients with relapsed or refractory cutaneous T-cell lymphoma, J Clin Oncol, 25, 4293, 10.1200/JCO.2007.11.4207 Wollina, 2003, Multicenter study of pegylated liposomal doxorubicin in patients with cutaneous T-cell lymphoma, Cancer, 98, 993, 10.1002/cncr.11593 Duvic, 2007, Phase 2 trial of oral vorinostat (suberoylanilide hydroxamic acid, SAHA) for refractory cutaneous T-cell lymphoma (CTCL), Blood, 109, 31, 10.1182/blood-2006-06-025999 Olsen, 2007, Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma, J Clin Oncol, 25, 3109, 10.1200/JCO.2006.10.2434 Whittaker, 2010, Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma, J Clin Oncol, 28, 4485, 10.1200/JCO.2010.28.9066 Piekarz, 2009, Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma, J Clin Oncol, 27, 5410, 10.1200/JCO.2008.21.6150 Atadja, 2009, Development of the pan-DAC inhibitor panobinostat (LBH589): successes and challenges, Cancer Lett, 280, 233, 10.1016/j.canlet.2009.02.019 Prince, 2009, Panobinostat (LBH589): a potent pan-deacetylase inhibitor with promising activity against hematologic and solid tumors, Future Oncol, 5, 601, 10.2217/fon.09.36 Ellis, 2008, Histone deacetylase inhibitor panobinostat induces clinical responses with associated alterations in gene expression profiles in cutaneous T-cell lymphoma, Clin Cancer Res, 14, 4500, 10.1158/1078-0432.CCR-07-4262 Cheson, 1999, Report of an international workshop to standardize response criteria for non-Hodgkin’s lymphomas. NCI sponsored International Working Group, J Clin Oncol, 17, 1244, 10.1200/JCO.1999.17.4.1244 Olsen, 2011, J Clin Oncol, 29, 2598, 10.1200/JCO.2010.32.0630 Tsambiras, 2001, Infectious complications of cutaneous T-cell lymphoma, Cancer Control, 8, 185, 10.1177/107327480100800213 Axelrod, 1992, Infections complicating mycosis fungoides and Sezary syndrome, JAMA, 267, 1354, 10.1001/jama.1992.03480100060031 Dalton, 1997, Cutaneous T-cell lymphoma, Int J Dermatol, 36, 801, 10.1046/j.1365-4362.1997.00329.x Duvic M, Dummer R, Hirawat S, et al. Definition of progressive disease impacts the outcome in cutaneous T-cell lymphoma (CTCL) trials. In: International society for cutaneous lymphomas annual meeting, 2009. Giver, 2011, Rapid recovery from panobinostat (LBH589)-induced thrombocytopenia in mice involves a rebound effect of bone marrow megakaryocytes, Leukemia, 25, 362, 10.1038/leu.2010.262 Bishton, 2011, Deciphering the molecular and biological processes that mediate histone deacetylase inhibitor-induced thrombocytopenia, Blood, 117, 3658, 10.1182/blood-2010-11-318055 Younes, 2012, Panobinostat in patients with relapsed/refractory Hodgkin’s lymphoma after autologous stem-cell transplantation: results of a phase II study, J Clin Oncol, 30, 2197, 10.1200/JCO.2011.38.1350