Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy

Journal of Clinical Oncology

Volumn 30, Issue 6, 2012, Pages 631-636

  Coiffier, Bertrand ^a   Pro, Barbara ^c   Prince, H Miles ^d,e   Foss, Francine ^g   Sokol, Lubomir ^h   Greenwood, Matthew ^f   Caballero, Dolores ⁱ   Borchmann, Peter ^j   Morschhauser, Franck ^b   Wilhelm, Martin ^k   Pinter Brown, Lauren ^l   Padmanabhan, Swaminathan ^m   Shustov, Andrei ⁿ   Nichols, Jean ^o   Carroll, Susan ^o   Balser, John ^p   Balser, Barbara ^p   Horwitz, Steven ^q  

^a HOSPICES CIVILS DE LYON   (France)

^b LILLE UNIVERSITY HOSPITAL   (France)

^c FOX CHASE CANCER CENTER   (United States)

^d PETER MACCALLUM CANCER CENTRE   (Australia)

^e UNIVERSITY OF MELBOURNE   (Australia)

^f ROYAL NORTH SHORE HOSPITAL   (Australia)

^g YALE CANCER CENTER   (United States)

^h H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

ⁱ HOSPITAL UNIVERSITARIO DE SALAMANCA   (Spain)

^j UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

^k KLINIKUM NÜRNBERG   (Germany)

^l UCLA MEDICAL CENTER   (United States)

^m UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

ⁿ UNIVERSITY OF WASHINGTON   (United States)

^o Celgene   (United States)

^p Veristat   (United States)

^q MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ROMIDEPSIN;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; ASTHENIA; CANCER RELAPSE; CHILL; CONSTIPATION; COUGHING; DIARRHEA; DISEASE COURSE; DRUG EFFICACY; DRUG FEVER; DRUG SAFETY; DYSGEUSIA; FATIGUE; FEMALE; FOLLOW UP; HEADACHE; HUMAN; HYPOKALEMIA; LEUKOPENIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEUTROPENIA; OPEN STUDY; PERIPHERAL EDEMA; PERIPHERAL T CELL LYMPHOMA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SEPSIS; SIDE EFFECT; STEM CELL TRANSPLANTATION; STOMATITIS; SYSTEMIC THERAPY; TACHYCARDIA; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; VOMITING; WEIGHT REDUCTION;

ADULT; AGED; AGED, 80 AND OVER; ANTIBIOTICS, ANTINEOPLASTIC; DEPSIPEPTIDES; DIARRHEA; DISEASE-FREE SURVIVAL; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; HUMANS; KAPLAN-MEIER ESTIMATE; LYMPHOMA, T-CELL, PERIPHERAL; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PNEUMONIA; TREATMENT OUTCOME; VASCULAR DISEASES; VOMITING; YOUNG ADULT;

EID: 84857522968     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2011.37.4223     Document Type: Article

References (29)

1. López-Guillermo A, Cid J, Salar A, et al: Peripheral T-cell lymphomas: Initial features, natural history, and prognostic factors in a series of 174 patients diagnosed according to the R.E.A.L. Classification. Ann Oncol 9:849-855, 1998 (Pubitemid 28440443)
2. Harris NJ, Jaffe ES, Armitage JO: Lymphoma classification: From REAL to WHO and beyond, in DeVita VT, Hellman S, Rosenberg SA (eds): Cancer: Principles and Practice of Oncology Updates. Philadelphia, PA, Lippincott-Raven, 1999, pp 1-14
3. Ascani S, Zinzani PL, Gherlinzoni F, et al: Peripheral T-cell lymphomas: Clinico-pathologic study of 168 cases diagnosed according to the R.E.A.L. classification. Ann Oncol 8:583-592, 1997
4. Anderson JR, Armitage JO, Weisenburger DD: Epidemiology of the non-Hodgkin's lymphomas: Distributions of the major subtypes differ by geographic locations - Non-Hodgkin's Lymphoma Classification Project. Ann Oncol 9:717-720, 1998 (Pubitemid 28394156)
5. Dearden CE, Foss FM: Peripheral T-cell lymphomas: Diagnosis and management. Hematol Oncol Clin North Am 17:1351-1366, 2003 (Pubitemid 37523674)
6. Horwitz SM: Management of peripheral T-cell non-Hodgkin's lymphoma. Curr Opin Oncol 19:438-443, 2007
7. National Comprehensive Cancer Network: NCCN Clinical Practice Guidelines in Oncology: Non-Hodgkin's Lymphoma, V. 2, 2011
8. Vose J, Armitage J, Weisenburger D, et al: International peripheral T-cell and natural killer/T-cell lymphoma study: Pathology findings and clinical outcomes. J Clin Oncol 26:4124-4130, 2008
9. Reimer P: Impact of autologous and allogeneic stem cell transplantation in peripheral T-cell lymphomas. Adv Hematol 2010:320624, 2010
10. Foss F: Evolving therapy of peripheral T-cell lymphoma: 2010 and beyond. Ther Adv Hematol 2:161-173, 2011
11. Foss FM, Zinzani PL, Vose JM, et al: Peripheral T-cell lymphoma. Blood 117:6756-6767, 2011
12. Allos Therapeutics: FOLOTYN (Pralatrexate) [Package Insert]. Westminster, CO, Allos Therapeutics, 2009
13. O'Connor OA, Pro B, Pinter-Brown L, et al: Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: Results from the pivotal PROPEL study. J Clin Oncol 29:1182-1189, 2011
14. Peart MJ, Smyth GK, van Laar RK, et al: Identification and functional significance of genes regulated by structurally different histone deacetylase inhibitors. Proc Natl Acad Sci U S A 102:3697-3702, 2005 (Pubitemid 40354674)
15. Johnstone RW, Licht JD: Histone deacetylase inhibitors in cancer therapy: Is transcription the primary target? Cancer Cell 4:13-18, 2003 (Pubitemid 36904157)
16. Rasheed W, Bishton M, Johnstone RW, et al: Histone deacetylase inhibitors in lymphoma and solid malignancies. Expert Rev Anticancer Ther 8:413-432, 2008 (Pubitemid 351836289)
17. Bolden JE, Peart MJ, Johnstone RW: Anticancer activities of histone deacetylase inhibitors. Nat Rev Drug Discov 5:769-784, 2006 (Pubitemid 44348499)
18. Cress WD, Seto E: Histone deacetylases, transcriptional control, and cancer. J Cell Physiol 184:1-16, 2000 (Pubitemid 30349623)
19. Vigushin DM, Coombes RC: Histone deacetylase inhibitors in cancer treatment. Anticancer Drugs 13:1-13, 2002 (Pubitemid 34169522)
20. Santini V, Gozzini A, Ferrari G: Histone deacetylase inhibitors: Molecular and biological activity as a premise to clinical application. Curr Drug Metab 8:383-393, 2007
21. Piekarz RL, Robey R, Sandor V, et al: Inhibitor of histone deacetylation, depsipeptide (FR901228), in the treatment of peripheral and cutaneous T-cell lymphoma: A case report. Blood 98:2865-2868, 2001
22. Piekarz RL, Frye R, Prince HM, et al: Phase II trial of romidepsin in patients with peripheral T-cell lymphoma. Blood 117:5827-5834, 2011
23. Celgene: ISTODAX (Romidepsin) [Package Insert]. Summit, NJ, Celgene June 2011
24. Rizvi MA, Evens AM, Tallman MS, et al: T-cell non-Hodgkin lymphoma. Blood 107:1255-1264, 2006 (Pubitemid 43242357)
25. Cheson BD, Horning SJ, Coiffier B, et al: Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas: NCI sponsored International Working Group. J Clin Oncol 17:1244, 1999
26. Piekarz RL, Frye AR, Wright JJ, et al: Cardiac studies in patients treated with depsipeptide, FK228, in a phase II trial for T-cell lymphoma. Clin Cancer Res 12:3762-3773, 2006 (Pubitemid 44000258)
27. [No authors listed]: A predictive model for aggressive non-Hodgkin's lymphoma: The International Non-Hodgkin's Lymphoma Prognostic Factors Project. N Engl J Med 329:987-994, 1993
28. Whittaker SJ, Demierre MF, Kim EJ, et al: Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol 28:4485-4491, 2010
29. Piekarz RL, Frye R, Turner M, et al: Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. J Clin Oncol 27:5410-5417, 2009