PMID- 25279222
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20141003
LR  - 20211021
IS  - 2050-7771 (Print)
IS  - 2050-7771 (Electronic)
IS  - 2050-7771 (Linking)
VI  - 2
DP  - 2014
TI  - Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma.
PG  - 16
LID - 10.1186/2050-7771-2-16 [doi]
AB  - BACKGROUND: Histone deacetylase inhibitor romidepsin has demonstrated durable 
      clinical responses and tolerability in patients with relapsed/refractory 
      peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Selection of novel drug 
      therapies for patients with relapsed/refractory aggressive lymphoma requires not 
      only considerations regarding efficacy but also careful evaluation of toxicities 
      as well as overall clinical benefit. The purpose of this analysis was to examine 
      common adverse events (AEs) reported in pivotal trials of romidepsin in 
      relapsed/refractory PTCL or CTCL and to more clearly define the overall AE 
      profile in these populations. METHODS: Patients with relapsed/refractory PTCL or 
      CTCL were treated with romidepsin at 14 mg/m(2) as a 4-hour intravenous infusion 
      on days 1, 8, and 15 of 28-day cycles for up to 6 cycles; patients with at least 
      stable disease could extend therapy until progressive disease or another 
      withdrawal criterion was met. All enrolled patients who received >/= 1 dose of 
      romidepsin were included in the AE analyses. RESULTS: Overall, safety profiles of 
      common AEs were similar, although patients with relapsed/refractory PTCL had more 
      frequent hematologic toxicities and grade >/= 3 infections. In both patient 
      populations, the greatest incidence of grade >/= 3 AEs and the majority of 
      discontinuations due to AEs occurred during cycles 1-2. Early discontinuations 
      were primarily related to infection, thrombocytopenia, or electrocardiogram 
      abnormalities, confirming the need to closely monitor patients with poor bone 
      marrow reserve or other comorbidities. Despite this, 28% of patients with 
      relapsed/refractory PTCL and 36% of patients with relapsed/refractory CTCL 
      continued on romidepsin treatment for >/= 6 cycles. CONCLUSIONS: This study 
      demonstrates that patients with relapsed/refractory PTCL or CTCL have similar AE 
      profiles with romidepsin treatment, although patients with PTCL experienced more 
      frequent and more severe hematologic toxicities and more frequent grade >/= 3 
      infections. The greatest incidence of grade >/= 3 AEs and the majority of 
      discontinuations due to AEs occurred during treatment cycles 1-2. Extended dosing 
      of romidepsin can be tolerated in responding patients. TRIAL REGISTRATION: 
      NCT00426764,NCT00106431.
FAU - Foss, Francine
AU  - Foss F
AD  - Yale Cancer Center, PO Box 208028, 333 Cedar Street, TMP 3, New Haven, CT 
      06520-8028, USA.
FAU - Coiffier, Bertrand
AU  - Coiffier B
AD  - Hospices Civils de Lyon, Lyon, France.
FAU - Horwitz, Steven
AU  - Horwitz S
AD  - Memorial Sloan Kettering Cancer Center, New York, NY, USA.
FAU - Pro, Barbara
AU  - Pro B
AD  - Thomas Jefferson University, Philadelphia, PA, USA.
FAU - Prince, H Miles
AU  - Prince HM
AD  - Peter MacCallum Cancer Centre and University of Melbourne, East Melbourne, 
      Victoria, Australia.
FAU - Sokol, Lubomir
AU  - Sokol L
AD  - Moffitt Cancer Center, Tampa, FL, USA.
FAU - Greenwood, Matthew
AU  - Greenwood M
AD  - Royal North Shore Hospital, Sydney, New South Wales, Australia.
FAU - Lerner, Adam
AU  - Lerner A
AD  - Boston Medical Center, Boston, MA, USA.
FAU - Caballero, Dolores
AU  - Caballero D
AD  - Hospital Universitario de Salamanca, Salamanca, Spain.
FAU - Baran, Eugeniusz
AU  - Baran E
AD  - Wroclaw Medical University, Wroclaw, Poland.
FAU - Kim, Ellen
AU  - Kim E
AD  - University of Pennsylvania, Philadelphia, PA, USA.
FAU - Nichols, Jean
AU  - Nichols J
AD  - J Nichols LLC, Swampscott, MA, USA.
FAU - Balser, Barbara
AU  - Balser B
AD  - Veristat, LLC, Holliston, MA, USA.
FAU - Wolfson, Julie
AU  - Wolfson J
AD  - Veristat, LLC, Holliston, MA, USA.
FAU - Whittaker, Sean
AU  - Whittaker S
AD  - Guy's and St Thomas' Hospital, London, England, United Kingdom.
LA  - eng
SI  - ClinicalTrials.gov/NCT00426764
SI  - ClinicalTrials.gov/NCT00106431
PT  - Journal Article
DEP - 20140908
PL  - England
TA  - Biomark Res
JT  - Biomarker research
JID - 101607860
PMC - PMC4181623
OTO - NOTNLM
OT  - Adverse events
OT  - CTCL
OT  - Discontinuations
OT  - PTCL
OT  - Romidepsin
EDAT- 2014/10/04 06:00
MHDA- 2014/10/04 06:01
PMCR- 2014/09/08
CRDT- 2014/10/04 06:00
PHST- 2014/06/25 00:00 [received]
PHST- 2014/06/27 00:00 [accepted]
PHST- 2014/10/04 06:00 [entrez]
PHST- 2014/10/04 06:00 [pubmed]
PHST- 2014/10/04 06:01 [medline]
PHST- 2014/09/08 00:00 [pmc-release]
AID - 2050-7771-2-16 [pii]
AID - 10.1186/2050-7771-2-16 [doi]
PST - epublish
SO  - Biomark Res. 2014 Sep 8;2:16. doi: 10.1186/2050-7771-2-16. eCollection 2014.