PMID- 30160566
OWN - NLM
STAT- MEDLINE
DCOM- 20200430
LR  - 20200430
IS  - 1029-2403 (Electronic)
IS  - 1026-8022 (Linking)
VI  - 60
IP  - 3
DP  - 2019 Mar
TI  - Resminostat in patients with relapsed or refractory Hodgkin lymphoma: results of 
      the phase II SAPHIRE study.
PG  - 675-684
LID - 10.1080/10428194.2018.1492122 [doi]
AB  - This open-label, single-arm phase II study examined efficacy, safety, 
      pharmacokinetics, and biomarkers of histone deacetylase (HDAC) inhibitor 
      resminostat in patients with relapsed or refractory Hodgkin lymphoma. 
      Thirty-seven heavily pretreated patients received 600 (19 patients) or 800 mg (18 
      patients) oral resminostat daily for the initial 5 days of 14-day treatment 
      cycles. Objective response rate (ORR) (primary) was 34% reaching disease control 
      in 54% patients. Most patients (69%) showed reduced tumor size and reduced 
      [(18)F]-FDG uptake in target lesions (71%). Median progression-free survival 
      (PFS) was 2.3 months (95%CI [1.3; 3.3]) and median overall survival (OS) was 12.5 
      months (95%CI [9.6; 18.6]). Patients who responded or stabilized under 
      resminostat had a 10-month longer OS than patients who progressed. Efficacy 
      assessment, pharmacodynamics, and exploratory biomarker results followed plasma 
      levels, showed target engagement and epigenetic modulations. Common drug-related 
      adverse events (AEs) were nausea, vomiting, anemia, thrombocytopenia, and 
      fatigue, mainly grade 1 or 2.
FAU - Walewski, Jan
AU  - Walewski J
AD  - a Department of Lymphoid Malignancies , Maria Sklodowska-Curie Institute - 
      Oncology Center , Warszawa , Poland.
FAU - Paszkiewicz-Kozik, Ewa
AU  - Paszkiewicz-Kozik E
AD  - a Department of Lymphoid Malignancies , Maria Sklodowska-Curie Institute - 
      Oncology Center , Warszawa , Poland.
FAU - Borsaru, Gabriela
AU  - Borsaru G
AD  - b Clinical Hospital Coltea , Bucharest , Romania.
FAU - Hellmann, Andrzej
AU  - Hellmann A
AD  - c Department for Hematology and Transplantology , University Clinical Centre, 
      Medical University of Gdansk , Gdansk , Poland.
FAU - Janikova, Andrea
AU  - Janikova A
AD  - d Department of Internal Medicine, Hematology and Oncology , University Hospital 
      Brno , Brno , Czech Republic.
FAU - Warszewska, Agnieszka
AU  - Warszewska A
AD  - a Department of Lymphoid Malignancies , Maria Sklodowska-Curie Institute - 
      Oncology Center , Warszawa , Poland.
FAU - Mais, Anna
AU  - Mais A
AD  - e 4SC AG , Martinsried, Planegg , Germany.
FAU - Ammendola, Astrid
AU  - Ammendola A
AD  - e 4SC AG , Martinsried, Planegg , Germany.
FAU - Herz, Thomas
AU  - Herz T
AD  - e 4SC AG , Martinsried, Planegg , Germany.
FAU - Krauss, Babett
AU  - Krauss B
AD  - e 4SC AG , Martinsried, Planegg , Germany.
FAU - Henning, Stefan W
AU  - Henning SW
AD  - e 4SC AG , Martinsried, Planegg , Germany.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20180830
PL  - United States
TA  - Leuk Lymphoma
JT  - Leukemia & lymphoma
JID - 9007422
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Biomarkers)
RN  - 0 (Histone Deacetylase Inhibitors)
RN  - 0 (Hydroxamic Acids)
RN  - 0 (Sulfonamides)
RN  - 1578EUB98L (resminostat)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/administration & dosage/adverse 
      effects/pharmacokinetics/*therapeutic use
MH  - Biomarkers
MH  - Drug Resistance, Neoplasm
MH  - Female
MH  - Histone Deacetylase Inhibitors/administration & dosage/adverse 
      effects/pharmacokinetics/*therapeutic use
MH  - Hodgkin Disease/diagnosis/*drug therapy/etiology/mortality
MH  - Humans
MH  - Hydroxamic Acids/administration & dosage/adverse 
      effects/pharmacokinetics/*therapeutic use
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Positron Emission Tomography Computed Tomography
MH  - Positron-Emission Tomography
MH  - Recurrence
MH  - Retreatment
MH  - Sulfonamides/administration & dosage/adverse 
      effects/pharmacokinetics/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Hodgkin lymphoma
OT  - Resminostat
OT  - epigenetics
OT  - histone deacetylase
EDAT- 2018/08/31 06:00
MHDA- 2020/05/01 06:00
CRDT- 2018/08/31 06:00
PHST- 2018/08/31 06:00 [pubmed]
PHST- 2020/05/01 06:00 [medline]
PHST- 2018/08/31 06:00 [entrez]
AID - 10.1080/10428194.2018.1492122 [doi]
PST - ppublish
SO  - Leuk Lymphoma. 2019 Mar;60(3):675-684. doi: 10.1080/10428194.2018.1492122. Epub 
      2018 Aug 30.