PMID- 22547596
OWN - NLM
STAT- MEDLINE
DCOM- 20120816
LR  - 20220419
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 30
IP  - 18
DP  - 2012 Jun 20
TI  - Panobinostat in patients with relapsed/refractory Hodgkin's lymphoma after 
      autologous stem-cell transplantation: results of a phase II study.
PG  - 2197-203
LID - 10.1200/JCO.2011.38.1350 [doi]
AB  - PURPOSE: Hodgkin's lymphoma (HL) has no standard of care for patients who are 
      relapsed or refractory to autologous stem-cell transplantation (ASCT). This phase 
      II study examined safety and activity of panobinostat in this population. 
      PATIENTS AND METHODS: Panobinostat 40 mg was administered orally three times per 
      week. The primary end point was objective response rate (ORR) based on 
      investigator assessment of radiologic imaging. Secondary end points included ORR 
      by independent central review, time to response (TTR), duration of response 
      (DOR), progression-free survival (PFS), overall survival, and safety. Exploratory 
      biomarker analyses were performed. RESULTS: The 129 treated patients (median age, 
      32 years; range, 18 to 75 years) were heavily pretreated with a median of four 
      (range, two to seven) prior systemic regimens, and 41% did not respond to the 
      regimen immediately preceding panobinostat. Tumor reductions occurred in 96 
      patients (74%). Objective response was achieved by 35 patients (27%), including 
      30 (23%) partial responses and five (4%) complete responses. The median TTR was 
      2.3 months, median DOR was 6.9 months, and median PFS was 6.1 months. The 
      estimated 1-year overall survival rate was 78%. Common nonhematologic adverse 
      events (AEs)-diarrhea, nausea, vomiting, and fatigue-were generally grade 1 and 
      2. Most common grade 3 and 4 hematologic AEs-thrombocytopenia, anemia, and 
      neutropenia-were manageable. Early reductions in thymus and activation-regulated 
      chemokine were observed in patients achieving complete or partial response. 
      CONCLUSION: In the largest, prospective, multicenter, international trial 
      conducted in heavily pretreated patients with HL who relapsed or were refractory 
      to ASCT, panobinostat monotherapy demonstrated antitumor activity, resulting in 
      durable responses.
FAU - Younes, Anas
AU  - Younes A
AD  - MD Anderson Cancer Center, 1515 Holcombe Blvd, Unite 429, Houston, TX 77030, USA. 
      ayounes@mdanderson.org
FAU - Sureda, Anna
AU  - Sureda A
FAU - Ben-Yehuda, Dina
AU  - Ben-Yehuda D
FAU - Zinzani, Pier Luigi
AU  - Zinzani PL
FAU - Ong, Tee-Chuan
AU  - Ong TC
FAU - Prince, H Miles
AU  - Prince HM
FAU - Harrison, Simon J
AU  - Harrison SJ
FAU - Kirschbaum, Mark
AU  - Kirschbaum M
FAU - Johnston, Patrick
AU  - Johnston P
FAU - Gallagher, Jennifer
AU  - Gallagher J
FAU - Le Corre, Christophe
AU  - Le Corre C
FAU - Shen, Angela
AU  - Shen A
FAU - Engert, Andreas
AU  - Engert A
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20120430
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Hydroxamic Acids)
RN  - 0 (Indoles)
RN  - 9647FM7Y3Z (Panobinostat)
SB  - IM
CIN - J Clin Oncol. 2012 Jun 20;30(18):2171-2. PMID: 22547611
CIN - Cancer Discov. 2012 Jun;2(6):OF8. PMID: 22684466
MH  - Administration, Oral
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*administration & dosage/adverse effects
MH  - Disease-Free Survival
MH  - Female
MH  - *Hematopoietic Stem Cell Transplantation
MH  - Hodgkin Disease/*drug therapy/therapy
MH  - Humans
MH  - Hydroxamic Acids/*administration & dosage/adverse effects
MH  - Indoles
MH  - Male
MH  - Panobinostat
MH  - Recurrence
MH  - Retreatment
MH  - Treatment Failure
MH  - Young Adult
EDAT- 2012/05/02 06:00
MHDA- 2012/08/17 06:00
CRDT- 2012/05/02 06:00
PHST- 2012/05/02 06:00 [entrez]
PHST- 2012/05/02 06:00 [pubmed]
PHST- 2012/08/17 06:00 [medline]
AID - JCO.2011.38.1350 [pii]
AID - 10.1200/JCO.2011.38.1350 [doi]
PST - ppublish
SO  - J Clin Oncol. 2012 Jun 20;30(18):2197-203. doi: 10.1200/JCO.2011.38.1350. Epub 
      2012 Apr 30.