PMID- 32417993
OWN - NLM
STAT- MEDLINE
DCOM- 20201104
LR  - 20201104
IS  - 1437-7772 (Electronic)
IS  - 1341-9625 (Linking)
VI  - 25
IP  - 9
DP  - 2020 Sep
TI  - Effect of early adverse events resulting in sorafenib dose adjustments on 
      survival outcomes of advanced hepatocellular carcinoma patients.
PG  - 1672-1677
LID - 10.1007/s10147-020-01698-7 [doi]
AB  - BACKGROUND: Sorafenib is a current first-line treatment option for advanced 
      hepatocellular carcinoma (HCC). This study aimed to evaluate the impact of early 
      adverse events (AEs) requiring sorafenib dose adjustment on survival outcomes of 
      patients with advanced HCC. METHODS: The study was a secondary analysis of the 
      phase III clinical trial NCT00699374. A landmark Cox proportional hazard analysis 
      was used to evaluate the association between early AEs requiring sorafenib dose 
      adjustment with survival outcomes. The primary outcome was overall survival (OS) 
      with progression-free survival (PFS) as secondary. RESULTS: AEs requiring 
      sorafenib dose adjustment within the first 28 days of therapy were significantly 
      associated with OS (HR [95% CI]; dose interruption = 0.9 [0.7-1.2]; dose 
      reduction = 0.6 [0.5-0.9]; discontinuation = 1.7 [0.9-3.4]; P = 0.005). No 
      statistically significant association with PFS was identified (P = 0.148). 
      CONCLUSION: Sorafenib dose interruptions and reduction due to AEs did not 
      compromise the survival outcomes of patient with advanced HCC. Patients who 
      required a sorafenib dose reduction were observed to have more favourable OS 
      compared to those who did not experience an AE which required a dose adjustment.
FAU - Ruanglertboon, Warit
AU  - Ruanglertboon W
AUID- ORCID: 0000-0003-0540-7427
AD  - Department of Clinical Pharmacology, College of Medicine and Public Health, 
      Flinders University, Adelaide, Australia. warit.ruanglertboon@flinders.edu.au.
FAU - Sorich, Michael J
AU  - Sorich MJ
AD  - Department of Clinical Pharmacology, College of Medicine and Public Health, 
      Flinders University, Adelaide, Australia.
FAU - Rowland, Andrew
AU  - Rowland A
AD  - Department of Clinical Pharmacology, College of Medicine and Public Health, 
      Flinders University, Adelaide, Australia.
FAU - Hopkins, Ashley M
AU  - Hopkins AM
AD  - Department of Clinical Pharmacology, College of Medicine and Public Health, 
      Flinders University, Adelaide, Australia.
LA  - eng
GR  - 1159924/Cancer Council South Australia/
GR  - 1127220/Cancer Council South Australia/
GR  - PF-17-007/National Breast Cancer Foundation (AUS)/
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20200516
PL  - Japan
TA  - Int J Clin Oncol
JT  - International journal of clinical oncology
JID - 9616295
RN  - 0 (Antineoplastic Agents)
RN  - 25X51I8RD4 (Niacinamide)
RN  - 9ZOQ3TZI87 (Sorafenib)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*administration & dosage/adverse effects
MH  - Carcinoma, Hepatocellular/*drug therapy/mortality
MH  - Female
MH  - Humans
MH  - Liver Neoplasms/*drug therapy/mortality
MH  - Male
MH  - Middle Aged
MH  - Niacinamide/therapeutic use
MH  - Progression-Free Survival
MH  - Sorafenib/*administration & dosage/*adverse effects
MH  - Young Adult
OTO - NOTNLM
OT  - Adverse events
OT  - Dose adjustment
OT  - Prediction
OT  - Response
OT  - Sorafenib
OT  - Survival
EDAT- 2020/05/18 06:00
MHDA- 2020/11/05 06:00
CRDT- 2020/05/18 06:00
PHST- 2020/01/20 00:00 [received]
PHST- 2020/05/01 00:00 [accepted]
PHST- 2020/05/18 06:00 [pubmed]
PHST- 2020/11/05 06:00 [medline]
PHST- 2020/05/18 06:00 [entrez]
AID - 10.1007/s10147-020-01698-7 [pii]
AID - 10.1007/s10147-020-01698-7 [doi]
PST - ppublish
SO  - Int J Clin Oncol. 2020 Sep;25(9):1672-1677. doi: 10.1007/s10147-020-01698-7. Epub 
      2020 May 16.