PMID- 25099027
OWN - NLM
STAT- MEDLINE
DCOM- 20150422
LR  - 20220321
IS  - 1097-0215 (Electronic)
IS  - 0020-7136 (Linking)
VI  - 136
IP  - 6
DP  - 2015 Mar 15
TI  - The combination of transcatheter arterial chemoembolization and sorafenib is well 
      tolerated and effective in Asian patients with hepatocellular carcinoma: final 
      results of the START trial.
PG  - 1458-67
LID - 10.1002/ijc.29126 [doi]
AB  - This phase II, investigator-initiated, prospective single-arm multinational study 
      (ClinicalTrials.gov registration NCT00990860) evaluated sorafenib in combination 
      with doxorubicin-based transarterial chemoembolization (TACE) in patients with 
      intermediate-stage, unresectable hepatocellular carcinoma (HCC). Patients with 
      histologically or clinically diagnosed HCC received TACE with interrupted dosing 
      of sorafenib (sorafenib discontinued for 3 days before and 4-7 days after TACE). 
      TACE/sorafenib cycles were repeated every 6-8 weeks. Primary and secondary 
      objectives were, respectively: to evaluate the safety and tolerability of TACE 
      combined with sorafenib, and also their efficacy. The full analysis set comprised 
      192 patients (mean age 56.1 years). Most were male (87.0%), Eastern Cooperative 
      Oncology Group (ECOG) score 0 (81.8%), Child-Pugh A (91.8%) and Barcelona Clinic 
      Liver Cancer (BCLC) stage B (81.5%); 81.2% had chronic hepatitis B. Combined 
      TACE/sorafenib was well tolerated, with only 8.1% of patients discontinuing owing 
      to adverse events (AEs). The most common grade >/=3 AEs were palmar-plantar 
      erythrodysesthesia syndrome (15.1%) and decreased platelet count (10.9%). Serious 
      AEs (SAEs) occurred in 52 patients during the study; however, only four were 
      considered related to sorafenib. A mean of 2.7 TACE cycles were administered and 
      52.6% of patients achieved complete response in target lesions; 16.8% achieved 
      partial response, and 5.8% had progression of disease as their best response, 
      evaluated by modified RECIST. Median progression-free survival and time to 
      progression were 384 and 415 days, respectively, and the estimated 3-year overall 
      survival was 86.1%. This study suggests that the combination of TACE and 
      sorafenib is well tolerated and efficacious; the interrupted sorafenib dosing 
      schedule may have contributed to a considerably lower AE profile than observed in 
      other combination trials.
CI  - (c) 2014 UICC.
FAU - Chao, Yee
AU  - Chao Y
AD  - Division of Chemoradiotherapy, Cancer Center, Taipei Veterans General Hospital, 
      School of Medicine, National Yang-Ming University, Taipei, Taiwan.
FAU - Chung, Young-Hwa
AU  - Chung YH
FAU - Han, Guohong
AU  - Han G
FAU - Yoon, Jung-Hwan
AU  - Yoon JH
FAU - Yang, Jijin
AU  - Yang J
FAU - Wang, Jianhua
AU  - Wang J
FAU - Shao, Guo-Liang
AU  - Shao GL
FAU - Kim, Byung Ik
AU  - Kim BI
FAU - Lee, Teng-Yu
AU  - Lee TY
LA  - eng
SI  - ClinicalTrials.gov/NCT00990860
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140916
PL  - United States
TA  - Int J Cancer
JT  - International journal of cancer
JID - 0042124
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Phenylurea Compounds)
RN  - 25X51I8RD4 (Niacinamide)
RN  - 9ZOQ3TZI87 (Sorafenib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*therapeutic use
MH  - Carcinoma, Hepatocellular/mortality/pathology/*therapy
MH  - *Chemoembolization, Therapeutic/adverse effects
MH  - Combined Modality Therapy
MH  - Female
MH  - Humans
MH  - Liver Neoplasms/mortality/pathology/*therapy
MH  - Male
MH  - Middle Aged
MH  - Niacinamide/adverse effects/*analogs & derivatives/therapeutic use
MH  - Phenylurea Compounds/adverse effects/*therapeutic use
MH  - Prospective Studies
MH  - Sorafenib
OTO - NOTNLM
OT  - TACE
OT  - combination therapy
OT  - hepatocellular carcinoma
OT  - phase II
OT  - sorafenib
EDAT- 2014/08/08 06:00
MHDA- 2015/04/23 06:00
CRDT- 2014/08/08 06:00
PHST- 2013/10/22 00:00 [received]
PHST- 2014/03/11 00:00 [revised]
PHST- 2014/03/12 00:00 [accepted]
PHST- 2014/08/08 06:00 [entrez]
PHST- 2014/08/08 06:00 [pubmed]
PHST- 2015/04/23 06:00 [medline]
AID - 10.1002/ijc.29126 [doi]
PST - ppublish
SO  - Int J Cancer. 2015 Mar 15;136(6):1458-67. doi: 10.1002/ijc.29126. Epub 2014 Sep 
      16.