PMID- 29933095
OWN - NLM
STAT- MEDLINE
DCOM- 20190401
LR  - 20221207
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 100
DP  - 2018 Sep
TI  - Sorafenib in combination with gemcitabine plus cisplatin chemotherapy in 
      metastatic renal collecting duct carcinoma: A prospective, multicentre, 
      single-arm, phase 2 study.
PG  - 1-7
LID - S0959-8049(18)30808-6 [pii]
LID - 10.1016/j.ejca.2018.04.007 [doi]
AB  - BACKGROUND: Collecting duct carcinoma (CDC) is a rare type of renal cancer with a 
      poor prognosis. As there are no standard guidelines for the management of 
      metastatic CDC (mCDC), we evaluated the efficacy and safety of combined therapies 
      of sorafenib, gemcitabine, plus cisplatin in patients with mCDC. MATERIALS AND 
      METHODS: A prospective, multicentre, single-arm, open-label, phase 2 trial 
      (ClinicalTrials.gov identifier NCT01762150) that enrolled 26 mCDC patients with 
      no prior systemic chemotherapy. Patients were treated with sorafenib (400 mg 
      orally, twice daily) combined with chemotherapy (gemcitabine 1000 mg/m(2), 
      intravenously for 30-60 min on days 1 and 8, plus cisplatin 25 mg/m(2), 
      intravenously on days 1-3, repeated every 28 days for 4 cycles), until disease 
      progression, unacceptable toxicity, or study discontinuation for any other 
      reason. The primary end-points were progression-free survival (PFS) and 6-month 
      PFS rate. RESULTS: The 6-month PFS rate was 65%, and the median PFS was 8.8 
      months (95% confidence interval [CI]: 6.7-10.9) with a median overall survival of 
      about 12.5 months (95% CI: 9.6-15.4). The objective response rate was 30.8%, and 
      the disease control rate was 84.6%. The treatment was generally well tolerated. 
      Major grade 3/4 toxicities included leucopenia (26.9%), thrombocytopenia (23.1%), 
      anaemia (11.5%) and palmar-plantar erythrodysesthesia (7.7%). CONCLUSIONS: Though 
      the combination of sorafenib and chemotherapy demonstrated a similar outcome as 
      that of the previously reported regimens in patients with mCDC, this combination 
      may be a suitable option for patients who have low Eastern Cooperative Oncology 
      Group performance status or less metastatic sites.
CI  - Copyright (c) 2018 Elsevier Ltd. All rights reserved.
FAU - Sheng, Xinan
AU  - Sheng X
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Cao, Dengfeng
AU  - Cao D
AD  - Department of Pathology and Immunology, Washington University School of Medicine, 
      Saint Louis, MO 63017, USA.
FAU - Yuan, Jianlin
AU  - Yuan J
AD  - Department of Urology, Xijing Hospital, Fourth Military Medical University, 
      Xi'an, Shanxi 710031, China.
FAU - Zhou, Fangjian
AU  - Zhou F
AD  - State Key Laboratory of Oncology in South China, Collaborative Innovation Center 
      for Cancer Medicine, Department of Urology, Sun Yat-sen University Cancer Center, 
      Guangzhou, Guangdong 510060, China.
FAU - Wei, Qiang
AU  - Wei Q
AD  - Department of Urology, Institute of Urology, West China Hospital, Sichuan 
      University, Chengdu, Sichuan 610041, China.
FAU - Xie, Xiaodong
AU  - Xie X
AD  - Department of Oncology, Cancer Center of People's Liberation Army, General 
      Hospital of Shenyang Military Region, Shenyang, Liaoning 110016, China.
FAU - Cui, Chuanliang
AU  - Cui C
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Chi, Zhihong
AU  - Chi Z
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Si, Lu
AU  - Si L
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Li, Siming
AU  - Li S
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Mao, Lili
AU  - Mao L
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Lian, Bin
AU  - Lian B
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Tang, Bixia
AU  - Tang B
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Yan, Xieqiao
AU  - Yan X
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Wang, Xuan
AU  - Wang X
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Kong, Yan
AU  - Kong Y
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Dai, Jie
AU  - Dai J
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Bai, Xue
AU  - Bai X
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Zhou, Li
AU  - Zhou L
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China.
FAU - Guo, Jun
AU  - Guo J
AD  - Key Laboratory of Carcinogenesis and Translational Research (Ministry of 
      Education, Beijing), Department of Renal Cancer and Melanoma, Peking University 
      Cancer Hospital & Institute, Beijing 100142, China. Electronic address: 
      guoj307@126.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01762150
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20180619
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 9ZOQ3TZI87 (Sorafenib)
RN  - Q20Q21Q62J (Cisplatin)
RN  - 0 (Gemcitabine)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy/mortality/secondary
MH  - China
MH  - Cisplatin/*administration & dosage/adverse effects
MH  - Deoxycytidine/administration & dosage/adverse effects/*analogs & derivatives
MH  - Female
MH  - Humans
MH  - Kidney Neoplasms/*drug therapy/mortality/pathology
MH  - Male
MH  - Middle Aged
MH  - Progression-Free Survival
MH  - Prospective Studies
MH  - Protein Kinase Inhibitors/*administration & dosage/adverse effects
MH  - Sorafenib/*administration & dosage/adverse effects
MH  - Time Factors
MH  - Treatment Outcome
MH  - Gemcitabine
OTO - NOTNLM
OT  - Cisplatin
OT  - Gemcitabine
OT  - Metastatic collecting duct carcinoma
OT  - Progression-free survival
OT  - Sorafenib
EDAT- 2018/06/23 06:00
MHDA- 2019/04/02 06:00
CRDT- 2018/06/23 06:00
PHST- 2018/01/14 00:00 [received]
PHST- 2018/04/05 00:00 [revised]
PHST- 2018/04/12 00:00 [accepted]
PHST- 2018/06/23 06:00 [pubmed]
PHST- 2019/04/02 06:00 [medline]
PHST- 2018/06/23 06:00 [entrez]
AID - S0959-8049(18)30808-6 [pii]
AID - 10.1016/j.ejca.2018.04.007 [doi]
PST - ppublish
SO  - Eur J Cancer. 2018 Sep;100:1-7. doi: 10.1016/j.ejca.2018.04.007. Epub 2018 Jun 
      19.