PMID- 28456898
OWN - NLM
STAT- MEDLINE
DCOM- 20180828
LR  - 20221207
IS  - 1532-2807 (Electronic)
IS  - 1219-4956 (Linking)
VI  - 24
IP  - 2
DP  - 2018 Apr
TI  - Predictive Value of Early Skin Rash in Cetuximab-Based Therapy of Advanced 
      Biliary Tract Cancer.
PG  - 237-244
LID - 10.1007/s12253-017-0238-y [doi]
AB  - Randomized trials in advanced biliary tract cancer (BTC) did not show benefit of 
      cetuximab addition over chemotherapy. This is probably due to the lack of 
      predictive biomarkers. The aim of this study was to explore possible predictive 
      factors. Between 2009 and 2014, 57 patients were treated in 3-week cycles with 
      cetuximab (250 mg/m(2)/week, loading dose: 400 mg/m(2)), gemcitabine 
      (1000 mg/m(2) on day 1 and 8), and capecitabine (1300 mg/m(2)/day on days 1-14). 
      The objective response rate (ORR), progression-free (PFS) and overall survival 
      (OS) and the adverse events (AEs) were evaluated. An exploratory analysis was 
      performed to find possible predictive factors on clinicopathological 
      characteristics, routine laboratory parameters and early AEs, which occurred 
      within 2 months from the beginning of treatment. The ORR was 21%. The median PFS 
      and OS were 34 (95% CI: 24-40) and 54 (43-67) weeks, respectively. The most 
      frequent AEs were skin toxicities. In univariate analysis performance status, 
      previous stent implantation, thrombocyte count at the start of therapy, early 
      neutropenia and skin rash statistically significantly influenced the ORR, PFS 
      and/or OS. In multivariate Cox regression analysis only normal thrombocyte count 
      at treatment start and early acneiform rash were independent markers of longer 
      survival. In patients showing early skin rash compared to the others the median 
      PFS was 39 vs. 13 weeks and the median OS was 67 vs. 26 weeks, respectively. It 
      is suggested that early skin rash can be used as a biomarker to select patients 
      who would benefit from the treatment with cetuximab plus chemotherapy.
FAU - Rubovszky, Gabor
AU  - Rubovszky G
AUID- ORCID: 0000-0003-1723-5589
AD  - Department of Medical Oncology and Clinical Pharmacology "B", National Institute 
      of Oncology, Rath Gy. u. 7-9, Budapest, 1122, Hungary. garub@oncol.hu.
FAU - Budai, Barna
AU  - Budai B
AD  - Department of Molecular Immunology and Toxicology, National Institute of 
      Oncology, Budapest, Hungary.
FAU - Ganofszky, Erna
AU  - Ganofszky E
AD  - Department of Medical Oncology and Clinical Pharmacology "B", National Institute 
      of Oncology, Rath Gy. u. 7-9, Budapest, 1122, Hungary.
FAU - Horvath, Zsolt
AU  - Horvath Z
AD  - Institute of Oncology, University of Debrecen, Debrecen, Hungary.
FAU - Juhos, Eva
AU  - Juhos E
AD  - Department of Medical Oncology and Clinical Pharmacology "B", National Institute 
      of Oncology, Rath Gy. u. 7-9, Budapest, 1122, Hungary.
FAU - Madaras, Balazs
AU  - Madaras B
AD  - Department of Medical Oncology and Clinical Pharmacology "B", National Institute 
      of Oncology, Rath Gy. u. 7-9, Budapest, 1122, Hungary.
FAU - Nagy, Tunde
AU  - Nagy T
AD  - Department of Medical Oncology and Clinical Pharmacology "B", National Institute 
      of Oncology, Rath Gy. u. 7-9, Budapest, 1122, Hungary.
FAU - Szabo, Eszter
AU  - Szabo E
AD  - Department of Medical Oncology and Clinical Pharmacology "B", National Institute 
      of Oncology, Rath Gy. u. 7-9, Budapest, 1122, Hungary.
FAU - Pinter, Tamas
AU  - Pinter T
AD  - Department of Medical Oncology and Clinical Pharmacology "B", National Institute 
      of Oncology, Rath Gy. u. 7-9, Budapest, 1122, Hungary.
FAU - Toth, Erika
AU  - Toth E
AD  - Surgical and Molecular Tumor Pathology Centre, National Institute of Oncology, 
      Budapest, Hungary.
FAU - Nagy, Peter
AU  - Nagy P
AD  - Department of Molecular Immunology and Toxicology, National Institute of 
      Oncology, Budapest, Hungary.
FAU - Lang, Istvan
AU  - Lang I
AD  - Department of Medical Oncology and Clinical Pharmacology "B", National Institute 
      of Oncology, Rath Gy. u. 7-9, Budapest, 1122, Hungary.
FAU - Hitre, Erika
AU  - Hitre E
AD  - Department of Medical Oncology and Clinical Pharmacology "B", National Institute 
      of Oncology, Rath Gy. u. 7-9, Budapest, 1122, Hungary.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20170429
PL  - Switzerland
TA  - Pathol Oncol Res
JT  - Pathology oncology research : POR
JID - 9706087
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - PQX0D8J21J (Cetuximab)
RN  - 0 (Gemcitabine)
SB  - IM
CIN - Pathol Oncol Res. 2019 Apr;25(2):815. PMID: 29858970
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents, Immunological/administration & dosage/*adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Biliary Tract Neoplasms/*drug therapy/mortality
MH  - Capecitabine/administration & dosage/adverse effects
MH  - Cetuximab/administration & dosage/*adverse effects
MH  - Deoxycytidine/administration & dosage/adverse effects/analogs & derivatives
MH  - Disease-Free Survival
MH  - Drug Eruptions
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Proportional Hazards Models
MH  - Gemcitabine
OTO - NOTNLM
OT  - Acneiform rash
OT  - Cetuximab
OT  - Chemotherapy
OT  - Cholangiocarcinoma
OT  - Predictive marker
EDAT- 2017/05/01 06:00
MHDA- 2018/08/29 06:00
CRDT- 2017/05/01 06:00
PHST- 2017/02/21 00:00 [received]
PHST- 2017/04/25 00:00 [accepted]
PHST- 2017/05/01 06:00 [pubmed]
PHST- 2018/08/29 06:00 [medline]
PHST- 2017/05/01 06:00 [entrez]
AID - 10.1007/s12253-017-0238-y [pii]
AID - 10.1007/s12253-017-0238-y [doi]
PST - ppublish
SO  - Pathol Oncol Res. 2018 Apr;24(2):237-244. doi: 10.1007/s12253-017-0238-y. Epub 
      2017 Apr 29.