PMID- 24335595
OWN - NLM
STAT- MEDLINE
DCOM- 20141030
LR  - 20211021
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 19
IP  - 1
DP  - 2014 Jan
TI  - Adding preoperative radiotherapy plus cetuximab to perioperative chemotherapy for 
      resectable esophageal adenocarcinoma: a single-center prospective phase II trial.
PG  - 32-3
LID - 10.1634/theoncologist.2013-0254 [doi]
AB  - BACKGROUND: Local and systemic recurrence are important sources of treatment 
      failure following surgical resection of esophageal adenocarcinoma. We 
      hypothesized that adding preoperative cetuximab and radiotherapy (cetux-RT) to 
      perioperative chemotherapy would increase treatment efficacy with acceptable 
      toxicity. METHODS: In this prospective phase II trial, patients were treated with 
      three cycles of epirubicin, cisplatin, and capecitabine (ECX), followed by 
      cetux-RT. After surgery with curative intent, patients received three more cycles 
      of ECX. Primary endpoints were efficacy, determined by histopathological complete 
      response (pCR) rate, and safety, which was assessed with resectability rate. 
      RESULTS: Of the 12 patients enrolled in this trial, six received at least one 
      dose of cetux-RT. In five patients, cetux-RT was not started because of adverse 
      events (AEs) related to preoperative chemotherapy; one patient had progressive 
      disease. Addition of cetux-RT was well tolerated and did not interfere with the 
      resectability rate (100%). However, the pCR rate was 0, and 50% of patients 
      experienced serious adverse events (SAEs) postoperatively. CONCLUSION: With 12 
      patients enrolled, the lack of initial signs of efficacy and a high incidence of 
      postoperative SAEs prompted us to end this study prematurely. Perioperative ECX 
      was associated with considerable toxicity, and further treatment intensification 
      is problematic.
FAU - Ubink, Inge
AU  - Ubink I
AD  - Departments of Medical Oncology.
FAU - van der Sluis, Pieter
AU  - van der Sluis P
FAU - Schipper, Marguerite
AU  - Schipper M
FAU - Reerink, Onne
AU  - Reerink O
FAU - Voest, Emile
AU  - Voest E
FAU - Borel-Rinkes, Inne
AU  - Borel-Rinkes I
FAU - Wijrdeman, Harm
AU  - Wijrdeman H
FAU - Vleggaar, Frank
AU  - Vleggaar F
FAU - Agterof, Marriete
AU  - Agterof M
FAU - Overkleeft, Esther
AU  - Overkleeft E
FAU - Siersema, Peter
AU  - Siersema P
FAU - van Hillegersberg, Richard
AU  - van Hillegersberg R
FAU - Lolkema, M P
AU  - Lolkema MP
LA  - eng
SI  - ClinicalTrials.gov/NCT00827671
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20131212
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0W860991D6 (Deoxycytidine)
RN  - 3Z8479ZZ5X (Epirubicin)
RN  - 6804DJ8Z9U (Capecitabine)
RN  - PQX0D8J21J (Cetuximab)
RN  - Q20Q21Q62J (Cisplatin)
RN  - U3P01618RT (Fluorouracil)
RN  - Adenocarcinoma Of Esophagus
SB  - IM
MH  - Adenocarcinoma/drug therapy/radiotherapy/surgery/*therapy
MH  - Aged
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Capecitabine
MH  - Cetuximab
MH  - Chemoradiotherapy
MH  - Cisplatin/administration & dosage
MH  - Deoxycytidine/administration & dosage/analogs & derivatives
MH  - Epirubicin/administration & dosage
MH  - Esophageal Neoplasms/drug therapy/radiotherapy/surgery/*therapy
MH  - Female
MH  - Fluorouracil/administration & dosage/analogs & derivatives
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoadjuvant Therapy
MH  - Neoplasm Recurrence, Local/prevention & control
MH  - Perioperative Care/methods
MH  - Preoperative Care/methods
MH  - Prospective Studies
MH  - Survivors
PMC - PMC3903062
EDAT- 2013/12/18 06:00
MHDA- 2014/10/31 06:00
PMCR- 2013/12/12
CRDT- 2013/12/17 06:00
PHST- 2013/12/17 06:00 [entrez]
PHST- 2013/12/18 06:00 [pubmed]
PHST- 2014/10/31 06:00 [medline]
PHST- 2013/12/12 00:00 [pmc-release]
AID - theoncologist.2013-0254 [pii]
AID - 130254 [pii]
AID - 10.1634/theoncologist.2013-0254 [doi]
PST - ppublish
SO  - Oncologist. 2014 Jan;19(1):32-3. doi: 10.1634/theoncologist.2013-0254. Epub 2013 
      Dec 12.