Safety of epirubicin, cisplatin and capecitabin chemotherapy in patients with resectable oesophageal
or gastro-oesophageal junction adenocarcinoma outside clinical trials.
P.C. van der Sluis1, I. Ubink2, S. van der Horst1, J.J. Boonstra3, E.E. Voest2, I.H.M. Borel-Rinkes1, M.J.
Wiezer4, M.E.I. Schipper5, P.D. Siersema6, M. Los3, R. van Hillegersberg1, M.P. Lolkema2
University Medical Center Utrecht
1Division
of surgery, 2Department of Medical Oncology, 5Department of Pathology, 6Department of
Gastroenterology and Hepatology
St. Antonius Hospital Nieuwegein
3Department
of Internal Medicine and Oncology, 4Department of Surgery
Address for correspondence:
Department of Medical Oncology
University Medical Center Utrecht,
PO Box 85500
3508 GA Utrecht,
The Netherlands
Tel: +31-88-75-56265
Fax: +31-30-2523741
*Please
#Please
address the correspondence to m.p.j.k.lolkema@umcutrecht.nl
address correspondence during the review process to p.c.vandersluis-2@umcutrecht.nl
Key-words: Oesophageal adenocarcinoma, peri-operative chemotherapy,
ABSTRACT
Background: In this retrospective study an analysis was performed of safety and feasibility for
perioperative epirubicin, cisplatin and capecitabine (ECC) chemotherapy in a population based patient
group with resectable oesophageal and GOJ adenocarcinoma. Our goal was to compare safety and
efficacy in our cohort to the MAGIC trial study population.
Methods: The clinical data from 93 consecutive patients, treated with perioperative ECC for
resectable oesophageal or GOJ adenocarcinoma were analysed. All patients had a least 1 month
follow up since the last ECC dose. Source data verification of all grade 3, 4, and 5 adverse events was
performed by two independent observers,
Results: Chemotherapy treatment using ECC was found to result in more than expected toxicity
however this did not affect the rate of curative intent surgery. The most frequently reported toxicities
were grade 3 and 4 thromboembolic (16.2%) and cardiovascular (7.5%) events. Often these toxic
effects resulted in early discontinuation of chemotherapy treatment. A medical history of cardiac- and
vascular disease was independently associated with discontinuation of preoperative chemotherapy in
binary regression analysis. A medical history of cardiac disease alone was independently associated
with the occurrence of grade 3 and higher adverse events (p: 0.049). Despite the difficult delivery of
the planned therapy and its toxicity, our preliminary efficacy data suggest that this treatment strategy is
effective with a pCR rate of 8%.
Conclusion: This is the first study that evaluated the administration of 6 cycles of ECC based
perioperative
chemotherapy
in
a
homogeneous
population
of
patients
with
oesophageal
adenocarcinoma outside clinical trials. The regimen appeared more toxic than reported in mixed series
of patients with oesophageal and gastric cancer.