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©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Oct 27, 2016; 8(10): 706-712
Published online Oct 27, 2016. doi: 10.4240/wjgs.v8.i10.706
Phase II study of docetaxel, cisplatin and capecitabine as preoperative chemotherapy in resectable gastric cancer
Anneriet E Dassen, Nienke Bernards, Valery EPP Lemmens, Yes AJ van de Wouw, Koop Bosscha, Geert-Jan Creemers, Hans JFM Pruijt
Anneriet E Dassen, Koop Bosscha, Department of Gastrointestinal Surgery and Surgical Oncology, Jeroen Bosch Hospital, 5200 ME’s-Hertogenbosch, The Netherlands
Nienke Bernards, Geert-Jan Creemers, Department of Oncology, Catharina Hospital, 5602 ZA Eindhoven, The Netherlands
Nienke Bernards, Valery EPP Lemmens, Comprehensive Cancer South (IKZ), Eindhoven Cancer Registry, 5600 AE Eindhoven, The Netherlands
Valery EPP Lemmens, Department of Public Health, Erasmus MC University, 3000 CA Rotterdam, The Netherlands
Yes AJ van de Wouw, Department of Oncology, Vie Curi Hospital, 5900 BX Venlo, The Netherlands
Hans JFM Pruijt, Department of Oncology, Jeroen Bosch Hospital, 5200 ME’s-Hertogenbosch, The Netherlands
Author contributions: All authors contributed to this paper.
Institutional review board statement: The study was reviewed and approved by the METOPP (Institutional Review Board).
Clinical trial registration statement: ClinicalTrials.gov ID: NCT01517009.
Informed consent statement: All involved patients gave their written informed consent participating this clinical trial prior to study enrollment.
Conflict-of-interest statement: None declared.
Data sharing statement: Technical appendix, statistical code and dataset available from the corresponding author (a.dassen@erasmusmc.nl).
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Anneriet E Dassen, MD, PhD, Department of Gastrointestinal Surgery and Surgical Oncology, Jeroen Bosch Hospital, PO Box 90153, 5200 ME’s-Hertogenbosch, The Netherlands. a.dassen@erasmusmc.nl
Telephone: +31-73-5533641 Fax: +31-73-5532317
Received: May 18, 2016
Peer-review started: May 19, 2016
First decision: June 6, 2016
Revised: July 6, 2016
Accepted: August 6, 2016
Article in press: August 8, 2016
Published online: October 27, 2016
AIM
To investigate the feasibility of preoperative docetaxel, cisplatin and capecitabine (DCC) in patients with resectable gastric cancer.
METHODS
Patients with resectable gastric cancer fulfilling the inclusion criteria, were treated with 4 cycles of docetaxel (60 mg/m2), cisplatin (60 mg/m2) and capecitabine (1.875 mg/m2 orally on day 1-14, two daily doses) repeated every three weeks, followed by surgery. Primary end point was the feasibility and toxicity/safety profile of DCC, secondary endpoints were pathological complete resection rate and pathological complete response (pCR) rate.
RESULTS
All of the patients (51) were assessable for the feasibility and safety of the regimen. The entire preoperative regimen was completed by 68.6% of the patients. Grade III/IV febrile neutropenia occurred in 10% of all courses. Three patients died due to treatment related toxicity (5.9%), one of them (also) because of refusing further treatment for toxicity. Of the 45 patients who were evaluable for secondary endpoints, four developed metastatic disease and 76.5% received a curative resection. In 3 patients a pCR was seen (5.9%), two patients underwent a R1 resection (3.9%).
CONCLUSION
Four courses of DCC as a preoperative regimen for patients with primarily resectable gastric cancer is highly demanding. The high occurrence of febrile neutropenia is of concern. To decrease the occurrence of febrile neutropenia the prophylactic use of granulocyte colony-stimulating factor (G-CSF) should be explored. A curative resection rate of 76.5% is acceptable. The use of DCC without G-CSF support as preoperative regimen in resectable gastric cancer is debatable.
Core tip: The use of the combination of docetaxel, cisplatin and capecitabine in resectable gastric cancer has resulted in a high curative resection rate of 77%, although it also resulted in a high rate of febrile neutropenia, and in treatment related mortality.
