Perioperative chemotherapy with docetaxel, cisplatin and capecitabine (DCX) in gastro-oesophageal adenocarcinoma: a phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO){dagger}.
BACKGROUND
This prospective multicentre phase II trial assessed the feasibility and efficacy of perioperative chemotherapy with docetaxel, cisplatin and capecitabine (DCX) in patients with gastro-oesophageal adenocarcinoma.


METHODS
Patients with curatively resectable adenocarcinoma of the stomach, the gastro-oesophageal junction or the lower third of the oesophagus were enrolled. Patients received docetaxel 75 mg/m(2) plus cisplatin 60 mg/m(2) (day 1), followed by oral capecitabine 1875 mg/m(2) divided into two doses (days 1-14) every 3 weeks. There were three cycles preoperatively and three cycles postoperatively. The primary end point was the R0 resection rate.


RESULTS
Fifty-one patients were recruited and assessed for feasibility and efficacy. 94.1% of patients received all three planned cycles preoperatively, and 52.9% received three cycles postoperatively. The R0 resection rate was 90.2%. 13.7% of patients showed complete pathological remission (pCR). Toxicity was acceptably tolerable. Without prophylactic granulocyte colony-stimulating factor administration, neutropenic fever developed in 21.5% of patients preoperatively (grade 3 or 4) and in 11.1% of patients postoperatively.


CONCLUSIONS
DCX is a safe and feasible perioperative regimen in the treatment of gastro-oesophageal adenocarcinoma with a high percentage of cycles delivered pre- and postoperatively, compared with standard practice. The high efficacy in terms of R0 resection rate and pCR is very promising.
Department of Haematology, Oncology and Tumorimmunology, Campus Virchow-Klinikum, Charité - University Medicine Berlin, Berlin. Electronic address: peter.thuss@charite.de.
P C
PC
Thuss-Patience
3rd Medical Clinic, University Medicine Mannheim, Mannheim.
R D
RD
Hofheinz
Hubertus Wald Tumour Center, University Cancer Center Hamburg (UCCH), University Medical Center Hamburg-Eppendorf, Hamburg.
D
D
Arnold
Department of Haematology and Oncology, Städtisches Klinikum Dessau, Dessau.
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A
Florschütz
Department of Gastroenterology, Infectious Diseases and Rheumatology, Campus Benjamin-Franklin, Charité - University Medicine Berlin, Berlin.
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S
Daum
Department of Haematology, Oncology and Tumorimmunology, HELIOS-Klinikum Berlin-Buch, Berlin; Department of Medical Oncology and Haematology, St George's Hospital, Leipzig.
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A
Kretzschmar
Department of Medical Oncology and Haematology, St George's Hospital, Leipzig.
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L
Mantovani-Löffler
Department of Haematology, Oncology and Tumorimmunology, Campus Virchow-Klinikum, Charité - University Medicine Berlin, Berlin.
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D
Bichev
Department of Haematology, Oncology and Tumorimmunology, Campus Virchow-Klinikum, Charité - University Medicine Berlin, Berlin.
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K
Breithaupt
2nd Department of Medicine, University Medical Center Schleswig-Holstein, Kiel.
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M
Kneba
Department of Surgery, Städtisches Klinikum Braunschweig, Braunschweig; Department of General, Visceral and Transplant Surgery, Campus Virchow-Klinikum, Charité - University Medicine Berlin, Berlin.
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G
Schumacher
Department of General, Visceral and Transplant Surgery, Campus Virchow-Klinikum, Charité - University Medicine Berlin, Berlin.
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M
Glanemann
Department of Medical Statistics, Informatics and Documentation, University Hospital of Friedrich-Schiller University Jena, Jena.
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P
Schlattmann
Department of Haematology, Oncology, Palliative Medicine, HELIOS-Klinikum Bad Saarow, Bad Saarow, Germany.
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P
Reichardt
2nd Department of Medicine, University Medical Center Schleswig-Holstein, Kiel.
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B
Gahn
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D000077143:Docetaxel; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D004943:Esophagogastric Junction; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil