Perioperative chemotherapy with docetaxel, cisplatin and capecitabine (DCX) in gastro-oesophageal adenocarcinoma: a phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO){dagger}
P C Thuss-Patience, R D Hofheinz, D Arnold, A Florschütz, S Daum, A Kretzschmar, L Mantovani-Löffler, D Bichev, K Breithaupt, M Kneba, G Schumacher, M Glanemann, P Schlattmann, P Reichardt, B Gahn, P C Thuss-Patience, R D Hofheinz, D Arnold, A Florschütz, S Daum, A Kretzschmar, L Mantovani-Löffler, D Bichev, K Breithaupt, M Kneba, G Schumacher, M Glanemann, P Schlattmann, P Reichardt, B Gahn
Abstract
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.
Trial registration: ClinicalTrials.gov NCT00865982.
Source: PubMed