Docetaxel, cisplatin, and capecitabine (DCX) as perioperative chemotherapy in gastroesophageal adenocarcinoma: A phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO).

Abstract

4116 Background: Perioperative chemotherapy with ECF or ECX is the standard approach in Europe for resectable gastroesophageal cancer. Docetaxel significantly improves efficacy if added to cisplatin and 5-FU as palliative treatment. To translate this efficacy into the curative approach this study investigates docetaxel (D), cisplatin (C) and capecitabine (X) in the perioperative setting. Methods: Pts with curatively resectable adenocarcinoma of the distal esophagus, gastroesophageal junction (GEJ) or stomach were treated with 3 preop and 3 postop cycles of chemotherapy: D 75 mg/m2 d1, C 60 mg/m2 d1 and × 1875 mg/m2/d d1-14, q3w. G-CSF was not routinely administered. Results: Accrual is completed with 50 pts included. Here we report on the protocol specified interim safety analysis of the preop chemo and surgery after 15 patients: male/female:15/0; med. age 65 yrs (45-73); esophagus/GEJ/stomach: 2/12/1 pts; ECOG PS 0/1/2: 7/8/0 pts; reduction of preop chemo was necessary in 7/15 pts; chemo toxicity, see Table. Resection ypR0: 14/15 pts. Surgical complications: 3/15 pts: anastomotic leakage with septic shock (1 pt), pneumonia and thrombosis (1 pt); urinary tract infection (1 pt); mortality: 0/50. Conclusions: DCX seems well tolerated and can safely be administered as preoperative chemotherapy as part of a perioperative regimen. Updated results will be presented. Toxicity of preop chemotherapy (worst grade per pt) (n;%) CTC 1 CTC 2 CTC 3 CTC 4 Nausea 9 (60%) 3 (20%) 1 (7%) - Vomiting 3 (20%) 2 (13%) - - Loss of appetite 4 (27%) 4 (27%) 1 (7%) - Diarrhea 3 (20%) 5 (33%) 1 (7%) 1 (7%) Asthenia 7 (47%) 7 (47%) 1 (7%) - Stomatitis 6 (40%) 5 (33%) - - Alopecia 4 (27%) 11 (73%) - - Neutrop. fever - - 3 (20%) - Hand-foot syndrome 8 (53%) 3 (20%) - - Nail changes 5 (33%) - - - Taste changes 10 (67%) 3 (20%) - - Paresthesia 9 (60%) 1 (7%) - - Central neurotoxicity 1 (7%) 1 (7%) - - Visual disturbances 1 (7%) 2 (13%) - - Hearing impairment 2 (13%) - - - Dizziness 7 (47%) 2 (13%) - - Leukopenia 3 (20%) 4 (27%) 7 (47%) 1 (7%) Neutropenia 2 (13%) - 2 (13%) 11 (73%) thrombocytes 5 (33%) 3 (20%) - - Anemia 4 (27%) 2 (13%) - 1 (7%) Other 6 (40%) 4 (27%) 2 (13%)* - * GI-bleed., sigma-perf. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Roche, sanofi-aventis Roche, sanofi-aventis Roche, sanofi-aventis