Perioperative chemotherapy with docetaxel, cisplatin, and capecitabine (DCX) in gastroesophageal adenocarcinoma: A phase II study of the Arbeitsgemeinschaft Internistische Onkologie (AIO).

Abstract

4053 Background: Perioperative chemotherapy with ECF or ECX is a standard approach in Europe for resectable gastro-esophageal cancer. Docetaxel significantly improves efficacy if added to cisplatin and 5-FU as palliative treatment. To translate this efficacy into the curative approach this phase II 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 UICC stage > 2 were treated with 3 preop and 3 postop cycles of chemotherapy: D 75 mg/m2 d1, C 60 mg/m2 d1 and X 1875 mg/m2/d d1-14, q3w. Primary endpoint: R0 resection rate. G-CSF was not routinely administered. Results: From Nov 2008 to Jan 2010, a total of 51 pts were included. Pts' characteristics: Male/female: 48/3: Med. age: 65 yrs (37-74). Karnofsky PS: 100%/90%/80%/70%: 22/24/4/1pts. Lokalisation: distal esophagus 9.8%, GEJ 60.7%, gastric body 29.4%. Histology: intestinal 39.2%, diffuse 21.6%, not specified 39.2. Cycles delivered preop: 0/1/2/3: -/-/5.9/94.1% of pts, postop: 0/1/2/3: 27.5/13.7/5.9/52.9% of pts. 51.4% of pts starting postop chemo had at least one drug reduced. Main toxicities CTC grade 3 + 4 (>5%): preop/ postop: nausea 6.1%/ 5.6%, loss of appetite 6.1%/ 2.8%, diarrhea 12.2%/ 5.6%, neutropenic fever 22.5% /8.3%, leukopenia 46.9%/ 33.2%, neutropenia 79.5%/ 61.1% Efficacy: Surgical resection rate: R0: 90.2%, R1: 5.9%, no resection: 3.9%, reported D2 LN dissection: 82.4%, post-OP complications: 29.4%, 30 day mortality: 0%, Histopathologic remission rate (Becker et al. 2003): 1a: (pCR) 13.7%, 1b (<10% viable tumor cells): 7.8%. After a median follow up of 11.8 months (range 3.7-25.4) 9 pts had tumor recurrence so far. Conclusions: DCX can be safely administered as perioperative treatment for locally advanced esophagogastric adenocarcinoma with 94.1% of pts receiving all scheduled preop cycles and 52.9% receiving all postop cycles. Routine use of G-CSF may be considered. The pCR rate of 13.7% is among the highest reported thus far in comparable trials using three-drug regimens.