Pre-operative versus post-operative docetaxel-cisplatin-fluorouracil (TCF) chemotherapy in locally advanced resectable gastric carcinoma: 10-year follow-up of the SAKK 43/99 phase III trial

This is a SAKK/IEO prospective randomized phase III trial comparing docetaxel/cisplatin/fluorouracil (TCF) regimen preoperatively versus postoperatively in locally advanced resectable gastric cancer (RGC). Compared with MAGIC (Cunningham, NEJM 2006) and FFCD (Ychou, JCO 2011) trials, which were perioperative positive trials in resectable gastric cancer, ours was based on a more rigid baseline staging, including CT-scan, EUS, bone scan and laparoscopy. Furthermore it did not include esophageal cancers, as in the MAGIC, and it included for the vast majority distal gastric cancer, unlike the FFCD trial, which enrolled mainly junction cancers. The SAKK/IEO trial was conducted between December 1999 and August 2005 and it was early stopped at 70 patients due to slow accrual, as the EORTC trial in the same setting (Schuhmacher et al., JCO 2010). With a 10 year follow-up no statistically significant difference was observed for the primary endpoint, event free survival (EFS), even though it should be considered that the early interruption made the study underpowered. Interestingly EFS was higher than expected in both arms, with 2.5 years in arm A and B compared to the expected 1.98 vs. 1.29 years, respectively. Also the 5-y OS was high in both arms, overlapping to that of some Western adjuvant trials and better than that of other neoadjuvant chemotherapy trials in RGC, including MAGIC, FFCD and EORTC. Finally, TCF resulted better feasible before than after surgery, D2 resection was safe after TCF and pathological complete responses were promising.

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