A phase II trial of perioperative chemotherapy with folinic acid, 5-fluorouracil, and oxaliplatin in potentially resectable gastric cancer with regional lymph node metastasis

Abstract

4602 Background: Peri-operative chemotherapy in operable advanced gastric cancer (AGC) is still in a controversial area. Results from MAGIC trial suggest that a peri-operative regimen of ECF (epirubicin, cisplatin, 5-FU) decreased tumor size and significantly improved PFS and OS in patients with operable AGC (NEJM 355: 11, 2006). The aim of this study was to evaluate the efficacy and toxicity of folinic acid (FA), infusional 5-fluorouracil (5-FU), and oxaliplatin (modified FOLFOX6), administered every 2 wks in potentially operable AGC with regional lymph node (LN) metastasis. Methods: Previously untreated gastric adenocarcinoma patients with measurable LN on CT scan (clinical stage: cT2 or cT3, N+) were eligible. Staging also included a PET-CT and endoscopic ultrasonography (EUS). Patients received 4 cycles of neoadjuvant therapy with FA 100 mg/m2 (2-hr i.v.), 5-FU 2.4 g/m2 (46-hr continuous infusion), and oxaliplatin 100 mg/m2 (2-hr i.v.), followed by curative radical surgery including D2 dissection and 4 cycles of adjuvant modified FOLFOX6. Clinical responses were assessed by RECIST using CT scan before surgery and early metabolic responses were assessed by PET-CT after 2 cycles of chemotherapy. Results: Thirty-one patients were enrolled from Oct. 2004 to Nov. 2006 and currently, 29 of them are evaluable for response. Median age was 56 yrs (range, 35–69). Most patients had EUS T3N1or2 designation. Of 29 evaluable patients, PR were observed in 19 (66%), SD in 9 (31%), and PD in 1 (3%) patient. Early metabolic responses (SUV decrement = 35% by PET-CT) were significantly correlated with conventional radiographic response (p=0.037). The R0 resection rate was 90% and pathologic CR was 7%. Median follow-up duration was 11.8 mo. and median PFS has not been reached yet. Total 219 cycles were administered. G3/4 neutropenia occurred in 6 cycles (3.0%). Nausea G3/4 occurred in 1 cycle (0.5%) and diarrhea in 1 cycle (0.5%). There were no cases of peripheral neuropathy G3/4 or febrile neutropenia G3/4. Conclusions: Peri-operative chemotherapy with modified FOLFOX6 is very effective and feasible in patients with potentially resectable AGC with regional LN metastasis. Early response can be predicted by PET-CT. No significant financial relationships to disclose.