A phase II study of a modified FOLFOX6 regimen as neoadjuvant chemotherapy for locally advanced gastric cancer.

ABSTRACT

BACKGROUND: We evaluated the efficacy and safety of the modified FOLFOX6 (mFOLFOX6) regimen as a neoadjuvant chemotherapy in gastric cancer patients. METHODS: Seventy-three patients with T2-T4 or N+ were enroled. Preoperative chemotherapy consisted of three cycles of mFOLFOX6. The primary end points were the response rate and the R0 resection rate. Prognostic factors for overall survival (OS) were investigated using univariate and multivariate analyses. RESULTS: Sixty-seven (91.8%) patients completed 3 cycles, with grade 3-4 toxicity arising in 33.0%. The radiology response rate was 45.8%. Sixty-seven (91.8%) patients receiving radical surgery showed different levels of histological regression of the primary tumour, with a ⩾50% regression rate of 49.2%. ypTNM stage (HR 4.045, 95% CI 1.429-11.446) and tumours of diffuse and mixed type (HR 9.963, 95% CI 1.937-51.235; HR 8.890, 95% CI 1.157-68.323, respectively) were significantly associated with OS. The pathologic regression rate (GHR; ⩾2/3/<2/3, ⩾50%/<50%) was statistically significantly associated with OS according to a univariate analysis. CONCLUSIONS: Perioperative mFOLFOX6 was a tolerable and effective regimen for gastric cancer. The ypTNM stage was an independent predictor of survival. GHR ⩾50%/<50% could be used as a surrogate marker for selecting a postoperative chemotherapy regimen.