e18263 Background: Surgery with lymph node dissection is the primary treatment for patients with localized resectable gastric cancer. However, the prognosis of locally advanced gastric cancer is poor. One promising approach is neoadjuvant chemotherapy, however, the use of neoadjuvant chemotherapy consisting of oxaliplatin-based regimen for locally advanced gastric cancer has not been reported. Oxaliplatin-induced neurotoxicity may continue after the chemotherapy and interfere with patients’ daily activities. We conducted two prospective phase I study of oxaliplatin-based neoadjuvant chemotherapy for locally advanced gastric cancer and assessed the oxaliplatin-induced neuropathy using the FACT-Ga and FACT-GOG-Ntx assessments. Methods: We planned two cycles of oxaliplatin administration and evaluated oxaliplatin-induced neuropathy using the FACT-Ga and FACT-GOG-Ntx assessments. Patients with locally advanced gastric cancer received two cycles of neoadjuvant chemotherapy with oxaliplatin (100 or 130 mg/m2) on day 1, as well as S-1 (80 mg/m2/day, b.i.d.) or capecitabine (2000 mg/m2/day, b.i.d.) for 14 days, repeated every 3 weeks. They then underwent gastrectomy with curative D2/3 lymph-node dissection followed by adjuvant S-1 (80 mg/m2/day, b.i.d.) for one year. QoL was assessed at baseline and during treatment. Results: Twelve patients were enrolled and fully assessed the QoL. All patients were chmo-naïve and had a good performance status: median age 70y, 67% male. The mean dose intensity of delivered during the neoadjuvant chemotherapy was 96.0% for oxaliplatin. Peripheral neuropathy was observed in all patients but with no functional disorders. Median time to QoL deterioration in FACT-G and FACT-GOG-NTx was 3 weeks. There were correlation between oxaliplatin administration and QoL deterioration by the repeated-measures ANOVA. Conclusions: FACT-GOG-Ntx showed that sensory neuropathy caused a deterioration in QoL immediately after the initiation of preoperative oxaliplatin-based chemotherapy, but that QoL recovered after the neo-adjuvant chemotherapy. Clinical trial information: UMIN000015950,UMIN000015181.
Phase I Study of Epigenetic Priming with Azacitidine Prior to Standard Neoadjuvant Chemotherapy for Patients with Resectable Gastric and Esophageal Adenocarcinoma: Evidence of Tumor Hypomethylation as an Indicator of Major Histopathologic Response
