Phase I Study of Neoadjuvant Chemotherapy with Capecitabine and Oxaliplatin for Locally Advanced Gastric Cancer

Anticancer Res. 2017 Jul;37(7):3703-3710. doi: 10.21873/anticanres.11742.

Abstract

Aim: To determine the recommended dose of neoadjuvant chemotherapy of combined capecitabine and oxalipatin (G-XELOX) for locally advanced gastric cancer.

Patients and methods: Patients received two cycles of neoadjuvant chemotherapy with oxaliplatin on day 1 and capecitabine (2,000 mg/m2/day, b.i.d.) on days 1-14, repeated every 3 weeks. They then underwent gastrectomy with curative D2/3 lymph-node dissection followed by adjuvant therapy with S-1 for 1 year. De-escalation of oxaliplatin dose was planned (starting at level 1, oxalipatin 130 mg/m2).

Results: Six patients were enrolled. The maximum tolerated dose was not reached at level 1. Oxaliplatin at 130 mg/m2 combined with capecitabine at 2,000 mg/m2/day, b.i.d. had acceptable toxicity. No treatment-related death occurred. Most frequent drug-related adverse events during neoadjuvant G-XELOX were nausea and peripheral sensory neuropathy. One patient declined surgical resection, leaving five undergoing resection with curative intent, of whom four achieved pathological down-staging after neoadjuvant G-XELOX.

Conclusion: Neoadjuvant G-XELOX was feasible in patients with locally advanced gastric cancer.

Keywords: Gastric cancer; capecitabine; neoadjuvant chemotherapy; oxaliplatin; phase I; xeloda.

Publication types

  • Clinical Trial, Phase I

MeSH terms

  • Aged
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Capecitabine / adverse effects
  • Capecitabine / therapeutic use
  • Drug Combinations
  • Female
  • Gastrectomy
  • Humans
  • Male
  • Maximum Tolerated Dose
  • Neoadjuvant Therapy* / adverse effects
  • Neoplasm Staging
  • Organoplatinum Compounds / adverse effects
  • Organoplatinum Compounds / therapeutic use
  • Oxaliplatin
  • Oxonic Acid / adverse effects
  • Oxonic Acid / therapeutic use
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / pathology
  • Stomach Neoplasms / surgery
  • Tegafur / adverse effects
  • Tegafur / therapeutic use

Substances

  • Antineoplastic Agents
  • Drug Combinations
  • Organoplatinum Compounds
  • Oxaliplatin
  • S 1 (combination)
  • Tegafur
  • Oxonic Acid
  • Capecitabine