A phase II study of capecitabine plus oxaliplatin as first-line chemotherapy in elderly patients with advanced gastric cancer

Chemotherapy. 2012;58(1):1-7. doi: 10.1159/000335585. Epub 2012 Feb 3.

Abstract

Objective: This study aimed at assessing the efficacy and safety of oxaliplatin plus oral capecitabine (XELOX regimen) as first-line chemotherapy in elderly patients with advanced gastric cancer (AGC).

Patients and methods: Forty-six eligible patients aged ≥70 years with previously untreated AGC received oxaliplatin 130 mg/m(2) intravenously over a 2-hour period on day 1 plus oral capecitabine 850 mg/m(2) twice daily on days 1-14, every 3 weeks.

Results: All patients were evaluable for toxicity and 45 patients for efficacy. A median of 6 cycles (range 1-8) was administered. The overall response rate was 48.9% (95% CI 34-64) with 1 complete response, 21 partial responses, 15 stable diseases and 8 progressions. Median time to progression was 6.0 months (95% CI 3.9-8.1), and the median overall survival was 10.0 months (95% CI 8.6-11.4). Toxicity was fairly mild. Grade 3 toxicities included neutropenia (6.5%), thrombocytopenia (2.2%), nausea (2.2%), vomiting (4.3%), diarrhea (4.3%) as well as peripheral neuropathy (2.2%); grade 4 toxicities occurred in none of the patients.

Conclusion: The XELOX regimen with capecitabine at a lower dose of 850 mg/m(2) is active, fairly tolerable and conveniently delivered as first-line chemotherapy for elderly AGC patients.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Capecitabine
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / therapeutic use
  • Diarrhea / etiology
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / adverse effects
  • Fluorouracil / analogs & derivatives*
  • Fluorouracil / therapeutic use
  • Humans
  • Male
  • Nausea / etiology
  • Neutropenia / etiology
  • Organoplatinum Compounds / administration & dosage*
  • Organoplatinum Compounds / adverse effects
  • Oxaliplatin
  • Oxaloacetates
  • Peripheral Nervous System Diseases / etiology
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / mortality
  • Survival Rate
  • Thrombocytopenia / etiology
  • Vomiting / etiology

Substances

  • Organoplatinum Compounds
  • Oxaloacetates
  • Oxaliplatin
  • Deoxycytidine
  • Capecitabine
  • Fluorouracil

Supplementary concepts

  • XELOX