The multicenter, phase II prospective study of paclitaxel plus capecitabine as first-line chemotherapy in advanced gastric carcinoma

Oncologist. 2014 Feb;19(2):173-4. doi: 10.1634/theoncologist.2013-0137. Epub 2014 Jan 23.

Abstract

Background: The efficacy and toxicity of paclitaxel plus capecitabine (PX) as first-line treatment in advanced gastric cancer (AGC) was evaluated.

Methods: Patients with previously untreated AGC were included. PX was given every 3 weeks until a maximum of six cycles or progression. Capecitabine monotherapy was continued for patients without disease progression. The primary endpoint was progression-free survival, and secondary endpoints were objective response rate, overall survival (OS), and safety.

Results: Overall, 194 patients were treated per protocol and one patient was excluded because of allergy to paclitaxel. Response was evaluated in 175 patients, with an objective response rate of 34.8%. After a median follow-up of 33.2 months, disease progression was observed in 141 patients, 137 died, and 16 were lost to follow-up, with progression-free survival of 188 days and OS of 354 days. In multivariate Cox regression analysis, no factor remained an independent predictor of OS. Forty-five patients who received capecitabine monotherapy after PX had longer OS (531 days). Adverse events were mild (Fig. 1), and the most common grade 3-4 toxicities were leucopenia and neutropenia.

Conclusion: PX as a first-line treatment has promising efficacy in AGC. Based on these data, a phase III study has been launched for further investigation.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Capecitabine
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives
  • Disease Progression
  • Disease-Free Survival
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / adverse effects
  • Fluorouracil / analogs & derivatives
  • Humans
  • Male
  • Paclitaxel / administration & dosage
  • Paclitaxel / adverse effects
  • Prospective Studies
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / pathology
  • Survival Analysis

Substances

  • Deoxycytidine
  • Capecitabine
  • Paclitaxel
  • Fluorouracil

Associated data

  • ChiCTR/TRC-07000014