Phase II study of paclitaxel combined with capecitabine as second-line treatment for advanced gastric carcinoma after failure of cisplatin-based regimens

Cancer Chemother Pharmacol. 2009 Aug;64(3):549-55. doi: 10.1007/s00280-008-0903-7. Epub 2009 Jan 4.

Abstract

Purpose: To determine the safety and the efficacy of paclitaxel and capecitabine as second-line combination chemotherapy after failure of platinum regimens in advanced gastric cancer.

Methods: Patients with histologically proven gastric cancer and measurable metastatic disease received capecitabine 825 mg/m(2) twice daily (1,650 mg/m(2) per day) on days 1-14 and paclitaxel 175 mg/m(2) by intravenous infusion on day 1 every 3 weeks until disease progression or unacceptable toxicities.

Results: Between June 2003 and October 2005, 26 patients, of median age 59 years (range 41-84 years) were included in the study and were treated by paclitaxel/capecitabine combination. Overall response rate was 34.6% (95%CI = 17.2-55.7%) with one complete response and 42.3% (95%CI = 17.2-55.7%) of patients achieved a stable disease. Median progression-free survival was 4.5 months (95%CI = 4-4.5 months). Median overall survival was 7.5 months (95%CI = 6-10 months). Cumulated overall survival including cisplatin regimens was 15.5 months (95%CI = 11-18 months). Grade 3/4 adverse events included alopecia (30.8%), neutropenia (11.5%), hand foot skin reaction (11.5%), neuropathy (11.5%), arthralgias (7.5%), and anemia (3.8%).

Conclusions: Paclitaxel and capecitabine combination was safe and effective in advanced gastric cancer after failure of cisplatin regimens. The cumulated overall survival of 15.5 months suggests a particular interest of taxanes in second-line treatment after failure of platinum salts.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / pathology
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Capecitabine
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Disease-Free Survival
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / analogs & derivatives
  • Humans
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Paclitaxel / administration & dosage
  • Stomach Neoplasms / drug therapy*
  • Stomach Neoplasms / pathology
  • Survival Rate
  • Treatment Failure
  • Treatment Outcome

Substances

  • Deoxycytidine
  • Capecitabine
  • Paclitaxel
  • Fluorouracil