Phase II study of a gemcitabine and cisplatin combination regimen in taxane resistant metastatic breast cancer

Cancer Chemother Pharmacol. 2007 Feb;59(2):269-74. doi: 10.1007/s00280-006-0266-x. Epub 2006 Jun 9.

Abstract

Purpose: To determine the safety and efficacy of gemcitabine and cisplatin in patients with taxane resistant metastatic breast cancer.

Patients and methods: Thirty-three taxane resistant metastatic breast cancer patients were treated with gemcitabine 1,250 mg/m2 IV infusion over 30 min on days 1 and 8, and with cisplatin 75 mg/m2 by IV infusion over 1 h on day 1 in 21 day cycles.

Results: Of the 30 evaluable patients, there were 9 (30%) partial responses and no complete response, an overall objective response rate of 30%. Median time to progression and median survival duration for all study subjects were 7 (95% CI 5.1-8.9 months) and 15 months (95% CI 10.5-19.5 months), respectively. Toxicities included grade 3 and 4 leucopenia in 10 (30%), thrombocytopenia in 6 (18%), anemia in 2 (6%) and oral mucositis in 2 (6%). No grade 3 or 4 peripheral neuropathy, renal dysfunction, hepatic dysfunction, or nausea/vomiting was observed, and no treatment-related deaths occurred.

Conclusion: The described gemcitabine plus cisplatin combination was found to be an active and tolerable salvage regimen in patients with taxane resistant metastatic breast cancer.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Alopecia / chemically induced
  • Anemia / chemically induced
  • Antimetabolites, Antineoplastic / adverse effects
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / pathology
  • Bridged-Ring Compounds / administration & dosage
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives
  • Disease Progression
  • Drug Administration Schedule
  • Drug Resistance, Neoplasm / drug effects*
  • Female
  • Gemcitabine
  • Humans
  • Infusions, Intravenous
  • Leukopenia / chemically induced
  • Middle Aged
  • Neoplasm Metastasis
  • Recurrence
  • Severity of Illness Index
  • Stomatitis / chemically induced
  • Survival Rate
  • Taxoids / administration & dosage
  • Thrombocytopenia / chemically induced
  • Treatment Outcome

Substances

  • Antimetabolites, Antineoplastic
  • Bridged-Ring Compounds
  • Taxoids
  • Deoxycytidine
  • taxane
  • Cisplatin
  • Gemcitabine