[Results of clinical study with epirubicin hydrochloride injectable solution and cyclophosphamide in breast cancer]

Gan To Kagaku Ryoho. 1998 Sep;25(11):1721-9.
[Article in Japanese]


A 10-center cooperative clinical study with a new formulation of epirubicin hydrochloride injectable solution (Epirubicin-RTU) was conducted in patients with breast cancer. One course of treatment consisted of one intravenous administration of Epirubicin-RTU at the dose of 60 mg/m2 followed by a 3-week drug-free interval and concomitant daily administration of oral cyclophosphamide at 100 mg/day during the period between Days 1 through 14. At least, two courses of treatment were given. Among 20 registered cases, all 20 cases were eligible and 16 cases completed the whole course of the study. In 16 completers, PR was observed in 5 cases, indicating the efficacy rate of 31.3% (5/16).. No local irritation was observed at the injection sites. Adverse reactions frequently observed were leukopenia, neutropenia, anorexia, alopecia, and nausea/vomiting, which were all reversible and tolerable. From the above results, Adverse reactions both locally and systemically were tolerable. Intravenous administration of Epirubicin-RTU was considered to be useful for the treatment of breast cancer.

Publication types

  • Clinical Trial
  • English Abstract
  • Multicenter Study

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Alopecia / chemically induced
  • Anorexia / chemically induced
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / chemistry
  • Breast Neoplasms / drug therapy*
  • Cyclophosphamide / administration & dosage
  • Cyclophosphamide / adverse effects
  • Drug Administration Schedule
  • Etoposide / administration & dosage
  • Etoposide / adverse effects
  • Female
  • Humans
  • Infusions, Intravenous
  • Middle Aged
  • Nausea / chemically induced
  • Receptors, Estrogen / analysis
  • Vomiting / chemically induced


  • Receptors, Estrogen
  • Etoposide
  • Cyclophosphamide

Supplementary concepts

  • EC regimen