Phase II study of vinorelbine by oral route (in a hard gelatine capsule) for metastatic breast cancer patients. A trial of the phase I/II study group of the Association for Medical Oncology of the German Cancer Society

Onkologie. 1991 Feb;14(1):35-9. doi: 10.1159/000216942.

Abstract

17 patients with advanced low-risk breast carcinoma not previously pretreated by cytostatic agents were treated by Vinorelbine (VIN), 5'-Nor-anhydro-vinblastine, a new semisynthetic compound of the vinca alkaloid series. A dose of 130 mg per week was administered in a hard gelatine formulation for at least eight weeks. Out of 15 evaluable patients, no complete or partial remission was observed. However, there were 9 patients (60%) achieving no change and tumor stabilization, respectively, lasting for a median of 3.0 months. Main toxicities were leukopenia (17.7%, WHO grade 3-4), nausea and vomiting (17.7%, WHO grade 3-4), and acute diarrhea (70.6%, WHO grade 1-4). Thus, further trials with the oral medication used for this study are not recommended.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents*
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / mortality
  • Capsules
  • Carcinoma / drug therapy
  • Carcinoma / mortality
  • Carcinoma, Intraductal, Noninfiltrating / drug therapy
  • Carcinoma, Intraductal, Noninfiltrating / mortality
  • Combined Modality Therapy
  • Drug Evaluation
  • Female
  • Follow-Up Studies
  • Humans
  • Middle Aged
  • Neoplasm Metastasis
  • Neoplasms, Hormone-Dependent / drug therapy
  • Neoplasms, Hormone-Dependent / mortality
  • Survival Rate
  • Vinblastine / administration & dosage
  • Vinblastine / adverse effects
  • Vinblastine / analogs & derivatives*
  • Vinorelbine

Substances

  • Antineoplastic Agents
  • Capsules
  • Vinblastine
  • Vinorelbine