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.
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.
Queisser
W
W
Onkologisches Zentrum, III. Medizinische Klinik, Fakultät für Klinische Medizin Mannheim der Universität Heidelberg, Mannheim.
Doss
A
A
Wander
H E
HE
Bremer
K
K
Becher
R
R
Rieche
K
K
Delgado
F M
FM
Edler
L
L
D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D002214:Capsules; D002277:Carcinoma / Q000188:drug therapy / Q000401:mortality; D002285:Carcinoma, Intraductal, Noninfiltrating / Q000188:drug therapy / Q000401:mortality; D003131:Combined Modality Therapy; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy / Q000401:mortality; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D000970:Antineoplastic Agents; D002214:Capsules; D014747:Vinblastine; D000077235:Vinorelbine