Phase I study of oral vinorelbine and capecitabine in patients with metastatic breast cancer.
BACKGROUND
To determine the recommended doses of oral vinorelbine (VN) and capecitabine (C) in metastatic breast cancer.


METHODS
Eighteen patients with metastatic breast cancer received oral VN (on days 1 and 8) and C (on days 1 to 14) every three weeks at one of four dose levels: I) 60 mg/m(2) and 1650 mg/m(2)/day; II) 70 mg/m(2) and 1650 mg/m(2)/day; III) 70 mg/m(2) and 2000 mg/m(2)/day; IV) 80 mg/m(2) and 2000 mg/m(2)/day, respectively. The primary endpoint was to determine the recommended doses for the combination of oral VN and C in metastatic breast cancer. Secondary endpoints include evaluating response rate, safety profile and whether or not VN dosage escalation was required.


RESULTS
Severe neutropenia occurred in 28% of patients; and severe anaemia and leucopenia were observed in one patient each (6%). One patient developed febrile neutropenia. Non-hematological toxicities were rare. The response rate was 28% (95% CI: 10-54) in the intention-to-treat population.


CONCLUSIONS
The recommended dose is 80 mg/m(2) of oral VN on days 1 and 8, and 2000 mg/m(2)/day of C from days 1 to 14 in three weekly cycles. A phase II study with this schedule is currently under way.
Anton
Antonio
A
Medical Oncology Service, University Hospital Miguel Servet, Avda. Isabel La Católica 1-3, 50009 Zaragoza, Spain. aantont@salud.aragon.es
Lluch
Ana
A
Casado
Antonio
A
Provencio
Mariano
M
Muñoz
Montserrat
M
Lao
Juan
J
Bermejo
Begoña
B
Paules
Ana B
AB
Gayo
Javier
J
Martin
Miguel
M
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
D003841:Deoxycytidine; D014747:Vinblastine; D000069287:Capecitabine; D000077235:Vinorelbine; D005472:Fluorouracil