Paclitaxel plus vinorelbine: an active regimen in metastatic breast cancer patients with prior anthracycline exposure.
OBJECTIVE
To evaluate the anti-tumour activity and tolerance of the combination of paclitaxel plus vinorelbine in metastatic breast cancer (MBC) patients previously treated with anthracyclines.


METHODS
Fifty-six MBC patients who have had at least one previous anthracycline-containing chemotherapy regimen were enrolled in this phase II trial. Patients received paclitaxel (135 mg/m2 over one-hour infusion) and vinorelbine (30 mg/m2) both on day 1 of each three-week course of therapy (maximum eight courses or until disease progression was evident).


RESULTS
Six complete and nineteen partial responses were observed among the fifty-four assessable patients (response rate of 46%, 95% CI: 33%-60%). Responses were observed in all disease sites and in all subsets of patients. The response rates when paclitaxel plus vinorelbine were used as first, second and third-line chemotherapy for metastases were 67%, 41% and 35%, respectively. The response rate among anthracycline-refractory patients was 46% (6 of 13). Median time to progression in the overall patient group was 28 weeks. The main toxicities (CTC grade 2 or more) were alopecia, myelosuppression and peripheral neuropathy (85%, 46% and 19% of patients, respectively). Nine patients (17%) had neutropenic fever in fifteen of the three hundred twenty-eight courses administered (5%).


CONCLUSIONS
The combination of paclitaxel and vinorelbine on day 1 every three weeks is active in MBC patients with prior anthracycline exposure. The regimen is safe, well tolerated and convenient for the patients.
Martín
M
M
Medical Oncology Department, University Hospitals of Madrid, Spain. mmartin@hcsc.es
Lluch
A
A
Casado
A
A
Garciía Carbonero
I
I
de Paz
L
L
Esteban
C
C
Insa
A
A
Alfonso
R
R
García-Conde
J
J
Diaz-Rubio
E
E
D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects*; D012008:Recurrence; D012449:Safety; D013997:Time Factors; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D000903:Antibiotics, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D017239:Paclitaxel; D000077235:Vinorelbine