A phase II trial of vinorelbine and thiotepa in metastatic breast cancer.
BACKGROUND
Vinorelbine as single-agent has achieved an overall response rate of > 20% as second-line treatment and 40%-50% as first-line treatment. The aim of this study was to evaluate the activity and toxicity of the combination of vinorelbine and thiotepa as second-line treatment in patients with metastatic breast cancer.


METHODS
Thirty-three patients (31: anthracycline-based chemotherapy, 16: high-dose epirubicin) were given vinorelbine 30 mg/m2 and thiotepa 12 mg/m2 d 1 and 8 every 21 days.


RESULTS
Among the 32 evaluable patients two complete responses and seven partial responses were observed, for an overall response rate of 28% (C.I. 12-44). The median duration of response was 9 months and the median time to progression 6 months. Significant toxicity was primarily leukopenia (72%); anemia was also frequent (48%) as well as local phlebitis (39%).


CONCLUSIONS
The present study has shown this combination to be active as second-line treatment, and its toxic effects have been well tolerated. It should be considered a reasonable option for patients with metastatic disease who have already been treated with anthracyclines.
Fabi
A
A
Servizio di Oncologia Medica, Istituto Regina Elena per lo Studio e la Cura dei Tumori, Rome, Italy.
Tonachella
R
R
Savarese
A
A
Cirulli
S
S
Tomao
S
S
Conte
E
E
Cognetti
F
F
D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001855:Bone Marrow Diseases / Q000139:chemically induced; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004351:Drug Resistance; D005260:Female; D006801:Humans; D015993:Life Tables; D008593:Menopause; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010689:Phlebitis / Q000139:chemically induced; D012074:Remission Induction; D016879:Salvage Therapy; D016019:Survival Analysis; D013852:Thiotepa / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
D014747:Vinblastine; D013852:Thiotepa; D000077235:Vinorelbine