Paclitaxel and mitoxantrone in metastatic breast cancer: a phase II trial of the Italian Oncology Group for Cancer Research.
BACKGROUND
In a previous dose-finding trial, in previously treated patients with metastatic breast cancer (MBC), we showed that the combination of Mitoxantrone (M) and Paclitaxel (P) may be an interesting (response rate: 69%) and well-tolerated regimen. On the basis of these results, our group started a new trial in chemotherapy-naive patients with MBC.


METHODS
Forty-six women entered in this trial, and all patients were evaluated for response and toxicity. Schedule of treatment was P 175 mg/m2 over 3 hr day 1 and M 12 mg/m2 day 1, every 3 weeks. Patients were reevaluated every 3 months and chemotherapy was continued unless tumor progression or unacceptable toxicity occurred.


RESULTS
The intent-to-treat objective response was 61% (95% confidence interval: 49%-78%). Five patients (11%) obtained complete response and 23 (50%) partial response with a median time to failure of 14 months. The median survival was 22 months (range 1-39). The principal toxicity was hematological: 38 (82%) patients had grade 3 to 4 leukopenia; only 2 patients had grade 4 anemia and one grade 4 thrombocytopenia. Nonhematological toxicity (grade 3-4) was mild and cardiotoxicity was infrequent.


CONCLUSIONS
This trial suggests the combination of M and P is an active palliative regimen for patients with MBC. Toxicity was moderate. The infrequent development of cardiotoxicity suggests this combination may not share the problems reported with P plus doxorubicin combinations.
Di Costanzo
Francesco
F
Medical Oncology Unit, Department of Oncology, University Hospital Careggi, Florence, Italy. oncmed02@ao-careggi.toscana.it
Manzione
Luigi
L
Gasperoni
Silvia
S
Bilancia
Domenico
D
Acito
Luigi
L
Angiona
Sabrina
S
Mazzoni
Francesca
F
Giustini
Lucio
L
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D009202:Cardiomyopathies / Q000139:chemically induced; D017024:Chemotherapy, Adjuvant; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage / Q000009:adverse effects; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D016019:Survival Analysis; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000187:drug effects
D008942:Mitoxantrone; D017239:Paclitaxel