Abstract
Purpose: This phase II multicenter trial was aimed at investigating the activity of epirubicin-vinorelbine combination as first-line chemotherapy in metastatic breast cancer patients. Patients and Methods: Ninety-seven patients with metastatic breast cancer and no prior exposure to anthracyclines received the following regimen: epirubicin 100 mg/m2 by intravenous (IV) bolus infusion on day 1 plus vinorelbine 25 mg/m2 by 30-minute IV infusion on days 1 and 5, every 3 weeks for up to eight cycles. All patients also received granulocyte colony-stimulating factor (G-CSF) on days 7 to 12 of every cycle. Results: Objective responses, confirmed at least 4 weeks after the first documentation, were observed in 65 out of 92 assessable patients (70.6%; 95% Cl, 62% to 80%). Disease remained stable in 17 patients (18.5%). Responses were observed in all disease sites, being 94% in soft tissue, 60% in bone, and 66% in visceral disease. Median time to response, median duration of response, median time to progression, and median overall survival were 2, 9, 10, and 26 months, respectively. The dose-limiting toxicity was neutropenia, which was grade 4 in 36% of the patients, and was accompanied by fever in 26% of the cases. Grade 3 to 4 mucositis was encountered in 28% of the patients. Other toxicities were mild to moderate. No cardiotoxicity was observed. Conclusion: The epirubicin-vinorelbine combination with G-CSF support has been shown in this study to be highly active as first-line treatment of metastatic breast cancer patients, with significant although transient toxicity. This justifies further evaluation in the neoadjuvant setting and in early-stage breast cancer.
| Original language | English |
|---|---|
| Pages (from-to) | 2689-2694 |
| Number of pages | 6 |
| Journal | Journal of Clinical Oncology |
| Volume | 20 |
| Issue number | 11 |
| DOIs | |
| Publication status | Published - Jun 1 2002 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
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First-line treatment with epirubicin and vinorelbine in metastatic breast cancer. / Vici, Patrizia; Colucci, Giuseppe; Gebbia, Vittorio; Amodio, Antonella; Giotta, Francesco; Belli, Franca; Conti, Francesca; Gebbia, Nicola; Pezzella, Giuseppe; Valerio, Maria Rosaria; Brandi, Mario; Pisconti, Salvatore; Durini, Ernesto; Giannarelli, Diana; Lopez, Massimo.
In: Journal of Clinical Oncology, Vol. 20, No. 11, 01.06.2002, p. 2689-2694.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - First-line treatment with epirubicin and vinorelbine in metastatic breast cancer
AU - Vici, Patrizia
AU - Colucci, Giuseppe
AU - Gebbia, Vittorio
AU - Amodio, Antonella
AU - Giotta, Francesco
AU - Belli, Franca
AU - Conti, Francesca
AU - Gebbia, Nicola
AU - Pezzella, Giuseppe
AU - Valerio, Maria Rosaria
AU - Brandi, Mario
AU - Pisconti, Salvatore
AU - Durini, Ernesto
AU - Giannarelli, Diana
AU - Lopez, Massimo
PY - 2002/6/1
Y1 - 2002/6/1
N2 - Purpose: This phase II multicenter trial was aimed at investigating the activity of epirubicin-vinorelbine combination as first-line chemotherapy in metastatic breast cancer patients. Patients and Methods: Ninety-seven patients with metastatic breast cancer and no prior exposure to anthracyclines received the following regimen: epirubicin 100 mg/m2 by intravenous (IV) bolus infusion on day 1 plus vinorelbine 25 mg/m2 by 30-minute IV infusion on days 1 and 5, every 3 weeks for up to eight cycles. All patients also received granulocyte colony-stimulating factor (G-CSF) on days 7 to 12 of every cycle. Results: Objective responses, confirmed at least 4 weeks after the first documentation, were observed in 65 out of 92 assessable patients (70.6%; 95% Cl, 62% to 80%). Disease remained stable in 17 patients (18.5%). Responses were observed in all disease sites, being 94% in soft tissue, 60% in bone, and 66% in visceral disease. Median time to response, median duration of response, median time to progression, and median overall survival were 2, 9, 10, and 26 months, respectively. The dose-limiting toxicity was neutropenia, which was grade 4 in 36% of the patients, and was accompanied by fever in 26% of the cases. Grade 3 to 4 mucositis was encountered in 28% of the patients. Other toxicities were mild to moderate. No cardiotoxicity was observed. Conclusion: The epirubicin-vinorelbine combination with G-CSF support has been shown in this study to be highly active as first-line treatment of metastatic breast cancer patients, with significant although transient toxicity. This justifies further evaluation in the neoadjuvant setting and in early-stage breast cancer.
AB - Purpose: This phase II multicenter trial was aimed at investigating the activity of epirubicin-vinorelbine combination as first-line chemotherapy in metastatic breast cancer patients. Patients and Methods: Ninety-seven patients with metastatic breast cancer and no prior exposure to anthracyclines received the following regimen: epirubicin 100 mg/m2 by intravenous (IV) bolus infusion on day 1 plus vinorelbine 25 mg/m2 by 30-minute IV infusion on days 1 and 5, every 3 weeks for up to eight cycles. All patients also received granulocyte colony-stimulating factor (G-CSF) on days 7 to 12 of every cycle. Results: Objective responses, confirmed at least 4 weeks after the first documentation, were observed in 65 out of 92 assessable patients (70.6%; 95% Cl, 62% to 80%). Disease remained stable in 17 patients (18.5%). Responses were observed in all disease sites, being 94% in soft tissue, 60% in bone, and 66% in visceral disease. Median time to response, median duration of response, median time to progression, and median overall survival were 2, 9, 10, and 26 months, respectively. The dose-limiting toxicity was neutropenia, which was grade 4 in 36% of the patients, and was accompanied by fever in 26% of the cases. Grade 3 to 4 mucositis was encountered in 28% of the patients. Other toxicities were mild to moderate. No cardiotoxicity was observed. Conclusion: The epirubicin-vinorelbine combination with G-CSF support has been shown in this study to be highly active as first-line treatment of metastatic breast cancer patients, with significant although transient toxicity. This justifies further evaluation in the neoadjuvant setting and in early-stage breast cancer.
UR - http://www.scopus.com/inward/record.url?scp=0036605801&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0036605801&partnerID=8YFLogxK
U2 - 10.1200/JCO.2002.06.039
DO - 10.1200/JCO.2002.06.039
M3 - Article
C2 - 12039931
AN - SCOPUS:0036605801
VL - 20
SP - 2689
EP - 2694
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 11
ER -