Abstract
Background: This study was designed to explore the effectiveness and tolerability of a weekly regimen of epirubicin and vinorelbine plus granulocyte colony-stimulating factor (G-CSF). Patients and methods: Fifty- two patients with previously untreated advanced breast cancer were treated with epirubicin (25 mg/m2/week) and vinorelbine (25 mg/m2/week) with G-CSF support, for 24 consecutive weeks. Results: The median number of courses per patient was 22 (range 10-24). The administered dose intensity was 23 mg/m2 for both epirubicin and vinorelbine. Ten complete responses (19%) and 30 partial responses (58%) were obtained, for an overall response rate of 77%. None of the patients progressed during treatment. The median response duration and time to progression were both 10 months. A total of 1065 courses were assessed for toxicity. Grade 3 neutropenia was the most common toxic manifestation, (39% of patients), without febrile neutropenia or neutropenic sepsis. Two patients had grade 3 cardiac toxicity, which regressed without sequelae. Median survival was 31 months, with a median follow-up of 24 months (range 9-40). Conclusions: Owing to its effectiveness and tolerability, the weekly regimen of epirubicin and vinorelbine plus G-CSF may represent an acceptable alternative for patients with untreated metastatic breast cancer. It could be tested in the adjuvant and neoadjuvant setting.
| Original language | English |
|---|---|
| Pages (from-to) | 937-942 |
| Number of pages | 6 |
| Journal | Annals of Oncology |
| Volume | 10 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - 1999 |
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Keywords
- Breast cancer
- Dose-intensity
- Epirubicin
- G-CSF
- Vinorelbine
- Weekly schedule
ASJC Scopus subject areas
- Oncology
- Cancer Research
Cite this
Phase II study of epirubicin and vinorelbine with granulocyte colony- stimulating factor : A high-activity, dose-dense weekly regimen for advanced breast cancer. / Nisticò, C.; Garufi, C.; Barni, S.; Frontini, L.; Gallà, D. A P; Giannarelli, D.; Vaccaro, A.; D'Ottavio, A. M.; Terzoli, E.
In: Annals of Oncology, Vol. 10, No. 8, 1999, p. 937-942.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Phase II study of epirubicin and vinorelbine with granulocyte colony- stimulating factor
T2 - A high-activity, dose-dense weekly regimen for advanced breast cancer
AU - Nisticò, C.
AU - Garufi, C.
AU - Barni, S.
AU - Frontini, L.
AU - Gallà, D. A P
AU - Giannarelli, D.
AU - Vaccaro, A.
AU - D'Ottavio, A. M.
AU - Terzoli, E.
PY - 1999
Y1 - 1999
N2 - Background: This study was designed to explore the effectiveness and tolerability of a weekly regimen of epirubicin and vinorelbine plus granulocyte colony-stimulating factor (G-CSF). Patients and methods: Fifty- two patients with previously untreated advanced breast cancer were treated with epirubicin (25 mg/m2/week) and vinorelbine (25 mg/m2/week) with G-CSF support, for 24 consecutive weeks. Results: The median number of courses per patient was 22 (range 10-24). The administered dose intensity was 23 mg/m2 for both epirubicin and vinorelbine. Ten complete responses (19%) and 30 partial responses (58%) were obtained, for an overall response rate of 77%. None of the patients progressed during treatment. The median response duration and time to progression were both 10 months. A total of 1065 courses were assessed for toxicity. Grade 3 neutropenia was the most common toxic manifestation, (39% of patients), without febrile neutropenia or neutropenic sepsis. Two patients had grade 3 cardiac toxicity, which regressed without sequelae. Median survival was 31 months, with a median follow-up of 24 months (range 9-40). Conclusions: Owing to its effectiveness and tolerability, the weekly regimen of epirubicin and vinorelbine plus G-CSF may represent an acceptable alternative for patients with untreated metastatic breast cancer. It could be tested in the adjuvant and neoadjuvant setting.
AB - Background: This study was designed to explore the effectiveness and tolerability of a weekly regimen of epirubicin and vinorelbine plus granulocyte colony-stimulating factor (G-CSF). Patients and methods: Fifty- two patients with previously untreated advanced breast cancer were treated with epirubicin (25 mg/m2/week) and vinorelbine (25 mg/m2/week) with G-CSF support, for 24 consecutive weeks. Results: The median number of courses per patient was 22 (range 10-24). The administered dose intensity was 23 mg/m2 for both epirubicin and vinorelbine. Ten complete responses (19%) and 30 partial responses (58%) were obtained, for an overall response rate of 77%. None of the patients progressed during treatment. The median response duration and time to progression were both 10 months. A total of 1065 courses were assessed for toxicity. Grade 3 neutropenia was the most common toxic manifestation, (39% of patients), without febrile neutropenia or neutropenic sepsis. Two patients had grade 3 cardiac toxicity, which regressed without sequelae. Median survival was 31 months, with a median follow-up of 24 months (range 9-40). Conclusions: Owing to its effectiveness and tolerability, the weekly regimen of epirubicin and vinorelbine plus G-CSF may represent an acceptable alternative for patients with untreated metastatic breast cancer. It could be tested in the adjuvant and neoadjuvant setting.
KW - Breast cancer
KW - Dose-intensity
KW - Epirubicin
KW - G-CSF
KW - Vinorelbine
KW - Weekly schedule
UR - http://www.scopus.com/inward/record.url?scp=0032834188&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0032834188&partnerID=8YFLogxK
U2 - 10.1023/A:1008324329562
DO - 10.1023/A:1008324329562
M3 - Article
C2 - 10509155
AN - SCOPUS:0032834188
VL - 10
SP - 937
EP - 942
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 8
ER -