Phase II Study of Pegylated Liposomal Doxorubicin plus Vinorelbine in Breast Cancer with Previous Anthracycline Exposure.
dc.contributor.author | Martín, Miguel | |
dc.contributor.author | García-Donas, Jesús | |
dc.contributor.author | Casado, Antonio | |
dc.contributor.author | Moreno, Fernando | |
dc.contributor.author | Grande-Pulido, E. | |
dc.contributor.author | Díaz-Rubio, E. | |
dc.date.accessioned | 2024-01-24T08:25:39Z | |
dc.date.available | 2024-01-24T08:25:39Z | |
dc.date.issued | 2004 | |
dc.description.abstract | Thirty-five patients with metastatic breast cancer (MBC) entered a phase II study of pegylated liposomal doxorubicin 35 mg/m2 intravenously (I.V.) on day 1 plus vinorelbine 30 mg/m2 I.V. on day 1 every 4 weeks. Patients were required to have measurable disease, previous chemotherapy with an anthracycline-containing regimen, and a normal left ventricular ejection fraction (LVEF). Thirty-four patients were assessable for response and toxicity. The overall response rate (on an intent-to-treat basis) was 35% (12 of 34; 95% CI, 20%-54%). One complete response and 11 partial responses were noted. In addition, 14 patients (41%) had stable disease of > 4 months duration, and 7 patients (20.5%) had disease progression. The response rates to the combination when it was used as first- and second-line chemotherapy were 31% (4 of 13) and 38% (8 of 21), respectively. Median time to disease progression was 7 months (range, 1–35 months) and median overall survival was 13 months (range, 2 to > 62 months). Neutropenia was the most frequent toxicity (grade 4 in 44% of patients and 19% of cycles), but neutropenic fever was seen in only 3 cases. No septic deaths occurred. Nonhematologic grade 3 side effects included skin toxicity (palmar-plantar erythrodysesthesia syndrome, 6%) and mucositis (15%). Late alopecia was seen in 53% of patients (grade 1 in 41%, and grade 2 in 12%). The median LVEFs were 64% (range, 50%-81%) at baseline and 62% (range, 37%–70%) after treatment. Three patients presented an LVEF decrease to < 50%; however, no clinical heart failure was noted, and 2 of these patients recovered normal values after cessation of therapy. The combination of pegylated liposomal doxorubicin and vinorelbine can be safely administered to patients with anthracycline-pretreated MBC and is active in this population. | spa |
dc.description.extent | 5,92 MB | spa |
dc.identifier.doi | 10.3816/CBC.2004.n.041 | spa |
dc.identifier.issn | 1938-0666 | spa |
dc.identifier.uri | https://hdl.handle.net/10641/3807 | |
dc.language.iso | eng | spa |
dc.publisher | Clinical Breast Cancer | spa |
dc.relation.publisherversion | https://www.clinical-breast-cancer.com/article/S1526-8209(11)70390-1/pdf | spa |
dc.rights | Atribución-NoComercial-SinDerivadas 3.0 España | * |
dc.rights.accessRights | metadata only access | spa |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/es/ | * |
dc.subject | Cardiac toxicity | spa |
dc.subject | Hand-foot syndrome | spa |
dc.subject | Left ventricular ejection fraction | spa |
dc.subject | Metastatic disease | spa |
dc.title | Phase II Study of Pegylated Liposomal Doxorubicin plus Vinorelbine in Breast Cancer with Previous Anthracycline Exposure. | spa |
dc.type | journal article | spa |
dc.type.hasVersion | SMUR | spa |
dspace.entity.type | Publication |