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A phase II study of lipoplatin (liposomal cisplatin)-vinorelbine combination in HER-2-neunegative metastatic breast cancer

Show simple item record Farhat F.S. Temraz S. Kattan J. Ibrahim K. Bitar N. Haddad N. Jalloul R. Hatoum H.A. Nsouli G. Shamseddine A.I.
dc.contributor.editor Dec-2011 2017-10-05T15:39:41Z 2017-10-05T15:39:41Z 2011
dc.identifier 10.1016/j.clbc.2011.08.005
dc.identifier.issn 15268209
dc.description.abstract Background: Liposomal cisplatin (lipoplatin) has a mechanism of action similar to that of cisplatin, with reduced toxicities and enhanced or similar efficacy. We wanted to assess the efficacy and safety of a lipoplatin- vinorelbine combination in a phase II clinical trial in metastatic breast cancer (MBC). Methods: Thirty-five patients with HER-2-neunegative (HER-2-neu) MBC were enrolled. Lipoplatin 120 mg-m2 (days 1, 8, and 15) and vinorelbine 30 mg-m2 (days 1 and 8) were administered in a 21-day cycle. Results: Thirty-five patients were included in the intent-to-treat (ITT) analysis; 32 patients were evaluable for response. The objective response rate was 53.1percent. Complete response (CR) was achieved in 3 patients (9.4percent), partial response (PR) was seen in 14 patients (43.8percent), stable disease (SD) was obtained in 12 patients (37.5percent), and progressive disease (PD) was seen in 3 patients (9.4percent). Median time to disease progression was 8 months (range 6-10 months). After a median follow-up of 15.5 months, 18 patients were still alive; the median survival time was 22 months (95percent confidence interval [CI], 14-30). A total of 174 cycles were administered. Neutropenia was the most frequent hematologic toxicity, with grade 3-4 neutropenia observed in 44percent of cycles. Febrile neutropenia was observed in 4 patients (11.4percent). No grade 3-4 nephrotoxicity or neuropathy was noted. Grade 1-2 nephrotoxicity occurred in 8 patients (22.9percent) and grade 3 vomiting was seen in 3 patients (8.6percent). Conclusions: The results of this trial reveal that vinorelbine-lipoplatin is effective in treating patients with MBC. This regimen is well tolerated with no grade 3-4 nephrotoxicity or neuropathy. The investigation of this regimen as first-line treatment in MBC is warranted. © 2011 Elsevier Inc. All rights reserved.
dc.format.extent Pages: (384-389)
dc.language English
dc.publisher DALLAS
dc.relation.ispartof Publication Name: Clinical Breast Cancer; Publication Year: 2011; Volume: 11; no. 6; Pages: (384-389);
dc.source Scopus
dc.title A phase II study of lipoplatin (liposomal cisplatin)-vinorelbine combination in HER-2-neunegative metastatic breast cancer
dc.type Article
dc.contributor.affiliation Farhat, F.S., Hammoud Hospital University Medical Center, Saida, Lebanon
dc.contributor.affiliation Temraz, S., Division of Hematology-Oncology, Department of Internal Medicine, American University of Beirut Medical Center, PO Box: 113-6044, Beirut 1107 2802, Lebanon
dc.contributor.affiliation Kattan, J., Hotel Dieu de France University Hospital, Beirut, Lebanon
dc.contributor.affiliation Ibrahim, K., Hammoud Hospital University Medical Center, Saida, Lebanon
dc.contributor.affiliation Bitar, N., Sahel General Hospital, Beirut, Lebanon, Rafik Hariri University Hospital, Beirut, Lebanon
dc.contributor.affiliation Haddad, N., Pierre Fabre Medicament, Beirut, Lebanon
dc.contributor.affiliation Jalloul, R., Rafik Hariri University Hospital, Beirut, Lebanon
dc.contributor.affiliation Hatoum, H.A., Division of Hematology-Oncology, Department of Internal Medicine, American University of Beirut Medical Center, PO Box: 113-6044, Beirut 1107 2802, Lebanon
dc.contributor.affiliation Nsouli, G., Rafik Hariri University Hospital, Beirut, Lebanon
dc.contributor.affiliation Shamseddine, A.I., Division of Hematology-Oncology, Department of Internal Medicine, American University of Beirut Medical Center, PO Box: 113-6044, Beirut 1107 2802, Lebanon
dc.contributor.authorAddress Shamseddine, A.I.; Division of Hematology-Oncology, Department of Internal Medicine, American University of Beirut Medical Center, PO Box: 113-6044, Beirut 1107 2802, Lebanon; email:
dc.contributor.authorCorporate University: American University of Beirut Medical Center; Faculty: Faculty of Medicine; Department: Internal Medicine; Division: Hematology-Oncology;
dc.contributor.authorDepartment Internal Medicine
dc.contributor.authorDivision Hematology-Oncology
dc.contributor.authorFaculty Faculty of Medicine
dc.contributor.authorInitials Farhat, FS
dc.contributor.authorInitials Temraz, S
dc.contributor.authorInitials Kattan, J
dc.contributor.authorInitials Ibrahim, K
dc.contributor.authorInitials Bitar, N
dc.contributor.authorInitials Haddad, N
dc.contributor.authorInitials Jalloul, R
dc.contributor.authorInitials Hatoum, HA
dc.contributor.authorInitials Nsouli, G
dc.contributor.authorInitials Shamseddine, AI
dc.contributor.authorReprintAddress Shamseddine, AI (reprint author), Amer Univ Beirut, Med Ctr, Dept Internal Med, Div Hematol Oncol, POB 113-6044, Beirut 11072802, Lebanon.
dc.contributor.authorUniversity American University of Beirut Medical Center
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dc.description.citedCount 8
dc.description.citedTotWOSCount 11
dc.description.citedWOSCount 10
dc.format.extentCount 6
dc.identifier.coden CBCLB
dc.identifier.pubmedID 21993011
dc.identifier.scopusID 82255166309
dc.publisher.address 3500 MAPLE AVENUE, STE 750, DALLAS, TX 75219-3931 USA
dc.relation.ispartOfISOAbbr Clin. Breast Cancer
dc.relation.ispartOfIssue 6
dc.relation.ispartofPubTitle Clinical Breast Cancer
dc.relation.ispartofPubTitleAbbr Clin. Breast Cancer
dc.relation.ispartOfVolume 11
dc.source.ID WOS:000298159200006
dc.type.publication Journal
dc.subject.otherAuthKeyword Breast cancer
dc.subject.otherAuthKeyword Lipoplatin
dc.subject.otherAuthKeyword Metastatic
dc.subject.otherAuthKeyword Toxicity
dc.subject.otherAuthKeyword Vinorelbine
dc.subject.otherChemCAS epidermal growth factor receptor 2, 137632-09-8
dc.subject.otherChemCAS magnesium, 7439-95-4
dc.subject.otherChemCAS navelbine, 71486-22-1
dc.subject.otherChemCAS Cisplatin, 15663-27-1
dc.subject.otherChemCAS Receptor, erbB-2,
dc.subject.otherChemCAS Vinblastine, 865-21-4
dc.subject.otherChemCAS lipoplatin
dc.subject.otherChemCAS vinorelbine, 71486-22-1
dc.subject.otherIndex anthracycline
dc.subject.otherIndex cisplatin derivative
dc.subject.otherIndex epidermal growth factor receptor 2
dc.subject.otherIndex lipoplatin
dc.subject.otherIndex magnesium
dc.subject.otherIndex navelbine
dc.subject.otherIndex taxane derivative
dc.subject.otherIndex unclassified drug
dc.subject.otherIndex adult
dc.subject.otherIndex aged
dc.subject.otherIndex anemia
dc.subject.otherIndex anorexia
dc.subject.otherIndex article
dc.subject.otherIndex asthenia
dc.subject.otherIndex breast cancer
dc.subject.otherIndex cancer growth
dc.subject.otherIndex cancer survival
dc.subject.otherIndex clinical article
dc.subject.otherIndex diarrhea
dc.subject.otherIndex drug efficacy
dc.subject.otherIndex drug safety
dc.subject.otherIndex drug tolerability
dc.subject.otherIndex drug treatment failure
dc.subject.otherIndex drug withdrawal
dc.subject.otherIndex dyspnea
dc.subject.otherIndex febrile neutropenia
dc.subject.otherIndex female
dc.subject.otherIndex hair loss
dc.subject.otherIndex hearing loss
dc.subject.otherIndex human
dc.subject.otherIndex human tissue
dc.subject.otherIndex hypomagnesemia
dc.subject.otherIndex liver toxicity
dc.subject.otherIndex metastatic breast cancer
dc.subject.otherIndex multiple cycle treatment
dc.subject.otherIndex nausea and vomiting
dc.subject.otherIndex nephrotoxicity
dc.subject.otherIndex neuropathy
dc.subject.otherIndex neutropenia
dc.subject.otherIndex pain
dc.subject.otherIndex phase 2 clinical trial
dc.subject.otherIndex phlebitis
dc.subject.otherIndex stomatitis
dc.subject.otherIndex thrombocytopenia
dc.subject.otherIndex treatment response
dc.subject.otherIndex Adolescent
dc.subject.otherIndex Adult
dc.subject.otherIndex Aged
dc.subject.otherIndex Antineoplastic Combined Chemotherapy Protocols
dc.subject.otherIndex Breast Neoplasms
dc.subject.otherIndex Cisplatin
dc.subject.otherIndex Disease-Free Survival
dc.subject.otherIndex Female
dc.subject.otherIndex Humans
dc.subject.otherIndex Middle Aged
dc.subject.otherIndex Neoplasm Metastasis
dc.subject.otherIndex Receptor, erbB-2
dc.subject.otherIndex Sensory Receptor Cells
dc.subject.otherIndex Treatment Outcome
dc.subject.otherIndex Vinblastine
dc.subject.otherIndex Young Adult
dc.subject.otherKeywordPlus ANTHRACYCLINE TREATMENT
dc.subject.otherKeywordPlus LIPOSOMAL CISPLATIN
dc.subject.otherKeywordPlus SALVAGE REGIMEN
dc.subject.otherKeywordPlus VINORELBINE
dc.subject.otherKeywordPlus DOCETAXEL
dc.subject.otherKeywordPlus CHEMOTHERAPY
dc.subject.otherKeywordPlus MULTICENTER
dc.subject.otherKeywordPlus PACLITAXEL
dc.subject.otherKeywordPlus THERAPY
dc.subject.otherKeywordPlus TRIAL
dc.subject.otherWOS Oncology

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