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Liposomal-encapsulated doxorubicin plus cyclophosphamide as first-line therapy in metastatic breast cancer: a phase II multicentric study.
- Source :
-
Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2007 Jun; Vol. 18 Suppl 6, pp. vi66-9. - Publication Year :
- 2007
-
Abstract
- Background: The objective of this study is to evaluate the efficacy and toxicity of the liposome-encapsulated doxorubicin (TLC D-99) plus cyclophosphamide (CTX) as first-line treatment of metastatic breast cancer in light of the potential cardioprotective effect of TLC D-99 as compared with conventional doxorubicin.<br />Materials and Methods: Sixty-seven patients as defined according Simon's two-stage phase II design were enrolled. They received TLC D-99 at the dosage of 60 mg/m2 plus CTX 600 mg/m2, with cycles repeated every 3 weeks. Cardiac function was assessed by ultrasonography at baseline and every two cycles.<br />Results: The principal characteristics of the 67 enrolled patients were as follows: median age 60 years (range 33-75), median World Health Organization performance status of 1 (range 0-2) and dominant disease site (viscera/bone/soft tissue): 47/15/15 There were nine complete responses and 32 partial responses for an overall response rate of 64%; a further 14 patients had stable disease and the remaining nine patients progressed. Median number of administered cycles was six. Median duration of response was 10 and 9 months, respectively, for complete responders and partial responders. Median duration of survival was 17+ months (range 3 to 33+). Hematological toxicity consisted in leucopenia (G1-G2) in 21 patients and anemia (G1-G2) in 20 patients; G1 thrombocytopenia was observed only in 2 patients. Non-hematological toxicity was generally mild with G1-G2 nausea/vomiting in 23 patients and G1-G2 mucositis in 10. Hair loss was registered in 30 patients and it was G2 in 14 patients. As to concern cardiac toxicity, one patient developed an asymptomatic 20% decline of left ventricular ejection fraction from the baseline value.<br />Conclusions: The results of our study show that the combination of TLC D-99 plus CTX is active and well tolerated, with no unexpected toxicity.
- Subjects :
- Adult
Aged
Antibiotics, Antineoplastic administration & dosage
Antibiotics, Antineoplastic adverse effects
Antineoplastic Agents, Alkylating administration & dosage
Antineoplastic Agents, Alkylating adverse effects
Antineoplastic Combined Chemotherapy Protocols adverse effects
Breast Neoplasms pathology
Carcinoma, Squamous Cell drug therapy
Carcinoma, Squamous Cell secondary
Cyclophosphamide administration & dosage
Cyclophosphamide adverse effects
Doxorubicin administration & dosage
Doxorubicin adverse effects
Female
Humans
Liposomes
Middle Aged
Skin Neoplasms drug therapy
Skin Neoplasms secondary
Soft Tissue Neoplasms drug therapy
Soft Tissue Neoplasms secondary
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Breast Neoplasms drug therapy
Drug Delivery Systems
Subjects
Details
- Language :
- English
- ISSN :
- 0923-7534
- Volume :
- 18 Suppl 6
- Database :
- MEDLINE
- Journal :
- Annals of oncology : official journal of the European Society for Medical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 17591836
- Full Text :
- https://doi.org/10.1093/annonc/mdm228