© 2007 European Society for Medical Oncology
breast and ovarian cancer |
Liposomal-encapsulated doxorubicin plus cyclophosphamide as first-line therapy in metastatic breast cancer: a phase II multicentric study
1 Oncology Institute, Bari
2 "Vito Fazzi" Hospital, Lecce
3 Casa Sollievo della Sofferenza, San Giovanni Rotondo
4 Civic Hospital, Paola
5 Department of Oncology, University of Palermo, Palermo
6 Centro Catanese di Oncologia, Catania
7 Civic Hospital, Sciacca, Italy
* Correspondence to: Dr F. Giotta, Medical Oncology Department, Oncology Institute, Via Hanhemann 10, 70124 Bari, Italy. Tel/Fax: +39-080-5555621; E-mail: rancescogiotta{at}libero.it
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.
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.
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.
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.
Key words: liposomal-encapsulated doxorubicin, metastatic breast cancer, phase II study