Phase II study of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer

被引:62
作者
Rivera, E
Valero, V
Arun, B
Royce, M
Adinin, R
Hoelzer, K
Walters, R
Wade, JL
Pusztai, L
Hortobagyi, GN
机构
[1] Univ Texas, MD Anderson Canc Ctr, Dept Breast Med Oncol, Div Canc Med,Unit 424, Houston, TX 77030 USA
[2] MD Anderson Community Clin Oncol Program, Decatur, IL USA
关键词
D O I
10.1200/JCO.2003.03.111
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose : We conducted a phase II clinical trial to determine the clinical efficacy and safety of pegylated liposomal doxorubicin in combination with gemcitabine in patients with metastatic breast cancer. Patients and Methods: Patients were eligible if they had measurable disease, no prior chemotherapy for metastatic disease, and a performance status less than or equal to 2 on the Zubrod scale. Patients received pegylated liposomal doxorubicin 24 mg/m(2) intravenously on day 1, plus gemcitabine 800 mg/m(2) intravenously on days 1 and 8 of each 21-day cycle. Results: Of 49 patients enrolled, 27 had received prior adjuvant chemotherapy (19 with an anthracycline). Prior median cumulative anthracycline dose was 240 mg/m(2). In total, three complete responses and 21 partial responses were achieved in 46 assessable patients, for an overall response rate of 52% (95% confidence interval, 37% to 67%). Responses were observed in 11 (58%) of 19 patients with previous anthracycline exposure. Median response duration was 5.6 months, time to progression was 4.5 months, and overall survival was 16.1 months. Although the most common grade 3 to 4 toxicities were hematologic, few neutropenic complications resulted. The most frequent nonhematologic toxicities were nausea and vomiting, fatigue, stomatitis, and hand-foot syndrome. One patient previously treated with an anthracycline developed a transient decrease (21%) in the left ventricular ejection fraction, with cardiac function recovering within 2 months. Conclusion: Pegylated liposomal doxcrubicin in combination with gemcitabine is active and well tolerated in patients with metastatic breast cancer. Median overall survival was 16.1 months, and approximately 78% of patients derived clinical benefit from treatment. This regimen represents a therapeutic option for patients receiving front-line therapy for their metastatic breast cancer. (C) 2003 by American Society of Clinical Oncology.
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页码:3249 / 3254
页数:6
相关论文
共 32 条
[1]  
[Anonymous], 2002, P AM SOC CLIN ONCOL
[2]   The use of cardiac biopsy to demonstrate reduced cardiotoxicity in AIDS Kaposi's sarcoma patients treated with pegylated liposomal doxorubicin [J].
Berry, G ;
Billingham, M ;
Alderman, E ;
Richardson, P ;
Torti, F ;
Lum, B ;
Patek, A ;
Martin, FJ .
ANNALS OF ONCOLOGY, 1998, 9 (07) :711-716
[3]   Gemcitabine as first-line therapy in patients with metastatic breast cancer: A phase II trial [J].
Blackstein, M ;
Vogel, CL ;
Ambinder, R ;
Cowan, J ;
Iglesias, J ;
Melemed, A .
ONCOLOGY, 2002, 62 (01) :2-8
[4]   ADVANCED BREAST-CANCER - A PHASE-II TRIAL WITH GEMCITABINE [J].
CARMICHAEL, J ;
POSSINGER, K ;
PHILLIP, P ;
BEYKIRCH, M ;
KERR, H ;
WALLING, J ;
HARRIS, AL .
JOURNAL OF CLINICAL ONCOLOGY, 1995, 13 (11) :2731-2736
[5]  
Colbern G., 2001, P AN M AM SOC CLIN, V20, p47a
[6]   Phase I study of gemcitabine and liposomal doxorubicin in relapsed ovarian cancer [J].
D'Agostino, G ;
Ferrandina, G ;
Garganese, G ;
Salerno, MG ;
Lorusso, D ;
Farnetano, MG ;
Mancuso, S ;
Scambia, G .
ONCOLOGY, 2002, 62 (02) :110-114
[7]  
DAGOSTINO G, 2002, P AN M AM SOC CLIN, V21, pA219
[8]   Polyethylene glycol coated (pegylated) liposomal doxorubicin - Rationale for use in solid tumours [J].
Gabizon, A ;
Martin, F .
DRUGS, 1997, 54 (Suppl 4) :15-21
[9]   Neoadjuvant chemotherapy with a combination of pegylated liposomal doxorubicin (Caelyx®) and paclitaxel in locally advanced breast cancer:: a phase II study by the Hellenic Cooperative Oncology Group [J].
Gogas, H ;
Papadimitriou, C ;
Kalofonos, HP ;
Bafaloukos, D ;
Fountzilas, G ;
Tsavdaridis, D ;
Anagnostopoulos, A ;
Onyenadum, A ;
Papakostas, P ;
Economopoulos, T ;
Christodoulou, C ;
Kosmidis, P ;
Markopoulos, C .
ANNALS OF ONCOLOGY, 2002, 13 (11) :1737-1742
[10]  
HORWOOD K, 2002, P AN M AM SOC CLIN, V21, pA223