De Sanctis Rita, Quadrini Silvia, Longo Flavia, Lapadula Vittoria, Restuccia Rossella, Del Signore Ester, De Filippis Lucilla, Stumbo Luciano, Gori Bruno, Bianco Vincenzo, Speranza Iolanda, Basile Maria Luisa, Di Seri Marisa
Department of Molecular Medicine, Polyclinic Umberto I, Sapienza University, Rome, Italy.
Tumori. 2012 May-Jun;98(3):303-7. doi: 10.1177/030089161209800304.
Capecitabine is the reference treatment for anthracycline- and/or taxane-pretreated metastatic breast cancer (MBC). This study examined its efficacy, tolerability and impact on the quality of life of elderly patients with MBC.
Between January 2002 and December 2009, 75 consecutive elderly patients with MBC received first-line chemotherapy with capecitabine 1000 mg/m2 twice daily for 14 days every 3 weeks. Endpoints were efficacy, tolerability and clinical-benefit response measured every 3 cycles.
Median age was 76 years (range 65-88); median ECOG performance status was 1 (range 0-2); 51 patients (68%) had received adjuvant chemotherapy and all patients had received hormonal therapy. Median exposure was 6 cycles. After 3 cycles, 11 patients (14.7%) had a partial response, one patient experienced a complete response, and 49 patients (65.3%) had stable disease, amounting to a disease control rate of 81.3%. Stable disease was maintained in 45 patients (60%) after 6 cycles, in 21 patients (28%) after 9 cycles, and in 13 patients (17.3%) after 12 cycles. A clinical-benefit response was experienced by 42 patients (56%), indicating a positive impact on quality of life. Treatment was well tolerated, the most common grade 3 events being diarrhea (12%) hand-foot syndrome (8%), and mucositis (8%). Adverse events were managed with dose adjustments and supportive therapy when required.
Our results indicate that capecitabine is active and well tolerated in elderly patients with MBC. This dosing regimen warrants further study in the first-line setting for patients with less aggressive MBC who are not candidates for combination therapy.
卡培他滨是蒽环类和/或紫杉烷预处理的转移性乳腺癌（MBC）的参考治疗药物。本研究考察了其对老年MBC患者的疗效、耐受性及生活质量的影响。
2002年1月至2009年12月期间，75例连续的老年MBC患者接受一线化疗，卡培他滨1000mg/m²，每日2次，每3周给药14天。每3个周期测量疗效、耐受性及临床获益反应。
中位年龄为76岁（范围65 - 88岁）；中位ECOG体能状态为1（范围0 - 2）；51例患者（68%）接受过辅助化疗，所有患者均接受过激素治疗。中位治疗周期数为6个周期。3个周期后，11例患者（14.7%）部分缓解，1例患者完全缓解，49例患者（65.3%）病情稳定，疾病控制率为81.3%。6个周期后，45例患者（60%）病情维持稳定，9个周期后21例患者（28%）病情维持稳定，12个周期后13例患者（17.3%）病情维持稳定。42例患者（56%）有临床获益反应，表明对生活质量有积极影响。治疗耐受性良好，最常见的3级事件为腹泻（12%）、手足综合征（8%）和黏膜炎（8%）。必要时通过调整剂量和支持治疗来处理不良事件。
我们的结果表明，卡培他滨对老年MBC患者有效且耐受性良好。这种给药方案值得在一线治疗中对侵袭性较小、不适合联合治疗的MBC患者进行进一步研究。
