Gick Ute, Rochlitz Christoph, Mingrone Walter, Pestalozzi Bernhard, Rauch Daniel, Ballabeni Pierluigi, Lanz Doris, Hess Viviane, Aebi Stefan
Department of Medical Oncology, University Hospital Inselspital, Bern, Switzerland.
Oncology. 2006;71(1-2):54-60. doi: 10.1159/000100449. Epub 2007 Mar 5.
Paclitaxel and capecitabine have proven activity in the treatment of metastatic breast cancer (MBC). Paclitaxel increases the expression of thymidine phosphorylase, the enzyme that activates capecitabine. The purpose of this study was to evaluate the efficacy and tolerability of capecitabine in combination with weekly paclitaxel largely as first-line therapy in patients with MBC.
From April 2002 to September 2004, 19 patients with MBC received oral capecitabine (1,000 mg/m(2) twice daily on days 1-14) plus i.v. paclitaxel (80 mg/m(2) on days 1, 8 and 15) in a 21-day cycle for a maximum of 6 cycles.
After a median follow-up of 19.3 months the overall response rate was 63% with 1 complete response (5%) and 11 partial responses (58%). Disease was stabilized in 1 patient (5%) and 3 patients had progressive disease (16%). Three patients were unable to be assessed for response to treatment. Median time to progression was 3.3 months, median time to treatment failure 3.0 months and median overall survival 13.8 months. A substantial number of patients experienced major side effects. The most common treatment-related adverse events were hand-foot syndrome (53%; grade 3: 37%), alopecia (42%; grade 3: 26%), diarrhea (32%; grade 3: 11%) and neurotoxicity (32%; grade 3: 16%). Hematologic toxicities were uncommon.
The combination of capecitabine and paclitaxel appears to be active in MBC but the safety profile with the dosages used in this trial was unacceptably high and led to a short time to treatment failure. However, based on the efficacy data alternative schedules deserve further evaluation.
紫杉醇和卡培他滨已被证实对转移性乳腺癌（MBC）有治疗活性。紫杉醇可增加胸苷磷酸化酶的表达，该酶可激活卡培他滨。本研究的目的是评估卡培他滨联合每周一次紫杉醇作为MBC患者一线治疗的疗效和耐受性。
2002年4月至2004年9月，19例MBC患者接受口服卡培他滨（第1 - 14天，1000 mg/m²，每日2次）加静脉注射紫杉醇（第1、8和15天，80 mg/m²），每21天为一个周期，最多6个周期。
中位随访19.3个月后，总缓解率为63%，其中1例完全缓解（5%），11例部分缓解（58%）。1例患者疾病稳定（5%），3例患者疾病进展（16%）。3例患者无法评估治疗反应。中位疾病进展时间为3.3个月，中位治疗失败时间为3.0个月，中位总生存期为13.8个月。大量患者出现严重副作用。最常见的治疗相关不良事件为手足综合征（53%；3级：37%）、脱发（42%；3级：26%）、腹泻（32%；3级：11%）和神经毒性（32%；3级：16%）。血液学毒性不常见。
卡培他滨和紫杉醇联合方案在MBC中似乎有活性，但本试验所用剂量的安全性过高，导致治疗失败时间较短。然而，基于疗效数据，其他方案值得进一步评估。
