Regan M M, Pagani O, Walley B, Torrisi R, Perez E A, Francis P, Fleming G F, Price K N, Thürlimann B, Maibach R, Castiglione-Gertsch M, Coates A S, Goldhirsch A, Gelber R D
IBCSG Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston, MA, USA.
Oncology Institute of Southern Switzerland, Ospedale Italiano, Viganello, Lugano; Swiss Group for Clinical Cancer Research, Bern, Switzerland.
Ann Oncol. 2008 Jul;19(7):1231-1241. doi: 10.1093/annonc/mdn037. Epub 2008 Mar 5.
The role of chemotherapy in addition to combined endocrine therapy for premenopausal women with endocrine-responsive early breast cancer remains an open question, yet trials designed to answer it have repeatedly failed to adequately accrue. The International Breast Cancer Study Group initiated two concurrent trials in this population: in Premenopausal Endocrine Responsive Chemotherapy (PERCHE), chemotherapy use is determined by randomization and in Tamoxifen and Exemestane Trial (TEXT) by physician choice. PERCHE closed with inadequate accrual; TEXT accrued rapidly.
From 2003 to 2006, 1317 patients (890 with baseline data) were randomly assigned to receive ovarian function suppression (OFS) plus tamoxifen or OFS plus exemestane for 5 years in TEXT. We explore patient-related factors according to whether or not chemotherapy was given using descriptive statistics and classification and regression trees.
Adjuvant chemotherapy was chosen for 64% of patients. Lymph node status was the predominant determinant of chemotherapy use (88% of node positive treated versus 46% of node negative). Geography, patient age, tumor size and grade were also determinants, but degree of receptor positivity and human epidermal growth factor receptor 2 status were not.
The perceived estimation of increased risk of relapse is the primary determinant for using chemotherapy despite uncertainties regarding the degree of benefit it offers when added to combined endocrine therapy in this population.
对于内分泌反应型早期乳腺癌的绝经前女性,在联合内分泌治疗基础上加用化疗的作用仍未明确,然而旨在回答这一问题的试验一再未能充分招募到足够的患者。国际乳腺癌研究组针对该人群启动了两项并行试验:在绝经前内分泌反应型化疗(PERCHE)试验中,化疗的使用通过随机分组确定;在他莫昔芬与依西美坦试验(TEXT)中,则由医生选择。PERCHE试验因招募不足而结束;TEXT试验招募进展迅速。
2003年至2006年期间,1317例患者(890例有基线数据)在TEXT试验中被随机分配接受卵巢功能抑制(OFS)加他莫昔芬或OFS加依西美坦治疗5年。我们使用描述性统计以及分类和回归树方法,根据是否接受化疗来探究患者相关因素。
64%的患者选择了辅助化疗。淋巴结状态是化疗使用的主要决定因素(淋巴结阳性患者中88%接受了治疗,而淋巴结阴性患者中这一比例为46%)。地理位置、患者年龄、肿瘤大小和分级也是决定因素,但受体阳性程度和人表皮生长因子受体2状态并非决定因素。
尽管在该人群中,联合内分泌治疗时加用化疗所带来的获益程度存在不确定性,但对复发风险增加的感知估计仍是使用化疗的主要决定因素。