Habel Laurel A, Shak Steven, Jacobs Marlena K, Capra Angela, Alexander Claire, Pho Mylan, Baker Joffre, Walker Michael, Watson Drew, Hackett James, Blick Noelle T, Greenberg Deborah, Fehrenbacher Louis, Langholz Bryan, Quesenberry Charles P
Division of Research, Kaiser Permanente, Oakland, California, USA.
Breast Cancer Res. 2006;8(3):R25. doi: 10.1186/bcr1412. Epub 2006 May 31.
The Oncotype DX assay was recently reported to predict risk for distant recurrence among a clinical trial population of tamoxifen-treated patients with lymph node-negative, estrogen receptor (ER)-positive breast cancer. To confirm and extend these findings, we evaluated the performance of this 21-gene assay among node-negative patients from a community hospital setting.
A case-control study was conducted among 4,964 Kaiser Permanente patients diagnosed with node-negative invasive breast cancer from 1985 to 1994 and not treated with adjuvant chemotherapy. Cases (n = 220) were patients who died from breast cancer. Controls (n = 570) were breast cancer patients who were individually matched to cases with respect to age, race, adjuvant tamoxifen, medical facility and diagnosis year, and were alive at the date of death of their matched case. Using an RT-PCR assay, archived tumor tissues were analyzed for expression levels of 16 cancer-related and five reference genes, and a summary risk score (the Recurrence Score) was calculated for each patient. Conditional logistic regression methods were used to estimate the association between risk of breast cancer death and Recurrence Score.
After adjusting for tumor size and grade, the Recurrence Score was associated with risk of breast cancer death in ER-positive, tamoxifen-treated and -untreated patients (P = 0.003 and P = 0.03, respectively). At 10 years, the risks for breast cancer death in ER-positive, tamoxifen-treated patients were 2.8% (95% confidence interval [CI] 1.7-3.9%), 10.7% (95% CI 6.3-14.9%), and 15.5% (95% CI 7.6-22.8%) for those in the low, intermediate and high risk Recurrence Score groups, respectively. They were 6.2% (95% CI 4.5-7.9%), 17.8% (95% CI 11.8-23.3%), and 19.9% (95% CI 14.2-25.2%) for ER-positive patients not treated with tamoxifen. In both the tamoxifen-treated and -untreated groups, approximately 50% of patients had low risk Recurrence Score values.
In this large, population-based study of lymph node-negative patients not treated with chemotherapy, the Recurrence Score was strongly associated with risk of breast cancer death among ER-positive, tamoxifen-treated and -untreated patients.
Oncotype DX检测最近被报道可预测在接受他莫昔芬治疗的淋巴结阴性、雌激素受体（ER）阳性乳腺癌患者的临床试验人群中远处复发的风险。为了证实并扩展这些发现，我们评估了这项21基因检测在一家社区医院环境中淋巴结阴性患者中的表现。
对1985年至1994年期间诊断为淋巴结阴性浸润性乳腺癌且未接受辅助化疗的4964名凯撒医疗机构患者进行了一项病例对照研究。病例组（n = 220）为死于乳腺癌的患者。对照组（n = 570）为乳腺癌患者，在年龄、种族、辅助性他莫昔芬治疗、医疗机构和诊断年份方面与病例组个体匹配，且在其匹配病例死亡之日仍存活。使用逆转录聚合酶链反应（RT-PCR）检测方法，对存档的肿瘤组织进行16个癌症相关基因和5个参考基因表达水平的分析，并为每位患者计算一个综合风险评分（复发评分）。采用条件逻辑回归方法来估计乳腺癌死亡风险与复发评分之间的关联。
在对肿瘤大小和分级进行调整后，复发评分与ER阳性、接受他莫昔芬治疗和未接受他莫昔芬治疗的患者的乳腺癌死亡风险相关（分别为P = 0.003和P = 0.03）。在10年时，ER阳性、接受他莫昔芬治疗的患者中，低、中、高风险复发评分组的乳腺癌死亡风险分别为2.8%（95%置信区间[CI] 1.7 - 3.9%）、10.7%（95% CI 6.3 - 14.9%）和15.5%（95% CI 7.6 - 22.8%）。未接受他莫昔芬治疗的ER阳性患者的相应风险分别为6.2%（95% CI 4.5 - 7.9%）、17.8%（95% CI 11.8 - 23.3%）和19.9%（95% CI 14.2 - 25.2%）。在接受他莫昔芬治疗和未接受他莫昔芬治疗的两组中，约50%的患者复发评分值为低风险。
在这项针对未接受化疗的淋巴结阴性患者的大型基于人群的研究中，复发评分与ER阳性、接受他莫昔芬治疗和未接受他莫昔芬治疗的患者的乳腺癌死亡风险密切相关。
Zotero 插件
