JCO：老龄早期乳腺癌患者可通过他莫昔芬联合放疗控制长期局部复发

在2013年5月20日在线出版的《临床肿瘤学杂志》(Journal of Clinical Oncology)上，发表了麻省总医院Kevin S. Hughes博士等人的一项研究结果，该研究目的为，确定≥70岁的早期乳腺癌女性患者在保乳手术后，通过辅助放疗及他莫昔芬治疗是否可取得获益。

1994年7月至1999年2月期间，共有636例(≥70岁)雌激素受体呈阳性的临床I期(根据TNM 分期标准，T1N0M0)乳腺癌患者接受了乳腺肿瘤切除治疗，这些患者被随机分配接受他莫昔芬联合放疗方案(TamRT; 317例女性患者)，或单纯他莫昔芬方案治疗(Tam; 319例女性患者)。该研究主要终点为发生局部复发的时间、乳腺切除术频率、乳腺癌特异性生存率、远端转移时间及总生存率(OS)。

截至目前，该研究对治疗患者进行的随访中位时间为12.6年。在随访10年时，有98%的TamRT组患者未发生局部复发(95% CI, 96%至 99%)，Tam组患者则为90% (95% CI, 85% 至93%)。两组间在乳腺切除术时间、远端转移时间、乳腺癌特异性生存率或OS方面并无显著差异。TamRT与Tam组的10年OS分别为67% (95% CI, 62% 至72%) 及66% (95% CI, 61% 及 71%)。

这项研究通过长期随访发现，在控制局部复发方面，以往关于通过联合放疗可获得少许改善的结论仍然成立。然而，这并不能改善OS、无远端转移生存率或保乳情况。有赖于Tam在局部复发方面的应用价值，研究人员认为，Tam对于≥70岁、雌激素受体呈阳性的早期乳腺癌女性患者仍是一种合理手段。

Lumpectomy Plus Tamoxifen With or Without Irradiation in Women Age 70 Years or Older With Early Breast Cancer: Long-Term Follow-Up of CALGB 9343.
Abstract
PURPOSETo determine whether there is a benefit to adjuvant radiation therapy after breast-conserving surgery and tamoxifen in women age ≥70 years with early-stage breast cancer. PATIENTS AND METHODSBetween July 1994 and February 1999, 636 women (age ≥70 years) who had clinical stage I (T1N0M0 according to TNM classification) estrogen receptor (ER) -positive breast carcinoma treated by lumpectomy were randomly assigned to receive tamoxifen plus radiation therapy (TamRT; 317 women) or tamoxifen alone (Tam; 319 women). Primary end points were time to local or regional recurrence, frequency of mastectomy, breast cancer-specific survival, time to distant metastasis, and overall survival (OS).ResultsMedian follow-up for treated patients is now 12.6 years. At 10 years, 98% of patients receiving TamRT (95% CI, 96% to 99%) compared with 90% of those receiving Tam (95% CI, 85% to 93%) were free from local and regional recurrences. There were no significant differences in time to mastectomy, time to distant metastasis, breast cancer-specific survival, or OS between the two groups. Ten-year OS was 67% (95% CI, 62% to 72%) and 66% (95% CI, 61% to 71%) in the TamRT and Tam groups, respectively. CONCLUSIONWith long-term follow-up, the previously observed small improvement in locoregional recurrence with the addition of radiation therapy remains. However, this does not translate into an advantage in OS, distant disease-free survival, or breast preservation. Depending on the value placed on local recurrence, Tam remains a reasonable option for women age ≥70 years with ER-positive early-stage breast cancer.