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荷兰保乳手术联合放疗与乳房切除术治疗早期乳腺癌的 10 年生存比较:一项基于人群的研究。

10 year survival after breast-conserving surgery plus radiotherapy compared with mastectomy in early breast cancer in the Netherlands: a population-based study.

机构信息

Department of Research, Netherlands Comprehensive Cancer Organisation, Utrecht, Netherlands.

Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.

出版信息

Lancet Oncol. 2016 Aug;17(8):1158-1170. doi: 10.1016/S1470-2045(16)30067-5. Epub 2016 Jun 22.

Abstract

BACKGROUND

Investigators of registry-based studies report improved survival for breast-conserving surgery plus radiotherapy compared with mastectomy in early breast cancer. As these studies did not present long-term overall and breast cancer-specific survival, the effect of breast-conserving surgery plus radiotherapy might be overestimated. In this study, we aimed to evaluate 10 year overall and breast cancer-specific survival after breast-conserving surgery plus radiotherapy compared with mastectomy in Dutch women with early breast cancer.

METHODS

In this population-based study, we selected all women from the Netherlands Cancer Registry diagnosed with primary, invasive, stage T1-2, N0-1, M0 breast cancer between Jan 1, 2000, and Dec 31, 2004, given either breast-conserving surgery plus radiotherapy or mastectomy, irrespective of axillary staging or dissection or use of adjuvant systemic therapy. Primary outcomes were 10 year overall survival in the entire cohort and breast cancer-specific survival in a representative subcohort of patients diagnosed in 2003 with characteristics similar to the entire cohort. We estimated breast cancer-specific survival by calculating distant metastasis-free and relative survival for every tumour and nodal category. We did multivariable Cox proportional hazard analysis to estimate hazard ratios (HRs) for overall and distant metastasis-free survival. We estimated relative survival by calculating excess mortality ratios using life tables of the general population. We did multiple imputation to account for missing data.

FINDINGS

Of the 37 207 patients included in this study, 21 734 (58%) received breast-conserving surgery plus radiotherapy and 15 473 (42%) received mastectomy. The 2003 representative subcohort consisted of 7552 (20%) patients, of whom 4647 (62%) received breast-conserving surgery plus radiotherapy and 2905 (38%) received mastectomy. For both unadjusted and adjusted analysis accounting for various confounding factors, breast-conserving surgery plus radiotherapy was significantly associated with improved 10 year overall survival in the whole cohort overall compared with mastectomy (HR 0·51 [95% CI 0·49-0·53]; p<0·0001; adjusted HR 0·81 [0·78-0·85]; p<0·0001), and this improvement remained significant for all subgroups of different T and N stages of breast cancer. After adjustment for confounding variables, breast-conserving surgery plus radiotherapy did not significantly improve 10 year distant metastasis-free survival in the 2003 cohort overall compared with mastectomy (adjusted HR 0·88 [0·77-1·01]; p=0·07), but did in the T1N0 subgroup (adjusted 0·74 [0·58-0·94]; p=0·014). Breast-conserving surgery plus radiotherapy did significantly improve 10 year relative survival in the 2003 cohort overall (adjusted 0·76 [0·64-0·91]; p=0·003) and in the T1N0 subgroup (adjusted 0·60 [0·42-0·85]; p=0·004) compared with mastectomy.

INTERPRETATION

Adjusting for confounding variables, breast-conserving surgery plus radiotherapy showed improved 10 year overall and relative survival compared with mastectomy in early breast cancer, but 10 year distant metastasis-free survival was improved with breast-conserving surgery plus radiotherapy compared with mastectomy in the T1N0 subgroup only, indicating a possible role of confounding by severity. These results suggest that breast-conserving surgery plus radiotherapy is at least equivalent to mastectomy with respect to overall survival and may influence treatment decision making for patients with early breast cancer.

FUNDING

None.

摘要

背景

注册研究的研究者报告称,与乳房切除术相比,保乳手术加放疗可提高早期乳腺癌患者的生存率。由于这些研究未报告长期总生存率和乳腺癌特异性生存率,因此保乳手术加放疗的效果可能被高估。本研究旨在评估荷兰早期乳腺癌患者接受保乳手术加放疗与乳房切除术的 10 年总生存率和乳腺癌特异性生存率。

方法

在这项基于人群的研究中,我们从荷兰癌症登记处选择了 2000 年 1 月 1 日至 2004 年 12 月 31 日期间诊断为原发性、浸润性、T1-2 期、N0-1 期、M0 期乳腺癌的所有女性,这些女性接受了保乳手术加放疗或乳房切除术,无论腋窝分期或是否进行腋窝清扫或辅助全身治疗。主要结局为整个队列的 10 年总生存率和 2003 年诊断的具有与整个队列相似特征的代表性亚队列患者的乳腺癌特异性生存率。我们通过计算每个肿瘤和淋巴结类别的远处无转移生存率和相对生存率来估计乳腺癌特异性生存率。我们使用多变量 Cox 比例风险分析来估计总生存率和远处无转移生存率的风险比(HR)。我们通过使用一般人群的生命表计算超额死亡率比来估计相对生存率。我们采用多重插补来处理缺失数据。

结果

在本研究纳入的 37207 例患者中,21734 例(58%)接受了保乳手术加放疗,15473 例(42%)接受了乳房切除术。2003 年的代表性亚队列由 7552 例患者(20%)组成,其中 4647 例(62%)接受了保乳手术加放疗,2905 例(38%)接受了乳房切除术。无论未调整还是调整了各种混杂因素,与乳房切除术相比,保乳手术加放疗与整个队列的 10 年总生存率显著相关(HR 0.51[95%CI 0.49-0.53];p<0.0001;调整后的 HR 0.81[0.78-0.85];p<0.0001),而且这种改善在所有不同 T 期和 N 期乳腺癌亚组中仍然显著。在调整了混杂因素后,保乳手术加放疗与乳房切除术相比,在 2003 年队列中 10 年远处无转移生存率没有显著改善(调整后的 HR 0.88[0.77-1.01];p=0.07),但在 T1N0 亚组中(调整后 0.74[0.58-0.94];p=0.014)。与乳房切除术相比,保乳手术加放疗显著提高了 2003 年队列的 10 年相对生存率(调整后 0.76[0.64-0.91];p=0.003)和 T1N0 亚组的 10 年相对生存率(调整后 0.60[0.42-0.85];p=0.004)。

结论

在调整了混杂因素后,保乳手术加放疗与乳房切除术相比,在早期乳腺癌中显示出提高了 10 年总生存率和相对生存率,但仅在 T1N0 亚组中,保乳手术加放疗与乳房切除术相比,10 年远处无转移生存率有所改善,表明严重程度可能存在混杂因素。这些结果表明,保乳手术加放疗在总生存率方面至少与乳房切除术相当,可能会影响早期乳腺癌患者的治疗决策。

资金

无。

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