乳腺癌保乳治疗的疗效及预后

Prognosis and risk factors of 1 791 patients with breast cancer treated with breast-conserving surgery based on real-world data

目的总结早期乳腺癌经过保乳治疗的总体疗效，分析并探讨局部区域复发（LRR）、远处转移（DM）和患者生存的影响因素。方法回顾性分析1 791例病理分期为pT1～2N0～3，无锁骨上、内乳淋巴结转移及DM，经保乳治疗而未行新辅助治疗的乳腺浸润性癌患者的临床资料。生存分析的单因素分析采用Kaplan－Meier法和Log rank检验，多因素分析采用Cox回归模型。结果全组患者中位随访4.2年，5年LRR率、DM率、无病生存（DFS）率和总生存（OS）率分别为3.6%、4.6%、93.0%和97.4%。Luminal A型、Luminal B1型、Luminal B2型、HER－2过表达型和三阴型乳腺癌患者的5年LRR率分别为2.0%、6.1%、5.9%、0和10.0%，5年DM率分别为3.2%、6.7%、8.3%、4.8%和7.3%。术后病理N0患者中，689例行腋窝清扫术，652例行前哨淋巴结活检术。5年LRR率分别为3.3%和3.2%，5年OS率分别为98.2%和98.3%，差异均无统计学意义（P值分别为0.859和0.311）。1 576例患者行术后放疗，其5年LRR率较单纯手术患者显著降低（2.5%和12.9%）。常规分割放疗组和大分割放疗组患者的5年LRR率分别为2.7%和3.1%，差异无统计学意义（P＝0.870）。多因素Cox回归分析显示，患者年龄、脉管瘤栓情况、病理T分期、术后放疗、ER或PR状态与内分泌治疗是乳腺癌患者LRR的独立影响因素（均P〈0.05），组织学分级、病理N分期是乳腺癌患者DM的独立影响因素（均P〈0.05），患者年龄、脉管瘤栓情况、病理T分期和N分期、术后放疗、ER或PR状态与内分泌治疗情况是乳腺癌患者DFS的独立影响因素（均P〈0.05），组织学分级、病理N分期、ER或PR状态与内分泌治疗是乳腺癌患者OS的独立影响因素（均P〈0.05）。结论在标准治疗的基础上，保乳治疗后乳腺癌的10年LRR率不到10%。前哨淋巴结活检阴性者不必行腋窝淋巴结清扫。保乳术后放疗使用率较高，大分割放疗与常规分割放疗疗效无差别。乳腺癌保乳治疗后LRR和DM具有不同的高危因素。

ObjectiveTo investigate the overall efficacy of early breast cancer after breast-conserving treatment. To analyze risk factors affecting local regional recurrence （LRR）, distant metastasis （DM） and survival.Methods1 791 breast cancer patients treated with breast-conserving surgery were retrospectively analyzed. The inclusion criteria were pathologic diagnosis of invasive breast cancer without supraclavicular and internal mammary node metastasis, T1-2N0-3M0, and no neoadjuvant therapy. Univariate analysis of survival was performed by Kaplan-Meier method and log rank test. Cox regression model was used for multivariate analysis.ResultsThe median follow-up time was 4.2 years. For all patients, the 5-year LRR, DM, disease-free survival（DFS） and overall survival（OS） rates were 3.6%, 4.6%, 93.0% and 97.4%, respectively. The LRR rates of patients with Luminal A, Luminal B1, Luminal B2, HER-2 over-expressed and triple-negative breast cancer were 2.0%, 6.1%, 5.9%, 0 and 10.0%, while the DM rates were 3.2%, 6.7%, 8.3%, 4.8% and 7.3%, respectively. Among the N0 patients, axillary dissection was performed in 689 cases and sentinel lymph node biopsy in 652 cases. The 5-year LRR rates were 3.3% and 3.2% （P=0.859）, and the OS rates were 98.2% and 98.3% （P=0.311） respectively, which showed no statistically significant. There were 1 576 patients that underwent postoperative radiotherapy. Postoperative radiotherapy significantly reduced the 5-year LRR compared with surgery alone （2.5% vs 12.9%）. The 5-year LRR rates of patients who received conventional fractionated radiotherapy and hypo-fractionated radiotherapy were 2.7% and 3.1%, respectively. But the difference was not statistically significant （P=0.870）. Multivariate analysis showed that age, lymphovascular invasion, pathological T staging, postoperative radiotherapy, ER/PR status and endocrine therapy were independent factors of LRR in breast cancer patients （all P〈0.05）. Histological grade and pathological N staging were independent factors of DM （all P〈0.05）. The age, lymphovascular invasion, pathological T and N staging, postoperative radiotherapy, ER/PR status and endocrine therapy were independent factors for DFS （all P〈0.05）. Histological grade, pathological N staging, ER/PR status and endocrine therapy were factors for OS （all P〈0.05）.ConclusionsWith contemporary standard treatment, the recurrence rate of early breast cancer after breast conserving treatment is less than 10%. Node-negative patients after sentinel lymph node biopsy did not need axillary dissection. The overall utilization of radiotherapy after breast conserving surgery is satisfactory. Hypofractionated radiotherapy is as effective as conventional fractionated radiotherapy. Local regional recurrence and distant metastasis have different risk factors.