柳叶刀肿瘤分册：早期乳腺癌新辅助化疗保乳术后远期局部复发率高

《柳叶刀肿瘤分册》2018年1月Volume 19, No. 1, p27–39, January 2018

背景

对早期乳腺癌实行新辅助化疗相比手术后实施同样化疗,可以使保乳手术更加可行、更有可能消除微转移灶。我们对相关随机试验的个体患者数据合作进行了一项荟萃分析,研究了新辅助化疗的长期益处和风险,还研究了肿瘤特点对结果的影响。

方法

在2005年之前开始的早期乳腺癌的十项随机试验中，我们获取了4756名女性患者随机化分组前的肿瘤特征、临床肿瘤缓解情况、手术、复发以及死亡的信息,并将新辅助化疗与术后给予的相同化疗进行对比。主要结果为肿瘤缓解、局部治疗范围、局部和远处复发、乳腺癌死亡和总死亡率。（对缓解和保乳治疗率）采用标准回归、（对复发率和死亡率）采用Log-rank检验方法进行意向性治疗分析。

结果

从1983年到2002年患者进行这些临床试验，中位随访9年（IQR，5–14），最后一次随访为2013年。大多数是以蒽环类药物为基础的化疗（4756名妇女中有3838名（81%））。分组到新辅助化疗的妇女有超过三分之二(1947名中有1349名[69%])完全临床缓解或部分临床缓解。分组到新辅助化疗的患者保乳治疗率增加（2320名接受新辅助治疗的患者中有1504名[65%]，对比2318名接受辅助治疗的患者中有1135名[49%]）。与辅助化疗相比，新辅助化疗的患者与更高的局部复发率相关：新辅助化疗的15年局部复发率是21.4%，辅助化疗为15.9%（增加5.5%[95%CI，2.4–8.6]，比率为1.37[95%CI，1.17–1.61]，p=0.0001）。我们发现，对于远处复发（新辅助化疗的15年风险为38.2%对比辅助化疗38%；比率1.02[95%CI，0.92–1.14]，p=0.66）、乳腺癌死亡（34.4%vs33.7%，1.06[0.95–1.18]，p=0.31）或全因死亡（40.9%vs41.2%，1.04[0.94–1.15]，p=0.45），新辅助化疗和辅助化疗之间无明显差异。

结论

与未接受新辅助化疗且同样大小的肿瘤相比，经新辅助化疗缩小的肿瘤在保乳治疗后可能有更高的局部复发率。在经新辅助化疗缩小的肿瘤中，应当考虑采用降低保乳术后局部复发率增加的策略——如仔细的肿瘤定位、详细的病理评估和适当的放疗。

《壹篇》孟祥志

http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30777-5/fulltext

Background

Neoadjuvant chemotherapy (NACT) for early breast cancer can make breast-conserving surgery more feasible and might be more likely to eradicate micrometastatic disease than might the same chemotherapy given after surgery. We investigated the long-term benefits and risks of NACT and the influence of tumour characteristics on outcome with a collaborative meta-analysis of individual patient data from relevant randomised trials.

Methods

We obtained information about prerandomisation tumour characteristics, clinical tumour response, surgery, recurrence, and mortality for 4756 women in ten randomised trials in early breast cancer that began before 2005 and compared NACT with the same chemotherapy given postoperatively. Primary outcomes were tumour response, extent of local therapy, local and distant recurrence, breast cancer death, and overall mortality. Analyses by intention-to-treat used standard regression (for response and frequency of breast-conserving therapy) and log-rank methods (for recurrence and mortality).

Findings

Patients entered the trials from 1983 to 2002 and median follow-up was 9 years (IQR 5–14), with the last follow-up in 2013. Most chemotherapy was anthracycline based (3838 [81%] of 4756 women). More than two thirds (1349 [69%] of 1947) of women allocated NACT had a complete or partial clinical response. Patients allocated NACT had an increased frequency of breast-conserving therapy (1504 [65%] of 2320 treated with NACT vs 1135 [49%] of 2318 treated with adjuvant chemotherapy). NACT was associated with more frequent local recurrence than was adjuvant chemotherapy: the 15 year local recurrence was 21·4% for NACT versus 15·9% for adjuvant chemotherapy (5·5% increase [95% CI 2·4–8·6]; rate ratio 1·37 [95% CI 1·17–1·61]; p=0·0001). No significant difference between NACT and adjuvant chemotherapy was noted for distant recurrence (15 year risk 38·2% for NACT vs 38·0% for adjuvant chemotherapy; rate ratio 1·02 [95% CI 0·92–1·14]; p=0·66), breast cancer mortality (34·4% vs 33·7%; 1·06 [0·95–1·18]; p=0·31), or death from any cause (40·9% vs 41·2%; 1·04 [0·94–1·15]; p=0·45).

Interpretation

Tumours downsized by NACT might have higher local recurrence after breast-conserving therapy than might tumours of the same dimensions in women who have not received NACT. Strategies to mitigate the increased local recurrence after breast-conserving therapy in tumours downsized by NACT should be considered—eg, careful tumour localisation, detailed pathological assessment, and appropriate radiotherapy.

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