柳葉刀腫瘤分冊：早期乳腺癌新輔助化療保乳術後遠期局部復發率高

《柳葉刀腫瘤分冊》2018年1月Volume 19, No. 1, p27–39, January 2018

在早期乳腺癌中新輔助化療對比輔助化療的長期結果：來自十項隨機試驗的個體患者資料的薈萃分析

背景

對早期乳腺癌實行新輔助化療相比手術後實施同樣化療,可以使保乳手術更加可行、更有可能消除微轉移灶。我們對相關隨機試驗的個體患者資料合作進行了一項薈萃分析,研究了新輔助化療的長期益處和風險,還研究了腫瘤特點對結果的影響。

方法

在2005年之前開始的早期乳腺癌的十項隨機試驗中，

我們獲取了4756名女性患者隨機化分組前的腫瘤特徵、臨床腫瘤緩解情況、手術、復發以及死亡的資訊,並將新輔助化療與術後給予的相同化療進行對比。主要結果為腫瘤緩解、局部治療範圍、局部和遠處復發、乳腺癌死亡和總死亡率。（對緩解和保乳治療率）採用標準回歸、（對復發率和死亡率）採用Log-rank檢驗方法進行意向性治療分析。

結果

從1983年到2002年患者進行這些臨床試驗，

中位隨訪9年（IQR，5–14），最後一次隨訪為2013年。大多數是以蒽環類藥物為基礎的化療（4756名婦女中有3838名（81%））。分組到新輔助化療的婦女有超過三分之二(1947名中有1349名[69%])完全臨床緩解或部分臨床緩解。分組到新輔助化療的患者保乳治療率增加（2320名接受新輔助治療的患者中有1504名[65%]，對比2318名接受輔助治療的患者中有1135名[49%]）。與輔助化療相比，新輔助化療的患者與更高的局部復發率相關：新輔助化療的15年局部復發率是21.4%，輔助化療為15.9%（增加5.5%[95%CI，2.4–8.6]，比率為1.37[95%CI，1.17–1.61]，p=0.0001）。我們發現，對於遠處復發（新輔助化療的15年風險為38.2%對比輔助化療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），新輔助化療和輔助化療之間無明顯差異。

結論

與未接受新輔助化療且同樣大小的腫瘤相比，經新輔助化療縮小的腫瘤在保乳治療後可能有更高的局部復發率。在經新輔助化療縮小的腫瘤中，應當考慮採用降低保乳術後局部復發率增加的策略——如仔細的腫瘤定位、詳細的病理評估和適當的放療。

《壹篇》孟祥志

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

Long-term outcomes for neoadjuvant versus adjuvant chemotherapy in early breast cancer: meta-analysis of individual patient data from ten randomised trials

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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