紫杉類→蒽環(huán)類＋環(huán)磷酰胺是乳腺癌最常用的化療方案之一，而白蛋白紫杉醇與傳統(tǒng)的溶劑型紫杉醇相比，有效性和安全性顯著提高，劑量密集化療又可進(jìn)一步提高蒽環(huán)類＋環(huán)磷酰胺的有效性和安全性。不過，三陰性乳腺癌術(shù)前白蛋白紫杉醇→劑量密集蒽環(huán)類＋環(huán)磷酰胺新輔助化療對(duì)亞洲患者的有效性和安全性尚不明確。
2022年11月25日，美國轉(zhuǎn)化腫瘤學(xué)會(huì)《腫瘤學(xué)家》在線發(fā)表復(fù)旦大學(xué)附屬腫瘤醫(yī)院劉引、范蕾、王中華、邵志敏等學(xué)者的前瞻研究報(bào)告，首次探討了三陰性乳腺癌術(shù)前國產(chǎn)白蛋白紫杉醇→劑量密集蒽環(huán)類＋環(huán)磷酰胺新輔助化療對(duì)中國患者的安全性和有效性。
NCT03799679: Albumin-Bound Paclitaxel Followed by Epirubicin in Combination With Cyclophosphamide in Triple Negative Breast Cancer (Nanoparticle Albumin-Bound Paclitaxel Followed by Dose-Intensive Epirubicin in Combination With Cyclophosphamide as Neoadjuvant Chemotherapy in Triple Negative Breast Cancer) 該單中心非對(duì)照兩階段二期臨床研究于2018年11月26日～2019年11月30日從復(fù)旦大學(xué)附屬腫瘤醫(yī)院入組單側(cè)原發(fā)三陰性乳腺浸潤癌術(shù)前患者55例，每周第1天接受國產(chǎn)白蛋白紫杉醇125mg/m2連續(xù)12周，隨后每2周第1天接受表柔比星90mg/m2＋環(huán)磷酰胺600mg/m2連續(xù)8周。主要終點(diǎn)為總體病理完全緩解（ypT0/is ypN0）率。 結(jié)果，其中51例患者新輔助化療后病理緩解可評(píng)價(jià)：- 總體病理完全緩解率：43.1%（95%置信區(qū)間：29.3～57.8）
- 乳房病理完全緩解率：49.0%（95%置信區(qū)間：34.8～63.4）
- 客觀緩解率：80.0%（95%置信區(qū)間：67.0～89.6）
未見臨床病理因素與病理臨床緩解之間存在相關(guān)性。 55例患者≥3級(jí)不良事件發(fā)生率為63.6%，發(fā)生率最高的不良事件為脫發(fā)。未發(fā)生治療相關(guān)手術(shù)推遲或死亡。 因此，該研究結(jié)果表明，每周國產(chǎn)白蛋白紫杉醇→每2周表柔比星＋環(huán)磷酰胺新輔助化療對(duì)三陰性乳腺癌患者的耐受性良好、毒性反應(yīng)可控、抗腫瘤活性令人鼓舞，總體病理完全緩解率達(dá)43.1%，此前日本研究三陰性乳腺癌術(shù)前每3周白蛋白紫杉醇→每3周表柔比星＋環(huán)磷酰胺新輔助化療的總體病理完全緩解率僅15.4%、奧地利NEONAB研究三陰性乳腺癌術(shù)前每3周表柔比星＋環(huán)磷酰胺→每周白蛋白紫杉醇新輔助化療的總體病理完全緩解率為33.3%，故有必要進(jìn)一步開展多中心大樣本隨機(jī)對(duì)照三期臨床研究進(jìn)行驗(yàn)證。Oncologist. 2022 Nov 25. IF: 5.837Nab-paclitaxel Followed by Dose-dense Epirubicin/Cyclophosphamide in Neoadjuvant Chemotherapy for Triple-negative Breast Cancer: A Phase II Study.Liu Y, Fan L, Wang ZH, Shao ZM.Fudan University Shanghai Cancer Center, Shanghai Medical College, Fudan University, Shanghai, China.This article reports the results of a trial that evaluated the efficacy and safety of nab-paclitaxel followed by dose-dense epirubicin/cyclophosphamide as neoadjuvant therapy in patients with triple-negative breast cancer.BACKGROUND: The anti-tumor activity of nab-paclitaxel followed by epirubicin/cyclophosphamide (EC) as neoadjuvant chemotherapy (NAC) in Asian patients remain unclear, particularly in the aggressive subtype triple-negative breast cancer (TNBC). This study aimed to evaluate the efficacy and safety of this NAC regimen in TNBC.METHODS: In this Simon's two-stage, phase II study, treatment-naive patients with unilateral primary invasive TNBC were enrolled. Eligible patients received nab-paclitaxel 125 mg/m2 weekly on day 1 for 12 weeks, followed by dose-dense EC (epirubicin 90 mg/m2; cyclophosphamide 600 mg/m2) on day 1 for four 2-week cycles. The primary endpoint was the total pathological complete response (tpCR, ypT0/is ypN0) rate.RESULTS: A total of 55 eligible patients were enrolled and treated. After NAC, tpCR and breast pathological complete response were respectively observed in 43.1% (95% CI, 29.3-57.8) and 49.0% (95% CI, 34.8-63.4) of 51 evaluable patients for pathological response evaluation. 44 had an objective response as their best response (80.0%; 95% CI, 67.0-89.6). No correlations between clinicopathological variables and pathological/clinical response were observed. Grade 3 or more adverse events (AEs) occurred in 63.6% of 55 patients. The most frequent AEs were alopecia. No treatment-related surgical delay or death occurred.CONCLUSION: Nab-paclitaxel followed by dose-dense EC as NAC demonstrates promising anti-tumor activity and acceptable tolerability for patients with TNBC.KEYWORDS: neoadjuvant chemotherapy, breast cancer, triple-negative breast cancer, nab-paclitaxel- Nab-paclitaxel is a novel solvent-free formulation of paclitaxel with a more safety profile, has aroused great interest in cancer therapy.
- The anti-tumor activity and safety of nab-paclitaxel followed by dose-dense epirubicin/cyclophosphamide (EC) as neoadjuvant chemotherapy (NAC) in Asian patients remain unclear, particularly in the aggressive subtype triple-negative breast cancer (TNBC).
- Nab-paclitaxel followed by dose-dense EC has demonstrated encouraging anti-tumor activity and manageable toxicity with a high proportion of patients achieving a pathological response in the neoadjuvant setting for Chinese patients with TNBC.
ClinicalTrials.gov Identifier: NCT03799679DOI: 10.1093/oncolo/oyac223
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