紫杉类→蒽环类＋环磷酰胺是乳腺癌最常用的化疗方案之一，而白蛋白紫杉醇与传统的溶剂型紫杉醇相比，有效性和安全性显著提高，剂量密集化疗又可进一步提高蒽环类＋环磷酰胺的有效性和安全性。不过，三阴性乳腺癌术前白蛋白紫杉醇→剂量密集蒽环类＋环磷酰胺新辅助化疗对亚洲患者的有效性和安全性尚不明确。
2022年11月25日，美国转化肿瘤学会《肿瘤学家》在线发表复旦大学附属肿瘤医院刘引、范蕾、王中华、邵志敏等学者的前瞻研究报告，首次探讨了三阴性乳腺癌术前国产白蛋白紫杉醇→剂量密集蒽环类＋环磷酰胺新辅助化疗对中国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) 该单中心非对照两阶段二期临床研究于2018年11月26日～2019年11月30日从复旦大学附属肿瘤医院入组单侧原发三阴性乳腺浸润癌术前患者55例，每周第1天接受国产白蛋白紫杉醇125mg/m²连续12周，随后每2周第1天接受表柔比星90mg/m²＋环磷酰胺600mg/m²连续8周。主要终点为总体病理完全缓解（ypT0/is ypN0）率。- 总体病理完全缓解率：43.1%（95%置信区间：29.3～57.8）
- 乳房病理完全缓解率：49.0%（95%置信区间：34.8～63.4）
- 客观缓解率：80.0%（95%置信区间：67.0～89.6）
55例患者≥3级不良事件发生率为63.6%，发生率最高的不良事件为脱发。未发生治疗相关手术推迟或死亡。 因此，该研究结果表明，每周国产白蛋白紫杉醇→每2周表柔比星＋环磷酰胺新辅助化疗对三阴性乳腺癌患者的耐受性良好、毒性反应可控、抗肿瘤活性令人鼓舞，总体病理完全缓解率达43.1%，此前日本研究三阴性乳腺癌术前每3周白蛋白紫杉醇→每3周表柔比星＋环磷酰胺新辅助化疗的总体病理完全缓解率仅15.4%、奥地利NEONAB研究三阴性乳腺癌术前每3周表柔比星＋环磷酰胺→每周白蛋白紫杉醇新辅助化疗的总体病理完全缓解率为33.3%，故有必要进一步开展多中心大样本随机对照三期临床研究进行验证。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
本站仅提供存储服务，所有内容均由用户发布，如发现有害或侵权内容，请
点击举报。
