在雌激素受体阳性、人表皮生长因子受体2阴性、淋巴结阳性的绝经前乳腺癌患者中，比较新辅助化疗与新辅助内分泌治疗的III期新辅助全身试验的腋窝淋巴结清扫率及预后
Axillary Lymph Node Dissection Rates and Prognosis From Phase III Neoadjuvant Systemic Trial Comparing Neoadjuvant Chemotherapy With Neoadjuvant Endocrine Therapy in Pre-Menopausal Patients With Estrogen Receptor-Positive and HER2-Negative, Lymph Node-Positive Breast Cancer.
作者信息
Gwark Sungchan, Noh Woo Chul, Ahn Sei Hyun, Lee Eun Sook, Jung Yongsik, Kim Lee Su, Han Wonshik, Nam Seok Jin, Gong Gyungyub, Kim Seon-Ok, Kim Hee Jeong
机构信息
Department of Surgery, College of Medicine, Asan Medical Center, University of Ulsan, Seoul, South Korea.
Department of Surgery, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences, Seoul, South Korea.
出版信息
Front Oncol. 2021 Sep 30;11:741120. doi: 10.3389/fonc.2021.741120. eCollection 2021.
UNLABELLED
In this study, we aimed to evaluate axillary lymph node dissection (ALND) rates and prognosis in neoadjuvant chemotherapy (NCT) compare with neoadjuvant endocrine therapy (NET) in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), lymph node (LN)-positive, premenopausal breast cancer patients (NCT01622361). The multicenter, phase 3, randomized clinical trial enrolled 187 women from July 5, 2012, to May 30, 2017. The patients were randomly assigned (1:1) to either 24 weeks of NCT including adriamycin plus cyclophosphamide followed by intravenous docetaxel, or NET involving goserelin acetate and daily tamoxifen. ALND was performed based on the surgeon's decision. The primary endpoint was ALND rate and surgical outcome after preoperative treatment. The secondary endpoint was long-term survival. Among the 187 randomized patients, pre- and post- neoadjuvant systemic therapy (NST) assessments were available for 170 patients. After NST, 49.4% of NCT patients and 55.4% of NET patients underwent mastectomy after treatment completion. The rate of ALND was significantly lower in the NCT group than in the NET group (55.2% 69.9%, P=.046). Following surgery, the NET group showed a significantly higher mean number of removed LNs (14.96 11.74, P=.003) and positive LNs (4.84 2.92, P=.000) than the NCT group. The axillary pathologic complete response (pCR) rate was significantly higher in the NCT group (13.8% 4.8%, P=.045) than in the NET group. During a median follow-up of 67.3 months, 19 patients in the NCT group and 12 patients in the NET group reported recurrence. The 5-year ARFS (97.5% 100%, P=.077), DFS (77.2% 84.8%, P=.166), and OS (97.5% 94.7%, P=.304) rates did not differ significantly between the groups. In conclusion, although survival did not differ significantly, more NCT patients might able to avoid ALND, with fewer LNs removed with lower LN positivity.
CLINICAL TRIAL REGISTRATION
https://clinicaltrials.gov/ct2/show/NCT01622361, identifier NCT01622361.
未标注
在本研究中，我们旨在评估新辅助化疗（NCT）与新辅助内分泌治疗（NET）相比，雌激素受体阳性（ER+）/人表皮生长因子受体2阴性（HER2-）、淋巴结（LN）阳性、绝经前乳腺癌患者（NCT01622361）的腋窝淋巴结清扫（ALND）率及预后。这项多中心、3期、随机临床试验于2012年7月5日至2017年5月30日招募了187名女性。患者被随机分配（1:1）至接受24周NCT（包括阿霉素加环磷酰胺，随后静脉注射多西他赛）或NET（包括醋酸戈舍瑞林和每日他莫昔芬）治疗。ALND根据外科医生的决定进行。主要终点是术前治疗后的ALND率和手术结果。次要终点是长期生存。在187名随机分组的患者中，170名患者有新辅助全身治疗（NST）前后的评估数据。NST后，49.4%的NCT组患者和55.4%的NET组患者在治疗完成后接受了乳房切除术。NCT组的ALND率显著低于NET组（55.2%对69.9%，P = 0.046）。手术后，NET组切除的平均淋巴结数量（14.96对11.74，P = 0.003）和阳性淋巴结数量（4.84对2.92，P = 0.000）均显著高于NCT组。NCT组的腋窝病理完全缓解（pCR）率显著高于NET组（13.8%对4.8%，P = 0.045）。在中位随访67.3个月期间，NCT组有19名患者、NET组有12名患者报告复发。两组间的5年无远处复发生存率（97.5%对100%，P = 0.077）、无病生存率（77.2%对84.8%，P = 0.166）和总生存率（97.5%对94.7%，P = 0.304）差异均无统计学意义。总之，尽管生存率差异无统计学意义，但更多NCT组患者可能能够避免ALND，切除的淋巴结更少，淋巴结阳性率更低。
临床试验注册
https://clinicaltrials.gov/ct2/show/NCT01622361，标识符NCT01622361。
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