低危的、激素受体阳性的乳腺癌:新辅助内分泌治疗,足够了!
  • 新辅助内分泌治疗效果不佳的乳腺癌病人,直接手术还是换新辅助化疗,目前充满争议;
  • 本临床试验入组了绝经后临床分期II-III期激素受体阳性的病人,接受新辅助内分泌治疗(芳香化酶抑制剂,AI),其中部分病人在2-4周的AI治疗后,再次活检,如果Ki-67大于10%,换成新辅助化疗;
  • 基于Ki-67及临床病理特征定义了一个低危组:T1-2N0,Ki-67<2.7%, ER扩增大于2;
  • 仅2/35切换到新辅助化疗的病人达到pCR;低危组的病人,5年复发率仅为3.6%。
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Ki67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results From the American College of Surgeons Oncology Group Z1031 Trial (Alliance)

新辅助内分泌治疗耐药的乳腺癌患者,基于Ki-67选择是否继续新辅助化疗:来自Alliance研究的结果分析

10.1200/JCO.2016.69.4406

2017-04-01, Article

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Purpose To determine the pathologic complete response (pCR) rate in estrogen receptor (ER) -positive primary breast cancer triaged to chemotherapy when the protein encoded by the MKI67 gene (Ki67) level was > 10% after 2 to 4 weeks of neoadjuvant aromatase inhibitor (AI) therapy. A second objective was to examine risk of relapse using the Ki67-based Preoperative Endocrine Prognostic Index (PEPI). Methods The American College of Surgeons Oncology Group (ACOSOG) Z1031A trial enrolled postmenopausal women with stage II or III ER-positive (Allred score, 6 to 8) breast cancer whose treatment was randomly assigned to neoadjuvant AI therapy with anastrozole, exemestane, or letrozole. For the trial ACOSOG Z1031B, the protocol was amended to include a tumor Ki67 determination after 2 to 4 weeks of AI. If the Ki67 was > 10%, patients were switched to neoadjuvant chemotherapy. A pCR rate of > 20% was the predefined efficacy threshold. In patients who completed neoadjuvant AI, stratified Cox modeling was used to assess whether time to recurrence differed by PEPI = 0 score (T1 or T2, N0, Ki67 < 2.7%, ER Allred > 2) versus PEPI > 0 disease. Results Only two of the 35 patients in ACOSOG Z1031B who were switched to neoadjuvant chemotherapy experienced a pCR (5.7%; 95% CI, 0.7% to 19.1%). After 5.5 years of median follow-up, four (3.7%) of the 109 patients with a PEPI = 0 score relapsed versus 49 (14.4%) of 341 of patients with PEPI > 0 (recurrence hazard ratio [PEPI = 0 v PEPI > 0], 0.27; P = .014; 95% CI, 0.092 to 0.764). Conclusion Chemotherapy efficacy was lower than expected in ER-positive tumors exhibiting AI-resistant proliferation. The optimal therapy for these patients should be further investigated. For patients with PEPI = 0 disease, the relapse risk over 5 years was only 3.6% without chemotherapy, supporting the study of adjuvant endocrine monotherapy in this group. These Ki67 and PEPI triage approaches are being definitively studied in the ALTERNATE trial (Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment in Postmenopausal Women: A Phase III Study; clinical trial information: NCT01953588).

First Authors:
Matthew J Ellis,Vera J Suman

Correspondence Authors:
Matthew J Ellis

All Authors:
Matthew J Ellis,Vera J Suman,Jeremy Hoog,Rodrigo Goncalves,Souzan Sanati,Chad J Creighton,Katherine DeSchryver,Erika Crouch,Amy Brink,Mark Watson,Jingqin Luo,Yu Tao,Michael Barnes,Mitchell Dowsett,G Thomas Budd,Eric Winer,Paula Silverman,Laura Esserman,Lisa Carey,Cynthia X Ma,Gary Unzeitig,Timothy Pluard,Pat Whitworth,Gildy Babiera,J Michael Guenther,Zoneddy Dayao,David Ota,Marilyn Leitch,John A Olson,D Craig Allred,Kelly Hunt

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