2024年12月12日美国中部时间09:00(北京时间23:00),全球最大的乳腺癌研究会议——第47届圣安东尼奥乳腺癌研讨会(SABCS)召开第二场全体大会,由圣加仑乳腺癌大会(SGBCC)第一主席、奥地利维也纳大学外科迈克尔·格南特教授和上海国际乳腺癌论坛(SIBCS)第一主席、复旦大学附属肿瘤医院外科邵志敏教授共同主持,这三大会议曾被中国工程院孙燕院士戏称为国际乳腺癌3S。据悉,邵志敏教授还将登上第三场全体大会的讲台。
General Session 2
Moderator: Michael Gnant, Medical University of Vienna, Vienna, Austria, and Zhi-Ming Shao, Fudan University Shanghai Cancer Center, Shanghai, China
GS2-01: Exclusive endocrine therapy or radiation therapy in women aged 70+ years with luminal-like early breast cancer (EUROPA): preplanned interim analysis of a randomized phase 3 trial.
GS2-02: Impact of Tamoxifen Only after Breast Conservation Surgery for "Good Risk" Duct Carcinoma in Situ: Results from the NRG Oncology/RTOG 9804 and ECOG-ACRIN E5194 Trial
GS2-03: Does postmastectomy radiotherapy in 'intermediate-risk' breast cancer impact overall survival? 10-year results of the BIG 2-04 MRC SUPREMO randomised trial: on behalf of the SUPREMO trial investigators.
GS2-04: Discussant about GS2-01, 02, and 03
GS2-05: Early Oncologic Outcomes Following Active Monitoring or Surgery (+/- Radiation) for Low Risk DCIS: the Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET) Study (AFT-25).
GS2-06: Patient Reported Outcomes Following Active Monitoring or Surgery (+/- Radiation) for Low Risk DCIS in the Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET) Study (AFT-25).
GS2-07: No axillary surgery versus axillary sentinel lymph node biopsy in patients with early invasive breast cancer and breast-conserving surgery: Final primary results of the Intergroup-Sentinel-Mamma (INSEMA) trial.
GS2-08: Discussant Puneet Singh, MD Anderson Cancer Center, Houston, Texas
GS2-09: Overweight, obesity and prognosis in 206,904 women in the Early Breast Cancer Trialists' Collaborative Group (EBCTCG) database.
GS2-10: A long-term image-derived AI risk model for primary prevention of breast cancer.
GS2-11: APOBEC3 mutagenesis induces resistance-promoting genomic alterations in breast cancer.
GS2-12: AFT-38 PATINA: a Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy after Induction Treatment for Hormone Receptor-Positive (HR+)/HER-Positive Metastatic Breast Cancer
GS2-13: Discussant Sara Hurvitz, "Beyond proof of concept: evidence to support use of CDK4/6i for HER, too"
第二场全体大会公布了9项研究的10篇报告,其中6篇报告聚焦早期乳腺癌外科治疗“限免”问题,4篇报告全文已被国际知名学术期刊同步发表,而第一场全体大会仅1篇报告全文被《新英格兰医学杂志》同步发表。以下按期刊影响因子高低对已经发表全文的3项研究4篇报告进行介绍。
低风险早期乳腺癌患者保乳术后
前哨淋巴结活检限免
此前,在《新英格兰医学杂志》发表的SENOMAC研究,对于某些低风险早期乳腺癌患者保乳术后,前哨淋巴结活检已经向腋窝淋巴结清扫敲响了丧钟。此次,第二次全体大会和《新英格兰医学杂志》同时公布的INSEMA研究结果,又对限定人群敲响了免前哨淋巴结活检的钟声。
NCT02466737: Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery (INSEMA) Official Title: Comparison of Axillary Sentinel Lymph Node Biopsy Versus no Axillary Surgery in Patients With Early-stage Invasive Breast Cancer and Breast-conserving Surgery: a Randomized Prospective Surgical Trial. Intergroup-Sentinel-Mamma (INSEMA)-Trial 2024 SABCS GS2-07: No axillary surgery versus axillary sentinel lymph node biopsy in patients with early invasive breast cancer and breast-conserving surgery: Final primary results of the Intergroup-Sentinel-Mamma (INSEMA) trial. N Engl J Med. 2024 Dec 12. IF: 96.2. Axillary Surgery in Breast Cancer - Primary Results of the INSEMA Trial.
估计5年无侵袭癌生存率:91.9%比91.7%(95%置信区间:89.9~93.5、90.8~92.6) 风险比:0.91(95%置信区间:0.73~1.14)低于预设非劣效界值
腋窝复发率:1.0%比0.3% 全因死亡率:1.4%比2.4%
NCT02926911: Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS (COMET) Official Title: Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial 2024 SABCS GS2-05: Early Oncologic Outcomes Following Active Monitoring or Surgery (+/- Radiation) for Low Risk DCIS: the Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET) Study (AFT-25). 2024 SABCS GS2-06: Patient Reported Outcomes Following Active Monitoring or Surgery (+/- Radiation) for Low Risk DCIS in the Comparing an Operation to Monitoring, with or without Endocrine Therapy (COMET) Study (AFT-25). JAMA. 2024 Dec 12. IF: 63.1. Active Monitoring With or Without Endocrine Therapy for Low-Risk Ductal Carcinoma In Situ: The COMET Randomized Clinical Trial. JAMA Oncol. 2024 Dec 12. IF: 22.5. Patient-Reported Outcomes for Low-Risk Ductal Carcinoma In Situ: A Secondary Analysis of the COMET Randomized Clinical Trial. JAMA. 2024 Dec 12. IF: 63.1. Is It Time to Abandon Surgery for Low-Risk DCIS? JAMA. 2024 Dec 12. IF: 63.1. Am I a Survivor?
乳腺导管原位癌手术:264例比82例 被诊断为乳腺浸润癌:19例比27例 2年同侧浸润癌累积发生率:4.2%比5.9%(低1.7%,95%置信区间上限为0.95%,表明积极监测并不劣于积极治疗) 浸润癌特征:相似
NCT04134598: ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer (EUROPA) Official Title: ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years With Luminal A-like Early Stage Breast Cancer (EUROPA): a Randomized Phase 3 Trial 2024 SABCS GS2-01: Exclusive endocrine therapy or radiation therapy in women aged 70+ years with luminal-like early breast cancer (EUROPA): preplanned interim analysis of a randomized phase 3 trial. Lancet Oncol. 2024 Dec 12. IF: 41.6. Single-modality endocrine therapy versus radiotherapy after breast-conserving surgery in women aged 70 years and older with luminal A-like early breast cancer (EUROPA): a preplanned interim analysis of a phase 3, non-inferiority, randomised trial.
整体健康状况评分平均变化:-3.40比-9.79(95%置信区间:-7.82~+1.03、-14.45~-5.13,P=0.13、P<0.0001) 校正后平均相差:+6.39(95%置信区间:0.14~12.65,P=0.045)
治疗相关不良事件发生率:67%比85%
3~4级关节疼痛发生率:0比7% 3~4级盆腔器官脱垂发生率:0比3% 3~4级疲劳、潮热、肌痛、骨痛和骨折发生率:0比2% 严重不良事件发生率:15%比15% 治疗相关死亡发生率:0比0 同侧乳腺肿瘤复发率:0比0 对侧乳腺肿瘤发生率:2%比1% 局部区域复发率:0比0 远处转移发生率:0比0