【一周新资讯--乳腺癌 336】2024 W4501

主要研究结果：

• 共纳入16项研究、1133例接受ADC联合ICI的患者，包含6种ADC

• 总体上，≥3级AE为55.3%，治疗终止率为30.0%，导致死亡的AE为3.0%

• 相比于ADC或ICI单药的研究，联合治疗的最常见AE发生率相似，但增加了特异性毒性，如ILD/肺炎(T-DXd联合ICI为15.0%，T-DXd单药为11.5%)

• 汇总的ORR为48.8%，CR为9.0%；PD-L1阳性肿瘤的疗效数值上更好

参考文献：

Villacampa G, Cresta Morgado P, Carità L, Navarro V, Pascual T, Dienstmann R. Safety and efficacy of antibody-drug conjugates plus immunotherapy in solid tumours: A systematic review and meta-analysis. Cancer Treat Rev. 2024 Oct 18;131:102847. doi: 10.1016/j.ctrv.2024.102847. Epub ahead of print. PMID: 39454548.

主要研究结果：

• 纳入辅助内分泌治疗期间或完成辅助内分泌治疗后12个月内复发的PIK3CA突变/HR+/HER2-局部晚期或转移性乳腺癌

• 随机分为inavolisib 9mg/d PO联合哌柏西利-氟维司群组或安慰剂联合哌柏西利-氟维司群组(161/164)

• 中位随访分别为21.3与21.5个月

• 主要终点为研究者评估的PFS

• 中位PFS分别为15.0与7.3个月(HR=0.43; 95%CI:0.32-0.59; P<0.001)

• ORR分别为58.4%与25.0%

• 3/4级：中性粒细胞减少分别为80.2%与78.4%，高血糖分别为5.6%与0%，口腔炎或黏膜炎分别为5.6%与0%，腹泻分别为3.7%与0%，无3或4级皮疹

• 因AE终止任何研究药物治疗分别为6.8%与0.6%

参考文献：

Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596. doi: 10.1056/NEJMoa2404625. PMID: 39476340.

主要研究结果：

• 回顾性分析了501例NAC有完全临床缓解的cT1-4，N1-3M0期患者，接受单纯SLNB或或靶腋窝清扫(TAD)

• 中位随访42个月，腋窝和局部区域复发率分别为0.4%(2例)和0.8%(4例)

• SLNB组与TAD组、乳房阳性与阴性pCR、SLN方法、总体转移性淋巴结1个与≥2个，或转移类型为微转移的孤立肿瘤细胞与宏转移间的DFS/疾病特异性生存(DSS)均无显著性差异

• 多变量分析：非Luminal病理学患者的DFS/DSS可能更差，且不增加腋窝复发

参考文献：

Muslumanoglu M, Cabioglu N, Igci A, Karanlık H, Kocer HB, Senol K, Mantoglu B, Tukenmez M, Çakmak GK, Ozkurt E, Gulcelik MA, Emiroglu S, Mollavelioglu B, Yildirim N, Bademler S, Zengel B, Trabulus DC, Ugurlu MU, Uras C, Ilgun S, Akgul GG, Akcan A, Yormaz S, Ersoy YE, Ozbas S, Dilege E, Citgez B, Bolukbasi Y, Altınok A, Dag A, Basaran G, Utkan NZ, Ozcinar B, Arici C, AlJorani I, Kara H, Yigit B, Sen E, Erozgen F, Soyder A, Celik B, Kilic HG, Zer L, Sakman G, Yeniay L, Atahan K, Varol E, Veliyeva V, Goktepe B, Velidedeoglu M, Karaman N, Soran A, Aydiner A, Yılmaz R, Ibis K, Ozmen V. Combined analysis of the MF18-02/MF18-03 NEOSENTITURK studies: ypN-positive disease does not necessitate axillary lymph node dissection in patients with breast cancer with a good response to neoadjuvant chemotherapy as long as radiotherapy is provided. Cancer. 2024 Oct 30. doi: 10.1002/cncr.35610. Epub ahead of print. PMID: 39476303.

主要研究结果：

•  共纳入1840例BRCA1和1750例BRCA2女性致病变异携带者

•  BRCA1携带者的对侧乳腺癌、卵巢癌、合并非乳腺/卵巢癌、结直肠癌和子宫内膜癌SPC风险增加

•  BRCA2携带者的对侧乳腺癌、卵巢癌、胰腺癌和合并非乳腺/卵巢癌SPC风险增加

•  与无BRCA1/BRCA2致病变异携带女性相比

•  BRCA1携带者的对侧乳腺癌、卵巢癌、合并非乳腺/卵巢癌和结直肠癌SPC风险增加

•  BRCA2携带者的对侧乳腺癌、卵巢癌、胰腺癌SPC风险增加

•  对侧乳腺癌/卵巢癌/合并非乳腺-卵巢癌的10年累积风险：

•  BRCA1=16%/6.3%/7.8%

•  BRCA2=12%/3.0%/6.2%

•  非携带者=3.6%/0.4%/4.9%

•  男性BRCA2携带者的对侧乳腺癌和前列腺癌SPC风险高于非携带者

参考文献：

Allen I, Hassan H, Walburga Y, Huntley C, Loong L, Rahman T, Allen S, Garrett A, Torr B, Bacon A, Knott C, Jose S, Vernon S, Lüchtenborg M, Pethick J, Santaniello F, Goel S, Wang YW, Lavelle K, McRonald F, Eccles D, Morris E, Hardy S, Turnbull C, Tischkowitz M, Pharoah P, Antoniou AC. Second Primary Cancer Risks After Breast Cancer in BRCA1 and BRCA2 Pathogenic Variant Carriers. J Clin Oncol. 2024 Oct 29:JCO2401146. doi: 10.1200/JCO.24.01146. Epub ahead of print. PMID: 39475295.