乳腺癌局部治療進(jìn)展

1、會(huì)計(jì)學(xué)1乳腺癌局部治療進(jìn)展乳腺癌局部治療進(jìn)展Giuliano AE, McCall L, Beitsch PD, Whitworth PW,Blumencranz PW, Leitch AM, Saha S, Hunt K,Brennan M, Ballman KV, Morrow MPresented By Armando Giuliano at 2016 ASCO Annual Meeting Abstract 1007研究支持假說(shuō)： 接受保乳術(shù)與輔助系統(tǒng)化療的乳腺癌患者單純接受SLND與 I、II級(jí)ALND相比能取得相近的局部區(qū)域控制率與生存期。Presented By Armando

2、Giuliano at 2016 ASCO Annual Meeting Abstract 1007Presented By Armando Giuliano at 2016 ASCO Annual Meeting Abstract 1007Presented By Armando Giuliano at 2016 ASCO Annual Meeting Abstract 1007Presented By Armando Giuliano at 2016 ASCO Annual Meeting Abstract 1007106例（27.4%）接受了ALND的患者在前哨淋巴結(jié)（SN）外找到陽(yáng)性淋

3、巴結(jié)。Presented By Armando Giuliano at 2016 ASCO Annual Meeting Abstract 1007Presented By Armando Giuliano at 2016 ASCO Annual Meeting Abstract 1007Presented By Armando Giuliano at 2016 ASCO Annual Meeting Abstract 1007Presented By Armando Giuliano at 2016 ASCO Annual Meeting Abstract 1007Presented By

4、Armando Giuliano at 2016 ASCO Annual Meeting Abstract 1007Presented By Armando Giuliano at 2016 ASCO Annual Meeting Abstract 1007Presented By Armando Giuliano at 2016 ASCO Annual Meeting Abstract 1007Presented By Armando Giuliano at 2016 ASCO Annual Meeting Abstract 1007Presented By Armando Giuliano

5、 at 2016 ASCO Annual Meeting Abstract 1007Presented By Armando Giuliano at 2016 ASCO Annual Meeting Abstract 1007Presented By Elizabeth Mittendorf at 2016 ASCO Annual MeetingPresented By Elizabeth Mittendorf at 2016 ASCO Annual Meeting思考Howlader N， et al.: SEER cancer statistics review. Bethesda: Na

6、tional Cancer Institute, 19752008.Carmichael AE: Does local surgery have a role in the management of stage IV breast cancer? Eur J Surg Oncol 2003;29:20112019Cardoso F, ESMO Guidelines Working Group: Locally recurrent or metastatic breast cancer: ESMO clinical recommendations for diagnosis, treatmen

7、t and follow-up. Ann Oncol 2009;20 Suppl 4:1518.Surveillance, Epidemiology, and End Results(SEER) Program ().SEER*Stat Database: Mortality all COD, Aggregated with State, Total U.S. (19692010) , National Cancer Institute, DCCPS, Surveillance Research Program, Surveillance System B

8、ranch, released April 2013. underlying mortality data provided by NCHS (www. /nchs).Ann Surg Oncol (2013) 20:28282834Presented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 1005Atilla Soran, MD, MPH, FACS,Magge-Womens Hospital of UPMCVahit Ozmen, Serdar Ozbas, Hasan Karanlik, Mahmut Mu

9、slumanoglu,Abdullah Igci, Zafer Canturk, Zafer Utkan, Cihangir Ozaslan, Turkkan Evrensel,Cihan Uras, Erol Aksaz, Aykut Soyder, Umit Ugurlu, Cavit Col, Neslihan Cabioglu, Betul Bozkurt, Efe Sezgin, Ronald Johnson, Barry LemberskyPresented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 1005Prese

10、nted By Atilla Soran at 2016 ASCO Annual Meeting Abstract 1005主要終點(diǎn)：評(píng)價(jià)手術(shù)切除原發(fā)腫瘤對(duì)女性IV期乳腺癌患者OS的影響次要終點(diǎn)：發(fā)病率、局部-區(qū)域疾病進(jìn)展/復(fù)發(fā)、生活質(zhì)量Presented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 1005納入/排除標(biāo)準(zhǔn)：納入標(biāo)準(zhǔn)：u 活檢證實(shí)為原發(fā)乳腺癌u 現(xiàn)階段分期為IV期乳腺癌u 年齡18歲u 原發(fā)乳腺腫瘤可手術(shù)完整切除u 具備足夠的器官功能可耐受方案中設(shè)計(jì)的局部放療與系統(tǒng)治療排除標(biāo)準(zhǔn)：u 原發(fā)乳腺腫瘤不可手術(shù)完整切除，或伴

11、有遷延的感染、出血或壞死u 患者體質(zhì)較差不能耐受局部放療與系統(tǒng)治療u 之前診斷有其他惡性腫瘤史（不包括皮膚基底細(xì)胞癌及皮膚鱗狀細(xì)胞癌、宮頸上皮內(nèi)瘤變u 妊娠期或哺乳期u 患者不適合進(jìn)行足夠的隨訪與無(wú)法完成知情同意條款Presented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 1005統(tǒng)計(jì)分析：1.經(jīng)過(guò)對(duì)過(guò)去回顧性研究（2007年之前）的思考，認(rèn)為假設(shè)兩組間3年總生存絕對(duì)差異在18%（局部-區(qū)域手術(shù)組為35%，單純系統(tǒng)治療組為17%）。2.假設(shè)有10%的脫落率因失訪而產(chǎn)生。3.生存分析使用95%的可信區(qū)間（=0.05）與90%的檢

12、驗(yàn)效能（=0.9）的單側(cè)log-rank檢驗(yàn)，樣本量估算需要271例患者經(jīng)過(guò)隨機(jī)分組。Presented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 1005Presented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 10051.根據(jù)患者與主治醫(yī)生的傾向/原發(fā)病灶侵犯程度選擇接受保乳術(shù)（BCS）或乳房切除術(shù)。2.臨床/活檢判定區(qū)域淋巴結(jié)轉(zhuǎn)移或SLN（+）需行腋窩淋巴結(jié)清掃術(shù)。3.必須達(dá)到切緣干凈。4.保乳術(shù)（BCS）后需全乳放療（WBRT）。5.乳房切除術(shù)后的放療根據(jù)

13、疾病侵犯程度與該中心的實(shí)踐經(jīng)驗(yàn)。6.研究者判斷是否行轉(zhuǎn)移灶活檢。7.經(jīng)隨機(jī)分組后，標(biāo)準(zhǔn)治療（ST）組患者即接受化療，手術(shù)組患者在完整切除原發(fā)腫瘤后接受化療。8.所有激素受體（HR）陽(yáng)性乳腺癌患者接受了內(nèi)分泌治療（HT）。9.c-erb B2陽(yáng)性（IHC 3+陽(yáng)性 或 FISH +）接受了曲妥珠單抗治療。10. 給予雙膦酸鹽的治療需根據(jù)臨床醫(yī)生的判斷。11.對(duì)于遠(yuǎn)隔轉(zhuǎn)移所在部位的相關(guān)治療（手術(shù)或放療）需根據(jù)研究者的判斷。Presented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 1005Presented By Atilla So

14、ran at 2016 ASCO Annual Meeting Abstract 1005Presented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 1005Presented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 1005Presented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 1005Presented By Atilla Soran at 2016 ASCO Annual Meeting

15、Abstract 1005Presented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 1005Presented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 10051.在36個(gè)月的隨訪中是否行原發(fā)乳腺腫瘤切除兩組在生存率上相近。2.更長(zhǎng)的隨訪提示手術(shù)組患者的中位生存期（46個(gè)月 vs. 33個(gè)月；HR：0.66）與5年總生存率（41.6% vs. 24.4%）分別有統(tǒng)計(jì)學(xué)上的顯著改善。3.罹患惰性MBC（如ER陽(yáng)性、HER2 neu陰性、骨寡轉(zhuǎn)移）與55歲以下的患者

16、人群能夠從初始手術(shù)中得到顯著的生存獲益。4.初診IV期乳腺癌患者中接受原發(fā)腫瘤切除不增加30天死亡率。5.標(biāo)準(zhǔn)治療組的局部區(qū)域復(fù)發(fā)率是手術(shù)組的11倍（LRR：手術(shù)組 1% vs. 標(biāo)準(zhǔn)治療組 11%）6.多發(fā)肝和/或肺轉(zhuǎn)移可能提示初始手術(shù)預(yù)后不佳。Presented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 1005 轉(zhuǎn)移性乳腺癌的生存較過(guò)去有明顯改善，手術(shù)在原發(fā)腫瘤的處理中有重要的作用。 PS評(píng)分、年齡、伴隨疾病必須納入考量； 轉(zhuǎn)移癌的腫瘤負(fù)荷需納入考量； 手術(shù)的獲益依靠對(duì)腫瘤的完整切除； 腋窩淋巴結(jié)清掃、局部-區(qū)域放療應(yīng)該納入

17、考量，不管其轉(zhuǎn)移如何。Presented By Atilla Soran at 2016 ASCO Annual Meeting Abstract 1005King TA, Lyman JP, Gonen M, Reyes S, Boafo C, Plichta J, Hwang ES, Rogu HS, Liu M, Boughey JC, Jacobs LK, Krontiras H, McGuire K, Storniolo A, Nanda R, Golshan M, Isaacs C, Meszoely IM, Van Poznak C,Babiera G, Norton L, Mo

18、rrow M, Wolff AC, Winer EP, Hudis CA轉(zhuǎn)化性乳腺癌研究聯(lián)盟Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006初診IV期乳腺癌中手術(shù)對(duì)原發(fā)腫瘤處理的作用仍然存在很大爭(zhēng)議?；厮菪詳?shù)據(jù)提示存在一致的生存獲益：HR 0.69（0.63-0.77），p0.00001- 大部分證據(jù)為多模式治療- 大部分證據(jù)中較少有ER陽(yáng)性的腫瘤支持生存獲益的前瞻性研究數(shù)據(jù)有限Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006Prese

19、nted By Tari King at 2016 ASCO Annual Meeting Abstract 1006Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006 TBCRC 013：前瞻性注冊(cè)研究描述近年來(lái)IV乳腺癌患者的特征- 對(duì)一線治療的反應(yīng)率- 接受原發(fā)腫瘤切除患者的比率- 手術(shù)決策的制定流程*與常見(jiàn)預(yù)后因素、手術(shù)、生存相關(guān)聯(lián)的原發(fā)腫瘤分子學(xué)特征判定無(wú)法控制的局部病灶事件與姑息手術(shù)需要的頻次完成相關(guān)腫瘤分子學(xué)層面研究*Presented at ASbrS 2016 Presented By Tari K

20、ing at 2016 ASCO Annual Meeting Abstract 1006納入標(biāo)準(zhǔn)：-初診IV期乳腺癌且原發(fā)腫瘤結(jié)構(gòu)完整-在原發(fā)腫瘤行手術(shù)切除后3個(gè)月內(nèi)確診轉(zhuǎn)移性乳腺癌-組織取自原發(fā)腫瘤與轉(zhuǎn)移病灶入組時(shí)間：2009年7月2012年4月-共納入127例合格的患者，14家中心，2個(gè)隊(duì)列-隊(duì)列A：初診IV期乳腺癌且原發(fā)腫瘤結(jié)構(gòu)完整的患者（n=112）-隊(duì)列B：在原發(fā)腫瘤行手術(shù)切除后3個(gè)月內(nèi)確診為轉(zhuǎn)移性乳腺癌的患者相關(guān)文獻(xiàn)-Fackler MJ et al. Novel methylated biomarkers and a robust assay to detect circula

21、ting tumor DNA in metastatic breast cancer. Cancer Res 2014-King T et al. Prognostic impact of 21-Gene Recurrece Score in Patients with Stage IV Breast Cancer: TBCRC013. JCO 2016Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006 隊(duì)列A的結(jié)果處理：112例初診IV期乳腺癌且原發(fā)腫瘤結(jié)構(gòu)完整的患者均由醫(yī)生制定一線系統(tǒng)治療方案對(duì)一線治療出現(xiàn)反應(yīng)者

22、（醫(yī)生判定轉(zhuǎn)移病灶的SD、PR、CR）可進(jìn)入討論行下一步選擇性手術(shù)選擇性手術(shù)在沒(méi)有局部癥狀或需要局部控制的前提下完成患者與腫瘤的特征、對(duì)系統(tǒng)治療的反應(yīng)、原發(fā)腫瘤切除與3年OS之間的相關(guān)性使用log rank檢驗(yàn)、K-M法、Cox回歸進(jìn)行生存分析。Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006Presented By Tari King at 2016 ASCO Annual Meetin

23、g Abstract 1006Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006Presented By Tari King at 201

24、6 ASCO Annual Meeting Abstract 1006Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006Presented

25、 By Tari King at 2016 ASCO Annual Meeting Abstract 1006Presented By Tari King at 2016 ASCO Annual Meeting Abstract 1006 在這項(xiàng)前瞻性注冊(cè)研究，初診乳腺癌患者的3年總生存率為70%。 大部分患者（85%）的生存與接受的一線治療及其反應(yīng)率顯著相關(guān)。 患者選擇手術(shù)很可能是由于單個(gè)器官轉(zhuǎn)移與即將接受一線化療。 手術(shù)不對(duì)各個(gè)腫瘤亞型的生存都有影響。 HER2狀態(tài)與患者年齡仍然是重要預(yù)后因素，需要更深入的研究確定能從手術(shù)中獲益的患者亞群。 不應(yīng)在臨床研究外選擇對(duì)原發(fā)腫瘤進(jìn)行手術(shù)。Pres

26、ented By Tari King at 2016 ASCO Annual Meeting Abstract 1006| 64 對(duì)系統(tǒng)治療有反應(yīng)的患者中，對(duì)姑息手術(shù)的需求不常見(jiàn)，手術(shù)對(duì)其PFS并不是負(fù)面的影響，患者選擇手術(shù)很可能是由于單個(gè)器官轉(zhuǎn)移與即將接受一線化療，需要更深入的研究確定能從手術(shù)中獲益的患者亞群，不應(yīng)在臨床研究外選擇對(duì)原發(fā)腫瘤進(jìn)行手術(shù)。MF07-01 Vs TBCRC013指南證據(jù)：中國(guó)/NCCN指南/ABC2真實(shí)世界：IV期乳腺癌的特點(diǎn) 局部治療的意義 人文關(guān)懷| 66 SLND的臨床研究可以較好的指導(dǎo)臨床治療選擇。 原發(fā)IV期乳腺癌的臨床研究不易開(kāi)展，來(lái)自于這些研究數(shù)據(jù)的結(jié)果指導(dǎo)臨床需要權(quán)衡利弊慎重選擇。系統(tǒng)治