ÂÞÊÏÆìÏÂADCÒ©ÎïºÕÈüÀ³(R)»ñÅú ΪÔçÆÚÈéÏÙ°©ÖÎÁÆ´øÀ´Ð¾ö²ßµã

ÉϺ£ 2020Äê1ÔÂ24ÈÕ /ÃÀͨÉç/ -- ÂÞÊÏÖÆÒ©ÖйúÐû²¼£¬¹ú¼ÒÒ©Æ·¼à¶½¹ÜÀí×ܾÖÕýʽÅú×¼´´Ð°ÐÏòÒ©ÎïºÕÈüÀ³ ® £¨Ó¢ÎÄÉÌÆ·Ãû£º Kadcyla ® £¬Í¨ÓÃÃû£º¶÷ÃÀÇúÍ×Öéµ¥¿¹£©£¬µ¥Ò©ÊÊÓÃÓÚ½ÓÊÜÁË×ÏɼÍéÀàÁªºÏÇúÍ×Öéµ¥¿¹Îª»ù´¡µÄи¨ÖúÖÎÁƺóÈԲдæÇÖÏ®ÐÔ²¡ÔîµÄ HER2ÑôÐÔÔçÆÚÈéÏÙ°©»¼Õߵĸ¨ÖúÖÎÁÆ¡£×÷ΪȫÇò »ñÅúµÄ µ¥Ò©ÖÎÁÆʵÌåÁöµÄ¿¹ÌåÒ©ÎïżÁªÎADC£¬Antibody-Drug Conjugates£©£¬Í¬Ê±Ò² ÊÇ H ER2°ÐÏò ADC ²úÆ·£¬´Ë´ÎºÕÈüÀ³ ® µÄ»ñÅú£¬·á¸»ÁËÎÒ¹ú HER2ÑôÐÔÈéÏÙ°©»¼ÕßÔÚи¨ÖúÖÎÁÆÊÖÊõºóÈÔÓвд没ÔîÇ¿»¯¸¨ÖúÖÎÁƵÄÑ¡Ôñ£¬ÈÃÕⲿ·Ö¸ßΣ¸´·¢·çÏյĻ¼ÕßÀëÖÎÓú¸ü½üÒ»²½¡£

ÔçÆÚÈéÏÙ°©ÖÎÓú֮·Éϵľ«ÒæÇó¾«È«ÐÂ×÷ÓûúÖÆÖúÁ¦ÁÙ´²Í»ÆÆ

±¾´ÎºÕÈüÀ³®µÄ»ñÅúÊÇ»ùÓÚ KATHERINE Ñо¿£¬ÕâÊÇÒ»¸öÕë¶Ôи¨ÖúÖÎÁÆÊÖÊõºóÈÔÓвд没ÔîµÄ HER2ÑôÐÔÈéÏÙ°©»¼Õߣ¬ÈçºÎÓÅ»¯¸¨ÖúÖÎÁƵÄÈ«Çò¡¢¶àÖÐÐÄ¡¢III Æڹؼü×¢²áÐÔÁÙ´²Ñо¿¡£¾¡¹ÜºÕÈüÍ¡®£¨ÇúÍ×Öéµ¥¿¹£©ºÍÅÁ½ÝÌØ®£¨ÅÁÍ×Öéµ¥¿¹£©µÄÉÏÊиıäÁË HER2ÑôÐÔÈéÏÙ°©»¼ÕßȺÌåµÄÁÙ´²½á¾Ö£¬µ« HER2ÑôÐÔÔçÆÚÈéÏÙ°©»¼Õ߸¨ÖúÖÎÁÆʹÓúÕÈüÍ¡®£¨ÇúÍ×Öéµ¥¿¹£©£¬10ÄêºóÈÔÓÐÔ¼25%µÄ HER2ÑôÐÔÔçÆÚÈéÏÙ°©»¼Õ߻Ḵ·¢×ªÒÆ¡£¶øи¨ÖúÖÎÁÆʹÓúÕÈüÍ¡®£¨ÇúÍ×Öéµ¥¿¹£©+ÅÁ½ÝÌØ®£¨ÅÁÍ×Öéµ¥¿¹£©Ë«°ÐÖÎÁƺó£¬Ò²ÈÔÓÐÔ¼40-60%µÄ»¼Õßδ´ïµ½ pCR£¬¶øÕâЩи¨ÖúÖÎÁƺóδ´ïµ½ pCR µÄ»¼Õß5ÄêÄÚ¸´·¢·çÏÕ¸ßÓÚ pCR µÄ»¼Õߣ¬ÉÙÊý·çÏÕÉõÖÁ½Ó½ü80%[1]¡£ºÕÈüÀ³®£¨¶÷ÃÀÇúÍ×Öéµ¥¿¹£©ÎªÕⲿ·Ö»¼ÕßͬÑù´øÀ´Ï£Íû¡£

KATHERINE Ñо¿ÏÔʾ£¬ºÕÈüÀ³®£¨¶÷ÃÀÇúÍ×Öéµ¥¿¹£©×黼Õ߸¨ÖúÖÎÁƺó3ÄêÄÚ£¬ÎÞÇÖÏ®ÐÔ°©Éú´æÂÊ£¨iDFS£©´ïµ½88.3%£¬ÇúÍ×Öéµ¥¿¹µ¥Ò©×éΪ77%£¬Á½×é¾ø¶Ô²îÒì11.3% £¨HR:0.5, 95% CI:0.39-0.64, P<0.001£©£¬¶øÇÒ KATHERINE Ñо¿Ò²Ö¤ÊµÔÚʹÓà T-DM1ÒÔºó£¬ÎÞÂÛ ER ÑôÐÔ»¹ÊÇÒõÐÔ£¬ÊÇ·ñ¿ÉÊÖÊõ£¬ÉõÖÁÖ×Áö²ÐÁôºÜСµÄ»¼Õß¡¢Ð¡ÓÚ1cm »òÕßÁܰͽáÒõÐԵĻ¼Õߣ¬·çÏÕ±È HR Ϊ0.6 £¬Òâζ×ŶÔÓÚи¨ÖúÖÎÁÆÊÖÊõºóÈÔÓвд没ÔîµÄHER2ÑôÐÔÈéÏÙ°©»¼Õߣ¬ÔÚʹÓö÷ÃÀÇúÍ×Öéµ¥¿¹ÖÎÁƺó£¬Äܹ»½øÒ»²½½µµÍ50%µÄ¼²²¡¸´·¢¼°ËÀÍö·çÏÕ[2]¡£

¶Ô´Ë£¬KATHERINEÑо¿ÖйúÖ÷ÒªÑо¿Õß¡¢¸´µ©´óѧÖ×ÁöÑо¿ËùËù³¤¡¢ÈéÏÙ°©Ñо¿ËùËù³¤¡¢¸´µ©´óѧ¸½ÊôÖ×ÁöÒ½Ôº´óÍâ¿ÆÖ÷ÈμæÈéÏÙÍâ¿ÆÖ÷ÈÎÉÛÖ¾Ãô½ÌÊÚ±íʾ£º¡°KATHERINE Ñо¿Îª HER2ÑôÐÔÈéÏÙ°©»¼ÕßµÄÓÅ»¯ÖÎÁÆÌí¼ÓÁËеÄÀï³Ì±®Ê½Ö¤¾Ý£¬¸üΪÔÚ½ÓÊÜи¨Öú¿¹HER2°ÐÏòÖÎÁƺóÁÆЧǷ¼Ñ»¼ÕßµÄÁÙ´²Ñ¡Ôñ¿ª±ÙÁËеĵÀ·¡£¡±

ºÕÈüÀ³®£¨¶÷ÃÀÇúÍ×Öéµ¥¿¹£©ÔÚÖÎÁÆÖÐÄÜÓÐÈç´Ë¾ªÑ޵ıíÏÖ£¬ÓëÆ䴴еÄ×÷ÓûúÖƲ»ÎÞ¹Øϵ¡£ºÕÈüÀ³®£¨¶÷ÃÀÇúÍ×Öéµ¥¿¹£©Êǽ«¾­µäµÄ¿¹ HER2°ÐÏòÒ©ÎïºÕÈüÍ¡®£¨ÇúÍ×Öéµ¥¿¹£©ÓëÒÖÖÆ΢¹Ü¾Û¼¯µÄ»¯ÁÆÒ©ÎïÃÀµÇËØͨ¹ýÁòÃÑÁ¬½Ó×ÓÁ¬½Ó³ÉµÄÎȶ¨µÄ¿¹ÌåżÁªÒ©Î¾ßÓаÐÏòÖ×Áöϸ°ûµÄɱÉËÌص㣬Ҳ±»³ÉΪ¡°ÉúÎïµ¼µ¯¡±¡£ºÕÈüÀ³®£¨¶÷ÃÀÇúÍ×Öéµ¥¿¹£©¿ÉÏòHER2ÑôÐÔ°©Ï¸°ûÖ±½ÓµÝËÍǿЧ»¯ÁÆÒ©Î³ä·Ö·¢»Ó°ÐÏòÒ©ÎïµÄ×÷Óã¬ÓÖÄܽøÐл¯ÁÆɱÉË×÷Ó㬲¢¿ÉͬʱÏÞÖƽ¡¿µ×éÖ¯ÃâÊÜÆ亦¡£

¡°KATHERINE Ñо¿Ö¤ÊµÍ¨¹ý¶÷ÃÀÇúÍ×Öéµ¥¿¹Ç¿»¯¸¨ÖúÖÎÁƽøÒ»²½½µµÍÁË50%µÄ»¼Õ߸´·¢»òËÀÍö·çÏÕ£¬ÕâÊÇ HER2ÑôÐÔÈéÏÙ°©µÄÖÎÁƽø³ÌÉϾßÓиïÃüÐԵĽø²½£¬½«ÔÚÁÙ´²ÖÎÁÆÖÐΪ»¼Õß´øÀ´ÐµÄÍ»ÆÆ¡£¡±KATHERINEÑо¿²Î¼Óµ¥Î»¡¢É½¶«Ê¡Ö×ÁöÒ½ÔºÈéÏÙ²¡ÖÐÐÄÖ÷ÈΡ¢ÈéÏÙ°©MDTÊ×ϯר¼ÒÍõÓÀʤ½ÌÊÚ²¹³äµÀ¡£

ÔçÆÚÈéÏÙ°©»¼ÕßÈÔ´æÔڸ߸´·¢·çÏÕÐÂҩΪºóÐøÖÎÁÆ´øÀ´Ðµľö²ßµã

Ä¿Ç°ÔÚ HER2ÑôÐÔÔçÆÚÈéÏÙ°©ÖÎÁÆÖУ¬ÊÖÊõÇ°µÄи¨ÖúÖÎÁƺÍÊÖÊõºóµÄ¸¨ÖúÖÎÁƶ¼ÊÇÔçÆÚÖ×Áö×ÛºÏÖÎÁƵÄÒ»²¿·Ö¡£ÔçÆÚÈéÏÙ°©µÄÖÎÁÆÄ¿µÄÊÇΪ»¼ÕßÌṩ×î¼ÑÖÎÓú»ú»á¡£ÈéÏÙ°©Ð¸¨ÖúÖÎÁÆÄ¿±ê²»½öÊǽ«²»¿ÉÊÖÊõµÄÈéÏÙ°©½µÆÚΪ¿ÉÊÖÊõÈéÏÙ°©£»½«²»¿É±£ÈéµÄÈéÏÙ°©½µÆÚΪ¿É±£ÈéµÄÈéÏÙ°©£»¶øÇÒ¿É»ñµÃÌåÄÚÒ©ÎïÃô¸ÐÐÔÐÅÏ¢£¬´Ó¶øÖ¸µ¼ºóÐøÖÎÁÆÒÔ¸ÄÉÆ»¼Õߵij¤ÆÚÉú´æ¡£KATHERINE Ñо¿ÏÔʾ¶Ôи¨ÖúÖÎÁÆÊÖÊõºóÈÔÓвд没ÔîµÄ»¼Õߣ¬¸¨ÖúÖÎÁƽ׶ÎʹÓúÕÈüÀ³®£¨¶÷ÃÀÇúÍ×Öéµ¥¿¹£©£¬¿É½µµÍ50%µÄ»¼Õß·¢Éú°©Ö¢¸´·¢»òËÀÍöµÄ·çÏÕ¡£Òò´Ë¸ù¾Ýи¨ÖúÖÎÁƺó»¼ÕßÊÇ·ñÄܹ»´ïµ½ pCR£¬½«³ÉΪδÀ´¸öÌ廯¸¨ÖúÖÎÁƵÄÖÎÁƾö²ßµã¡£

¾Ý Neosphere Ñо¿[3]ÏÔʾ£¬Óëµ¥´¿ºÕÈüÍ¡®£¨ÇúÍ×Öéµ¥¿¹£©µÄÖÎÁÆÏà±È£¬ÅÁ½ÝÌØ®£¨ÅÁÍ×Öéµ¥¿¹£©ÁªºÏºÕÈüÍ¡®£¨ÇúÍ×Öéµ¥¿¹£©µÄи¨Öú¿¹ HER2ÖÎÁƿɸÄÉƸßΣ»¼ÕߵIJ¡ÀíѧÍêÈ«»º½â£¨pCR£©ÂÊ£¬µ«ÈÔÓÐ60%µÄ»¼Õß²»ÄÜÔÚи¨ÖúÖÎÁƺó£¬ÊµÏÖ²¡ÀíѧÍêÈ«»º½â£¨pCR£©¡£

Ϊ´Ë£¬KATHERINEÑо¿²Î¼Óµ¥Î»¡¢ÖÐɽ´óѧÖ×Áö·ÀÖÎÖÐÐÄÈéÏÙ°©ÄÚ¿ÆÊ×ϯר¼ÒÍõÊ÷É­½ÌÊÚÖ¸³ö£º¡°ÔÚ¾«×¼Ò½Ñ§Ê±´úµÄÁÙ´²ÖÎÁÆÖУ¬·ûºÏÐèÇóµÄ¸ßΣ HER2ÑôÐÔÈéÏÙ°©»¼Õ߶¼Ó¦¿¼ÂǽÓÊÜи¨ÖúÖÎÁÆ¡£»¼ÕßÔÚ½ÓÊÜи¨ÖúÖÎÁƺó£¬ÎÞÂÛÊÇ·ñ´ïµ½²¡ÀíѧÍêÈ«»º½â£¨pCR£©£¬ÕâЩ¸ßΣ»¼Õ߶¼¾ßÓÐÒ»¶¨µÄ¸´·¢·çÏÕ¡£¶ÔÓÚ´ïµ½ÁË pCR µÄ»¼Õߣ¬Ó¦¸Ã¼ÌÐø֮ǰµÄ¿¹ HER2°ÐÏòÖÎÁÆ£»¶ÔÓÚδ´ïµ½ pCR µÄ»¼Õߣ¬±¾´ÎºÕÈüÀ³®µÄ»ñÅú£¬ÄÜÓÐЧ½µµÍÕâÀ໼Õߵĸ´·¢·çÏÕ¡£¡±

Ò©Æ·Ñз¢²»¶Ï´´ÐÂÖ𲽸²¸ÇÈéÏÙ°©È«²¡³Ì

ÔÚHER2ÑôÐÔÈéÏÙ°©µÄÖÎÁÆÁìÓòÖУ¬ÂÞÊÏÑз¢µÄÒ©Æ·Òѽ¨Á¢Æð´Ó×î³õµÄи¨ÖúÖÎÁÆ¡¢ÊõºóµÄ¸¨ÖúÖÎÁÆ¡¢ÒÔ¼°ÍíÆÚÒ»ÏßÖÎÁÆÈ«³ÌµÄ¿¹ HER2ÖÎÁÆÌåϵ£¬Ô½À´Ô½¶àµÄÖйú»¼Õß´ÓÖÎÁÆÖлñÒæ¡£

ÂÞÊÏÖÆÒ©Öйú×ܲÃÖܺç±íʾ£º¡°2019Äê5Ô£¬ºÕÈüÀ³®£¨¶÷ÃÀÇúÍ×Öéµ¥¿¹£©ÔçÆÚ HER2ÑôÐÔÈéÏÙ°©¸¨ÖúÖÎÁÆÊÊÓ¦Ö¢ÔÚÃÀ¹ú»ñÅú£¬12ÔÂÓÖÔÚÅ·ÃË»ñÅú¡£µÃÒæÓÚÖйú²»¶Ï¼ÓËÙµÄÐÂÒ©ÉóÆÀÉóÅú£¬±¾´ÎºÕÈüÀ³®Öйú»ñÅúʱ¼ä»ù±¾ÓëÅ·ÃÀͬ²½¡£½ñºó£¬ÂÞÊϽ«Ò»Èç¼ÈÍùµØ±ü³Ö¡®ÏÈ»¼ÕßÖ®Ðè¶øÐС¯µÄÀíÄÓë¸÷·½Ð¯ÊÖ½«¸ü¶àµÄ´´Ð²úÆ·¸ü¿ìµØÒý½øÖйú£¬Âú×ã¹ã´óÖйúÈéÏÙ°©»¼ÕßµÄδ¾¡Ö®Ðè¡£¡±

³ýÁË HER2ÑôÐÔÈéÏÙ°©£¬ÂÞÊÏÖÆÒ©Ò²ÔÚÄ¿Ç°×îΪÐ×ÏÕµÄÈéÏÙ°©·ÖÀàÖ®Ò» -- ÈýÒõÐÔÈéÏÙ°©ÖÎÁÆÁìÓòÈ¡µÃ½øÕ¹¡£Æ俹 PD-L1Ö×ÁöÃâÒßÖÎÁÆÒ©ÎTecentriq®£¨°¢ÌæÀûÖéµ¥¿¹£©£¬×÷ΪÖÎÁÆÈýÒõÐÔÈéÏÙ°©µÄÖ×ÁöÃâÒßÁÆ·¨Ò©ÎïÒѾ­»ñµÃ FDA Åú×¼¡£Tecentriq®¿ÉÒÔÓëÖ×Áöϸ°ûºÍÖ×Áö½þÈóÃâÒßϸ°ûÉϱí´ïµÄ PD-L1ÅäÌåµ°°×½áºÏ£¬×è¶ÏÆäÓë PD-1ºÍ B7.1ÊÜÌåµÄÏ໥×÷Óá£Í¨¹ý×è¶Ï PD-L1ͨ·£¬Tecentriq®¿ÉÒÔÓÐЧ¼¤»îTϸ°û¡£

[1] Symmans W F, Wei C, Gould R, et al. Long-term prognostic risk after neoadjuvant chemotherapy associated with residual cancer burden and breast cancer subtype[J]. Journal of Clinical Oncology, 2017, 35(10): 1049.

[2] von Minckwitz G, Huang C S, Mano M S, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer[J]. New England Journal of Medicine, 2019, 380(7): 617-628.

[3] The lancet oncology, 2016, 17(6): 791-800.

Ïà¹ØÈÈ´ÊËÑË÷£º