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¥ý·PÁÂCliff¤j¹L¥hªº¶K¤å¡A´þ¾i¤F¤p¦Ï¡A¨ì²{¦b«·s¦^¨ý¤´µM«á«l¤Q¨¬ù! ¤]·PÁ¦ѥv¤j¡B²q·Q¤jªº¸ê°T¤À¨É~ ±zÌè¦n¦P®ÉÂI¥X¤F¦P¬O§K¬ÌÀøªk¤¤PD-1¡BPD-L1ªº«n©Ê¨Ó! ¦³µÛ½T¹êªº«e¨Ò¥i´`¡A·Q¥²¤j®a¥i¥H´î¤Ö¤ß¤¤¤£¤Öªº²qºÃ»P·W±i¡C³o¦¸¤]¯un·PÁ¯E¹©ªº¸Ñª¼¡A¤~¦³¾÷·|Åý¤j®a¬Ý¨£°ê¤º¬Y¨Ç±M®a̹ï§K¬Ì·sÃĪº²z¸Ñ¨s³º°±¯d¦bþ¤@Ó¶¥¬q¡A©Ç¥u¯à©Ç¯E¹©¶]±o¤Ó¥ý¶i¤F¡A³o¨Ç±M®a©Î³\ÁÙ°±¯d¦b·í¦~ªº¥j¤«¸Ìù! ¥xÁÞ¤j¡A±zªºÅÜDªºÁÞ¤k¡A¦³ÃzÂI¡AÅý§Ú®tÂI¤£¤ä....¨þ¨þ! |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2016/3/2 ¤U¤È 11:47:54²Ä 1109 ½g¦^À³
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¦Ñ¥v¤j ¦U¦ì¤j¤j: ÁÂÁ´£¨Ñ¥²ªv§´Opdivo¥Î©óµÇ²ÓMÀùRCCªº¤T´ÁÁ{§Éªºµo®i¥v ¤]¬O¤@ÁûPFS ¥¼¹F¼Ð OS¹F¼ÐÀò±oFDAÃÄÃÒªºÃÄ) ²q·Q¤j Faith ¤j °ß±©¤j ¦Ñ´¤j ±Û«a¤j µ½¤H¤j Åó±ø±ø¤j ¤p©_¤j ¦U¦ì¤j¤j ¦Y¤F¦Ñ¥v¤j³o¨âÁû©w¤ß¤Y¦pªGÁÙ¨S®Ä ¦A¦Y¤U±³o¤@Áû: Opdivo(Nivolumab)¥Î©óÂಾ©Ê«D¤p²ÓMªÍÀù,³o¤]¬O¤@ÁûPFS ¥¼µª¼ÐÁ`¦s¬¡´Á¹F¼ÐÀò±oFDAÃÄÃÒªº§K¬ÌÀøªkÃĪ« ¹êÅç²Õ292¤H Opdivo (Nivolumab) »P ¹ï·Ó²Õ290¤H docetaxel ¼Ú¬wµµm¾J¡E The phase 3 open-label 582 patients «ÂI²z¦p¤U ¦³¿ù½Ð§ó¥¿ 1 Median PFS was comparable between the cohorts at 2.3 months in the Opdivo arm compared with 4.2 months in the docetaxel group. ( ¹êÅç²ÕPFS 2.3Ó¤ë ¹ï·Ó²ÕPFS 4.2Ó¤ë ) 2 Data from an interim analysis presented at the 2015 ASCO Annual Meeting showed a median OS of 12.2 months with Opdivo versus 9.4 months with docetaxel (´Á¤¤¤ÀªR¦b2015¦~ASCO ¦~·|µoªí ¹êÅç²ÕOS 12.2Ó¤ë ¹ï·Ó²ÕOS 9.4 Ó¤ë ) 3 ORR was 19 percent with the PD-1 inhibitor compared with 12 percent with chemotherapy («ÈÆ[¤ÏÀ³²v¹êÅç²Õ19% ¹ï·Ó²Õ 12% ) ORR =CR+PR 4 Higher PD-L1 expression was associated with improved survival outcomes among the 78 percent of patients for whom PD-L1 status was detectable. (%78¯f¤H¤¤PD-L1 ªºª¬ªp¬O¥i´ú¨ìªº ¸û°ªPD-L1 ªí²{ »P Á`¦s¬¡´Á§ïµ½¦³Ãö) 5 In PD-L1¡Vpositive patients (PD-L1 expression on at least 1 percent of tumor cells), median OS was improved by 41 percent among 123 individuals treated with Opdivo versus 123 patients who received docetaxel (median OS was 17.2 months vs 9.0 months). (PD-L1 ¶§©Ê¯f¤H (¸~½F²ÓM¦Ü¤Ö1ӦʤÀ¤ñªºPD-L1 ªí²{) Á`¦s¬¡´Á§ïµ½41% ) 6 The OS benefit continued to rise as PD-L1 levels increased. The reduction in the risk of death was 57 percent (median OS = 18.2 months) and 60 percent (median OS = 19.4 months) for patients expressing PD-L1 on at least 5 percent and at least 10 percent of their tumor cells, respectively. (PD-L1 ªí²{¦Ü¤Ö5ӦʤÀ¤ñ median OS = 18.2 months °§C¦º¤`·ÀI57% ) (PD-L1 ªí²{¦Ü¤Ö10ӦʤÀ¤ñmedian OS = 19.4 months °§C¦º¤`·ÀI60% ) ¸Ô²Ó¸ê°T½Ð¾\Ū http://www.curetoday.com/articles/fda-expands-opdivo-approval-in-lung-cancer |
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·|û¡G¦³«í10141521 µoªí®É¶¡:2016/3/2 ¤U¤È 11:03:58²Ä 1108 ½g¦^À³
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µ½¤H¤j ¨S°ÝÃD,¤p§Ì©ú¤é¸ÕµÛ¨Ì±zªº°ÝÃD°Ý°Ý¬Ý,Y¦³¶i¤@¨B¦^ÂÐ,¤p§Ì¦A§â¦^ÂÐPO¤W¨Ó |
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·|û¡G¦Ñ¥v10140531 µoªí®É¶¡:2016/3/2 ¤U¤È 09:29:46²Ä 1107 ½g¦^À³
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¤À¨É¥²ªv§´Opdivo¥Î©óµÇ²ÓMÀùRCCªº¤T´ÁÁ{§É 406¤H¤À¨ìOpdivo¹êÅç²Õ¡A397¤H¤À¨ìeverolimus(Afinitor)¹ï·Ó²Õ¡A¶}©ñ¦¡Á{§É¡A2015¦~7/20¦]¬°¹êÅç²ÕÀu¶VªºOS¤w¸g¹F¨ì¥Dnendpoint¡A©Ò¥Hindependent Data Monitoring Committee ´£¦³Û°±¡A¦P¦~9/16¨ú±oBTD¥H¤ÎPriority Review¡A9/26¦bECC·|ijµoªí¼Æ¾Ú¡Aªí©w¤µ¦~3/16¬OFDA³Ì«á¼f¬d¤é¡A¦ýFDA¶W¦³®Ä²v¦b¥h¦~11/23®Öã¡C§Ú²q´úFDA±o¥H§Ö³t®Ö㪺ì¦]¦³¤T¡A¤@¬OFDA¤w¸g¼f¹LOpdivo¥Î©óªÍÀù¡B¶Â¦â¯À½F¡A²M·¡¨äÃĪ«¾÷Âà¡A¤G¬O¶}©ñ¦¡Á{§ÉÆ[¹îOS¡A¥²ªv§´¾ã²z¼Æ¾Úªº®É¶¡¤j´T´î¤Ö¡A¤T¬OFDA¹ï©ó¥¼º¡¨¬ªºÂåÀø»â°ì·¥¨ã¼u©Ê Á{§É¼Æ¦r2015¦~11/11µoªí©ó·s^®æÄõÂå¾Ç´Á¥Zhttp://www.nejm.org/doi/full/10.1056/NEJMoa1510665#t=articleResults 1. OS¬O25Ó¤ë¤ñ¤W19.6¤ë¡A³o¬OFDA¥Dn®Öã²z¥Ñ¡AThose treated with Opdivo lived an average of 25 months after starting treatment compared to 19.6 months in those treated with Afinitor. This effect was observed regardless of the PD-L1 expression level of patients¡¦ renal cell tumors¡A¾ã²Õ¤@°_¬Ý´N¤w¸g¹F¼Ð¡A¨S¦³¦Ò¼{PD-L1ªí²{²v°ª§Cªº°Ï§O¡C¤å³¹¤º¥t¦³¤ÀªRPD-L1ªí²{²v°ª§CªºOS 2. ORR¬O25% vs. 5% 3. PFSªº°Q½×«Ü¦³½ì¡A¹êÅç²Õ4.6Ó¤ëvs.¹ï·Ó²Õ4.4Ó¤ë¡A¤å¥½discussion³o¼Ë»¡¡Gthe results of a comparison of progression-free survival between the nivolumab group and the everolimus group suggest that progression-free survival was not a surrogate for overall survival in this study¡C§Ú¥Î¸Ø±iªº»y·N½Ķ´N¬O»¡¡A§AÌ¥xÆW´CÅé°°±M®aÁÙ¦b¬ÝPFS¡A§K¬ÌÀøªkªºÁ{§Én¬ÝOS°Õ¡C§ó²`¤J¤ÀªRPFS¡A¥ḺN¤»Ó¤ëÁÙ¥¼PD©Î¦º¤`ªº¿W¥ß¥X¨Ó¬Ý¡APFS¬O15.6Ó¤ë¤ñ¤W11.7Ó¤ë¡CThe analysis of this subgroup of patients yielded a median progression-free survival of 15.6 months in the nivolumab group and 11.7 months¡]¬°¤è«K¾\Ū§Ú§â«H¿à°Ï¶¡®³±¼¡^¡K¡K The late separation of the progression-free survival curves suggested a potential delayed benefit in progression-free survival with nivolumab. This delayed benefit was subsequently quantified in a sensitivity analysis that included patients who had not had disease progression or died at 6 months; the median progression-free survival was longer with nivolumab than with everolimus in this subgroup of patients. These patients probably contributed to the overall survival benefit that was observed with nivolumab in this study¡C |
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·|û¡Gµ½¤H10137888 µoªí®É¶¡:2016/3/2 ¤U¤È 07:24:00²Ä 1106 ½g¦^À³
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¦³«í¤j, «D±`·PÁ±z¤À·Q¸ß°Ý¤½¥qªº°ÝÃD©M¦^ÂÐ. ¯à¤£¯à³Â·Ð±z¦A¸ß°Ý¤½¥q¤U¦C°ÝÃD? 1.µo¥ÍDelay Response©Minfiltrationªº¨ü¸ÕªÌ¬O§_¤´µM©w´Á¦^Âå°|°µ¹q¸£Â_¼h±½´y (CT scan)¤Î¨ä¥¦Àˬd? 2.¦pªG¤´µM©w´ÁÀˬd, ¸~½F¤j¤pªºÅܤƦp¦ó? ¬OÅܤj©ÎÅܤp©Î«O«ùéw? ¤ñ¨Ò¤j´n¦U¦h¤Ö%? ·PÁ±z! |
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·|û¡G¤p·s10141589 µoªí®É¶¡:2016/3/2 ¤U¤È 06:46:28²Ä 1105 ½g¦^À³
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ÁÂÁ·Q·Q¤j¸ê°T =============== ¸~½F§K¬ÌªvÀø³QScienceÂø»x¦C¬°2013¦~«×¤Q¤j¬ì¾Ç¬ð¯}²Ä¤@¦ì¡A³QNatureÂø»x¦C¬°2014¦~³Ìȱo´Á«Ýªº¤Q¤j¶i®i¤§¤@¡C¦b§Y±N¥l¶}ªºASCO·|ij¡A¸~½F§K¬ÌªvÀø¤]¬O³ÌȱoÃöª`ªº¶i®i¤§¤@¡C¦b«Ü¦h§K¬ÌÀËÅçÂIÃþ§ÜÅ骺Á{§É¸ÕÅ礤¡A¥X²{¤F¥H«e¤£±`¥Îªº¤@Ó¸~½FÀø®Äµû»ù¼Ð·ÇirRC¡C¤µ¤Ñɦ¹¾÷·|¤¶²Ð¸~½FªvÀøÀø®Äµû»ùªº¼Ð·Çªºµo®i¨Ã«ÂI¤¶²ÐirRC¡C ¾î¬Ý¦¨À°¼¦¨®p¡Aªö¥Î¤£¦Pªº¼Ð·Çµû»ù¦P¤@Ó±wªÌ©ÎÁ{§É¸ÕÅç¥i¯à·|±o¨ì§¹¥þ¤£¦Pªºµ²ªG¡C¥Ñ©ó§@¥Î¾÷»s¦U²§¡A¸~½FªvÀøÀø®Äªºµû»ù¸û¬°½ÆÂø¡A¦]¦Óªö¥Î¦X¾Aªº¼Ð·Ç¶i¦æµû»ù«D±`«n¡C ¸~½FªvÀøÀø®Äµû»ù¼Ð·Çªºµo®i ¸~½FªºÀø®Äµû»ù¼Ð·Ç¬OÁ{§ÉªvÀø¤è®×¡]ÃĪ«©Î¨ä¥L¾Þ§@¡^¬O§_¦³®Äªº°Ñ¦Ò¨Ì¾Ú¡A¤]¬°¤£¦PªºÁ{§É¸ÕÅç³Ð³y¤F¥i¤ñ±ø¥ó¡C¬ü°ê°ê®a½Ã¥Í¬ã¨s°|¡]national institutes of health, NIH¡^¦¦b1960¦~¥N´N²Õ´±M®a»s©w¤F¸~½FÁ{§É¸ÕÅ窺¼Ð·Ç»P³W½d¡A´£¥X¥HÆ[¹î¸~½Fªº¤j¤p¨Ó§@¬°¦³µL½w¸ÑÀø®Äªº¨Ì¾Ú¡C1976¦~¡A¬ã¨sµo²{즳¼Ð·Çªº´ú¶q¤èªk¦b¼v¹³¾Ç¶EÂ_§Þ³N¶i¨Bªº±¡§Î¤U¤w¸g¸¨«á¡A¥@¬É½Ã¥Í²Õ´¡]worldhealth organization, WHO¡^¬°¦¹©ó1979¦~¥l¶}¤F°ê»Ú·|ij¡A»s©w¤F¹êÅé½FÀø®Äµû»ù²Î¤@¼Ð·Ç§YWHO¼Ð·Ç¡A¨Ã©ó1981¦~µoªí¦bCancerÂø»x¤W¡CWHO¼Ð·Çªº´ú¶q¤èªk¬°¤Gºû´ú¶qªk©ÎºÙÂù®|´ú¶qªk¡A¥H¸~½F¤j¤pªºÅܤƨӵû§P±wªÌ¹ïªvÀøªº¤ÏÀ³¡A¥]¬A¡G§¹¥þ½w¸Ñ¡]complete response, CR¡^¡B³¡¤À½w¸Ñ¡]partial response, PR¡^¡Béw¡]stable disease, SD¡^©M¶i®i¡]progressive disease, PD¡^¡CWHO¼Ð·Ç¹ï±À°ÊÀø®Äµû»ùªº³W½d¤Æ¡B¬ì¾Ç¤Æµo´§¤F¥¨¤j§@¥Î¡C¦ýÀHµÛ®É¶¡ªºµo®i¡A¤H̵o²{WHO¼Ð·Ç¤]¦³¯Ê³´¡A¦p¹ï¦³¨Ç¯f¨_ªº©w¸q¼Ò½k¡A¹ï¼Æ¥Ø¦h¦Óª½®|¤pªº¸~½F¯f¨_Ãø¥H·Ç½Tµû»ù¡F¤@¨Ç·sªº¼v¹³§Þ³Nªº¥X²{¤]¹ï¸~½F¤j¤p´ú¶q©MÀø®Äµû»ù²£¥Í¤F½ÄÀ»¡C1999¦~¡AJamesµ¥´£¥X¤F¥H¸~½F³Ìªø®|ªºªø«×¥N´ÀÄÑ¿n¨Ó¥Nªí¸~½F¤j¤pªº¤@ºû´ú¶qªk¡]³æ®|´ú¶qªk¡^¡A¦]¬°¸~½Fªø¶bªºª½®|»P¸~½F²ÓM¼Æ¶qªºÅܤÆÃö«Y¤ñ¸~½FÂù®|¼¿n»P¸~½F²ÓM¼Æ¶qªºÅܤÆÃö«Y§ó¬°±K¤Á¡A¤@¨Çµ²ªG¤]Åã¥Ü¤@ºû´ú¶qªk¤èªk²³æ¥BÀø®Ä§PÂ_§ó½T¤Á¡C¦b¦¹°ò¦¤W¡A¼Ú¬wÀù¯g¬ã¨s»PªvÀø²Õ´¡]European organisation for research and treatment of cancer, EORTC¡^¡B¬ü°ê°ê¥ßÀù¯g¬ã¨s©Ò¡]national cancer institute, NCI¡^¤Î¥[®³¤j°ê¥ßÀù¯g¬ã¨s©Òªº±M®aÁp¦X¶i¦æ¤F¥²nªº×§ï©M¸É¥R¡A¨Ã©ó2000¦~µoªí¤F·sªº¸~½FÀø®Äµû»ù¼Ð·Ç¡]response evaluation criteriain solid tumors, RECIST¡^¡C2009¦~¡ARECIST¼Ð·Ç¥X²{¤F1.1ª©¡A¥Dnªº¤£¦P¬O¡G³W©w¨C¾¹©x³Ì¦h2ӥؼЯf¨_¡B¼W¥[¤F²O¤Úµ²ªºµû»ù¡B¹ï°©¯f¨_µ¥°µ¤F¯S®í»¡©úµ¥¡C ·íµM¡ARECIST¼Ð·Ç¤]¦³¨ä§½©Ê¡C¨Ò¦p¨Ã¤£¾A¦X©ó¬Y¨Ç¸~½FÃþ«¬¡A¤×¨ä¬O¨º¨Ç«D¥~©P¥Íªø«¬¡]¦p´c©Ê¯Ý½¤¶¡¥Ö½F¡^©MªÅµÄż¾¹¸~½F¡]¦p¹ºÞÀù¡^¡A¦¹¥~¡AWHO©ÎRECIST¼Ð·Ç³£¬O¨Ì¿à¸~½F¤j¤pªºÅܤƶi¦æµû»ù¡A¦ý¬O¤@¨Ç¤À¤l¹v¦VÃĪ«¡A¤×¨ä¬O¥H§Ü¦åºÞ§Î¦¨¬°¥Dn§@¥Î¾÷»sªºÃĪ«¡AªvÀø«á±`±`¾ÉP¸~½FÃa¦º¨Ã§Î¦¨ªÅ¬}©Î²G¤Æ¡A¦Ó¸~½F¤j¤p¨ÃµL©úÅ㪺ÅܤƬƦܦ³©Ò¼W¤j¡]¦ý¸~½F¤º³¡¤wµL¡§¦s¬¡¸~½F¡¨©Î«Ü¤Ö¡§¦s¬¡¸~½F¡¨¡^¡A³o®É¦pªG«öWHO©ÎRECIST¼Ð·Ç¡A³o¨ÇÃĪ«¦bÁ{§É¹êÅ礤¨Ã¨S¦³Åã¥Ü§ÜÀù¬¡©Ê¡A¦ý«o¦bµL¯e¯f¶i®i´Á¡]progression-freesurvival, PFS¡^©MÁ`¥Í¦s¡]overall survival, OS¡^¤WÅã¥Ü¤F¹ê¹ê¦b¦bªºÀò¯q¡A¦]¦¹WHO©ÎªÌRECIST¼Ð·Ç±`±`Ãø¥H«ÈÆ[¯u¹ê¦aµû»ù¤À¤l¹v¦VÃĪ«ªºÀø®Ä¡C 2008¦~¡A¬ü°ê¨xż¯f¬ã¨s¨ó·|¡]American association for thestudy of liver diseases, AASLD¡^¹{¥¬¤F°w¹ï¹v¦VªvÀøÃĪ«ªvÀø¨xÀùªº§ï¨}RECIST¼Ð·Ç¡]modified RECIST, mRECIST¡^¡C¸Ó¼Ð·Ç´£¥X¦b¨xÀùÀø®Äµû»ù®É¡Aªö¥Î¼W±j±½´y°ÊºACT©ÎMRInÁ׶}Ãa¦º©Î²G¤Æ°Ï¡A´ú¶q¨ä´Ý¦s¸~½F¡A¥HÅã¥Ü³y¼v¾¯Äá¨úªº¯fÅܽd³ò©Î°Ï°ì§Y°Ê¯ß´Á±j¤Æªº¦s¬¡¸~½F¡]viable tumor¡^ªºÅܤƨӵû¦ôÀø®Ä¡A³o¤@«¤j§ï¶i¡A¹ï¨xÀù³oºØ¸û¬°¯S®íªº¸~½F¡A´£¥X¤F¸û¬°«ÈÆ[©M¯u¹êªºµû»ù¤èªk¡C ¦b¥t¥~¤@Ó¹v¦VªvÀøÃĪ«¥ì°¨´À¥§ªvÀøG¸z¶¡½è½F¡]gastrointestinal stroma tumors, GIST¡^ªºÁ{§É¹ê½î¤¤¡Aµo²{RECIST¼Ð·Ç³q±`·|§C¦ô¤FGIST±wªÌ±µ¨ü¥ì°¨´À¥§ªvÀø«á¯u¥¿ªºÁ{§ÉÀò¯q¡A¤£¯à·Ç½T¦Ó¥þÄѪº¤Ï¬M±wªÌªºÀø®Äª¬ªp¡CMDAndersonÀù¯g¤¤¤ßªºHaesun Choi»{¬°¦pªG¦P®É¦Ò¼{¨ìCTÀˬd¤¤¸~½F±K«×©M¸~½F¤j¤p¨â¤èÄѪºÅܤơA´N¥i¥H±Ó·P¡B·Ç½T¦aµû¦ô¥ì°¨´À¥§ªºÀø®Ä¡A¦]¦¹´£¥X¤FGISTÀø®Äµû»ùªº·s¼Ð·Ç§YChoi¼Ð·Ç¡CChoi¼Ð·Ç¬O¥H¸~½F·s¥Í¦åºÞ©M±K«×§ïÅܬ°°ò¦ªº·sµû»ù¼Ð·Ç¡CÁöµMChoi¼Ð·Ç¬O¬°¤Fµû¦ôGIST¦Óµo®i°_¨Óªº¡A¦ý¤@¨ÇÁ{§É¸ÕÅçªí©ú¡AChoi¼Ð·Ç¤]¤ñRECIST¼Ð·Ç§ó¾A¦X¤@¨Ç¨ä¥Lªº¹v¦VªvÀøÃĪ«¦p¯Á©Ôµá¥§©ÎĬ¥§´À¥§ªvÀøµÇÀùªºÀø®Äµû»ù¡CChoi¼Ð·Ç§â¡§½w¸Ñ¡¨©w¸q¬°¼W±jCT¤¤¸~½FÅé¿nÁY¤p>10%©Î¸~½F±K«×¤U°>15%¡A¦Ó¦bmChoi¼Ð·Ç¤¤¡A«h§â¡§½w¸Ñ¡¨©w¸q¬°¼W±jCT¤¤¸~½FÅé¿nÁY¤p>10%¥B¸~½F±K«×¤U°>15%¡C ¦bÁ{§É¹ê½î¤¤¡AÁÙ¥X²{¤FSACT¼Ð·Ç¡BMASS¼Ð·Ç©MPERCIST¼Ð·Ç¡A³o¨Ç¼Ð·Ç¨Ï¥Î¸û¤Ö¡A¨Ã«D¥D¬y¡A¦b¦¹¤£§@¤¶²Ð¡CmRECIST¡BChoi¡BmChoi¡BSACT©MMASS¼Ð·Ç¦b¤@©wµ{«×¤W¸Ñ¨M¤F |
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·|û¡G·Q·Q10140340 µoªí®É¶¡:2016/3/2 ¤U¤È 05:53:44²Ä 1104 ½g¦^À³
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¤p·s¤j: §ï±Ä¥Î§K¬ÌÀøªk¾A¥ÎªºIRRC(Immune-Related Response Criteria) ¬Û¹ï©ó¶Ç²Îªº¤èªk¬°(RECIST)response Evaluation Criteria in Solid Tumors |
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·|û¡G¤p·s10141589 µoªí®É¶¡:2016/3/2 ¤U¤È 05:29:12²Ä 1103 ½g¦^À³
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½Ð±Ð¦U¦ì¤j¤j²{¦³ªºÀËÅ禳¨S¦³¤èªk©Î¶q´ú¦]¥´¤FOBI822¬°µo¥Í®û¼íªº¨}¦n²{¶H,¦Ó¤£·|»~§P¬°´_µoªº¤èªk,¥H¸ê¯E¹©3´Á¹êÅ窺§ï¶i³]p? |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2016/3/2 ¤U¤È 04:47:53²Ä 1102 ½g¦^À³
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2016/3/2 ¤U¤È 04:44:52²Ä 1101 ½g¦^À³
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¦Ñ¥v¥S ¦Ñ¥v¥S ¦hÁ¤F! ¨Ìð´Â¼f¬üÆ[ ÁÞ¤k¥»¨Ó´N¤ñ¸ûD¨Ç¡A¥[¤W§ðÀ» ¼Ä¤H¥Ø¼Ð®É·|¦³®û¼í²{¶H¬Ý°_¨Ó¤SÅÜD¤@¨Ç¡A³Ìªñ¤S¤H¤H³Û¤j¡A§Æ±æ¤£·|D¤Ó¦h¡C |
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·|û¡G¦Ñ¥v10140531 µoªí®É¶¡:2016/3/2 ¤U¤È 04:18:34²Ä 1100 ½g¦^À³
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¥xÁÞ¤j©çÁ §Ú¼g±o¤Ó²²¤¡A§Úªº·N«ä¬O¦b¯E¹©¥¿¦¡¤½¶}¼Æ¾Ú¤§«e §ÚÌÀ³¸Ó§ó§V¤O¾\ŪPD-1,PD-L1³o¨ÇÀWÀWÀò±oBTDªº§K¬ÌÃĪ«ªºÁ{§É¼Æ¾Ú µ¥¨ì¯E¹©±ÈµP §Ṳ́~¯à«Ü§Öªº²z¸Ñ¼Æ¾Ú¨ì©³¦n¤£¦n¡A©Î¬O¦n¨ì¤°»òµ{«×¡H°÷¤£°÷®æBTD¡H °÷¤£°÷®æ¤J¿ïBest of ASCO¡H¤µ¦~Best of ASCO¦b7/15~16¦bµØ²±¹y ¦¹®É²³¤H³Û¥´¡A¯E¹©»ÝnASCO©ÎBTD¨Ó¥¤Ï |
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Faith¤j HerceptinªºÁ{§É¸ÕÅç±`n¨DHER2(+)¬°¦¬®×±ø¥ó¡AÀH«K§ì¤@ӨӬݴNª¾¹D ¡uhttps://clinicaltrials.gov/ct2/show/NCT00136539?term=trastuzumab&rank=744 ¡v ¡uCriteria¡G Inclusion Criteria: --Patients must have Stage II or III histologically diagnosed breast cancer --Primary invasive breast cancers that overexpress the HER2/neu oncogene --¡K¡K²¤¡v §Q¯A¤j¤t¤j¡G ¤p§Ì¥H¦Û¤v©Òª¾´£¨Ñ°Q½×¡C 30£ggªº¾¯¶q¨Ó¦Û©ó1998¦~ªºPhase I study for Prostatic Ca.¡G¡uhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC21925/ ¡v ¦b¡u3£gg¡B10£gg¡B30£gg¡B100£gg of Globo H¡vªº¾¯¶q¤U°µ¸ÕÅç¡Aµ²ªG¡u¡K¡KThe 30-£gg dose appeared to be optimal and has been selected for use in future trials¡K¡K¡v¡C ¦Ó¥Bµo²{³Ì°ª§ÜÅé¿@«×³£¥X²{¦b5¦Ü13¶g¶¡¡C¡]¥iª¦¤å104/7/1¤U¤È09:20:11 OBI-822¡BOBI-833¥H¥~ªº²£«~ª©±¡^ 822¤@´Á¸ÕÅ礤¡AIgM»PIgG titer®øªøÅܤƹϡG¡]For Prostate Ca¡^ ¬Ý30£ggªº½u§Y¥i¡]¦]¬°¤@/¤G/¤T´Á³£¬O¥´30£gg¡^¡A¨CӹϪº¥ª¤W¤è¦³5Ӷ¦â´Â¤U¤p½bÀY¡Aªí¥Ü¬I¥´ªº¶g¼Æ¡A¤@´Á¥u¥´¤¾¯¡Aµ²ªG©â¦åÀËÅç¥X¨Óªº³Ì°ª§ÜÅé¿@«×³£¥X²{¦b5¦Ü13¶g¶¡¡A¥B¦b²Ä19¶g®É¡AÁöµM¥´¤F²Ä¤¾¯¡A«o§e²{³Ì§C§ÜÅé¿@«×¡C¡]±q1998¦~ÄáÅ@¸¢Àù¤Î«á¨Óªº¨ÅÀù¨ü¸ÕªÌ¸ÕÅç¬Ò±o¨ìÃþ¦üµ²ªG¡^ IgM¡G ¡uhttp://www.ncbi.nlm.nih.gov/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Click%20on%20image%20to%20zoom&p=PMC3&id=21925_pq0990752002.jpg ¡v IgG¡G ¡uhttp://www.ncbi.nlm.nih.gov/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Click%20on%20image%20to%20zoom&p=PMC3&id=21925_pq0990752003.jpg ¡v ¥t¥~ ¤£ª¾¹D¤j®a¦³¨S¦³ª`·N¨ì¦³ÃöDr. Hope S Rugo¹ï¸Ñª¼µ²ªGªºµû»y¡A¤½¥qµo¥¬ªº¤¤¤å«¤j°T®§»P^¤åªº·s»D½Z¡A¨âªÌ¤º®eªº®t²§¡C ¤¤¤å«¤j°T®§¡]2/21 15:33:39¡^¡G ¡u¬ü°ê¥[¦{¤j¾Çª÷¤s¤À®Õ®üÛ¡E}°Ç®a®xºî¦XÀù¯g¤¤¤ß¨ÅÀùÁ{§É¸ÕÅç±Ð¨|¥D¥ô±Ð±Â¡BH. RugoÂå¾Ç³Õ¤h»{¬°¡A¡y³o¶µ¬ã¨sÅã¥Ü¡A¹ï¦³§K¬Ì¤ÏÀ³ªí²{ªÌ¤w¹F¨ì¥DnÀø®Ä«ü¼Ð¡A¦P®ÉÃÒ¹ê¥H§K¬ÌÀøªkªvÀø¨Å¸¢Àù±wªÌªº¦³®Ä©Ê¡F³o¨Çµ²ªG©M¼Æ¾Ú±N¤ä«ù±N¶}®iªº¤U¤@¨B¥þ²y©Ê¤T´ÁÁ{§É¸ÕÅç¬ã¨s¡A¨äµ²ªG¤]¥i¶i¤@¨BÄÄ©úOBI-822»ùÈ¡A§@¬°¦¹¤@¥Rº¡§Æ±æªº·s²£«~µù¥U°ò¦¡C¡z¡v ²Ä¤@¥y¡G¡u³o¶µ¬ã¨sÅã¥Ü¡A¹ï¦³§K¬Ì¤ÏÀ³ªí²{ªÌ¤w¹F¨ì¥DnÀø®Ä«ü¼Ð¡K¡v ^¤åªº·s»D½Z¡G³o¤@½g¨ä¹ê¬O¤½¥qªº·s»D½Z¡A³Qª©¤Í»~¥H¬°¬O¥~´C³ø¾É¡C ¡]http://www.prnewswire.com/news-releases/obi-pharma-reports-topline-results-from-obi-822821-randomized-controlled-phase-23-clinical-trial-in-patients-with-metastatic-breast-cancer-300223585.html ¡^ ¡uWhile the study did not meet its originally designed primary endpoint, the encouraging efficacy seen in patients who demonstrated an immune response to the vaccine support the validity of an immunological approach to treating breast cancer and these data will help us develop a global phase 3 study that will provide the data to further elucidate the value of OBI-822 and support the registration of this promising new product,¡v ²Ä¤@¥y¡G¡uWhile the study did not meet its originally designed primary endpoint¡K¡K¡v¡C ´£¨ì¡uÁöµM³oÓ¸ÕÅ祼º¡¨¬·íªì³]pªº¥Dn«ü¼Ð¡K¡K¡v¡A¾ã¬qŪ§¹¨ä¹ê¨Ã¥¼¦³¡u¹F¨ì¥DnÀø®Ä«ü¼Ð¡vªº±Ôz¡ADr.Rugoªº¥Î¦r/¥ÎµüÅãµM·¥¬°ÂÔ·V¡C ²z·íĶ¬°¡G¡uÁöµM³oÓ¬ã¨s¡]study¡^¥¼¯àº¡¨¬·íªì³]pªº¥Dn«ü¼Ð¡]originally designed primary endpoint¡^¡A¦ý¦b¹ï¬Ì]¦³§K¬Ì¤ÏÀ³ªº±wªÌ¨¤W¬Ý¨ì¥O¤H®¶¾ÄªºÀø®Ä¡]encouraging efficacy¡^¡A³o¼ËªºÀø®Ä¤ä«ù¥H§K¬ÌÀøªk¡]immunological approach¡^¨ÓªvÀø¨ÅÀù¡A¦Ó¥B³o¨Ç¼Æ¾Ú¦³§U©ó§Ú̶}®i¥þ²y©Ê¤T´ÁÁ{§É¸ÕÅç¬ã¨s¡A³oÓ¬ã¨s¡]global phase 3 study¡^ªº¼Æ¾Ú±N¶i¤@¨BÄÄ©úOBI-822ªº»ùÈ¡A§@¬°¦¹¤@¥Rº¡§Æ±æªº·s²£«~µù¥Uªº°ò¦¡C¡v ÁöµM¥y¸q±µªñ¡A¦ý¬O¬ì¾Ç¤å³¹ÀE»Ë¥²¸û¡AÓ¤Hı±o¤¤¤å«¤j°T®§Â½Ä¶³¡¤À¤´¦³§ïµ½ªÅ¶¡¡AÀ³¸Ó§óÄYÂÔ¤@ÂI¡C |
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§Q¯A¤jªº°ÝÃD¤½¥q¦b³Ì·sªº§ë¸ê¤H»¡©ú·|¦³´£¨ì³¡¤Àµª®×~§Q¯A¤j¥i¥Hªá§¹¾ãªº®É¶¡¬Ý¤@¤U!¤½¥q¬O¦³¨Ì¾Ú»P·Qªkªº~¤£¬OÀH«K»¡ªº! ¥t¥~§Ú»{¬°§Q¯A¤jªº°ÝÃD¤]¬O¯E¹©§ó¤jªº°Ó¾÷©Ò¦b,¸Õ·Q·Q§A¬OÀù¯g¯f±w,Âå¥Í§i¶D§A§A¤£¾A¦XOBIÀøµ{,¦]¬°§Aªº§ÜÅé¼Æ¤£¨¬,¦ý¯f±w·|¦^µªÂå¥Í¤°»ò? ¯f±w·|»¡:§Úª¾¹DOBIÀøµ{¦³³\¦h¤H¬¡±o«Ü¦n,³Â·ÐÂå¥Í¤]À°§Ú¸Õ¬Ý¬Ý§a!³oÓ¿ú§ÚÄ@·N¥X~¤Ï¥¿°Æ§@¥Î¤£°ª!¸Õ¸Õ¬Ý§a!°£¦¹¤§¥~~¯f±wÁÙ·|§Æ±æ¥´¤[¤@ÂI,¾¯¶q¥´«¤@ÂI(PS:¤p§Ì¤£ª¾¹D¾¯¶q¯à§_¦h¥´¼Ú)!©Ò¥H¥un¦³¤H¦s¬¡ªº¦n¦nªº~¨S®Äªº¤H¤]·|«ÜÄ@·N±µ¨üOBIÀøµ{ªº! |
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¤£ª¾¹D¶Kþ¡A¬Ý¨ì¦Ñ¥v¤j¦b³o¡A´N¸ò¶K§a¡I ¬Ý°_¨Ó¤j®a¹ï©ó¤½¥q»¡×¥¿Á{§É¤T´Á·|±Ä¥Î "¯f±w¥|°w/¤K¶g«á²£¥Í§ÜÅéªÌ¤~·|¯Ç¤J¹êÅç" ªº»¡ªk»á¯à±µ¨ü¡C§Ú¬Ý¨ì³oºØ»¡ªk¬Æ¬°°g´b¡G¥Ø«eªºÁ{§É¤T´Á©ú©ú¬O(1).©T©w¾¯¶q¡A§YOPT-822/OPT-821 (30 £gg/100 £gg) +Cyclophosphamide; (2).¨S¦³¦b©Û¦¬¯f±w®É¹ï¯f¤Hªº§K¬Ì¨t²Î¥[¥H¿z¿ï¡C¨º»ò½Ð°Ý¡G 1. ¯E¹©¬°¤°»ò³o»ò½T©w¡A¥Ø«e¾¯¶q´N¬O³Ì¨Î¾¯¶q¡H¬°¤°»ò¤£¬O¥[¿¾¯¶q¡A¬Ý¬Ý¯à§_ÁYµu²£¥Í§ÜÅ骺®É¶¡¨ì¥|¶g¡H¬Æ¦Ü¦]¬°¥[±j¾¯¶q©ÎÁYµuµ¹ÃĶ¡¹j¡A¨ë¿E²{¦æÁ{§É¤¤¤£¯à²£¥ÍÁÞ§ÜÅ骺¯f±w¡A¤]¯à²£¥ÍÁÞ§ÜÅé¡H²¨¥¤§¡A¥H°õ¦æ¹LªºÁ{§É¤@¤G¤T¡A¦X¨Öªk»¡·|ªºµ²½×¨Ó¬Ý¡A¯E¹©þ¶µ¹êÅç©Îþ¨Ç¼Æ¾Ú¡AÃÒ©ú¤F¥Ø«e³]p¬O³Ì¨Î¾¯¶q¡H 2. ¯E¹©¬°¤°»ò³o»ò½T©w¡A¤£»Ý¦b·N©Û¦¬¯f±wªº§K¬Ì¨t²Î±j®z¡A¤@©w¬O¥|°w/¤K¶g¬°Æ[¹î¯f±w²£¥Í§ÜÅ骺³Ì¨Î¸Ñ¡H¦pªG¹ï¯f±wªº¬Y¨Ç§K¬Ì«ü¼Ð°µ¿z¿ï¡A·|¤£·|¥Ø¼Ð¯f±w§ó²M·¡¡B§ó¦³®Ä¡H¤Ï¹L¨Ó»¡¡A¯E¹©²{¦b¤w¸g¦³¨¬°÷ªºÁ{§É¸ê®ÆÃÒ©ú¡A¯f±wªºþ¨Ç¥ý´Á¿z¿ï§K¬Ì«ü¼Ð¡A»P«áÄò²£¥ÍÁÞ§ÜÅé»P§_ªº¤§¶¡Ãö«Y¤F¶Ü¡H 3. ¤j®a³£¦b»¡¸~½F³QTcell®û¼í¡A©Ò¥H¼vÅTPFS¡A±µ¤U¨Ón¥HOS¬°¥D¡C¦ý¬O¸~½F®û¼íªº«ÂI¬O¡A¸~½F¤º³¡¨ì©³µo¥Í¤F¬Æ»òÅܤơH¯E¹©¥Ø«eªºÁ{§É¸ê®Æ¡A¦³©w´Á¹ï¯f±w¸~½F°µbiopsy/MRI¡A¥H¤ÎÁÞ§ÜÅé/CD4+/INFµ¥§K¬Ì«ü¼Ð¡A©Ò¥H¯à²M·¡¦bÁÞ§ÜÅé²£¥Í«á¡A¯f±w¸~½F®û¼í¤º³¡¨ì©³µo¥Í¤F¬Æ»ò¨Æ¶Ü¡HÁÙ¬O¡A¥u¦³§P§O¸~½F¤j¤p¤ÎMRI¦Ó¤w¡A¨Ã¨S¦³¯f²z¨ú¼Ë¡A¥H¤Î§K¬Ì¨t²ÎªººÊ´ú¡H ·Ó³o¤TÓ°ÝÃD·Q¤U¨Ó¡A¦U¦ì«D±`½T©w¯E¹©³o¥|°w/¤K¶g§@¬°¿zÀ˯f±w²£¥ÍÁÞ§ÜÅé»P§_ªº´£®×¡A¬O³Ì¨Î¾¯¶q¶Ü¡H´«Ó¨¤«×Á¿¡A¥H²{¦æ¹êÅç³]p¡A¯E¹©¦³¨¬°÷¸ê®Æ»¡©ú¯f±w§K¬Ì¨t²Î»Pª`®g822¤§«á²£¥ÍÁÞ§ÜÅ骺Ãö«Y¤F¶Ü¡H§Ú¦n¹³...ÁÙ¨S¦³³Q»¡ªA¡C |
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·|û¡G¦Ñ¥v10140531 µoªí®É¶¡:2016/2/23 ¤U¤È 08:30:33²Ä 929 ½g¦^À³
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¤p©_¤j»¡¨ì"°£«D§ó§ïPFS§PPDªº¼Ð·Ç(¦n¤[¥H«eª©¤W¦³¤H°Q½×¹L³oijÃD¡A§Ñ¤F©ñ¦bþ¨à¤F)" ¥H¤U¬OÀq§JKEYTRUDAªº¹ê¨Ò ¤èªk Patients from 3 melanoma cohorts treated with Pembrolizumab 2 mg/kg Q3W, 10 mg/kg Q3W, or 10 mg/kg Q2W in the Phase I KEYNOTE-001 trial served as the source population. Tumor imaging was performed every 12 weeks. Response was assessed by irRC and RECIST v1.1 by independent central review. Patients were managed by irRC by investigator. Early and delayed pseudo-progression were identified using centrally assessed irRC data among patients treated with Pembrolizumab who were followed by imaging for ≥28 weeks as of May 2014. Early pseudo-progression was defined as unconfirmed PD at assessment 1 (ie, week 12) and non-PD at assessment 2. Delayed pseudo-progression was defined as PD at any time point followed by non-PD at the next assessment. Survival data as of May 2014 were analyzed in all 411 patients enrolled in KEYNOTE-001 µ²½× Pembrolizumab-treated patients with melanoma may experience unique patterns of response and should be managed accordingly. Analysis of OS suggests that conventional RECIST may underestimate the benefit of Pembrolizumab in approximately 10% of patients. These and other data suggest that new standards for response criteria should be considered for PD-1 inhibitors and other immunotherapies http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4288385/ ¬ÝK-M¹Ï´N«Ü²M·¡ |
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