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µy·LŪ¤FMLKCCªºWolchokÂå®v2009¦~11/24ªº¤å³¹Guidelines for the Evaluation of Immune Therapy Activity in Solid Tumors: Immune-Related Response Criteria http://clincancerres.aacrjournals.org/content/15/23/7412.full.pdf ¥LÆ[¹î¶Â¦â¯À½FCTLA-4§í¨î¾¯Yervoyªº¤G´ÁÁ{§É ¦b123¦ì¦b²Ä12¶g³Q§P©wPDªº¯f¤H¤¤¡A¦³57¦ìÄ~Äò°lÂÜ¡Aµ²ªG¦³22¤H¬O¦³¤ÏÀ³ªº¡A ¨ä¤¤5¦ìÄÝ©óirPR¡A17¦ìÄÝ©óirSD ³o22¤H¦û¦¹Á{§É227¤Hªº9.4% ¦ý¥Ñ©ó¨Ã¤£¬O©Ò¦³123¦ì³Q§P©wPDªº¯f¤H³£¦³©µªø°lÂÜ¡A©Ò¥H¹ê»Ú¦³¤ÏÀ³ªº¯f¤H¼ÆÀ³¸Ó³Q§C¦ô "the actual number of patients with responses after PD in these studies may be underestimated" ¨Ì¦¹«·sµeOSªºK-M¹Ï ³o22¦ìªºOS´X¥G¤£¨È©óCR/PR/SDªº31.2Ó¤ë¡A»·Àu©ó¯u¥¿PDªº5.45Ó¤ë Yervoy°w¹ï¸~½F¦³¥|ºØ©ú½Tªº¼Ò¦¡¡A«e¨âºØ¬O¶Ç²Îªº¤ÏÀ³¡A«á¨âºØ¬O·s¨£ªº¤ÏÀ³ a>shrinkage in baseline lesions, without new lesions; b>durable stable disease c>responses after an initial increase in total tumor burden d> a reduction in total tumor burden during or after the appearance of new lesion(s) at time points later than week 12 "All patterns were associated with favorable survival." µ½¤H¥S¡A§ÚµL¯à¦^µª§Aªº°ÝÃD¡A¥H¤Uªº¤å¦r¤Þ¦Û¦¹½g¤å³¹µ¹§A°Ñ¦Ò Yervoy¤T¶g¥´¤@°w¡A¤@¦@¥´4°w12¶g ¦³41¤HÄÝ©óearly PD(¦b²Ä12¶g«e´N³Q§PPD) ¦ýearly PDªº¤H¥un¨S¦³¦bÁ{§É¤W¥X²{§Ö³t´c¤Æ¡A¦]¬°¦Ò¼{¨ì§K¬ÌÀøªkªº¯S©Ê¡A ³o¨Ç¤H¤´·|Ä~Äò±µ¨üªvÀø¡A¨Ã¥B§óÂÔ·V¦aÆ[¹î¥L̪º§K¬Ì¤ÏÀ³ It was expected that some patients treated with ipilimumab would experience increased objective tumor burden and/or new lesions before a response was obtained . Thus, patients with PD before week 12 (per WHO criteria), but without rapid clinical deterioration, continued ipilimumab treatment and were observed with a stringent imaging schedule to allow detection of an antitumor response. ©Î³\¤£¤[±N¨Ó¦b§K¬ÌÀøªk·í¹D¤U Á{§É³]p©Î³\·|¦³¨Ç½Õ¾ã 1>§PPDªºÄ~ÄòªvÀø 2>©µªøÆ[¹î´Á |
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·|û¡Gµ½¤H10137888 µoªí®É¶¡:2015/7/6 ¤W¤È 12:03:59²Ä 1649 ½g¦^À³
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Cliff¤j, «D±`·PÁ±zªº±M·~¸Ñ»¡, ¤£¥u¤p§Ì, ¬Û«H¯E¤Í̤S¾Ç²ß§l¦¬¤@¨Ç¦³ÃöÁ{§É¸ÕÅ窺ª¾ÃÑ, «D±`·PÁ¤S·P°Ê!!! |
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µ½¤H¤j¡G ±zªº°ÝÃD»á¨ã¥Nªí©Ê¡AÀ³¸Ó«Ü¦h¤H·Qª¾¹D¡A¦ý¬O¥H¤U«D±M·~ªº¸Ñµª³»¦h¥u¯à¸Ñ¨M³¡¥÷ªººÃ°Ý¡A¸Ñ¨M¤@Ó°ÝÃDºâ¤@Ó¡A±z´N±N´N±N´N¦h¦h¥]²[¡C ½Ðª`·N¥H¤U©Ò¦³Âù¤Þ¸¹¡y¡zªº³¡¥÷Äݤp§ÌÓ¤H·N¨£¡AµLªkt³d¹ï¿ù¡C¨ä¥Lªº³¡¥÷Straight from the horse¡¦s mouth. ´XºØª¬ªp¡G I. Discontinuation of treatment¡G¡y¤¤¤î¥ÎÃÄ¡z¡]§t¯uÃÄ»P¦w¼¢¾¯¡^ II. Withdrawal of study¡G¡y°h¥X¸ÕÅç¡H¡z III. Removal from therapy¡G¡y²¾¥X¸ÕÅç¡H¡z IV. Off study¡G¡yµ²®×¡z V. Completion of study¡G¡y§¹¦¨¸ÕÅç¡z I. Discontinuation of treatment¡G ¥X²{¥ô¦óGrade 4©Î«ùÄò¨â¶g¥H¤WªºGrade 3ÃĪ«¬ÛÃö¬r©Ê¡C ©Ò¦³¤¤¤îªvÀøªºÓ®×¡A³£nÄ~Äò°lÂܨìPD©Î¶i¤J¡y¦s¬¡°lÂÜ´Á¡z¡C ¡y¦s¬¡°lÂÜ´Á¡z¡G Withdrawal ©Î Completion ªÌ¡A©Ò¦³©|¦s¬¡ªºÓ®×¤´·|³Q¦w±Æ¨C12¶g¤@¦¸ªº°lÂÜ¡]¹q¸Ü©Î¨ì°|¡^¡A¦ÛÀH¾÷¤À²Õºâ°_¦s¬¡°lÂÜ´Áªø¹F¤¦~¡C II. Withdrawal of study¡G ¡y¨ü¸ÕªÌ¥D°ÊºM¦^¨ü¸Õ¦P·N®Ñ¡H¡z III. Removal from therapy¡G 1.²Å¦XRECIST1.1±ø¥ó³Q§PPDªÌ 2.¤£°t¦X¡B¤£¦X§@ 3.¥D°ÊºM¦^¨ü¸Õ¦P·N®ÑªÌ 4.¥X²{¤£´M±`ªºÂå¾Çª¬ªp¡GY¥X²{¯S®íª¬ªp¡A¥O¥D«ùªÌ»{¬°¤¤¤î¥ÎÃĹï¨ü¸ÕªÌ¸û¦³§Q¡F©Î©ó¥ô¦ó®ÉÔµo²{Ä~Äò¥ÎÃĹï¨ü¸ÕªÌ¦³®`®É¡A¦¹®É¨ü¸ÕªÌ¥i¯à·|°h¥X¸ÕÅç¡]Withdrawal¡^¡A¦¹®É°h¥Xªº²z¥Ñ¥²¶·²M²M·¡·¡¡C 5.¨ü¸ÕªÌÃh¥¥©Î¶·±Â¨Å¡C¡]¡yn¨D¨ü¸ÕªÌ°±¤îÃh¥¥©Î°±¤î±Â¨Å¥H§¹¦¨¸ÕÅç¬O¤£¤H¹Dªº¡A©Ò¥H«Øij²¾¥X¸ÕÅç¡z¡^ ³Q²¾¥X¸ÕÅ窺¨ü¸ÕªÌ¤´»Ý«öªí³Q°lÂÜ24Ӥ리¶°¥²n¼Æ¾Ú¡A°£«D¥X²{²Å¦XOff studyªºª¬ªp©Î¬O¨ü¸ÕªÌ¥D°ÊºM¦^¨ü¸Õ¦P·N®Ñ¡C IV. Off study¡G ·í¨ü¸ÕªÌ¥X²{¦º¤`©Î¥¢ÂܩκM¦^¨ü¸Õ¦P·N®Ñ®É¡C ¦º¤`¡G¥ô¦óì¦]©ÒP¡C ¥¢ÂÜ¡]°lÂܤ£¨ìӮס^¡G¦Ü¤Ö¨â¦¸°lÂܤ£¨ì®É¦Ò¼{¦C¤J¡C ºM¦^¨ü¸Õ¦P·N®Ñ¡G¨ü¸ÕªÌºM¦^¨ü¸Õ¦P·N®Ñ¡u¥B¡v©Úµ´°lÂܮɦC¤J¡C ì«h¤W¦]¬°¥ô¦ó¦]¯À¦Ó¤¤Â_ªvÀøªÌ¡A§tªvÀø¥¢±Ñ¡]¦pPD¡^¡BªvÀø¤¤Ãh¥¥©Î¨ä¥L¥ô¦óì¦]¡A¬Ò¶·«ö¬J©w®Éµ{§¹¦¨¥H¤Uªíq°lÂܶµ¥Ø¡Aª½¨ì¨ü¸ÕªÌ¥D°ÊºM¦^¨ü¸Õ¦P·N®Ñ©Î¶i¤J¦s¬¡°lÂÜ´Á¬°¤î¡G ²z¾ÇÀˬd¡B´úvital signs¡B§¿²G±`³W¡B¦å²G±`³W¡B¤@°ï¥Í¤Æ¡]§t¤@¯ë¥Í¤Æ¶µ¥Ø¡B¹q¸Ñ½è¡B¾ý¯»–¡¡B¯×ªÕ–¡¡B¦å¯×¡Bcortisol¡B¥Òª¬¸¢¥\¯à¤ÎCA-153µ¥¡^¡B§Ü®Ö»Ä§ÜÅé¡]¡y¥Î¨Ó¬Ý¦³¨S¦³²£¥Í¤£¥²nªº¦ÛÅé§K¬Ì§ÜÅé¡z¡^¡B´ú§ÜGH§ÜÅé¤Î²ÓM§K¬Ì¤ÏÀ³¡B¤Q¤G¾Éµ{¤ß¹q¹Ï¡B¤ßŦ¶Wµªi´ú¥ª¤ß«Ç·i¥X²v¡B¯Ý¸¡°©¬Ö¹q¸£Â_¼h¡B¦³µL¨ÖªAÃĪ«¡BNCI CTCAE v4.0°Æ§@¥Îµ¥µ¥¡C¡]¡yºÃ°Ý¡GªvÀø¤¤Ãh¥¥ªÌ¤]n°µ¯Ý¸¡°©¬Ö¹q¸£Â_¼h¡H¬J¥X¦Û°¨¼L¥u¦n·Óµn¡A¸ÑŪ¬Ý¦U¦ì¡z¡^ ¡y©Ò¥H¬Ý¨Ó¥D°ÊºM¦^¨ü¸Õ¦P·N®ÑªÌ¡A¥i¥H§K°µ¥H¤WªººØºØ»ö¾¹Àˬd¡A¦ý¤´·|³Q¦w±Æ¨C12¶g¤@¦¸ªº¦s¬¡°lÂÜ¡]¹q¸Ü©Î¨ì°|¡^¡A¦ÛÀH¾÷¤À²Õºâ°_¦s¬¡°lÂÜ´Áªø¹F¤¦~¡C¡z ¦^¨ìµ½¤H¤jªº°ÝÃD¡G 1.¦pªG¥u¥´6°w, «á±ªº3°w¬O§_Ä~Äò¥´? ©Î³Q°±¤îªvÀø? A¡G¡H¡H 2.³Q§PŪ´c¤Æ«á, ¥H«á¬O§_¤´µM©w´Á¦^Âå°|À˹î©ç·Ó? A¡G¡y¬Oªº¡Cª½¨ì°lÂÜ´Áº¡©Î¥X²{²Å¦XOff studyªºª¬ªp¡C¦ý¤£¬O©ç·Ó¡A¦Ó¬O¦w±Æ°µ¹q¸£Â_¼h¡]¯Ý¡B¸¡¡B°©¬Ö¡^¡A³oÓ¡u©ç·Ó¡v¤§µü¡A¦bª©¤W³Q»~¬°©çX¥ú¤[¨o¡C¡z 3.¦pªG¤U¦¸À˹î©ç·Ó, µo²{¸~½FÁY¤p¤F, ¬O§_¨ú®ø´c¤Æªº¬ö¿ý¨Ã«ì´_ªvÀø? ¦ý¬OªvÀø©P´Á¤w¸g§ïÅÜ, ¬O§_¼vÅTÀø®Ä? A¡G¡y³o¤@ÃD§Ú¤£ª¾¹D¡A¶È´£¨Ñ¤@¶µ¸ê®Æ¨Ñ°ª¤â°Ñ¦Ò/¸ÑŪ¡z¡G¡uNew response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)¡v¡A¸Ì±©Òªþªº¤@ÓQ&A¡C ¡uQ¡GA patient has a 32% decrease in sum cycle 2, a 28% decrease cycle 4 and a 33% decrease cycle 6. Does confirmation of PR have to take place in sequential scans or is a case like this confirmed PR? A¡GIt is not infrequent that tumour shrinkage hovers around the 30% mark. In this case, most would consider PR to have been confirmed looking at this overall case. Had there been two or three non-PR observations between the two time point PR responses, the most conservative approach would be to consider this case SD¡v ¡y¨CÓӮצn¹³¤£¬O¥u³Q§PŪ¤@¦^¦Ó¤w¡A¾Ú±x¨C¤@¦¸°µ¹q¸£Â_¼h°lÂܮɪº¤ù¤l³£n¸ò«e¤@¦¸°lÂÜ¥H¤Î¦¬®×®Éªº°ò·Ç¤ù¤l°µ¤ñ¸û¡A¨Ó¨M©wPFS/PD/SD/PR/CR¡K¡K¨ä¥Lªº¦³½Ð°ª¤â¸ÑŪ¡z¡C 4.¦pªG¤£¦AÀ˹î©ç·Ó, ¦ý¬O±wªÌªº¸~½F¹ê»Ú¤W¬OÁY¤p¤F, ±N¼vÅT¾ãÓÁ{§É¸ÕÅ窺µ²ªG, «ç»ò¿ì? A¡G¡H¡H ¿ù»~¤§³B·q½Ð«ü¥¿¡F¥¼ºÉ¤§³B¦³½Ð°ª¤â¡C |
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·|û¡Gµ½¤H10137888 µoªí®É¶¡:2015/7/5 ¤W¤È 02:08:34²Ä 1647 ½g¦^À³
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¦Ñ¥v¥S, «D±`·PÁ±z´£¨Ñªº¸ê°T. ¤p§Ì¦³¤@ºÃ°Ý, ·Q¤£³q«ç»ò¿ì, ½Ð±Ð¦Ñ¥v¥S, ¤p©_¤j, ²q·Q¤j, Cliff¤j, ¥xÁÞ¤j, ±ø¤jµ¥¯E¤Í : ¦pªG¸ÕÅç²Õ¸Ì¦³¨Ç±wªÌ²£¥Í®û¼í²{¶H, è¦n¦^Âå°|À˹î, ©ç¤Uªº¼v¤ù³Q LR©M CR§PŪ¬°´c¤Æ, 1. ¦pªG¥u¥´6°w, «á±ªº3°w¬O§_Ä~Äò¥´? ©Î³Q°±¤îªvÀø? 2. ³Q§PŪ´c¤Æ«á, ¥H«á¬O§_¤´µM©w´Á¦^Âå°|À˹î©ç·Ó? 3. ¦pªG¤U¦¸À˹î©ç·Ó, µo²{¸~½FÁY¤p¤F, ¬O§_¨ú®ø´c¤Æªº¬ö¿ý¨Ã«ì´_ªvÀø? ¦ý¬OªvÀø©P´Á¤w¸g§ïÅÜ, ¬O§_¼vÅTÀø®Ä? 4. ¦pªG¤£¦AÀ˹î©ç·Ó, ¦ý¬O±wªÌªº¸~½F¹ê»Ú¤W¬OÁY¤p¤F, ±N¼vÅT¾ãÓÁ{§É¸ÕÅ窺µ²ªG, «ç»ò¿ì? |
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·|û¡G¦Ñ¥v10140531 µoªí®É¶¡:2015/7/4 ¤U¤È 02:33:14²Ä 1646 ½g¦^À³
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¡Õ±q²Ä¤@©¡ð¼ú¥Í§ÞÂåÃļú½ÍÀù¯g§K¬ÌªvÀøªº®i±æ¡Ö ±i´º»Ê¡B±iª÷°í¡]¥xÆWÂå¬ÉSep 2014¡^ ......¶Ç²Îªº©TºA¸~½F¤ÏÀ³µû¦ô¼Ð·Ç(RECIST criteria)¨Ã¤£¾A¥Î©ó§K¬ÌªvÀø¡A³o¬O¦]¬°§K¬ÌªvÀø¤@¶}©l·|³y¦¨§K¬Ì²ÓMªº®û¼í¡A¨Ï±o¸~½F¬Ý°_¨Ó§ó¤j¡A¨Ã¤£¨£±o¤@©w¬O´c¤Æªº¸ñ¶H¡FWolchokÂå®v´£¥X¤F¤ñ¸û¾A¦X§K¬ÌªvÀøªºµû¦ô¼Ð·Ç¡AºÙ¬°§K¬Ì¬ÛÃö¤ÏÀ³µû¦ô¼Ð·Ç(immunerelatedresponse criteria, irRC)¡A´£¥X¦³4ºØ¤ÏÀ³ªº«¬ºA¡G¸~½FÁY¤p¡B¸~½F¤j¤pªø´Áéw©Î½wºCÅܤp¡B¸~½F¤@¶}©lÅܤj«áÁY¤p¡B²£¥Í·sªº¯f¨_«á¸~½F¦AÁY¤p¡C¥t¥~§K¬ÌªvÀøn¹F¨ì¤ÏÀ³ªº®É¶¡¡A¤@¯ë¤ñ¸ûªø¡A»P¶Ç²Î¤ÆÀø«Ü¤£¤@¼Ë¡C¦Ó¤@¨Ç¸~½FÁöµM¨S¦³Åܤp¡A¦ý«o¥i¥Hªø®É¶¡ºû«ùéwªº¯f¤H¡A¥i¥H¦]¦¹Àò±oªø´Á¦s¬¡ªº¦n³B¡F¤]¥Ñ©ó¥H¤W´XÂI¡AÅý²ßºD¶Ç²Î¤ÆÀø©Î¬O¼Ð¹vªvÀøªºÂå®vÌ¡A¥i¯à¥²¶·¤F¸Ñ§K¬ÌªvÀøªº³o¨Ç¯SÂI¡A¤]n¼ô±x³o¨Ç§K¬Ì¬ÛÃö°Æ§@¥Îªº³B²z...... 2014¦~ASCO´¿°Q½×¨ì³¡¤À§K¬ÌÀøªk¯f¤HY¨Ì·ÓRECIST1.1¥i¯à´£¦»~§PPD http://www.immunotherapyofcancer.org/content/pdf/2051-1426-2-S3-P103.pdf ©Îhttp://meetinglibrary.asco.org/content/130631-144 Bearing industry demands and RECIST shortcomings in mind we introduce a modification of the irRC to better address patients¡¦ treatment and sponsors¡¦ analysis needs for targeted immunotherapy developments in oncology with irRECIST, based on adaptation of unidimensional measurements aligned with RECIST 1.1.Sponsors developing monoclonal antibodies for oncology patients are aware that with RECIST 1.1, as the most common assessment criteria, investigators may declare a patient progressive disease too early, when the compound did not have sufficient time to show its treatment effect. ¥h¦~¦³½g¤å³¹°w¹ïMerckªºKeytrudaÁ{§É°Q½×¡Aµo²{¦³12%¯f¤H(N=53)¬ORECIST1.1§PPD¦ýirRC¥¼§PPD ¥Ø´ú³o53¦ì¯f¤HªºM OS ¬O20Ó¤ë ©úÅã¤ñRECIST1.1»PirRC¬Ò§PPDªºM OSªº6.XӤ밪¥X³\¦h °Q½× 1>MerckÀ³¸Óª¾¹DirRC§ó¾A©óµû¦ô§K¬ÌÀøªk¡H 2>MerckÀ³¸Óª¾¹D822±Ä¥ÎRECIST1.1¡H 3>822¾A¤£¾A¥ÎirRC¡H 4>¦³Àu¥ýij¬ùÅvªºMerck·|¤£·|¥HirRC¼Ð·Ç¬Ý822ªºPD¡H 5>¤é«á¬ÛÃöÁ{§É·|¤£·|§ï±ÄirRC¦Ó´£°ª822¾AÀ³¯gªºPFS»POS ¥H¤WÂÕ«ä»F¦]®ï¬ß822»PMerck¦X§@¡A¦³³Ò½Ñ¦ì¥ý¶iÄÄ©ú |
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¦U¦ì¤j¤j ¥H¤U¨Æ¥óªºµo¥Í³£·|¼W¶i¯E¹© ªº»ùÈ¡A¿ò¾Ñªº¬O§Ṳ́£ª¾¦ó®É ·|µo¥Í¡A¥u¦n¦u®è«Ý¨ß ¦³¨Ç¨Æ¥ó¾_¾Ù©Ê°÷±j¥i¯à¥X²{ ¤@ªÑÃø¨DªºÁ`¶R¶i±¡ªp 1OBI833Á{§É¤@´Á®Ö㤽§i 2OBI822¯Ø¸¢Àù¶i¤J¤G´ÁÁ{§É 3¸Ñª¼¼Æ¾Ú¤½§i 4OBI822§Z±_Àù¤G´ÁÁ{§É ¼Æ¾Ú¤½§i»P¶i¤J¤T´ÁÁ{§É 5¨ÅÀùOBI822¼Ú¤é¬ü¦æ¾P ¦X§@±ÂÅvª÷¤½§i¡A©Î¾ãÓ OBI822¨t¦C¦æ¾P¦X§@±ÂÅv ª÷¤½§i 6¬ü°êFDAÃÄÃÒ®Ö㤽§i¡A¥xÆWÃÄÃÒ®Ö㤽§i ¼Ú·ùÃÄÃÒ®Ö㤽§i |
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OBI-833 ¦b¥x¤j.. https://www.ntuh.gov.tw/RECO/%E7%A0%94%E7%A9%B6%E5%80%AB%E7%90%86%E5%A7%94%E5%93%A1%E6%9C%83%E6%9C%83%E8%AD%B0%E7%B4%80%E9%8C%84/B%E7%A0%94%E7%A9%B6%E5%80%AB%E7%90%86%E5%A7%94%E6%9C%83%E6%9C%83%E8%AD%B0%E7%B4%80%E9%8C%84/NTUH_REC_B_64%E6%9C%83%E8%AD%B0%E7%B4%80%E9%8C%84%E4%B8%8A%E7%B6%B2%E7%89%8820150213.pdf |
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Juno up 53% after hours on 10-year Celgene deal Jun 29 2015, 16:40 ET | About: Juno Therapeutics (JUNO) | By: Douglas W. House, SA News Editor • Juno Therapeutics (NASDAQ:JUNO) jumps 53% after hours on robust volume in response to its announcement of a 10-year collaboration with Celgene (NASDAQ:CELG) to develop and commercialize novel immunotherapies for the treatment of cancer and autoimmune diseases. • • Under the terms of the agreement, Celgene will make an upfront payment of ~$1B which includes an equity investment of ~$850M (9.1M shares at $93 per share). Celgene has the option of being Juno¡¦s commercialization partner for oncology and cell therapy autoimmune product candidates, including its CD19- and CD22-directed CAR-T product candidates, exclusive of B-Cell Maturation Antigen. • • Juno will be responsible for R&D in North America and will retain commercialization rights in these territories. Celgene will be responsible for development and commercialization in the rest of the world and will pay Juno royalties on net sales. Celgene has the right to select two programs, exclusive of CD19 and CD22, whereby the two firms will share equally in costs and profits in all territories except China. Under certain circumstances, Celgene may select a third program. • • Juno has the option of co-developing and co-commercializing certain Celgene-originated product candidates that target T cells. Costs and profits will be shared with Celgene on a 70/30 basis (70% - Celgene). • • The upfront payment consists of $150M in cash plus the purchase of 9,137,672 shares of Juno common stock at $93 per share. Under certain circumstances, Celgene could acquire up to a 30% stake in Juno. • • The companies will host a conference call at 5 pm ET today to discuss the deal. |
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µ½¤H¤j: §Aªº¶K¤å: ¦pªG CR§PŪ´c¤Æªº¤H¼Æ·|¤ñ LR§PŪ´c¤Æªº¤H¼Æ¤Ö, ¦³¤H·|¤£¿ï¦nÄ«ªG¦Y, «o¬DÄêÄ«ªG¦Y??? ¦A¦¸·w%$#@!£~£~! ¥ý§O¹ï¤½¥q°Ê®ð§a, ¤Z¨Æ¥ý²`«ä¼ô¼{¬°¤W , ¸ÕµÛ·Q·Q : 1> ¦pªG¤½¥q±À¨Ó±À¥h (¹³±ÀI¹Ï ) ³£¥²¶·µ¥¨ì 2016/8 ¤~·|¸Ñª¼ , ¨º»ò, ¤½¥q·íµM¤£·|§ï¦¨¥HLR §@¬°§PŪ¼Ð·Ç¡C ³o¬O¥ô¦ó¤H¨©~CEO³£·|«ä¦Ò¨ìªº°ÝÃD¡C 2> ¬O§_n§ï¦¨LR§PŪ©Ò±a¨Óªº§Q¯q »P ³y¦¨M_PFS ªº·l¥¢, ³o¨âªÌ¤§¶¡, ¬O¤@ºØ trade-off ªºÃö«Y, ¤½¥q¥²µM·|Åv¿Å»´«±o¥¢¡C ¬GµL©Ò¿×¤£¬D¦nÄ«ªG, «o¬DÄêÄ«ªGªº°ÝÃD¡C 3> ·Q·íµM¦Õ, ¤½¥q¦pªG«Ü¦³§â´¤, ´N·|¥h¸òªk³W³æ¦ì °Ó¶q, ¤´µM¥ÎCR °µ§PŪ¼Ð·Ç, ¦ý¬O§â289¤H ªº¸Ñª¼±ø¥ó, °¬°250¤H(©Î¨ä¥L¤H¼Æ) , ³o¼Ë¦P¼Ë¥i¹F¨ì´£«e¸Ñª¼ªº§Q¯q, ¤SµL·l©óM_PFS , §A»{¬°©O? ¨ä¦¸, §Aªº¶K¤å: "¤G/ ¤T´ÁProtocol ³]p ¤w¸g©w³Ì¦h¥uÆ[¹îPFS 24 Ó¤ë"? ¯E¤Í̦ۤv·Q·Q©Mºâºâ, ¦³³oºØ¤£¤T¤£¥|ªºÁ{§É¸ÕÅç¶Ü? ¦³³o»ò¦h´c¤Æ©M²æ°kªº¤H¶Ü? 1>¡§¤£ºÞ¦ó®É¶i¤JÁ{§É, ³£¥uÆ[¹î24 Ó¤ë ¡§ , ³o¸ò¤£¤T¤£¥|§è¤£¤WÃö«Y§a, ³oºØ¦b«Ü¦hÀù¯gÁ{§Épµe®Ñ¤WÀ³¸Ó³£·|¬Ý¨ì¡C ( ¤½¥qªºÁ{§Épµe®Ñ¦´N¼g¦n¨CÓ¤H³Ì¦hÆ[¹î2¦~, ¬O§Ṳ́j®a³£²¨©¿¤F) «Øij§A¤£n®³§Ú̦ۤvªº²¨©¿¨Ó®ð¦Û¤v 3> °£«D¹ê»Ú¤WªºM_PFS ¬O·|¶W¹L24Ó¤ë, §_«h, §âM_PFS ¨î¦b24 Ó¤ë¹ïÁ{§É²£¥Í¼Æ¾Ú¬O¤@¼Ëªº , ¨S¬Æ»ò®t§O¡C 4> ¯E¤Í̤£¬O´X¥G³£»{¬°M_PFS¥un¶W¹L20 Ó¤ë, ´N¤w¸g¬O¤j¬ð¯}, ´N¦³¨¬°÷Ävª§¤O·m¥«³õ¤F¶Ü? ³o¼Ë24Ӥ몺¤ÑªáªO¤S«ç·|¬O§QªÅ©O? 5> ¹ï´Á«Ý´£«e¨ì¤µ¦~©³©Î©ú¦~ªì ´N¸Ñª¼ªº¤H¦Ó¨¥, ´Nºâ¨S¦³24Ӥ몺¤ÑªáªO, Ãø¹DM_PFS ´N·|¦n«Ü¦h? À³¸Ó¤£·|§a , ¥i¯à¤]¥u¦n1~3 Ó¤ë§a! ? ©Ò¥H ¤Å´d¤Å³ß *** ¤p§Ì·Ð´oªº¬O, YªG¯unµ¥¨ì2016/8 ¤~¸Ñª¼, ±ß¶i¤J¥«³õªº·l¥¢Ãø¥H¦ôp, ¤p§Ì»{¬°³o¤]¬O¤½¥qªø¦Ò¡B¶Ë¸£µ¬ªº¦a¤è§a¡C «u ¤£·Q¤F,²Ö¤F, ¾Ç¾Ç Cliff, ªø´Á¥ð®§¥h¤F |
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·|û¡G¯E§b10139724 µoªí®É¶¡:2015/6/25 ¤U¤È 03:48:20²Ä 1571 ½g¦^À³
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Faith ¤j, ¦U¦ì¤j¤j Herceptin¹ï¨ÅÀù¥½´Á¯f¤HªºPFS¬O6~9Ó¤ë 822¬O¥H§ïµ½50%¨Ó³]pÁ{§É¡A¨º¹F°}¤£À³¸Ó¬O9~13.5Ó¤ë? (PFS=9 ºâ¹LÃö¶Ü?) ¦pªG822 PFS¬O15, µ²ªG©|¥i¦Ó¤w§a? ¥u¬O§Ú¤£À´±i¸³»¡¦bÁ{§É¹êÅ礦~«áµo²{¡A´_µo¤H¼Æ¸û·íªì¹wpªºn¤Ö«Ü¦h, ¨º«ç»ò§ÚÌ·|±Àºâ¥X¤@Ó©|¥iªº¼Æ¾Ú©O? |
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·|û¡G¤p©_10138298 µoªí®É¶¡:2015/6/25 ¤U¤È 02:45:25²Ä 1570 ½g¦^À³
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¦Ñ¥v¥S¡A ¥uºÞLR¡A¤£ºÞCR¡ACRªº¤£½T©w©Ê¤Ó°ª¡A´N¥ÎLR±À¡A«O¦uªº´N¥ÎLRªºM PFS·í§@CRªºM PFS¡A¼ÖÆ[ªº´N¥ÎLRªºM PFS*10%©Î*20%·í°µÃØ«~¡A¥ô¦ó®É¶¡¨M©w¸Ñª¼¡A²M¤F¸ê®Æ¶]²Îp¡AY¦³¶]LRªº¸ê®Æ¡A¤]·|¶]CRªº¸ê®Æ¡C ¡ydropoutªÌ¤j³¡¤À¦]¬°LR§PPD¤§«á¤~°h¥X¥t´M¨ä¥LÀøªk¡A¦]¦¹¨ì¤FCRÅܦ¨³]¡z ¤p§Ìı±odropoutªÌÀ³¸Ó¬O¦bLR¥¼§PPD«e´N¨M©wÂ÷¶}¤F¡ALRY§P¤FPD¡A´N¤w¸g½T©w¤FÁ{§Éªº°^Äm¡A¸Ó±wªÌ¬O§_Ä@·NÄ~Äò¯d¤U¨Ó¡Aª½¨ì¤]¦bCR§PPD¡AÀ³¸Ó¬O¥Lªº¦Û¥Ñ·NÄ@¡C©Ò¥H37¤H»P¥ô¤@®É¶¡ªºLR-CR(¤£ºÞ®É¶¡®t)ªº®t²§À³¸ÓÄݩʤ£¦P¡C ¥t¡Aªø§ÀPDªº°²³]¦]24Ӥ몺¤ÑªáªO¦Ó¦³¤F·sÅܼơAÀR«Ý24Ó¤ëÂç²M«á¦A°µ±Àºâ¡C¤p§Ì¤w¦³¯ó½Z¡A¦³»Ýn¦A¾ã²z¥´¦r¡A¹ïM PFSªº¼vÅT®t²§¨Ã¤£¤j¡C |
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·|û¡G¤p©_10138298 µoªí®É¶¡:2015/6/25 ¤U¤È 02:22:47²Ä 1569 ½g¦^À³
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¥xÁÞ¤j¡A ¡y1. 2012¦~©³ «e¦¬®×ªºªø§À¥¼PDªº¹êÅç²Õ¨ü¸Õ¨ì¸Ñª¼½T©w¤é´Á¬°¤î(°²³]10¤ë) ¦pªG¥¼µo¥Í¨Æ¥ó,¦s¬¡¤w¶W¹L34Ó¤ë, ³o§å¤HPFS¦p¦óºâ ? 2. 2012¦~©³«e¦¬®×ªºªø§À¥¼PDªº¹êÅç²Õ¨ü¸Õªº¤H¶V¦h¬O§_¶V¯à¯à¼W¥[PFS?¡z 1.¤p§ÌŪ°_¨Óªº·N«ä¬O¡A2012¦~©³«e¦¬®×ªº¹êÅç²Õ±wªÌ¦³66¤H¡A¨ì2015¦~10¤ë¡A³o§å¤HªºPFS«ç»òºâ¡H¦pªG¥uºâ³o66¤H¡A´N§â³o66¤H«öPFS±Æ§Ç¡A·|¦³¤Ö¼Æµuµu¤£¨ì10Ó¤ë´N´c¤Æªº¡A¤]·|¦³1XÓ¤ë©Î2XÓ¤ë©Î¤Ö¼Æ¨ì2015¦~10¤ë¤´¥¼´c¤Æªº¡AµeK-M¨ç¼Æ¨D³o66¤HªºPFS¡C¦pªG©â¼Ë¼Ë¥»»P¥ÀÅé«Ü±µªñ¡A³o66¤HªºM PFSÀ³¸Ó»P¾ãÅé¹êÅç²Õ233¤HªºM PFS¬Û¥h¤£»·¡C 2.¬Y¤@®É¶¡¡A¨Ò¦p2015/5¦n¤F¡A¥¼PD¦³349-229-37=83¡A°²³]¹ï·Ó²Õ¤w¥þ³¡PD¡A¨º³o83¤H¥þ¬O¹êÅç²Õ¥¼PD¡AÃĪº®Ä¥Î´N¬O¦b2015/5³o®É¨èÅý233¤H¥ÎÃIJըì¤F2015/5¤´¦³83¤H¥¼PD¡A¦pªG2012¦~©³«e¦¬®×ªºªø§À¥¼PDªº¹êÅç²Õ¨ü¸Õªº¤H¶V¦h¡A³]¬°N¡A«h±ß´Á¦¬®×ªº¥¼PD±wªÌ=83-N(¨ä¾lªø§Àªº¥¼PD¥ý¤£p)¡AN¶V¤j¡A«h83-N¶V¤p¡A83-N¶V¤p¡Aªí¥Ü±ß´Á¦¬®×ªº¥¼PD±wªÌ¶V¤Ö¡A±ß´Á¦¬®×ªº¥¼PD±wªÌ(¥i¯à¤j¬ù¦b2014/1~2014/8)¶V¤Ö¡A´Nªí¥Ü¦³§ó¦hªº±ß´Á¦¬®×ªº±wªÌ¤w¦¨¬°µuªº¤wPD¼Æ¾Ú¡A¦ÓM PFS¬O¥Ñ¤j¬ù«e80¦ì(¨Ì¶}ª¼®É¶¡¦±ß¦b²Ä80~110¦ì¤§¶¡)¥Ñ¤p±Æ¨ì¤jªºÓ§O±wªÌPFS¨Ó¨M©w¡A¦]¦¹N¶V¤j¡A«hM PFS¶V¤p¡C¦]¬°ÃĮħ@¥Î¦b¸û¦hªºªø§À±wªÌ¡A¤@¯ë¤j¦h¼Æªº±wªÌ¦n³B¤Ï¦Ó¤Ö¤F¡C |
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·|û¡GQQ10140589 µoªí®É¶¡:2015/6/25 ¤U¤È 01:15:00²Ä 1568 ½g¦^À³
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¥xÁÞ¤j, µ½¤H¤j, ¦U¦ì¤j¤j: ·Q½Ð±Ð¦U¦ì¤j¤j, 822ªºÁ{§É¦¬®×¨î¬°¦Ü¤Ö±µ¨ü¤@½u¤ÆÀøÃĪ«ªºÂಾ©Ê¨ÅÀù±wªÌ, ¨ºYÃĦ¨¥\¤W¥«, 822 ·|¬O2 ½uÃÄ¶Ü ? ÁÙ¬O1½uÃÄ ? ¤p°ÝÃD, ¤j§xÂZ. ³Â·Ð¦U¦ì¤F. |
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·|û¡Gµ½¤H10137888 µoªí®É¶¡:2015/6/25 ¤U¤È 12:41:54²Ä 1567 ½g¦^À³
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FDA Phase 2 Last updated: August 12, 2014 Current Primary Outcome Measures: Progression Free Survival (PFS) [ Time Frame: Progression or up to 2 years ] Secondary Outcome Measures: Overall Survival (OS) [ Time Frame: 5 years ] Estimated Study Completion Date: December 2016 Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure) ±qFDA Phase 2, ¬°¤F²ÎpPFS, ¤½¥q¤w¹w©wAugust 2016¬°¦¬¶°¸ê®Æªº³Ì«á¤é´Á, »P2014¦~8¤ë§¹¦¨349¤H¦¬®×«á³Ì¦hÆ[¹î2¦~(up to 2 years)¬Û¦X. up to 2 years¬O¦¬®×«á¥þ³¡¨ü¸ÕªÌ³£Æ[¹î2¦~? ©ÎªÌ¬O¨C¦ì¨ü¸ÕªÌ¦Û°Ñ¥[«á¥uÆ[¹î2¦~? ¦pªG¬O¨C¦ì¨ü¸ÕªÌ¦Û°Ñ¥[«á¥uÆ[¹î2¦~, ¯uªº¦p£~£~¤jªº "·w%$#@!£~£~!" ¤£¥u£~£~¤j·w%$#@!£~£~! FDA TFDA ¯E¤Í ¤Î©M¦¹Á{§É¸ÕÅ禳Ãöªº¤H³£·w%$#@!£~£~! ¦U´Á¶¡¦¬¨ìªº¤H¼Æ»P¸ÕÅç²Õ¤À°tªº¤H¼Æ. ¤é´Á.......¤H¼Æ...¸ÕÅç²Õ. 2011-12....47......31......¦Û2014¦~01¤ë¥H«á, ¥¼´c¤ÆªÌ¤£¦AÀˬd©Î·Ó X¥ú¤ù 2012-06....23......16......¦Û2014¦~07¤ë¥H«á, ¥¼´c¤ÆªÌ¤£¦AÀˬd©Î·Ó X¥ú¤ù 2012-12....29......19......¦Û2015¦~01¤ë¥H«á, ¥¼´c¤ÆªÌ¤£¦AÀˬd©Î·Ó X¥ú¤ù 2013-06....99......66......¦Û2015¦~07¤ë¥H«á, ¥¼´c¤ÆªÌ¤£¦AÀˬd©Î·Ó X¥ú¤ù 2013-12....60......40 2014-05....52......35 2014-07....32......21 2014-08....07....... 5 Á`¼Æ........349....233 2014-12-31 LR PD: 187 / Others 26, PD + Others 213, ¥¼´c¤ÆªÌ 136 2015-05-24 LR PD: 229 / Others 37, PD + Others 266, ¥¼´c¤ÆªÌ 83 "¤G/ ¤T´ÁProtocol ³]p ¤w¸g©w³Ì¦h¥uÆ[¹îPFS 24 Ó¤ë"? ¯E¤Í̦ۤv·Q·Q©Mºâºâ, ¦³³oºØ¤£¤T¤£¥|ªºÁ{§É¸ÕÅç¶Ü? ¦³³o»ò¦h´c¤Æ©M²æ°kªº¤H¶Ü? ¥ò´º¤jªº¶K¤å: "ì¥ýProtocol ³]p¥HCR °µ§PŪªº¼Ð·Ç, ¦Vªk³W³æ¦ì¥Ó½Ð§ï¬°¥HLR °µ§PŪ¼Ð·Ç" ¦pªG CR§PŪ´c¤Æªº¤H¼Æ·|¤ñ LR§PŪ´c¤Æªº¤H¼Æ¤Ö, ¦³¤H·|¤£¿ï¦nÄ«ªG¦Y, «o¬DÄêÄ«ªG¦Y??? ¦A¦¸·w%$#@!£~£~! ´c¤Æ289¤H¸Ñª¼, ¬O«ü´c¤Æ¤H¼Æ¹F289¤H®É¥²¶·±j¨î¸Ñª¼, ¨Ã¤£¬O«ünµ¥¨ì289¤H´c¤Æ¤~¸Ñª¼. ¦b´c¤Æ¥¼¹F289¤H¤§«e, ¤½¥q¥i¥Hµû¦ô¨M©w³Ì¦³§Qªº®É¾÷¸Ñª¼. |
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·|û¡G¤p©_10138298 µoªí®É¶¡:2015/6/25 ¤U¤È 12:37:48²Ä 1566 ½g¦^À³
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£«¬Â¤j¡A ¥i§_½Ð±z¥´Å¥¤@¤U ¦í¼Ú¤ñ®J¸ôªºªB¤Í¡A§Y¨Ï¤@ª½³£¦í±o«ÜµÎ¾A ¦íº¡¨â¦~´N³W©wn·h¨«¶Ü¡H(¦³³W©w¥L̤µ¦~8¤ë¯²¬ù¨ì´Á´N¥²¶··h¨«¶Ü) ¥t¥~¡A¥H«eÅ¥±zÁ¿ ³o¨â¦ìªB¤Í¨C¤@Ó¤ë¥X¤@½ë»·ªù ÁÙ¬O¨âÓ¤ë¥X¤@½ë»·ªù¡H ÁÂÁ±z |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2015/6/25 ¤U¤È 12:30:48²Ä 1565 ½g¦^À³
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¦U¦ì¤j¤j ¨Ì¾Ú¨ÅÀùOBI822Á{§É³]p Time Frame: Progression or up to 2 years Æ[¹î¨ì(´c¤Æ©Î¦º¤`)©Î¹F¨ì2¦~ 1 2014¦~8¤ë¥H«e¦¬®×ªÌÆ[¹î¨ì´c¤Æ©Î¦º¤` pºâPFS¥i¥H¶W¹L24Ó¤ë 2 2014¦~8¤ë³Ì«á¦¬®×¨º´X¦ì¦]¨ü©ó¹êÅç®É¶¡ªº´Á 2016 ¦~¤K¤ë ¥u¯àÆ[¹î2¦~ 3 2011¦~ 2012¦~ 2013¦~¤¤µ¥¸û¦´Á¦¬®×ªÌ Æ[¹î¨ì´c¤Æ©Î¦º¤`¬°¤î ¥i¯à¬O7Ó¤ë 10Ó¤ë 12Ó¤ë 18Ó¤ë 24Ó¤ë 28Ó¤ë 33Ó¤ë 42Ó¤ë ¤£·|¨ü©ó24Ó¤ë ¨ü«K³à¥¢Àø®Äªº·Ç½T©Ê ¥H¤W¬OÓ¤H¸ÑŪ ³o´X¤Ñ¦A¥´¹q¸Ü¦Ü¦³Á{§ÉÂå¾Ç©Òªº¤j¾Ç¸ß°Ý±Ð±Â double check «Kª¾µ²ªG Estimated Primary Completion Date: August 2016 Primary Outcome Measures: Progression Free Survival (PFS) [ Time Frame: Progression or up to 2 years ] [ Designated as safety issue: No ] Secondary Outcome Measures: Overall Survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ] Estimated Enrollment: 342 Study Start Date: December 2011 Estimated Study Completion Date: December 2016 Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure) |
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·|û¡G¹Ç§AÅó±ø±ø10135894 µoªí®É¶¡:2015/6/25 ¤W¤È 11:48:11²Ä 1564 ½g¦^À³
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£~£~¤j¡A ·íªì¹êÅç³]p©Î³\´N¬O¦]¬°»{¬°822 M PFS¤£·|¶W¹L24Ó¤ë¡A©Ò¥H¥un°lÂÜ2¦~´N°÷¤F¡A ¶W¹L24Ӥ몺¤H´Nºâ¥¼´_µo¡A³]«á¤]¬O¤£¼vÅTM PFS ±qPD 187/PD 229µ¥±Àºâ¥XªºM PFS¡An·Q>24, ±j¤H©ÒÃø§a ¦ý±À¦ô¥i¯àµ²ªGÁÙºâ®t±j¤H·N¡A M PFS>15¦b300¤¸À³¤£·|½ß¥»¡AM PFS 20«h»´ÃP½¨âµf¡A¨ä¹ê¤£»Ý¦b·N @¤£¦í©Ê¤lªº¤H¿ï¾Ü¥X³õÆ[±æµL¥i«p«D¡A¥»¨Óµ¥«Ý´N¦³®É¶¡¦¨¥»¡A ¥úÀY¤jô³ßÅwªáÂI®É¶¡¦¨¥»³¨¤j³½¡AnÁÈ¿ú¤]¤£«æ©ó¤@®É¡A¥unµ¥¤U¥h´N·|¦³¤F |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2015/6/25 ¤W¤È 11:11:53²Ä 1563 ½g¦^À³
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£~£~¤j ¦C¤J³]¸ê®Æ 24+ ¤H¼Æ¶V¦h ¤¤¦ìPFS·|¶V±µªñ24 ¤H¼Æ¶V¤Ö ¤¤¦ìPFS·|¶VÂ÷24¶V»· ¦ýÂ÷¦h»· ¬Ý«e±PD®É¶¡ªø«×ªºªøµu ¤p§Ì²q´ú: ¤½¥q·|µ¥¨ì289¤H¤~¸Ñª¼ ¸Ñª¼®É¶¡¥²±N«á©µ ©Ò¥H¤~¦³±NPDªº»{©w ¥ÑCR §ï¬° LR ªº¦Ò¼{ ³o¼Ë«á©µªº®É¶¡´N¤£·|¤Óªø ¥B¹ï¤¤¦ìPFSpºâªº¼vÅT ¥ÑCR §ï¬° LR ¥²µM·|±N¤¤¦ìPFS©Ô§C? ¦ý¤½¥q¥Hµ¥¨ì289¤H¤~¸Ñª¼ ³]¸ê®Æ·|ÅÜ¤Ö ³o¼Ë¹F0.5ÃöÁäA«e±ªº´c¤Æ¤H¼Æ·|¼W¥[ ·|¦³¸ÉÀv¤¤¦ìPFSªº§@¥Î ¦ýY¬O¦p¦Ñ¥v¤j©Ò¨¥ ¡§¤p©_¥S¼Ò«¬ªº100³]¼Æ¤¤¥]¬A¹êÅç²ÕGlobo H-´c¤Æ¦Ó¤¤³~Â÷¶}¡A²{¦b³o¨ÇGlobo H-À³¸Ón²¾¨ìPD²Õ¥h ¡§ ³oºØ ¸ÉÀv¤¤¦ìPFSªº§@¥Î ¥i¯à´N·|³Q©è±¼³¡¥÷(¤£ª¾³o¨Ç¤H¼Æ¦³¦h¤Ö) ¦AªÌ µ¥¨ì289¤H¤~¸Ñª¼ ¥i¥HÆ[¹î¨Ã»`¶°¤j³¡¤À¥ÎÃIJձwªÌªºª¬ªp ¥H§@¬°FDA¤T´Á¸ÕÅç³]pªº°Ñ¦Ò ¥t¥~ ³]¸ê®Æ¤¤ 24+ ªº¦h¹è ©Î³\¤]¬O¤½¥q·Q²Îpªº ¸£¤¤¤@¤ù²V¶Ã ·Q¤F¤S·Q ¸Ó«ç»ò¦ô ¤¤¦ìPFS ¤£ª¾¤j®a¦³·Qªk¶Ü? ¤p§Ì¦³«O¦u¦ô ¦ý©ÈÅÞ¿è¿ù»~ »~¾É¤j®a ÁÙ¬O¯dµÛ¦Û¤v°Ñ¦Ò´N¦n ¶È¨Ñ°Ñ¦Ò ½Ð±z¨Ì¦Û¤vªº·Qªk¨Mµ¦ ÁÂÁ¤j®a! |
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·|û¡G²á²á10140340 µoªí®É¶¡:2015/6/25 ¤W¤È 10:58:30²Ä 1562 ½g¦^À³
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¥i¨£¤½¥q·Qªº¸ò§ÚÌ·Qªº¯uªº¤£¦P....¤p§ÌÁÙ¬O¿ï¾Ü¬Û«H³o¨Ç´X¤Q¦~¬Æ¦Ü¤@½ú¤l³£¦b³o¦æ·~¥´ºuªº¤H°µªº§PÂ_... ¦pªG¥LÌ·Qªº¸ò§Ṳ́@¼Ë, ¨º¯uªº¤]¬OSOMETHING WRONG, ·sÃĤ]´N¤£·|³o»ò§xÃø¤F. ²¦³ºÃĮĥun¦³¤@©wµ{«×ªº¦n, ³o³£¬O¤@¥ó¦n¨Æ, ¨Ã«Dn¥H¦t©z¯Åµ´¹ïÀ£Ë©Êªº³Ó§Q¤~¬O³Ó§Q.. ©Î³\§ÚÌn¦h«ä¦Ò¬°¦ó¤½¥q¬O³o¼Ë¤l·Qªºì¦]¤F. ÃÄ·~¸ò¹q¤l·~¯uªº¤j¤j¤£¦P°Ú! ¤@Ó¬O²£¥X«÷·~ÁZ¨C¦~³£¥i¦³·s²£«~, ¤@Ó¬O±Ï¤H¥un¦³«¤j¬ð¯}´N¥i¥H½æ¤Q¦~°Ú! |
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·|û¡G£~£~10134649 µoªí®É¶¡:2015/6/25 ¤W¤È 10:48:45²Ä 1561 ½g¦^À³
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ªº½T¼vÅTPFS«D±`¤j§r! «ç»ò·|³o¼Ë³]p©O?¦Ê«ä¤£¸Ñ...... ++++++++++++++++++++++++++++++++++++++++++++++++ ¤Þz¥ò´º¤jªº: 1> ¤G/ ¤T´ÁProtocol ³]p ¤w¸g©w³Ì¦h¥uÆ[¹îPFS 24 Ó¤ë, ¨C2Ó¤ë©ç¤@¦¸X ¥ú¤ù, ¶W¹L24Ӥ뤧«á, ¬°¸`¬Ù¶O¥Î, ´N¤£¦b©çX¤ù, ¦]¦¹, ¨CÓ¤HªºPFS ³Ì¦h´N¬O24Ó¤ë¡C ¬G¸Ñª¼«á§Y¨Ï¯u¹êªºM_PFS ¶W¹L30Ó¤ë, ¦ýÁ{§É¼Æ¾Ú¤WÅã¥Üªº¤]¥u ¦³24Ó¤ë¡C ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ |
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·|û¡G£~£~10134649 µoªí®É¶¡:2015/6/25 ¤W¤È 10:19:34²Ä 1560 ½g¦^À³
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¶W¹L24Ӥ뤣¦Ascan¬On¦C¤J¤°»ò? ¦C¤J´c¤Æ?¨S´c¤Æ¤£¥i¯à, ¦C¤J°h¥X?¤]¨S¦³°h¥X¤£¥i¯à, ¤£¦Ascan¤£¥Nªí¤£¦b²Îp¤º§a? ¤@©wnscan¤~¯à§P©w¬O§_´c¤Æ¶Ü? ·w%$#@!£~£~! |
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1.´X¥G¨S´c¤Æªº´N¬ONED?³o¬OOBI-822«nªº¯S¦â¤§¤@¬O¶Ü? ©Î¤Ö¼Æ¹L¤@¬q®É¶¡¤~´c¤Æªº,¦pªG¸É¥´¥i¯à¥i¥H«ùÄòºû«ù¤£´c¤Æ§a? 2.©Ò¥H¤£¤îªvÀø®ÉµL°Æ§@¥Î,ªvÀø«á(Y¦³®Ä)´N(¤j³¡¤À)NED 3.OBI-822:µL®Äªº´NµL®Ä,¦³®Äªº¤j¦hNED? ¨ä¥LÃÄ:µL®Äªº´NµL®Ä,¦³®Äªº¥u¬O©µªø¥Í©R¡C³o¼Ë¬O§_ªí¥Ü±N¨ÓºâOS·|«ÜÅå¤H?°²¦p¤@´Á¼Æ¾Ú,¦s¬¡¤U¨Óªº¦Üª÷¤´¦s¬¡,¤£ª¾¹D¬O§_¦³¤H¯àpºâ¤@¤U,¤@´Á¼Æ¾ÚOS²{¦b¦h¤Ö¤F? 4.±N¨Ó´I§tGLOBO-Hªº¤£¥´OBI-822¤£´N«Ü¥i±¤?¨ÅÀùªì¤¤´Á,¶X§K¬Ì¨t²Î¥\¯à¤´°·¦b®É,YÀË´ú´I§tGLOBO-HÀ³»°§Ö¥´OBI-822§a? 5.Y§ï¥HLR¬°·Ç,¨º»òPFS²{¦b´N¤w¸g©w¤F,³ÌºC¯à©wªº±¡ªp¬O37¤HÄÝ©ó¹ï·Ó²Õ¥B¹ï·Ó²Õ¥þ³¡´c¤Æ:¹ï·Ó²Õ¦pªG116¤H(§t¨º37¤H),Á`¤H¼Æ349¤H¦©±¼¹ï·Ó²Õ116¤H³Ñ233¤H,233¤Hªº¤@¥b117¤H,¨º»òLR229¤H¦´N¶W¹L117¤H¤F¡C§ÚªºÅÞ¿è¹ï¶Ü?¤£¸Ñª¼¥u¬O¬°¤FÅýPFS¼Æ¦r¤j¤@ÂI¬O¶Ü? 6.·|¤£·|8¤ë·|ij¨M©w¥ß§Y¸Ñª¼?¦pªG©ì©µ¨ì©ú¦~2¤ë¸Ñª¼,§Ú¦ôpPFS¼W¥[¤£¨ì2Ó¤ë(¦]¬°¤j¦h´c¤Æ,´c¤Æªº´N¤£¦A°^ÄmPFS§a?)¡C½Ð¦U¦ì«ü¥¿§Úªº¿ù»~¡CÁÂÁÂ! |
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¥ò´º¥S´£¨ì ¤µ¦~¨Ó½T¹ê¬O´c¤Æ¤H¼Æ¦b´î½w, ¬°®£¸Ñª¼µ¥«Ý¤Ó¤[, ¤½¥q©ó8¤ë±M®a·|ij«á·|¦Ò¼{±N ì¥ýProtocol ³]p¥HCR °µ§PŪªº¼Ð·Ç, ¦Vªk³W³æ¦ì¥Ó½Ð§ï¬°¥HLR °µ§PŪ¼Ð·Ç¡C Y¦¹¬°¯u¡A¤ÏË¥i¥H±N´X¶µ±ÀºâPFSªºÅܼƮ³¶}¡Adropout37¤H¤]¥i¥H¤£¥Î²z·|¡A»\¨ÌCliff¥S´£¨Ñªº¤å³¹ Generally, no further assessments are available after progression has been declared by the LE, and the patients may have already moved on to new therapies (based on the investigator¡¦s decision) before the BICR is conducted. This process may lead to a considerable number of patients declared to have progressive disease by the LE but censored by the BICR dropoutªÌ¤j³¡¤À¦]¬°LR§PPD¤§«á¤~°h¥X¥t´M¨ä¥LÀøªk¡A¦]¦¹¨ì¤FCRÅܦ¨³] 12/31 PD187¤H¥H¤Î5/25 PD229¤H¬O²{¦³³Ì½T©wªº¼Æ¦r¡A¤£¥Î¥hºÞCRªº®É¶¡¸¨®t©Î§PŪ»~®t «ö¤p©_¥S¤é«e±Àºâ¨Ì¼Ëµe¸¬Äª¤@¤U¡A²Ä80¤HªºÃöÁäA«Ü¥i¯à¤w¸g¥X²{¤F¡A®e§Ú¹°¶V¤@¤U ¦]¤£¥Î¦Ò¼{dropout ©Ò¥H¹ï·Ó²Õ§PPD¤H¼Æ¥i¨ú95%=110¤H «h¹êÅç²ÕPD¤H¼Æ=229-110=119 ªø§À53¤H ¦pªGªø§ÀPD¦ô13¤H¡A«h119-13=106 (106-80)/6=4.3(1¤ë¥X²{ÃöÁäA) ¦pªGªø§ÀPD¦ô27¤H¡A«h119-27=92 (92-80)/6=2(3¤ë¥X²{ÃöÁäA) ¦pªGªø§ÀPD¦ô40¤H¡A«h119-40=79(5¤ë¥X²{ÃöÁäA) ¤p©_¥S¼Ò«¬ªº100³]¼Æ¤¤¥]¬A¹êÅç²ÕGlobo H-´c¤Æ¦Ó¤¤³~Â÷¶}¡A²{¦b³o¨ÇGlobo H-À³¸Ón²¾¨ìPD²Õ¥h¡A©Ò¥H¦^±À³]100¤H§ä´M¨å«¬ªºÃöÁäA¶}©lªº¤ë¥÷¡A¤Ï¦Ó¥i¥H±q2013¦~10¤ë©¹«e±À2~3Ó¤ë ¤p§Ì´¼²L¥u¯à¹°¶V¦Ü¦¹ ¨ä¥L¦³³Ò¤p©_¥SÄÀºÃ |
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Dear ±ø¤j~¤p©_¤j~ ±ø¤j~ ¸ò±z½Ð±Ð¤@¤U¡A±z¤å³¹©Ò´£¨ìªº PD229®É, ¦]¬°¹êÅç²Õ´_µo+°h¥XªÌ(À³¸Ó³£¬O¹êÅ祼º¡¤@¦~©~¦h)«Ü¥i¯à¤w¸g¶W¹L¤H¼Æ¤@¥b ©Ò¥HM PFS´X¥G¤w¸g¨M©w¡A¦pªG²{¦b´_µoªº³£¬O±ß´Á¦¬®×¡A«h·|ÅýM PFS§ó§C¦Ó«D§ó°ª ------------- ¥i§Ú«ôŪ¤p©_¤jªº¨º½g°Ñ¦Ò¤åÄm¹ï©óK-Mªº¤å³¹Á|¨Òªº®ÉÔ¡A§Úµo²{³]¸ê®Æ¦bK-Mø»s³B²zªº®ÉÔ¡A¬O¥¦æµe¥X¥h°é°_¨Ó¤@ÓÂIªº³á¡A¨Ã¤£·|ÅýK-M¨º±ø½u¦V¤Uª½½u¼Yµe¤U¥h¡A¥u¦³eventµo¥Íªº®ÉÔ¤~·|¦V¤Uµe~ ©Ò¥H¦pªG²{¦bPD229 ¡A¦ý¥un"¹êÅç²Õ"´_µoªº¤H¼Æ¨S¦³¶W¹L¤@¥b(5¤ëÀ³¸Ó¬OÁÙ¨S)¡A§Ú»{¬°M-PFS ¬OÁÙ¨S¥X²{ªºC(¤£»Ýn§â°h¥Xªºothers³]¸ê®Æ¤H¼Æ¥[¶i¨Ó¬Ý¬O§_¶W¹L¹êÅç²Õªº¤@¥b¡A¦]¬°¨º¨Ç¸ò©¡®É¸Ñª¼®ÉÔªº¥¼´_µo³]¸ê®Æ N+ ¤@¼Ë¡A¬O¤£·|ÅýK-M¤U²¾ªº)¡A¦Ó¥B¤]¤£·|¦C¤JM-PFSpºâ¡A(§Úªº·N«ä¬O»¡¡A¸Ñª¼·í¤ÑpºâM-PFSªº®ÉÔ¤£·|¦]¬°¤¤³~°h¥Xªº¤H¬O2+ ©Î©|¥¼´_µoªº¤H¬O 6+¡A´NÅýM-PFS ·|²£¥Í¥ª²¾)¡A¦Ó¬Oª½±µ¬ÝK-M Áa¶b0.5¹ïÀ³ªº¾î¶b¤ë¥÷¼Æ§Y¥i¡C©Ò¥H²{¦bÀ³¸ÓM-PFSÀ³¸Ó»¡ÁÙ¨S¥X²{ªº~(°²³]¦pªGCR/LR < 0.8 ¥B ¹ï·Ó²Õ¶W¹L90%¤w¸g´_µo) ¤p©_¤j¡A½Ð°Ý§Ú³o¼Ë²z¸Ñ¬O§_¥¿½T©O? ·PÁ¨â¦ì¤j¤j«ü±Ð |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2015/6/23 ¤U¤È 11:01:45²Ä 1530 ½g¦^À³
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QQ ¤j ¼vÅT±ÂÅvª÷¦]¯À¥]¬A 1²£«~¥«³õ¤j¤p 2±M§Q¨Ï¥Î¦~¼Æ 3Àò±oÃÄÃÒ¾÷²v 4¬O¤G´Á±ÂÅv©Î¬O¤T´Á±ÂÅv (°Ñ¦Ò¸ê°T4) 5¬O³æÃıÂÅvÁÙ¬O¨t¦C±ÂÅv 6Àø®Äµû¦ô¬O§_¦³¨¬°÷Ävª§¤O ¥i°Ñ¦Ò¸ê°T 1 3¤ëªk»¡¤¸´I¨º¥»³ø§i,¦³³Ìªñ§K¬ÌÀøªk±ÂÅvª÷ª¬ªp (¨ä¤¤´XÓ¨t¦C±ÂÅvª÷¬Û·íÃe¤j¥iÆ[)(¶W¹L2Óbillion) 2 ¤é²±µû¦ô¨ÅÀùOBI 822 0.85Ó billion 3 ¦pªG²£«~¦³¼ç¤O,¦³¯S³ÐÀø®Ä¤S¬O¥¼¨Ó¥D¬yÀøªk,Ó¤H²q´ú ¤jÃļtn±ÂÅv¤£·|·Q³æÃıÂÅv,¾ãÓOBI 822¨t¦C±ÂÅv¤~¬O ¥LÌ·Qnªº,¦³¬ãµo¦¨¥\¦Aµ¹±ÂÅvª÷,¯à®³¨ì©Ò¦³16ºØÀù¯gªº¸g¾PÅv ³Ì«n,¤£¥²¥H«á¤@Ó¤@Ó¥h½Í ,Ãm¤é¶O®É 4https://tw.news.yahoo.com/optimer%E5%A4%A7%E8%B3%BA64%E5%84%84%E7%9A%843%E7%A5%95%E6%8B%9B-20110220-104651-052.html |
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·|û¡G»¨10136549 µoªí®É¶¡:2015/6/23 ¤U¤È 07:54:18²Ä 1529 ½g¦^À³
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¤U±¬OÓ¤H°Ñ¦Òª©¤W¤j¤jªºPFS¹w¦ô¼Æ¾Ú¡Aµ¹¤j®a°Ñ¦Ò¡A¨Ã½Ð°Ý¬O§_¦³°ÝÃD 2015/05 (LR/OTHER) = (229/37) ¹êÅç²Õ¤H¼Æ:233 ¹ï·Ó²Õ¤H¼Æ:116 «nÅܼÆ(°Ñ¦Òµ½¤H¤jªº°²³]): 1. IF ¹êÅç²Õ OTHER:18 ¹ï·Ó²Õ OTHER:19 2. IF ¹ï·Ó²Õ°²³]³Ñ2¤H¥¼´_µo¡A«h¹ï·Ó²Õ´_µo¤H¼Æ= 116-19-2 = 95 3. IF CR/LR = 0.75¡A 229*0.75 =172¡A«h¹êÅç²Õ´_µo= 172-95 =77¡A ¹êÅç²Õ¥¼´_µo= 233-77-18 =138¡A³]¤H¼Æ= 138+18 =156 ¬°¤F¤è«K¤ÀªR»P¸ÑÄÀ: ¤À§O§â¹êÅç²ÕÁ`¤H¼Æ233¡B´_µo¤H¼Æ77¡B³]¤H¼Æ156¤H¡A¥H¤Q¤H¬°¤@Ó³æ¦ì==> 23 8 15 ¦¬®×¤é´Á 2012/12 2013/06 2013/09 2014/04 2014/08 ¦Ü2015/05¤ë¼Æ 29 23 20 13 9 (¤ë) (µù@:¥§¡ 32 26 21 16 11) ¹êÅç²Õ¦¬®×¤H¼Æ 66 66 20 57 24 (233¤H) ²¤Æ¤H¼Æ 6 7 2 5 3 ( 23¤H) ²¤ÆPFS¼Æ¦C: 29 29 29 29 29 29 23 23 23 23 23 23 23 20 20 13 13 13 13 13 9 9 9 ´_µo8¤HªºPFS¼Æ¦C³Ì®t±¡ªp: 29- 29- 29- 29- 29- 29- 23- 23- 23 23 23 23 23 20 20 13 13 13 13 13# 9 9 9 «hPFS= 13 ¥Ñ©ó¹êÅç²Õ´_µo©|¥¼¹F¤¤¦ì¼Æ116(?)¡A©Ò¥H¤½¥q¨M©w¤£¥i²{¦b¸Ñª¼¡AÁÙ¥i¥H¦hµ¥´XÓ¤ë=13+ (µù@:¥§¡= 16+ µ¥«Ý¤ë¼Æ) PFS¼Æ¦C¥§¡±¡ªp: 29 29 29 29 29 29 23 23 23 23 23 23# 23 20 20 13 13 13 13 13 9 9 9 «hPFS= 23 ¥Ñ©ó¹êÅç²Õ´_µo©|¥¼¹F¤¤¦ì¼Æ116(?)¡A©Ò¥H¤½¥q¨M©w¤£¥i²{¦b¸Ñª¼¡AÁÙ¥i¥H¦hµ¥´XÓ¤ë=23+ (µù@:¥§¡= 26+µ¥«Ý¤ë¼Æ) Ó¤H·P·Q1:³Ì®tÈ13+(16+)µy·L´dÆ[¤£¦p¹w´Á¡A¥§¡È23+(26+)«hÆZ¦nªº¡C¾ãÅé¦Ó¨¥ÁÙ¬OÆZ¼ÖÆ[´Á«Ýªº¡C ·P·Q2:PFS 18+ ¨ä¹êÀ³¸Ó´N¥i¥H¾_Åå¥@¬É¤F? |
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·|û¡GQQ10140589 µoªí®É¶¡:2015/6/23 ¤U¤È 04:47:07²Ä 1527 ½g¦^À³
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¦Ñ¥v¤j¤j: ÁÂÁ±z´£¨Ñªº¬Ã¶Q¸ê°T. §Ú«D¤u«DÂ奻¬ì, ©Ò¥H¦³®Én»`¶°¸ê®Æ, ´h¦bG¤j¤j«e ³£¤£ª¾¦p¦ókey ¤J. ¦]¬G¸g±`³Â·Ðª©¤W¦U¦ì¤j¤j, ¯u¬OºF·\. ÁöµM¬O¥^¥^«ôŪ¤F±z´£¨Ñªº¸ê°T, ¦ýªì¨B¬Ý¨Ó, §Úªº¦k©ÀÁÙ¯u«D¦k©À, ¤ä¼µºâ¦³¤O. »á·P¦w¼¢. ±zªñ¨â¤é´£¨Ñªº¸ê®Æ, ®e§Ú¥J²Ó¸ÔŪ®ø¤Æ, Y¦³ºÃ°Ý, ÁÙ¥ø¬ß±z¤£§[«ü¾É. ÁÂÁ |
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¤½¥q»¡¸Ñª¼³Ì¨Î®É¶¡¦b¦~©³©Î©ú¦~ªì ¬O§_Áô§t·t¥Ü¤¤¦ì¼Æªº®É¶¡ÂI? ·í§ÚÌ¥Hworst case 2015/5 PD=229, ¤w¹L¤¤¦ì¼Æ, ¨º»Ýnµ¥¦~©³©Î©ú¦~ªì? |
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·|û¡G¹Ç§AÅó±ø±ø10135894 µoªí®É¶¡:2015/6/23 ¤U¤È 03:25:01²Ä 1525 ½g¦^À³
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¤p©_¤j¡A ±zªººâªk¥¿½T¡A¤p§Ì¨S¦³»¡²M·¡ ¦pªG¦³3¦ì±wªÌ¸ÕÅç¡A2¦ì´_µo¡A1¦ì5Ó¤ë¡A1¦ì10Ó¤ë¡A«h¥H²Ä2Ó´_µo®É¶¡10Ó¤ëºâ¤¤¦ì¼Æ ¦pªG²Ä3¦ì´_µo®É¡A®É¶¡´Nn¤ñ¸û«e2¦ì¡A¦pªG¶W¹L10Ó¤ë¡A¤¤¦ì¼ÆÁÙ¬O¤£ÅÜ ¦pªG¤p©ó5Ó¤ë¡A³oÓ±wªÌµ²ªG·|´¡¶¤¡AÅý¤¤¦ì¼ÆÅܦ¨5Ó¤ë ¦pªG¤p©ó10Ó¤ë¡A°²¨Ï8Ó¤ë¡A«h¤¤¦ì¼Æ·|Åܦ¨8Ó¤ë PD229®É, ¦]¬°¹êÅç²Õ´_µo+°h¥XªÌ(À³¸Ó³£¬O¹êÅ祼º¡¤@¦~©~¦h)«Ü¥i¯à¤w¸g¶W¹L¤H¼Æ¤@¥b ©Ò¥HM PFS´X¥G¤w¸g¨M©w¡A¦pªG²{¦b´_µoªº³£¬O±ß´Á¦¬®×¡A«h·|ÅýM PFS§ó§C¦Ó«D§ó°ª |
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·|û¡G¦Ñ¥v10140531 µoªí®É¶¡:2015/6/23 ¤U¤È 02:28:09²Ä 1524 ½g¦^À³
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¥H¤U´£¨ÑQQ¥Sµû¦ô 14¦~«e(2001.6)Merck¶}ªº»ù½X¦p¤U Merck has expanded its oncology pipeline through a co-development and marketing agreement with Biomira. Biomira could receive up to $150 million in up-front license fees, milestones, and equity for rights to two vaccines: Theratope, in phase III metastatic breast cancer trials, and BLP25, for non-small cell lung cancer (phase II). ¥h¦~4¤ë28¤éMerck©MAgenus¦X§@¡AÄÝ©ó³Ì¦´Ápre-clinical³æ§Ü¶}µo Agenus Inc. announced today that the company has entered into a collaboration and license agreement with Merck, through a subsidiary, for the discovery and development of therapeutic antibodies to immune checkpoints for the treatment of cancer. Under the terms of the agreement, Agenus will discover and optimize fully human antibodies against two undisclosed Merck checkpoint targets using the 4-Antibody Retrocyte Display® platform. Merck will be responsible for clinical development and commercialization of candidates generated under the collaboration. Under the terms of the agreement, Agenus is eligible to receive approximately $100 million in potential payments associated with the completion of certain clinical, regulatory and commercial milestones for two candidates from Merck. In addition, Agenus is eligible to receive royalty payments on worldwide product sales. |
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·|û¡GQQ10140589 µoªí®É¶¡:2015/6/23 ¤U¤È 02:05:42²Ä 1523 ½g¦^À³
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·|û¡G¦Ñ¥v10140531 µoªí®É¶¡:2015/6/23 ¤U¤È 02:01:38²Ä 1522 ½g¦^À³
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QQ¥S §¹¾ã¤T´Á³ø§ihttp://theoncologist.alphamedpress.org/content/16/8/1092 Experimental design. The study population consisted of 1,028 women with MBC across 126 centers who had previously received chemotherapy and had had either a complete or a partial response or no disease progression. All women received one-time i.v. cyclophosphamide (300 mg/m2) 3 days before s.c. injection of 100 £gg STn-KLH plus adjuvant (treatment group) or 100 £gg KLH plus adjuvant (control group) at weeks 0, 2, 5, and 9. Subsequently, STn-KLH without adjuvant or KLH without adjuvant was then administered monthly for 4 months, and then quarterly until disease progression, without cyclophosphamide ¤G´Á¥´¡H°w¡A¨S¦L¶H¡A¤À¬°(a)ªvÀø«eÀR¯ßª`®g²Õcyclo¡A(b)ªvÀø«e¤fªAcyclo¿õ©Î¤£¨Ï¥Î ¦]¬°Biomira»{¬°(a)¤ñ(b)¦n ©Ò¥H¤T´ÁªvÀø«e·|¥ýÀR¯ßª`®g¤@¦¸cyclo¡A¤T´Á¥´9°wSTn-KLH¡A¤À§O¦b0¡B2¡B5¡B9¡B13¡B17¡B21¡B25¡B37¶g¬I¥´ |
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·|û¡GQQ10140589 µoªí®É¶¡:2015/6/23 ¤U¤È 12:24:40²Ä 1521 ½g¦^À³
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¥xÁÞ¤j: ±z¤£¥u¦³±M·~ªºª¾ÃÑ, ¦P®É¤]±Ð¾É§Ú«Ü¦hµ¦²¤¤Wªº¶i°h. ¨C¦¸¤]´£¨Ñ°Ñ¦Òªººô¯¸. °£¤FÁÂÁ ÁÙ¬OÁÂÁ §Ú¤]«Ü´Á«Ý±ÂÅvªº¸ê°T. ¤§«eªÑªF·|®É¶ÀÁ`¦³´£¨ì¹©¸¡ªYªº±ÂÅvª÷ÃB/°Ï°ì, °µ¬°»P822ªº¤ñ¸û. §Ú¨ä¹ê¬O¸£¤¤¦³¤@±ÂÅvª÷ªº¤j¬ù¼Æ¦r, ¦pªG¹ï·Ó¶ÀÁ`©Ò»¡, À³ »P§Ú¦ôºâ¬Û¶Z¦³. ¥u¬O³oª÷ÃB·|¯}«Ü¦hªº¬ö¿ý©Ò¥H¤£´±´£¥X. ½Ð°Ý±z¬O§_ª¾¹D ¹³³oºØ±ÂÅvª÷ÃBªº°Ñ¦Ò¨Ì¾Ú, ¦³¤°»ò¸ê®Æ¥i¥H¬d¾\¶Ü ? ¦Ñ¥v¤j: ÁÂÁ§A¹ïSTn Theratope¤T´Á¥¢±Ñªº¤À¨É. ¸Ñ¤F§Ú¤j³¡¤ÀªººÃ´b. ½Ð°ÝTheratopeªº¤T´Á¦¬®×Á{§É³]p¬O©M¤G´Á¬Û¦P¶Ü ? |
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·|û¡G¤p©_10138298 µoªí®É¶¡:2015/6/23 ¤U¤È 12:14:16²Ä 1520 ½g¦^À³
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Honhon¤j¡AWalden¤j¡A ¥H¤Uºô§} http://www.cde.org.tw/Content/Files/Knowledge/b0801107-dd21-41ef-8c7d-4c6c2edf1bd7.pdf ¦³®×¨Ò¡B¹Ï«¬©M»¡©ú¡A©Î³\¹ï±z©Î¦³À°§U¡A¥i¥H°Ñ¦Ò¬Ý¬Ý¡C Honhon¤j¡A ¸Ñª¼®É¶¡ÂI¦b¬P´Á¤» ¬P´Á¤@(¤µ¤Ñ´c¤Æ), ¬P´Á¤G(·í¤Ñ´c¤Æ), ¬P´Á¤T(µL´c¤Æ) M PFS=5¤Ñ PFS§Ç¦C¡G0¡A3+¡A5 (+ªí¥Ü³]) µeK-M¨ç¼Æ¡A0.5ªº¤ô¥½u¬Û¥æ¦b5¡AM PFS=5 ¡yYµL´c¤Æªº¤H¦b¬P´Á¤Ñ´c¤Æ...¨ºM-PFS¸Óºâ¦h¤Ö?¡z ¸Ñª¼®É¶¡ÂI¦b¬P´Á¤Ñ ¬P´Á¤@(¬P´Á¤»´c¤Æ), ¬P´Á¤G(·í¤Ñ´c¤Æ), ¬P´Á¤T(¬P´Á¤Ñ´c¤Æ) PFS§Ç¦C¡G0¡A4¡A5 µeK-M¨ç¼Æ¡A0.5ªº¤ô¥½u¬Û¥æ¦b4¡AM PFS=4 ©ÎªÌ¤w¬O¥þ³¡´c¤Æªº§Ç¦C´N¬Ý¤¤¶¡¨º¤@ӼƾÚ=4 ¦]¬°¦³¯Ç¤J³]¸ê®Æ¡A©Ò¥H¬P´Á¤»¸Ñª¼ªº¨Ò¤l¡AM PFS¬O5¤£¬O3 ¬P´Á¤Ñ¸Ñª¼ªº¨Ò¤l¨S¦³³]¸ê®Æ¡A©Ò¥HM FPS´N¬O4 ¦³¥¼PD©|¦s¦b®É¡AM PFS¤´·|ÀHµÛ¸Ñª¼®É¶¡¦Ó§ïÅÜ¡A¥un¤w¬ï¶V¹L0.5¤ô¥½u¥B¼Æ¾Ú¤w¤jP¦¨¼ô¡AM PFSµy·L¦h¤@ÂI©Î¤Ö¤@ÂI¹ïÁ{§É¹êÅçµ²ªG¨S¦³¼vÅT¡C Walden¤j¡A Á|¨Ò¦n¤F~ °²³]¤µ¤Ñ¸Ñª¼¡A¦@ 7 ¦ì¯f±w Case1 : PFS ¼Æ¦C: 1, 2, 3+, 4, 5+, 6+, 7 ½Ð°Ý¦¹®É M-PFS ¬O 7 Ó¤ë¡A ¨S¿ù§a? >>>>>>M PFS=7(ø¹Ïªk¨D¥X) ¨S¿ù Case 2: ¤@¼Ë°²³]¤µ¤Ñ¸Ñª¼ PFS ¼Æ¦C : 1, 2, 3 , 4+, 5+, 6+, 7+ ÁÙ¨S¹L¥b¡AM-PFS «ç»ò¿ì? ¥i¥H¥Î 4 Ó¤ëºâ¶Ü? >>>>>¼Æ¾Ú¥¼¦¨¼ô¡A¥¼¹F0.5¤ô¥½u¡A¥u¯à»¡M-PFS¤@©w¤j©ó4Ó¤ë¡A¥i¥H¦Aµ¥¦Ü¤Ö¤@ÓPD«á¸Ñª¼ ¥H¤W¡A½Ð°Ñ¦Ò¡C |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2015/6/23 ¤W¤È 11:50:35²Ä 1519 ½g¦^À³
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QQ ¤j ¥Ø«e¬ãµo¨ÅÀù¥D°Ê§K¬ÌÀøªk 822OBI¨«¦b¥@¬É²Ä¤@,¬ãµo¤¤ªº¨ÅÀùÃĦp A Therapeutic Vaccines: 1 NeuVax™ (Nelipepimut-S or E75) (¦b¤T´Á), ¨âÓ¦b1 2´Á 2GVAX ,¦³¤TÓ¨ÅÀùÃĦbÁ{§É¤¤( ¤@¤G´Áªº¤ñ¸û¦h) B Checkpoint Inhibitors: ¤@¤G´Áªº¤ñ¸û¦h 1¥Ø«e¥«±¤WÁÙ¨S¦³ PD-1, PD-L1ªº¨ÅÀùÃĪ«³Q®Öã 2±q¤@´Áºâ¨ì¤T´Á ¯à¦¨¥\ªºÃĪ«¬ù¦Ê¤¤¨ú¤ ¨ú¤» 3¥¼¨Ó¤½¥q·|¬ÝÁ{§Éµ²ªG,Áp¦X¥ÎÃĩΩ¹«e±À¶i¬O¥¼¨Ó¬AÂX®i¥«³õµ¦²¤, »Ýn¦AÁ{§É¤~¯à¥Î, 4²q´úªì´Á¦p822 + cyclophosphamide ¯à¶}¥X¤£¿ùªºPFS¥Ñ©ó°â»ù,Àø®Ä ,°Æ§@¥Î ³£«Ü¦³Ävª§¤O ¥ý³æ§L§ðÀ»´X¦~¦P®É¶i¦æÁp¦X¥ÎÃÄÁ{§É ,·í°l§L¨ì¤F¦A±ÄÁp¦X¥ÎÃĵ¦²¤, 5 Áp¦X¨ì¨}ÃÄÃÄ»ù¶Q¬O¥²µMÁͶÕ,¶PÀù¥(¬ü°ê¬ù4¸U¬ü¤¸) (¶PÀù¥+¶P¯e§´+¼Ú¬wµµm¾J 12¸U¬ü¤¸) °Ñ¦Ò¥H¤Uºô¯¸ http://www.cancerresearch.org/cancer-immunotherapy/impacting-all-cancers/breast-cancer |
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·|û¡G¤p©_10138298 µoªí®É¶¡:2015/6/23 ¤W¤È 11:40:04²Ä 1518 ½g¦^À³
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¥xÁÞ¤j¡A ¡y¶}¨Ï°Ñ¥[OBI822¹êÅç²Õ¤»Ó¤ë«á³Q§P©wCR/PDªº¯f±w,¤EÓ¤ë«á ©Î¤@¦~«á°lÂܦpªGµo²{¸~½FÁY¤p ,¯à§_¦A«·s§P©w¨S¦³CR/PD ? ¦]°lÂÜ´Á¦³¤G¦~, (¹ï³¡¤À¯f±w¨Ó»¡§K¬ÌÀøªkµo´§ÃĮĻݤ@¬q®É¶¡)¡z A BICR, however, has its own limitations since it is often conducted in a prespecified but retrospective manner in which patients¡¦ radiographs are reviewed after all assessments have been performed. ±qCliff¤j§ä¨ìªº¤å³¹¡]http://dij.sagepub.com/content/47/2/167.full¡^¤¤ªºÁ{§É®×¨Ò´¶¹M¨Ó¬Ý¡ALR/PDªº§PÂ_¤ñ¸û¼eÃP¡A´N¬O±wªÌ¹F¨ìÃxÁ{PD±ø¥ó®É¡AÁ{§ÉÂå¥Í´N·|ª½±µ°µ¥XPDªº§PÂ_¡A¦³¥i¯à¬OÅý±wªÌ©|¦³¾÷·|¥h§ä¨ä¥LªºªvÀø¤è¦¡(¤å³¹¤¤¤j³¡¤ÀªºÁ{§É¤£ºÞ¹êÅç²Õ©Î¹ï·Ó²Õ¡AM PFS³£¤£¤Óªø¡A¤@¥¹PD¡A³q±`¯f±¡´N«ÜÃø¦A¨ü¨ì±±¨î)¡A¦]¬°ÃxÁ{PD¤§«á¤@¬q®É¶¡¸~½F¦AÅܤpªº±¡ªp¦bÁ{§ÉÂå¥Íªº¸gÅ礤¨Ã¤£¦h¨£¡AÁ{§ÉÂå¥ÍÄU»¡¤wPDªº±wªÌ¤@ª½¯d¤U¨ÓÄ~Äò°µÀˬd¨S¦³¹D²z¡C¦ý³o¼Ëªº¡u¸û¼eÃP¡v§PÂ_¼Ð·Ç¬O¦P®É©ñ½Ñ¹êÅç²Õ»P¹ï·Ó²Õªº±wªÌ¡AY³Ì«á¦]¬°LR/PD»PCR/PDªº§PŪ®t²§¦Ó³y¦¨³Ì²×CR¦bM PFS¦³Àu©óLRªºM PFSªº¼vÅT¡A³o¼Ëªº¦n³B¤]¥i¯à¦P®É§@¥Î¦b¹êÅç²ÕªºM PFS »P¹ï·Ó²ÕªºM PFS¤W±¡A¤]´N¬OCliff¤j©Òn»¡ªº¡ACR/PD»PLR/PDªº§PŪ®t²§¡A¦bBICR HR»PLE HR¹Ï«¬¤W¡A¹ï¼Ë¥»ùؤj¦h¼ÆªºÁ{§É¸ÕÅç¦Ó¨¥¡A¨âªÌ¬O¬Û·í¤@Pªº¡C´«¥y¸Ü»¡¡A¦]¬°CR/PD»PLR/PDªº§PŪ®t²§Y³y¦¨¤F³Ì²×M PFSªº¼vÅT¡A¦]¬°¡u¸û¼eÃP¡v§PÂ_¼Ð·Ç¬O¦P®É©ñ½Ñ¹êÅç²Õ»P¹ï·Ó²Õªº±wªÌ¡A¦n³B¨â²Õ³£¦³¡A¦]¦¹¤£·|³y¦¨BICR HR©úÅãÀu©ó(¼Æ¦r§Cªº¤ñ¸ûÀu)LE HR¡A²³æ»¡´N¬O¤£¤Ó·|¦]¬°¥ÎLR©ÎCRªº¼Æ¾Ú°µ²Îp¤ÀªR¦Ó©úÅã§ïÅܤF¨â²ÕªºHR¡A©ÎªÌ©úÅã§ïÅܤF¨â²ÕªºpÈ¡C 1.³q±`LR/PDªº¼Ð·Ç·|¡u¸û¼eÃP¡v¡A³Q§P©wCR/PDªº¯f±w¦ÓLR¤´¥¼PDªº±wªÌÀ³¸Ó¤£¦h¡A¦]¦¹³Q§P©wCR/PDªº¯f±w¤j¦hLR¤]¦P®É§PPD©Î¤w§PPD©ÎªÌ¤@¨â´Á«á¤]³Q LR§PPD¡ALR§PPD¤§«á³q±`´N¤£·|¦A¦³±wªÌªºÀˬd¸ê®Æ¡A¦b¤Wz¤å³¹¤¤¤j³¡¥÷ªº®×¨ÒÀ³¸Ó¬O³o¼Ëªº©~¦h¡C822¥i¯à¦]±wªÌ¥Í¦s«~½è¦n¡A±wªÌÄ~Äò¯d¤U¨Ó¨C´Á°µÀˬdªº·NÄ@¸û°ª¡AÅý¿W¥ß¤¤¤ß¦³§óªøªº®É¶¡¥i¥HÆ[¹î¸~½FªºÅܤơA¦Ó°µ¥X§ó¥¿½Tªº§PŪ¡A¤W¬q^¤å¤¤¦³retrospectiveªº¦r²´¡A¥i¯à¿W¥ß¤¤¤ß¬O¥Î´X´Áªº³sÄò¹Ï¤ù°µ§PŪ¡A¦Ó«D¥Î¬Y¤@´Áªº®É¶¡¾î¤Á±°µ§PŪ¡A©Ò¥H¤£¯à±Æ°£³oÓ¥i¯à©Ê¡A¦ý¯u¹êªº±¡ªp¯uªº¤£±o¦Óª¾ 2.£«¬Â¤j¦í¦b¼Ú¤ñ®J¸ôªº¨âÓªB¤Í¡A¦í¶i¥h3Ó¤ë«á´Nı±oª¬ªp¤£¿ù¡A¤§«á´XÓ¤ë¶V¦í¶VµÎªA¡A¦ý¦í¨ì¤F6Ó¤ë«á¤]¨S¦³Ä±±o¦A§óµÎªA¡A´Nºû«ù³o¼Ë¤£¿ùª¬ºA¡C¦]¦¹n»¡¨ä¥Lªº¤H·h¥h¼Ú¤ñ®J¸ô¡A«e6Ӥ볣¦í±o¤£µÎªA¡A9Ó¤ë©Î1¦~«á¤~ºCºC·PıµÎªA¡A¤£¯à»¡¨S¦³¡A¦ýÀ³¸Ó¤£¬O´¶¹Mªº±¡§Î¡C ¥H¤W³£¬O±À½×¡A¶È¨Ñ°Ñ¦Ò¡C |
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·|û¡G±Û«a10139522 µoªí®É¶¡:2015/6/23 ¤W¤È 10:43:52²Ä 1517 ½g¦^À³
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Faith¤j¦³±z¯u¦n¡A¤µ¤Ñ¥X¥Zªº¤Ñ¤UÂø»x¤À¨É§Ö¼Öªº¯¦³Z¡A¨ä¤¤¤@©Û¬O§V¤OÅý¦Û¤v·P¬V§Ö¼Ö¡C²üÄõ¬ã¨s¤Hû¥ý«eÃÒ¹ê¡A¤HÃþªº®£Äß©M¶û´cµ¥t±±¡ºü·|³z¹L¦½¤ô¤Æ¾Çª«½è®ð¨ý¶Ç»¼¡Cªñ¨Ó¡A³\¦h¼Ú¬w¬ì¾Ç®a¤]»¡¡A§Ö¼Ö¤]¥i¥H³z¹L®ð¨ý¶Ç»¼¡C¦h¸ò¨º¨Çª¾¨¬¥B¿n·¥ªº¤H¬Û³B¡AÂ÷·R©ê«è¡B´dÆ[©MÁ`¬O°Û¤Ï½Õªº¤H»·¤@ÂI¡A¥i¥HÅý§A§ó§Ö¼Ö¡C¦b¦¹ªÑ»ù§C°g»X¹Ð¤§»Ú¡A±z´N¬O¥¿¦Vª¾¨¬¥B¿n·¥ªº¤H¡A¸ò±z¾Ç²ß¡C |
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·|û¡GQQ10140589 µoªí®É¶¡:2015/6/23 ¤W¤È 10:06:13²Ä 1516 ½g¦^À³
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·|û¡GQQ10140589 µoªí®É¶¡:2015/6/23 ¤W¤È 09:59:45²Ä 1515 ½g¦^À³
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¥xÁÞ¤j: ÁÂÁ±z¤À¨Éªº·Qªk, ¹ï©ó§Ú³oºØ¤£¿ÚÃĪ«¾P°â¬Ü¨¤ªº, ¤Ó¬Ã¶Q¤F. ¥HÁp¦X¥ÎÃĪº¤è¦¡§Ö³t¨ú±o¥«³õ, ¦P®É±N¼Äx¤Æ¬°¤Íx. §Ú쥻´N¤@ª½¯Ô¤ßY¤£±ÂÅvªº°Ï°ì, ¾P°â¤è±¥i¯à¸û¬°Á}¨¯. ²¦³º, ¤j®a³£ª¾¹D, °ê»Ú«¬¤jÃļt¨S¦³¨º»ò¦nÀ³¹ïªº. ¥u¬O¥Ø«e¥«±¤W¦³ PD-1, PD-L1ªº¤w®ÖãÃĪ«¶Ü? §Ú¥uª¾¦³¤@Àq§J Keytruda, ¦ý¾AÀ³¯g¨Ã¨S¦³¥½´Á¨ÅÀù. YÁp¦X¶Pº¸»XÀøªk, ¥H¦Ñ¥v¤j´£¨Ñªº Theratope®×¨Ò, ¦³¨S¦³¥i¯à¨ü¨ìÁ{§É×¥¿¯Ç¤J¶Pº¸»XªvÀøªºì¦] ? ½Ð±Ð±z, Y822¶¶§Q¤W¥«¾P°â, ¯à·f°tªºÃĪ«¦³þ´X´Ú ? ³oºØ·f°tªvÀø, »Ýn ¦A«×Á{§É¤è¯à¨Ï¥Î? ÁÙ¬O¥ý·f°t¦P®É¥i°µ¬ã¨s ? ¨Ì¾Ú§Úªº»{ª¾, ¦n¹³¨S³o¤è±ªº°ÝÃD, ¦ý¤£½T©w, ½Ð±z¤@¨Ö«ü¾É. ·PÁ |
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·|û¡GFaith10138335 µoªí®É¶¡:2015/6/23 ¤W¤È 09:18:33²Ä 1514 ½g¦^À³
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Cliff¤j~Æg!!¥ð®§¬O¬°¤F¨«§óªø»·ªº¸ô!¦n¦n¥ð®§¤@µf ¦ý¤]´Á«Ý¯à¾¨§Ö¦A¾\Ū±z´£¨Ñªº¸ê®Æ(ÁöµM«Ü¦h^¤å¤p§Ì³£ª½±µ¥Îgoogle½Ķ,½±oùù°Õ°Õªº,«¢«¢«¢) »P¯E¤Í̤À¨É¤p§Ì³o´X¤Ñ¥ð®§±o¨ìªº¤ß±o «·s¾\Ū¬P¨°¤jªº¸ê®Æ,¬Ý¨ì³o¤@¬q(¨ú¦Ûhttp://obipharma.blogspot.tw/2015/03/2015332.html) "OBI-822»P»â¾ÉÃþ§OÃĪ«¤ñ¸û --Herceptin¡G¨ÅÀù²Ä¤T¤jÃÄHerceptin©ó2014¦~¾P°â66»õ¬ü¤¸¡A¯à¨Ï¥ÎªÌ¶È¥e23%¡A¤ÏÆ[Globo H¥i¥H¨Ï¥Îªº¨ÅÀù¯f¤H¥i¥H¦û60~80%(Á`¸g²z©ó·|³õ»¡¬O60~90%)¡C --PD-1¡G20%¯f¤H¦³ªí²{¡A¥i¥H±µ¨üªvÀø¡C¦Ó¥BOBI-822¤]¥i¥H»PPD-1Áp¦X¨Ï¥Î¡C" ¯E¤ÍÌ,¤p§Ì¬Ý¨ì60-80%«á,¬ðµM¤Ï±À,¤]´N¬O¦³20-40%¥i¯àµL®Ä ¨º»ò PD229-¦w¼¢¾¯²Õ-§ì20%µL®Äªº PD229¤¤,¥ÎÃIJզ©±¼µL®Äªº,¯u¥¿´_µoªº¤H¼ÆÁÙ¯uªº¨Sì¨Ó·Q¹³¤¤¦h§r!!¦óªp¤p§Ì¬O¥ÎLRªº229,«¢«¢«¢ ´N~ÂI¨ì¬°¤îÅo(³oÓºô¶«Ü¦h¤H¦A¬Ý,«O¦u¤@ÂI¦n,«¢«¢«¢~~~) ²{¦b´Nn¬Ý¦³¸gÅ窺¤½¥q,«ç»ò§ì¸Ñª¼®É¶¡¤F,¤£«æ¤£«æ ¦pªG¤p§Ìªº·Qªk¦³»~,Á٬߯E¤ÍÌ«ü¥¿,·PÁ |
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·|û¡G²q·Q10136148 µoªí®É¶¡:2015/6/23 ¤W¤È 08:56:52²Ä 1513 ½g¦^À³
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¦Ñ¥v¤j¤j ±z¦n¥Î¥\ ¦³«ÂI ¤H¤S«È®ð ºÙ©I¤p§Ì«e½ú ¤p§Ì¾á«Ý¤£°_ ¤p§Ì¥i¯àµêªø±z´X·³ µM¦bª¾ÃѪº»â°ì¤W ÁÙ¬O¤@Ó«á½ú ÁÂÁ±z§ä¤F³o»ò¦h¸ê®Æ ´£¨Ñ¤j®a°Ñ¦Ò °Q½× §Ú¦~·³º¥ªø °O©Ê¶V®t °O±oTheratope´¿¦³¤@¬q®É¶¡ ¤j®a°Q½×¹L ¦ý¤w§Ñ¤F¦bþӮɬq þÓª©± Theratope·|¥¢±Ñ ¥i¯à¦pD§b¤j´£¨Ñªº ¡¨¤Q¦~¦^ÅU ¡¨ ¡§ Epidemiologic studies showed that STn expression was highly restricted in normal tissue and was seen in approximately 25% to 30% of breast cancer cases ¡§ ¨ãSTnªº±wªÌ¤ñ¨Ò¥»´N¤£°ª Y¹B®ð¤£¦n ¿ï¶i¹êÅ窺±wªÌ µ´¤j³¡¤À¤S¨S¦³¸Ó§Üì ¦ÛµM¤£·|¦³Àø®Ä ©¯¦n822 ¦³¤T¼Ð¹v ÁÙ¦³¦h¶µ¾÷¨î ¤p§Ì¤ß¤¤©Ò±¾©Àªº ¥u¬O822¤ÞPªº§ÜÅé¶q ¨ì©³°÷¤£°÷? µ²¦X±þ¼Äªº®ÄªG¦n¤£¦n¦Ó¤w? ¦ý822¸ÕÅç ¤½¥q¦³p´ú§ÜÅé¶q ©Î³\¬O´£¨Ñ¥¼¨Ó¸Ñª¼²Îp¤Î¤T´ÁÁ{§É³W¹ºªº°Ñ¦Ò Ó¤H§PÂ_ 822¸ÕÅç¤w¶i¦æ¬Æ¤[ ¤£¦¨¥\ªº¦MÀI´ÁÀ³¤w¹L¥h? ¥u¦b©ó¤¤¦ìPFS¨ì©³·|³B¦b¨ºÓ¦ì¶¥¦Ó¤w? ÁÂÁ±z´£¨Ñ«Ü¦h¦³«ÂI¤S¬Æ¨ã°Ñ¦Òªº¸ê®Æ ¤j®a¤@°_§V¤O ¦ÛµM·|²z¥X¤@ӫس]©Êªºµ²½×¨Ó ·PÁ±z ¤]½Ð¥H«á§O¦AºÙ©I¤p§Ì«e½ú ÁÂÁ±z³á! |
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·|û¡GWalden10140608 µoªí®É¶¡:2015/6/23 ¤W¤È 12:28:43²Ä 1512 ½g¦^À³
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Dear ±ø¤j~ ¤p©_¤j¡Aºa®¦¤j¡Bhonhon¤j~ ÁÙ¦³¨ä¥L°ª¤â¤j¤jÌ §ÚÁÙ¬O¹ï©óK-M pºâM -PFS ®É¡A¹ï©ó³]¸ê®Æ¬O«ç»òÓ³B²zªk¦³¨ÇºÃ°Ý¡A§Æ±æ¦A½T©w¤@¤U(¦]¬°¨º¤ÑKYÁ¿±o¤p§ÌÁÙ¬OÅ¥¤£¤Ó²M·¡) Á|¨Ò¦n¤F~ °²³]¤µ¤Ñ¸Ñª¼¡A¦@ 7 ¦ì¯f±w Case1 : PFS ¼Æ¦C: 1, 2, 3+, 4, 5+, 6+, 7 ½Ð°Ý¦¹®É M-PFS ¬O 7 Ó¤ë¡A ¨S¿ù§a? Case 2: ¤@¼Ë°²³]¤µ¤Ñ¸Ñª¼ PFS ¼Æ¦C : 1, 2, 3 , 4+, 5+, 6+, 7+ ÁÙ¨S¹L¥b¡AM-PFS «ç»ò¿ì? ¥i¥H¥Î 4 Ó¤ëºâ¶Ü? |
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·|û¡G¦Ñ¥v10140531 µoªí®É¶¡:2015/6/22 ¤U¤È 11:44:30²Ä 1511 ½g¦^À³
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²q·Q«e½ú STnÁÞ§ÜìTheratope¤T´Á¥¢±Ñ¡A«Ü¦h±M®a¦³©Ò°Q½×¡A§Úªº«á¨£¤§©ú¬O¤@¶ô¸H¿j¡A§Æ±æ¯à¤Þ¥X¤j¶ôªº¬ü¥É ÂÕ»~¤§³B©|¬è¥]®e 1>Theratope¦³¨âÓ¤G´ÁÁ{§É¡A(¸ÕÅç¤@)¹êÅç²Õ50¤H¡A¤À¬°(A) ¥´Theratope«e¥ýÀR¯ßª`®g§C¾¯¶qcyclophosphamide¥H¤Î(B) ¥´Theratope«e¥ý¤fªAcyclo¿õ©Î¨S¨Ï¥Îcyclo¡A¹ï·Ó²Õ104¤H¬O¥u¦³±µ¨ü¶Ç²Î¤ÆÀøÀR¯ßª`®gcyclo¡A¦Ó¥BÄÝ©ó¦^·¹©Ê¬ã¨s(retrospective control patients¡A®³¥H«eªºÁ{§É¸ê®Æ·í¹ï·Ó²Õ)¡AOS¬O19.1Ó¤ë¡G9.2Ó¤ë¡A¦pªG¶È¨ú¹êÅç²Õªº(A)¡A«hOS¬O26.5Ó¤ë¡G9.2Ó¤ë¡C²³æ»¡¡A¹êÅç²Õ¤ñ¹ï·Ó²ÕÀu¡A¹êÅç²Õ(A)¤S¤ñ¹êÅç²Õ(B)Àu¡AÀR¯ßª`®g¨ë¿Eªº§K¬Ì¤ÏÀ³·|¤ñ¤fªA©úÅã¡C (¸ÕÅç¤G)¨â²Õ³£¦³¥´Theratope¡A¤À¬°(A) ¥´Theratope«e¥ýÀR¯ßª`®g§C¾¯¶qcyclo¥H¤Î(B) ¥´Theratope«e¥ý¤fªAcyclo¿õ©Î¨S¨Ï¥Îcyclo¡AOS¬O19.7Ó¤ë¡G12.6Ó¤ë¡C¦³¥y»á«nªº¸Ü»¡we noted that patients in the intravenously administered cyclo group had a lower percentage of patients showing progressive disease at 9 weeks¡AÀR¯ßª`®g¯f¤H¦b9¶gªº´c¤Æ²v¸û§C¡Alower percentage¨ì©³¦³¦h§C¡H¬O§_¨¬¥H¦³²Îp¤Wªº·N¸q¡H§Ú¨S¬Ý¨ìºë½Tªº¼Æ¦r 2>Theratope¤T´Á±q1998¦~11¤ë¶}©l¦¬®×¡A¦ý¦]¦¬®×³t«×¤ÓºC¡A©Ò¥H×¥¿p¹º®Ñ¡A¤¹³\¥¿±µ¨ü¶Pº¸»XªvÀøªº°ü¤k¯Ç¤JÁ{§É¡A¦ûÁ`¦¬®×¯f±wªº31%¡CAs a result of slow study accrual, a protocol amendment was implemented that allowed the inclusion of women receiving concomitant hormone therapy to treat their MBC¡CFollowing the protocol amendment, 31% of the patients received hormone therapy in addition to the study medication¡CÁ{§Éµ²ªGTTP was 3.4 months in the treatment group and 3.0 months in the control group. The median survival times were 23.1 months and 22.3 months.³£¨S¦³¹F¨ìÅãµÛ®t²§¦Ó§i¥¢±Ñ(±q³oÓ¹êÅç¥i¥Hµy·L´£®¶822ªº«H¤ß¡A¦]¬°¥[¤J31%¶Pº¸»XªvÀøªº¯f±w¡ATTP¤]¤~3Ó¤ë) 3>¶PÀù¥1995¦~¶}©l¤T´ÁÁ{§É¡A¹ï·Ó²Õ¤À¨â²Õ¡A(A)¤p¬õ²ù+cyclo¡AOS=21.4Ó¤ë¡ATTP=6.1Ó¤ë¡AN=138¡A(B)¤Ó¥¬vµµ§ü¾J¡AOS=18.4Ó¤ë¡ATTP=3Ó¤ë¡AN=96¡C¥þÅé¹êÅç²ÕOS¡G¥þÅé¹ï·Ó²ÕOS¬O25.1¡G20.3(P=0.046)¡A¥þÅé¹êÅç²ÕTTP¡G¥þÅé¹ï·Ó²ÕTTP¬O7.4¡G4.6(P<0.001)¡C¶PÀù¥1998¦~9¤ë®Öã¤W¥« 4>Theratope¤T´Á±q1998¦~11¤ë¶}©l¦¬®×¡A¦X²z§PÂ_BiomiraªÖ©w¦³¬Ý¹L¶PÀù¥ªº¤T´Á¼Æ¾Ú¡AÃø¹D¤£Ä±±oTheratope¤G´Á¹ï·Ó²ÕªºOS=9.2&12.6¡A©M¶PÀù¥¹ï·Ó²Õ18.4&21.4¬Û¤ñ¡A§C±o¦³ÂIÁxŸ¤ßÅå¡H¦Ó¤G´Á©Ò¿×lower percentage of patients showing progressive disease at 9 weeks¬O§_¦³²Îp¤Wªº·N¸q¥çÄÝ¥¼ª¾¡C³o¨âÓ°ª«×¤£½T©w©Ê«o¦¨¬°Æ[¹î¤T´ÁÁ{§Éªºend point¡A¦Ó¥BÁÙ×¥¿protocol¦¬®×±ø¥ó´£°ª¤£½T©w©Ê¡C 5>Theratope¤G´Á¹ï·Ó²ÕOS²§±`ªº§C¡A¦]¦Ó¬ðÅã¹êÅç²ÕªºÀu²§¡A·Pı¦³ÂI¹³°ò¨È¤G´Á¡A¨S¥´ÃĪºA²Õ´_µo²v50%²§±`°ª¡A¦]¦Ó¬ðÅãB²Õ´_µo²v37%ªºÀu²§¡A¦ý©¿µø³N«á¤@¦~´_µo²v¬ù¥u30%¡A¬Æ¦Ü©¿µøC²Õ´_µo²v°ª¹F59%ªº¨Æ¹ê¡A©Ò¥H¤~»~¸Ñ°ò¨È¤G´Á¼Æ¾Ú«Ü¦n¡C |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2015/6/22 ¤U¤È 10:44:45²Ä 1510 ½g¦^À³
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¦Ñ¥v¤j ¦U¦ì¤j¤j ÁÂÁ§A´£¨Ñ±ÂÅv«n¸ê°T,°£¤F¸Ñª¼ §Ú·Q¤j®a·|«Üª`·N±ÂÅv³o¤è±¸ê°T ¥t¥~¦³¤@¨Ç·Qªk¤À¨É: 1§ÚÌ´Á±æªºPFS¬O¶V°ª¶V¦n»P¤½¥q´Á¬ßªºPFS ¬O¤£¦Pªº,¯¸¦b¤½¥qªº¥ß³õn¦Ò¼{ªº ¦]¯À´N·|¤ñ¸û¦h¤¸,¦p¤W¥«®Éµ{,¦p¦æ¾P³q¸ô¦X§@µ¦²¤Áp·ù,ÃĪ«Áp¦X¥ÎÃĵ¥, 2¨ÅÀùOBI822¬°¤F´£°ª§K¬Ì¤O¥[¤F¤@Ó¤£°_²´ªº¤ÆÀøÃÄ,¼eÃP¨Ó»¡¨ä¹ê¬O³æÃÄPK 3¨ÅÀùOBI822 ¸Ñª¼«áªºPFSn¦³¨¬¥H§l¤Þ¤j¼tªº¥Ø¥ú,Ó¤H»{¬°¥un¤pŧY¥i,n¯dÂI ¦X§@ªÅ¶¡,¤]¥iºÉ§Ö¶i¤J¥«,³õ§ð«°±°¦a,¦U¦ì¤j¤jµû¦ôªºPFS ¥§¡¼Æ¬ù¦b20¦Ü24¶¡,À³¥i º¡¨¬³o¤@±ø¥ó,PFS 20¦Ü24°t¦X§C°Æ§@¥Î,¶i¥i³æ§L§@¾Ô ,¤]¥i¾÷°ÊÁp¦XPD1 PDL1 ©Î¨ä¥L¦³¼ç¤OªºÃĪ«,¤@Á|¸ó¶VPFS 27¦Ü30 ªº¨î°ªÂI,µ¦²¤Áp·ù,¦³¿ú¤@°_ÁÈ,¿W§]¥«³õ, ¤]¬O¤@ºØ·ÀI (¤£·|Åý¯E¹©³´¤J³æ§L§@¾Ô,¯Ê¥F³q¸ô,µLªkÁp¦X¥ÎÃijгyÀ禬©tªÚ¦Û½àªº§x§½) ( ·Q·Q¶PÀù¥³æÃÄPFS¬ù6¦Ü7Ó¤ë,Áp¦X¦h¤ÖÃĤ~¯àÅý³oÁûÃÄ¿W»â·Ä̤Q´X¦~) , ¤p©_¤j: ¤µ¤Ñ¤¤¤È¶K¤å»¡©ú«D±`¸Ô²Ó,²Ä¤GÂI·Q½Ð±Ð? 1¨º¨Ç¥¼³Q§P©wCR/PDªº«Ý§P¯f±w,¸g¹L¤@¬q®É¶¡¤U¦¸¦Aµû©w®É¦³¾÷·|¸~½F³v¨BÁY¤p ¬Æ¦Ü©óNED©Î«O«ùªø´Áéw ¥t¥~¤@ºØ±¡ªp½Ð±Ð 2¶}¨Ï°Ñ¥[OBI822¹êÅç²Õ¤»Ó¤ë«á³Q§P©wCR/PDªº¯f±w,¤EÓ¤ë«á ©Î¤@¦~«á°lÂܦpªGµo²{¸~½FÁY¤p ,¯à§_¦A«·s§P©w¨S¦³CR/PD ? ¦]°lÂÜ´Á¦³¤G¦~, (¹ï³¡¤À¯f±w¨Ó»¡§K¬ÌÀøªkµo´§ÃĮĻݤ@¬q®É¶¡) |
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·|û¡Ghonhon10140192 µoªí®É¶¡:2015/6/22 ¤U¤È 10:22:24²Ä 1509 ½g¦^À³
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¤p©_¤j °Q½×¤@¤U ¨Ì±z¤W¤@½gªº¼gªk ¸Ñª¼®É¶¡ÂI¦b¬P´Á¤» ¬P´Á¤@(¤µ¤Ñ´c¤Æ), ¬P´Á¤G(·í¤Ñ´c¤Æ), ¬P´Á¤T(µL´c¤Æ) M PFS=5¤Ñ ¸Ñª¼®É¶¡ÂI¦b¬P´Á¤Ñ ¬P´Á¤@(¬P´Á¤»´c¤Æ), ¬P´Á¤G(·í¤Ñ´c¤Æ), ¬P´Á¤T(¬P´Á¤Ñ´c¤Æ) M PFS=4¤Ñ ±ß¤@¤Ñ¸Ñª¼¡AM PFS¤Ï¦ÓÅܤ֤F¡A¦n¹³©Ç©Çªº ¤p§Ì³Ìªñ¦b¬d¦s¬¡¤ÀªRªºK-Mªk ı±o±z¦ü¥G§â³]¸ê®Æ±Æ°£¦b¦s¬¡¤ÀªR¤§¥~¤F ³o¼ËÀ³¸Ó¦³¹HK-M¨ç¼Æªº©w¸q§a K-M¨ç¼Æ´N¬O§Q¥Î¯AÀI²v¨Ópºâ³]¸ê®Æªº³B²z¤èªk¡A¤£¬O¶Ü¡H |
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·|û¡G¦Ñ¥v10140531 µoªí®É¶¡:2015/6/22 ¤U¤È 09:45:52²Ä 1508 ½g¦^À³
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¤é²±±i¸g²z¤µ¤Ñµoªº^¤å³ø§i¡A»P6/4¤¤¤åª©®t¤£¦h ¦ý±ÂÅv¨º¬qªº¤å¦r¤ñ¤¤¤åª©¥Í°Ê¤@¨Ç Several global big pharmaceuticals have paid attention on OBI-822 for years, and we conjecture that potential out-licensing pharmaceuticals including Merck. On 06/03/2015, OBI Pharma indicated if the offering price is quite acceptable, Merck will have a priority to in-license OBI-822 due to its historical relationship with OBI-Pharma. The glaring PD-1 drug-KEYTRUDA® developed by Merck has just been approval, and if OBI-822 wins Merck¡¦s favor,which implies the potential of Carbohydrate Vaccines is still way beyond market¡¦s awareness. |
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·|û¡G¤p©_10138298 µoªí®É¶¡:2015/6/22 ¤U¤È 07:25:40²Ä 1507 ½g¦^À³
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ºa®¦¤j¡A±ø¤j¡A ©êºp¡A¨S¦³®Õ¥¿¼Æ¦r ¦³¤@ӼƦr¥´¿ù¤F ¸Ñª¼®É¶¡ÂI¦b¬P´Á¤» ¬P´Á¤@(¤µ¤Ñ´c¤Æ), ¬P´Á¤G(·í¤Ñ´c¤Æ), ¬P´Á¤T(µL´c¤Æ) M PFS=5¤Ñ PFS§Ç¦C¡G0¡A3+¡A5 (+ªí¥Ü³]) µeK-M¨ç¼Æ¡A0.5ªº¤ô¥½u¬Û¥æ¦b5¡AM PFS=5 ¡yYµL´c¤Æªº¤H¦b¬P´Á¤Ñ´c¤Æ...¨ºM-PFS¸Óºâ¦h¤Ö?¡z ¸Ñª¼®É¶¡ÂI¦b¬P´Á¤Ñ ¬P´Á¤@(¬P´Á¤»´c¤Æ), ¬P´Á¤G(·í¤Ñ´c¤Æ), ¬P´Á¤T(¬P´Á¤Ñ´c¤Æ) PFS§Ç¦C¡G0¡A4¡A5 µeK-M¨ç¼Æ¡A0.5ªº¤ô¥½u¬Û¥æ¦b5¡AM PFS=4 ©ÎªÌ¤w¬O¥þ³¡´c¤Æªº§Ç¦C´N¬Ý¤¤¶¡¨º¤@ӼƾÚ=4 §ï¬°>>>>>>>> ¸Ñª¼®É¶¡ÂI¦b¬P´Á¤» ¬P´Á¤@(¤µ¤Ñ´c¤Æ), ¬P´Á¤G(·í¤Ñ´c¤Æ), ¬P´Á¤T(µL´c¤Æ) M PFS=5¤Ñ PFS§Ç¦C¡G0¡A3+¡A5 (+ªí¥Ü³]) µeK-M¨ç¼Æ¡A0.5ªº¤ô¥½u¬Û¥æ¦b5¡AM PFS=5 ¡yYµL´c¤Æªº¤H¦b¬P´Á¤Ñ´c¤Æ...¨ºM-PFS¸Óºâ¦h¤Ö?¡z ¸Ñª¼®É¶¡ÂI¦b¬P´Á¤Ñ ¬P´Á¤@(¬P´Á¤»´c¤Æ), ¬P´Á¤G(·í¤Ñ´c¤Æ), ¬P´Á¤T(¬P´Á¤Ñ´c¤Æ) PFS§Ç¦C¡G0¡A4¡A5 µeK-M¨ç¼Æ¡A0.5ªº¤ô¥½u¬Û¥æ¦b4¡AM PFS=4 ¡K¡K¡K¡K¦³¿ùªº¼Æ¦r¦b³o¤@¦æ ©ÎªÌ¤w¬O¥þ³¡´c¤Æªº§Ç¦C´N¬Ý¤¤¶¡¨º¤@ӼƾÚ=4 |
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·|û¡G¤p©_10138298 µoªí®É¶¡:2015/6/22 ¤U¤È 12:57:47²Ä 1506 ½g¦^À³
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¬JµM¨«¹L¡A´N¯d¤U²ª¸ñ§a¡I ¦pªG¤j®a¶K§¹³£n¨D§R¤å ¥²´Iºô´N¨SªF¦è¥i¥HŪ¤F ±ß¨Óªº¤H¤]´N¬Ý¤£¨ì¤F ª©¥D¡A³o¬O§Úªº·N¨£¡C ¨ä¹ê§Ú¤]·QÂǦ¹¾÷·|¸ò¤j®a¤½§i¤@¤U¡A½Ð¦U¦ìµo¤å«e¥J²Ó·Q¦n«á¦Aµo¥X¡A ²¦³º§Ú¤£¯à±`±`³o¼ËÀ°¦U¦ì§R¤å¡AÁ`¤£¥i¯à®É¨è¨nµÛ°Q½×°Ï¡A ©Ò¥H³Â·Ð¦U¦ì·|û̺ɶq°t¦X¤@¤U§a¡I·PÁ¤F~BYª©¥D
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·|û¡Gºa®¦10139955 µoªí®É¶¡:2015/6/22 ¤U¤È 12:31:29²Ä 1505 ½g¦^À³
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±ø¤j ¤p©_¤j ÁÂÁ¸ÑÄÀ:) |
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·|û¡G±Û«a10139522 µoªí®É¶¡:2015/6/22 ¤U¤È 12:24:05²Ä 1504 ½g¦^À³
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·PÁ¤p©_¤j¶i¤@¨B¸ÔºÉ»¡©ú¡ACRªºPD§P©w©MLRªº®t¶Z¤´¦s¦³¤£½T©wªºÅܼơA¥u¦³IRC©M¯E¹©¤T¥¨ÀY¤FµM©ó¯Ý¡A©Ò¥H¥Ø«e³Ì¦n©ê«ù¤TºØ¥i¯à©Ê¦b¤ß¤¤¡A«h¤£·|²_¬°¥u¬Ý¨ì¦Û¤v·Q¬Ýªº¦Ó¥¢¥h¥þ¤è¦ì§PÂ_¡C |
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·|û¡GQQ10140589 µoªí®É¶¡:2015/6/22 ¤U¤È 12:19:25²Ä 1503 ½g¦^À³
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¥¤ß¦Ó½×¤j: ¥H§Úªº²L¨£, Æ[¹î¯E¤Í̦bª©¤Wªº¤¬°ÊµL¥~¥G: 1) ´£¨Ñ/¤À¨É 2) ÄÄÄÀ/±Ð¾É 3) ¨D±Ð/¦^À³/·PÁ ¤j®a¦]¬°¤ß©Ê, өʪº¤£¦P, ¹ï©ó¤åªöªº¿ï¥Î, Ãã·Jªºªí¹F,, ÄYÂÔ, «ÕÀq, Á¾¨õ, µR§Q, ¥¹ê¡K. ¤£¤@., µoªíªº¤è¦¡¦h¼Ë¦h«º, ¦p°µ¹Ú, ¤Û¨, ¤Æ¨ ¡K ¦U²§. ¡§Â×´I¡¨¨â¦r¤£¨¬¥H§Î®e. ¶}©ñ¦¡¥¥xªº»ùÈ´N¦b©ó¤H¤H¦³Åv¥H¦U¦¡¦U¼Ëªº«¬ºA¥h°µµ½·Nªºµoªí. Æ[ªÌ, ¶·¦³¯à¤O¦Û¦æ¿z¿ï¹LÂoª©¤W¸ê°T, ¦Û¥D¨M©w§l¯Ç±Æ¥¸, ¦Û¦æt³d. ¹ê¦b¤£»Ýn¦]¤£»{¦P¥L¤Hªºªí¹F¸àÄÀ¤è¦¡¦Ó²£¥Í²ö¦W. §ó¦óªp, «Ü¦hªº¹ï¸Ü¶K¤å¬°ª©¤ÍÌ·í¨ÆªÌ©¼¦¹¶¡·¾³q¤¬²á, ·§»P¥L¤HµL¯A. YÅw³ß, ¥[¤J°Q½×, ´ê¨º¤@¨¤., Y°f²´, ²zÀ³¦Û¦æ¹LÂo¸õ¹L. ±¹ïÀù¯g, À³¸Ó¨S¦³¤H·|¤£Á¾¨õ, ¤£µê¤ß§a ? ¥Í©RªºµL±`ÁÙ¦³§ó¦nªº½ÒÃD»ò ? ¥u¬O, ³oY§è¤Wª©¤W¤j¤jªºªí¹F¤è¦¡, ¬O§_¦³¨Ç²o±j©O ? ±o¸o¤F. |
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·|û¡G¤p©_10138298 µoªí®É¶¡:2015/6/22 ¤U¤È 12:00:13²Ä 1502 ½g¦^À³
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¥xÁÞ¤j¡A±Û«a¤j¡A¯E§b¤j¡A²q·Q¤j Cliff¤j§ä¨ìªº¤å³¹¡]http://dij.sagepub.com/content/47/2/167.full ¡^¡A Introductionªº²Ä¤T¬q A BICR, however, has its own limitations since it is often conducted in a prespecified but retrospective manner in which patients¡¦ radiographs are reviewed after all assessments have been performed. Generally, no further assessments are available after progression has been declared by the LE, and the patients may have already moved on to new therapies (based on the investigator¡¦s decision) before the BICR is conducted. This process may lead to a considerable number of patients declared to have progressive disease by the LE but censored by the BICR. Since these patients will be more likely to have disease progression by the next scheduled visit compared to patients not determined to have disease progression by the LE, their censoring by the BICR may be informative. Informative censoring may result in biased treatment effect estimates, especially if not balanced across treatment arms ¡y¸Ó¦ìLR/PDªº±wªÌ±µ¤U¨Ó¦³¤GºØ¿ï¾Ü¡A¤@¬O¦bPFSªº°lÂÜ´Á¤º(Á|822¬°¨Ò¬O2¦~)Ä~Äò³ø¨ì¡A¦]¦¹±µ¤U¨ÓÁ{§ÉÂå¥Í¤´¥i¦¬¶°¨ì¸Ó±wªÌSCANªº¸ê®Æ¥H°e¨ì¿W¥ß¤¤¤ß¡A¿W¥ß¤¤¤ß¥i¥H¤@ª½¦³¥R¤Àªº¸ê°T¥H§PÂ_¥L¦ó®Éµo¥ÍPD(¥i¯à¬O¸òÁ{§ÉÂå¥Í§PÂ_ªº¦P¤@´Á¡A¤]¥i¯à¦bµu¼Èªº¥¼¨Ó´X´Á´N§PÂ_¬°PD¡A¤]¥i¯à¦b¾÷²v¤ñ¸û§Cªº±¡ªp¤U¤@ª½¨ì¶}ª¼®É³£¦b¿W¥ß¤¤¤ß«O«ù¥¼PD)¡C¥t¤@ºØ¿ï¾Ü¬O¡A¤U¦¸¤£¥h¤F¡A¦b«Ü¦hªºÁ{§É¹êÅ礤¡A±wªÌ¥i¯à¦]¬°¤w¸gPD¦Ó¿ï¾Ü¤U¦¸¤£¥h¤F¡AÁ{§ÉÂå¥Í¤£·|¦A¦¬¶°¨ì¥ô¦ó¸ê®Æ¡A¦ÛµM¦a¿W¥ß¤¤¤ß¤]¤£·|¦A¦¬¨ì¥ô¦ó¸ê®Æ°µ§PŪ¡A¦]¦¹´N¦b·í´Á¬ö¿ý¬°³]¸ê®Æ¡A¦]¦¹¸Ó±wªÌ¤]¤£·|¥X²{¦bNo of Events¡A¨S¦³¥X²{¦bNo of Events¤£ªí¥Ü¥L¤@ª½³£¬O¥¼PD¡C¸Ó±wªÌ¤w¸gÁ{§É§P¬°PD¡A¦]¦¹¸ò¨S¦³²z¥Ñªº¤¤³~Â÷¶}¬O¤£¤@¼Ëªº¡C¡z ¬Y¤@´Á¡A¬Y¨Ç¤ñ¨Òªº³QÁ{§ÉÂå¥Í§PPDªº±wªÌ±µ¤U¨Ó¦³¥H¤U´XºØ¥i¯à¡G ¤@¡A¥H«á¦A¤]¤£¥hÀˬd¤F¡A¥Ã»·¦¨¬°³]¸ê®Æ¡A¬JµM¦¨¬°³]¸ê®Æ¡A·íµM¦A¤]Æ[¹î¤£¨ìÅܦ¨PD¡A©Ò¥H¦A¤]¤£·|¦bNo of Events¤¤¥X²{¡ACliff¤j§ä¨ìªº¤å³¹¤¤ªºÁ{§É¹êÅç¨Ò¤l¡A³\¦hCR»·¤p©óLR¦ýM PFS¨S¦³ÅãµÛÅܤƪº¡A¥H³oÃþ©~¦h¡C ¤G¡A¦]¬°¦bªvÀø´Á¶¡(Á|822¬°¨Ò¬O9Ó¤ë)¡A©ÎªÌ¦bPFSªº°lÂÜ´Á¤º(Á|822¬°¨Ò¬O2¦~)¡AÁöµM³QÁ{§ÉÂå¥Í§PÂ_¬°LR/PD¡A°ò©ó»PÁ{§ÉÂå¥Íªº«H¥ô·P¡AÁöµMÁ{§ÉÂå¥Í¤w§PPD¡A¦ý¨Åé°·±dª¬ªp¨S¦³«æÂઽ¤U¡A¦]¦¹±wªÌ¨M©wÄ~Äò«ö·Ó®É¶¡³ø¨ì°µÀˬd¡A¿W¤O¤¤¤ß¤´·|¦³«áÄòªº¸ê®Æ°µ§PŪ¡A¦ý¤]¥u¬O±ß¤F´X´Á¡AÁÙ¬O§P´c¤Æ¤F¡A§P¤F´c¤Æ¤§«á¡A´N·|¥X²{¦bCR/PDªº°O¿ý¤W¡A¤]´N¬O¥X²{¦bNo of Events¤¤¡A¦pªG¦³¤@¨Ç¨¬°÷ªº³oÃþ±wªÌ¡A³Ì²×ªºM PFS¡ACR·|Àu©óLR¡C ¤T¡A³o¤@Ãþ¬O¤j®a³Ì´Á«Ýµo¥Íªº¡AÁöµMÁ{§ÉÂå¥Í§PLR/PD¡A¦ý±wªÌ´¿¦³¬õ¸~¤ÏÀ³¡A«H¤ß¤Q¨¬¡AµL½×¦p¦ó±µ¤U¨Ó¨C¤@´Á³£ÁÙ¬O¨ÓÀˬd¡A¶W¹L2¦~°lÂÜ´Áªº¤]Ä~Äò¨ìÂå¾Ç¤¤¤ßÀˬd(¦pªG¥i¥Hªº¸Ü)¡A¦]¦¹¿W¤O¤¤¤ß¤´·|¦³«áÄòªº¸ê®Æ°µ§PŪ¡A¥B¦]¬°822¯S®íªº§K¬ÌÀøªk¡A³QÁ{§ÉÂå¥Í§P¤FPD¡A³ºµM¸~½F¤@ª½ºû«ù¤@¼Ë¤j¤p¬Æ¦ÜÁÙÁY¤p¡A¦]¦¹¤@ª½¨ìÆ[¹î¨ìªº®É¶¡(¨Ò¦p2014/12/31©Î2015/5/25©Î¸Ñª¼®É)¡A³£¤´µM¬O¥¼PD¡A©Ò¥H¤]¤@ª½ºû«ùCR»PLRªº®t¶Z¡A¤]¤@ª½¤£·|¥X²{¦bNo of Events¤¤¡C ¥H¤W¯ÂÄݱÀ½×¡A¸ò¹ê»Ú±¡ªp¥¼¥²¬Û¦P¡A¥i®Ú¾Ú¦Û¤vªº§ë¸êÄÝ©Ê¡A¦b¤£¦PºØÃþ°µ¾A·íªº¤ñ¨Ò½Õ°t¡A¥H¨D±o¦Û¤v³ßÅw¥B¦w¤ßªºM PFS¡A¨ÓÅw³ßªï±µ¸Ñª¼¤éªº¨ì¨Ó¡C |
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·|û¡G¤p©_10138298 µoªí®É¶¡:2015/6/22 ¤W¤È 11:01:16²Ä 1501 ½g¦^À³
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ºa®¦¤j¡A±ø¤j ¡y4. ¬P´Á¤@(¤µ¤Ñ´c¤Æ), ¬P´Á¤G(·í¤Ñ´c¤Æ), ¬P´Á¤T(µL´c¤Æ) M PFS=5¤Ñ -->¹ïªº ¦ý³oӱƥX¨Ó§Ú´N¤S¦³ÂIºÃ°Ý..YµL´c¤Æªº¤H¦b¬P´Á¤Ñ´c¤Æ...¨ºM-PFS¸Óºâ¦h¤Ö? --> ¤µ¤ÑºâM PFS=5 ©ú¤Ñ¬P´Á¤Ñºâ¡AM PFSÁÙ¬O¤@¼Ë¡A¦]¬°¤¤¦ì¼Æ¤w¸g¥X²{¡z ¸Ñª¼®É¶¡ÂI¦b¬P´Á¤» ¬P´Á¤@(¤µ¤Ñ´c¤Æ), ¬P´Á¤G(·í¤Ñ´c¤Æ), ¬P´Á¤T(µL´c¤Æ) M PFS=5¤Ñ PFS§Ç¦C¡G0¡A3+¡A5 (+ªí¥Ü³]) µeK-M¨ç¼Æ¡A0.5ªº¤ô¥½u¬Û¥æ¦b5¡AM PFS=5 ¡yYµL´c¤Æªº¤H¦b¬P´Á¤Ñ´c¤Æ...¨ºM-PFS¸Óºâ¦h¤Ö?¡z ¸Ñª¼®É¶¡ÂI¦b¬P´Á¤Ñ ¬P´Á¤@(¬P´Á¤»´c¤Æ), ¬P´Á¤G(·í¤Ñ´c¤Æ), ¬P´Á¤T(¬P´Á¤Ñ´c¤Æ) PFS§Ç¦C¡G0¡A4¡A5 µeK-M¨ç¼Æ¡A0.5ªº¤ô¥½u¬Û¥æ¦b5¡AM PFS=4 ©ÎªÌ¤w¬O¥þ³¡´c¤Æªº§Ç¦C´N¬Ý¤¤¶¡¨º¤@ӼƾÚ=4 ¥H¤W¬OM PFSªºpºâ¡A½Ð°Ñ¦Ò¡C |
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