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ªÅªÅ¤j±z¦n¡A§Ú·Q¦Ñ´­¤jÀ³¸Ó¥u¬O¹ï±zªºµo¨¥®É¶¡­è¦n¦b¶}½L«e¦³¤@ÂIÂIªº¤p·N¨£¦Ó¤w¡A½Ð±z¤£­n¨£©Ç

±zªº¨£¸ÑÆZ¦³·N«äªº¡A¦pªG±z¦³¿³½ì¶i¤@¨Bªº§ó»{ÃѬP¬P¡AÆZ§Æ±æ±z¯à±N±z¬Ý¨ìªº¤@¨ÇºÃ°Ýª½±µ¼g«Hµ¹¥_·¥¬PÃÄ·~

§Ú©Ò¤F¸Ñªº¤½¥q°T®§¦^ÂЫܧ֡AÀ³¸Ó¯àº¡¨¬±zªº¨Dª¾±ý¡A¥B±N±zªººÃ°Ý¸Ñµª

¤µ¤Ñªº¬P¬PÆZ¨ë¿Eªº¡A¤£¤p¤ß¤µ¤Ñ¤U¨®ªº¬P¤Í¯¬ºÖ§A­Ì¤F¡AÁÙ¦b¨®¤Wªº¬P¤Í­Ì¡A®¥³ß¦U¦ì¡AÄCÀY¤S¤Ö¤@ÁûÅo

·PÁ¬P¤Í­Ìªº§V¤O¡AÅý³Ì«á¬P¬P¦b¶g¥½¯d¤U¬õ¬õªº¡A¬õ¬õªº

¶g¥½©ñ°²¤F¡A¥i¥H¨ÓªM58·x·x¤ß¡A²ö§Ñªì°J

Go go Polaris!

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G®È¤H10142235  µoªí®É¶¡:2017/12/1 ¤U¤È 04:20:43²Ä 2137 ½g¦^À³
¶}ª©ªº¥ØªºÀ³¸Ó¬O¼s¯Ç¶®¨¥¡A¦Ó«D±Æ°£²§¤v¡I¦Ñ·¨¤j¬O¾á¤ß¦³¤ß¤H¾Þ§Ë¡AªÅ¤]¤j©ú¥Õ¤H¡A¹ê¦b¤£¥²°h¥X¦¹ª©§a¡I

²z©Êªº°Q½×¡A¬O¦h¼Æ¨Ó³o¸Ì³}ªº¥Í§Þ¤§¤Íªº´Á«Ý§a¡I¦¹¨èªº¥Í§Þ¦p¦¹§N²M¡AÁÙ·|¨Ó³}ªº¡AÀ³¸Óµ½«Ý¡C

¦Ü©óµ¹³½¡A©Î³¨³½¯à¤O¡A¤j®aÀ³¸Ó¦³¯à¤OªÌ¦Û¨ú©Ò»Ý¡AµL¯à¤OªÌ¦p§Ú¡A´N¬O¦h¬Ý¦hÅ¥¡A¦hÆ[¹î¡C

ªÑ¥«¸ÞÃÔ¡A¦ý¦³¯u¤~¹ê®ÆªºªÑ²¼¡A®É¶¡·|²^¿ï¥X¨Ó¡I°O±oªÅ¤]¤j»¡¹L¡A¥¢±Ñªº¸gÅç¡A¥¿¬O§O¤Hªº­ÉÃè¡I²z©Ê«ä¦Ò¤£«ô¯«§a¡I

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GªÅ¤]ªÅªÅ10145331  µoªí®É¶¡:2017/12/1 ¤U¤È 03:27:03²Ä 2136 ½g¦^À³
¦Ñ´­¤j¡A¹ï¤£°_¡A¥ý¦^µªºÃ´bªÌ¤jªº¾¯¶q°ÝÃD¡C

ºÃ´bªÌ¤j¡A·PÁ±zªº´£¿ô¡C°µ¼Æ¾Ú¤ñ¸û®É¡A¤@¦V¦Û§Ú­n¨DºÉ¤O°µ¨ì¡A¾ï¤l¤ñ¾ï¤l¡BÄ«ªG¤ñÄ«ªG¡C

³o¤G­Ó¬Odose escalation trial¡A¦³¯S§Oª`·N¨ì¾¯¶q°ÝÃD¡A©Ò¥H¨Ã¤£¬O®³¥þ³¡ªº¼Æ¾Ú¨Ó¤ñ¡A¦Ó¬OMTD¤ñRP2D¡C

°ß®£¤@®É¤£¬d¡A§Ë¿ù¤F¡C¸g¦A¤@¦¸¬d¬Ý­ì¤å¡A½T»{¤GªÌ¾¯¶q¬O¬Û¦Pªº¡C²¤»¡¦p¤U¡G

Gemcitamine ³£¬O 1000 mg/m2

2011½×¤å¡G±µ¨ünab-paclitaxe 100, 125, or 150 mg/m2 ¨ü¸ÕªÌ¤À§O¬° 20¡B44¡B3¤H¡AÁ`­p67¤H¡C

67¤H¼Æ¾Ú¡GOR = 46%¡AmPFS = 7.1¡AmOS = 10.3

44¤H¼Æ¾Ú(nab-paclitaxe 125)¡GORR = 48%¡AmPFS = 7.9¡AmOS = 12.2

2011½×¤å¡G±µ¨ünab-paclitaxe 125 + ADI 18 mg/m2 weekly©Î36 mg/m2 weekly¤À§O¬°3¡B15¤H¡AÁ`­p18¤H¡C

18¤H¼Æ¾Ú¡G­Ó¤H¥¼§ä¨ì

11¤H¼Æ¾Ú(nab-paclitaxe 125)¡GORR = 45.5%¡AmPFS = 6.1¡AmOS = 11.3

¥H¤W¼Æ¾Ú¡A¦³¿ù»~³B¡A·Ð½ÐºÃ´bªÌ¤j¡A¤£§[¦A¦¸«ü¥¿¡C

¦^¨ì¦Ñ´­¤j¥æ¥Nªº¥\½Ò¡G

1. RECIST 1.0 and RECIST 1.1ªº®t²§©Ê¡C¤GªÌ®t²§­«ÂI²­z¡G

Åܧó¯f¨_´ú¶q¼Æ¥Ø¡A¼W¥[°©¯fÅÜ¡A§óºë½T©w¸q¹q¸£Â_¼h±½´y (CT scan)¡B²O¤Úµ²¡B¯e¯f´c¤Æµû¦ô¤èªkµ¥¡C

New response evaluation criteria in solid tumours: Revised RECIST guideline, p238¦³¤ñ¸ûªí¡A·q½Ðª©¤Í¦Û¦æ°Ñ¾\¡C

ctep.cancer.gov/protocoldevelopment/docs/recist_guideline.pdf

¥t­Ó­«ÂI¬ORECIST 1.0¸ò1.1§PŪªº¬ÛÃö©Ê¦p¦ó¡H1.0§P©wPR¡A1.1¬O¤£¬O¤]§P©wPR¡H

¬ã¨s«ü¥X¤GªÌ¬ÛÃö©Ê°ª¡AÀ˪þ¼Æ½g±´°QRECIST 1.1»P1.0 agreement in response assessmentªº½×¤å¡C

doi:10.2214/AJR.09.3928

doi:10.18632/oncotarget.7322

doi: 10.7150/jca.11794

doi: 10.7150/jca.11316

doi: 10.2214/AJR.14.13236

2. effect size, sample size, power, type 1 error¶¡ªºÃö«Y¡C

effect size, power, type 1 error ³o´X­Ó¦]¯À¦@¦P¨M©wsample size¡C

effect size¤j¡Apower¤p¡Atype 1 error¤j  sample size¤p¡C

phase 3ªºeffect size¡A±`°Ñ¦Òphase 1 or 2ªºµ²ªG¡C

Phase 3ªºpower, type 1 error¡A³q±`¤À§O¬°80 or 90 %¡AÂù§À0.05¡C

phase 2ªºpower, type 1 error¼u©Ê¤j¡A¥i¤À§O¬°60 or 70 %¡A³æ§À0.1 or 0.2¡C

3. gem + nab-pac phase 1/2ªºmaterial and method,

¥Ñ©ó¤£¬Ohead to head¡A¤G²Õ¼Æ¦r¤£¥iÀH«Kª½±µ¤ñ¸û¡A¤w¦b²Ä2150½g¦^Âбj½Õ¡C

¬°¨D¤GªÌ¦b¸ÕÅ羯¶q¤Î¯Ç¤J¸ÕÅç«eªºªvÀø¬Û¦ü¡A¬G¿ïMTD 44¤H»P RP2D 11¤H¬Û¤ñ¡C

¤w©ó«e¤å»¡©ú¸ÕÅ羯¶q¤G­Ó±Ú¸s¬Û¦P¡A±µ¤U¨Ó¬Ý¯Ç¤JªÌ±ø¥ó¬Û¤£¬Û¦ü

2011½×¤åp 4549¡Gno previous treatment¡Badjuvant therapy, tumor recurrence must have occurred > 6 months after the last treatment¡BECOG 0,1

2011½×¤åexpansion cohort¡Gno prior treatment¡B¤ÆÀø¬O»²§U©Êªº¥BÀøµ{µ²§ô¶W¹L6­Ó¤ëªº¥i¥H¯Ç¤J¡BECOG 0,1

¥H¤W¦³¿ù»~¡B¤£§¹µ½³B¡A·Ð½Ð¦Ñ´­¤j¡A¤£§[¦A¦¸«ü¥¿¡C

¹ï¾Þ§Ë¼Æ¾Úªº§âÀ¸²¤ª¾¤@¡B¤G¡A¤]µyÀ´detection bias¡Bselection bias§Î¦¨ªº­ì¦]¡C

¦]¦¹¡A°µ¼Æ¾Ú¤ñ¸û®É¡A·|ºÉ¤O±Æ°£³o¨Ç·~»Ù¡C

­Ó¤H¦b¥²´Iºô¤Wµo¤å¡AµL¥ô¦ó¯S®í¥ß³õ¡A¹ï¥ô¦ó¤½¥q¡B¥ô¦ó²£«~µL¦h¡BªÅ³ß¦n¡C

¥Øªº«Ü³æ¯Â¡G¤À¨É­Ó¤H¸gÅç¡BÂ×´I°Q½×¡C¤£¦Û¶q¤Oªº´Á±æ¬O¡G·M¨£¯à¹ïª©¤Í¦Û¦æ³¨³½ªº¯à¤O¡A¦³¨Ç·Lªº°^Äm¡C

³ß¦n©ïºbªº¥»©Ê¨ÏµM¡A­Ó¤HÂսצh°w¹ï»P¦Û¤v¸gÅç¡B¬Ýªk¤£¦Pªºª©¤å¡C

¦b¥»ª©¦p¦¹¡A¥Lª©¥ç¬O¡C¦Ñ´­¤j¦p¤£³ß³oºØ¥Õ¥Øªº¦æ¬°¡A¥H«á¡A´N¤£¦b¶Qª©ÄmÁà¤F¡C

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G­@¦ÌµX10144792  µoªí®É¶¡:2017/12/1 ¤U¤È 02:55:07²Ä 2135 ½g¦^À³
¤p¶§¤j!

§AÁȧAªº°]¡A§Ú­Ì¦³¦Û¤vªºsense~

¨C­Ó¤H°l¨D°]´I¼Ðªº¤£¦P¡A§Ú­Ó¤Hªº½×½Õ¬O

µ´¤£¶R¹CÀ¸ªÑ¡A¦]¬°¨º¬OÅý¤H¤ß¯BÄꪺ­ì¤¿¡A

¯¬§A²ü¥]º¡º¡¡A¦h°µÂI¦n¨Æ¬O¯uªº¡A¤£­n²_¬°

¡u¥\¼w»¡¡v´N¦n!

Good luck!

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¤£­n¦b°µ¹Ú¤F~´Á«Ý¶V¤j¥¢±æ´N¶V¤j

¬Ý¬Ý¯u¦nª±¦A¬Ý¬ÝµVµV´Nª¾¹D¤F¡C

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·|­û¡GDavid Xu10143450  µoªí®É¶¡:2017/12/1 ¤U¤È 02:01:18²Ä 2133 ½g¦^À³
¬P¤Í¤È¦w

¤]³\¬O¥ýÃÛ«á¸õ§a

´Á«Ý¸ÕÅç¶i«×¤Î¼Æ¾Ú¦³¦n®ø®§

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¤p¬P¬P¤H½t«Ü®t­C!

³s63³£¥i¥H¯}~

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¨SÃö«Y~¨S¤H­nªº«Ä¤l³q±`³£

¥i¥Hªø±o¤S¤j¤S¦n¡A¥[ªo¡G)

Good news in a row!!!

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GºÃ´bªÌ10140504  µoªí®É¶¡:2017/12/1 ¤W¤È 10:39:52²Ä 2131 ½g¦^À³
ªÅ¤]ªÅªÅ¤j´£¨ìªº¼Æ¾Ú

gem + nab-pac, published in 2011

At the MTD, (¬Û·íRP2D)

OR = 48%, mOS = 12.2

¥H¤W¼Æ¾Ú¬O¨Ó¦Û³o¨â¬q¬q¸Ü¡GPatients with previously untreated advanced pancreatic cancer were treated with 100, 125, or 150 mg/m(2) nab-paclitaxel followed by gemcitabine 1,000 mg/m(2) on days 1, 8, and 15 every 28 days. At the MTD, the response rate was 48%, with 12.2 median months of overall survival (OS)

³o­ÓMTDªº¾¯¶q¡]¤ñ¥_·¥¬Pªº¥ÎÃľ¯¶q°ª¡^©M¦¬®×¯f¤Hªºª¬ªp¸ò§Ú­Ìªº¤p¬P¬P³£¤£¦P,¹ê¦bÃø¥H¤ñ¸û

´Á«ÝªÅ¤j¦¬½L«áªº¤À¨É,¥¿¦n¥i¥HÀ°¬P¤Í­Ì¦A½Æ²ß¤@¤U RECIST 1.0©MRECIST 1.1

·P®¦

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­@¦ÌµX¤j¡A­n¦A¤@¦¸³Û­Þ¡C

±z»¡ªº¡u¤pµØµØ¡v¡A¸³¦r½ú¡BÁ`¦r½ú¡Bªø¦r½ú®³¨Ó»~¾É§½¥~¤Hªº¸Ü³N¤]¨S¤Ö¹L¡C

­Ó¤H¤]´¿«ü¥X¨ä½Ķªº¸Û«H°ÝÃD¡C

¹êµL¹ï­þ¤@­Ó¤½¥q¡B­þ¤@­Ó²£«~¦³¯S§Oªº°¾¦n©Î°¾´c¡C

¦]½t¨ã©M¡A­è¦n¬Ý¨ìı±o¥i¥H¤À¨É­Ó¤H¸gÅ窺®×¨Ò¡A´N¦h¼L¤G¥y¡C

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¦Ñ·¨¤j¦­!

¤pªºµo²{¡AªÅ¤j¦n¹³¥u¹ï¥L¿WÄÁªº¡u¤pµØµØ¡v¦n~

¥»¨Ó¤pªº¤]¦³¤pµØ¡A¤£¹L¥þ³¡Åܤp¬P¬P¤F~

Go go Polaris!!!

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¦Ñ´­¤j¡A¤£»Ý¤õ®ð¨º»ò¤j§a¡A¹ê¤£ª¾±z¹ï©óµo¤åªº®É¶¡³o»ò¦b·N¡A·|§ï¶i¡C

¤£¹L¡A­n¬°¦Û¤v³Û­Þ¤@¤U¡C

­Ó¤H¦­°_¡A¤@¤é¤§­p¦b©ó±á¡A¬ÝµÛ¡B·QµÛ´Nµo¤å¤F¡A¦b¥»ª©¦p¦¹¡A¦b¥Lª©¥ç¬O¡C

±z¥æ¥Nªº¥\½Ò¡A´N½L«á¦^¤F¡C

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·|­û¡G¦³FUªº¤H10136189  µoªí®É¶¡:2017/12/1 ¤W¤È 08:17:37²Ä 2127 ½g¦^À³
Opps~~
¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡G¦Ñ´­10141055  µoªí®É¶¡:2017/12/1 ¤W¤È 07:54:23²Ä 2126 ½g¦^À³
ªÅ¤jÁ`¬O¦b¶}½L«e¤À¨É¤@¨Ç¤ù­±ªºªF¦è,°Ê¾÷¤£³æ¯Â!!!¦pªG§A¯u¬O¬°¬P¤Í¬°¥Í§Þ½Ð§A°±¤î³oºØ¶}½L«eªº´c¦H¦æ¬°!

µ¹§A¨â­Ó¥\½Ò

1. ½Ð¸Ô­zRECIST 1.0(gem+nab-pac phase 1/2) and RECIST 1.1ªº®t²§©Ê(adi+gem+nab-pac RP2D)

2. ½Ð¸Ô­zeffect size, sample size, power, type 1 error¤§¶¡ªºÃö«Y

¥t¥~

½Ð±z§âgem+nab-pac phase 1/2³o½gªº¨C¤@­Ó²Ó¸`¦p¦Ñ´­¤À¨Éªº¤è¦¡¤À¨É¥X¨Ó,¥]¬Amaterial and method, 3­Ódose§A¬°¤°»ò¥u¬D¦nªº»¡?untreated or prior chemotherapy?........

§Æ±æ¯Âºé¬O¦]¬°§Aªº¥Õ¥Ø,¥H«á¦pªG¦A¦b¶}½L«e´£¨Ñ¤ù­±ªº¸ê®Æ,¥ø¹Ï»~¾É§ë¸ê¤j²³,´N·|«Ê±þ§A¦b¦¹ª©ªºPO¤åÅv§Q,½Ð¦Û­«!

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
·|­û¡GªÅ¤]ªÅªÅ10145331  µoªí®É¶¡:2017/12/1 ¤W¤È 07:06:43²Ä 2125 ½g¦^À³
¦Ñ´­¤j¡A·PÁ±zªº¨¯³Ò¡C

gem + nab-pacªºORR¥u¦³23%¡A³o¬O861¦W¨ü¸ÕªÌªºµ²ªG¡C·í¨ü¸ÕªÌÅܦh¡AÀø®ÄÁY¤pªº²{¶H¡AÆZ±`¨£¡C

¥H¤U¡Agem + nab-pac¹ïpancreatic cancerªvÀøªº effect size¡A¨Ó¦Û¥t¤@½g¨ü¸ÕªÌ¸û¤Ö(67¤H)ªº¸ÕÅç¡C

Gemcitabine Plus nab-Paclitaxel Is an Active Regimen in Patients With Advanced Pancreatic Cancer: A Phase I/II Trial

J Clin Oncol 29:4548-4554. DOI: 10.1200/JCO.2011.36.5742

¥Ñ©ó¤£¬Ohead to head¡A¤G²Õ¼Æ¦r¤£¥iª½±µ¤ñ¸û¡A¶È¨Ñ°Ñ¦Ò¡C

gem + nab-pac, published in 2011

At the MTD, (¬Û·íRP2D)

OR = 48%, mOS = 12.2

adi + gem + nab-pac, published in 2017

At RP2D

ORR=45.5%, mOS 11.3

¦^ÂÐ¥»¤å ¦^¤W¥«Âd°Q½×°Ï1­¶
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­@¦Ì¤j,§A¬O¦b·d¯º¶Ü¡H

·|­û¡G¦Ñ´­10141055 µoªí®É¶¡:2017/8/28 ¤U¤È 11:19:22²Ä 385 ½g¦^À³----À³¸Ó¬O¦b¥Ø«eªº²Ä9­¶

¦A¬Ý¤@¤U·íªìªº¤º®e§a,·Å¬Gª¾·s,°£¤F³Ì·sªº,¥_·¥¬Pªº¸ê°T¦Ñ´­¤w¸g¤À¨É§¹¤F!

¤µ¤Ñªº·s»D½Z¤£ºâ­«°T¡A¦ý¬O«o«Ü­«­n¡I¦]¬°¤S¦A¤@¦¸¦aÃÒ¹ê¤F¤½¥qªº¸Û«H¹s¯Ê¥¢¡A©M¶i«×«D¦ýµL¸¨«á¡A

ÁÙ¶W«e¤F¡I------³o¦b²{¦bªº¥xÆW¥Í§Þ¤½¥q¬O¤£¥i¯àªº¥ô°È§r¡I³£¨S¤°»ò¿úªº¤½¥q¡A³ºµM¤@ª½¥æ¥X¦p¦¹

Àu²§ªº¦¨ÁZ³æ¡H¯u¬O....¤Ó¤£¥i«äij¤F¡I

¦Ñ´­ªº¤Q½b¤¤¨Ã¨S¦³¯ØŦÀù¡A¬O¦]¬°¤j¨Æ¥ó¨ÓÁ{®É¡A¯ØÀùÀ³¸ÓÁÙ¨S§¹¦¨¡A¨ä¹ê¤W§«ô¦Ñ´­´N¬Ý¨ì³o½g¤å

³¹µoªí¤F¡A¬O2017/08/18µoªíªº¡ACancer¬OÂå¬ÉªvÀøÀù¯g¬ÛÃö¬ì¨tªºÂå®v¥²Åªªº´Á¥Z¡A08/20¦Ñ´­´N°á

§¹¤F¡A¥u¬O©MASCO®Éªº¸ê®Æ®t¤£¦h¡B¤½¥q¤]¨Sµo·s»D½Z¡A©Ò¥H¤]¨S¦b·N¡A¨S·Q¨ì¤½¥qÁÙ¯u¬O§C½Õ¡A¹j¤F

¤Q¤Ñ¤~Á¿¥X¨Ó¡I¥»¨ÓÁÙ¦b©_©ÇWhy¤µ¤Ñªº½LÁÙ®¼±jªº¡A­ì¨Ó¬O³o½gªºÃö«Y¡A¨ºÁÙ¯u·|¤@ª½±j¨ì¦~©³¡A¦]¬°

³oºØµ¥¯Åªº¹êÅç¼Æ¾Ú©M½×¤å¹ï¥_·¥¬P¨Ó»¡----¤T­Ó¦r----¦hµÛ©O¡I

2017ªº«á¥b¦~¯u¬O¦³½ìªº¥b¦~¡I¦]¬°¦n®ø®§À³¸Ó·|±µ¿æ¦Ó¨Ó¡AÅý¤H®Ú¥»´NÀ³±µ¤£·v¡I

ÁÙ¬O¨Ó¬Ý¬Ý­ì¤å§a

A phase 1/1B trial of ADI?PEG 20 plus nab?paclitaxel and gemcitabine in patients with

advanced pancreatic adenocarcinoma

DOI: 10.1002/cncr.30897, Received: February 23, 2017;

Revised: June 6, 2017; Accepted: June 12, 2017--------¬Ý¬Ý§r¡I¤@¦¸´N­×§ï¨ì©w¦ìªº¡A¥s°µ

¤j®v¡I²Ä¤@§@ªÌ©M³d¥ô§@ªÌ³£¬O±¾³o¦ìMaeve A. Lowery, MD, Gastrointestinal Oncology Service--

À³¸Ó¤ñ¸¯©|Ghassan K. Abou-Alfa, MD¹à¤@ÂI

Memorial Sloan Kettering Cancer Center----------¥xÆW¦h¤Ö¥Í§Þ¤½¥q·Q¦b³o¸Ì¶i¦æÁ{§É¹êÅç¦Ó¤£

¥i±o¡A¹ï¥_·¥¬P«o¬O®a±`«K¶º¤@¼Ë¡IÃø©ÇASCO, ESMO, AACR¥_·¥¬P³sÁ¿³£Ãi±oÁ¿¡I

Published online: Aug 18, 2017-----10¤Ñµoªíªº¡A²{¦b¤~Á¿¡I¦³°÷§C½Õªº¤½¥q¡A´«°µ¬O§O®a¡A

Accepted: June 12, 2017----³o¤Ñ´Nµo·s»D¡A·d¤£¦nÁÙ¶}°OªÌ·|¡Aµo§G­«°T«¨¡I

¯f¤H=18¦ìmetastatic pancreatic cancer, ECOG 0,1

´¿¸g±µ¨ü¹L1¦¸¨ä¥LªvÀøªº(dose-escalation cohort);

no prior treatment (expansion cohort)---¦ý¬O¦pªG·íªìªº¤ÆÀø¬O»²§U©Êªº¥BÀøµ{µ²§ô¶W¹L6­Ó¤ëªº¥i¥H¯Ç¤J

¨C¥|¶g¤@­ÓÀøµ{

gemcitabine (1000 mg/m2); nab-paclitaxel (125 mg/m2)--¨C¶g1¦¸¡A¨C¥|¶g¦@3¦¸

IM ADI-PEG 20 18 mg/m2 weekly (cohort 1, n=3)

IM ADI-PEG 20 36 mg/m2 weekly (cohort 2, n=6; expansion cohort, n=9)

primary endpoint= ¨M©wMTD(maximum tolerated dose) and RP2D (recommended phase 2 dose)

¬ã¨s´Á¶¡=November 2014~and September 2015

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Phase III IMpower150 study showed Roche¡¦s TECENTRIQ and Avastin plus chemotherapy significantly reduced the risk of disease worsening or death in the initial treatment of people with a type of advanced lung cancer

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- TECENTRIQ and Avastin + carboplatin and paclitaxel (Arm B)

- Avastin + carboplatin and paclitaxel (Arm C, control arm)

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This analysis of the IMpower150 PFS endpoint was only statistically powered to demonstrate a comparison between Arm B versus Arm C.

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Roche«áÄòTecentriq+car+pac Phase 3 NSCLCªºClinical trial NCT01633970µL¯e¦Ó²×¡H¦bFDAªºClinical trialºô¯¸¤W¤w¬d¤£¨ì³o­Ó¹êÅç¡H¦]¬°±qIMpower 150´N¥i¥Hª¾¹DT+ car+pacªº®ÄªG¦p¦ó!!!

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consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.

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¡´¥_·¥¬P¤@©w·|ªíºt¡A¦Ü¤Ö¤@¦¸¡A¥xÆW¿³ÂdªÑº¦°±ªO(50%)ªº©_Æ[¡I²{¦b·|¦³¤H»¡³o¬O¦Ñ´­»¡ªº¤j¯º¸Ü¡Aµ¥µÛ¬Ý§a¡I³o¤@¥y·|Åܯ«¸Ü¥Ã««¤d¥jªº¡I

¦pªG¦³¤H¦]¬°¶}½L«eªº¤@¨Ç­t­±¨¥½×´N·|½æªÑªº¸Ü¡A§A­Ì¯uªº¤£¾A¦X§ë¸ê¥Í§ÞªÑ¡I¤£¹L¡A´N¦Ñ´­Æ[¹î©M·PÀ³¤j²³ªº¤ß²zºÏ³õ¡A³o¼Ëªº¶ÌB­ÌÀ³¸Ó³£½æªº®t¤£¦h¤F¡I

¡´³Ì«á¡A¶}©l¨Ó­Ë¼Æ²Ä¤@¼C¡÷ADI+Pem+Cis, NSCLCªºORR¼Æ¾Ú§a¡I

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ÁpÃĪº±ø¥ó¬OA+B>B,¦r­±¤Wªº·N«ä¬O»¡A¥²»Ý¦³¥¿­±ªºÀø®Ä¡A¤£¯à¬O½Þ¶¤¤Í¡A¤]´N¬O»¡¤£¯à¬O-A+BªÅ¤j¸ò¤Ñ¨Ï¤j´£¨Ñªº¸ê®Æ¨Ó¬Ýªº¸Ü¡A¤TºØÃĪº³æÃÄ°ò¥»Àø®Ä²Ê¦ô¬O ADI=CR 9.5% cytarabine=CR 35% FOLFOX=8%

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ADI + cytarabine = 50% (¤ñA+B¦A§ó¦h¤@ÂIÂI)

A + B = 9.5 + 35 = 44.5%

ADI + FOLFOX = 22% (¤ñA+B¦A§ó¦h¤@ÂIÂI)

A + B = 9.5 + 8 = 17.5%

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