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¤Ñ©R¤j «e½g¤À¨ÉMPFS¹êÅç²Õ(ASLAN001+CAP.)5~5.6¤ë VS.¹ï·Ó²Õ(CAP.) 1.8~2.6¤ë, P < 0.05 ½Ð°Ý¹êÅç²ÕmPFS¬O¦p¦ó¦ôºâ¥X¨Óªº¡HÁÂÁ¸Ѵb¡C
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ORR ¹êÅç²Õ(ASLAN001+CAP.)15~17% VS.¹ï·Ó²Õ(CAP.)1.2~4.0% , P < 0.05
MPFS¹êÅç²Õ(ASLAN001+CAP.)5~5.6¤ë VS.¹ï·Ó²Õ(CAP.) 1.8~2.6¤ë, P < 0.05
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ORR ¹êÅç²Õ(ASLAN001+CAP.)20~21%(±µªñARQ 087 ORR21%)(% VS.¹ï·Ó²Õ(CAP.)1.2~4.0%
MPFS¹êÅç²Õ(ASLAN001+CAP.)6¤ë(±µªñARQ087 MPFS6Ó¤ë) VS.¹ï·Ó²Õ(CAP.) 1.8¤ë,
aslanpharma.com/app/uploads/2018/06/2018-ASCO-ASLAN001-009.pdf
Exploratory objectives: • Part 1 1. To explore the role of HER family status as a predictor of benefit to varlitinib 2. To explore possible relationships between HER family and downstream signaling protein and phospho-protein expression levels and clinical outcomes 3. To explore possible relationships between gene mutational status and clinical outcomes
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¦]À³¹ïµ¦: • ¤w°w¹ïÂà¥X±ÂÅv¤§À禬³Ð³y«Ø¥ß°lÂܾ÷¨î: ¥»¤½¥q¤w±Nvarlitinib ©óÁú°ê¦a°Ï¤§ÃĪ«°Ó«~¤ÆÅv§Q±Â Åv»P²{¥NÃļt¡AASLAN002 ¥þ²y¤§ÃĪ«°Ó«~¤ÆÅv§Q±ÂÅv»PBMS¡A³Ð³y¦´Á¶¥¬q¤§À禬¡A°§C· ÀI¡C¥»¤½¥q¨Ã«ùÄò©ó¨ä¥L°Ï°ì´M§ä±ÂÅv¹Ù¦ñ¡A¥]¬A¤é¥»¤Î¼Ú¬w¤§±ÂÅv¡C • ·~¬ÉÂ×´Iªº¸gÅç»P©¹¨ÓÃö«Y: ¥»¤½¥q¸gÀç¹Î¶¤¦b·~¬É¨ã³Æ²`«p¨}¦nªº¤H¯ßÃö«Y¡A±`»P¥þ²y¥Dn¤j ¼tªºÃöÁä¨Mµ¦ªÌ¥æ¬y; ¥»¤½¥q¨Æ·~¶}µo³¡ªù¥H©¹¤]¦³²³¦h¦¨¥\®×¨Ò¡AÂ×´Iªº¸gÅçÀ³¯à½T«O¶¶§Q§¹ ¦¨ÃĪ«Âà¥X±ÂÅv¡C
(5) ¬Y¨Ç¾AÀ³¯g¦p¨ÅÀùªºÁ{§É¸ÕÅç¯Ó®É¥B©ù¶Q¡AYµL¦X§@¹Ù¦ñ¡A¨È·à±d©Î»Ý·s¸êª÷Ѻª`¤~¯à¦Û¦æ§¹¦¨ varlitinib ©Ò¦³ªº¸ÕÅç
¦]À³¹ïµ¦: • ¥»¤½¥q¹wp±Nvarlitinib Âà¥X±ÂÅv¡A¥Ñ¦X§@¹Ù¦ñ¥þÅv¶i¦æ¨ÅÀùÁ{§É¸ÕÅç¡A¥»¤½¥q¤w¹w¯d¥R¨¬¸êª÷ °õ¦æ¥Ø«e¶i¦æ¤¤ªº¸ÕÅç¡A¸ÕÅçµ²ªG¦³§U©ó½T«O¥¼¨Ó¤§¹ï¥~±ÂÅv¡C • ¥»¤½¥q²{ª÷³¡¦ì¥R¨¬¡A¯à°÷¤äÀ³©Ò¦³¨M©w¶i¦æ¤§Á{§É¸ÕÅç¡C¥»¤½¥q·|¹ï¦UºØ¾AÀ³¯g±Æ©w¶}µo¤§ Àu¥ý¶¶§Ç¡AY¸êª÷¤£¨¬«h¤£·|±Ò°ÊÁ{§É¸ÕÅç¡C |
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ascopubs.org/doi/abs/10.1200/JCO.2018.36.4_suppl.429# ¼vÅT¤G½uÀø®Äªº¬ÛÃö¦]¯À
www.croh-online.com/article/S1040-8428(13)00113-3/pdf
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1.±aNON-HER ORR ¨ÑÄm30%x7.6%=2.28%(Âù¤ÆÀø)
2.HER ORR ¨ÑÄm 20%-2.28%=17.72%(Âù¤ÆÀø¡ÏASLAN 001) (1)¨Ì¾ÚARQ 087 , ASLAN001 ¦Ü¤Ö¨ÑÄm21%x70%=14.7% (2)Âù¤ÆÀøÃĪ«¨ÑÄmORR 17.72-16%=1.72%¡X¡X(A)
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µ²½× :¹ï·Ó²Õ4%¥H¤º,PȬҥi<5%.
¡X¡X¡X¡X¡X¡X¡X
°²³]¥»Á{§É±wªÌ¦³HER®a±Ú¨ü¾¹ªÌ¦û70%,¡AµLHER(NON-HER)±wªÌ30%
¨Ì¾Ú ARQ087 1bÀø®Ä ORR21% ¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X¡X- 1. Y¹ï·Ó²Õ¬°³æ¤ÆÀøÃĪ«ORR 1.2%
NON-HER: ³æ¤ÆÀøÃĪ«¨ÑÄm ORR 30%x1.2%=0.36% HER: ASLAN001 ¨ÑÄmORR 70%x21%=14.7% ¡Ï³æ¤ÆÀøÃĪ«¨ÑÄm ORR 1.2%/7.6%x1.72%(A)=0.27%
¦Xp ¹w¦ô¹êÅç²ÕORR = 14.7%¡Ï0.36%¡Ï0.27%=15.33%
ORR 15.33% VS 1.2%
9.2/60 VS 0.72/60
X^2 =6.148, P =1.3%
2.Y¹ï·Ó²Õ¬°³æ¤ÆÀøÃĪ«ORR 2.4%
NON-HER ORR ³æ¤ÆÀøÃĪ«¨ÑÄm 30%x2.4%=0.72% HER ASLAN001 70%x21%=14.7% ¡Ï³æ¤ÆÀøÃĪ«2.4%/7.6%x1.72%=0.54%
¦Xp ¹w¦ô¹êÅç²ÕORR = 14.7%¡Ï0.72%¡Ï0.54%=15.96%
ORR 15.96% VS 2.4%
9.58/60 VS 1.44/60
X^2 =5.092, P =2.4%
3. Y¹ï·Ó²Õ¬°³æ¤ÆÀøÃĪ«ORR 3.6%
NON-HER ORR ³æ¤ÆÀøÃĪ«¨ÑÄm 30%x3.6%=1.08% HER ASLAN001 70%x21%=14.7% ¡Ï³æ¤ÆÀøÃĪ«3.6%/7.6%x1.72%=0.81%
¦Xp ¹w¦ô¹êÅç²ÕORR = 14.7%¡Ï1.08%¡Ï0.81%=16.59%
ORR 16.59% VS 3.6%
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X^2 =4.234 P =4.0%
4. Y¹ï·Ó²Õ¬°³æ¤ÆÀøÃĪ«ORR 4.0%
NON-HER ORR ³æ¤ÆÀøÃĪ«¨ÑÄmORR 30%x4.0%=1.2% HER ASLAN001 ORR 70%x21%=14.7% ¡Ï³æ¤ÆÀøÃĪ«ORR 4.%/7.6%x1.72%=0.91%
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ORR 16.81% VS 4.0%
10.01/60 VS 2.4/60
X^2 =3.927 P =4.8%
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¤@¡BPhase 1/2 Study of ARQ 087 in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations clinicaltrials.gov/ct2/show/NCT01752920?term=arqule Study Type : Interventional (Clinical Trial) Actual Enrollment : 109 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase 1/2 Study of ARQ 087 in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations, Including Intrahepatic Cholangiocarcinoma With FGFR2 Gene Fusion Study Start Date : December 2012 Estimated Primary Completion Date : June 2018 Estimated Study Completion Date : December 2018
Experimental: ARQ 087 Subjects will receive ARQ 087 orally at dose levels specified for their respective dose cohorts on a 28-day schedule. Subjects will receive treatment with ARQ 087 until progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria is documented.
ARQ 087 ¤G缐Áx¹DÀùICCA 1/2´ÁÁ{§É, ¨S¥Î¤ÆÀøÃĪ«. ¥u¥ÎARQ087 ¹êÅç²Õ³æÃÄ. ORR ¹F21%(3/29) MPFS ªñ6Ó¤ë(2017 ASCO)
¤G¡BARQ 087 in Subjects With FGFR2 Gene Fusion Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
clinicaltrials.gov/ct2/show/NCT03230318?term=087-301&rank=1
Study Design Go to sections Study Type : Interventional (Clinical Trial) Estimated Enrollment : 100 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Pivotal Trial of ARQ 087 in Subjects With FGFR2 Gene Fusion Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma Actual Study Start Date : November 10, 2017
Estimated Primary Completion Date : September 2020 Estimated Study Completion Date : March 2021
Drug: ARQ 087 ARQ 087 will be orally administered at 300 mg once per day one hour prior to or two hours after a meal and is supplied as 100 mg capsules.
³Ìªñªº¤G´ÁÁx¹DÀù¤G½u¡A¤]¬OµL¥Î¥ô¦ó¤ÆÀøÃĪ«.
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¦¹¦¸±z´£¨Ñªº¬O¤¤¦ì¼ÆN=22¦ì¡A¦@761¦ì±wªÌªº¸ê®Æ. ¦@25¶µ(14¶µII´ÁÁ{§É¸ÕÅç¡A9¶µ¦^ÅU©Ê¤ÀªR©M2¨Ò¯f¨Ò³ø§i) ,¨t²Î©Êªº¦^ÅU¤Î2´ÁÁ{§É³ø§i ¥§¡¤ÏÀ³PR 7.7¢H¡]95¢HCI 4.6-10.9¡^.
¬Ý¨Ó¤W¦¸ORR=1.2%(3/255) ³æÃÄ¡ÏORR7.6%(5/66) Âù¤ÆÀøªvÀøªº¬ã¨s¤£¦b¦¹¦¸ªº²Îp½d³ò!
Efficacy of fluoropyrimidine-based chemotherapy in patients with advanced biliary tract cancer after failure of gemcitabine plus cisplatin: retrospective analysis of 321 patients
www.ncbi.nlm.nih.gov/pmc/articles/PMC5344285/
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ÀH¾÷NCRN III´ÁABC-02¸ÕÅ笰±ß´ÁÁx¹DÀù¡]ABC¡^¤¤¶¶¹`©M¦N¦è¥LÀØÁp¦XªvÀøªº¤@½u¤ÆÀø´£¨Ñ¤FA¯ÅÃÒ¾Ú¡C¥»¨t²Î¤åÄmºîz¦®¦bµû¦ôABC±wªÌ¦bÁ`¥Í¦s¡]OS¡^¡A¤ÏÀ³¡A¬r©Ê©M¥Í¬¡½è¶q¤è±¨Ï¥Î¤G½u¤ÆÀøªºÃÒ¾Ú¤ô¥¡C¨Ï¥ÎMedline¡AASCO¡AESMO©MWorld Gastrointestinal Congress¼Æ¾Ú®w½T©w²Å¦X±ø¥óªº¬ã¨s¡C·j¯Á³Ì«á§ó·s©ó2013¦~12¤ë15¤é¡C²Å¦X±ø¥óªº¬ã¨s³ø§i¤F±µ¨ü¤G½u¥þ¨¤ÆÀøªºABC±wªÌªº¥Í¦s²v©M/©Î¤ÏÀ³¼Æ¾Ú¡C¸Ó¨t²Îµû»ù¤w¦bPROSPERO¼Æ¾Ú®w¡]½s¸¹CRD42013004205¡^¤¤µù¥U¡C¦bMedline¡]n = 342¡^¡AASCO¡]n = 160¡^¡AESMO¡]n = 27¡^©M¥@¬ÉG¸z¤j·|¡]n = 29¡^ªº·j¯Á¤¤½T©w¤F555¶µ¬ã¨s¡C¤G¤Q¤¶µ¬ã¨s²Å¦X±ø¥ó¡G14¶µII´ÁÁ{§É¸ÕÅç¡A9¶µ¦^ÅU©Ê¤ÀªR©M2¨Ò¯f¨Ò³ø§i¡CÁ`¦@³ø§i¤F¨Ó¦Û761¦W±wªÌªº¼Æ¾Ú¡A¨C¶µ¬ã¨s¤¤¥]¬Aªº±wªÌªº¤¤¦ì¼Æ¬°22¡]½d³ò9-96¡^¡C¥§¡OS¬°7.2Ó¤ë[95¢H¥i«H°Ï¶¡¡]CI¡^6.2-8.2] [²Ä¤G¶¥¬q¡G6.6¡]95¢HCI 5.1-8.1¡^;¦^ÅU©Ê¤ÀªR¡G7.7¡]95¢HCI 6.5-8.9¡^]¡C¥§¡µL¶i®i¥Í¦s´Á¡]PFS¡^¡A¤ÏÀ³²v¡]RR¡^©M¯e¯f±±¨î²v¬°3.2Ó¤ë¡]95¢HCI 2.7-3.7¡^¡A7.7¢H¡]95¢HCI 4.6-10.9¡^©M49.5¢H¡]95¢HCI 41.4-¤À§O¬°57.7¡^¡C¹ï©ó©Ò¦³¬ã¨s¡]r = 0.54; P = 0.01¡^©MOS»PPFS¡]r = 0.61; P = 0.04¡^©MOS©MRR¡]r = 0.62; P = 0.03¡^ªºII´Á¡AOS©MPFS¤§¶¡ªº³Ì¨Î¬ÛÃö©Ê¬ã¨s¤À§O¡C¤wª¾Áx¹DÀù¬O¤Æ¾Ç¤ÏÀ³©Ê¯e¯f¡C¨S¦³¨¬°÷ªºÃÒ¾Ú¡]C¯Å¡^±ÀÂËABCªº¤G½u¤ÆÀø¤è®×¡A¾¨ºÞ²{¦³¼Æ¾Úªí©ú¤@²Õ±wªÌ¥i¯à·|¨ü¯q¡C»Ýn¶i¤@¨Bªº«e¤©Ê©MÀH¾÷¬ã¨s¨ÓÄÄ©ú¤G½u¤ÆÀø¦b³oºØ±¡ªp¤Uªº¬Û¹ï»ùÈ¡C The randomized NCRN phase III ABC-02 trial provided level-A evidence for first-line chemotherapy with cisplatin and gemcitabine combination in advanced biliary cancer (ABC). This systematic literature review aims to evaluate the level of evidence for the use of second-line chemotherapy for patients with ABC in terms of overall survival (OS), response, toxicity and quality of life. Eligible studies were identified using Medline, ASCO, ESMO and the World Gastrointestinal Congress databases. Searches were last updated on 15 December 2013. Eligible studies reported survival and/or response data for patients with ABC receiving second-line systemic chemotherapy. This systematic review was registered in the PROSPERO database (No. CRD42013004205). Five hundred and fifty-eight studies were identified from the searches in Medline (n = 342), ASCO (n = 160), ESMO (n = 27) and World Gastrointestinal Congress (n = 29). Twenty-five studies were eligible: 14 phase II clinical trials, 9 retrospective analyses and 2 case reports. In total, data from 761 patients were reported with median number of patients included in each study of 22 (range 9-96). The mean OS was 7.2 months [95% confidence interval (CI) 6.2-8.2] [phase II: 6.6 (95% CI 5.1-8.1); retrospective analysis: 7.7 (95% CI 6.5-8.9)]. The mean progression-free survival (PFS), response rate (RR) and disease control rate were 3.2 months (95% CI 2.7-3.7), 7.7% (95% CI 4.6-10.9) and 49.5% (95% CI 41.4-57.7), respectively. The best correlations were between OS and PFS for all studies (r = 0.54; P = 0.01) and between OS and PFS (r = 0.61; P = 0.04) and OS and RR (r = 0.62; P = 0.03) for phase II studies, respectively. Biliary tract cancer is known to be a chemo-responsive disease. There is insufficient evidence (level C) to recommend a second-line chemotherapy schedule in ABC, although the available data suggest that a cohort of patients may benefit. Further prospective and randomized studies are needed to clarify the relative value of second-line chemotherapy in this setting.
PMID 24769639 [Indexed for MEDLINE]
www.ncbi.nlm.nih.gov/m/pubmed/24769639/ |
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