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°£¾ÏȯÀÚ¿¡°Ô ADI-PEG 20 ´Üµ¶Åõ¿© È¿°ú ¿¬±¸ : Phase III randomized study

 

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ÁøÇàµÈ °£¼¼Æ÷¾Ï(Hepatocellular carcinoma, HCC) ȯÀÚ¿¡°Ô ADI-PEG 20 ´ÜÀÏ¿ä¹ýÀº »ýÁ¸±â°£(Overall Survival, OS) Çâ»ó¿¡ È¿°ú°¡ ÀÖ½À´Ï±î?

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ADI-PEG 20 ´ÜÀÏ¿ä¹ý¿¡¼­ OS Áß¾Ó°ªÀº 7.8°³¿ùÀ̾ú°í ÇÁ¶ó¼¼º¸¸¦ Åõ¿©ÇÑ ±×·ìÀº 7.4°³¿ù·Î ADI-PEG 20 ´ÜÀÏ¿ä¹ýÀÌ OS¿¡ È¿°ú°¡ ÀÖÀ½À» ÀÔÁõÇÏÁö ¸øÇß½À´Ï´Ù.

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Phase III randomized study of second line ADI-PEG 20 plus best supportive care versus placebo plus best supportive care in patients with advanced hepatocellular carcinoma (2018). Ann Oncol. 2018 Jun 1;29(6):1402-1408.

Doi: 10.1093/annonc/mdy101.

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ÁøÇàµÈ °£¼¼Æ÷¾ÏȯÀÚ¿¡°Ô ¸ÅÁÖ ADI-PEG 20(18 mg/m2 versus placebo intramuscular injection weekly) Ä¡·áÈ¿°ú

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Phase III randomized clinical trial study

-NCT 01287585 µî·ÏµÊ : www.clinicaltrials.gov

-Multiinstitutional, randomized, placebo-controlled phase III clinical trial

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18¼¼ ÀÌ»óÀÇ ±¹¼ÒÀûÀ¸·Î ÁøÇàµÈ HCC ȯÀÚ 635¸í

Eligible patients were randomized (2 : 1) to receive either weekly ADI-PEG 20 18 mg/m2 or placebo intramuscularly (i.m.) in a double-blinded fashion, with best supportive care.

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ADI-PEG 20 monotherapy (18 mg/m2), n=424

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placebo intramuscularly (i.m.), n=211

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-ÁÖ¿ä Æò°¡ÁöÇ¥ : »ýÁ¸(Overall Survival, OS)

-2Â÷ Æò°¡ÁöÇ¥ : ¾ÈÀü¼º(safety)°ú ³»¾à¼º(tolerability

NCI CTCAE (Common Terminology Criteria for CTCAE) V.4.02À» ¹ÙÅÁÀ¸·Î, ¹ÝÀÀ·ü, ¹«ÁøÇà»ýÁ¸ (PFS), ¹× ÁøÇà½Ã°£(TtP)

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»ýÁ¸·ü ºñ±³°á°ú : 7.8°³¿ù ADI-PEG 20 ±×·ì vs. 7.4°³¿ù ÇÁ¶ó¼¼º¸ ±×·ì[hazard ratio = 1.022 (95% CI, 0.847–1.233), P= 0.884]. PFS Áß¾Ó°ª : ¾çÂÊ µ¿ÀÏÇÏ°Ô 2.6 °³¿ù[hazard ratio = 1.175 (95% CI, 0.964–1.432), P = 0.075].

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High

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