中国ALK阳性NSCLC患者生活质量现状及专家洞见白皮书

中国临床肿瘤学会(CSCO)肿瘤支持与康复治疗专家委员会2025年7月 ⢁㸐 䑘⢁ 䍦㑇᷉䐱㩞⫔䁈䐸㒗ⳡ䐯䐱㾥᷊㶖ㅽ㉝᷉⟗⤛䄞㋧⫔䁈⭻䄜⶞㭕䄞䊛᷊⿧䁳᷉䐱㩞⫔䁈䐸㒗ⳡ䐯䐱㾥 ᷊㝬⽋㘛᷉䎄ㅎ⫔䁈䄞䁈䊛⶞㭕㩼䄾ⴓ䄞䊛᷊ ⢁㸐 ᷉➕㾶㬰㝦㿓᷍㝦㘜⤜⳷㻩⽔᷊ 塳䙜᷉⿋䐱㋧ゝ⫔䁈㵍イ䄞䁈䊛⶞㭕㵍イ䄞䊛᷊⺚㡅㩎᷉㩞Ⰼ㬂䐸㒗䄞䊛᷊⼯䐟䇣᷉ⶄㅉ㬂䐸㒗䄞䊛᷊㒖䈋㲳᷉䐱⺛䄞䁈㋧䁈䊛䐸㒗䄞䊛᷊㔿㯹㻝᷉⼴㚰㬂䐸㒗䄞䊛᷊㕎㧒᷉㑪㛟㬂䐸㒗䄞䊛᷊㝬䊟䅙᷉䐱⺛㋧ゝゝ㭖⫔䁈⶞㭕⭻䄜䄞䊛᷊㯯㻝᷉㩞㹘㬂䐸㒗䄞䊛᷊㰐㒛⿋᷉㚰⥞⫔䁈⭻䄜⶞㭕䄞䊛᷊㶕㆙㑝᷉䐱⺛㦬㘒ㆃ⳦㉝䓽䄞䊛᷊㾅㌝᷉䐱㚰⫔䁈㼇䁦ⱟ䄞䊛᷊䄇㸥㿄᷉㯥⪉㬂䐸㒗䄞䊛᷊䇻㡑㲯᷉⺄㹘䄞㋧⫔䁈⶞㭕䐸㒗䄞䊛᷊䍦⽍㗘᷉㋶㉝㉝䄞⫔䁈㹘㈊䄞䊛᷊䍵㉝᷉⡒㈊⫔䁈䐸㒗䄞䊛᷊䍵䁿㤐᷉⼴㚰㬂䐸㒗䄞䊛᷊ 㚠㔝 Contents 1.㚠⢋㦬㦛⭥䁂䋒.......................................................................................................222.⮘⥊㸫㉎...................................................................................................................243.㵔ェⳞⳉ...................................................................................................................254.㭞㈾㬶ゐ䈌䐫㑠㋹䐧...............................................................................................25 ᷉ⱟ᷊㬽ⳤ䎀⭥〚⡟㾦㻃⼮䎐㑧㈎㏛...............................................................................261.㬽ⳤ䎀⭥〚⡟㦬㋻䁈㾦㻃.......................................................................................262.䄞㪛㼁⹹䎐㑧㈎䂊...................................................................................................283.⿝䎀㼁⹹䐯㑧㈎㏛...................................................................................................294.䄞㪛⼮⿝䎀䁂䋒ALK-TKI⭥㋝㑠䅓㯹.................................................................30 ᷉㧞᷊䐱⺛䄞㪛⼮ALK䂕㾵NSCLC⿝䎀ⰵ䇻HRQoLゑ㡅PROM⭥㦰䐋⼮㲍Ⱙ..321.䄞⿝ⰵHRQoL⭥㦰䐋⼮㲍Ⱙ................................................................................322.䄞⿝ⰵHRQoL PROM⭥㦰䐋⼮㲍Ⱙ....................................................................343.䄞⿝㦰㸋䇇ⶤ⥃㑠HRQoL⭥ㅸⰯ........................................................................364.䄞⿝ⰵ➊㵕⭥㲍Ⱙ...................................................................................................375.䄞⿝ⰵ⹨䓋䄧⭥㲍Ⱙ...............................................................................................41 ᷉㯥᷊HRQoLゑPROMs䊻䐱⺛ALK䂕㾵NSCLC㒍䈓⭥䇇䇤㻷䓕ゑ䄞⿝ⰵ㡅⭥㠻⫞431.㑺⪓㬖ペ䐱⭥HRQoL⹖㵉㤊㌗ᷛ䄞㪛㬖ペ䈌⿝䎀㠻⫞....................................432.㑺⪓㬖ペ䐱䅓HRQoLⱒ⿐⮘䎜䐯㑧㉗⥀⭥㤊㌗................................................443.HRQoL PROMs⭥㬚䇤㤊㌗...................................................................................44 4.䄞⿝ⰵHRQoLゑPROM䇇䇤⭥㠻⫞...................................................................475.⿝䎀〒㦂HRQoL㼁⹹䐋㬗⭥⧄ボ㤟⭡................................................................49 ᷉㹆᷊䄞⿝㬴ㅨ㻣᷍HRQoL PROMs䊻䐱⺛ALK䂕㾵NSCLC㒍䈓䇇䇤⭥䇑㼍䅓㯹501.䄞㪛㋋㬝㬚䇤HRQoL PROMs⭥䔉➎䅓㯹..........................................................502.䄞⿝䁂䋒HRQoL PROMs㬒ⷘ㋝㔨䅓㯹⭥䐹䄋⧭Ⱙ..........................................51㯥᱃㲷㔼䈌䍚㶜ᷛⰵ䇻䐱⺛HRQoL⭥Ⱅ⥍⼮㸕㎕䍚㶜.......................................................55 ᷉䄜᷊䄞⿝ⰵHRQoLゑ㡅PROMs㦰䐋䈌䇇䇤㤊㌗⭥Ⱅ⥍..........................................551.䊻ⰵHRQoLゑPROMs㦰䐋㩰᷍䄞⿝㯌Ⳟ㉚䇱⫞㳂ⷀ᷍⿝䎀ⷝ⹹䓃HRQoLⶥ㩧᷍ⱙ䄞㪛ⰵ㠡⹡⹅㉀⭥㑬ㆃ䋓䇦䇻⿝䎀.................................................................552.䊻⹹ポ䐃䓕ⰵHRQoL⭥䇑㼍㩰᷍䄞㪛㈼ㅚ⳯➊㼁⹹䐃䓕᷍⿝䎀ⷝ⹹䓃㲼㵕ゑ㪒㈎㻖㵔㼁⹹䐃䓕᷍䐃䓕⹽㏎䐈⧷⫞ゴ㣠.................................................................563.HRQoL PROMs䊻䐱⺛⭥䇇䇤㩱⪇䊻䋈㠻ㅸⰯ᷍䇇䇤㬽㻿䅓㯹ⱁ䂚᷍䄞⿝㠶⢊㠻⫞㳂㪞㬫䇤㾵᱃ㆃⰢ⢄㏜㾵䈌ゴ㣠㞁䁖.................................................................56 ᷉ⱟ᷊㸕㎕ALK䂕㾵NSCLC⿝䎀HRQoL⹽㏎⭥㣒䊻ⶥ㆙Ⳟ㼓................................571.䄞Ⳟᷛ䋗ゴ㼁⹹㞁䁖᱃䇦⿐㳏㾕㒘⧭...................................................................582.⿝ⳞᷛⱁㅸⰯ㣠⿐⿝䎀㦰䐋᱃㳂㪞㞅⼰Ⱙ...........................................................583.䄞㑧㳆㻖ᷛ㈼ㅚⱁ㸍䅓㯹᷍㵧ⰐPRO䈌㑺⪓㬖ペ㪏Ⱙ㦻⼰.............................594.㵧㆙HRQoL䈌䄞⿝⹹䓃䐃䓕⭥䇦⿐⹽㏎............................................................63 ⤯㋝㸥㻸.......................................................................................................................................69 ⭻䄜䍣 䍋䄋 䄜᱃䍋䄋 ⳯➊㬨䄜⷗㦌㤓㾵⭥ㅂ㋖㸫㳃᷍㡅䐱⳨㾂㻙⟜⳯➊᷉NSCLC᷊䍝⳯➊⿝䎀⭥80%-85%᱄ALK䂕㾵⳨㾂㻙⟜⳯➊᷉NSCLC᷊㬨NSCLC⭥䐹䄋䁨㾮᷍䊻䐱⺛⳯➊⿝䎀䐱䊝䍝3-7%᱄ⶤ㏁⿝䎀ⳃ⤂㛋㒅㤂᷍㹝䁭㬘ㅰ㩺᱃䄵㻺➊㸋䑘᷍㣳㚵䓋䄧ⳃ㪛㔫ⷀ᷍ⷙ⿝䎀⫙㎕⳨⧄⫔⭥㑺⪓⶛⭄⼮㪛』䐫㑠䇑㼍᱄ALK-㎳➒㰂ゅ㗙䄷䐧ア᷉ALK-TKIs᷊⭥⨗㻷᷍㋋㡕㑬ALK䂕㾵NSCLC㈌䓝䐯㑧⭥㾣㬒⫛᷍れ⫔ⶥ㩧㑬⿝䎀⭥䊅⽔᱄ 㰇䓦ALK-TKI䐯㑧㑧㾈⭥⤜ⰰ㳂㪞᷍ALK䂕㾵NSCLC⿝䎀⭥㪛⫇㠻㻵䑙䁴⧅᷍⤠⳷⿝䎀䓽㪛⫇㠻᷉OS᷊㋪⫐5–7㛋᷍ん⤂䑑⤞㆙㧌“㕞⤂⿐”⹽㏎ㅸⰯ᱄䊻䎃䄜⡔㈑㻣᷍㧈⼯䊻䁴⧅㪛⫇⭥㵍㬒㳂㪞⿝䎀⭥ㅂ㋖㼁⹹㪛』䐫㑠᷉HRQoL᷊᷍䄲⧪㸋䄵⿝䎀㸋䐱㾥⭥㑺⪓⹽㏎⭥䐹䄋㚠⢋᱄ HRQoL䔘㸋⽃㑠⿝䎀㪎㾥ㅂ㋖䈌㪈。⹇㚽䓕㲍⭥⼬㾥䐙⢋᷍䎞㦶䅇㬽⭞⺛カ䐙㚰䈌㑺⪓㬖ペ⭥⺄ⳛ⹹䓃᱄HRQoL⭥⺇ⳗ⿐㠡⹡䇱㎖䇻㋧䁈᱃㋪㋠⭥⥃㑠⹅㉀᷍䔏⧄ボ⭥㸋⿝䎀⡉⷇ㆂ㈷㑠⢎᷉PROM᷊᱄㦜ⱙ᷍䐱⺛㻷䇱⭥㸥㻸䑘䄋ゐ䐱䇻䊻㋧䁱〓㑺⪓㬵䂊⡔㈑㻣䇇䇤PROM㠡⹡➊䐃⿝䎀⭥HRQoL᷍ⱙ䎌ⰵ⳯➊⿝䎀᷍䇩㡅㬨ALK䂕㾵NSCLC⿝䎀䊻㦶⧄㑺⪓㬖ペ䐱⭥PROM䇇䇤㻷䓕᷍㩱㦒ⳇ㻖㵔㾵⮘⥊䈌䐅㈾〞㎼᷍䖞㿉㳏⤚䎃䄜㒍䈓⭥䐅㈾㋶➸᱄ 㪏㧌㲞㈠䄞⿝㯌ⳞⰵHRQoLゑPROMs⭥㦰䐋⥏䅍䈌㲍Ⱙ㤄㼓᷍⤜㆗㚽⹜⟐䑛㑺⪓䄞㪛ⷝ㦌㘇⭹㏎ㆃ⿝䎀ⰵ㪛』䐫㑠ⷘ㸍Ⱙ᷉㧈㤜㳆⹇㚽᱃㾥㏎䓕㲍⼮㪈。ㅨ㩌᷊⭥⥏䅍⿐䐹㬴⧭Ⱙ᷍䄵ゑ⤜㵍䐃䓕ⰵ⿝䎀㪛』䐫㑠⭥㲹Ⰹ䇑㼍᷍⿚㚽㸋㸡㪛䎟⥀䐧Ⰹ䎀㳂⹊〚䇻⡟㵢䄞㑧㸥⿐㲹䎘⭥䁎䐅㉗⥀䄡㈾᱄㦜ⱙ᷍㚠㣑㩱㦒ⳇⰵ䐱⺛䄞㪛⼮ALK䂕㾵NSCLC⿝䎀ⰵHRQoLゑ㡅PROM㦰䐋䈌㲍Ⱙ⭥㻖㵔㲞㰘䈌㘉㭗᱄ ⪬㶃᷍HRQoLゑ㡅PROMs䊻㑺⪓㬖ペ䐱㘇㑺䑏ⱁ㳕䍞᷍㏞㧈⿝䎀⼮䄞㪛ⰵPROM㦰䐋Ⱙ⤜䔄᱃㑠⢎㳏㾕⶛⭄ㅰ⫔᱃䇇䇤㞁䁖㦒ⳇ᱃㭞㈾㬶ゐ⼮ㆃⰢ㒘⧭㰊㠍⿐⭩㸫㳃᱄㪏㧌㑬ㆃ䊻䄞⿝ヅ䇑㼍PROMs䇇䇤⭥䇑㼍䅓㯹䄵ゑ䄞⿝ⰵ䇻HRQoLゑPROMs⭥㠻⫞᷍䇱䑛䇻⪺㆙㸕㎕HRQoL䊻㑺⪓㬖ペ䐱⭥⺇ⳗ⿐⹽㏎᷍⭌䎌ⰵALK䂕㾵NSCLC㒍䈓᷍㩱㦒ⳇ䁱㈠㲞㲷HRQoL PROMs䇇䇤⭥䇑㼍䅓㯹⼮䄞⿝ⰵ㡅⭥㠻⫞᱄ 䊻⪬⡔㈑㻣᷍⡟㼏㚠㘇㼓䐱⺛䄞㪛ゑ䄜㼀㬚䇤ALK-TKI䐯㑧⭥ALK䂕㾵NSCLC⿝䎀᷍㋋䍚㑬㦌⺛㾵⭥㸫㉎⮘⥊᷍ⰵHRQoLゑ㡅PROMs䊻䎇㬖㬡ㆈ䐱⭥㦰䐋㯏㠞䈌㲍Ⱙ᱃䇇䇤㬖ペ䈌⹹ポ䇑㼍䅓㯹㆙㾱㑬㻖㵔㠡⹡᱄ ⡟⪯⮘⥊⤪䇤ㆂ⹚⿐㸫㉎䎌ⰵ䄞㪛⼮⿝䎀㋋䍚⳨ⶪ䊅㾵⽂ⰰ㘇⮘⥊᷍㵉⺞㼀㩰Ⳟ㬞᷍⳷⢑䍱㚝ⴜ⼰㚪㧌/㝦⨞⢋䓝⭥䄞㪛⼮⿝䎀ⷘ200㘜᱄ⰵ䇻䄞㪛㦛㳆᷍⡟㼏㚠ㅌ㚪㧌䐱⺛㧞゗⼮ⱟ゗䄞䊛㉀䇱ALK䂕㾵NSCLC䎐㑧㈎䂊⭥䐸㒗㚻㋧᱃⽕㹝㚻㋧᱃㾹㶃㋧〓⳦㑧㋧䄞㪛᷍䐑⧧㸋䑘䐯䄞㬇ゑ䄵㩰᱄ⰵ䇻⿝䎀㦛㳆᷍⡟㼏㚠ㅌ㚪㧌䄜㼀䐯㑧㬒ㅴ㬽⺞ALK-TKI⭥㈷⤠㶎㠻〓䓋䄧㾵ALK䂕㾵NSCLC᷉IIIA-IV㠻᷊⧪㛋⿝䎀᱄ 䓵2024㛋10䊣㸫㉎䎞㬞ⳃ⳦䄵㎕᷍ㅹ䐢2024㛋11䊣᷍⪴ⴜ⼰㚪㧌/㝦⨞⢋䓝⭥327㘜䄞㪛⼮466㘜⿝䎀䐱⳷⢑㬶ゐ㑬200⳾䇱㾈㸫㉎᷉ゕ㸿⹹ポ㦒㬈㼏⭥㶋䎜㸫㉎᷊㚪㧌䔏䐶⳷㹗᱄ 䊻㬽ⳤ䎀⭥〚⡟㾦㻃⼮䎐㑧㈎㏛Ⳟ㘇᷍㶋⧪㸫㉎⭥200㘜䄞㪛䐱᷍61.5%㸋㚱㾵᷍䐱㸜㛋㒅㸋45㰋᷍80.5%⭥䄞㪛䐑