amakuru

Mu bushakashatsi bwa oncology, ingamba zifatika zifatika, nko kubaho nta terambere (PFS) no kubaho nta ndwara (DFS), ziragenda zisimbuza imigenzo gakondo yo kubaho muri rusange (OS) kandi zabaye ishingiro ry’ibanze ryo kwemeza ibiyobyabwenge byemejwe n’ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge (FDA) n’ikigo cy’ubuvuzi cy’Uburayi (EMA). Izi ngamba zitezimbere imikorere yubuvuzi no kugabanya ibiciro muguhuza ibintu byinshi (urugero, gukura kw'ibibyimba, indwara nshya, urupfu, nibindi) muburyo bumwe, ariko nanone bitera ibibazo.

Impinduka kumpera yikigereranyo cya antitumor

Mu myaka ya za 70, FDA yakoresheje igipimo cyo gusubiza (ORR) mugihe yemeje imiti ya kanseri. Mu myaka ya za 1980, ni bwo Komite Ngishwanama ku biyobyabwenge bya Oncology (ODAC) na FDA bamenye ko iterambere mu mibereho, ubuzima bwiza, imikorere y'umubiri, n'ibimenyetso bifitanye isano n'ibibyimba bitajyanye na ORR. Mubigeragezo byubuvuzi bwa oncology, OS ninziza nziza yubuvuzi bwo gupima inyungu zamavuriro. Nubwo bimeze bityo ariko, ORR ikomeje kuba iyindi miti ivura iyo itekereje kwemeza byihuse imiti ya kanseri. Mu igeragezwa ry'ukuboko kumwe ku barwayi bafite ibibyimba bitavunika, ORR nayo ifatwa nk'impera y'ibanze ya clinique.

Hagati ya 1990 na 1999, 30 ku ijana by'ibizamini bya kanseri byemewe na FDA byakoresheje OS nk'ibanze rya mbere ry’amavuriro. Mugihe ubuvuzi bugamije bwagiye buhinduka, ingingo zambere zamavuriro zikoreshwa mugusuzuma imiti irwanya kanseri nayo yarahindutse. Hagati ya 2006 na 2011, iyo mibare yagabanutse kugera kuri 14.5 ku ijana. Nkuko umubare wibigeragezo byamavuriro hamwe na OS nkuko iherezo ryibanze ryagabanutse, ikoreshwa ryanyuma nka PFS na DFS ryabaye kenshi. Inkunga nigihe ntarengwa bitera iyi ntera, kuko OS isaba ibigeragezo birebire hamwe nabarwayi benshi kuruta PFS na DFS. Hagati ya 2010 na 2020, 42% by'ibigeragezo byateganijwe (RCTS) muri oncology bifite PFS nkibibanza byabo byambere. 67% by'imiti igabanya ubukana yemejwe na FDA hagati ya 2008 na 2012 yari ishingiye ku zindi ngingo, 31% muri zo zari zishingiye kuri PFS cyangwa DFS. FDA ubu izi ibyiza byubuvuzi bya DFS na PFS kandi ibemerera gukoreshwa nkibisobanuro byambere mubigeragezo bashaka ibyemezo byemewe. FDA yatangaje kandi ko PFS n’ibindi bisobanuro bishobora gukoreshwa mu kwihutisha kwemeza imiti y’indwara zikomeye cyangwa zangiza ubuzima.

Iherezo ntirizagenda rihinduka nkuko imiti mishya yatejwe imbere, ariko kandi nuburyo bwo gupima amashusho na laboratoire butera imbere. Ibi bigaragazwa no gusimbuza ibipimo by’umuryango w’abibumbye ryita ku buzima (OMS) n’ibipimo bya RECIST yo gusuzuma isuzuma ry’ingirakamaro mu bibyimba bikomeye (RECIST). Mugihe abaganga biga byinshi kubyerekeye ibibyimba, abarwayi bamaze gufatwa nkaho bahagaze barashobora gusanga bafite micrometastase mugihe kizaza. Mu bihe biri imbere, ingingo zimwe zishobora kutagikoreshwa, kandi ingingo nshya zishobora kuvuka kugirango byihute kwemeza ibiyobyabwenge. Kwiyongera kwa immunotherapy, kurugero, kwatumye hashyirwaho umurongo ngenderwaho mushya wo gusuzuma nka irRECIST na iRECIST.

Guteranya ingingo yanyuma

Isozero ryibanze rikoreshwa cyane mubushakashatsi bwubuvuzi, cyane cyane kuri oncologiya na cardiologiya. Ihuriro ryibanze ritezimbere imbaraga zibarurishamibare mukongera umubare wibyabaye, kugabanya ingano yicyitegererezo isabwa, igihe cyo gukurikirana, ninkunga.
Ikoreshwa cyane ryibintu byanyuma mubitekerezo byumutima ni ibintu bikomeye byumutima nimiyoboro y'amaraso (MACE). Muri oncology, PFS na DFS zikoreshwa kenshi nka proksi zo kubaho muri rusange (OS). PFS isobanurwa nkigihe cyo gutoranya kugera ku ndwara cyangwa urupfu. Iterambere ryibibyimba rikomeye risobanurwa ukurikije amabwiriza ya RECIST 1.1, harimo no kuba hari ibisebe bishya no kwaguka kw'ibikomere. Kurokoka ibyabaye (EFS), DFS, hamwe no kubaho bidasubirwaho kubaho (RFS) nabyo nibisanzwe bihuriza hamwe. EFS ikoreshwa mubigeragezo byo kuvura neoadjuvant, naho DFS ikoreshwa mubushakashatsi bwamavuriro yubuvuzi bujyanye.

Ingaruka zitandukanye mubuvuzi butandukanye kumpera yanyuma

Gutanga raporo y'ibisubizo gusa bishobora kuganisha no gutekereza ko ingaruka zo kuvura zikoreshwa kuri buri kintu cyabaye, ntabwo byanze bikunze ari ukuri. Icyifuzo cyingenzi mugukoresha amaherezo yibintu ni uko ubuvuzi buzahindura ibice muburyo busa. Nyamara, ingaruka zo kuvura antitumor ku bihinduka nko gukura kw'ibibyimba by'ibanze, metastasis, ndetse no gupfa rimwe na rimwe bigenda mu buryo bunyuranye. Kurugero, imiti ifite ubumara bukabije irashobora kugabanya ikibyimba ikwirakwizwa ariko ikongera impfu. Uku niko byagenze mu igeragezwa rya BELLINI ry’abarwayi barwaye myeloma yongeye kwisubiraho / yangiritse, aho PFS yateye imbere ariko OS yari hasi kubera umubare munini w’ubuvuzi bujyanye no kwandura.

Byongeye kandi, hari amakuru yibanze yerekana ko gukoresha chimiotherapie kugirango ugabanye ikibyimba cyibanze byihutisha gukwirakwira mu bihe bimwe na bimwe kuko chimiotherapie ihitamo ingirabuzimafatizo zishobora gutera metastasis. Icyerekezo hypothesis ntabwo ishobora gufata mugihe hari umubare munini wibyabaye muburyo bwanyuma, nkuko bimeze kubisobanuro bimwe na bimwe bya PFS, EFS, na DFS. Kurugero, allogeneic hematopoietic stem selile transplantation therapy akenshi ikoresha amaherezo yibintu birimo urupfu, kanseri yongeye kubaho, hamwe nindwara ziterwa na host (GVHD), izwi nka GVHD yubusa RFS (GRFS). Ubuvuzi bugabanya kwandura GVHD bushobora kongera umuvuduko wa kanseri, kandi nibindi. Muri iki gihe, ibipimo bya GVHD nibisubiramo bigomba gusesengurwa ukundi kugirango bipime neza igipimo cy’inyungu-zivurwa.

Raporo yerekana ibipimo bitandukanye byabaye kubisubizo bigoye byemeza ko ingaruka zo kuvura kuri buri kintu ziri mu cyerekezo kimwe; "Iterambere ryujuje ubuziranenge" (ni ukuvuga itandukaniro mu cyerekezo) riganisha ku gukoresha nabi impera zanyuma.

EMA irasaba "gusesengura kugiti cyubwoko bwibyabaye ukoresheje imbonerahamwe yerekana incamake kandi, aho bibaye ngombwa, isesengura ry’ingaruka zo guhatanira kumenya ingaruka z’ubuvuzi kuri buri gikorwa". Ariko, kubera imbaraga z’ibarurishamibare zidahagije z’ubushakashatsi bwinshi, itandukaniro rikomeye mubyabaye mubisubizo byahurijwe hamwe ntirishobora kuboneka.

Kubura gukorera mu mucyo gutanga raporo yibyabaye

Mu bigeragezo byumutima, biramenyerewe gutanga impanuka yibintu byose (nka stroke, infocarite myocardial, ibitaro, nurupfu) hamwe na MACE iherezo. Ariko, kuri PFS nibindi bisobanuro byanyuma mubigeragezo byubuvuzi bwa oncology, iki gipimo ntikurikizwa. Isesengura ry’ubushakashatsi 10 buherutse gusohoka mu binyamakuru bitanu byambere bya oncology byakoresheje PFS nk'iherezo ryerekanye ko batatu (6%) bonyine ari bo bavuze ko bapfuye ndetse n’ibyabaye mu iterambere; Ubushakashatsi bumwe gusa bwatandukanije iterambere ryaho na metastasis ya kure. Byongeye kandi, ubushakashatsi bumwe bwatandukanije iterambere ryaho n’akarere ka kure, ariko ntabwo bwatanze umubare w’abantu bapfa mbere yuko indwara ikomeza.

Impamvu zinyuranye mugutanga ibipimo ngenderwaho kubisobanuro byanyuma muri kardiologiya na oncology ntibisobanutse. Ikintu kimwe gishoboka nuko amaherezo yibintu nka PFS na DFS aribipimo byerekana imikorere. MACE yakomotse ku musaruro w’umutekano kandi yakoreshejwe bwa mbere mu kwiga ingorane ziterwa na coronary intervention. Inzego zishinzwe kugenzura zifite amahame yo hejuru yo gutanga ibisubizo by’umutekano, bityo rero hakenewe inyandiko zirambuye zerekana ibintu bibi mu bigeragezo by’amavuriro. Iyo MACE yakoreshejwe cyane nkumusozo wibikorwa, birashobora kuba akamenyero ko gutanga ingano ya buri gikorwa. Indi mpamvu yerekana amahame atandukanye yo gutanga raporo nuko PFS ifatwa nkikusanyirizo ryibintu bisa, mugihe MACE ifatwa nkikusanyirizo ryibintu bitandukanye (urugero, inkorora na infirasiyo ya myocardial). Ariko, ikibyimba cyibanze gikura hamwe na metastase ya kure biratandukanye cyane cyane mubijyanye ningaruka zamavuriro. Ibi bisobanuro byose birakekwa, ariko biragaragara ko ntanumwe murimwe wasobanura raporo ituzuye. Kubigeragezo bya oncologiya bikoresha impera yanyuma, cyane cyane iyo ihuriro ryanyuma ariryo ryambere ryambere cyangwa rikoreshwa muburyo bwo kugenzura, kandi mugihe iherezo ryibintu bihari nkicyiciro cya kabiri, raporo yibikorwa yibikorwa bigomba kuba ihame.