Mishonga mitsva iri kubuda panguva yakakurumidza kune varwere vane kenza yeropa , kana hematologic malignancies, yakadai seyeukemia , lymphoma, uye multiple myeloma .
Ikoko pasi apa kurapwa mberi kunogona kuonekwa sematanho mashomanana, panzvimbo pekukurumidza kusvetuka mberi; zvisinei, kurapwa uku kunogona kupa hupenyu hunobatsira hunogona kuva hwechinangwa kune avo vanobatwa.
Mune zvimwe zviitiko, kubuda kwemishonga kunogona kutowedzera moto wetariro unopisa-kuti kurapwa kwakadai sepasina marrow transplant zvingaguma zvichitsvakwa-asi zvisati zvaitika, izvi zvingangodaro zvisati zvava kusarudza.
Kuwana mukupona kunofanirwa kuongororwa pamwechete nemigumisiro uye chepfu; mumamiriro ezvinhu aya, varwere vanowanzoda kurarama pamwe chete uye vanogona (hunhu hwehupenyu), uye kwenguva refu sezvavanokwanisa (kupona).
Munguva pfupi yapfuura Yakagamuchirwa Maitirwo
Zvinodhaka | Dendaase Studied | Kuenzanisa Kubatsira |
Inotuzumab ozogamicin (Besponsa) | Kudzorerwa kana kuratidzira B-cell ALL |
|
Lenalidomide (Revlimid) | Ichangobva kuongororwa yakawanda myeloma |
|
Daunorubicin uye cytarabine liposome yejojo (Vyxeos) | Chiitiko chitsva chinorapwa-AML (t-AML) AML ne myelodysplasia-related changes (AML-MRC) |
|
1. Inotuzumab Ozogamicin (Besponsa) yeAcute Lymphocytic Leukemia
Inenge 5 970 mitsva itsva yeicute lymphocytic leukemia (ALL) yaitarisira muUnited States muna 2017, ine vanenge 1 440 vakafa mugore rimwe chete, maererano neAmerican Cancer Society inofungidzira. Pasinei nekuvandudzika mumakumi emakore achangopfuura mukurapa mararamiro akawanda eropa, zviratidzo zvevarwere ava vose zvinoramba zviri varombo.
Allogeneic stem-cell transplantation ( bone marrow kupera kubva kune anopa) inopa chivimbiso, chinogona, chekurapa kwevakuru nevese. Zvisinei, kune chipingamupinyi chinofanira kukundwa: iyo yakaderera mitengo yekuregererwa kwakakwana uye ikozvino chemotherapy regimens. Simba rekushandiswa kwemasero rinowanzodikanwa kuti munhu ave akawana kukanganiswa kwakakwana kwezvirwere, uye zvinosuruvarisa, izvi zvinoreva kuti vanhu vashomanana vashoma vakadzoka zvakare kana kuti vanoramba B-cell ALL (chirwere chinodzoka, pasinei nekurapa) chinogona kusvika pakugadziriswa.
Nokudaro, vashandisi vezvinodhaka vave vachitsvaga zvishandiso zvitsva zvinotarisa masero aya ane kenza. Kurwisa masero ane chiratidzo chinonzi CD22 inogona kuva chinhu chimwe chete ichocho, mumamiriro ezvinhu akanaka. CD22 imomo inoshandiswa nemamwe masero mumumuviri uye akaiswa nemasero aya, anenge seatiti, kunze kwekamuri, mukati memusero memunyu. Mune varwere vane B-cell ALL, masero ane kenza ane iyi CD22 molecule mune anenge 90 muzana yematambudziko-uye ayo akanaka zvakanaka mune bhizinesi rekenza kurapwa.
Inotuzumab ozogamicin (Besponsa) inorwisa anti-CD22 monoclonal antibody inobatanidza calicheamicin, inyanzvi inogona kuuraya masero anotarirwa.
Inotuzumab ozogamicin inonzi conjugate nokuti inonzi anticorpine yakanamatirwa, kana inogadziriswa, inhengo inogona kuuraya masero. Chikamu che-antibody chinotsvaka masero ane marker yeCD22, uye chikamu che conjugate chinoparadza sero rinotarisirwa.
I-FDA inobvumirana neototuzumab ozogamicin inobva pauchapupu hunobva kuchipatara chekuongorora umo vatsvakurudzi vakaongorora kuchengetedza kwemishonga pamwe nekubudirira kwacho kuchienzanisa neimwe nzira yemakemikirini inonzi regimen. Uyu muedzo waisanganisira 326 varwere vakanga vadzoka zvakare kana kuti vakaramba B-cell ALL uye avo vakagamuchira rimwe kana maviri vasati vapora.
Maererano neCDA, yevane 218 vakaongororwa varwere, 35.8 muzana avo vakagamuchira inotuzumab ozogamicin vakawana kupindura kwakakwana, kwemwedzi 8.0 mizana; yevarwere vakagamuchira mamwe maitiro echemotherapy, 17,4 muzana chete vakawana kupindura kwakakwana, kwemwedzi 4.9.
Nokudaro, inotuzumab ozogamicin inokosha inoshandiswa kurapwa kwarudzo yekudzokorora kana kukanganisa B-cell ALL.
Nhengo dzinowanzobatwa ne inotuzumab ozogamicin dzinosanganisira mazana emaplatelets (thrombocytopenia), mazinga mashoma emamwe masero eropa rega (neutropenia, leukopenia), utachiona, masero mashoma emasero matsvuku eropa (anemia), kuneta, kubuda ropa zvikuru (hemorrhage), fever ( pyrexia), nausea, misoro, mashoma masero emachena masero ane fever (febrile neutropenia), kuora kwechiropa (transaminases uye / kana gamma-glutamyltransferase yakawedzera), kurwadziwa kwepamuviri, uye mazinga akakura ebilirubin muropa (hyperbilirubinemia). Kana uchida mamwe mashoko ekuchengeteka, ona zvakakwana zvinotsanangura mashoko.
2. Lenalidomide (Revlimid) Mushure mekushandura mu Multiple Myeloma
Maintenance therapy ne lenalidomide inotevera autologous hematopoietic stem cell transplantation (kupfurikidza nemafuta emapfupa kupfurikidza nemupiro wega) kuwedzerwa kufa kwehuwandu nema25 muzana zvichienzaniswa ne placebo kana kuonekwa pakati pevarwere vane mishonga yakawanda inonzi myeloma, zvichienderana nemigumisiro yezvinoitwa meta-analysis yakangobva kuitwa.
McCarthy uye vaaishanda navo vakaongorora dambudziko revarwere kubva pamatatu matatu emakiriniki kubva kuUnited States, France neItaly. Zvidzidzo izvi zvaisanganisira varwere vachangobva kuongororwa vese myeloma vakawana ivo vakazvipira (autologous) bone marrow transplant uye ipapo 1,208 vavo vakarapwa ne lenalidomide mushure mezvo, apo 603 varwere vakagamuchira nzvimbo yebo kana kuti vaingocherechedza, kana kuongororwa.
Varwere vanorapwa ne lenalidomide vakanga vawedzera kubudirira, pasina kufambira mberi kwechirwere chavo, zvichienzaniswa nevaya vakagamuchira placebo kana kucherechedza (52.8 mwedzi kusvika kumwedzi 23.5). Vose 490 varwere vakafa. Chimwe chinhu chakakosha chekupona chakaonekwa muboka re lenalidomide.
Chimwe chikamu chikuru chevarwere vari muboka re lenalidomide vakawana hematologic yechipiri chekutanga chirwere uye chiremara chakasimba chechipiri chekutanga kuuraya; zvisinei, zviyero zvekufambira mberi, kufa nekuda kwezvikonzero zvose, kana kuurayiwa semusana we myeloma vose vakange vari mukuru pane boka rekuona.
3. Fixed-Combination Chemotherapy for Acute Myeloid Leukemia
AML inofambira mberi nokukurumidza kenza inotanga mumufupa wepafu uye nokukurumidza inokonzera kuwanda kwemajena eropa muropa muropa. Vanenge 21,380 vanhu vachaonekwa kuti vane AML gore rino, uye vanenge 10,590 varwere vane AML vachafa nehosha.
Vyxeos inogadziriswa-kusanganiswa kwe chemotherapy madawa daunorubicin uye cytarabine inogona kubatsira vamwe varwere kurarama kwenguva yakareba kupfuura kana vakagamuchira mishonga miviri yakasiyana. IA FDA inobvumira Vyxeos mukurapa kwevanhu vakuru vane marudzi maviri ehemiyoyi yemheyoyoyo (AML):
- Chiitiko chitsva chinorwara-AML (t-AML), uye
- AML ne myelodysplasia-related changes (AML-MRC).
T-AML inoitika sechinhu chinokonzera chemotherapy kana mazaisai mukati me8 kusvika ku10 muzana yevarwere vose vanobatwa nekenza. Paavhareji, inoitika mukati memakore mashanu mushure mekurapa. AML-MRC inoratidziro ye AML iyo inobatanidza nekuve nehupenyu hwehumwe hutano hweropa nekumwe kuchinja kukuru mukati memasero eukemia. Vose varwere vane t-AML uye avo vane AML-MRC vane tarisiro yeupenyu hushoma.
Mune chirwere chemakiriniki, 309 varwere vakanga vachangobva kuongororwa t-AML kana AML-MRC avo vakanga vasina kurasikirwa kuti vawane Vyxeos kana kuti vakashandiswa zvakasiyana-siyana kurapwa kwa daunorubicin uye cytarabine, varwere vakagamuchira Vaxeos vakararama kwenguva yakareba kupfuura varwere vakagamuchira kurapa kwakasiyana kwe daunorubicin uye cytarabine (median kunyanya kupona kwemwedzi 956 kusvika kumwedzi 5.95).
Matambudziko anowanzowanzosanganisira zviitiko zvinokonzera ropa (kushaya ropa), fivha nechepasi masero eropa ropa (febrile neutropenia), kuputika, kuputika kwemasumbu (edema), kusuruvara, kuvhiringidzika kwemucous membrane (mucositis), nezvimwe zvinetso zvakashata zvinosanganisira matumbo emagunha , zvirwere zvakakomba uye zvisina kukodzera mwoyo rhythm (arrhythmia).
> Sources:
> FDA News Release. FDA inobvumira mushonga mutsva kuvanhu vakuru vakadzokorora zvakare kana kuratidzira acute lymphoblastic leukemia. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm572131.htm.
> FDA News Release. FDA inobvumira kurapwa kokutanga kwemamwe marudzi evarombo-anofungidzira acute myeloid leukemia. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569883.htm.
> FDA Inobvumira Kushandisa Kwakanaka kweLenalidomide mu Multiple Myeloma. https://www.cancer.gov/news-events/cancer-currents-blog/2017/fda-lenalidomide-myeloma-maintenance.