Ukwelashwa kwamatsha kufana nokukhula ngokukhawuleza kwezigulana ezinegazi , okanye i-hematologic malignancies, ezinjenge- leukemia , i-lymphoma kunye ne-myeloma yam .
Ezi zilandelayo zonyango zonyango zingabonwa njengamanyathelo amancinci, kunokuba ziqhube phambili; Nangona kunjalo, ezi zonyango zingabonelela ngeenzuzo ezinokuthi zibe nefuthe kakhulu kubo abo bachaphazelekayo.
Kwezinye iziganeko, ukunyanga okunyukayo kunokuthi kugcine i-flame ethembayo-ukuba unyango oluthile olunjenge-bone marrow lokufakelwa lungagqithiselwa-ekugqibeleni, oku kungenakukhetha.
Ukuzuza kwimpilo kufuneka kuthathelwe ingqalelo kunye nemiphumo emibi kunye nobutyhefu; kwezi meko, izigulane zifuna ukuhlala zombini kunye nokuba zinako (umgangatho wobomi), kunye nokuba zide kangakanani (ukusinda).
Iimpawu zonyango ezivunyiweyo
Iziyobisi | Izifo ezifundwayo | Inzuzo yokufanisa |
Inotuzumab ozogamicin (Besponsa) | Ukubuyiselwa okanye ukukhankanya i- B-cell YONKE |
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Lenalidomide (Revlimid) | I-myeloma entsha inokuxilongwa |
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I-Daunorubicin kunye ne-cytarabine liposome ye-injection (i-Vyxeos) | I-AML ehlobene nonyango ngokutsha (t-AML) I-AML kunye neenguqu ze-myelodysplasia (i-AML-MRC) |
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1. I-Inotuzumab Ozogamicin (Besponsa) yeLukmycy Acute Lymphocytic
Amanqaku angama-5,970 amatsha e- lymphocytic leukemia (BONKE) ayekulindeleke e-United States ngo-2017, malunga nokufa kwabangu-1,440 ngaloo nyaka, ngokutsho kwe-American Cancer Society. Nangona kukho ukuphuculwa kwamashumi eminyaka kutshanje kwonyango lweengcingo ezininzi zegazi, ukugxekwa kwezi zi gulane zihlala zihlwempu.
I-Allogeneic stem-cell transplantation ( ithambo lomnxeba wokutshintshwa kumniki-mali) linikeza isithembiso, mhlawumbi, sokonyango kubantu abadala. Nangona kunjalo, kukho inzame ekufuneka iyanqotshwe: amazinga aphantsi okuxolelwa ngokupheleleyo kunye ne-current chemotherapy regimens. I-stem cell transplantation idinga ukuba umntu uphumelele ukuxolelwa ngokupheleleyo kwezi zifo, kwaye ngelanga, oko kuthetha ukuba abantu abancinci abaye baphinde baphinde baphinde bakhuphe i-B-cell YONKE (isifo esibuyele, nangona unyango) sinokufikelela kwisipiliso.
Ngaloo ndlela, abaphuhlisi beziyobisi baye bafuna amatsha amathuluzi okujolisa kuloo maseli omhlaza. Ukuhlaselwa kweeseli ezinommaki obizwa ngokuba ngu-CD22 ingaba yinto enye enjalo, kwiimeko ezifanelekileyo. I-CD22 yi-molecule eyenziwa ngamaseli athile emzimbeni kwaye afakwa ngala maseli, phantse njengamathegi, ngaphandle kweseli, ngaphakathi kwimbumba yesellu. Kwizigulane ezine-B-cell ZONKE, iiseli zomhlaza zinalo i-molecule ye-CD22 malunga neepesenti ezingama-90 zeemeko-kwaye ezo zizinto ezintle kwiimeko zonyango lomhlaza.
I-Inotuzumab ozogamicin (Besponsa) yintsholongwane yokulwa ne-CD22 ye-monoclonal edibene ne calicheamicin, i-arhente engabulala amaseli ajoliswe kuyo.
I-Inotuzumab ozogamicin ibizwa ngokuba yi-conjugate kuba li-antibody eliqhotyoshelwe kuyo, okanye idibene nayo, i-agent engakwazi ukubulala amaseli. Inxalenye ye-antibody ifuna iiseli ezinomgcini we-CD22, kwaye inxalenye ye-conjugate iyonakalisa iseli elijoliswe kuyo.
I-FDA ivunyiwe i-inotuzumab ozogamicin ngokusekelwe kububungqina besilingo sekliniki apho abaphandi bavavanya ukhuseleko kunye nefuthe leziyobisi xa kuthelekiswa nezinye iirimimethrapi. Olu vavanyo lwaluquka izigulane ezingama-326 ezaziye zaphinda ziphinde zatshintshile okanye zithintela i-B-cell YONKE kwaye yayifumane enye okanye ezimbini zonyango.
Ngokutsho kwe-FDA, kwezigulane ezingama-218 ezivandlakanyweyo, ama-35.8 eepesenti abafumana i-inotuzumab ozogamicin bafumana impendulo epheleleyo, malunga neenyanga eziyi-8.0; zezigulane ezithe zanikwa enye i-chemotherapy, i-17.4 ekhulwini kuphela yabona impendulo epheleleyo, kwiinyanga ezingama-4.9.
Ngaloo ndlela, i-inotuzumab ozogamicin yindlela ekhethiweyo yokonyango olutsha ngokutsha okanye ukukhankanya i-B-cell YONKE.
Iziphumo eziqhelekileyo ezichaphazelekayo ze-inotuzumab ozogamicin ziquka amanqanaba aphantsi eeplatelets (thrombocytopenia), amanqanaba aphantsi kwamaseli egazi amhlophe athile (i-neutropenia, i-leukopenia), ukusulelwa, amanqanaba aphantsi eeseli zegazi ezibomvu (i-anemia), ukukhathala, ukuphuma kwamanzi (ukubola kwegazi), umkhuhlane ( i-pyrexia), isicupunu, intloko, amanqanaba amancinci egazi ezimhlophe nge-fever (i-febrile neutropenia), umonakalo wesibindi (i-transaminases kunye / okanye i-gamma-glutamyltransferase yanda), intlungu yesisu, kunye namazinga aphezulu e-bilirubin egazini (hyperbilirubinemia). Ngolwazi olongezelelweyo lwenkcukacha, jonga ulwazi olupheleleyo olucacileyo.
2. Lenalidomide (Revlimid) Emva kokutshintshela kwi-Myeloma yamaninzi
Ukwelapha isondlo nge-lenalidomide elandela i-autologous stemous stem cell transplantation (i-bone marrow transplant through self donation) iyanciphisa amaxabiso okufa ngamaphesenti angama-25 xa kuthelekiswa ne-placebo okanye ukubonwa phakathi kwezigulane ezine-myeloma ezininzi ezandula zifumene i-myeloma.
UMcCarthy kunye noogxa bahlalutye idatha yezigulane kwiimvavanyo ezintathu zonyango ezivela kwi-United States, eFransi nase-Itali. Ezi zifundo ziquka izigulane ezine-myeloma ezininzi ezandula zifumene i-myeloma ezazithobela ngokuzenzekelayo (i-autologous).
Izigulane eziphathwe nge-lenalidomide zenze ngcono ukuphila, ngaphandle kokuqhubeka kwesifo sabo, xa kuthelekiswa nalabo bafumana indawo ye-placebo okanye ukubonwa (iinyanga ezingama-52.8 nxamnye neenyanga ezingama-23.5). Izifo ezingama-490 zafa. Inzuzo enkulu yokusinda yabonwa kwiqela lenalidomide.
Ininzi enkulu yezigulane kwiqela le-lenalidomide lafumana i-hematologic yesibini yesifo esiyintloko kunye nesisu esomeleleyo sesibini esona sonyango; Nangona kunjalo, amazinga okuqhubela phambili, ukufa ngenxa yezizathu zonke, okanye ukufa ngenxa ye-myeloma bonke bebakhulu kakhulu kwiqela le-placebo / i-observation.
3. I-Fixed-Combination Chemotherapy kwi-Acute Myeloid Leukemia
I-AML ngumhlaza oqhubekayo ngokukhawuleza oqala emnzini wethambo kwaye ngokukhawuleza kubangele inani elongeziweyo lamaseli egazi ezimhlophe kwigazi. Abantu abangama-21,380 baya kufumana i-AML kulo nyaka, kwaye malunga ne-10,590 izigulane ezine-AML ziya kufa kwesi sifo.
I-Vyxeos yinto edibeneyo ye-chemotherapy drugs i-daunorubicin kunye ne-cytarabine enokunceda ezinye izigulane ziphile ixesha elide kunokuba ziza kufumana iindlela zokwelapha ezimbini. I-FDA ivumile iVixeos ukuba yonyango lwabantu abadala abaneentlobo ezimbini ze-leememia ye-leememia (AML):
- I-AML ehlobene neyeza-t-AML (i-T-AML), kwaye
- I-AML kunye neenguqu ze-myelodysplasia (i-AML-MRC).
I-T-AML ibonakala njengengxube ye-chemotherapy okanye i-radiation malunga ne-8 ukuya kwi-10 ekhulwini yazo zonke izigulane eziphathwe ngumhlaza. Ngokomyinge, kwenzeka kwiminyaka emihlanu emva kokunyanga. I-AML-MRC luhlobo lwe-AML edibeneyo kunye neembali zeengxaki ezithile zegazi kunye nezinye iinguqu eziphambili kwiiseli ze-leukemia. Zomibini izigulane ezine-t-AML kunye nalabo abane-AML-MRC banomdla ophantsi kakhulu.
Kwizilingo zekliniki, izigulane ezingama-309 ezine-TL-AML okanye i-AML-MRC ezandul 'ukufumana i-AML-MRC ezingenakulinganiswa ukuba zithole i-Vyxeos okanye zonyango ezilawulwa ngokwahlukileyo ze-daunorubicin kunye ne-cytarabine, izigulane ezamkela i-Vyxeos zaziphila ixesha elide kunezigulane ezamkelekileyo unyango lwe-daunorubicin kunye ne-cytarabine jikelele ukusinda kwiinyanga ezili-956 ngokumalunga neenyanga ezingama-5.95).
Iziphumo eziqhelekileyo ezibandakanyekayo zibandakanya iziganeko eziphazamisayo (ukuphazamiseka kwemizimba), umkhuhlane kunye nombolo ephantsi yamhlophe yegazi (i-febrile neutropenia), ukugqithisa, ukuvuvukala kwezicubu (i-edema), isicupunu, ukuvuvukala kweembrane (mucositis), kunye nezinye iziphumo ezimbi ezibandakanya iingxaki zesisu , izifo ezinzulu kunye neengcamango ezingenangqondo (i-arrhythmia).
> Imithombo:
> FDA News Release. I-FDA iyavuma unyango olutsha kubantu abaye baphinde baphinde baphinde baphinde baphinde baphinde baphinde baxhomekeke kwi-lymphoblastic leukemia. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm572131.htm.
> FDA News Release. I-FDA iyavuma unyango lokuqala kwiintlobo ezithile zeentlupheko zokuhlaziya i-leukemia. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569883.htm.
> I-FDA iyavuma ukusetyenziswa kweLenalidomide kwiMountel Myeloma. https://www.cancer.gov/news-events/cancer-currents-blog/2017/fda-lenalidomide-myeloma-tointenance.