Izindlela ezintsha zokwelapha zivela ngesilinganiso esisheshayo kweziguli ezinegazi legazi , noma i-hematologic malignancies, njenge- leukemia , i-lymphoma, ne- myeloma eminingi .
Izinyathelo ezingezansi zokwelapha zingase zibhekwe njengezinyathelo ezincane, kunokuba zibheke phambili; Kodwa-ke, lezi zindlela zokwelashwa zingase zinikeze izinzuzo zokuphila ezingaba nenjongo kakhulu kulabo abathintekayo.
Kwezinye izimo, izindlela zokwelapha ezikhulayo zingase zigcine ngisho nomlilo wethemba elivuthayo-ukuthi ukwelashwa okukwelapha njengokuthungwa komnkantsha we-bone kungase kugcine kususelwa-kanti ngaphambili, lokhu kungenzeka ukuthi akuzange kube yindlela yokukhetha.
Ukuzuza ekusindeni kufanele kucatshangwe kanye nemiphumela emibi kanye nobuthi; kulezi zimo, iziguli zifuna ukuhlala kokubili kanye nokuthi zingakwazi (ikhwalithi yokuphila), futhi isikhathi eside ngangokunokwenzeka (ukusinda).
Izindlela zokwelashwa zamukelwa kamuva
Isidakamizwa | Izifo ezifundwayo | Inzuzo Yokuqhathanisa |
Inotuzumab ozogamicin (Besponsa) |
| |
I-Lenalidomide (Revlimid) | I-myeloma eminingi eningi ihlolwe |
|
I-Daunorubicin ne-cytarabine liposome yomjovo (i-Vyxeos) | I-AML ehlobene ne-therapy (t-AML) ehlushwa kabusha. I-AML nezinguquko ezihlobene ne-myelodysplasia (AML-MRC) |
|
1. I-Inotuzumab Ozogamicin (Besponsa) ye-Acute Lymphocytic Leukemia
I-American Cancer Society iyachaza ukuthi cishe amacala amasha angu-5 970 we-acute lymphocytic leukemia (KONKE) ayekulindeleke e-United States ngo-2017, futhi cishe abantu abangaba ngu-1 440 bafa ngonyaka ofanayo. Naphezu kokuthuthukiswa emashumini eminyaka amuva ekwelapheni kwegazi eziningi zegazi, ukubikezelwa kwalezi ziguli ZONKE zihlala zihlupheka.
I-allogeneic stem-cell transplantation (ukufakelwa komnyofu we-bone umnikelo ovela kumnikezeli) unikezela isithembiso, okungenzeka, somuthi kubantu abadala bonke. Kodwa-ke, kukhona isithintelo okumelwe sinqobe: amazinga aphansi okuxoxwa okuphelele kanye nemikhakha yamanje yamakhemikhali. Ukufakelwa kwe-cell stem ngokuvamile kudinga ukuthi umuntu uzuze ukukhululwa okuphelele kwezifo, futhi ngeshwa, lokho kusho ukuthi abantu abadala abambalwa abanesifo esiphendukayo noma esiphezulu se-B-cell (isifo esibuyele emuva, naphezu kokwelashwa) singathola ukufakelwa kwesitshalo.
Ngakho-ke, abathuthukisi bezidakamizwa bebefuna amathuluzi amasha okubhekiswe kulawa maseli anomdlavuza. Ukuhlaselwa kwamaseli anomaka obizwa nge-CD22 kungaba yinye ithuluzi elinjalo, ezimweni ezifanele. I-CD22 iyi-molecule eyenziwa ngamaseli athile emzimbeni futhi afakwe la maseli, cishe amathegi, ngaphandle kweseli, ngaphakathi kwekhanda leseli. Kuziguli ezine-B-cell Konke, amangqamuzana anomdlavuza ane molecule ye-CD22 emaphesenti angama-90 amacala-futhi lawo amabizo omuhle ebhizinisini yokwelashwa komdlavuza.
I-Inotuzumab ozogamicin (Besponsa) i-antibody-anti-CD22-monoclonal antibody ehlanganiswe ne-calicheamicin, i-agent engakwazi ukubulala amaseli ahlosiwe.
I-inotuzumab ozogamicin ibizwa ngokuthi i-conjugate ngoba i-antibody ehlanganisiwe, noma ihlanganiswa nayo, i-agent engakwazi ukubulala amaseli. Ingxenye ye-antibody ifuna amangqamuzana anomaka we-CD22, futhi ingxenye ye-conjugate ibhubhisa iseli elihlosiwe.
I-FDA ivume i-inotuzumab ozogamicin ngokusekelwe ebufakazini besilingo somtholampilo lapho abacwaningi bahlola khona ukuphepha nokusebenza kwezidakamizwa kuqhathaniswa neminye imithi ye-chemotherapy. Lesi sivivinyo sasihlanganisa iziguli ezingama-326 ezazibuyiselwe emuva noma zingu-B-cell ZONKE futhi zathola ukwelashwa okukodwa noma ezimbili.
Ngokusho kwe-FDA, kweziguli ezingu-218 ezihlolwe, amaphesenti angu-35.8 abathola i-inotuzumab ozogamicin ayiphendule ngokuphelele, ngezinyanga eziyi-8.0 eziphakathi; kweziguli ezathola i-chemotherapy ehlukile, amaphesenti angu-17,4 kuphela athola impendulo ephelele, ngezinyanga ezingu-4.9 eziphakathi.
Ngakho-ke, i-inotuzumab ozogamicin iyindlela ebalulekile yokwelapha entsha ye-B-cell evuliwe noma ekhonjisiwe.
Imiphumela emibi evamile ye-inotuzumab ozogamicin ihlanganisa amazinga aphansi amaplethi (thrombocytopenia), amazinga aphansi amangqamuzana egazi amhlophe (i-neutropenia, i-leukopenia), ukutheleleka, amazinga aphansi amangqamuzana egazi abomvu (i-anemia), ukukhathala, ukuphaphazeka okukhulu (ukubola kwegazi), umkhuhlane ( i-pyrexia), i-nausea, ikhanda eliphansi, amazinga aphansi wamaseli amhlophe egazi anesifo somkhuhlane (i-febrile neutropenia), ukulimala kwesibindi (i-transaminases kanye / noma i-gamma-glutamyltransferase yanda), ubuhlungu besisu, namazinga aphezulu we-bilirubin egazini (hyperbilirubinemia). Ukuze uthole ulwazi olwengeziwe lokuphepha, bheka imininingwane ephelele yokucacisa.
2. Lenalidomide (Revlimid) Ngemuva kokutshala ku-Myeloma eminingi
Ukwelashwa kwesondlo nge-lenalidomide elandela i-autologous i-hematopoietic stem cell transplantation (i-bone marrow transplant via self donation) yanciphisa izinga lokufa ngamaphesenti angu-25 kuqhathaniswa ne-placebo noma ukubhekwa phakathi kweziguli ezine-myeloma esanda kutholakala, ngokusho kwemiphumela yamuva yokuhlola i-meta-analysis.
UMcCarthy nozakwabo bahlaziya idatha yeziguli ezivela ekulingweni kwemitholampilo emithathu evela e-United States, eFrance nase-Italy. Lezi zifundo zazihlanganisa neziguli ezine-myeloma eziningi ezitholakale zitholakale zathola ukufakelwa komnkantsha we-self-donated (autologous) bese kuthi abangu-1,208 babo baphathwa nge-lenalidomide kamuva, kuyilapho iziguli ezingama-603 zithola i-placebo noma zibonwa nje, noma ziqashwe.
Iziguli eziphathwe nge-lenalidomide zenze ngcono ukuqhubeka, ngaphandle kokuqhubeka kwesifo sabo, uma kuqhathaniswa nalabo abathola i-placebo noma ukubonwa (izinyanga ezingu-52.8 nxambili nezinyanga ezingu-23.5). Isibalo seziguli ezingu-490 zafa. Inzuzo ebalulekile yokusinda yabonakala eqenjini le-lenalidomide.
Isibalo esikhulu seziguli esigabeni se-lenalidomide sabhekana nesifo se-hematologic yesibili esiswini esiyinhloko nesifo esiqinile esiswini sesibili esisodwa; Kodwa-ke, amazinga okuqhubeka, ukushona ngenxa yezizathu zonke, noma ukushona ngenxa ye-myeloma bonke babekhulu kakhulu eqenjini le-placebo / lokubona.
3. I-Fixed-Combination Chemotherapy ye-Acute Myeloid Leukemia
I-AML ngumdlavuza oqhubekayo ngokushesha oqala emnothweni wethambo futhi ngokushesha ubangele inani elanda lamaseli amhlophe egazini. Abantu abangaba ngu-21,380 bayotholakala ukuthi bane-AML kulo nyaka, kanti iziguli ezingaba ngu-10,590 ezine-AML zizofa ngesifo.
I-Vyxeos iyinhlanganisela eqondile yezidakamizwa ze-chemotherapy i-daunorubicin ne-cytarabine engasiza ezinye iziguli ziphile isikhathi eside kunokuba zizothola lezi zindlela ezimbili zokwelapha ngokwahlukana. I-FDA ivumile iVixeos ekwelapheni abantu abadala abanezinhlobo ezimbili ze-acute myeloid leukemia (AML):
- I-AML ehlobene ne-therapy (t-AML) ehlobene ne-Newly diagnostic, futhi
- I-AML nezinguquko ezihlobene ne-myelodysplasia (AML-MRC).
I-T-AML ibonakala njengenkinga ye-chemotherapy noma imisebe ngamaphesenti angaba ngu-8 ukuya kwangu-10 kuwo wonke iziguli eziphathwe umdlavuza. Ngokwesilinganiso, kwenzeka eminyakeni emihlanu emva kokwelashwa. I-AML-MRC uhlobo lwe-AML oluhlotshaniswa nokuba nomlando wezinkinga ezithile zegazi nezinye izinguquko eziphambili ngaphakathi kwamaseli wegazi. Zombili iziguli ezine-t-AML nalabo abane-AML-MRC banezinjongo eziphansi kakhulu zokuphila.
Esivivinyweni somtholampilo, iziguli ezingu-309 ezine-t-AML noma i-AML-MRC esanda kutholakala ukuthi zithole ama-Vyxeos noma zelashwa ngokwehlukana ze-daunorubicin ne-cytarabine, iziguli ezathola i-Vyxeos zaziphila isikhathi eside kuneziguli ezithole ukwelashwa okuhlukile kwe-daunorubicin ne-cytarabine (emaphakathi ukusinda jikelele izinyanga ezingu-956 vs. izinyanga ezingu-5.95).
Imiphumela emibi evamile yayihlanganisa imicimbi yokugaya (ukulimala), umkhuhlane onama-white cell count count (febrile neutropenia), ukuqhuma, ukuvuvukala kwezicubu (i-edema), i-nausea, ukuvuvukala kwamangqamuzana omzimba (mucositis), kanye neminye imiphumela emibi kuhlanganise nezinkinga zomzimba , izifo ezinzima kanye neshyindo senhliziyo engavamile (arrhythmia).
> Imithombo:
> I-FDA News Release. I-FDA ivumela ukwelashwa okusha kubantu abadala ngokuphindaphindiwe noma ukuphikisana ne-acute lymphoblastic leukemia. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm572131.htm.
> I-FDA News Release. I-FDA ivumela ukwelashwa kokuqala ngezinhlobo ezithile zokuhlukumezeka okubi kakhulu kwe-lemonemia. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569883.htm.
> I-FDA ivumela ukusetshenziswa okusha kwe-Lenalidomide ku-Myeloma eminingi. https://www.cancer.gov/news-events/cancer-currents-blog/2017/fda-lenalidomide-myeloma-maintenance.