Izifo ezithandathu zokuphila-eziseMpilo , i- Zytiga , i-Xtandi, i-Xofigo, kunye ne- Jevtana-ziza kutholakala ekuphatheni umdlavuza wesibeletho kwiminyaka emihlanu edlulileyo. Ngethamsanqa, unyango lwamaxesha aludala olunjenge-radiation, i-Lupron, ne-Taxotere luhlala lusebenza kakuhle. Ngokuqhelekileyo, umdlavuza weprotate uqhubekela phambili ngokuthe ngcembe, oku kuthetha ukuba ukufa kungasetyenziselwa ixesha elide.
Nangona zonke ezi zinto zithembekileyo, amadoda angama-28,000 aphethwe ngumhlaza wesibeletho ngamnye ngonyaka. Kwiimeko ezininzi, ukufa kubonakala ngenxa yokuba umhlaza ekugqibeleni unokumelana nawo onke amachiza aqhelekileyo aphaliswe apha ngasentla. Ukuba oku kwenzekayo, isinyathelo esilandelayo esilungileyo kukuqwalasela unyango lwe-labels ezifana nezamayeza avunyelwe yi-FDA kwezinye iintlobo zomhlaza, uthi umhlaza wengqondo okanye umdlavuza wemiphunga, umzekelo. Ingxaki ikhethwa phakathi kweendlela ezininzi. Ukuba uya kuthatha ibhokhwe ebumnyameni, yimuphi umpu okufanele ukhethe?
I-Agent-Label Agents: Ibali leMonde
Ukufuna i-agent e-off-label esebenzayo ingaba nenkokhelo enkulu xa ufumana inhlanhla. Ukususela kumbono we-FDA, isilwanyana esivunyiweyo singasetyenziselwa ukusetyenziswa okungavumelekanga xa umboneleli wezempilo evakalelwa kukuba unempilo yesigulane sakhe, nokuba kungenxa yokuba akukho mvume evunyelwe ukunyanga imeko okanye ngenxa yokuba isigulane siye sazama zonke ezivunyiweyo unyango ngaphandle kokubona iziphumo.
Makhe ndibalise ibali likaBill. Wayefumanisa okokuqala ekupheleni kuka-2010 kunye ne-PSA ye-4.2 kunye nomlinganiselo we- Gleason we-3 + 4 kwaye waphathwa ngokuhlinzwa ukuze asuse iprotrate. Umqondiso wokuqala wenkxalabo eyongezelelekileyo kukuba ingxelo yakhe yokugula yayibonisa umdlavuza ngaphandle komda weprotate. Isiphumo sakhe seGleason saye sahlaziywa saba ngu-4 + 5 = 9, kwaye i-PSA yakhe ayizange iphinde ibe yintsi emva kokuba isalathisi isuswe.
Ngomhla ka-Matshi 2011, wafumana umbane ojoliswe kummandla womzimba apho iprotrate yayisetyenziswa khona, kodwa i-PSA yahlala isezantsi ixesha elifutshane. Emva koko waqala uLupron, kodwa i-tumor yakhe yaba ngumlingo phakathi konyaka. Kwiminyaka emithathu ezayo, waphathwa ngamachiza adweliswe ngasentla, i-Provenge, i-Zytiga, i-Xtandi kunye ne-Taxotere. Ngohlobo lwe-2014, umhlaza wakhe wasasazeka ngokubanzi kwi-bone yomthambo wakhe. Ukwelashwa kunye ne-Xofigo yaqalwa ngoFebruwari 2014. Ngelishwa, wavelisa ukuhluleka komnxeba oqhubekayo, ukuphuhliswa okuqhelekileyo kumadoda onomdlavuza ongaphantsi kolawulo lwe-prostate. Ukuveliswa kwakhe kweeseli ezibomvu zegazi kwakunobungozi kangangokuthi wayeza kugcinwa kuphela ephila kunye nokunyelwa kwegazi. Xa i-Xofigo yavalwa ngo-Agasti 2014, i-PSA ivukile ngaphezu kwe-120. Ithuba likaBhili lokuhlala kwezinye iinyanga ezintandathu lingaphantsi kweyesi-10.
Ukufika kweli nqanaba, omnye ugqirha wayephethe icala lakhe. Ngaphambi kokuba atshintshe isondlo kwonyango lwakhe kwi-ofisi yam udokotela wakhe odlulileyo waqala uBhili kwiyeza-off label-name Mekinist. I-Mekinist yipilisi e-FDA-evunyelwe i-melanoma ye-metastatic. Ukususela ekusebenziseni umhlaza wesibeletho (ukusetyenziswa ngaphandle kweleyibhile) ayihlanganiswa yinshuwalense, uBill wathenga ipilisi ngokwakhe ngeendleko ze-R10 000 ngenyanga.
Nangona kunjalo, utyalomali lwakhe luhlawulwe. NgoDisemba 2014 i-PSA yehla ukuya kwi-18.96, umongo wakhe waqala ukusebenza kwakhona, kwaye wayengasayi kufuna enye igazi.
Impilo kaYilwayo iphuculwe kakhulu kangangokuthi wabuyela emsebenzini wakhe ngokuzeleyo kwaye wayethatha rhoqo uhambo lwakhe kunye neentsapho zakhe eYurophu nakwiindawo ezahlukeneyo e-US kwiminyaka emibini ezayo. I-Mekinist yaxhomekeka kakuhle ngaphandle kwemiphumo echaphazelekayo. Ngelishwa, umdlavuza wakhe weprotate ekugqibeleni waba ngumxhasi kuMekinist kwaye umhlaza waqala ukuqhubeka. Imizamo yethu eyongezelelekileyo yokufumana enye i-bullet bullet bullet ayiphumelelanga kwaye yahlutha kwisifo ekuqaleni kuka-2016.
I-Mekinist yeBill yayimangalisa inhlanhla. Emva kokubonakalisa impendulo enomdlavuza omkhulu, wayenako ukukholisa inkampani yakhe yomshuwalense ukuba ihlawule iindleko. Ukuphumelela kwesiphumo somhlaza kwisithuba esilandelayo sesi sifo siyamangalisa ngokwenene, isivumelwano sokuveliswa kwemveliso ephuhliswayo kwiinkampani zonyango. Ngenxa yokuba amaninzi amatsha amanxeba aphuhliswayo, iingxaki zokufumana inzuzo, njengeliso likaBill, ukuphindaphindiweyo ziphucula.
Ukuhlolwa kweGenesis: Iindlela zokuSebenza ngokuSebenzayo
Ingxaki ngoku kukuba kukho inani elinjalo lamagosa amatsha avunyelwe kuzo zonke iintlobo ezahlukeneyo zomhlaza. Uyazi njani ukuba yiyiphi i-arhente yokukhetha? Sizame ukunika i-Mekinist kwezinye izigulana ezimbalwa, kodwa kungekho nzuzo ebonakalayo yokulwa nomdlavuza. Oku akumangalisi ukuba ucinga ukuba umhlaza wesifo seprotate akusisifo esinye. Sekuninzi siye sabona indlela eyahlukileyo ngayo indlela izigulane ezithatha ngayo amaqela ahlukeneyo. Nangona kunjalo, kukho enye indawo yenkqubela phambili yezobuchwepheshe ezinokuthi zisinceda ukuhlenga izigulane ezithile zonyango. Ukufika kokuhlolwa kofuzo kweeseli zesisu kunokugqitywa ekupheleni kwexesha lokukhetha unyango ngokungaqhelekanga.
Ingcamango kukuba ukhethe unyango ngokuchonga imbonakalo yezofuzo zeseli zomhlaza ngokulandelana kwemfuza. Ukukhula kwamaselula okungalawulwayo, "umhlaza," kubangelwa ukungaziphathi kakuhle. Iimpawu eziphathekayo ezizitshintshileyo ezinxulumene nokukhula kwamaselula zingangena kwisithuba "kwi". Ezi zinguqu ziyakwazi ukuchongwa ngokulandelana kwemfuza. Kuye kwafumanisa i-geni ezingama-50 ukuba ukungasebenzi kakubi kumhlaza wesibeletho. Uhlalutyo lwe-Genetic lweethambo zesisu lubonisa ukuba kwiseli yesifo somhlaza malunga neentsholongwane ezine zifunyanisiwe. Nangona kunjalo, inani lezinto eziphilayo ezifunyenweyo zingabalwa ukusuka kumbalwa ukuya kwelinye ukuya ngaphezulu kwe-10.
Eyona nto inomdla njengoko isithembiso solu hlobo lwe "smart" izandi, kukho imingeni eninzi yokuyithatha. Ukulandelelana kweGenes kungakwazi ukujonga ngokucacileyo izakhi zegesi ngamagama, kodwa kungekho rhoqo umsebenzi we-gene. Xa sisazi umsebenzi, sihlala sinamayeza athile okulwa neengxaki zendalo. Ngona xa kukho unyango olusebenzayo ukuphatha isini esithile esingasebenzi kakubi kolunye uhlobo lomhlaza, akukho mqinisekiso yokuba ukulawula kwayo kuya kusebenza ngokusemdlalweni wesibeletho. Ngokomzekelo, i-Mekinist icingelwa ukuba iyasebenza ekuchaseni ukungaziphathi kakuhle kohlobo olubizwa ngokuba yi- GNAS kwizigulane ezine-melanoma. Nangona kunjalo, njengangoku, asikho idatha ebonisa ukuba iMekinist iya kusebenza kwiigulane ze-prostate zeGNAS .
Izindlela zokuVavanywa kweGenesis
Ngokwenene sizama ukufumana iiseli zomhlaza kwiimvavanyo zofuzo kuYilwayo nge-biopsy elandelwayo. Ngelishwa, i-biopsy ayiphumelelanga kuba akukho neseli ezinokukhubazeka ezifumanekayo. Amava ethu nge-biopsy ukufumana iiseli zesisu ezivela kwisithambo sokuvavanya i-genetic kwizigulane ze-prostate zegulane ziye zaphumelela kuphela kwisiqingatha sezigulane esazame ngazo ukwenza i-biopsy. Kuze kube kutshanje, i-biopsy yamathambo yindlela eyodwa yendlela yokufikelela kwizinto eziphathekayo kwiiyununu zethambo. Kodwa i-Bone biopsy, nangona kunjalo, iyanzima kwaye ayikhathazi idinga inaliti enkulu. Ngethamsanqa, iteknoloji iyaqhubeka nokuqhubela phambili ngokukhawuleza. Ukuphumelela kwangoku kukufumanisa ukuba i-DNA ye-tumor ekhutshwe egazini esuka kumaseli omhlaza afunyanwa kwaye ivavanywe ngokuhlolwa kwegazi.
Uvavanyo lwegazi lweDNA lulula kakhulu kunokuba wenze i-bone biopsy. Ngaphandle kwento elula, i-DNA egazini iyingxenye ye-DNA ekhishwe kuzo zonke izicubu kuwo wonke umzimba. Izinto eziphathekayo ezivela kwi-biopsy ye-tumor esisodwa aziyi kuxelela ibali elipheleleyo kuba umdlavuza ungenalo ukungaqiniseki ukuba iziza zomhlaza ezahlukeneyo ezivela kwisigulane esifanayo zizahlukahluka.
I-Blood test ye-DNA ye-tumor ikhona ngokufumaneka kwezorhwebo. Inkampani eyenza i-assay ibizwa ngokuba yi-Guardant Health. Bambiza i-assay yabo yegazi ehlola iimvavanyo zesifo somhlaza we-Guardant360. Iimvavanyo zeesilingo ezi-70 zenguqu eziqhelekileyo ezibonakala kumhlaza. Izifundo zenzelwe ukuvavanya ukuba iifomu ezingavumelekanga zifunyenwe kumdlalo wegazi izifo ezingaqhelekanga ezifunyenwe yi-biopsy yendabuko kwisigulane esifanayo. I-assay yegazi ibonakala yenza kakuhle kakhulu.
Emva kokuba iGene engavumelekanga iyabonwa
Ngoko masibuyele kumxholo wethu oyintloko wokusebenzisa ulwazi olususukwini lwe-genetic ukukhetha unyango lomhlaza welebula kumadoda anomdlavuza wesibeletho ophelile ukhetho lwawo oluvunyiweyo lwe-FDA. Xa i-geni engavamile ifunyenwe kukho iziphumo ezine ezineziphumo:
- Akukho nonyango eyaziwayo inxulumene nalo mzimba wesifo esingavamile.
- Kukho unyango oluvunyiweyo lwe-FDA lwe-prostate umdlavuza okhoyo kule geni ethile
- Kukho unyango oluvunyiweyo lwe-FDA olusebenza ngolunye uhlobo lomhlaza (imiphunga, iinjongo, i-melanoma, njl.) Enokuthi ibe nomdlavuza we-prostate nomhlaza wesibeleko kunye nale mfuza engavamile.
- Kukho ii-agents ezintsha ezivandlakanywa kule nqobo yezinto ezingaqhelekanga kwiimvavanyo zeclini okanye ngumhlaza wesifo somhlaza okanye olunye uhlobo lomhlaza. Izigulane ezinolu hlobo lokuguqulwa kwamanzi ziyakwazi ukuphendula kule nkonzo echaphazelekayo ngokuqwalasela indlela yokwenza i-agent eyaziwayo.
Ukuqwalasela oku ngasentla ngokwemigaqo ethile, iziphumo ezimbini zokuqala aziyi kuba luncedo olukhulu kwizigulane. Ngokukodwa, ngokubhekiselele kwisiphumo sesibini, ezininzi izigulane ezenza uvavanyo lofuzo lomhlaza wesifo seprotate sele ziphelile ukhetho lwe -FDA oluvunyiweyo lwe-prostate-oluchaphazeleka ngumhlaza. Iziphumo zesithathu neyesine yizo eziza kubhekisela kuhlobo lonyango oluya kulahlekelwa ngasemva kwemininzi yezinto ezingabikho kwiileyibhile.
Ngenhlanhla ukuba iphrofayili yesifa soBill ayinakuze ifunyenwe naphezu kwemizamo yethu engcono. Iimpembelelo zeMekinist kwixesha elide kunye nomgangatho wobomi kwakunzima kakhulu. Kule nkalo, asiyazi ukuba impendulo yakhe ebalulekileyo yenzeke ngenxa yokuba engasebenzi kakuhle kwe-GNAS, enye i-gene okanye inxalenye ethile yeendiza. Nangona kunjalo, ngoku kufumaneka lula kweenkcukacha zofuzo ngokuhlolwa kwegazi kunye ne-Guardant360, siya kukwazi ukufunda ukuba yeyiphi imithi yokwelapha inokubangela impendulo yomhlaza esekelwe kwiprofayili nganye yesiguli.