November 2022: Kune varwere vakura vane kenza yepamusoro kana metastatic biliary tract cancer, Food and Drug Administration yakabvumidza durvalumab (Imfinzi, AstraZeneca UK Limited) pamwe chete negemcitabine uye cisplatin (BTC).
Kubudirira kweTOPAZ-1 (NCT03875235), chirongwa chemarudzi akawanda, chisingaverengeki, chechipiri-bofu, che placebo chakanyoresa varwere ve685 vane histologically yakasimbiswa munharaunda yepamusoro, isingagadziriswi, kana kuti metastatic BTC asi vakanga vasati vagamuchira chirongwa chechirwere chechirwere chepamusoro, yakaongororwa.
Izvi zvinotevera kuparara kwekutongwa kwemarudzi nevarume: 50% varume uye 50% vakadzi; makore epakati 64 makore (kubva pa20-85); uye 47% yevatori vechikamu vaiva nemakore 65 kana kupfuura. Mukuwedzera kune kenza yenduru uye extrahepatic cholangiocarcinoma, 56 muzana yevarwere vaivawo ne intrahepatic cholangiocarcinoma.
Varwere vakapihwa chero nguva kuti vagamuchire:
Durvalumab 1,500 mg pazuva 1, pamwe gemcitabine 1,000 mg/m2 uye cisplatin 25 mg/m2 pamazuva 1 uye 8 ega ega 21-zuva kutenderera kusvika ku8 mitsetse, ipapo 1,500 mg ye durvalumab mavhiki mana, kana
Placebo paZuva 1 + inoteverwa ne placebo mavhiki mana oga oga, inoteverwa ne gemcitabine 1,000 mg/m2 uye cisplatin 25 mg/m2 paMazuva 1 uye 8 ega ega 21-zuva kutenderera kusvika ku8 mitsetse.
Kusvikira chirwere ichi chichienderera mberi kana kuti migumisiro yakave isingagoneki, durvalumab kana placebo yakaenderera mberi. Kana murwere aive akagadzikana muchipatara uye achiwana rubatsiro rwekiriniki, sekuongororwa nemuongorori, kurapwa kwakabvumidzwa kupfuura kufambira mberi kwechirwere.
Mhedzisiro yekutanga yekubudirira yaive kupona kwese (OS). Kwemavhiki makumi maviri nemana ekutanga, kuongororwa kwebundu kwakaitwa mavhiki matanhatu ega ega; mushure mezvo, dzakaitwa mavhiki masere ega ega, kusvikira kufambira mberi kwechirwere kwakaratidza. Vanhu vakagoverwa kuti vagamuchire durvalumab ne gemcitabine uye cisplatin vakaratidza kuvandudzwa kwakakosha muOS zvichienzaniswa nevarwere vakanga vangopiwa kuti vawane placebo ne gemcitabine uye cisplatin. Mumapoka edurvalumab uye placebo, yepakati OS yaive mwedzi 24 (6% CI: 8, 12.8) uye 95 mwedzi (11.1% CI: 14, 11.5), zvichiteerana (hazard ratio 95; 10.1% CI: 12.5, 0.80; =95). Mumapoka e-durvalumab uye placebo, kurarama kwepakati-pasina kupfuurira kwaiva mwedzi 0.66 (0.97% CI: 0.021, 7.2) uye mwedzi 95 (6.7% CI: 7.4, 5.7), maererano. Mumaoko e-durvalumab uye placebo, muongorori-akaongorora huwandu hwekupindura huwandu hwaive 95% (5.6% CI: 6.7% - 27%) uye 95% (22% CI: 32% - 19%), maererano.
Zviitiko zvinowanzoitika zvakashata zvinosangana nevarwere (20%) zvaive pyrexia, lethargy, kusvotwa, kuvimbiswa, kuderera kwechido, uye kurwadziwa kwepamuviri.
Kana yakabatanidzwa ne gemcitabine uye cisplatin, chirongwa chinokurudzirwa che durvalumab chinenge 1,500 mg mavhiki matatu ega ega kune varwere vane uremu hwemuviri pasi pe30 kg, inoteverwa ne1,500 mg masvondo mana ose senhengo imwe chete kusvikira kufambira mberi kwechirwere kana kusagadzikana kunotyisa. Chiyero chinokurudzirwa kune vanhu vane uremu hwemuviri husingasviki 30 kg ndeye 20 mg/kg mavhiki matatu ega ega gemcitabine uye cisplatin, inoteverwa ne20 mg/kg mavhiki mana ega ega kusvikira chirwere ichi chichienderera mberi kana kune huturu husingagoneki.
View full prescribing information for Imfinzi.
