Nov 2023: Kune varwere vevana vane gore rimwe chete zvichikwira vane chirwere chisingaperi (CP) Ph + chisingaperi myelogenous leukemia (CML), ingave ichangobva kuwanikwa (ND) kana isingashiviriri kana kusashivirira (R/I) kukurapa kwakapfuura, iyo Food and Drug Administration yakabvumidza bosutinib. Bosulif, Pfizer). Pamusoro pezvo, riini capsule dosage fomu ine 50 mg uye 100 mg concentration yakabvumidzwa neFDA.
Muedzo weBCHILD (NCT04258943) wakaongorora kushanda kwe bosutinib muvarwere vevana vane ND CP Ph+ CML uye R/I CP Ph+ CML. Muyedzo wacho waive wakawanda, usiri wakasarudzika, uye wakavhurika-label, uine zvinangwa zvekuona inokurudzirwa dosi, kufungidzira kuchengetedzwa uye kushivirira, kuongorora kushanda, uye kuongorora. bosutinib pharmacokinetics muhuwandu hwevarwere. Muedzo wacho waisanganisira varwere ve21 vane ND CP Ph + CML vakabatwa pa 300 mg / m2 kamwe chete zuva nezuva uye varwere ve28 vane R / I CP Ph + CML vakabatwa ne bosutinib pa 300 mg / m2 kusvika 400 mg / m2 muromo kamwe chete zuva nezuva.
Makuru cytogenetic mhinduro (MCyR), yakakwana cytogenetic mhinduro (CCyR), uye hombe molecular mhinduro (MMR) ndiyo yaive yekutanga efficacy mhedzisiro metrics. Iyo huru (MCyR) uye yakakwana (CCyR) cytogenetic mhinduro dzevarwere vevana vane ND CP Ph + CML vaiva 76.2% (95% CI: 52.8, 91.8) uye 71.4% (95% CI: 47.8, 88.7), maererano. 28.6% (95% CI: 11.3, 52.3) yaiva MMR, uye mwedzi 14.2 yaiva nguva yekutevera yepakati (range: 1.1, 26.3 mwedzi).
Iyo huru (MCyR) uye yakakwana (CCyR) cytogenetic mhinduro dzevarwere vevana vane R / I CP Ph + CML vaiva 82.1% (95% CI: 63.1, 93.9) uye 78.6% (95% CI: 59, 91.7), maererano. 50% (95% CI: 30.6, 69.4) yaiva MMR. Vaviri vevarwere ve14 vakasvika MMR vakarasikirwa neMMR mushure mekugamuchira kurapwa kwe13.6 uye 24.7 mwedzi, zvichiteerana. Kutevera kwemwedzi ye23.2 yaive yepakati (renji: 1, 61.5 mwedzi).
Pakati pevarwere vevana, manyoka, marwadzo emudumbu, kurutsa, kusvotwa, mapundu, kupera simba, kusagadzikana kwechiropa, kutemwa nemusoro, pyrexia, kuderera kwechido, uye kusvotekana ndizvo zvaiwanzotaurwa mhedzisiro (≥20%). Muvarwere vevana, yakawedzera creatinine, yakawedzera alanine aminotransferase kana aspartate aminotransferase, yakaderera chena masero eropa, uye kuderera kweplatelet count ndiyo yainyanya kuwanda yerabhoritari isina kunaka iyo yakawedzera kubva pakutanga (≥45%).
Kune varwere vevana vane ND CP Ph + CML, iyo yakakurudzirwa dosage ye bosutinib ndeye 300 mg / m2 muromo kamwe chete zuva nezuva nechikafu; kuvarwere vevana vane R/I CP Ph+ CML, iyo yakakurudzirwa dosage ndeye 400 mg/m2 nemuromo kamwe chete pazuva nekudya. Zviri mukati memakapisi zvinogona kusanganiswa neyogati kana maapurosauce kune vanhu vasingakwanise kuzvimedza.
