natgillin/translations-raw huggingface dataset:
After this period, throw away any capsules that have not been used.
Vse kapsule, ki jih v tem obdobju ne porabite, morate zavreči.
Patients should not start treatment with Lynparza until they have recovered from haematological toxicity caused by previous anticancer therapy (haemoglobin, platelet and neutrophil levels should be ≤CTCAE grade 1).
Bolniki ne smejo začeti zdravljenja z zdravilom Lynparza, dokler ne okrevajo po hematotoksičnih učinkih predhodnega zdravljenja proti raku (koncentracije hemoglobina, trombocitov in nevtrofilcov morajo biti stopnje 1 ali manj po CTCAE).
Retreatment with olaparib was not permitted following progression on olaparib.
Če je bolezen med uporabo olapariba napredovala, ponovno zdravljenje z olaparibom ni bilo dovoljeno.
What Lynparza is and what it is used for
Kaj je zdravilo Lynparza in za kaj ga uporabljamo
At the time of the analysis of PFS the median duration of treatment was 19.4 months for olaparib and 5.6 months for placebo.
V času analize preživetja brez napredovanja bolezni je prejemanje olapariba mediano trajalo 19,4 meseca in placeba 5,6 meseca.
Secondary efficacy endpoints included OS (overall survival), DCR (disease control rate) defined as confirmed CR/PR + SD (stable disease), HRQoL (health related quality of life), and disease related symptoms.
Sekundarni cilji študije so obsegali celokupno preživetje (OS), delež obvladanja bolezni (DCR - disease control rate), opredeljen kot potrjen CR/PR + SD (stabilna bolezen), zdravstveno kakovost življenja in z boleznijo povezane simptome.
• The usual recommended dose is 8 capsules (400 mg) taken by mouth twice a day (a total of 16 capsules each day).
• Običajni priporočeni odmerek je 8 kapsul (400 mg) in ga je treba zaužiti dvakrat na dan (skupaj 16 kapsul vsak dan).
One pack contains 448 capsules (4 bottles of 112 capsules).
Eno pakiranje vsebuje 448 kapsul (4 plastenke po 112 kapsul).
The limited data for these somatic tumour BRCA (sBRCA) mutated patients show that fewer patients on olaparib reported progression events or death events compared with placebo (Table 3).
Maloštevilni podatki o bolnicah s temi somatskimi tumorskimi mutacijami gena BRCA (sBRCA) kažejo, da je bilo dogodkov napredovanja bolezni ali smrti med prejemnicami olapariba manj kot med prejemnicami placeba (preglednica 3).
Women of childbearing potential/contraception in females Women of childbearing potential should not become pregnant while on Lynparza and not be pregnant at the beginning of treatment.
Ženske v rodni dobi ne smejo biti noseče na začetku zdravljenja z zdravilom Lynparza in ne smejo zanositi med zdravljenjem.
Male patients and their female partners of childbearing potential should use reliable contraception during therapy and for 3 months after receiving the last dose of Lynparza (see section 4.6).
Moški bolniki in njihove partnerke v rodni dobi morajo med zdravljenjem in še 3 mesece po prejetju zadnjega odmerka zdravila Lynparza uporabljati zanesljivo kontracepcijo (glejte poglavje 4.6).
-----olaparib 400 mg bd twice daily, ____ placebo, x-axis=time from randomisation in months, yaxis=PFS (progression-free survival), n-olaparib= number of patients at risk-olaparib, n-placebo=number of patients at risk-placebo
-----olaparib 400 mg dvakrat na dan, ____placebo, os x = čas od randomizacije v mesecih, os y = PFS (preživetje brez napredovanja bolezni), n-olaparib = število ogroženih bolnic-olaparib, n-placebo = število ogroženih bolnic-placebo
Lynparza co-administration with strong or moderate CYP3A inducers is not recommended.
Sočasna uporaba zdravila Lynparza in močnih ali zmernih induktorjev CYP3A ni priporočljiva.
Haematological toxicity has been reported in patients treated with Lynparza, including clinical diagnoses and/or laboratory findings of generally mild or moderate (CTCAE grade 1 or 2) anaemia, neutropenia, thrombocytopenia and lymphopenia.
Pri bolnikih, zdravljenih z zdravilom Lynparza, so bili opisani hematotoksični učinki, vključno s klinično diagnozo in/ali laboratorijskimi izsledki, na splošno blage ali zmerne (stopnja 1 ali 2 po CTCAE) anemije, nevtropenije, trombocitopenije in limfocitopenije.
In patients with mild renal impairment (creatinine clearance 51 to 80 ml/min), AUC increased by 24% and Cmax by 15% compared with patients with normal renal function.
Pri bolnicah z blago okvaro ledvic (očistek kreatinina 51 do 80 ml/min) je bila vrednost AUC povečana za 24 % in vrednost Cmax za 15 % v primerjavi z bolnicami z normalnim delovanjem ledvic.
Please note Lynparza is also available as a 50 mg capsule.
Vedeti morate, da je zdravilo Lynparza na voljo tudi v obliki 50 mg kapsul.
A clinical study to evaluate the impact of itraconazole, a known CYP3A inhibitor, has shown that coadministration with olaparib increased mean olaparib Cmax by 42% (90% CI: 33-52%) and mean AUC by 170% (90% CI: 144-197%).
Klinična študija za oceno vpliva itrakonazola, ki je znan zaviralec CYP3A, je pokazala, da je njegova sočasna uporaba z olaparibom povečala srednjo vrednost Cmax olapariba za 42 % (90 % IZ: 33 do 52 %) in srednjo vrednost AUC olapariba za 170 % (90 % IZ:144 do 197 %).
In BRCA1/2-deficient in vivo models, olaparib given after platinum treatment resulted in a delay in tumour progression and an increase in overall survival compared to platinum treatment alone that correlated with the period of olaparib maintenance treatment.
V modelih pomanjkanja gena BRCA1/2 in vivo je olaparib, uporabljen po zdravljenju na osnovi platine, upočasnil napredovanje tumorja in je podaljšal celokupno preživetje v primerjavi s samostojnim zdravljenjem na osnovi platine, ki je koreliral z obdobjem vzdrževalnega zdravljenja z olaparibom.
Figure 5 Study 19: Kaplan Meier plot of OS in the FAS (79% maturity) DCO 09 May 2016
Slika 5 Študija 19: Kaplan-Meierjevi krivulji celokupnega preživetja v FAS (79 % zrelost) DCO 9. maj 2016
HDPE plastic bottle with a child-resistant closure containing 112 hard capsules.
Plastenka iz HDPE z zaporko, varno za otroke; vsebuje 112 trdih kapsul.
PFS (63% maturity)
PFS (~63 % zrelost)
Capsule shell Hypromellose Titanium dioxide (E171) Gellan gum (E418) Potassium acetate
Ovojnica kapsule hipromeloza titanov dioksid (E171) gelanski gumi (E418) kalijev acetat
The time from randomisation to start of second subsequent therapy or death (TSST) was 6.1 months longer for olaparib-treated patients (HR 0.43; 95% CI 0.29-0.64; p=0.00003; median 21.4 months versus 15.3 months).
Čas od randomizacije do začetka drugega nadaljnjega zdravljenja ali smrti (TSST) je bil med prejemnicami olapariba 6,1 meseca daljši (ROg 0,43; 95 % IZ: 0,29 do 0,64, p = 0,00003; mediana 21,4 meseca v primerjavi s 15,3 meseca).
For germline breast cancer susceptibility genes (gBRCA1/2) mutated human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, patients must have confirmation of a deleterious or suspected deleterious gBRCA1/2 mutation before Lynparza treatment is initiated.
Bolniki, ki imajo HER2- (receptor humanega epidermalnega rastnega faktorja 2) negativnega metastatskega raka dojk z germinalno mutacijo genov dovzetnosti za raka dojk (gBRCA1/2), morajo imeti pred uvedbo zdravila Lynparza potrjeno škodljivo ali domnevno škodljivo mutacijo gBRCA1/2.
• Capsule shell: hypromellose, titanium dioxide (E171), gellan gum (E418), potassium acetate.
• Ovojnica kapsule: hipromeloza, titanov dioksid (E171), gelanski gumi (E418), kalijev acetat.
Patients with germline or somatic BRCA1/2 mutations were identified prospectively either from germline testing in blood via a local test (n=208) or central test (n=181) or from testing a tumour sample using a local test (n=2).
Bolnice z germinalnimi ali somatskimi mutacijami gena BRCA1/2 so identificirali prospektivno bodisi s testiranjem germinalne linije v krvi z lokalnim testom (n = 208) ali s centralnim testiranjem (n = 181) bodisi s testiranjem vzorca tumorja z lokalnim testom (n = 2).
In replicating cells this leads to DNA double strand breaks (DSBs) when replication forks meet the PARP-DNA adduct.
V celicah, ki se razmnožujejo, to povzroči dvoverižne prekinitve DNA (DSBs-double-strand breaks), ko podvojevalne vilice naletijo na adukt PARP-DNA.
There is limited experience of overdose with olaparib.
Izkušenj s prevelikim odmerjanjem olapariba je malo.
Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide black (E172) (150 mg tablets only)
Obloga tablete hipromeloza makrogol 400 titanov dioksid (E171) rumeni železov oksid (E172) črni železov oksid (E172) (samo 150-mg tablete)
There are limited clinical data available in non-Caucasian patients.
Kliničnih podatkov o bolnikih, ki niso belci, je malo.
In BRCA-deficient in vivo models, olaparib given after platinum treatment resulted in a delay in tumour progression and an increase in overall survival compared to platinum treatment alone.
V modelih pomanjkanja gena BRCA in vivo je olaparib, uporabljen po zdravljenju na osnovi platine, upočasnil napredovanje tumorja in je podaljšal celokupno preživetje v primerjavi s samostojnim zdravljenjem na osnovi platine.
What Lynparza contains
Kaj vsebuje zdravilo Lynparza
• if you experience any new or worsening symptoms of shortness of breath, coughing, or wheezing.
• če se vam na novo pojavijo ali se vam poslabšajo kratka sapa, kašelj ali piskajoče dihanje.
The recommended dose reduction is to 250 mg (one 150 mg tablet and one 100 mg tablet) twice daily (equivalent to a total daily dose of 500 mg).
Priporočeno zmanjšanje odmerka je na 250 mg (ena 150-mg tableta in ena 100-mg tableta) dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 500 mg).
There are limited data in patients with somatic BRCA mutated tumours; 10 patients in the olaparib arm and 10 patients in the placebo arm were defined as having somatic BRCA1/2 mutation.
Podatkov pri bolnicah s somatsko tumorsko mutacijo BRCA je malo; Somatsko mutacijo gena BRCA1/2 je imelo 10 bolnic v skupini z olaparibom in 10 bolnic v skupini s placebom.
At the time of the analysis of PFS the median duration of treatment was 8 months for olaparib and 4 months for placebo.
V času analize preživetja brez napredovanja bolezni je prejemanje olapariba mediano trajalo 8 mesecev in placeba 4 meseca.
Figure 6 OlympiAD: Kaplan-Meier plot of BICR PFS in patients with gBRCA1/2-mutated HER2-negative metastatic breast cancer (77% maturity) DCO 09 December 2016
Slika 6 OlympiAD: Kaplan-Meierjev prikaz PFS (BICR) pri bolnikih s HER2-negativnim metastatskim rakom dojk z mutacijo gBRCA1/2 (77 % zrelost), DCO 09. december 2016
Effect of other medicinal products on olaparib
Farmakokinetično medsebojno delovanje Vpliv drugih zdravil na olaparib
-----olaparib 400 mg bd twice daily, ____placebo, x-axis=time from randomisation in months, yaxis=OS (overall survival), n-olaparib= number of patients at risk-olaparib, n-placebo=number of patients at risk-placebo
-----olaparib 400 mg dvakrat na dan, ____placebo, os x = čas od randomizacije, os y = OS (celokupno preživetje), n-olaparib = število ogroženih bolnic-olaparib, n-placebo = število ogroženih bolnic-placebo
Patients with platinum-sensitive relapsed (PSR) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy should start treatment with Lynparza no later than 8 weeks after completion of their final dose of the platinum-containing regimen.
Bolnice s ponovitvijo (PSR - platinum sensitive relapsed) epitelijskega raka visokega gradusa z izvorom v jajčnikih, jajcevodih ali peritoneju, občutljivega na platino, ki so v odzivu (popolnem ali delnem) na kemoterapijo na osnovi platine, morajo začeti zdravljenje z zdravilom Lynparza najpozneje v 8 tednih po zadnjem odmerku sheme zdravljenja na osnovi platine.
Do not drink grapefruit juice while you are being treated with Lynparza.
Med jemanjem zdravila Lynparza ne pijte grenivkinega soka.
Olaparib inhibits CYP3A4 in vitro and is predicted to be a mild CYP3A inhibitor in vivo.
Olaparib in vitro zavira CYP3A4 ter in vivo predvidoma blago zavira CYP3A.
In normal cells, homologous recombination repair (HRR), which requires functional BRCA1 and 2 genes, is effective at repairing these DNA DSBs.
V normalnih celicah te dvoverižne prekinitve DNA učinkovito odpravi homologno popravljanje z rekombinacijo (HRR - homologous recombination repair), ki pa zahteva funkcionalna gena BRCA 1 in 2.
Haematological toxicity
Hematološki toksični učinki
Figure 4 Study 19: Kaplan-Meier plot of PFS in the FAS (58% maturity - investigator assessment) DCO 30 June 2010
Slika 4 Študija 19: Kaplan-Meierjevi krivulji preživetja brez napredovanja bolezni v FAS (58 % zrelost - raziskovalčeva ocena) DCO 30. junij 2010
Pack of 448 capsules (4 bottles of 112 capsules).
Pakiranje s 448 kapsulami (4 plastenke po 112 kapsul).
bd Twice daily; PFS progression-free survival; DCO data cut off; CI confidence interval; NR not reached.
PFS = preživetje brez napredovanja bolezni, DCO = datum zamejitve podatkov, IZ = interval zaupanja, ND = ni doseženo
The investigator assessment of PFS was supported with a blinded independent central radiological review of PFS (HR 0.25; 95% CI 0.18-0.35; p<0.0001; median 30.2 months for olaparib and 5.5 months placebo).
Raziskovalčevo oceno PFS je potrdil slepljen neodvisen centralni radiološki pregled glede PFS (ROg 0,25, 95 % IZ 0,18 do 0,35, p < 0,0001, mediana 30,2 meseca z olaparibom in 5,5 meseca s placebom).
Therefore, known strong (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, boceprevir, telaprevir) or moderate (e.g. erythromycin, diltiazem, fluconazole, verapamil) inhibitors of this isozyme are not recommended with Lynparza (see section 4.4).
Zato sočasna uporaba zdravila Lynparza z znanimi močnimi zaviralci (npr. s itrakonazolom, telitromicinom, klaritromicinom, zaviralcem proteaz okrepljenim z ritonavirjem ali kobicistatom, boceprevirjem, telaprevirjem) ali zmernimi zaviralci (npr. z eritromicinom, diltiazemom, flukonazolom, verapamilom) tega izoencima ni priporočljiva (glejte poglavje 4.4).
Proportion of patients alive progression during platinum treatment and in the (neo)adjuvant setting provided the last dose was received at least 12 months prior to randomisation.
Predhodno zdravljenje s platino je bilo dovoljeno v metastatskem okviru, če ni bilo dokazov o napredovanju bolezni med zdravljenjem s platino, in v okviru (neo)adjuvantnega zdravljenja, če je bolnik zadnji odmerek prejel vsaj 12 mesecev pred randomizacijo.
Before Lynparza treatment is initiated for first-line maintenance treatment of high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC) or primary peritoneal cancer (PPC), patients must have confirmation of deleterious or suspected deleterious germline and/or somatic mutations in the breast cancer susceptibility genes (BRCA) 1 or 2 using a validated test.
Pred začetkom zdravljenja z zdravilom Lynparza kot prvo linijo vzdrževalnega zdravljenja epitelijskega raka visokega gradusa z izvorom v jajčnikih (EOC - epithelial ovarian cancer), jajcevodih (FTC - fallopian tube cancer) ali peritoneju (PPC - primary peritoneal cancer), morajo imeti bolnice z validiranim testom potrjene škodljive ali domnevno škodljive germinalne ali somatske mutacije genov BRCA (genov dovzetnosti za raka dojk) 1 ali 2.
How to take Lynparza
Kako jemati zdravilo Lynparza
Platinum free interval was > 12 months in 60% and 6-12 months in 40% of the patients.
Obdobje brez platine je bilo pri 60 % bolnic > 12 mesecev in pri 40 % bolnic > 6-12 mesecev.
• maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
• vzdrževalno zdravljenje odraslih bolnic z napredovalim (stadij III in IV po FIGO) epitelijskim rakom visokega gradusa z izvorom v jajčnikih, jajcevodih ali peritoneju z mutacijo gena BRCA1/2 (germinalno in/ali somatsko), ki so v odzivu (popolnem ali delnem) po zaključeni prvi liniji kemoterapije na osnovi platine.
No olaparib or placebo-treated patients discontinued due to diarrhoea.
Nobena bolnica, zdravljena z olaparibom, ali prejemnica placeba ni prekinila zdravljenja zaradi driske.
In normal cells, homologous recombination repair (HRR) pathway is effective at repairing these DNA DSBs.
V normalnih celicah te dvoverižne prekinitve DNA učinkovito odpravi pot homolognega popravljanja z rekombinacijo (HRR - homologous recombination repair).
Platinum free interval was >12 months in 60% and >6-12 months in 40% of the patients.
Obdobje brez platine je bilo pri 60 % bolnic > 12 mesecev in pri 40 % bolnic > 6 - 12 mesecev.
Lynparza capsules (50 mg) should not be substituted for Lynparza tablets (100 mg and 150 mg) on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation.
Pomembne razlike v odmerjanju med kapsulami in tabletami zdravila Lynparza Kapsul zdravila Lynparza (50 mg) se ne sme zamenjati s tabletami zdravila Lynparza (100 mg in 150 mg) na podlagi miligrama za miligram, ker se odmerjanje in biološka uporabnost med eno in drugo obliko razlikujejo.
Only PSR patients with partially platinum-sensitive disease (platinum-free interval of 6 to 12 months) and patients with platinum-sensitive disease (platinum-free interval of >12 months) who were in response following completion of last platinum-based chemotherapy were enrolled.
Vključene so bile samo PSR bolnice v odzivu po dokončanju zadnje kemoterapije na osnovi platine, ki so imele delno na platino občutljivo bolezen (interval brez platine od 6 do 12 mesecev), in bolnice, ki so imele na platino občutljivo bolezen (interval brez platine > 12 mesecev.
Demographic and baseline characteristics were generally well balanced between the olaparib and placebo arms.
Demografske in izhodiščne značilnosti so bile med skupino z olaparibom in skupino s placebom na splošno dobro uravnotežene.
Previous platinum-based therapy in (neo)adjuvant setting metastatic setting in (neo)adjuvant and metastatic setting 3 (1) Previous anthracycline treatment in (neo) adjuvant setting metastatic setting
Predhodno zdravljenje na osnovi platine (%) (neo)adjuvantno zdravljenje zdravljenje metastatske bolezni (neo)adjuvantno zdravljenje in zdravljenje metastatske bolezni Predhodno zdravljenje z antraciklinom (neo)adjuvantno zdravljenje zdravljenje metastatske bolezni Predhodno zdravljenje s taksanom (neo)adjuvantno zdravljenje zdravljenje metastatske bolezni
Do not use this medicine after the expiry date which is stated on the carton and the bottle after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in plastenki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Hard capsule 448 capsules (4 bottles of 112 capsules)
trda kapsula 448 kapsul (4 plastenke po 112 kapsul)
Demographic and baseline characteristics were generally well balanced between the olaparib and placebo treatment arms.
Demografske in izhodiščne značilnosti so bile na splošno dobro uravnotežene med terapevtsko skupino z olaparibom in skupino s placebom.
--------------Placebo bd - - - - - - - - - Olaparib 400 mg bd
-------------- placebo dvakrat na dan - - - - - - - - - olaparib 400 mg dvakrat na dan
• Printing ink: shellac, iron oxide black (E172).
• Črnilo za tisk na kapsuli: šelak, črni železov oksid (E172).
Lynparza is available as 100 mg and 150 mg tablets.
Zdravilo Lynparza je na voljo v 100-mg in 150-mg tabletah.
PAES: In order to further define the efficacy of olaparib in patients with platinum sensitive relapsed somatic BRCA mutated high grade serous ovarian cancer, the MAH should conduct and submit the results of a phase IV, open label, single arm, nonrandomised, multicentre study in patients with relapsed platinum sensitive ovarian cancer who are in complete or partial response following platinum based chemotherapy and who carry loss of function germline or somatic BRCA mutation(s).
PAES: Za dodatno potrditev učinkovitosti olapariba pri bolnicah z recidivom na platino občutljivega slabo diferenciranega seroznega raka jajčnikov in mutacijo gena BRCA, mora imetnik dovoljenja izvesti in predložiti rezultate odprte, nerandomizirane multicentrične študije IV. faze z eno skupino pri bolnicah z recidivom na platino občutljivega raka jajčnikov, ki so po kemoterapiji na osnovi platine v popolnem ali delnem odzivu in so nosilke izgube funkcije ene ali več mutacij gena BRCA germinalno ali somatsko.
Appropriate clinical monitoring is recommended for patients receiving CYP3A substrates with a narrow therapeutic margin concomitantly with olaparib.
Bolnike, ki sočasno z olaparibom prejemajo substrate CYP3A z ozkim terapevtskim oknom, je priporočljivo ustrezno klinično spremljati.
Lynparza is not recommended for use in patients with severe hepatic impairment (Child-Pugh classification C), as safety and pharmacokinetics have not been studied in these patients.
Uporabe zdravila Lynparza se ne priporoča pri bolnikih s hudo okvaro jeter (klasifikacija Child-Pugh C), ker varnost in farmakokinetika pri tej skupini bolnikov nista bili raziskani.
TFST - DCO 09 May 2016
TFST - DCO 9. maj 2016
Lynparza 150 mg tablets are green to green/grey, oval, bi-convex, film-coated tablets, marked with “OP150” on one side and plain on the other.
150 mg tablete zdravila Lynparza so zelene do zeleno-sive, ovalne, bikonveksne, filmsko obložene tablete z oznako "OP150" na eni strani in brez oznak na drugi strani.
Missing dose If a patient misses a dose of Lynparza, they should take their next normal dose at its scheduled time.
Če bolnik izpusti odmerek zdravila Lynparza, mora vzeti naslednji normalni odmerek ob običajno predvidenem času.
OS (64% maturity) - DCO 25 September 2017
Celokupno preživetje (64 % zrelost) - DCO 25. september 2017
There are no data from the use of olaparib in pregnant women, however, based on the mode of action of olaparib, Lynparza should not be used during pregnancy and in women of childbearing potential not using reliable contraception during therapy and for 1 month after receiving the last dose of Lynparza.
Toda glede na način delovanja olapariba se zdravila Lynparza ne sme uporabljati med nosečnostjo ali pri ženskah v rodni dobi, ki ne uporabljajo zanesljive kontracepcije med zdravljenjem in še en mesec po prejetju zadnjega odmerka zdravila Lynparza.
Figure 8 OlympiAD: Kaplan-Meier plot of OS in patients with gBRCA1/2-mutated HER2-negative metastatic breast cancer (64% maturity) DCO 25 September 2017
Študija OlympiAD: Kaplan-Meierjev prikaz celokupnega preživetja pri bolnikih z gBRCA1/2-mutiranim HER2-negativim metastatskim rakom dojk (64 % zrelost), DCO 25. september 2017
PAES: In order to further confirm the efficacy of olaparib as maintenance treatment after the first-line platinum-containing chemotherapy in patients with BRCA mutated high grade serous ovarian cancer, the MAH should submit the updated PFS2, updated OS and final OS results of the study D0818C00001 (SOLO1), a phase III randomised double-blind placebo-controlled multicentre study.
PAES: Za dodatno potrditev učinkovitosti olapariba med vzdrževalnim zdravljenjem po prvi liniji kemoterapije, ki vsebuje platino, pri bolnicah s seroznim rakom jajčnikov visokega gradusa z mutacijo gena BRCA mora imetnik dovoljenja za promet predložiti posodobljene rezultate PFS2, posodobljene rezultate OS in končne rezultate OS študije D0818C00001 (SOLO1), randomizirane dvojno slepe, s placebom kontrolirane multicentrične študije III. faze.
Subgroup analysis indicated PFS benefit of olaparib versus comparator in TNBC (HR 0.43; 95% CI: 0.29-0.63, n=152) and HR+ (HR 0.82; 95% CI: 0.55-1.26, n=150) patient subgroups.
Analiza podskupin je pokazala korist olapariba na preživetje brez napredovanja bolezni v primerjavi s primerjalnim zdravilom tako v podskupini bolnikov s TNBC (ROg 0,43; 95 % IZ: 0,29 do 0,63; n = 152) kot v podskupini s HR+ (ROg 0,82; 95 % IZ: 0,55 do 1,26; n = 150).
HR (95% CI) P value (2-sided)
ROg (95 % IZ) Vrednost p (2-stranska)
If you are not sure, talk to your doctor, pharmacist or nurse before taking Lynparza.
Če ste negotovi, se pred začetkom jemanja zdravila Lynparza posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.