natgillin/translations-raw huggingface dataset:
Please note Lynparza is also available as a 100 mg and 150 mg tablet.
Vedeti morate, da je zdravilo Lynparza na voljo tudi v obliki 100 mg in 150 mg tablet.
Patients with CR defined by the investigator had HR 0.34 (95% CI 0.24-0.47); median PFS not reached on olaparib vs 15.3 months on placebo.
Bolnice, ki so imele po raziskovalčevi oceni popoln odziv (CR), so imele ROg 0,34 (95 % IZ 0,24 do 0,47); mediano PFS z olaparibom ni bilo doseženo, s placebom pa je bilo 15,3 meseca.
OS - DCO 09 May 2016
OS - DCO 9. maj 2016
The safety and efficacy of olaparib as maintenance therapy were studied in patients with newly diagnosed advanced (FIGO Stage III-IV) high-grade serous or endometrioid BRCA1/2 mutated (BRCA1/2m) ovarian cancer following completion of first-line platinum-based chemotherapy in a Phase III randomised, double-blind, placebo-controlled, multicentre trial.
Varnost in učinkovitost olapariba za vzdrževalno zdravljenje so raziskali pri bolnicah z na novo diagnosticiranim, napredovalim (stadij III-IV po FIGO), seroznim ali endometrioidnim rakom jajčnikov visokega gradusa in mutacijo gena BRCA1/2 (BRCA1/2m) po zaključeni prvi liniji kemoterapije na osnovi platine, in sicer v randomiziranem, dvojno slepem, s placebom kontroliranem, multicentričnem preskušanju III. faze.
Local or central testing of blood or tumour samples for BRCA1/2 mutations has been used in different studies.
V različnih študijah so uporabili lokalno ali centralno testiranje vzorcev krvi ali tumorja za mutacije genov BRCA1/2.
bd Twice daily; NR Not reached; CI Confidence interval; PFS Progression-free survival; PFS2 Time to second progression or death; OS Overall survival; TFST Time from randomisation to first subsequent anti-cancer therapy or death.
2x/dan = dvakrat na dan, ND = ni doseženo, IZ = interval zaupanja, PFS = preživetje brez napredovanja bolezni, PFS2 = čas do drugega napredovanja bolezni ali do smrti, OS = celokupno preživetje, TFST = čas od randomizacije do prvega nadaljnjega zdravljenja proti raku ali smrti.
There are no animal studies on the excretion of olaparib in breast milk.
Študij na živalih o izločanju olapariba v mleko ni. Ni znano, ali se olaparib ali njegovi presnovki izločajo v materino mleko.
The median PFS improvement was 6.9 months over placebo for olaparib-treated patients (HR 0.18; 95% CI 0.10-0.31; p<0.00001; median 11.2 months versus 4.3 months).
Mediano podaljšanje PFS v primerjavi s placebom je bilo med bolnicami, ki so prejemale olaparib, 6,9 meseca (ROg 0,18; 95 % IZ: 0,10 do 0,31, p < 0,00001; mediana 11,2 meseca v primerjavi s 4,3 meseci).
Distribution The in vitro protein binding is approximately 82% at clinically relevant concentrations of 10 µg/mL.
Porazdelitev Ob klinično pomembni koncentraciji 10 µg/ml je vezava na beljakovine in vitro približno 82 %.
Adverse drug reactions are listed by MedDRA System Organ Class (SOC) and then by MedDRA preferred term in Table 1.
Neželeni učinki zdravila so navedeni v preglednici 1 po organskih sistemih MedDRA in prednostnih izrazih po MedDRA.
• indigestion or heartburn (dyspepsia)
• težave z želodcem ali zgaga (dispepsija)
The study compared the efficacy of Lynparza capsule maintenance treatment (400 mg [8 x 50 mg capsules] twice daily) taken until progression with placebo treatment in 265 (136 olaparib and 129 placebo) PSR high grade serous ovarian cancer patients who were in response (CR or PR) following completion of platinum-containing chemotherapy.
Študija je primerjala učinkovitost vzdrževalnega zdravljenja s kapsulami zdravila Lynparza (400 mg [8 x 50-mg kapsul] dvakrat na dan), uporabljanimi do napredovanja bolezni, in placeba pri 265 PSR bolnicah s slabo diferenciranim seroznima rakom jajčnikov (136 na olaparibu in 129 na placebu), ki so bile v odzivu (CR ali PR) po dokončanju kemoterapije na osnovi platine.
Lynparza is contraindicated during breast-feeding and for 1 month after receiving the last dose, given the pharmacologic property of the product (see section 4.3).
Zdravilo Lynparza je kontraindicirano med obdobjem dojenja in, glede na farmakološke lastnosti, še en mesec po prejetju zadnjega odmerka (glejte poglavje 4.3).
HR (95% CI) P value* (2-sided)
ROg (95 % IZ) Vrednost p* (2-stranska)
Lynparza 100 mg tablets are yellow to dark yellow, oval, bi-convex, film-coated tablets, marked with “OP100” on one side and plain on the other.
100 mg tablete zdravila Lynparza so rumene do temno rumene, ovalne, bikonveksne, filmsko obložene tablete z oznako "OP100" na eni strani in brez oznak na drugi strani.
bd Twice daily; PFS progression-free survival; CI confidence interval
PFS = preživetje brez napredovanja bolezni, IZ = interval zaupanja
In the olaparib-treated group, 23.5% (n=32/136) of patients remained on treatment for ≥2 years as compared with 3.9% (n=5/128) of the patients on placebo.
V skupini, zdravljeni z olaparibom, je na zdravljenju ≥ 2 leti ostalo 23,5 % (n = 32/136) bolnic, v skupini s placebom pa 3,9 % (n = 5/128) bolnic.
Table 2 Efficacy results for newly diagnosed patients with BRCA1/2m advanced ovarian cancer in SOLO1
Rezultati učinkovitosti pri na novo diagnosticiranih bolnicah z napredovalim rakom jajčnikov in BRCA1/2m v študiji SOLO1
Women of childbearing potential must use two forms of reliable contraception before starting Lynparza therapy, during therapy and for 1 month after receiving the last dose of Lynparza, unless abstinence is the chosen method of contraception (see section 4.4).
Ženske v rodni dobi morajo pred začetkom zdravljenja z zdravilom Lynparza, med zdravljenjem z zdravilom Lynparza in še en mesec po prejetju zadnjega odmerka uporabljati dve obliki zanesljive kontracepcije, razen če je izbrana metoda kontracepcije abstinenca (glejte poglavje 4.4).
Patients can continue treatment until radiological disease progression, unacceptable toxicity or for up to 2 years if there is no radiological evidence of disease after 2 years of treatment.
Prva linija vzdrževalnega zdravljenja napredovalnega raka jajčnikov z mutacijo gena BRCA: Bolnice lahko nadaljujejo zdravljenje do radiološkega napredovanja bolezni, nesprejemljive toksičnosti ali do največ 2 leti, če po 2 letih zdravljenja ni radioloških znakov bolezni.
The study compared the efficacy of Lynparza maintenance treatment (300 mg [2 x 150 mg tablets] twice daily) taken until progression with placebo treatment in 295 patients with high-grade serous or endometrioid PSR ovarian cancer (2:1 randomisation: 196 olaparib and 99 placebo) who were in response (CR or PR) following completion of platinum-containing chemotherapy.
Študija je primerjala učinkovitost vzdrževalnega zdravljenja z zdravilom Lynparza (300 mg [dve 150-mg tableti] dvakrat na dan), uporabljanim do napredovanja bolezni, in uporabo placeba pri 295 bolnicah s slabo diferenciranim seroznim ali endometrioidnim PSR rakom jajčnikov (randomizacija v razmerju 2:1: 196 olaparib, 99 placebo), ki so bile v odzivu (popolnem odzivu [CR] ali delnem odzivu [PR]) po dokončanju kemoterapije na osnovi platine.
Male patients should not donate sperm during therapy and for 3 months after receiving the last dose of Lynparza.
Moški bolniki med zdravljenjem z zdravilom Lynparza in še 3 mesece po zadnjem odmerku tega zdravila ne smejo darovati sperme.
Within the BRCA-mutated population the disease control rate at 24 weeks was 57% and 24% for patients in the olaparib and placebo groups, respectively.
V populaciji z mutacijo gena BRCA je bil po 24 tednih delež obvladanja bolezni v skupini z olaparibom 57 % in v skupini s placebom 24 %.
The primary endpoint was PFS (progression-free survival) based on investigator assessment using RECIST 1.0.
Primarni cilj študije je bilo preživetje brez napredovanja bolezni (PFS - progression-free survival) na podlagi raziskovalčeve ocene in z uporabo RECIST 1.0.
A summary of the primary objective outcome for patients with gBRCA1/2m PSR ovarian cancer in SOLO2 is presented in Table 3 and Figure 3.
Povzetek izida primarnega cilja pri PSR bolnicah z rakom jajčnikov in gBRCA1/2m v študiji SOLO2 prikazujeta preglednica 3 in slika 3.
Although patient numbers were limited, 13.2% (n=18/136) of the patients in the olaparib-treated group remained on treatment for ≥5 years as compared with 0.8% (n=1/128) in the placebo group.
Čeprav je bilo število bolnic majhno, je v skupini, ki je prejemala olaparib, ≥ 5 let ostalo na zdravljenju 13,2 % (n = 18/136) bolnic, v skupini, ki je prejemala placebo, pa 0,8 % (n = 1/128) bolnic.
Dyspnoea includes PTs of dyspnoea and dyspnoea exertional; Stomatitis includes PTs of aphthous ulcer, mouth ulceration and stomatitis.
Stomatitis vključuje prednostne izraze aftozni ulkus, razjeda v ustih in stomatitis.
Patients with PR at study entry had PFS HR 0.31 (95% CI 0.18, 0.52; median PFS 30.9 months on olaparib vs 8.4 months on placebo).
Bolnice, ki so imele ob vstopu v študijo delen odziv (PR), so imele ROg za PFS 0,31 (95 % IZ 0,1 do, 0,52; mediano PFS z olaparibom je bilo 30,9 meseca in s placebom 8,4 meseca).
There are no data in patients with severe impairment or end-stage renal disease (creatinine clearance <30 ml/min).
Podatkov pri bolnikih s hudo okvaro ledvic ali končno odpovedjo ledvic (očistek kreatinina < 30 ml/min) ni.
Most patients were ECOG performance status 0 (81%), there are no data in patients with performance status 2 to 4.
Večina bolnic je imela stanje zmogljivosti po ECOG 0 (81 %); kliničnih podatkov pri bolnicah s stanjem zmogljivosti od 2 do 4 ni.
Keep doing so for as long as your doctor, pharmacist or nurse tells you to.
Z jemanjem zdravila nadaljujte toliko časa, kot vam naroči zdravnik, farmacevt ali medicinska sestra.
Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum-based chemotherapy.
Zdravilo Lynparza je indicirano kot monoterapija za vzdrževalno zdravljenje odraslih bolnic z mutacijo gena BRCA (germinalno ali somatsko), pri katerih je prišlo do ponovitve seroznega epitelijskega raka visokega gradusa z izvorom v jajčnikih, jajcevodih ali peritoneju, občutljivega na platino, ki so v popolnem ali delnem odzivu na kemoterapijo na osnovi platine.
Figure 3 SOLO2: Kaplan-Meier plot of PFS in patients with gBRCA1/2m PSR ovarian cancer (63% maturity - investigator assessment)
Slika 3 SOLO2: Kaplan-Meierjevi krivulji preživetja brez napredovanja bolezni pri PSR bolnicah PSR rakom jajčnikov in z gBRCA1/2m (63 % zrelost - raziskovalčeva ocena)
No statistically significant differences were observed between olaparib and placebo in patient reported symptoms or HRQoL as measured by improvement and worsening rates in the FACT/NCCN Ovarian Symptom Index (FOSI), Trial Outcome Index (TOI) and Functional Analysis of Cancer TherapyOvarian total score (FACT-O total).
(FACT/NCCN Ovarian Symptom Index), indeksa TOI (Trial Outcome Index) in celotne ocene FACT-O (Functional Analysis of Cancer Therapy-Ovarian total).
In the olaparib arm 55% of the patients had only 2 prior lines of treatment with 45% receiving 3 or more prior lines of treatment.
V skupini z olaparibom je imelo 55 % bolnic le 2 predhodni liniji zdravljenja, 45 % pa jih je predhodno prejemalo 3 linije zdravljenja ali več.
Lynparza is not recommended for use in patients with severe renal impairment or end-stage renal disease (creatinine clearance ≤ 30 ml/min), as safety and pharmacokinetics have not been studied in these patients.
Uporaba zdravila Lynparza se ne priporoča pri bolnikih s hudo okvaro ledvic ali končno odpovedjo ledvic (očistek kreatinina ≤ 30 ml/min), ker varnost in farmakokinetika pri tej skupini bolnikov nista bili raziskani.
bd Twice daily; OS Overall survival; DCO data cut off; CI confidence interval; TFST time from randomisation to start of first subsequent therapy or death.
OS = celokupno preživetje, DCO = datum zamejitve podatkov, IZ = interval zaupanja TFST = čas od randomizacije do začetka prvega nadaljnjega zdravljenja ali smrti.
For the secondary endpoint of OS, the HR for olaparib versus placebo was 0.62 (95% CI 0.42-0.93; p=0.02140; median 34.9 months versus 30.2 months) (Table 2).
Za sekundarni cilj študije celokupno preživetje je bilo razmerje ogroženosti med olaparibom in placebom 0,62 (95 % IZ: 0,42 do 0,93, p = 0,02140; mediana 34,9 meseca v primerjavi z 30,2 meseca) (preglednica 2).
The safety and efficacy of olaparib as maintenance therapy were studied in a Phase III randomised, double-blind, placebo-controlled trial in patients with germline BRCA1/2-mutated PSR ovarian, fallopian tube or primary peritoneal cancer.
Varnost in učinkovitost olapariba kot vzdrževalnega zdravljenja so raziskali v randomiziranem, dvojno slepem, s placebom kontroliranem preizkušanju III. faze pri bolnicah, ki so imele PSR raka jajčnikov, jajcevodov ali primarnega peritonealnega raka z germinalno mutacijo gena BRCA1/2.
--------------Placebo bd - - - - - - - - - Olaparib 400 mg bd Number of patients at risk:
-------------- placebo dvakrat na dan - - - - - - - - - olaparib 400 mg dvakrat na dan Število ogroženih bolnic:
No Lynparza dose adjustment is required for patients with mild renal impairment.
Odmerka zdravila Lynparza pri bolnikih z blago okvaro ledvic ni treba prilagoditi.
In the placebo arm 61% of patients had received only 2 prior lines with 39% receiving 3 or more prior lines of treatment.
V skupini s placebom je 61 % bolnic prejemalo le 2 predhodni liniji zdravljenja, 39 % pa jih je predhodno prejemalo 3 linije zdravljenja ali več.
A total of 32 (23.5%) patients received treatment for ≥2 years in the olaparib group compared with 5 (3.9%) patients in the placebo group.
V skupini z olaparibom je zdravljenje ≥ 2 leti prejemalo skupaj 32 (23,5 %) bolnic, v skupini s placebom pa 5 (3,9 %) bolnic.
N Number of events/number of randomised patients; bd Twice daily; OS Overall survival; PFS Progression-free survival; CI Confidence interval; DCO Data cut off; TSST Time from randomisation to start of second subsequent therapy or death.
N: število dogodkov/število randomiziranih bolnic, OS: celokupno preživetje, PFS: preživetje brez napredovanja bolezni, IZ: interval zaupanja, DCO: datum zamejitve podatkov, TSST: čas od randomizacije do začetka drugega nadaljnjega zdravljenja ali smrti.
Lynparza may influence your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Lynparza lahko vpliva na vašo sposobnost upravljanja vozil in strojev.
Lynparza 50 mg hard capsules
Lynparza 50 mg trde kapsule
Each film-coated tablet contains 100 mg of olaparib.
Ena filmsko obložena tableta vsebuje 100 mg olapariba.
gBRCA1/2-mutated HER2-negative metastatic breast cancer:
HER2-negativen metastatski rak dojk z mutacijo gBRCA1/2
At 24 and 36 months, respectively, 68% and 45% patients remained in CR in the olaparib arm, and 34% and 22% of patients in the placebo arm.
Po 24 mesecih je ostalo v popolnem odzivu (CR) 68 % bolnic v skupini z olaparibom in 45 % v skupini s placebom, po 36 mesecih pa je bil ta delež 34 % v skupini z olaparibom in 22 % v skupini s placebom.
In the olaparib arm 44% of the patients had only 2 prior lines of treatment with 56% receiving 3 or more prior lines of treatment.
V skupini z olaparibom je imelo 44 % bolnic le 2 predhodni liniji zdravljenja, 56 % pa jih je predhodno prejemalo 3 linije zdravljenja ali več.
Most patients were ECOG performance status 0 (77%), there are no data in patients with performance status 2 to 4.
Večina bolnic je imela stanje zmogljivosti po ECOG 0 (77 %), kliničnih podatkov pri bolnicah s stanjem zmogljivosti od 2 do 4 ni.
If you are having sex, you should use two effective methods of contraception while taking this medicine and for 1 month after taking the last dose of Lynparza.
Če imate spolne odnose, morate med jemanjem zdravila Lynparza in še en mesec po vzetju zadnjega odmerka zdravila Lynparza uporabljati dve učinkoviti metodi kontracepcije.
For patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min) the recommended dose of Lynparza is 200 mg (two 100 mg tablets) twice daily (equivalent to a total daily dose of 400 mg) (see section 5.2).
Priporočeni odmerek zdravila Lynparza za bolnike z zmerno okvaro ledvic (očistek kreatinina 31 do 50 ml/min) je 200 mg (dve 100-mg tableti) dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 400 mg) (glejte poglavje 5.2).
These findings occurred at exposures below those seen clinically.
Pri podganah so opazili tudi minimalne degenerativne učinke na prebavila.Te spremembe so se pojavile pri izpostavljenostih, ki so bile nižje od klinično opaženih.
0 Olaparib 300 mg bd 0 Placebo bd
olaparib 300 mg 2x/dan placebo
Sixty-three percent (63%) of the patients had upfront debulking surgery and of these the majority (75%) had no macroscopic residual disease.
Večina bolnic (78 %) je imela stanje zmogljivosti po ECOG 0, podatkov pri bolnicah s stanjem zmogljivosti od 2 do 4 ni. Triinšestdeset odstotkov (63 %) bolnic je imelo predhodno operacijo za zmanjšanje tumorja in večina od teh (75 %) ni imela makroskopsko vidnih ostankov bolezni.
The study met its primary objective demonstrating a statistically significant improvement in investigator assessed PFS for olaparib compared with placebo with a HR of 0.30 (95% CI 0.22-0.41; p<0.0001; median 19.1 months olaparib vs 5.5 months placebo).
Študija je dosegla svoj primarni cilj in je dokazala statistično značilno izboljšanje raziskovalčeve ocene PFS z olaparibom v primerjavi s placebom z ROg 0,30 (95 % IZ 0,22 do 0,41, p < 0,0001, mediana 19,1 mesecev z olaparibom in 5,5 meseca s placebom).
Patients with BRCA1/2 mutations were identified from germline testing in blood via a local test or by central testing at Myriad.
Bolnike z mutacijami gena BRCA1/2 so identificirali s testiranjem germinalne linije v krvi bodisi z lokalnim testom bodisi s centralnim testom na Myriad.
At the final OS analysis (data cut off [DCO] 9 May 2016) at 79% maturity, the hazard ratio comparing olaparib with placebo was 0.73 (95% CI 0.55-0.95; p=0.02138 [did not meet pre-specified significance level of <0.0095]; median 29.8 months olaparib versus 27.8 months placebo).
Ob končni analizi (datum zamejitve podatkov (DCO - data cut off) 9. maj 2016) je bilo za celokupno preživetje ob 79 % zrelosti razmerje ogroženosti med olaparibom in placebom 0,73 (95 % IZ 0,55 do 0,95, p = 0,02138 [ni doseglo vnaprej določene ravni značilnosti < 0,0095], mediana 29,8 meseca z olaparibom in 27,8 meseca s placebom).
If a further dose reduction is required, then reduction to 200 mg (two 100 mg tablets) twice daily (equivalent to a total daily dose of 400 mg) is recommended.
Če je potrebno še dodatno zmanjšanje odmerka, je priporočljivo zmanjšanje na 200 mg (dve 100-mg tableti) dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 400 mg).
HR
ND
There was no evidence of disease at study entry (CR), defined by the investigator as no radiological evidence of disease and cancer antigen 125 (CA-125) within normal range, in 73% and 77% of patients in the olaparib and placebo arms, respectively.
73 % bolnic v skupini z olaparibom in 77 % bolnic v skupini s placebom ni imelo nobenih dokazov bolezni ob vstopu v študijo (CR), opredeljeno kot odsotnost radioloških znakov bolezni po raziskovalčevi oceni in raven antigena CA-125 v normalnem območju.
For patients with moderate renal impairment (creatinine clearance 31 to 50 ml/min) the recommended dose of Lynparza is 300 mg twice daily (equivalent to a total daily dose of 600 mg) (see section 5.2).
Priporočeni odmerek zdravila Lynparza za bolnice z zmerno okvaro ledvic (očistek kreatinina 31 do 50 ml/min) je 300 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 600 mg) (glejte poglavje 5.2).
The recommended Lynparza dose reduction is to 150 mg taken twice daily (equivalent to a total daily dose of 300 mg) with a strong CYP3A inhibitor or 200 mg taken twice daily (equivalent to a total daily dose of 400 mg) with a moderate CYP3A inhibitor (see sections 4.2 and 4.4).
Priporočeno zmanjšanje odmerka zdravila Lynparza je 150 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 300 mg) v primeru uporabe z močnim zaviralcem CYP3A ali 200 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 400 mg) v primeru uporabe z zmernim zaviralcem CYP3A (glejte poglavji 4.2 in 4.4).
A summary of key secondary objective outcomes for patients with BRCA1/2-mutated and BRCA1/2 wt/VUS PSR ovarian cancer in Study 19 is presented in Table 6 and for all patients in Study 19 in Table 6 and Figure 5.
Povzetek izidov ključnih sekundarnih ciljev za PSR bolnice z rakom jajčnikov in z mutacijo gena BRCA1/2 in BRCA1/2 wt/VUS v študiji 19 je prikazan v preglednici 6, za vse bolnice v študiji 19 pa v preglednici 6 in na sliki 5.
Patients with BRCA1/2 mutations were identified either from germline testing in blood via a local test or by central testing at Myriad or from testing a tumour sample using a test performed by Foundation Medicine.
Bolnice z mutacijami gena BRCA1/2 so identificirali bodisi s testiranjem germinalne linije v krvi z lokalnim testom bodisi s centralnim testom na Myriad ali s testiranjem vzorca tumorja s testom, izvedenim s strani Foundation Medicine.
Patient-reported outcome (PRO) data indicate no difference for the olaparib-treated patients as compared to placebo as assessed by the change from baseline in the TOI of the FACT-O.
Podatki o izidu po navedbi bolnic (PRO - patient-reported outcome) na podlagi spremembe indeksa TOI (Trial Outcome Index) lestvice FACT-O (Functional Analysis of Cancer Therapy - Ovarian) od izhodišča ne kažejo razlik med prejemnicami olapariba in prejemnicami placeba.
Median time (months) (95% CI)
Mediani čas (meseci) (95% IZ)
The recommended Lynparza dose reduction is to 100 mg taken twice daily (equivalent to a total daily dose of 200 mg) with a strong CYP3A inhibitor or 150 mg taken twice daily (equivalent to a total daily dose of 300 mg) with a moderate CYP3A inhibitor (see sections 4.2 and 4.4).
Priporočeno zmanjšanje odmerka zdravila Lynparza je 100 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 200 mg) v primeru uporabe z močnim zaviralcem CYP3A ali 150 mg dvakrat na dan (to ustreza celotnemu dnevnemu odmerku 300 mg) v primeru uporabe z zmernim zaviralcem CYP3A (glejte poglavji 4.2 in 4.4).
A total of 18 (13.2%) patients received treatment for ≥5 years in the olaparib group compared with 1 (0.8%) patient in the placebo group.
V skupini z olaparibom je zdravljenje ≥ 5 let prejemalo skupaj 18 (13,2 %) bolnic, v skupini s placebom pa 1 (0,8 %) bolnica.
Multipack containing 112 (2 packs of 56) film-coated tablets.
Skupno pakiranje s 112 filmsko obloženimi tabletami (2 pakiranji po 56).
The investigator assessment of PFS was consistent with a blinded independent central radiological review of PFS. At the final analysis (DCO 9 May 2016), the time from randomisation to start of first subsequent therapy or death (TFST) was 9.4 months longer for olaparib-treated patients (HR 0.33; 95% CI 0.22-0.49; p<0.00001; median 15.6 months versus 6.2 months).
Ob končni analizi (DCO 9. maj 2016) je bil čas od randomizacije do začetka prvega nadaljnjega zdravljenja ali smrti (TFST) med prejemnicami olapariba 9,4 meseca daljši (ROg 0,33; 95 % IZ: 0,22 do 0,49, p < 0,00001; mediana 15,6 meseca v primerjavi s 6,2 meseca).
Lynparza 100 mg film-coated tablets Each film-coated tablet contains 100 mg olaparib.
Lynparza 100 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 100 mg olapariba.
o A test is used to find out whether you have BRCA-mutated breast cancer.
o Za ugotavljanje tega, ali imate raka dojk z mutacijo BRCA, se uporablja poseben test.
In the placebo arm 49% of patients had received only 2 prior lines with 51% receiving 3 or more prior lines of treatment.
V skupini s placebom je 49 % bolnic prejemalo le 2 predhodni liniji zdravljenja, 51 % pa jih je predhodno prejemalo 3 linije zdravljenja ali več.