FrancophonIA/ELRC3.0 huggingface dataset:
English: This leaflet was last revised in <{MM/YYYY}> Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Denne indlægsseddel blev senest ændret <{MM/YYYY}> Du kan finde yderligere oplysninger om Zelboraf på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: The efficacy of vemurafenib has been evaluated in 336 patients from a phase III clinical trial (NO25026) and 278 patients from two phase II clinical trials (NP22657 and MO25743).
Danish: Virkningen af vemurafenib er blevet vurderet hos 336 patienter fra et klinisk fase III-studie (NO25026) og 278 patienter fra to kliniske fase II-studier (NP22657 og MO25743).
English: In an in vitro bone marrow cytotoxicity study, slight cytotoxicity was observed in some lympho-haematopoietic cell populations of rat, dog and human at clinically relevant concentrations.
Danish: I et in vitro cytotoksicitetsstudie af knoglemarven blev der observeret mindre cytotoksicitet i nogle lymfo-hæmatopoietiske cellepopulationer hos rotte, hund og menneske ved klinisk relevante koncentrationer.
English: Surveillance for non-cuSCC should occur as outlined in section 4.4.
Danish: Kontrol for non-cuSCC bør foregå som beskrevet i pkt.
English: PHARMACEUTICAL FORM AND CONTENTS 56 x 1 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 56 x 1 filmovertrukket tablet
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: · på anmodning fra Det Europæiske Lægemiddelagentur · når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Results from the phase II study (NP22657) in patients who failed at least one prior therapy
Danish: Resultater fra fase II- studiet (NP22657) hos patienter med mindst en mislykket tidligere behandling
English: In a phase III clinical trial (MO25515, N= 3219), a higher incidence of potentiation of radiation toxicity was reported when vemurafenib patients received radiation prior to and during vemurafenib therapy (9.1%) compared to those patients who received radiation and vemurafenib concomitantly (5.2 %) or to those whose radiation treatment was prior to vemurafenib (1.5%).
Danish: I et fase III-studie (MO25515, n=3.219) blev der rapporteret højere frekvens af forværring af stråletoksicitet når vemurafenib patienter fik strålebehandling før og under vemurafenib-behandling (9,1%) sammenlignet med patienter som fik strålebehandling samtidig med vemurafenib (5,2 %) eller med patienter som fik strålebehandling før vemurafenib-behandling (1,5%).
English: BORR extracranial n (%)a
Danish: Bedste samlede ekstrakraniel responsrate n (%)a
English: In addition, patients should undergo a chest Computerised Tomography (CT) scan, prior to treatment and every 6 months during treatment.
Danish: Yderligere bør patienterne få foretaget en computer tomografi (CT)-scanning af brystkassen før igangsættelse af behandling og hver 6. måned under behandlingen.
English: They are available in aluminium perforated unit dose blisters in packs of 56 x 1 tablets.
Danish: De fås i aluminium perforeret enkeltdosis blister i pakninger med 56 x 1 tablet.
English: Management of adverse drug reactions or QTc prolongation may require dose reduction, temporary interruption and/or treatment discontinuation (see tables 1 and 2).
Danish: Håndtering af bivirkninger eller QTc-forlængelse kan kræve en dosisreduktion, midlertidig afbrydelse og/eller seponering af behandlingen (se tabel 1 og 2).
English: QT prolongation may lead to an increased risk of ventricular arrhythmias including Torsade de Pointes.
Danish: QT-forlængelse kan medføre øget risiko for ventrikulære arytmier inklusive torsades de pointes-takykardi.
English: The population elimination half-life estimated by the population PK analysis for vemurafenib is 51.6 hours (the 5th and 95th percentile range of the individual half-life estimates is 29.8 - 119.5 hours).
Danish: Populationseliminationshalveringstiden estimeret ved den populationsfarmakokinetiske analyse for vemurafenib er 51,6 timer (det 5. og 95. percentil-interval for de individuelle estimater for halveringstid er 29,8119,5 timer).
English: In the phase II study, AUC0-8h and Cmax at day 1 were 22.1 ± 12.7 µg⋅h/mL and 4.1 ± 2.3 µg/mL.
Danish: I fase II-studiet var AUC0-8t og Cmax ved dag 1 henholdsvis 22,1 ± 12,7 µg·t/ml og 4,1 ± 2,3 µg/ml.
English: dacarbazine 75 (22)
Danish: Dacarbazin 75 (22)
English: The primary efficacy objective of the study was best overall response rate (BORR) in the brain of metastatic melanoma patients with previously untreated brain metastases, as assessed by an independent review committee (IRC).
Danish: Studiets primære effektmål var den bedste samlede responsrate i hjernen hos patienter med metastatisk melanom, som ikke tidligere havde fået behandling for hjernemetastaser, vurderet af en uafhængig vurderingskomité (IRC).
English: Results from the phase II study (MO25743) in patients with brain metastases
Danish: Resultater fra fase II-studiet (MO25743) hos patienter med hjernemetastaser
English: dacarbazine 236 (70)
Danish: Dacarbazin 236 (70)
English: The effect of food on steady state vemurafenib exposure is currently unknown.
Danish: Virkningen af mad på steady-state eksponeringen af vemurafenib er ikke kendt på nuværende tidspunkt.
English: ● The recommended dose is 4 tablets twice a day (a total of 8 tablets).
Danish: Hvor mange tabletter skal du tage · Den anbefalede dosis er 4 tabletter to gange dagligt (sammenlagt 8 tabletter).
English: Analysis of centralised ECG data from an open-label uncontrolled phase II QT sub-study in 132 patients dosed with vemurafenib 960 mg twice daily (NP22657) showed an exposure-dependent QTc prolongation.
Danish: Analyse af centraliserede ekg-data fra et open-label, ukontrolleret, fase II QT-substudie hos 132 patienter doseret med vemurafenib 960 mg to gange dagligt (NP22657) viste en eksponeringsafhængig QTc-forlængelse.
English: A risk for increased exposure in patients with severe renal impairment cannot be excluded.
Danish: Der kan ikke udelukkes en risiko for øget eksponering hos patienter med svær nedsat nyrefunktion.
English: They should not be chewed or crushed.
Danish: Tabletterne bør ikke tygges eller knuses.
English: Non-censored results at time of cross-over: March 31 2011: HR (95% CI) = 0.47 (0.35, 0.62); October 3 2011: HR (95% CI) = 0.67 (0.54, 0.84); February 1 2012: HR (95% CI) = 0.76 (0.63, 0.93); December 20 2012: HR (95% CI) = 0.79 (0.66, 0.95)
Danish: Ikke-censurerede resultater på overkrydsningstidspunktet [Hazard ratio (95 % konfidensinterval)]: 31. marts 2011: 0,47 (0,35-0,62); 3. oktober 2011: 0,67 (0,54-0,84); 1. februar 2012: 0,76 (0,63-0,93); 20. december 2012:
English: Table 10: Efficacy of vemurafenib in patients with brain metastases
Danish: Tabel 10: Vemurafenibs effekt hos patienter med hjernemetastaser
English: Co-administration of itraconazole, a strong CYP3A4/Pgp inhibitor, increased steady state vemurafenib AUC by approximately 40%.
Danish: Samtidig anvendelse af itraconazol, en kraftig CYP3A4/P-gp-hæmmer, øgede steady-state af vemurafenib AUC med ca. 40%.
English: The recommended dose of vemurafenib is 960 mg (4 tablets of 240 mg) twice daily (equivalent to a total daily dose of 1,920 mg).
Danish: Den anbefalede dosis af vemurafenib er 960 mg (4 tabletter á 240 mg) to gange dagligt (svarende til en total daglig dosis på 1.920 mg).
English: The effects of P-gp and BCRP inhibitors that are not also strong CYP3A4 inhibitors are unknown.
Danish: Indvirkningen af P-gp- og BCRP-hæmmere, som ikke også er kraftige CYP3A4-hæmmere er ikke kendt.
English: Reversible toxic effects (hepatocellular necrosis and degeneration) in the liver at exposures below the anticipated clinical exposure (based on AUC comparisons) were noted in the 13-week dog study.
Danish: Reversible toksiske virkninger (hepatocellulær nekrose og degeneration) i leveren ved eksponeringer under den forventede kliniske eksponering (baseret på AUC sammenligninger) blev bemærket i et 13-ugers studie hos hunde.
English: Monitoring should continue for 6 months following discontinuation of vemurafenib or until initiation of another anti-neoplastic therapy.
Danish: Monitorering bør fortsætte i 6 måneder efter seponering af vemurafenib eller indtil igangsættelse af anden antineoplastisk behandling.
English: Mild induction of CYP2B6 by vemurafenib was noted in vitro at a vemurafenib concentration of 10 µM.
Danish: Der blev observeret en mild induktion af CYP2B6 in vitro ved en vemurafenib-koncentration på 10 µM.
English: Effect of other medicinal products on vemurafenib
Danish: Virkning af andre lægemidler på vemurafenib
English: Liver enzymes (transaminases and alkaline phosphatase) and bilirubin should be measured before initiation of treatment and monitored monthly during treatment, or as clinically indicated.
Danish: Leverenzymer (aminotransferaser og alkalisk fosfatase) og bilirubin bør måles før behandlingsstart og monitoreres månedligt under behandlingen eller som klinisk indiceret.
English: Monitor patients routinely for ophthalmologic reactions.
Danish: Patienter skal monitoreres rutinemæssigt for øjenreaktioner.
English: The most common (≥ 5%) Grade 3 ADRs were cuSCC, keratoacanthoma, rash, arthralgia and gamma-glutamyltransferase (GGT) increased.
Danish: De mest almindelige bivirkninger (≥ 5%) af grad 3 var cuSCC, keratoakantom, udslæt, artralgi og øget gamma-glutamyltransferase (GGT).
English: No data are available in patients with melanoma harbouring rare BRAF V600 mutations other than V600E and V600K.
Danish: Der er ingen data tilgængelige for patienter med melanom med andre sjældne BRAF-V600-mutationer end V600E og V600K.
English: No adjustment to the starting dose is needed for patients with mild or moderate renal impairment.
Danish: Det er ikke nødvendigt at justere startdosis for patienter med let eller moderat nedsat nyrefunktion.
English: This can occur on the area that was treated with radiation, such as the skin, esophagus, bladder, liver, rectum, and lungs.
Danish: Dette kan forekomme på områder, som er blevet behandlet med stråler, såsom huden, spiserøret, blæren, leveren, endetarmen og lungerne.
English: Repeat-dose toxicology studies identified the liver and bone marrow as target organs in the dog.
Danish: Studier af toksicitet efter gentagne doser identificerede leveren og knoglemarven som de organer, som toksicitet er rettet mod hos hunden.
English: Concomitant administration of strong CYP3A4 inhibitors or inducers or inhibitors/inducer of transport protein activity may alter vemurafenib concentrations.
Danish: Samtidig administration af kraftige CYP3A4 hæmmere eller induktorer eller hæmmere/induktorer af transport protein aktiviteten kan ændre vemurafenibs koncentrationer.
English: Vemurafenib moderately inhibited CYP2C8 in vitro.
Danish: Vemurafenib hæmmede CYP2C8 in vitro moderat.
English: Nine of the 132 patients enrolled into NP22657 had V600K mutation-positive tumours according to retrospective Sanger sequencing.
Danish: 9 ud af 132 patienter i NP22657 havde V600K-mutationspositive tumorer vist ved retrospektive Sanger-sekventering.
English: ● Do not take Zelboraf regularly on an empty stomach.
Danish: Hvordan skal du tage tabletterne · Tag ikke Zelboraf regelmæssigt på tom mave.
English: Limited pharmacokinetic data from six adolescent patients aged between 15 and 17 years with stage IIIC or IV BRAF V600 mutation positive melanoma suggest that vemurafenib pharmacokinetic characteristics in adolescents are generally similar to those in adults.
Danish: Begrænsede farmakokinetiske data fra 6 unge patienter mellem15 og 17 år med stadie IIIC eller IV BRAF-V600-mutationspositivt melanom tyder på, at vemurafenibs farmakokinetiske egenskaber hos unge generelt er sammenlignelige med de farmakokinetiske egenskaber hos voksne.
English: Serious ophthalmologic reactions, including uveitis, iritis and retinal vein occlusion, have been reported.
Danish: Der er blevet rapporteret alvorlige øjenreaktioner, herunder uveitis, iritis og retinal veneokklusion.
English: Most lesions classified as “other” (43%) were benign skin lesions (e.g. verruca vulgaris, actinic keratosis, benign keratosis, cyst/benign cyst).
Danish: De fleste læsioner, der blev klassificeret som ”andet” (43 %), var benigne hudlæsioner (f.eks. vorter, aktinisk keratose, benign keratose, cyste/benign cyste).
English: No signs of genotoxicity were identified in in vitro assays (bacterial mutation [AMES Assay], human lymphocyte chromosome aberration) nor in the in vivo rat bone marrow micronucleus test conducted with vemurafenib.
Danish: Der blev ikke identificeret tegn på genotoksicitet i in vitro assays (bakteriel mutation [AMES Assay], human lymfocytkromosomaberration) eller i in vivo kernelegmetest af knoglemarv hos rotter udført med vemurafenib.
English: Symptoms of allergic reactions may include swelling of the face, lips or tongue, difficulty breathing, rash, or fainting sensation.
Danish: Symptomer på allergiske reaktioner kan inkludere hævelse af ansigt, læber eller tunge, åndedrætsbesvær, udslæt eller besvimelsesfornemmelse.
English: The pharmacokinetic parameters for vemurafenib were determined using non-compartmental analysis in a phase I and phase III studies (20 patients after 15 days of dosing at 960 mg twice daily, and 204 patients in steady state day 22) as well as by population PK analysis using pooled data from 458 patients.
Danish: De farmakokinetiske parameter for vemurafenib blev bestemt ved anvendelse af en non-kompartment analyse i fase I- og fase III-studier (20 patienter efter 15 dages dosering på 960 mg to gange dagligt og 204 patienter i steady-state ved dag 22) såvel som ved populationsfarmakokinetisk analyse, som brugte sammenlagte data fra 458 patienter.
English: Do not use Zelboraf after the expiry date which is stated on the carton and the blister after EXP.
Danish: Brug ikke Zelboraf efter den udløbsdato, der står på pakningen og blister efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: A total of 57 patients out of 673 whose tumours were analysed retrospectively by sequencing were reported to have BRAF V600K mutation-positive melanoma in NO25026.
Danish: I alt 57 patienter ud af 673, hvis tumorer retrospektivt blev analyseret ved sekventering, havde BRAFV600K-mutationspositivt melanom i NO25026.
English: ● Use an appropriate method of contraception during your treatment and for at least 6 months after the end of your treatment.
Danish: Graviditet og amning · Brug en passende præventionsmetode under din behandling og i mindst 6 måneder efter din behandling er afsluttet.
English: A clinical drug interaction study demonstrated that multiple oral doses of vemurafenib (960 mg twice daily) increased the exposure of a single oral dose of the P-gp substrate digoxin, approximately 1.8 and 1.5 fold for digoxin AUClast and Cmax, respectively.
Danish: Et klinisk lægemiddelinteraktionsstudie viste, at gentagne orale doser af vemurafenib (960 mg to gange dagligt) øgede eksponeringen af en enkelt oral dosis af P-gp-substratet digoxin henholdsvis ca. 1,8 gange for AUClast og 1,5 gange for Cmax.
English: It cannot be excluded that vemurafenib may increase the exposure of medicines transported by BCRP (e.g. methotrexate, mitoxantrone, rosuvastatin).
Danish: Det kan ikke udelukkes, at vemurafenib kan øge eksponeringen af lægemidler, der transporteres af BCRP (f.eks. methotrexat, mitoxantron, rosuvastatin).
English: Your doctor will also do some blood tests to check your liver and kidney functions before you start taking Zelboraf and during treatment.
Danish: Din læge vil også tage nogle blodprøver for at undersøge din lever- og nyrefunktion før og under behandling med Zelboraf.
English: Results from the Phase III study (NO25026) in previously untreated patients An open-label, multicentre, international, randomised phase III study supports the use of vemurafenib in previously untreated patients with BRAF V600E mutation-positive unresectable or metastatic melanoma.
Danish: Resultater fra fase III-studiet (NO25026) i tidligere ubehandlede patienter Et open-label, multicenter, internationalt, randomiseret fase III-studie understøtter anvendelse af vemurafenib i tidligere ubehandlede patienter med BRAF-V600E-mutationspositivt ikke-operabelt eller metastatisk melanom.
English: The geometric mean ratios between the fed and fasted states for Cmax and AUC were 2.5 and 4.6 to 5.1 fold, respectively.
Danish: Ratio mellem de geometriske middelværdier af Cmax og AUC i ikke-fastende versus fastende tilstand var henholdsvis 2,5-fold og 4,6til 5,1 fold.
English: Stop taking Zelboraf and talk to your doctor immediately if you get a skin rash with any of the following symptoms: blisters on your skin, blisters or sores in your mouth, peeling of your skin, fever, redness or swelling of your face, hands, or soles of your feet.
Danish: Stop med at tage Zelboraf og tal omgående med din læge, hvis du får hududslæt med nogen af de følgende symptomer: Blister på din hud, blister eller sår i din mund, afskalning af din hud, feber, rødme eller hævelse af dit ansigt, dine hænder eller fodsåler.
English: ● Abnormal kidney blood test results (creatinine increased).
Danish: · Unormale blodprøveresultater for nyrefunktionen (stigning i kreatinin).
English: Vemurafenib is absorbed with a median Tmax of approximately 4 hours following a single 960 mg dose (four 240 mg tablets).
Danish: Vemurafenib absorberes med en median Tmax på ca. 4 timer, efter en enkeltdosis på 960 mg (fire 240 mg tabletter).
English: In the non-compartmental analysis, after dosing with 960 mg vemurafenib twice daily the Day 15 / Day 1 ratio ranged from 15- to 17-fold for AUC, and 13to 14-fold for Cmax, yielding AUC0-8h and Cmax of 380.2 ± 143.6 µg⋅h/mL and 56.7 ± 21.8 µg/mL, respectively, under steady-state conditions.
Danish: I non-kompartment analysen efter dosering med 960 mg vemurafenib to gange dagligt vekslede dag 15/dag 1-forholdet fra 15- til 17-fold for AUC og 13- til 14-fold for Cmax, hvilket gav AUC0-8t og Cmax på henholdsvis 380,2 ± 143,6 µg·t/ml og 56,7 ± 21,8 µg/ml ved steady-state betingelser.
English: In vitro studies have demonstrated that vemurafenib is a substrate of the efflux transporters P-gp and BCRP.
Danish: In vitro-studier har vist, at vemurafenib er et substrat for efflux-transporterne P-gp og BCRP.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: 6.6 Regler for bortskaffelse Ikke anvendte lægemidler samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Cases of cuSCC have been reported in patients treated with vemurafenib.
Danish: Der er blevet rapporteret tilfælde af cuSCC hos patienter behandlet med vemurafenib.
English: The safety and efficacy of vemurafenib in children less than 18 years old have not been established.
Danish: Vemurafenibs sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Patients should undergo a head and neck examination, consisting of at least a visual inspection of oral mucosa and lymph node palpation prior to initiation of treatment and every 3 months during treatment.
Danish: Patienterne bør have foretaget en hoved- og halsundersøgelse, der som minimum består af en visuel inspektion af den orale slimhinde og palpering af lymfeknuder før igangsættelse af behandling og hver 3. måned under behandlingen.
English: See monitoring measures in section 4.4.
Danish: Se monitoreringstiltag i pkt.
English: BRAFV600G BRAFV600M BRAFV600A
Danish: BRAFV600D BRAFV600G
English: Table 6: Kinase inhibitory activity of vemurafenib against different BRAF kinases Kinase
Danish: Tabel 6: Vemurafenibs kinasehæmmende aktivitet mod forskellige BRAF-kinaser
English: If co-administration cannot be avoided, it needs to be considered that vemurafenib may decrease plasma concentrations of CYP3A4 substrates and thereby their efficacy may be impaired.
Danish: Hvis samtidig anvendelse ikke kan undgås skal det tages i betragning, at vemurafenib kan nedsætte plasma koncentrationen af CYP3A4 substrater og derved kan deres virkning nedsættes.
English: Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Hydroxypropylcellulose
Danish: Croscarmellosenatrium Silica, kolloid vandfri Magnesiumstearat Hydroxypropylcellulose
English: Basal cell carcinoma, new primary melanoma(3)
Danish: Basalcellekræft, nyt primært melanom(3)
English: Anal examinations and pelvic examinations (for women) are recommended before and at the end of treatment or when considered clinically indicated.
Danish: Analundersøgelser og bækkenundersøgelser (for kvinder) anbefales før og ved afslutning af behandling eller når det anses for klinisk indiceret.
English: Following discontinuation of vemurafenib, monitoring for non-cuSCC should continue for up to 6 months or until initiation of another anti-neoplastic therapy.
Danish: Efter seponering af vemurafenib bør monitorering af non-cuSCC fortsættes i op til 6 måneder eller indtil igangsættelse af anden antineoplastisk behandling.
English: Permanent discontinuation of vemurafenib treatment is recommended if the QTc increase meets values of both >500 ms and >60 ms change from pre-treatment values.
Danish: Permanent seponering af behandling med vemurafenib anbefales, hvis QTc-stigningen når værdier på både > 500 ms og > 60 ms ændring fra værdier før behandlingsstart.
English: Zelboraf may decrease the efficacy of some oral contraceptives.
Danish: Zelboraf kan mindske virkningen af nogle orale præventionsmidler.
English: Potentiation of radiation toxicity(i)
Danish: Forværring af stråletoksicitet(i)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om Zelboraf findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: This inhibitory effect was confirmed in the ERK phosphorylation and cellular anti-proliferation assays in available melanoma cell lines expressing V600-mutant BRAF.
Danish: Denne hæmmende virkning blev bekræftet i ERK-fosforylerings- og cellulære antiproliferationsanalysers i tilgængelige melanom-cellelinjer, som udtrykte v600-muteret BRAF.
English: In a clinical trial, co-administration of vemurafenib decreased the AUC of midazolam (CYP3A4 substrate) by an average 39% (maximum decrease up to 80%).
Danish: I et klinisk forsøg nedsatte samtidig anvendelse af vemurafenib AUC for midazolam (CP3A4 substrat) med gennemsnitlig 39% (maksimal nedsættelse var på 80%).
English: Stop taking Zelboraf and get medical help immediately if you have any symptoms of an allergic reaction such as swelling of the face, lips or tongue, difficulty breathing, rash, or fainting sensation.
Danish: Stop med at tage Zelboraf og søg omgående lægehjælp, hvis du har nogen symptomer på en allergisk reaktion, såsom hævelse af ansigt, læber eller tunge, åndedrætsbesvær, udslæt eller besvimelsesfornemmelse.
English: Exercise caution and consider additional INR (International Normalised Ratio) monitoring when vemurafenib is used concomitantly with warfarin.
Danish: Forsigtighed skal udvises og yderligere INR (international normaliseret ratio)-monitorering overvejes, når vemurafenib anvendes samtidig med warfarin.
English: In animal studies, vemurafenib was found to cross the placenta.
Danish: Dyrestudier viste, at vemurafenib passerer placenta.
English: Most patients were male (56%) and Caucasian (99%), the median age was 54 years (24% were ≥ 65 years), all patients had ECOG performance status of 0 or 1, and the majority of patients had stage M1c disease (65%).
Danish: Den mediane alder var 54 år (24 % var ≥ 65 år), alle patienter have ECOG performance status på 0 eller 1, og størstedelen af patienterne havde stadie M1c-sygdom (65 %).