FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were treated with pembrolizumab until unacceptable toxicity or disease progression.
Danish: Patienterne blev behandlet med pembrolizumab indtil uacceptabel toksicitet eller sygdomsprogression.
English: Median in months (95% CI) PFS
Danish: Median i måneder (95% CI) PFS
English: Overall Response Rate Overall response rate (95% CI) Complete response % Partial response % p-Value
Danish: Samlet responsrate Samlet responsrate (95% CI) Komplet respons % Partielt respons % p-værdi
English: Use of pembrolizumab in urothelial carcinoma patients who have received prior platinum-containing chemotherapy
Danish: Brug af pembrolizumab hos patienter med urotelialt karcinom, som tidligere har fået platinbaseret kemoterapi
English: Pembrolizumab + Axitinib vs. Sunitinib
Danish: Pembrolizumab + Axitinib versus Sunitinib
English: The study excluded patients with autoimmune disease or those receiving immunosuppression; further exclusion criteria were a history of severe or life-threatening immunerelated adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent dose) for greater than 12 weeks; ongoing adverse reactions ≥ Grade 2 from previous treatment with ipilimumab; previous severe hypersensitivity to other monoclonal antibodies; a history of pneumonitis or interstitial lung disease; HIV, hepatitis B or hepatitis C infection and ECOG Performance Status ≥ 2.
Danish: Yderligere eksklusionskriterier var en anamnese med svære eller livstruende immunrelaterede bivirkninger som følge af behandling med ipilimumab, defineret som en hvilken som helst grad 4-toksicitet eller en grad 3-toksicitet, som krævede behandling med kortikosteroider (> 10 mg prednison dagligt eller en dosis ækvivalent hermed) i mere end 12 uger; igangværende bivirkninger ≥ grad 2 fra tidligere behandling med ipilimumab; patienter, der tidligere har haft svær overfølsomhed over for andre monoklonale antistoffer; patienter med pneumonitis eller interstitiel lungesygdom i anamnesen; patienter med hiv-, hepatitis B- eller hepatitis C-infektion og ECOG-performance-status ≥ 2.
English: RFS Hazard ratio* (95% CI) RFS rate at 6 months
Danish: HR* for RFS (95% CI) RFS-rate ved måned 6
English: There were no notable effects in the male and female reproductive organs in monkeys based on 1-month and 6-month repeat dose toxicity studies (see section 5.3).
Danish: Der var ingen betydningsfuld indvirkning på forplantningsorganerne hos han- og hunaber i toksicitetsstudier af 1 måned og 6 måneders varighed med gentagne doser.
English: feeling tired, or chest pain; inflammation of the covering of the heart - hair colour changes; dry, itchy skin; small skin bumps, lumps or sores
Danish: træthed eller brystsmerter; betændelse i hjertesækken - ændret hårfarve; tør, kløende hud; små buler eller sår på huden.
English: Patients with clinically significant renal (creatinine > 1.5 x ULN) or hepatic (bilirubin > 1.5 x ULN, ALT, AST > 2.5 x ULN in the absence of liver metastases) abnormalities at baseline were excluded from clinical trials, therefore information is limited in patients with severe renal and moderate to severe hepatic impairment.
Danish: Patienter med klinisk signifikant nedsat nyrefunktion (kreatinin > 1,5 x ULN) eller leverfunktion (bilirubin > 1,5 x ULN, ALAT, ASAT > 2,5 x ULN med fravær af levermetastaser) ved baseline blev ekskluderet fra kliniske studier.
English: Medical management guidelines for both medicines should be followed (see section 4.2 and refer to the SmPC for axitinib).
Danish: Retningslinjerne for medicinsk behandling for begge lægemidler skal følges (se pkt.
English: KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the firstline treatment of metastatic non-squamous NSCLC in adults whose tumours have no EGFR or ALK positive mutations.
Danish: KEYTRUDA, i kombination med pemetrexed og platinbaseret kemoterapi, er indiceret til førstelinjebehandling af metastatisk ikke-planocellulær NSCLC hos voksne uden EGFR- eller ALKpositive mutationer i tumorer.
English: Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible.
Danish: Patienter med aktiv autoimmun sygdom eller lidelser, som krævede behandling med immunsuppressiva, eller slimhindemelanom eller okulært melanom var uegnede til studiet.
English: Treatment with pembrolizumab and axitinib continued until RECIST v1.1-defined progression of disease as verified by BICR or confirmed by the investigator, unacceptable toxicity, or for pembrolizumab, a maximum of 24 months.
Danish: Behandlingen med pembrolizumab og axitinib fortsatte indtil sygdomsprogression defineret i henhold til RECIST v1.1 baseret på BICR-vurdering eller bekræftet af investigator, uacceptabel toksicitet, eller for for pembrolizumab, i højst 24 måneder.
English: The study population characteristics were: median age of 62 years (range: 26 to 90); 38% age 65 or older; 73% male; 79% White and 16% Asian; 80% had a Karnofsky Performance Score (KPS) 90-100 and 20% had KPS 70-80; patient distribution by IMDC risk categories was 31% favourable, 56% intermediate and 13% poor.
Danish: Karakteristika for studiepopulationen var: medianalder på 62 år (interval: 26 til 90); 38% i alderen 65 år eller ældre; 73% mænd; 79% kaukasere og 16% asiatere; 80% havde en Karnofsky Performance-Score (KPS) på 90-100, og 20% havde en KPS på 70-80; patientfordelingen ifølge IMDC-risikokategorier var 31% lav risiko, 56% middel risiko og 13% høj risiko.
English: This 96 hour total hold from reconstitution may include up to 6 hours at room temperature (at or below 25°C).
Danish: Den samlede opbevaringstid på 96 timer efter rekonstitution kan inkludere opbevaring i op til 6 timer ved stuetemperatur (ved eller under 25 °C).
English: The median time to onset of hyperthyroidism was 1.4 months (range 1 day to 22.5 months).
Danish: Den mediane tid til indtræden af hypertyroidisme var 1,4 måneder (interval: 1 dag til 22,5 måneder).
English: Patients had PD-L1 expression with a  50% tumour proportion score (TPS) based on the PD-L1 IHC 22C3 pharmDx
Danish: Patienterne havde PD-L1ekspression med tumour proportion score (TPS)  50% baseret på PD-L1 IHC 22C3 pharmDx
English: The safety and efficacy of pembrolizumab were investigated in KEYNOTE-040, a multicentre, openlabel, randomised, controlled study for the treatment of histologically confirmed recurrent or metastatic HNSCC of the oral cavity, pharynx or larynx in patients who had disease progression on or after platinum-containing chemotherapy administered for recurrent or metastatic HNSCC or following platinum-containing chemotherapy administered as part of induction, concurrent, or adjuvant therapy, and were not amenable to local therapy with curative intent.
Danish: Pembrolizumabs sikkerhed og virkning blev undersøgt i KEYNOTE-040, et åbent, randomiseret, kontrolleret multicenterstudie til behandling af histologisk bekræftet recidiverende eller metastatisk HNSCC i mundhulen, svælget (farynx) eller struben (larynx) hos patienter, som havde sygdomsprogression under eller efter platinbaseret kemoterapi administreret til behandling af recidiverende eller metastatisk HNSCC eller efter platinbaseret kemoterapi administreret som en del af induktionsbehandling, samtidig behandling eller adjuverende behandling, og som ikke var modtagelige for lokal kurativt intenderet behandling.
English: • KEYTRUDA 200 mg every 3 weeks
Danish: • KEYTRUDA 200 mg hver 3. uge
English: Common thrombocytopaenia, lymphopaenia febrile neutropaenia, leukopaenia, lymphopaenia anaemia, neutropaenia, leukopaenia, thrombocytopaenia
Danish: Almindelig trombocytopeni, lymfopeni febril neutropeni, leukopeni, lymfopeni anæmi, neutropeni, leukopeni, trombocytopeni
English: 4Q 2023
Danish: 4. kvartal 2023
English: After reconstitution, 1 mL of concentrate contains 25 mg of pembrolizumab.
Danish: Efter rekonstitution indeholder 1 ml koncentrat 25 mg pembrolizumab.
English: Treatment with pembrolizumab continued until RECIST 1.1-defined progression of disease as determined by the investigator, unacceptable toxicity, or a maximum of 24 months.
Danish: Behandling med pembrolizumab fortsatte indtil sygdomsprogression defineret i henhold til RECIST 1.1 efter investigators vurdering, uacceptabel toksicitet eller i højst 24 måneder.
English: Rare immune thrombocytopenic purpura, haemolytic anaemia, pure red cell aplasia, haemophagocytic lymphohistiocytosis eosinophilia
Danish: Sjælden immun trombocytopenisk purpura, hæmolytisk anæmi, ren erytrocyt aplasi, hæmofagocytisk lymfohistiocytose eosinofili
English: • Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL.
Danish: • Træk det påkrævede volumen (op til 4 ml (100 mg)) koncentrat op og overfør det til en intravenøs infusionspose, der indeholder natriumchlorid 9 mg/ml (0,9%) eller glucose 50 mg/ml (5%) for at fremstille den færdige infusionsvæske med en endelig koncentration på 1 til 10 mg/ml.
English: • Equilibrate the vial to room temperature (at or below 25°C).
Danish: • Lad hætteglasset opnå stuetemperatur (ved temperaturer på eller under 25 °C).
English: Chemotherapy:
Danish: Kemoterapi:
English: The safety and efficacy of pembrolizumab were evaluated in KEYNOTE-045, a multicentre, randomised (1:1), controlled study for the treatment of locally advanced or metastatic urothelial carcinoma in patients with disease progression on or after platinum-containing chemotherapy.
Danish: Pembrolizumabs sikkerhed og virkning blev vurderet i KEYNOTE-045, et randomiseret (1:1), kontrolleret multicenterstudie til behandling af lokalt fremskredent eller metastatisk urotelialt karcinom hos patienter med sygdomsprogression ved eller efter platinbaseret kemoterapi.
English: The median time to onset of nephritis was 5.0 months (range 12 days to 21.4 months).
Danish: Den mediane tid til indtræden af nefritis var 5,0 måneder (interval: 12 dage til 21,4 måneder).
English: Common severe skin reactions s,
Danish: erytem, tør hud alvorlige hudreaktioner s,
English: Patients with mild or moderate infusion reaction may continue to receive pembrolizumab with close monitoring; premedication with antipyretic and antihistamine may be considered.
Danish: Patienter med lette eller moderate infusionsreaktioner kan fortsætte med at få pembrolizumab under tæt monitorering.
English: The median follow-up time was 7.8 months (range: 0.1 to 19.1 months).
Danish: Den mediane opfølgningstid var 7,8 måneder (interval: 0,1 til 19,1 måneder).
English: Median in months (95% CI) Objective Response Rate ORR % (95% CI) p-Value
Danish: Median i måneder (95% CI) Objektiv responsrate ORR % (95% CI) p-værdi
English: #) of patients with duration ≥ 12 months
Danish: #) patienter med varighed ≥ 12 måneder
English: Uncommon pericardial effusion, pericarditis pericardial effusion myocarditis
Danish: Ikke almindelig perikardieeffusion, perikarditis perikardieeffusion myokarditis
English: Assessment of tumour status was performed at baseline, after randomisation at Week 12, then every 6 weeks thereafter until Week 54, and then every 12 weeks thereafter.
Danish: Der blev foretaget vurdering af tumorstatus ved baseline, efter randomiseringen i uge 12, herefter hver 6. uge indtil uge 54, og herefter hver 12. uge.
English: No clinically important differences in the clearance of pembrolizumab were found between patients with mild or moderate renal impairment and patients with normal renal function.
Danish: Der blev ikke påvist klinisk betydningsfulde forskelle i pembrolizumabs clearance mellem patienter med let eller moderat nedsat nyrefunktion og patienter med normal nyrefunktion.
English: The study population characteristics were: median age of 65 years (range: 29 to 88); 55% age 65 or older; 81% male; 77% White; ECOG performance status of 0 (29%) and 1 (71%); and 8% with treated brain metastases at baseline.
Danish: Karakteristika for studiepopulationen var: medianalder på 65 år (interval: 29 til 88); 55% i alderen 65 år eller ældre; 81% mænd; 77% kaukasere; ECOG-performance status 0 (29%) og 1 (71%); og 8% med behandlede hjernemetastaser ved baseline.
English: The median time to onset of hepatitis was 3.6 months (range 8 days to 21.4 months).
Danish: Den mediane tid til indtræden af hepatitis var 3,6 måneder (interval: 8 dage til 21,4 måneder).
English: Placebo + Pemetrexed + Platinum Chemotherapy n=206
Danish: Placebo + pemetrexed + platinbaseret kemoterapi n=206
English: Duration of Response Median in months (range) % with duration ≥6 months
Danish: Responsvarighed Median i måneder (interval) % med varighed ≥ 6 måneder
English: Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with chemotherapy) before initiating treatment in patients with head and neck squamous cell carcinoma whose tumours express PD-L1 (see section 5.1).
Danish: Lægen bør overveje benefit/risk-forholdet for de tilgængelige behandlingsmuligheder (pembrolizumab som monoterapi eller pembrolizumab i kombination med kemoterapi), før behandling initieres hos patienter med planocellulært hoved-hals karcinom, hvis tumorer udtrykker PD-L1 (se pkt.
English: Each mL of concentrate contains 25 mg of pembrolizumab.
Danish: Hver ml koncentrat indeholder 25 mg pembrolizumab.
English: Patients were treated with pembrolizumab until disease progression or unacceptable toxicity.
Danish: Patienterne blev behandlet med pembrolizumab indtil sygdomsprogression eller uacceptabel toksicitet.
English: Assessment of tumour status was performed at 9 weeks after the first dose, then every 6 weeks through the first year, followed by every 12 weeks thereafter.
Danish: Vurdering af tumorstatus blev foretaget 9 uger efter første dosis, derefter hver 6. uge i det første år, og efterfølgende hver 12. uge.
English: Eighty-four percent had M1c stage and 8% of patients had a history of brain metastases.
Danish: 84% havde melanom i M1c-stadiet, og 8% af patienterne havde hjernemetastaser i anamnesen.
English: Ocular melanoma
Danish: Okulært melanom
English: • a kind of kidney cancer called renal cell carcinoma.
Danish: • en bestemt type nyrekræft kaldet renalcellekarcinom.
English: The median time to onset of hypothyroidism was 3.5 months (range 1 day to 19.6 months).
Danish: Den mediane tid til indtræden af hypotyroidisme var 3,5 måneder (interval: 1 dag til 19,6 måneder).
English: In patients with NSCLC, pneumonitis occurred in 107 (4.9%), including Grade 2, 3, 4 or 5 cases in 39 (1.8%), 30 (1.4%), 10 (0.5%) and 9 (0.4%), respectively.
Danish: Hos patienter med NSCLC forekom pneumonitis hos 107 (4,9%), inklusive tilfælde af grad 2, 3, 4 eller 5 hos henholdsvis 39 (1,8%), 30 (1,4%), 10 (0,5%) og 9 (0,4%) patienter.
English: Chemotherapy n=179
Danish: Kemoterapi n=179
English: The primary efficacy outcome measures were PFS as assessed by IRO using RECIST version 1.1 and OS.
Danish: De primære resultatmål var PFS, baseret på IRO-vurdering i henhold til RECIST version 1.1, og OS.
English: KEYNOTE-189: Controlled trial of combination therapy in non-squamous NSCLC patients naïve to treatment
Danish: KEYNOTE-189: Kontrolleret studie af kombinationsbehandling hos behandlingsnaive patienter med ikkeplanocellulær NSCLC
English: Chemotherapy n=272
Danish: Kemoterapi n=272
English: The median duration was not reached (range 3 days to 26.2+ months).
Danish: Medianvarigheden blev ikke nået (interval: 3 dage til 26,2+ måneder).
English: Table 15: Efficacy Results in KEYNOTE-407
Danish: Tabel 15: Effektresultater i KEYNOTE-407
English: Based on the stratified Cox proportional hazard model Based on stratified log-rank test
Danish: Baseret på den stratificerede Cox proportional hazard-model Baseret på stratificeret log rank-test
English: Patients who tolerated axitinib 5 mg twice daily for 2 consecutive treatment cycles (i.e. 6 weeks) with no > Grade 2 treatment-related adverse events to axitinib and with blood pressure well controlled to ≤ 150/90 mm Hg were permitted dose escalation of axitinib to 7 mg twice daily.
Danish: (dvs. 6 uger) uden > grad 2 behandlingsrelaterede bivirkninger ved axitinib og som havde et velkontrolleret blodtryk på ≤ 150/90 mm Hg, var det tilladt at øge dosis af axitinib til 7 mg to gange dagligt.
English: The study excluded patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within 2 years of treatment, a medical condition that required immunosuppression, or who were previously treated with 3 or more systemic regimens for recurrent and/or metastatic HNSCC.
Danish: Patienter med nasofaryngealt karcinom, aktiv autoimmun sygdom, der havde krævet systemisk behandling inden for de seneste 2 år efter behandling, lidelser, som krævede behandling med immunsuppressiva, eller som tidligere havde fået 3 eller flere systemiske regimer til behandling af recidiverende og/eller metastatisk HNSCC, blev ekskluderet fra studiet.
English: Colitis led to discontinuation of pembrolizumab in 29 (0.5%) patients.
Danish: Colitis medførte seponering af pembrolizumab hos 29 (0,5%) patienter.
English: KEYNOTE-052: Open label trial in urothelial carcinoma patients ineligible for cisplatin-containing chemotherapy
Danish: KEYNOTE-052: Åbent studie med patienter med urotelialt karcinom, der er uegnede til cisplatinbaseret kemoterapi
English: • From a microbiological point of view, the product, once diluted, should be used immediately.
Danish: • Ud fra en mikrobiologisk synsvinkel skal lægemidlet anvendes straks efter fortynding.
English: Assessment of tumour status was performed every 6 weeks through Week 18, every 9 weeks through Week 45 and every 12 weeks thereafter.
Danish: Vurdering af tumorstatus blev foretaget hver 6. uge til og med uge 18, hver 9. uge til og med uge 45 og hver 12. uge derefter.
English: KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
Danish: KEYTRUDA som monoterapi er indiceret til førstelinjebehandling af metastatisk ikke-småcellet lungecancer (NSCLC) hos voksne, hvis tumorer udtrykker PD-L1 med tumour proportion score (TPS) ≥ 50% uden EGFR- eller ALK-positive mutationer i tumor.
English: Animal reproduction studies have not been conducted with pembrolizumab; however, in murine models of pregnancy blockade of PD-L1 signaling has been shown to disrupt tolerance to the foetus and to result in an increased foetal loss (see section 5.3).
Danish: I dyremodeller med drægtige mus er det blevet påvist, at blokering af PD-L1-signalet kan påvirke tolerancen for fostret og medføre et stigende antal fostertab (se pkt.
English: Median in months (95% CI) Objective Response Rate ORR
Danish: Median i måneder (95% CI) Objektiv responsrate ORR
English: In subgroup analyses, a reduced survival benefit of pembrolizumab compared to docetaxel was observed for patients who were never-smokers or patients with tumours harbouring EGFR activating mutations who received at least platinum-based chemotherapy and a tyrosine kinase inhibitor; however, due to the small numbers of patients, no definitive conclusions can be drawn from these data.
Danish: I analyser af subgrupper viste pembrolizumab en reduceret fordel med hensyn til overlevelse sammenlignet med docetaxel hos patienter, som aldrig havde røget, og hos patienter med EGFRaktiverende mutationer, der som minimum havde fået platinbaseret kemoterapi og en tyrosinkinasehæmmer.
English: • Withdraw the required volume up to 2 mL (50 mg) of KEYTRUDA and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL.
Danish: • Træk det påkrævede volumen (op til 2 ml (50 mg)) Keytruda op og overfør det til en intravenøs infusionspose, der indeholder natriumchlorid 9 mg/ml (0,9%) eller glucose 50 mg/ml (5%) for at fremstille den færdige infusionsvæske med en endelig koncentration på 1 til 10 mg/ml.
English: Patients with the following conditions were excluded from clinical trials: active CNS metastases; ECOG PS ≥ 2 (except for urothelial carcinoma and RCC); HIV, hepatitis B or hepatitis C infection; active systemic autoimmune disease; interstitial lung disease; prior pneumonitis requiring systemic corticosteroid therapy; a history of severe hypersensitivity to another monoclonal antibody; receiving immunosuppressive therapy and a history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent) for greater than 12 weeks.
Danish: Patienter med følgende tilstande blev ekskluderet fra kliniske studier: patienter med aktive metastaser i centralnervesystemet; patienter med ECOG-performance-status ≥ 2 (med undtagelse af urotelialt karcinom og RCC); patienter med hiv-, hepatitis B- eller hepatitis C-infektion; patienter med aktiv systemisk autoimmun sygdom; patienter med interstitiel lungesygdom; patienter med pneumonitis i anamnesen, der krævede behandling med systemiske kortikosteroider; patienter, der tidligere har haft svær overfølsomhed over for andre monoklonale antistoffer; patienter i immunsuppressiv behandling samt patienter, der tidligere har haft alvorlige immunrelaterede bivirkninger ved behandling med ipilimumab, defineret som toksicitet af grad 4 eller af grad 3, hvor kortikosteroider (> 10 mg/dag af prednison eller ækvivalent hermed) i mere end 12 uger var nødvendig.
English: Based on patients with a best overall response as confirmed complete or partial response Based on Kaplan-Meier estimation
Danish: Baseret på patienter med en bedste samlet respons, der er bekræftet som komplet eller partielt respons Baseret på Kaplan-Meier-estimering
English: Among the 542 randomised patients in KEYNOTE-045, baseline characteristics were: median age 66 years (range: 26 to 88), 58% age 65 or older; 74% male; 72% White and 23% Asian; 56% ECOG performance status of 1 and 1% ECOG performance status of 2; and 96% M1 disease and 4% M0 disease.
Danish: Blandt de 542 randomiserede patienter i KEYNOTE-045 var baseline-karakteristika følgende: median alder 66 år (interval: 26 til 88), 58% i alderen 65 år eller ældre; 74% mænd; 72% hvide og 23% asiater; 56% havde ECOG-performance-status på 1, og 1% havde ECOG-performance-status på 2; og 96% havde M1 sygdom, og 4% havde M0 sygdom.
English: For patients with Grade 3 or Grade 4 endocrinopathy that improved to Grade 2 or lower and is controlled with hormone replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed.
Danish: Hos patienter med grad 3 eller grad 4hypertyroidisme, som bedres til grad 2 eller derunder, kan det overvejes at fortsætte behandlingen med pembrolizumab efter langsom udtrapning af kortikosteroider, hvis det er nødvendigt (se pkt.
English: erythema, dry skin, vitiligo t, eczema, alopecia, dermatitis acneiform severe skin reactions s,
Danish: Almindelig alvorlige hudreaktioner s, erytem, tør hud, vitiligo t, eksem, alopeci, akneiform dermatitis alvorlige hudreaktioner s,
English: • a kind of skin cancer called melanoma
Danish: • en bestemt type hudkræft kaldet melanom (modermærkekræft)
English: Among the 1,019 patients, the baseline characteristics were: median age of 54 years (25% age 65 or older); 62% male; and ECOG PS of 0 (94%) and 1 (6%).
Danish: Hos de 1.019 patienter var baseline-karakteristika: medianalder 54 år (25% i alderen 65 år eller ældre); 62% mænd og ECOG-performance-status 0 (94%) og 1 (6%).