natgillin/translations-raw huggingface dataset:
De alvorligste bivirkninger var immunrelaterede bivirkninger og alvorlige infusionsreaktioner (se pkt. 
The most serious adverse reactions were immune-related adverse reactions and severe infusion-related reactions (see section 4.4).
PD-L1-negativ n=428 
PD-L1 negative n=428
Sygdomskarakteristika var: 21% HPV-positive og 95% havde sygdom i stadie IV (stadie IVa 21%, stadie IVb 6% og stadie IVc 69%). 
Disease characteristics were: 21% HPV positive and 95% had Stage IV disease (Stage IVa 21%, Stage IVb 6%, and Stage IVc 69%).
Randomiseringen blev stratificeret ud fra PD-L1tumorekspression (TPS < 1% [negativ] versus TPS ≥ 1%), investigators valg af paclitaxel eller nabpaclitaxel og geografisk område (Østasien versus ikke Østasien). 
Randomisation was stratified by tumour PD-L1 expression (TPS < 1% [negative] vs. TPS ≥ 1%), investigator's choice of paclitaxel or nabpaclitaxel, and geographic region (East Asia vs. non-East Asia).
Samlet overlevelse (%) 
Overall Survival (%)
I tabel 23 og 24 opsummeres de centrale effektresultater for pembrolizumab hos patienter, hvis tumorer udtrykte PD-L1 med CPS ≥ 1 i KEYNOTE-048 ved den endelige analyse udført med en median opfølgningstid på 13 måneder for pembrolizumab i kombination med kemoterapi og med en median opfølgningstid på 11,5 måneder for pembrolizumab som monoterapi. 
Tables 23 and 24 summarise key efficacy results for pembrolizumab in patients whose tumours expressed PD-L1 with a CPS ≥ 1 in KEYNOTE-048 at the final analysis performed at a median follow-up of 13 months for pembrolizumab in combination with chemotherapy and at a median follow-up of 11.5 months for pembrolizumab monotherapy.
Infektioner og parasitære sygdomme Almindelig pneumoni pneumoni pneumoni 
Infections and infestations Common pneumonia pneumonia pneumonia
Hos de patienter, som var evaluerbare for PD-L1-ekspression (98%), var 82% PD-L1-positive, og 18% var PD-L1-negative. 
Among patients who were evaluable for PD-L1 expression (98%), 82% were PD-L1 positive and 18% were PD-L1 negative.
Grad 2 med aspartataminotransferase (ASAT) eller alaninaminotransferase (ALAT) > 3-5 gange ULN eller totalbilirubin > 1,5-3 gange ULN 
Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 to 5 times ULN or total bilirubin > 1.5 to 3 times ULN
OS-rate i måned 24 
OS rate at 24 months
55% af de patienter, som var randomiseret til kemoterapi-armen, krydsede over og fik efterfølgende behandling med pembrolizumab. 
Of the patients randomised to the chemotherapy arm, 55% crossed over and subsequently received treatment with pembrolizumab.
Patienterne skal monitoreres for ændringer i leverfunktionen (ved behandlingsstart, periodevist i løbet af behandlingen og som indiceret på basis af den kliniske vurdering) og for symptomer på hepatitis, og andre årsager skal udelukkes. 
Patients should be monitored for changes in liver function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and symptoms of hepatitis, and other causes excluded.
KEYTRUDA, som monoterapi eller som kombinationsbehandling, skal seponeres permanent ved grad 4 eller tilbagevendende grad 3 immunrelaterede bivirkninger, medmindre det er specificeret anderledes i tabel 1. 
KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued for Grade 4 or recurrent Grade 3 immune-related adverse reactions, unless otherwise specified in Table 1.
KEYTRUDA aktiverer T-cellemedieret respons, herunder anti-tumorrespons, ved at blokere PD-1-bindingen til PD-L1 og PD-L2, som er udtrykt i antigenpræsenterende celler, og som kan udtrykkes af tumorer eller andre celler i tumorens mikromiljø. 
KEYTRUDA potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment.
- Lægen vil give dig Keytruda som en infusion i en vene (intravenøst) over en periode på ca. 
- Your doctor will give you KEYTRUDA through an infusion into your vein (IV) for about
Alle på nær to patienter var kaukasere. 
All but two patients were white.
45% havde en ECOG-performance-status på 1, 40% havde forhøjet LDH, og 23% havde en BRAF-muteret tumor. 
Forty-five percent had an ECOG Performance Status of 1, 40% had elevated LDH and 23% had a BRAF mutated tumour.
Ikke nået (1,4+; 18,2+) 
Not reached (1.4+, 18.2+)
Studiet viste statistisk signifikante forbedringer i OS og ORR for patienter, der var randomiseret til pembrolizumab sammenlignet med kemoterapi. 
The study demonstrated statistically significant improvements in OS and ORR for patients randomised to pembrolizumab as compared to chemotherapy.
% igangværende respons 
% ongoing
Patienterne skal monitoreres for ændringer i nyrefunktionen, og andre årsager til nedsat nyrefunktion skal udelukkes. 
Patients should be monitored for changes in renal function, and other causes of renal dysfunction excluded.
18,9 (11, foreligger ikke) 
18.9 (11, not available)
Immunrelaterede bivirkninger, inklusive svære og dødelige tilfælde, er forekommet hos patienter, der fik pembrolizumab. 
Immune-related adverse reactions, including severe and fatal cases, have occurred in patients receiving pembrolizumab.
Hypotyroidisme kan behandles med substitution uden afbrydelse af behandlingen. 
Hypothyroidism may be managed with replacement therapy without treatment interruption.
I henhold til AJCC-stadieklassificering, 8. udgave, blev i alt 82 forsøgspersoner klassificeret som stadie IIIA; 42 i armen med pembrolizumab og 40 i placebo-armen; med i alt 13 RFS-hændelser; 6 i armen med pembrolizumab og 7 i placebo-armen. 
th edition classification, a total of 82 subjects were classified as stage IIIA; 42 in the pembrolizumab arm and 40 in the placebo arm; with a total of 13 RFS events; 6 in the pembrolizumab arm and 7 in the placebo arm.
Der skal udvises forsigtighed, hvis pembrolizumab-behandling overvejes hos en patient, der har oplevet en alvorlig eller livstruende hudreaktion under tidligere behandling med andre immunstimulerende cancerlægemidler. 
Caution should be used when considering the use of pembrolizumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immunestimulatory anticancer agents.
Der var ingen statistisk signifikant forskel mellem pembrolizumab og kemoterapi i den endelige OS-analyse, som ikke var korrigeret for den potentielt konfunderende effekt af overkrydsningen. 
There was no statistically significant difference between pembrolizumab and chemotherapy in the final OS analysis that was not adjusted for the potentially confounding effects of crossover.
Kaplan-Meier-kurverne for OS og PFS baseret på yderligere fire måneders opfølgning er vist i figur 16 og 17. 
The Kaplan-Meier curves for OS and PFS based on an additional four months of follow up are shown in Figures 16 and 17.
Det skal besluttes, om amning skal ophøre eller behandling med pembrolizumab skal seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele ved pembrolizumab-behandlingen for moderen. 
A decision should be made whether to discontinue breast-feeding or to discontinue pembrolizumab, taking into account the benefit of breast-feeding for the child and the benefit of pembrolizumab therapy for the woman.
Ved urotelial cancer sås et højere antal dødsfald indenfor 2 måneder med pembrolizumab sammenlignet med kemoterapi (se pkt. 
In urothelial cancer, a higher number of deaths within 2 months was observed in pembrolizumab compared to chemotherapy (see section 5.1).
Tabel 29: Effektresultater i KEYNOTE-426 ud fra IMDC-risikokategori 
Table 29: Efficacy Results in KEYNOTE-426 by IMDC Risk Category
Pembrolizumab nedbrydes via non-specifikke metaboliseringsveje; metaboliseringen bidrager ikke til pembrolizumabs clearance. 
Pembrolizumab is catabolised through non-specific pathways; metabolism does not contribute to its clearance.
Der var ingen statistisk signifikant forskel mellem pembrolizumab og kemoterapi med hensyn til PFS. 
There was no statistically significant difference between pembrolizumab and chemotherapy with respect to PFS.
Det skal du vide, før du får Keytruda 
What you need to know before you are given KEYTRUDA
45% havde ikke tidligere fået behandling for fremskredent melanom. 
Forty-five percent had no prior therapies for advanced melanoma.
Ikke nået (NA; NA) 
Not reached (NA, NA)
Keytruda styrker immunsystemets evne til at bekæmpe kræft. 
KEYTRUDA works by helping your immune system fight your cancer.
Randomiseringen blev stratificeret ud fra PD-L1tumorekspression (TPS ≥ 50% eller < 50%), HPV-status (positiv eller negativ) og ECOG-PS (0 versus 1). 
Randomization was stratified by tumour PD-L1 expression (TPS ≥ 50% or < 50%), HPV status (positive or negative), and ECOG PS (0 vs. 1).
Antal patienter 
Number of patients OS
Respons: Bedste objektive respons, der er bekræftet komplet eller partielt respons 
Response: Best objective response as confirmed complete response or partial response
Patienter med EGFR-aktiverende mutationer eller ALK-translokation havde også sygdomsprogression, mens de var i godkendt behandling for disse mutationer inden behandling med pembrolizumab. 
Patients with EGFR activation mutation or ALK translocation also had disease progression on approved therapy for these mutations prior to receiving pembrolizumab.
2 patienter (< 0,1%) seponerede pembrolizumab som følge af hypotyroidisme. 
Two patients (< 0.1%) discontinued pembrolizumab due to hypothyroidism.
Gennemsigtige til hvide proteinholdige partikler kan forekomme i den fortyndede infusionsvæske. 
Translucent to white proteinaceous particles may be seen in diluted solution.
Data vedrørende pembrolizumabs virkning og sikkerhed i kombination med platinbaseret kemoterapi er begrænset i denne patientpopulation. 
Data about efficacy and safety of pembrolizumab in combination with platinum chemotherapy are limited in this patient population.
Størstedelen af de rapporterede bivirkninger ved monoterapi var af sværhedsgrad 1 eller 2. 
The majority of adverse reactions reported for monotherapy were of Grade 1 or 2 severity.
Efter administration af pembrolizumab 200 mg hver 3. uge til patienter med cHL var den observerede mediane Cmin ved steady state op til 40% højere end den, som blev observeret ved andre tumortyper, der blev behandlet med samme dosis. 
Following administration of pembrolizumab 200 mg every 3 weeks in patients with cHL, the observed median Cmin at steady-state was up to 40% higher than that in other tumour types treated with the same dosage; however, the range of trough concentrations is similar.
Psykiske forstyrrelser Almindelig insomni insomni insomni 
Psychiatric disorders Common insomnia insomnia insomnia
Baseret på bedst respons for stabil sygdom eller bedre Baseret på Kaplan-Meier-estimering; omfatter 84 patienter med 6 måneders respons eller længere 
Based on best response of stable disease or better Based on Kaplan-Meier estimates; includes 84 patients with response of 6 months or longer
Grad ≥ 3 med ASAT eller ALAT > 5 gange ULN eller total-bilirubin > 3 gange ULN 
Grade ≥ 3 with AST or ALT > 5 times ULN or total bilirubin > 3 times ULN
Insulin skal administreres ved type 1-diabetes, og behandlingen med pembrolizumab skal pauseres i tilfælde af grad 3-hyperglykæmi, indtil der er opnået metabolisk kontrol (se pkt. 
Insulin should be administered for type 1 diabetes, and pembrolizumab should be withheld in cases of Grade 3 hyperglycaemia until metabolic control is achieved (see section 4.2).
Tabel 22: ORR og OS ved PD-L1-ekspression 
Table 22: ORR and OS by PD-L1 Expression
76% af patienterne havde tidligere fået cisplatin, 23% havde tidligere fået carboplatin, og 1% var blevet behandlet med andre platinbaserede regimer. 
Seventy-six percent of patients received prior cisplatin, 23% had prior carboplatin, and 1% was treated with other platinum-based regimens.
Blandt de patienter, som var evaluerbare for PD-L1-ekspression (79%), var 69% (n=294) PD-L1-positive, og 31% (n=134) var PD-L1-negative. 
Among patients who were evaluable for PD-L1 expression (79%), 69% (n=294) were PD-L1 positive and 31% (n=134) were PD-L1 negative.
Immunsystemet Almindelig infusionsreaktioner infusionsreaktioner infusionsreaktioner 
Immune system disorders Common infusion related reaction infusion related reaction a infusion related reaction
Se tabel 28 for p-værdien for inferentiel test af OS baseret på den præspecificerede interimanalyse, hvor der er nået statistisk signifikans. 
See Table 28 for p-Value for inferential test of OS based on the pre-specified interim analysis, where statistical significance has been reached.
Median opfølgningstid på 10,1 måneder Median opfølgningstid på 52,8 måneder BICR-vurdering (blinded independent central review) i henhold til IWG (International Working Group)kriterierne, revideret i 2007, ud fra PET/CT-scanninger Baseret på patienter (n=145) med et respons ud fra uafhængig vurdering Baseret på patienter (n=18) med et respons ud fra uafhængig vurdering Baseret på Kaplan-Meier-estimering; inkluderer 31 patienter med respons på 6 måneder eller længere Baseret på Kaplan-Meier-estimering; inkluderer 9 patienter med respons på 6 måneder eller længere Baseret på Kaplan-Meier-estimering; inkluderer 7 patienter med respons på 12 måneder eller længere 
Median follow-up time of 10.1 months Median follow-up time of 52.8 months Assessed by blinded independent central review according to the 2007 revised International Working Group (IWG) criteria by PET CT scans Based on patients (n=145) with a response by independent review Based on patients (n=18) with a response by independent review Based on Kaplan-Meier estimation; includes 31 patients with responses of 6 months or longer Based on Kaplan-Meier estimation; includes 9 patients with responses of 6 months or longer Based on Kaplan-Meier estimation; includes 7 patients with responses of 12 months or longer
Svære endokrinopatier, herunder binyrebarkinsufficiens, hypofysitis, type 1-diabetes mellitus, diabetisk ketoacidose, hypotyroidisme og hypertyroidisme er observeret i forbindelse med pembrolizumabbehandling. 
Severe endocrinopathies, including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism have been observed with pembrolizumab treatment.
Patienter med ECOG-performance-status ≥ 2 blev ekskluderet fra de kliniske studier med melanom, NSCLC, cHL og HNSCC (se pkt. 
Patients with ECOG performance status score ≥ 2 were excluded from the clinical trials of melanoma, NSCLC, cHL, and HNSCC (see sections 4.4 and 5.1).
Ikke almindelig forhøjet amylase forhøjet bilirubin i blodet, forhøjet amylase forhøjet amylase 
Uncommon amylase increased blood bilirubin increased, amylase increased amylase increased
* Baseret på den stratificerede Cox proportional hazard-model NR = Ikke nået 
* Based on the stratified Cox proportional hazard model NR = not reached
PD-L1-positiv 
PD-L1 positive
- Keytruda kan skade det ufødte barn eller øge risikoen for, at det dør. 
- KEYTRUDA can cause harm or death to your unborn baby.
67% af patienterne havde M1-sygdom og størstedelen havde sygdom i stadie IV (stadie IV 32%, stadie IVa 14%, stadie IVb 4% og stadie IVc 44%). 
Sixty-seven percent (67%) of patients had M1 disease and the majority had Stage IV disease (Stage IV 32%, Stage IVa 14%, Stage IVb 4%, and Stage IVc 44%).
HR* (98% CI) p-værdi (stratificeret log-rank) RFS ved måned 6 RFS-rate RFS ved måned 12 RFS-rate RFS ved måned 18 RFS-rate 
Hazard ratio* (98% CI) p-Value (stratified log-rank) RFS at 6 months RFS rate RFS at 12 months RFS rate RFS at 18 months RFS rate
Se tabel 28 for p-værdien for inferentiel test af PFS baseret på den præspecificerede interimanalyse, hvor der er nået statistisk signifikans. 
See Table 28 for p-Value for inferential test of PFS based on the pre-specified interim analysis, where statistical significance has been reached.
I tabel 4 opsummeres de centrale effektresultater efter den endelige analyse hos patienter, der tidligere har været behandlet med ipilimumab, og KaplanMeier-kurven for PFS er vist i figur 3. 
Table 4 summarises key efficacy measures at the final analysis in patients previously treated with ipilimumab, and the KaplanMeier curve for PFS is shown in Figure 3.
Du kan også få kortikosteroider, før du får Keytruda i kombination med kemoterapi for at forebygge og/eller behandle kvalme, opkastning og andre bivirkninger forårsaget af kemoterapi. 
Corticosteroids may also be given to you before receiving KEYTRUDA in combination with chemotherapy to prevent and/or treat nausea, vomiting, and other side effects caused by chemotherapy.
Sjælden myokarditis myokarditis k, perikarditis 
Rare myocarditis myocarditis k, pericarditis
Ikke kendt afstødning af transplanterede solide organer 
Uncommon sarcoidosis Not known solid organ transplant rejection
Forekomsten af bivirkninger af grad 3-5 var 76% for kombinationsbehandling med pembrolizumab og 71% for sunitinib alene. 
Incidences of Grades 3-5 adverse reactions were 76% for pembrolizumab combination therapy and 71% for sunitinib alone.
• Tilsæt vandet ned langs siden af hætteglasset og ikke direkte ned i det frysetørrede pulver for at undgå skumdannelse. 
• To avoid foaming, deliver the water along the walls of the vial and not directly on the lyophilised powder.
Hypotyroidisme gik over hos 153 (23,7%) patienter, 10 med sequelae. 
Hypothyroidism resolved in 153 (23.7%) patients, 10 with sequelae.
L-histidin-hydrochloridmonohydrat Saccharose 
L-histidine hydrochloride monohydrate Sucrose
Der findes ingen information vedrørende overdosering med pembrolizumab. 
There is no information on overdose with pembrolizumab.
15% af patienterne havde sygdomsprogression efter tidligere platinbaseret neoadjuvant eller adjuvant kemoterapi. 
Fifteen percent of patients had disease progression following prior platinumcontaining neoadjuvant or adjuvant chemotherapy.
* Cetuximab, platinbaseret behandling og 5-FU Baseret på den stratificerede Cox proportional hazard-model ‡ Respons: Bedste objektive respons, der er bekræftet komplet eller partielt respons 
* Cetuximab, platinum, and 5-FU † Based on the stratified Cox proportional hazard model ‡ Response: Best objective response as confirmed complete response or partial response
Baseret på modellering og simulering af forholdet mellem dosis og eksponering med hensyn til pembrolizumabs virkning og sikkerhed er der ingen klinisk signifikant forskel i virkning eller sikkerhed blandt doserne på 200 mg hver 3. uge, 2 mg/kg hver 3. uge og 400 mg hver 6. uge som monoterapi (se pkt. 
Based on the modelling and simulation of dose/exposure relationships for efficacy and safety for pembrolizumab, there are no clinically significant differences in efficacy or safety among the doses of 200 mg every 3 weeks, 2 mg/kg every 3 weeks, and 400 mg every 6 weeks as monotherapy (see section 4.2).
Thyroideafunktion og hormonniveauer skal monitoreres for at sikre passende hormonsubstitutionsbehandling. 
Thyroid function and hormone levels should be monitored to ensure appropriate hormone replacement.
Patienter med EGFR- eller ALK-positive mutationer i tumor bør også have været i targeteret behandling inden behandling med KEYTRUDA. 
Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.
De vigtigste resultatmål objektiv responsrate (ORR) og komplet remissionsrate (CRR) blev baseret på BICR (blinded independent central review)-vurdering i henhold til IWG (International Working Group)kriterierne revideret i 2007. 
The major efficacy outcome measures (ORR and CRR) were assessed by blinded independent central review according to the 2007 revised International Working Group (IWG) criteria.
Hypofysefunktion og hormonniveauer skal monitoreres for at sikre passende hormonsubstitutionsbehandling. 
Pituitary function and hormone levels should be monitored to ensure appropriate hormone replacement.
16% havde sygdomsprogression efter platinbaseret neoadjuverende eller adjuverende kemoterapi, og 84% havde tidligere fået 1-2 systemiske regimer for metastatisk sygdom. 
Sixteen percent (16%) had disease progression following platinum-containing neoadjuvant or adjuvant chemotherapy, and 84% had received 1-2 prior systemic regimens for metastatic disease.
Fordelene ved behandling med pembrolizumab skal afvejes mod risikoen for mulig organafstødning hos disse patienter. 
The benefit of treatment with pembrolizumab versus the risk of possible organ rejection should be considered in these patients.
Patienterne skal derfor monitoreres for ændringer i thyreoideafunktionen (ved behandlingsstart, periodevist i løbet af behandlingen og som indiceret på basis af den kliniske vurdering) samt for kliniske tegn og symptomer på thyreoideasygdomme. 
Patients should be monitored for changes in thyroid function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and clinical signs and symptoms of thyroid disorders.
• Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse 
Obligation to conduct post-authorisation measures
Komplikationer, inklusive graft versus host-sygdom (GVHD), hos personer der gennemgår knoglemarvstransplantation (stamcelletransplantation), hvor der anvendes stamceller fra en donor 
Complications, including graft-versus-host-disease (GVHD), in people with bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).
Keytruda gives til patienter, når de har fået foretaget en operation for at fjerne modermærkekræft for at forebygge, at deres kræft vender tilbage (adjuverende behandling). 
People get KEYTRUDA after they have had surgery to remove melanoma to help prevent their cancer from coming back (adjuvant therapy).
Yderligere biomarkører, ud over PD-L1-ekspressionsstatus ved immunhistokemi (IHC) (f.eks. PD-L2, RNA-signatur osv.), der er prædiktive for pembrolizumabs virkning, skal undersøges sammen med yderligere information om mønstret for PD-L1-ekspression indhentet i igangværende NSCLC-studier (P001, P010, P024 og P042) og studier med urotelialt karcinom (KN045, KN052), HNSCC-studiet (KN040) og studiet med adjuverende behandling af resekteret stadie II-melanom (KN716): 
Additional biomarkers other than PD-L1 expression status by Immunohistochemistry (IHC) (e.g. PD-L2, RNA signature, etc.) predictive of pembrolizumab efficacy should be investigated together with more information regarding the pattern of expression of PD-L1 obtained in the ongoing NSCLC studies (P001, P010, P024 and P042) and urothelial carcinoma studies (KN045, KN052), HNSCC study (KN040) and resected Stage II melanoma adjuvant study (KN716):
Klargøring og administration af infusionsvæske 
Preparation and administration of the infusion
16% havde stadie IIIA; 46% havde stadie IIIB; 18% havde stadie IIIC (1-3 positive lymfeknuder), og 20% havde stadie IIIC (≥ 4 positive lymfeknuder); 50% var positive for BRAF V600-mutation og 44% var BRAF vildtype. 
Sixteen percent had stage IIIA; 46% had stage IIIB; 18% had stage IIIC (1-3 positive lymph nodes) and 20% had stage IIIC (≥ 4 positive lymph nodes); 50% were BRAF V600 mutation positive and 44% were BRAF wild-type.
• Hvis ALAT eller ASAT er ≥ 3 gange ULN, men < 10 gange ULN uden samtidig total-bilirubinværdi ≥ 2 gange ULN, skal både KEYTRUDA og axitinib pauseres, indtil disse bivirkninger bedres til grad 0-1. 
• If ALT or AST ≥ 3 times ULN but < 10 times ULN without concurrent total bilirubin ≥ 2 times ULN, both KEYTRUDA and axitinib should be withheld until these adverse reactions recover to Grades 0-1.
Antal (%) patienter med hændelse 
Number (%) of patients with event
Levermetastaser med grad 2 forhøjelse af ASAT eller ALAT, hepatitis med ASAT- eller ALAT-stigning på ≥ 50% i forhold til baseline, og som varer ≥ 1 uge 
In case of liver metastasis with baseline Grade 2 elevation of AST or ALT, hepatitis with AST or ALT increases ≥ 50% and lasts ≥ 1 week
Docetaxel 75 mg/m2 hver 3. uge 
Docetaxel 75 mg/m2 every 3 weeks