natgillin/translations-raw huggingface dataset:
I ikke - kliniske in vitro assays og i in vivo tumormodeller har erlotinibs primære metabolitter OSI- 420 og OSI- 413, som dannes ved O- demetylering af sidekæderne, samme effekt som erlotinib.
The primary metabolites OSI-420 and OSI-413 of erlotinib produced by O-demethylation of either side chain have comparable potency to erlotinib in non-clinical in vitro assays and in vivo tumour models.
13 Plasmakoncentrationerne af metabolitterne er < 10% af erlotinibs plasmakoncentrationer, og har samme farmakokinetik som erlotinib.
They are present in plasma at levels that are < 10% of erlotinib and display similar pharmacokinetics as erlotinib.
9%) af en oral dosis udskilles renalt.
Erlotinib is excreted predominantly as metabolites via the faeces (> 90%) with renal elimination accounting for only a small amount (approximately 9%) of an oral dose.
Mindre end 2% af den oralt administrerede dosis udskilles som moderstoffet.
Less than 2% of the orally administered dose is excreted as parent substance.
En populationsfarmakokinetisk analyse hos 591 patienter, som fik Tarceva som enkeltstof, viste en gennemsnitlig tilsyneladende clearance på 4, 47 l/ time med en median halveringstid på 36, 2 timer.
A population pharmacokinetic analysis in 591 patients receiving single agent Tarceva shows a mean apparent clearance of 4.47 l/hour with a median half-life of 36.2 hours.
7- 8 dage.
Therefore, the time to reach steady state plasma concentration would be expected to occur in approximately 7-8 days.
Forhøjede serumkoncentrationer af total bilirubin og AAG- koncentrationer var ledsaget af en reduceret erlotinib- clearance.
Increased serum concentrations of total bilirubin and AAG concentrations were associated with a reduced erlotinib clearance.
Rygere havde dog en øget clearance- hastighed.
However, smokers had an increased rate of erlotinib clearance.
Dette blev bekræftet i et farmakokinetisk studie hos ikke - rygere og hos cigaretrygende raske forsøgspersoner, der fik en enkelt oral erlotinib dosis på 150 mg.
This was confirmed in a pharmacokinetic study in non-smoking and currently cigarette smoking healthy subjects receiving a single oral dose of 150 mg erlotinib.
Det geometriske middeltal af Cmax var 1056 ng/ ml hos ikke- rygerne og 689 ng/ ml hos rygerne med en middelratio for rygerne i forhold til ikke- rygerne på 65, 2% (95% konfidensinterval:
The geometric mean of the Cmax was 1056 ng/mL in the non-smokers and 689 ng/mL in the smokers with a mean ratio for smokers to non-smokers of 65.2% (95% CI:
44, 3 til 95, 9; p= 0, 031).
44.3 to 95.9, p = 0.031).
Det geometriske middeltal for AUC0- inf var 18726 ng• t/ ml hos ikke- rygerne og 6718 ng• t/ ml hos rygerne med en middelratio på 35, 9% (95% konfidensinterval:
The geometric mean of the AUC0-inf was 18726 ng•h/mL in the non-smokers and 6718 ng•h/mL in the smokers with a mean ratio of 35.9% (95% CI:
23, 7 til 54, 3; p < 0, 0001).
23.7 to 54.3, p < 0.0001).
Det geometriske middeltal for C24t var 288 ng/ ml hos ikke- rygerne og 34, 8 ng/ ml hos rygerne med en middelratio på 12, 1% (95% konfidensinterval:
The geometric mean of the C24h was 288 ng/mL in the non-smokers and 34.8 ng/mL in the smokers with a mean ratio of 12.1% (95% CI:
4, 82 til 30, 2; p= 0, 0001).
4.82 to 30.2, p = 0.0001).
I det pivotale fase III- NSCLC- studie opnåede rygere en erlotinibplasmakoncentration ved steady- state på 0, 65 µg/ ml (n=16), hvilket var ca.
In the pivotal Phase III NSCLC trial, current smokers achieved erlotinib steady state trough plasma concentration of 0.65 µg/mL (n=16) which was approximately 2-fold less than the former smokers or patients who had never smoked (1.28 µg/mL, n=108).
2 gange mindre end koncentrationen, som blev opnået hos tidligere rygere eller hos patienter, der aldrig havde røget (1, 28 µg/ ml, n=108).
This effect was accompanied by a 24% increase in apparent erlotinib plasma clearance.
Denne virkning var ledsaget af en 24% stigning i erlotinibs tilsyneladende plasmaclearance.
In a phase I dose escalation study in NSCLC patients who were
I et fase I- dosis - eskaleringsstudie hos NSCLC- patienter, som var rygere, indikerede en farmakokinetisk analyse ved steady- state en dosis- proportional stigning i erlotinibeksponeringen, når Tarceva- dosis blev øget fra 150 mg til den maksimale toleransdosis på 300 mg.
13 current smokers, pharmacokinetic analyses at steady-state indicated a dose proportional increase in erlotinib exposure when the Tarceva dose was increased from 150 mg to the maximum tolerated dose of 300 mg.
I dette studie var steady- state - plasmakoncentrationen ved en dosis på 300 mg hos rygere 1, 22 µg/ ml (n=17).
Steady-state trough plasma concentrations at a 300 mg dose in current smokers in this study was 1.22 µg/mL (n=17).
11%.
Based on population pharmacokinetic analysis, the presence of an opioid appeared to increase exposure by about 11%.
Der blev lavet en anden populationsfarmakokinetisk analyse, hvori der indgik erlotinibdata fra 204 patienter med pancreas- cancer, som fik erlotinib plus gemcitabin.
A second population pharmacokinetic analysis was conducted that incorporated erlotinib data from 204 pancreatic cancer patients who received erlotinib plus gemcitabine.
Analysen viste, at de kovarianter, som påvirkede clearance af erlotinib hos patienter fra pancreasstudiet var meget lig med dem, som blev set i den tidligere enkeltstof- farmakokinetiske analyse.
This analysis demonstrated that covariants affecting erlotinib clearance in patients from the pancreatic study were very similar to those seen in the prior single agent pharmacokinetic analysis.
Der blev ikke fundet nye kovarianteffekter.
No new covariate effects were identified.
Samtidig administration af gemcitabin havde ingen effekt på erlotinibs clearance fra plasma.
Co-administration of gemcitabine had no effect on erlotinib plasma clearance.
Der foreligger ingen specifikke studier hos børn eller ældre patienter.
There have been no specific studies in paediatric or elderly patients.
Hos patienter med sufficient leverfunktion inklusive patienter med primær leverkræft eller levermetastaser var de sammenlignelige værdier 29300 ng• t/ ml og 1090 ng/ ml.
In patients with solid tumours and with moderately impaired hepatic function (Child-Pugh score 7-9), geometric mean erlotinib AUC0-t and Cmax was 27000 ng•h/mL and 805 ng/mL, respectively, as compared to 29300 ng•h/mL and 1090 ng/mL in patients with adequate hepatic function including patients with primary liver cancer or hepatic metastases.
I
No data are available regarding the influence of severe hepatic dysfunction on the pharmacokinetics of erlotinib.
14 populationsfarmakokinetiske analyser ledsagedes øgede serumkoncentrationer af total bilirubin af en langsommere hastighed af erlotinib- clearance.
In population pharmacokinetic analysis, increased serum concentrations of total bilirubin were associated with a slower rate of erlotinib clearance.
Erlotinib og dets metabolitter udskilles i mindre udstrækning gennem nyrerne, da mindre end 9% af en enkeltdosis udskilles i urinen.
Erlotinib and its metabolites are not significantly excreted by the kidney, as less than 9% of a single dose is excreted in the urine.
I populationsfarmakokinetiske analyser blev der ikke observeret sammenhæng mellem erlotinib- clearance og creatinin- clearance, men der er ingen data tilgængelige hos patienter med creatinin- clearance < 15 ml/ min.
In population pharmacokinetic analysis, no clinically significant relationship was observed between erlotinib clearance and creatinine clearance, but there are no data available for patients with creatinine clearance < 15 ml/min.
Virkninger af kronisk behandling, som observeredes hos mindst en dyreart eller i et studie, omfattede virkninger på cornea (atrofi, ulceration), hud (follikulær degeneration og inflammation, rødme og alopeci), ovarier (atrofi), lever (levernekrose), nyre (renal papillær nekrose og tubulær dilatation), mave- tarmkanalen (forsinket gastrisk tømning og diarré).
Chronic dosing effects observed in at least one animal species or study included effects on the cornea (atrophy, ulceration), skin (follicular degeneration and inflammation, redness, and alopecia), ovary (atrophy), liver (liver necrosis), kidney (renal papillary necrosis and tubular dilatation), and gastrointestinal tract (delayed gastric emptying and diarrhoea).
Disse fund blev observeret ved eksponeringer, som lå betydeligt under klinisk relevante eksponeringer.
These findings were observed at exposures well below clinically relevant exposures
På basis af virkningsmekanismen har erlotinib potentialet til at være teratogent.
Based on the mode of action, erlotinib, has the potential to be a teratogen.
Data fra reproduktionstoksikologiske tests på rotter og kaniner i doser i nærheden af maksimum tolererbar dosis og/ eller maternale toksiske doser viste reproduktionstoksiske (embryotoksicitet hos rotte, embryoresorption og foetotoksicitet hos kaniner) og udviklingstoksiske (nedsat vækst af unger og nedsat overlevelse hos rotter) virkninger, men ingen teratogenicitet og ingen påvirkning af fertiliteten.
Data from reproductive toxicology tests in rats and rabbits at doses near the maximum tolerated dose and/or maternally toxic doses showed reproductive (embryotoxicity in rats, embryo resorption and foetotoxicity in rabbits) and developmental (decrease in pup growth and survival in rats) toxicity, but was not teratogenic and did not impair fertility.
Erlotinib blev testet negativ i konventionelle genotoksiske studier.
Erlotinib tested negative in conventional genotoxicity studies.
Der er observeret en let fototoksisk hudreaktion hos rotter efter UV- bestråling.
A mild phototoxic skin reaction was observed in rats after UV irradiation.
Lactosemonohydrat Cellulose, mikrokrystallinsk (E460) Natriumstivelsesglykolat type A Natriumlaurylsulfat Magnesiumstearat (E470 b)
Lactose monohydrate Cellulose, microcrystalline (E460) Sodium starch glycolate Type A Sodium laurilsulfate Magnesium stearate (E470 b)
Hydroxypropylcellulose (E463) Titandioxid (E171) Macrogol Hypromellose (E464)
Hydroxypropyl cellulose (E463) Titanium dioxide (E171) Macrogol Hypromellose (E464)
Gult påtrykt blæk:
Printing ink yellow:
Shellac (E904) Gul jernoxid (E172)
Shellac (E904) Iron oxide yellow (E172)
15 6. 3 Opbevaringstid
6. 3 Shelf life
PVC- blister forseglet med alufolie indeholdende 30 tabletter.
PVC blister sealed with aluminium foil containing 30 tablets.
Tarceva 100 mg En filmovertrukken tablet indeholder 100 mg erlotinib (som erlotinibhydrochlorid).
Tarceva 100 mg One film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride).
Filmovertrukken tablet Hvide til gullige, runde, bikonvekse tabletter påtrykt ‘ Tarceva 100 ’ og logo i gråt på den ene side.
Film-coated tablet White to yellowish, round, biconvex tablets with ‘Tarceva 100’ and logo printed in grey on one side.
Den anbefalede daglige dosis af Tarceva er 100 mg, som tages mindst én time før eller to timer efter indtagelse af føde, i kombination med gemcitabin (se produktresuméet for gemcitabin for pancreas cancer indikationen).
The recommended daily dose of Tarceva is 100 mg taken at least one hour before or two hours after the ingestion of food, in combination with gemcitabine (see the summary of product characteristics of gemcitabine for the pancreatic cancer indication).
17 Hvis dosisjustering er nødvendig, skal dosis reduceres med 50 mg ad gangen (se pkt.
When dose adjustment is necessary, reduce in 50 mg steps (see section 4.4).
Tarceva findes i styrker på 25 mg, 100 mg og 150 mg.
17 Tarceva is available in strengths of 25 mg, 100 mg and 150 mg.
18 Afhængig af den diagnostiske evaluering skal behandling med Tarceva stoppes hos patienter, som udvikler akutte nye og/ eller progredierende, uforklarlige lungesymptomer, som f. eks. dyspnø, hoste og feber.
18 In patients who develop acute onset of new and/or progressive unexplained pulmonary symptoms such as dyspnoea, cough and fever, Tarceva therapy should be interrupted pending diagnostic evaluation.
50% af patienterne, der modtager Tarceva, og moderat eller svær diarré bør behandles med f. eks. loperamid.
Diarrhoea has occurred in approximately 50% of patients on Tarceva and moderate or severe diarrhoea should be treated with e.g. loperamide.
Nogle tilfælde var sekundære til svær dehydrering på grund af diarré, opkastning og/ eller appetitløshed mens andre tilfælde opstod i forbindelse med konkomitant kemoterapi.
Some cases were secondary to severe dehydration due to diarrhoea, vomiting and/or anorexia, while others were confounded by concomitant chemotherapy.
Der skal udvises forsigtighed, når ciprofloxacin eller potente CYP1A2- hæmmere (f. eks. fluvoxamin) kombineres med erlotinib.
Caution should be exercised when ciprofloxacin or potent CYP1A2 inhibitors (e.g. fluvoxamine) are combined with erlotinib.
19 Forbehandling eller samtidig administration af Tarceva ændrede ikke clearance af de prototypiske CYP3A4- substrater, midazolam og erythromycin, men nedsatte tilsyneladende den orale biotilgængelighed af midazolam med op til 24%.
19 of the concomitantly administered CYP3A4/2C8 substrate paclitaxel.
Signifikante interaktioner ved clearance af andre CY P3A4- substrater er derfor usandsynlig.
Significant interactions with the clearance of other CYP3A4 substrates are therefore unlikely.
Patienter med lavt ekspressionsniveau af UGT1A1 eller med genetiske glukoronidiseringssygdomme (f. eks.
Patients with low expression levels of UGT1A1 or genetic glucuronidation disorders (e.g.
Der skal derfor iagttages forsigtighed, når erlotinib kombineres med en potent CYP3A4- hæmmer, f. eks. med antimykotika af azol- gruppen (dvs. ketoconazol, itraconazol og voriconazol), proteasehæmmere, erytromycin eller claritromycin.
Therefore, caution should be used when erlotinib is combined with a potent CYP3A4 inhibitor, e.g. azole antifungals (i.e. ketoconazole, itraconazole, voriconazole), protease inhibitors, erythromycin or clarithromycin.
Hvis det bliver tolereret godt i mere end 2 uger, kan det overvejes at hæve dosis yderligere til 450 mg under fortsat tæt kontrol.
For patients who require concomitant treatment with Tarceva and a potent CYP3A4 inducer such as rifampicin an increase in dose to 300 mg should be considered while their safety (including renal and liver functions and serum electrolytes) is closely monitored, and if well tolerated for more than 2 weeks, further increase to 450 mg could be considered with close safety monitoring.
Patienter, som stadig ryger, skal derfor opfordres til at stoppe med at ryge så tidligt så muligt inden behandlingen med Tarceva initieres, idet plasmakoncentrationerne ellers reduceres.
The refore, patients who are still smoking should be encouraged to stop smoking as early as possible before initiation of treatment with Tarceva, as plasma erlotinib concentrations are reduced otherwise.
Samtidig administration af P - glycoptoteinhæmmere, f. eks. cyclosporin og verapamil kan medføre ændret distribution og/ eller
Concomitant administration of inhibitors of Pgp, e.g. cyclosporine and verapamil, may lead to altered distribution and/or altered elimination of erlotinib.
Konsekvenserne af denne interaktion for f. eks.
The consequences of this interaction for e.g.
Samtidig administration af erlotinib med omeprazol, som er en syrepumpehæmmer, nedsætter erlotinibeksponering [AUC] og maksimumkoncentrationen [Cmax] med henholdsvis 46% og 61%.
20 erlotinib with omeprazole, a proton pump inhibitor (PPI), decreased the erlotinib exposure [AUC] and maximum concentration [Cmax] by 46% and 61%, respectively.
Hvis Tarceva derimod blev administreret forskudt enten 2 timer før eller 10 timer efter 150 mg ranitidin 2 gange daglig, blev erlotinibeksponeringen [AUC] og maksimumkoncentrationerne [Cmax] kun reduceret med henholdsvis 15% og 17%.
However, when Tarceva was dosed in a staggered manner 2 hours before or 10 hours after ranitidine 150 mg b.i.d., erlotinib exposure [AUC] and maximum concentrations [Cmax] decreased only by 15% and 17%, respectively.
De fleste var af grad 1/ 2, og intervention var ikke nødvendig.
Most were Grade 1/2 in severity and manageable without intervention.
21 6% af de Tarceva- behandlede patienter, og hver af dem medførte afbrydelse af behandlingen hos 1% af patienterne.
Grade 3/4 rash and diarrhoea occurred in 9% and 6%, respectively in Tarceva-treated patients and each resulted in study discontinuation in 1% of patients.
6% og 1% af patienterne.
Dose reduction for rash and diarrhoea was needed in 6% and 1% of patients, respectively.
I studie BR. 21 var den mediane tid indtil starten af udslæt 8 dage og den mediane tid indtil starten af diarré 12 dage.
In study BR. 21, the median time to onset of rash was 8 days, and the median time to onset of diarrhoea was 12 days.
De bivirkninger, som i det pivotale studie BR. 21 optrådte hyppigere (≥3%) hos Tarceva- behandlede patienter end hos patienter, som fik placebo, og som optrådte hos mindst 10% af patienterne i Tarceva- gruppen, er sammenfattet i henhold til National Cancer Institute- Common Toxicity Criteria (NCI- CTC) Grade i tabel 1.
21 Adverse events occurring more frequently (≥3%) in Tarceva-treated patients than in the placebo group in the pivotal study BR.21, and in at least 10% of patients in the Tarceva group, are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 1.
MedDRA term Totalt antal patienter med uønsket
MedDRA Preferred Term Total patients with any AE Infections and infestations
Den mediane
In the Tarceva plus gemcitabine arm, Grade 3/4 rash and diarrhoea were each reported in 5% of patients.
22 tid til starten af udslæt og diarré var hhv.
The median time to onset of rash and diarrhoea was 10 days and 15 days, respectively.
Både udslæt og diarré medførte dosisreduktion hos 2% af patienterne og afbrydelse af studiet hos op til 1% af patienterne, som fik Tarceva plus gemcitabin.
Rash and diarrhoea each resulted in dose reductions in 2% of patients, and resulted in study discontinuation in up to 1% of patients receiving Tarceva plus gemcitabine.
Bivirkninger, som i det pivotale studie PA. 3 optrådte hyppigere (≥ 3%) hos patienter behandlet med Tarceva 100 mg plus gemcitabin end hos patienter behandlet med placebo plus gemcitabin, og som optrådte hos mindst 10% af patienterne i gruppen, som fik Tarceva 100 mg plus gemcitabin, er sammenfattet i tabel 2 i henhold til National Cancer Institute Common Toxicity Criteria (NCI- CTC).
22 Adverse events occurring more frequently (≥3%) in Tarceva 100 mg plus gemcitabine-treated patients than in the placebo plus gemcitabine group in the pivotal study PA.3, and in at least 10% of patients in the Tarceva 100 mg plus gemcitabine group, are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 2.
Meget almindelige bivirkninger i studie PA. 3 (100 mg gruppen)
Very common ADRs in study PA.3 (100 mg cohort)
Erlotinib N = 259 Alle
Erlotinib N = 259 Any
Infektion *
Infection* Metabolism and nutrition disorders
Hovedpine Neuropati Luftveje, thorax og mediastinum Hoste
Headache Neuropathy Respiratory ,thoracic and mediastinal disorders
< 1 36 0 12 0 13 0 9
36 1 2 13 9
Sikkerhedsevalueringen af Tarceva er baseret på data fra 759 patienter, der blev behandlet med mindst en dosis Tarceva på 150 mg som monoterapi i fase III NSCLC- studiet BR. 21, fase II NSCLC- studiet
Safety evaluation of Tarceva is based on the data from 759 patients treated with at least one 150 mg dose of Tarceva monotherapy during Phase III NSCLC study BR.21, Phase II NSCLC study A248-1007, and three Phase II studies in populations other than NSCLC:
248- 101 (ovariecancer), A248- 1003 (hoved- halskræft) og OSI2288g (metastatisk brystkræft) og fra 285 patienter, som fik Tarceva 100 eller 150 mg plus gemcitabin i fase III pancreas- cancer- studiet PA. 3.
248-101 (ovarian cancer), A248-1003 (head and neck cancer), and OSI2288g (metastatic breast cancer) and the 285 patients who received Tarceva 100 or 150 mg plus gemcitabine in the phase III pancreatic cancer study PA.3.
Følgende betegnelser anvendes for at graduere bivirkningerne efter hyppighed: meget almindelig (> 1/ 10); almindelig (> 1/ 100, < 1/ 10); ikke almindelig (> 1/ 1. 000, < 1/ 100); sjælden (> 1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000), herunder enkeltstående indberetninger.
23 The following terms are used to rank the undesirable effects by frequency: very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1,000, < 1/100); rare (> 1/10,000, < 1/1000); very rare (< 1/10,000) including isolated reports.
Meget almindeligt forekommende bivirkninger fremgår af tabel 1 og 2, mens bivirkninger med anden hyppighed er sammenfattet herunder:
Very common ADR’s are presented in Tables 1 and 2, ADR’s in other frequency categories are summarized below.
Almindelig:
Common (in PA.3):
Hirsutisme, øjenvippe - / øjenbrynforandringer og skrøbelige og løse negle.
Hirsutism, eyelash/eyebrow changes and brittle and loose nails.
Erlotinib er en epidermal vækstfaktorreceptor/ human epidermal vækstfaktorreceptor type 1 (EGFR også kendt som HER1) tyrosinkinasehæmmer.
24 Erlotinib is an epidermal growth factor receptor/human epidermal growth factor receptor type 1 (EGFR also known as HER1) tyrosine kinase inhibitor.
I ikke- kliniske modeller medfører hæmning af EGFR phosphortyrosin cellestase og/ eller celledød.
In non-clinical models, inhibition of EGFR phosphotyrosine results in cell stasis and/or death.
Virkningen af Tarceva på samlet overlevelse var sammenlignelig hos patienter med baseline performance status (ECOG) på 2- 3 (HR = 0, 77; konfidensinterval 0, 6- 1, 0) eller 0- 1 (HR = 0, 73; konfidensinterval 0, 6 - 0, 9), mandlige patienter (HR = 0, 76; konfindensinterval 0, 6- 0, 9) eller kvindlige patienter (HR = 0, 80, konfidensinterval 0, 6- 1, 1), patienter < 65 år (HR = 0, 75; konfidensinterval 0, 6- 0, 9) eller ældre patienter (HR = 0, 79; konfidensinterval 0, 6- 1, 0), patienter med ét tidligere regime (HR = 0, 76; konfidensinterval 0, 6- 1, 0) eller mere end ét tidligere regime (HR = 0, 75; konfidensinterval 0, 6- 1, 0), kaukasiere (HR = 0, 79; konfidensinterval 0, 6- 1, 0) eller asiatiske patienter (HR = 0, 61; konfidensinterval 0, 4- 1, 0), patienter med adenokarcinom (HR = 0, 71; konfidensinterval 0, 6- 0, 9) eller planocellulært karcinom (HR = 0, 67; konfidensinterval 0, 5- 0, 9), men ikke hos patienter med anden histologi (HR 1, 04; konfidensinterval 0, 7- 1, 5), patienter med stadie IV sygdom ved diagnosetidspunktet (HR = 0, 92; konfidensinterval 0, 7- 1, 2) eller < stadie IV sygdom ved diagnosetidspunktet (HR = 0, 65; konfidensinterval 0, 5- 0, 8).
The effect of Tarceva on overall survival was similar in patients with a baseline performance status (ECOG) of 2-3 (HR = 0.77, CI 0.6-1.0) or 0-1 (HR = 0.73, 0.6-0.9), male (HR = 0.76, CI 0.6-0.9) or female patients (HR = 0.80, CI 0.6-1.1), patients < 65 years of age (HR = 0.75, CI 0.6-0.9) or older patients (HR = 0.79, CI 0.6-1.0), patients with one prior regimen (HR = 0.76, CI 0.6-1.0) or more than one prior regimen (HR = 0.75, CI 0.6-1.0), Caucasian (HR = 0.79, CI 0.6-1.0) or Asian patients (HR = 0.61, 0.4-1.0), patients with adenocarcinoma (HR = 0.71, CI 0.6-0.9) or squamous cell carcinoma (HR = 0.67, CI 0.5-0.9), but not in patients with other histologies (HR 1.04, CI 0.7-1.5), patients with stage IV disease at diagnosis (HR = 0.92, CI 0.7-1.2) or < stage IV disease at diagnosis (HR = 0.65, 0.5-0.8).
25 Den mediane PFS var 9, 7 uger i Tarceva- gruppen (95% konfidensinterval; 8, 4 til 12, 4 uger) sammenlignet med 8, 0 uger i placebo- gruppen (95% konfidensinterval; 7, 9 til 8, 1 uger).
The median PFS was 9.7 weeks in the Tarceva group (95% CI, 8.4 to 12.4 weeks) compared with 8.0 weeks in the placebo group (95% CI, 7.9 to 8.1 weeks).
RECIST).
25 A survival benefit of Tarceva was also observed in patients who did not achieve an objective tumour response (by RECIST).