natgillin/translations-raw huggingface dataset:
Overall Survival – Patients with Distant Metastases 1.0
Celokupno preživetje – bolniki z metastazami v oddaljenih organih 1, 0
Survival Probability
0, 8 HR = 0, 80 0, 7 Verjetnost preživetja
HR = 0.80 (95% CI:
(95% interval zaupanja:
0.3 0.2
0, 3 0, 2 0, 1
Placebo +
placebo + gemcitabin (n = 197)
Median OS = 5.93 months
mediana OS = 5, 93 meseca
0.1 gemcitabine (n = 197) Median OS = 5.0 6 months 0.0
0, 0 mediana OS = 5, 06 meseca
In a post-hoc analysis, patients with favourable clinical status at baseline (low pain intensity, good QoL and good PS) may derive more benefit from Tarceva.
V post- hoc analizi so ugotovili, da imajo lahko bolniki z ugodnim kliničnim stanjem pred začetkom zdravljenja (nizka jakost bolečine, dobra kakovost življenja in dobro stanje zmogljivosti) večjo korist od zdravljenja z zdravilom Tarceva.
In a post-hoc analysis, patients on Tarceva who developed a rash had a longer overall survival compared to patients who did not develop rash (median OS 7.2 months vs 5 months, HR:0.61).
V post- hoc analizi so bolniki, ki so se zdravili z zdravilom Tarceva in pri katerih se je pojavil kožni izpuščaj, imeli daljše celokupno preživetje v primerjavi z bolniki, pri katerih se izpuščaj ni pojavil (mediana celokupnega preživetja 7, 2 meseca v primerjavi s 5 meseci, razmerje ogroženosti 0, 61).
90% of patients on Tarceva developed rash within the first 44 days.
Pri 90% bolnikov, ki so se zdravili z zdravilom Tarceva, se je kožni izpuščaj pojavil v prvih 44 dneh.
A fter oral administration, erlotinib peak plasma levels are obtained in approximately 4 hours after oral dosing.
Absorpcija: po peroralnem zaužitju so maksimalne koncentracije erlotiniba v plazmi dosežene v približno 4 urah.
A study in normal healthy volunteers provided an estimate of the absolute bioavailability of 59%.
Študija pri zdravih prostovoljcih je pokazala oceno absolutne biološke uporabnosti 59%.
Erlotinib has a mean apparent volume of distribution of 232 l and distributes into tumour tissue of humans.
13 Porazdelitev: erlotinib ima srednji navidezni volumen porazdelitve 232 l in se porazdeljuje v tumorska tkiva pri ljudeh.
In a study of 4 patients (3 with non-small cell lung cancer [NSCLC], and 1 with laryngeal cancer) receiving 150 mg daily oral doses of Tarceva, tumour samples from surgical excisions on Day 9 of treatment revealed tumour concentrations of erlotinib that averaged 1,185 ng/g of tissue.
V študiji štirih bolnikov (trije so imeli nedrobnocelični rak pljuč, eden pa rak grla), ki so prejemali zdravilo Tarceva v odmerku 150 mg enkrat na dan peroralno, so po kirurškem izrezu v vzorcih tumorjev na deveti dan zdravljenja koncentracije erlotiniba znašale v povprečju 1185 ng/ g tkiva.
This corresponded to an overall average of 63% (range 5-161%) of the steady state observed peak plasma concentrations.
To je ustrezalo 63% (razpon 5– 161%) celokupnega povprečja največjih plazemskih koncentracij, ki so jih opazili v stanju dinamičnega ravnovesja.
The primary active metabolites were present in tumour at concentrations averaging 160 ng/g tissue, which corresponded to an overall average of 113% (range 88-130%) of the observed steady state peak plasma concentrations.
To je ustrezalo 113% (razpon 88– 130%) celokupnega povprečja največjih plazemskih koncentracij, ki so jih opazili v stanju dinamičnega ravnovesja.
Plasma protein binding is approximately 95%.
Vezava na plazemske proteine znaša približno 95%.
Erlotinib binds to serum albumin and alpha-1 acid glycoprotein (AAG).
Erlotinib se veže na serumski albumin in alfa- 1 kisli glikoprotein.
Erlotinib is metabolised in the liver by the hepatic cytochromes in humans, primarily CYP3A4 and to a lesser extent by CYP1A2.
Presnova: erlotinib se pri ljudeh presnavlja v jetrih z jetrnimi citokromi, v glavnem s CYP3A4, v manjši meri pa tudi s CYP1A2.
There are three main metabolic pathways identified:
Znane so tri glavne poti presnove:
1) O-demethylation of either side chain or both, followed by oxidation to the carboxylic acids; 2) oxidation of the acetylene moiety followed by hydrolysis to the aryl carboxylic acid; and 3) aromatic hydroxylation of the phenyl-acetylene moiety.
1) O- demetiliranje ene stranske verige ali obeh, ki mu sledi oksidacija v karboksilno kislino; 2) oksidacija acetilenske skupine, ki ji sledi hidroliza v arilkarboksilno kislino in 3) aromatska hidroksilacija fenilacetilenske skupine.
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.
Primarna presnovka erlotiniba OSI- 420 in OSI- 413, ki nastaneta z O- demetiliranjem katere koli stranske verige, imata primerljivo učinkovitost z erlotinibom v nekliničnih in vitro metodah in in vivo tumorskih modelih.
They are present in plasma at levels that are < 10% of erlotinib and display similar pharmacokinetics as erlotinib.
V plazmi sta prisotna v koncentracijah, manjših od 10% koncentracije erlotiniba, in kažeta podobno farmakokinetiko kakor erlotinib.
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.
Izločanje: erlotinib se po peroralnem dajanju v glavnem izloča v obliki presnovkov z blatom (> 90%), v manjšem obsegu pa tudi prek ledvic (približno 9%).
Less than 2% of the orally administered dose is excreted as parent substance.
Manj kot 2% peroralno zaužitega odmerka se izloča v nespremenjeni obliki.
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.
Populacijska farmakokinetična analiza je pri 591 bolnikih, ki so prejemali le zdravilo Tarceva, pokazala srednji navidezni očistek 4, 47 l/ uro z mediano razpolovnega časa 36, 2 ure.
Pharmacokinetics in special populations:
Farmakokinetika pri posebnih populacijah
Patient factors, which correlated with erlotinib pharmacokinetics, were serum total bilirubin, AAG and current smoking.
Dejavniki, ki so bili pri bolniku povezani s farmakokinetiko erlotiniba, so bili serumski celokupni bilirubin, koncentracije alfa- 1 kislega glikoproteina in trenutno kajenje.
Increased serum concentrations of total bilirubin and AAG concentrations were associated with a reduced erlotinib clearance.
Zvišane serumske koncentracije celokupnega bilirubina in koncentracije alfa- 1 kislega glikoproteina so bile povezane z zmanjšanjem očistka erlotiniba.
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:
Geometrijska sredina Cmax je bila 1056 ng/ ml pri nekadilcih in 689 ng/ ml pri kadilcih s povprečnim razmerjem za kadilce glede na nekadilce 65, 2% (95 -% interval zaupanja:
44.3 to 95.9, p = 0.031).
44, 3 do 95, 9; p = 0, 031).
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:
Geometrijska sredina AUC0- ∞ je bila 18726 ng• h/ ml pri nekadilcih in 6718 ng• h/ ml pri kadilcih s povprečnim razmerjem 35, 9% (95 -% interval zaupanja:
23.7 to 54.3, p < 0.0001).
23, 7 do 54, 3; p < 0, 0001).
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:
Geometrijska sredina C24h je bila 288 ng/ ml pri nekadilcih in 34, 8 ng/ ml pri kadilcih s povprečnim razmerjem 12, 1% (95 -% interval zaupanja:
4.82 to 30.2, p = 0.0001).
4, 82 do 30, 2; p = 0, 0001).
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).
V ključni študiji faze III pri nedrobnoceličnem raku pljuč je bila najmanjša koncentracija erlotiniba v stanju dinamičnega ravnovesja pri bolnikih, ki so med zdravljenjem kadili, 0, 65 µg/ ml (n = 16), kar je bilo približno 2- krat manj, kot pri nekdanjih kadilcih ali bolnikih, ki niso nikoli kadili (1, 28 µg/ ml, n = 108).
In a phase I dose escalation study in NSCLC patients who were
Temu učinku se je pridružilo tudi zmanjšanje navideznega plazemskega očistka erlotiniba za 24%.
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.
V študiji faze I s povečevanjem odmerka pri bolnikih z nedrobnoceličnim rakom pljuč so farmakokinetične analize v stanju dinamičnega ravnotežja pri bolnikih, ki so kadili, pokazale od odmerka odvisno povečanje izpostavljenosti erlotinibu, ko se je odmerek zdravila Tarceva povečeval iz 150 mg do največjega odmerka, ki so ga še prenašali, 300 mg.
Steady-state trough plasma concentrations at a 300 mg dose in current smokers in this study was 1.22 µg/mL (n=17).
Najmanjša plazemska koncentracija v stanju dinamičnega ravnovesja pri 300- mg odmerku pri kadilcih je bila v tej študiji 1, 22 µg/ ml (n = 17).
Based on the results of pharmacokinetic studies, current smokers should be advised to stop smoking while taking Tarceva, as plasma concentrations could be reduced otherwise.
14 Na osnovi rezultatov farmakokinetičnih študij, je treba kadilcem svetovati, naj prekinejo kajenje, medtem ko se zdravijo z zdravilom Tarceva, ker so sicer lahko plazemske koncentracije zmanjšane.
Based on population pharmacokinetic analysis, the presence of an opioid appeared to increase exposure by about 11%.
Populacijska farmakokinetična analiza je pokazala, da lahko prisotnost opioida poveča izpostavljenost za približno 11%.
There have been no specific studies in paediatric or elderly patients.
Specifičnih študij pri otrocih ali starejših bolnikih niso izvedli.
Erlotinib is primarily cleared by the liver.
Jetrna okvara: erlotinib se v glavnem izloča prek jeter.
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.
Pri bolnikih s solidnimi tumorji in zmerno jetrno okvaro (7– 9 točk po Child- Pughovi lestvici) je bila geometrijska sredina AUC0- t erlotiniba 27000 ng• h/ ml in Cmax erlotiniba 805 ng/ ml, v primerjavi z AUC0- t 29300 ng• h/ ml in Cmax 1090 ng/ ml pri bolnikih z ustreznim delovanjem jeter, vključno z bolniki s primarnim rakom jeter ali zasevki v jetrih.
Erlotinib and its metabolites are not significantly excreted by the kidney, as less than 9% of a single dose is excreted in the urine.
Ledvična okvara: erlotinib in njegovi presnovki se ne izločajo v velikem obsegu prek ledvic, saj se jih po enkratnem odmerku v urin izloči manj kot 9%.
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.
V populacijski farmakokinetični analizi niso opazili klinično pomembne povezave med očistkom erlotiniba in očistkom kreatinina, vendar za bolnike s kreatininskim očistkom < 15 ml/ min podatkov ni.
These findings were observed at exposures well below clinically relevant exposures
Te učinke so opazili pri izpostavljenosti, ki je bila močno pod primerljivo stopnjo klinične izpostavljenosti.
Based on the mode of action, erlotinib, has the potential to be a teratogen.
Glede na mehanizem delovanja obstaja možnost, da bi erlotinib lahko imel teratogeno delovanje.
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.
Niso pa našli dokazov za teratogenost in vpliv na plodnost.
These findings were observed at clinically relevant exposures.
Te učinke so opazili pri izpostavljenosti primerljivi s klinično.
A mild phototoxic skin reaction was observed in rats after UV irradiation.
Pri podganah so po obsevanju z UV- žarki opazili blago fototoksično kožno reakcijo.
Lactose monohydrate Cellulose, microcrystalline (E460) Sodium starch glycolate Type A Sodium laurilsulfate Magnesium stearate (E470 b)
Jedro tablete: laktoza monohidrat mikrokristalna celuloza (E460) natrijev karboksimetilškrob (vrsta A) natrijev lavrilsulfat magnezijev stearat (E470b)
Hydroxypropyl cellulose (E463) Titanium dioxide (E171) Macrogol Hypromellose (E464)
Obloga tablete: hidroksipropilceluloza (E463) titanov dioksid (E171) makrogol hipromeloza (E464)
Shellac (E904) Iron oxide yellow (E172)
Rumeno barvilo za tisk: šelak (E904) rumeni železov oksid (E172)
Tarceva 100 mg One film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride).
Tarceva 100 mg Ena filmsko obložena tableta vsebuje 100 mg erlotiniba (v obliki erlotinibijevega klorida).
Film-coated tablet White to yellowish, round, biconvex tablets with ‘Tarceva 100’ and logo printed in grey on one side.
Filmsko obložena tableta Bele do rumenkaste, okrogle, bikonveksne tablete s sivim napisom “ Tarceva 100 ” in logom na eni strani.
When dose adjustment is necessary, reduce in 50 mg steps (see section 4.4).
18 Kadar je potrebno odmerek prilagoditi, ga zmanjšujemo v korakih po 50 mg (glejte poglavje 4. 4).
17 Tarceva is available in strengths of 25 mg, 100 mg and 150 mg.
Zdravilo Tarceva je na voljo v jakostih 25 mg, 100 mg in 150 mg.
Confounding or contributing factors such as concomitant or prior chemotherapy, prior radiotherapy, pre-existing parenchymal lung disease, metastatic lung disease, or pulmonary infections were frequent.
19 sočasna ali predhodna kemoterapija, predhodna radioterapija, predhodno obstoječa parenhimska pljučna bolezen, metastatska pljučna bolezen ali pljučne okužbe.
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.
Pri bolnikih, pri katerih se akutno pojavijo novi in/ ali poslabšajo nepojasnjeni pljučni simptomi, kot so dispneja, kašelj in zvišana telesna temperatura, je zdravljenje z zdravilom Tarceva treba prekiniti, dokler ni znana diagnoza.
Diarrhoea has occurred in approximately 50% of patients on Tarceva and moderate or severe diarrhoea should be treated with e.g. loperamide.
Pri približno 50% bolnikov, ki so se zdravili z zdravilom Tarceva, se je pojavila driska.
Some cases were secondary to severe dehydration due to diarrhoea, vomiting and/or anorexia, while others were confounded by concomitant chemotherapy.
V nekaterih primerih je bila vzrok huda dehidracija zaradi driske, bruhanja in/ ali anoreksije, pri drugih pa je k nastanku pripomogla sočasno prejeta kemoterapija.
Caution should be exercised when ciprofloxacin or potent CYP1A2 inhibitors (e.g. fluvoxamine) are combined with erlotinib.
Pri kombinaciji ciprofloksacina ali močnega zaviralca CYP1A2 (npr. fluvoksamina) z erlotinibom je potrebna
In another clinical study, erlotinib was shown not to affect pharmacokinetics
V drugi klinični študiji erlotinib ni vplival na farmakokinetiko paklitaksela, substrata CYP3A4/ 2C8, ki so ga jemali sočasno.
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.
Če bolnik ta odmerek dobro prenaša več kot 2 tedna, pride v poštev nadaljnje povečanje odmerka na 450 mg ob skrbnem spremljanju varnosti.
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.
Zato je treba bolnikom kadilcem svetovati, naj kajenje opustijo čim prej pred začetkom zdravljenja z zdravilom Tarceva, saj bodo sicer plazemske koncentracije zmanjšane.
Erlotinib is a substrate for the P-glycoprotein active substance transporter.
21 Erlotinib je substrat P- glikoproteina, prenašalca zdravilnih učinkovin.
Concomitant administration of inhibitors of Pgp, e.g. cyclosporine and verapamil, may lead to altered distribution and/or altered elimination of erlotinib.
Sočasna uporaba zaviralcev Pgp, kot sta ciklosporin in verapamil, lahko vodi v spremenjeno porazdelitev in/ ali spremenjeno izločanje erlotiniba.
20 erlotinib with omeprazole, a proton pump inhibitor (PPI), decreased the erlotinib exposure [AUC] and maximum concentration [Cmax] by 46% and 61%, respectively.
Sočasno dajanje erlotiniba z omeprazolom, zaviralcem protonske črpalke, je zmanjšalo izpostavljenost erlotinibu [AUC] za 46% in maksimalno koncentracijo [Cmax] za 61%.
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.
Ko pa so zdravilo Tarceva dajali ločeno, to je 2 uri pred ali 10 ur po 150 mg ranitidina (ki so ga bolniki jemali dvakrat na dan), se je izpostavljenost erlotinibu [AUC] zmanjšala samo za 15%, maksimalna koncentracija [Cmax] pa samo za 17%.
4.8 Undesirable effects
22 4. 8 Neželeni učinki
Most were Grade 1/2 in severity and manageable without intervention.
Večina jih je bila glede na jakost stopnje 1/ 2 in je minila brez zdravljenja.
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.
Pri obeh primerih je bilo zdravljenje v študiji treba prekiniti pri 1% bolnikov.
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.
V študiji BR. 21 je bila mediana časa do pojava kožnega izpuščaja 8 dni, do pojava driske pa 12 dni.
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.
Neželeni dogodki, ki so se v ključni študiji BR. 21 pojavili pogosteje (≥ 3%) pri bolnikih, ki so jemali zdravilo Tarceva, kot pri bolnikih, ki so prejemali placebo, in pri vsaj 10% bolnikov, ki so prejemali zdravilo Tarceva, so povzeti po lestvici skupnih kriterijev toksičnosti Nacionalnega inštituta za raka (NCI- CTC) v preglednici 1.
* Severe infections, with or without neutropenia, have included pneumonia, sepsis, and cellulitis. ** Can lead to dehydration, hypokalemia and renal failure. *** Rash included dermatitis acneiform.
23 ** Lahko vodi v dehidracijo, hipokaliemijo in ledvično odpoved. *** Kožni izpuščaj vključuje dermatitis podoben aknam.
In the Tarceva plus gemcitabine arm, Grade 3/4 rash and diarrhoea were each reported in 5% of patients.
V skupini, ki je prejemala zdravilo Tarceva in gemcitabin, so o kožnem izpuščaju in driski, obeh stopnje 3/ 4, poročali obakrat pri 5% bolnikov.
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.
Neželeni dogodki, ki so se v ključni študiji PA. 3 pojavili pogosteje (≥ 3%) pri bolnikih, zdravljenih z zdravilom Tarceva 100 mg in gemcitabinom, kot v skupini, ki je prejemala placebo in gemcitabin, in pri najmanj 10% bolnikov v skupini, zdravljeni z zdravilom Tarceva 100 mg in gemcitabinom, so povzeti po lestvici skupnih kriterijev toksičnosti Nacionalnega inštituta za raka (NCI- CTC) v preglednici 2.
Headache Neuropathy Respiratory ,thoracic and mediastinal disorders
glavobol nevropatija Bolezni dihal, prsnega koša in mediastinalnega prostora
1 0
24
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.
Neželeni učinki so navedeni po pogostnosti na naslednji način: zelo pogosti (> 1/ 10), pogosti (> 1/ 100, < 1/ 10), občasni (> 1/ 1. 000, < 1/ 100), redki (> 1/ 10. 000, < 1/ 1. 000), zelo redki (< 1/ 10. 000), vključno s posameznimi primeri.
Very common ADR’s are presented in Tables 1 and 2, ADR’s in other frequency categories are summarized below.
Zelo pogosti neželeni učinki so navedeni v preglednicah 1 in 2, neželeni učinki drugih pogostnosti pa so povzeti spodaj.
Hirsutism, eyelash/eyebrow changes and brittle and loose nails.
alopecija. suha koža. zanohtnica. poraščenost moškega tipa pri ženskah, spremembe trepalnic/ obrvi, krhki nohti in odstopanje nohtov od kože.
Eye disorders:
25 Očesne bolezni:
24 Erlotinib is an epidermal growth factor receptor/human epidermal growth factor receptor type 1 (EGFR also known as HER1) tyrosine kinase inhibitor.
Erlotinib je zaviralec tirozinske kinaze receptorja za epidermalni rastni dejavnik/ humanega receptorja za epidermalni rastni dejavnik tipa 1 (EGFR, prav tako poznan kot HER1).
In non-clinical models, inhibition of EGFR phosphotyrosine results in cell stasis and/or death.
V nekliničnih modelih zaviranje fosfotirozina EGFR povzroči zastoj in/ ali smrt celice.
The median overall survival was 6.7 months in the Tarceva group (95% CI, 5.5 to 7.8 months) compared with 4.7 months in the placebo group (95% CI, 4.1 to 6.3 months).
26 Tarceva 6, 7 meseca (95 -% interval zaupanja; 5, 5 do 7, 8 meseca), v primerjavi s 4, 7 meseca v placebo skupini (95 -% interval zaupanja; 4, 1 do 6, 3 meseca).
25 A survival benefit of Tarceva was also observed in patients who did not achieve an objective tumour response (by RECIST).
Koristen vpliv zdravila Tarceva na podaljšanje preživetja so opazili tudi pri bolnikih, ki niso dosegli objektivnega odgovora na zdravljenje (po kriterijih RECIST).
Patients were randomised to receive Tarceva or placebo once daily on a continuous schedule plus gemcitabine IV (1000 mg/m2, Cycle 1 - Days 1, 8, 15, 22, 29, 36 and 43 of an 8 week cycle; Cycle 2 and subsequent cycles - Days 1, 8 and 15 of a 4 week cycle [approved dose and schedule for pancreatic cancer, see the gemcitabine SPC]).
1., 8. in 15. dan 4- tedenskega cikla [odobreni odmerek in shema za rak trebušne slinavke, glejte Povzetek glavnih značilnosti zdravila za gemcitabin]).
Baseline demographic and disease characteristics of the patients were similar between the 2 treatment groups, 100 mg Tarceva plus gemcitabine or placebo plus gemcitabine, except for a slightly larger proportion of females in the erlotinib/gemcitabine arm compared with the placebo/gemcitabine arm:
27 Izhodiščne demografske značilnosti bolnikov in značilnosti njihove bolezni so bile podobne v obeh zdravljenih skupinah, v skupini, ki je prejemala zdravilo Tarceva 100 mg in gemcitabin, in skupini, ki je prejemala placebo in gemcitabin, razen nekoliko višjega deleža žensk v skupini, ki je prejemala erlotinib in gemcitabin, v primerjavi s skupino, ki je prejemala placebo in gemcitabin:
26 Overall Survival – All Patients 1.0
28 Celokupno preživetje – vsi bolniki 1, 0
0.69, 0.98), p = 0.028
0, 69; 0, 98), p = 0, 028 0, 6
Placebo + gemcitabine (n = 2 60) Median OS = 6.0 months
placebo + gemcitabin (n = 260) mediana OS = 6, 0 mesecev
0.1 gemcitabine (n = 197) Median OS = 5.06 months 0.0
0, 0 mediana OS = 5, 06 meseca
After oral administration, erlotinib peak plasma levels are obtained in approximately 4 hours after oral dosing.
Absorpcija: po peroralnem zaužitju so maksimalne koncentracije erlotiniba v plazmi dosežene v približno 4 urah.