natgillin/translations-raw huggingface dataset:
In a clinical study, the concomitant use of erlotinib with carboplatin and paclitaxel led to an increase of total platinum AUC0-48 of 10.6%.
V klinični študiji je sočasna uporaba erlotiniba s karboplatinom in paklitakselom povečala celokupno AUC0- 48 platine za 10, 6%.
There are no studies in pregnant women using erlotinib.
Ni podatkov o uporabi erlotiniba pri nosečnicah.
Studies in animals have shown some reproductive toxicity (see section 5.3).
Študije na živalih so pokazale določen vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
Because of the potential harm to the infant, mothers should be advised against breastfeeding while receiving Tarceva.
Zaradi možnega škodljivega vpliva na otroka naj doječe matere med zdravljenjem z zdravilom Tarceva ne dojijo.
No studies on the effects on the ability to drive and use machines have been performed; however erlotinib is not associated with impairment of mental ability.
Erlotiniba ne povezujejo s poslabšanjem mentalnih sposobnosti.
Non-small cell lung cancer (Tarceva administered as single agent in study BR.21):
Nedrobnocelični rak pljuč (zdravilo Tarceva kot samostojno zdravilo v študiji BR. 21)
Rash (75%) and diarrhoea (54%) were the most commonly reported adverse drug reactions (ADRs).
Kožni izpuščaj (75%) in driska (54%) sta bila najpogostejša neželena učinka, o katerih so poročali.
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.
Dose reduction for rash and diarrhoea was needed in 6% and 1% of patients, respectively.
Odmerek je bilo zaradi kožnega izpuščaja treba zmanjšati pri 6% bolnikov, zaradi driske pa 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.
6 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.
Very common ADRs in study BR.21
Zelo pogosti neželeni učinki v študiji BR. 21
Erlotinib N = 485
erlotinib n = 485 katera koli
Placebo N = 242
placebo n = 242
NCI-CTC
stopnja po lestvici NCI- CTC
Grade Grade
stopnja
3 4 Grade 3
3 stopnja
MedDRA Preferred Term Total patients with any AE Infections and infestations
navedba po MedDRA Skupno število bolnikov s katerim
Infection* Metabolism and nutrition disorders
okužba * Presnovne in prehranske motnje
Anorexia Eye disorders
anoreksija Očesne bolezni
Conjunctivitis Keratoconjunctivitis sicca Respiratory, thoracic and mediastinal disorders
konjunktivitis
Dyspnoea Cough Gastrointestinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora
Diarrhoea** Nausea Vomiting Stomatitis Abdominal pain Skin and subcutaneous tissue disorders
driska ** navzeja bruhanje stomatitis bolečina v trebuhu
< 1 2 2 0 1
0 0 0 0 < 1
0 0 0 0 < 1
Bolezni kože in podkožja
Rash*** Pruritus Dry skin General disorders and administration site conditions
kožni izpuščaj ***
0 0 0
13 12
0 0 0
< 1 0
* Severe infections, with or without neutropenia, have included pneumonia, sepsis, and cellulitis. ** Can lead to dehydration, hypokalemia and renal failure. *** Rash included dermatitis acneiform.
7 ** Lahko vodi v dehidracijo, hipokaliemijo in ledvično odpoved. *** Kožni izpuščaj vključuje dermatitis podoben aknam.
Pancreatic cancer (Tarceva administered concurrently with gemcitabine in study PA.3):
Rak trebušne slinavke (zdravilo Tarceva v kombinaciji z gemcitabinom v študiji PA. 3)
The most common adverse reactions in pivotal study PA.3 in pancreatic cancer patients receiving Tarceva 100 mg plus gemcitabine were fatigue, rash and diarrhoea.
Najbolj pogosti neželeni učinki v ključni študiji PA. 3 pri bolnikih z rakom trebušne slinavke, ki so prejemali zdravilo Tarceva 100 mg in gemcitabin, so bili utrujenost, kožni izpuščaj in driska.
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.
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.
Zaradi kožnega izpuščaja in driske so odmerek zmanjšali pri 2% bolnikov in zdravljenje prekinili pri manj kot 1% bolnikov, ki so prejemali zdravilo Tarceva in gemcitabin.
7 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.
Very common ADRs in study PA.3 (100 mg cohort)
Zelo pogosti neželeni učinki v študiji PA. 3 (100- mg
Erlotinib N = 259 Any
erlotinib n = 259 katera koli
Placebo N = 256
placebo n = 256
NCI-CTC
stopnja po lestvici NCI- CTC stopnja
Grade Grade
stopnja po lestvici NCI- CTC stopnja
3 4 Grade 3
3 4 stopnja 3
MedDRA Preferred Term Total patients with any AE Infections and infestations
navedba po MedDRA Skupno število bolnikov s katerim koli neželenim dogodkom Infekcijske in parazitske bolezni
Weight decreased Psychiatric disorders
zmanjšanje telesne mase Psihiatrične motnje
Depression Nervous system disorders
depresija Bolezni živčevja
Headache Neuropathy Respiratory, thoracic and mediastinal disorders
glavobol nevropatija Bolezni dihal, prsnega koša in mediastinalnega prostora
0 < 1
10 10
Cough Gastrointestinal disorders
kašelj Bolezni prebavil
Diarrhoea** Stomatitis Dyspepsia Flatulence Skin and subcutaneous tissue disorders
driska ** stomatitis dispepsija flatulenca Bolezni kože in podkožja
Rash*** Alopecia General disorders and administration site conditions
kožni izpuščaj ** alopecija
1 0
0 0
0 0
%%
Pyrexia Fatigue Rigors
pireksija utrujenost okorelost
3 14 0
3 0 14 2 0 0
* Severe infections, with or without neutropenia, have included pneumonia, sepsis, and cellulitis. ** Can lead to dehydration, hypokalemia and renal failure. *** Rash included dermatitis acneiform.
* Hude okužbe z nevtropenijo ali brez nje so vključevale pljučnico, sepso in celulitis. ** Lahko vodi v dehidracijo, hipokaliemijo in ledvično odpoved. *** Kožni izpuščaj vključuje dermatitis podoben aknam.
Other Observations:
Drugi neželeni učinki
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:
Varnost zdravila Tarceva so vrednotili na osnovi podatkov 759 bolnikov, ki so prejeli najmanj en 150 - mg odmerek zdravila Tarceva kot samostojno zdravilo v študiji BR. 21 faze III pri bolnikih z nedrobnoceličnim rakom pljuč, študiji A248- 1007 faze II pri bolnikih z nedrobnoceličnim rakom pljuč in treh študijah faze II v populacijah, ki niso imele nedrobnoceličnega raka pljuč:
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.
248- 101 (rak jajčnikov), A248- 1003 (rak vratu in glave) in OSI2288g (metastatski rak dojk), in 285 bolnikov, ki so prejemali zdravilo Tarceva 100 mg ali 150 mg in gemcitabin v študiji PA. 3 faze III za zdravljenje raka trebušne slinavke.
8 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.
Gastrointestinal bleeding.
gastrointestinalne krvavitve.
In clinical studies, some cases have been associated with concomitant warfarin administration (see section 4.5) and some with concomitant NSAID administration.
V kliničnih študijah so bile v nekaterih primerih povezane s sočasnim jemanjem varfarina (glejte poglavje 4. 5), v nekaterih primerih pa s sočasnim jemanjem nesteroidnih protivnetnih zdravil.
Common (in PA.3):
Pogosti (v PA. 3):
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.
Very common (in PA.3) Common (in BR.21):
Zelo pogosti (v PA. 3), pogosti (v BR. 21):
Liver function test abnormalities (including increased alanine aminotransferase [ALT], aspartate aminotransferase [AST], bilirubin).
nenormalnosti testov jetrne funkcije (vključno z zvišano alanin- aminotransferazo [ALT], aspartat- aminotransferazo [AST], bilirubinom).
These were mainly mild or moderate in severity, transient in nature or associated with liver metastases.
Večinoma so bile nepravilnosti blage do zmerne, prehodne narave ali povezane z jetrnimi metastazami.
Confounding factors have included pre-existing liver disease or concomitant hepatotoxic medications (see section 4.4).
K njenemu nastanku je lahko pripomogla predhodno obstoječa jetrna bolezen ali sočasno jemanje hepatotoksičnih zdravil (glejte poglavje 4. 4).
Eye disorders:
9 Očesne bolezni:
Conjunctivitis in study PA.3.
keratitis. konjunktivitis v študiji PA. 3.
Corneal ulcerations have been reported very rarely in patients receiving Tarceva as a complication of mucocutaneous inflammation.
O razjedah roženice (kot zapletu vnetja kože in sluznic) so pri bolnikih, ki so prejemali zdravilo Tarceva, poročali zelo redko.
Serious interstitial lung disease (ILD), including fatalities, in patients receiving Tarceva for treatment of NSCLC or other advanced solid tumours (see section 4.4).
krvavitev iz nosu. resna intersticijska pljučna bolezen, vključno s smrtnimi primeri pri bolnikih, ki so prejemali zdravilo Tarceva za zdravljenje nedrobnoceličnega raka pljuč ali drugih napredovalih solidnih tumorjev (glejte poglavje 4. 4).
Single oral doses of Tarceva up to 1000 mg erlotinib in healthy subjects, and up to 1600 mg in cancer patients have been tolerated.
Zdrave osebe so dobro prenašale enkratne peroralne odmerke erlotiniba do 1000 mg, bolniki z rakom pa do 1600 mg.
Repeated twice daily doses of 200 mg in healthy subjects were poorly tolerated after only a few days of dosing.
Zdrave osebe so ponavljajoče dajanje odmreka 200 mg dvakrat na dan slabo prenašale že po nekaj dneh jemanja.
Based on the data from these studies, severe adverse events such as diarrhoea, rash and possibly increased activity of liver aminotransferases may occur above the recommended dose.
Na osnovi podatkov teh študij se lahko pri odmerkih, ki so večji od priporočenega, pojavijo resni neželeni dogodki, kot so driska, kožni izpuščaj in morebiti povečanje aktivnosti jetrnih aminotransferaz.
Pharmacotherapeutic group: antineoplastic agent, ATC code:
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, oznaka ATC:
L01XE03
L01XE03.
9 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 efficacy and safety of Tarceva was demonstrated in a randomised, double-blind, placebo-controlled trial (BR.21), in 731 patients with locally advanced or metastatic NSCLC after failure of at least one chemotherapy regimen.
Bolniki so bili randomizirani v razmerju 2:
Patients were randomised 2:1 to receive Tarceva 150 mg or placebo orally once daily.
1 v skupino, ki je prejemala 150 mg zdravila Tarceva in v skupino, ki je prejemala placebo peroralno enkrat na dan.
Study endpoints included overall survival, progression-free survival (PFS), response rate, duration of response, time to deterioration of lung cancer-related symptoms (cough, dyspnoea and pain), and safety.
Cilji raziskave so bili celokupno preživetje (OS, overall survival), preživetje brez napredovanja bolezni (PFS, progression- free survival), odgovor na zdravljenje, trajanje odgovora, čas do poslabšanja simptomov, povezanih z rakom pljuč (kašelj, dispneja in bolečina) in varnost.
The primary endpoint was survival.
Primarni cilj raziskave je bilo preživetje.
About two-thirds of the patients were male and approximately one-third had a baseline ECOG performance status (PS) of 2, and 9% had a baseline ECOG PS of 3.
Terapijo, ki je vključevala platino, je predhodno prejelo 93% vseh bolnikov v skupini, ki je prejemala zdravilo Tarceva, in 92% vseh bolnikov, ki so prejemali placebo.
Ninety-three percent and 92% of all patients in the Tarceva and placebo groups, respectively, had received a prior platinum-containing regimen and 36% and 37% of all patients, respectively, had received a prior taxane therapy.
Terapijo, ki je vključevala taksane, je predhodno prejelo 36% bolnikov v skupini, ki je prejemala zdravilo Tarceva, in 37% vseh bolnikov v skupini, ki je prejemala placebo.
The adjusted hazard ratio (HR) for death in the Tarceva group relative to the placebo group was 0.73 (95% CI, 0.60 to 0.87) (p = 0.001).
Prilagojeno razmerje ogroženosti (HR, hazard ratio) za smrt v skupini, ki je jemala zdravilo Tarceva, je v primerjavi s placebo skupino znašalo 0, 73 (95 -% interval zaupanja; 0, 60 do 0, 87) (p = 0, 001).
The percent of patients alive at 12 months was 31.2% and 21.5%, for the Tarceva and placebo groups, respectively.
Odstotek preživelih bolnikov je pri 12 mesecih v skupini, ki je jemala zdravilo Tarceva, znašal 31, 2%, v placebo skupini pa 21, 5%.
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).
10 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).
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).
Učinek zdravila Tarceva na celokupno preživetje je bil podoben pri bolnikih z izhodiščnim stanjem zmogljivosti (ECOG) 2– 3 (HR = 0, 77, interval zaupanja 0, 6– 1, 0) ali 0– 1 (HR = 0, 73, interval zaupanja 0, 6– 0, 9), bolnikih moškega spola (HR = 0, 76, interval zaupanja 0, 6– 0, 9) ali bolnicah (HR = 0, 80, interval zaupanja 0, 6– 1, 1), bolnikih, mlajših od 65 let (HR = 0, 75, interval zaupanja 0, 6– 0, 9) ali starejših bolnikih (HR = 0, 79, interval zaupanja 0, 6– 1, 0), bolnikih z enim predhodnim zdravljenjem (HR = 0, 76, interval zaupanja 0, 6– 1, 0) ali več kot enim predhodnim zdravljenjem (HR = 0, 75, interval zaupanja 0, 6– 1, 0), belcih (HR = 0, 79, interval zaupanja 0, 6– 1, 0) ali Azijcih (HR = 0, 61, interval zaupanja 0, 4– 1, 0), bolnikih z adenokarcinomom (HR = 0, 71, interval zaupanja 0, 6– 0, 9) ali skvamoznim karcinomom (HR = 0, 67, interval zaupanja 0, 5– 0, 9), toda ne pri bolnikih z drugimi histologijami (HR 1, 04, interval zaupanja 0, 7- 1, 5), bolnikih s stadijem bolezni ob diagnozi IV (HR = 0, 92, interval zaupanja 0, 7– 1, 2) ali stadijem bolezni ob diagnozi < IV (HR = 0, 65, 0, 5– 0, 8).
Patients who never smoked had a much greater benefit from erlotinib (survival HR = 0.42, CI 0.28-0.64) compared with current or ex-smokers (HR = 0.87, CI 0.71-1.05).
Bolnikom, ki niso nikoli kadili, je erlotinib veliko bolj koristil (HR preživetja = 0, 42, interval zaupanja 0, 28– 0, 64) kakor bolnikom, ki še kadijo ali so kadili (HR = 0, 87, interval zaupanja 0, 71– 1, 05).
In the 45% of patients with known EGFR-expression status, the hazard ratio was 0.68 (CI 0.49-0.94) for patients with EGFR-positive tumours and 0.93 (CI 0.63-1.36) for patients with EGFR-negative tumours (defined by IHC using EGFR pharmDx kit and defining EGFR-negative as less than 10% tumour cells staining).
Pri 45% bolnikov z znanim statusom ekspresije EGFR, je bilo za bolnike z EGFR- pozitivnimi tumorji razmerje ogroženosti 0, 68 (interval zaupanja 0, 49– 0, 94), za bolnike z EGFR- negativnimi tumorji pa 0, 93 (interval zaupanja 0, 63– 1, 36); status ekspresije EGFR so določili z imunohistokemijo, z uporabo EGFR pharmDx kita.
In the remaining 55% of patients with unknown EGFR-expression status, the hazard ratio was 0.77 (CI 0.61-0.98).
Pri preostalih 55% bolnikov z neznanim statusom ekspresije EGFR je bilo razmerje ogroženosti 0, 77 (interval zaupanja 0, 61– 0, 98).
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).
Mediana preživetja brez napredovanja bolezni je bila v skupini, ki je jemala zdravilo Tarceva, 9, 7 tedna (95 -% interval zaupanja; 8, 4 do 12, 4 tedna), v primerjavi z 8 tedni v placebo skupini (95 -% interval zaupanja; 7, 9 do 8, 1 tedna).
The objective response rate by RECIST in the Tarceva group was 8.9% (95% CI, 6.4 to 12.0).
Objektivni odgovor na zdravljenje po kriterijih RECIST (Response Evaluation Criteria In Solid Tumours) je v skupini, ki je jemala zdravilo Tarceva, znašal 8, 9% (95 -% interval zaupanja; 6, 4 do 12, 0).
The first 330 patients were centrally assessed (response rate 6.2%); 401 patients were investigator- assessed (response rate 11.2%).
Prvih 330 bolnikov so ocenili centralno (odziv na zdravljenje 6, 2%); 401 bolnika pa so ocenili raziskovalci (odziv na zdravljenje 11, 2%).
The median duration of response was 34.3 weeks, ranging from 9.7 to 57.6+ weeks.
Mediana trajanja odgovora je bila 34, 3 tedna v razponu od 9, 7 do 57, 6+ tedna.
The proportion of patients who experienced complete response, partial response or stable disease was 44.0% and 27.5%, respectively, for the Tarceva and placebo groups (p = 0.004).
Delež bolnikov, ki so dosegli popolni odgovor, delni odgovor ali stabilno bolezen, je znašal 44, 0% v skupini, ki je jemala zdravilo Tarceva in 27, 5% v skupini, ki je jemala placebo (p = 0, 004).
10 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).
This was evidenced by a hazard ratio for death of 0.82 (95% CI, 0.68 to 0.99) among patients whose best response was stable disease or progressive disease.
To je bilo dokazano z razmerjem ogroženosti za smrt 0, 82 (95 -% interval zaupanja; 0, 68 do 0, 99) pri bolnikih, pri katerih je bil najboljši odgovor stabilna bolezen ali napredovanje bolezni.
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:
11 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:
Baseline Females Baseline ECOG performance status (PS) = 0 Baseline ECOG performance status (PS) = 1 Baseline ECOG performance status (PS) = 2 Metastatic disease at baseline
Pred začetkom zdravljenja ženski spol stanje zmogljivosti po ECOG 0 pred začetkom zdravljenja stanje zmogljivosti po ECOG 1 pred začetkom zdravljenja stanje zmogljivosti po ECOG 2 pred začetkom zdravljenja metastatska bolezen pred začetkom zdravljenja
Placebo 44% 32% 51% 17% 76%
placebo 44% 32% 51% 17% 76%
Survival was evaluated in the intent-to-treat population based on follow-up survival data.
Preživetje so vrednotili v populaciji, ki so jo nameravali zdraviti (ITT, intent- to- treat), na osnovi podatkov o preživetju, ki so jih dobili iz sledenja.
Results are shown in the table below (results for the group of metastatic and locally advanced patients are derived from exploratory subgroup analysis).
Izsledki so prikazani v spodnji preglednici (izsledki za skupini bolnikov z metastatsko in lokalno napredovalo boleznijo so iz eksploracijske analize podskupin).
Tarceva
interval
Placebo
Tarceva
Δ
Placebo razlika (Δ)
CI of
p- vre -
P-
zaupanja Δ Izid
Outcome
(meseci)
(months) (months) Overall Population
(meseci)
HR HR
zaupanja HR
value
dnost
Median overall survival
celotna populacija mediana celokupnega preživetja
Mean overall survival
preživetje
Metastatic Population Median overall survival
populacija z metastatsko boleznijo mediana celokupnega preživetja
Locally Advanced Population Median overall survival
populacija z lokalno napredovalo boleznijo mediana celokupnega preživetja
11 Overall Survival – All Patients 1.0
12 Celokupno preživetje – vsi bolniki 1, 0
Survival Probability
0, 8 HR = 0, 82 0, 7 Verjetnost preživetja
HR = 0.82 (95% CI:
(95% interval zaupanja:
0.6 9, 0.98), p = 0.028
0, 69; 0, 98), p = 0, 028 0, 6
Tarceva + gemcitabine (n = 261)
Tarceva + gemcitabin (n = 261)
Placebo + gemcitabine (n = 260) Median OS = 6.0 months
placebo + gemcitabin (n = 260) mediana OS = 6, 0 mesecev
Median OS = 6.4 months
mediana OS = 6, 4 meseca