natgillin/translations-raw huggingface dataset:
Therefore administration of Vectibix in combination with bevacizumab containing chemotherapy combinations should be avoided (see section 4.5 and section 5.1).
Zato se je treba izogniti uporabi Vectibixa v kombinaciji s kemoterapijo, ki vključuje bevacizumab (glejte poglavje 4. 5 in poglavje 5. 1).
Concomitant use of Vectibix and IFL or bevacizumab and chemotherapy combinations is not recommended (see sections 4.4 and 4.8).
Sočasna uporaba Vectibixa in IFL ali bevacizumaba in kombinacije kemoterapije ni priporočljiva (glejte poglavji 4. 4 in 4. 8).
Increased deaths were observed when panitumumab was administered in combination with bevacizumab and chemotherapy combinations (see section 4.4).
Če je bil panitumumab uporabljen v kombinaciji z bevacizumabom in kombinacijami kemoterapije, so ugotovili več smrti (glejte poglavje 4. 4).
There are no adequate data from the use of Vectibix in pregnant women.
Ni zadostnih podatkov o uporabi Vectibixa pri nosečnicah.
EGFR has been implicated in the control of prenatal development and may be essential for normal organogenesis, proliferation, and differentiation in the developing embryo.
EGFR je domnevno vpleten v nadzor antenatalnega razvoja in je morda nujen za normalno organogenezo, proliferacijo in diferenciacijo razvijajočega se zarodka.
Therefore, Vectibix has the potential to cause foetal harm when administered to pregnant women.
Zato obstaja možnost, da bi pri nosečnici uporabljeni Vectibix škodoval plodu.
In women of childbearing potential, appropriate contraceptive measures must be used during treatment with Vectibix, and for 6 months following the last dose.
Ženske v rodni dobi morajo med zdravljenjem z Vectibixom in še 6 mesecev po zadnjem odmerku uporabljati ustrezno kontracepcijsko zaščito.
If Vectibix is used during pregnancy or if the patient becomes pregnant while receiving this medicinal product, she should be advised of the potential risk for loss of the pregnancy or potential hazard to the foetus.
Če Vectibix uporabite med nosečnostjo ali če bolnica med zdravljenjem s tem zdravilom zanosi, jo morate seznaniti z možnim tveganjem za splav in možno nevarnostjo za plod.
Because human IgG is secreted into human milk, panitumumab might also be secreted.
Ker se v materinem mleku izločajo humani IgG, bi se lahko izločal tudi panitumumab.
The potential for absorption and harm to the
Ker ni znano, ali se Vectibix izloča v materinem mleku, je priporočljivo, da ženske med zdravljenjem z Vectibixom in še 3 mesece po zadnjem odmerku ne dojijo.
4 infant after ingestion is unknown.
4 Plodnost
Animal studies have shown reversible effects on the menstrual cycle and reduced female fertility in monkeys (see Section 5.3).
Študije na živalih so pokazale reverzibilne učinke na menstruacijski ciklus in manjšo plodnost opičjih samic (glejte poglavje 5. 3).
If patients experience treatment-related symptoms affecting their vision and/ or ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Če se bolnikom pojavijo z zdravilom povezani simptomi, ki vplivajo na vid in/ ali sposobnost koncentracije in reagiranja, je priporočljivo, da ne vozijo in ne upravljajo s stroji, dokler učinek ne mine.
Based on an analysis of all patients receiving Vectibix monotherapy (n = 920), the most commonly reported adverse reactions are skin reactions occurring in approximately 90% of patients.
Na podlagi analize vseh bolnikov, ki so dobivali monoterapijo z Vectibixom (n = 920), so najpogostejši neželeni učinki kožne reakcije; pojavijo se pri približno 90% bolnikov.
These reactions are related to the pharmacologic effects of Vectibix, and the majority are mild to moderate in nature with approximately 10% severe (grade 3 or higher, NCI-CTC).
Te reakcije so povezane s farmakološkimi učinki Vectibixa in so večinoma blage do zmerne, v približno 10% pa hude (3. ali višja stopnja po NCI- CTC).
Except where indicated, the data describe adverse reactions reported from clinical studies in patients with metastatic colorectal carcinoma who received panitumumab as a single agent:
Razen tam, kjer je posebej navedeno, ti podatki opisujejo neželene učinke, zabeležene v kliničnih študijah pri bolnikih z metastatskim kolorektalnim karcinomom, ki so dobivali panitumumab kot edino sredstvo.
MedDRA Organ System Skin and subcutaneous tissue disorders
Organski sistem po MedDRA Bolezni kože in podkožja
Frequency Very common (≥ 1/ 10)
Pogostnost Zelo pogosti (≥ 1/ 10)
Undesirable Effect Rash Erythaema Skin exfoliation Pruritus Dry skin Skin fissures Paronychia
Neželeni učinek osip eritem eksfoliacija kože srbenje suha koža fisure na koži paronihija
Gastrointestinal disorders General disorders and administrative site conditions
Bolezni prebavil Splošne težave in spremembe na mestu aplikacije
Diarrhoea Fatigue
driska utrujenost
General disorders and administrative site conditions Metabolism and nutrition disorders
Splošne težave in spremembe na mestu aplikacije Presnovne in prehranske motnje
Common (≥ 1/ 100 to < 1/ 10)
Pogosti (≥ 1/ 100 do < 1/ 10)
Infusion reactions (pyrexia, chills) Hypomagnesaemia Hypocalcaemia Hypokalaemia Dehydration
infuzijske reakcije (pireksija, mrzlica) hipomagneziemija hipokalciemija hipokaliemija dehidracija
Nausea Vomiting
navzeja bruhanje
Respiratory, thoracic and mediastinal disorders Nervous system disorders Eye disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora Bolezni živčevja Očesne bolezni
Dyspnoea Cough Headache Conjunctivitis Growth of eyelashes Increased lacrimation Ocular hyperaemia Dry eye Eye pruritus
dispneja kašelj glavobol konjunktivitis rast trepalnic močnejše solzenje hiperemija oči suhost oči srbenje oči
5 MedDRA Organ System Skin and subcutaneous tissue disorders
5 Organski sistem po MedDRA Bolezni kože in podkožja
Undesirable Effect Stomatitis Mucosal inflammation Onycholysis Hypertrichosis Alopecia Nasal dryness Dry mouth
Neželeni učinek stomatitis vnetje sluznice oniholiza hipertrihoza alopecija suhost nosu suha usta
The safety profile of panitumumab in patients whose tumour express KRAS wild-type (n = 123) was generally consistent with overall mCRC monotherapy set described above.
Varnostne značilnosti panitumumaba pri bolnikih z eksprimiranim divjim tipom KRAS (n = 123) so se na splošno ujemale z zgoraj opisanim celotnim naborom monoterapije za mKRR.
The only differences were that nausea, vomiting, dyspnoea and cough were reported as very common (≥ 1/ 10) in the KRAS wild-type arm whereas these adverse drug reactions were reported as common (≥ 1/ 100 to < 1/ 10) in the overall mCRC monotherapy population.
Edina razlika je bila, da so bili navzeja, bruhanje, dispneja in kašelj v kraku z divjim tipom KRAS zabeleženi zelo pogosto (≥ 1/ 10), v celotni populaciji z monoterapijo za mKRR pa pogosto (≥ 1/ 100 do < 1/ 10).
Two percent of patients with KRAS wild-type had diarrhoea reported as severe.
Pri dveh odstotkih bolnikov z divjim tipom KRAS je bila opisana huda driska.
In clinical trials potential infusion reactions (occurring within 24 hours of the first dose) which may include symptoms/ signs such as chills, fever, or dyspnoea, were reported in 2% of Vectibix treated patients, of which < 1% were severe (grade 3).
V kliničnih preskušanjih so o potencialnih infuzijskih reakcijah (nastalih v 24 urah po prvem odmerku) – vključujejo lahko simptome ali znake, kot so mrzlica, zvišana telesna temperatura ali dispneja – poročali pri 2% bolnikov, zdravljenih z Vectibixom; < 1% je bilo hudih (3. stopnja).
No patients had life-threatening (grade 4) or fatal (grade 5) infusion reactions to Vectibix.
Noben bolnik ni imel smrtno nevarnih (4. stopnja) ali smrtnih (5. stopnja) infuzijskih reakcij na Vectibix.
Most of the symptoms of potential infusion reactions were mild in intensity, resolved without treatment, were isolated occurrences and did not require alteration or interruption of Vectibix administration.
Večina simptomov potencialnih infuzijskih reakcij je bila blagih, minili so brez zdravljenja, so bili osamljen pojav in niso zahtevali sprememb ali prekinitve uporabe Vectibixa.
Skin rash most commonly occurred on the face, upper chest, and back, but could extend to the extremities.
Osip se je najpogosteje pojavil na obrazu, zgornjem delu prsnega koša in hrbtu, vendar se je lahko razširil na ude.
Subsequent to the development of severe skin and subcutaneous reactions, infectious complications including sepsis, in rare cases leading to death, and local abscesses requiring incisions and drainage were reported.
Po pojavu hudih kožnih in podkožnih reakcij so zabeležili infekcijske zaplete, vključno s sepso, ki so v redkih primerih povzročili smrt, in lokalne abscese, ki so potrebovali incizijo in drenažo.
The median time to first symptom of dermatologic reaction was 10 days, and the median time to resolution after the last dose of Vectibix was 28 days.
Mediani čas do prvega simptoma dermatoloških reakcij je bil 10 dni, mediani čas do izginotja po zadnjem odmerku Vectibixa pa 28 dni.
Doses up to 9 mg/ kg have been tested in clinical trials.
4. 9 Preveliko odmerjanje
There have been reports of overdose at doses up to approximately twice the recommended therapeutic dose.
Opisani so primeri prevelikega odmerjanja v odmerkih do približno dvakratnega priporočenega terapevtskega odmerka.
Pharmacotherapeutic group:
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa.
Antineoplastic agents, monoclonal antibodies, ATC code:
Oznaka ATC:
6 Mechanism of action
6 Mehanizem delovanja
EGFR is a transmembrane glycoprotein that is a member of a subfamily of type I receptor tyrosine kinases including EGFR (HER1/ c-ErbB-1), HER2, HER3, and HER4.
EGFR je transmembranski glikoprotein; spada v podskupino tipa I receptorskih tirozin- kinaz, ki vključujejo EGFR (HER1/ c- ErbB- 1), HER2, HER3 in HER4.
The KRAS (Kirsten rat sarcoma 2 viral oncogene homologue) gene encodes a small, GTP-binding protein involved in signal transduction.
Gen KRAS (Kirstenov homolog virusnega onkogena podganjega- sarkoma 2) kodira majhno beljakovino, ki veže GTP in je vpletena v prenos signalov.
A variety of stimuli, including that from the EGFR activates KRAS which in turn stimulates other intracellular proteins to promote cell proliferation, cell survival and angiogenesis.
KRAS nato stimulira druge znotrajcelične beljakovine za spodbudo proliferacije celic, preživetja celic in angiogeneze.
Activating mutations in the KRAS gene occur frequently in a variety human tumours and have been implicated in both oncogenesis and tumour progression.
Vpletene so v onkogenezo in napredovanje tumorjev.
The addition of panitumumab to radiation, chemotherapy and/ or other targeted therapeutic agents, in animal studies resulted in an increase in anti-tumour effects compared to radiation, chemotherapy or targeted therapeutic agents alone.
Dodatek panitumumaba obsevanju, kemoterapiji in/ ali drugim ciljanim terapevtskim sredstvom je v študijah na živalih povečal protitumorske učinke v primerjavi z uporabo obsevanja, kemoterapije ali ciljanih terapevtskih sredstev samih.
Data on the development of anti-panitumumab antibodies has been evaluated using two different immunoassays (an ELISA which detects high-affinity antibodies, and a Biosensor Immunoassay which detects both high and low-affinity antibodies), results from these assays indicated that the overall incidence of a post-dose anti-panitumumab antibody response was low.
Rezultati teh preizkusov kažejo, da je incidenca odziva s protitelesi proti panitumumabu po njegovi uporabi v celoti majhna.
Pre-dose antibodies were detected in 5 of 636 patients (< 1%) and 16/ 635 patients (2.5%) tested by the ELISA and Biosensor Immunoassay respectively.
Pred uporabo so s preizkusom ELISA protitelesa odkrili pri 5 od 636 bolnikov (< 1%) in s preizkusom Biosensor Immunoassay pri 16 od 635 bolnikov (2, 5%).
Post-dose neutralising antibodies were detected in 1 of 447 patients (0.2%) and 7 of 447 patients (1.6%) tested by the ELISA and Biosensor Immunoassay respectively.
Po uporabi so nevtralizacijska protitelesa odkrili s preizkusom ELISA pri 1 od 447 bolnikov (0, 2%) in s preizkusom Biosensor Immunoassay pri 7 od 447 bolnikov (1, 6%).
The detection of antibody formation is dependent on the sensitivity and specificity of the assay.
Na ugotovljeno incidenco pozitivnih izvidov za protitelesa z določenim preizkusom lahko vpliva več dejavnikov, med drugim ravnanje z vzorcem, sočasno uporabljana zdravila in osnovna bolezen.
The observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications and underlying disease, therefore, comparison of the incidence of antibodies to other products may be misleading.
Zato je lahko primerjava incidence protiteles z drugimi zdravili zavajajoča.
The efficacy of Vectibix in patients with metastatic colorectal cancer (mCRC) who had disease progression during or after prior chemotherapy was studied in a randomised controlled trial (463 patients) and open-label, single-arm trials (384 patients).
Učinkovitost Vectibixa pri bolnikih z metastatskim kolorektalnim rakom (mKRR), ki jim je bolezen napredovala med predhodno kemoterapijo ali po njej, so raziskali v randomiziranem kontroliranem preskušanju (463 bolnikov) in odprtih preskušanjih z enim krakom (384 bolnikov).
The safety of Vectibix in patients with mCRC who received at least one dose of Vectibix was evaluated in 920 patients.
Varnost Vectibixa pri bolnikih z mKRR, ki so dobili vsaj en odmerek Vectibixa, so ocenili pri 920 bolnikih.
Additional studies were performed with Vectibix as a single agent in patients with other solid tumours and in combination with chemotherapy with and without bevacizumab in patients with mCRC or in combination with chemotherapy in patients with non-small cell lung cancer.
Dodatne študije so bile narejene z Vectibixom kot edinim sredstvom pri bolnikih z drugimi čvrstimi tumorji ter v kombinaciji s kemoterapijo (z bevacizumabom in brez njega) pri bolnikih z mKRR ali v kombinaciji s kemoterapijo pri bolnikih z nedrobnoceličnim rakom na pljučih.
7 A multinational, randomised, controlled trial was conducted in 463 patients with EGFR-expressing metastatic carcinoma of the colon or rectum after confirmed failure of oxaliplatin and irinotecan- containing regimens.
7 Narejeno je bilo multinacionalno, randomizirano, kontrolirano preskušanje 463 bolnikov z metastatskim karcinomom na kolonu ali rektumu in eksprimiranim EGFR, po potrjenem neuspehu shem z oksaliplatinom in irinotekanom.
Patients were randomised 1:1 to receive Vectibix at a dose of 6 mg/ kg given once every two weeks plus best supportive care (not including chemotherapy) (BSC) or BSC alone.
Bolniki so bili v razmerju 1: 1 randomizirani bodisi na zdravljenje z Vectibixom v odmerku 6 mg/ kg enkrat na dva tedna in najboljšo podporno oskrbo (NPO) (kar ni vključevalo kemoterapije) bodisi na samo NPO.
Upon disease progression BSC alone patients were eligible to crossover to a companion study and receive Vectibix at a dose of 6 mg/ kg given once every two weeks.
Po napredovanju bolezni so bolniki, ki so prejemali samo NPO, lahko prešli v spremljajočo študijo in dobivali Vectibix v odmerku 6 mg/ kg enkrat na dva tedna.
Of 463 patients, 63% were male.
Od 463 bolnikov je bilo 63% moških.
The median age was 62 years (range 27 to 83), and 99% were Caucasian.
Mediana starost je bila 62 let (razpon: od 27 do 83), 99% je bilo belcev.
Three hundred and ninety-six (86%) patients had a baseline ECOG Performance Status of 0 or 1.
396 (86%) bolnikov je imelo izhodiščno zmogljivostni status po ECOG 0 ali 1.
Sixty-seven percent of patients had colon cancer and 33% had rectal cancer.
67% bolnikov je imelo raka na kolonu in 33% je imelo raka na rektumu.
The primary endpoint was progression-free survival (PFS).
Primarna končna točka je bilo preživetje brez napredovanja (PBN).
In an analysis adjusting for potential bias from unscheduled assessments, the rate of disease progression or death in patients who received Vectibix was reduced by 40% relative to patients that received BSC [Hazard Ratio = 0.60, (95% CI 0.49, 0.74), stratified log-rank p < 0.0001].
0, 49, 0, 74), stratificirani log- rang test: p < 0, 0001].
There was no difference seen in median PFS times as more than 50% of patients progressed in both treatment groups before the first scheduled visit.
Razlike v medianem preživetju brez napredovanja niso ugotovili, ker je pri več kot 50% bolnikov v obeh terapevtskih skupinah prišlo do napredovanja bolezni pred prvim načrtovanim pregledom.
The progression-free survival rates at the first scheduled visit (week 8) were 45.5% on Vectibix plus BSC and 24.6% on BSC alone, a difference of 20.9% [95% CI:
Deleža preživetja brez napredovanja na prvem pričakovanem obisku (8. teden) sta bila 45, 5% z Vectibixom in NPO in 24, 6% samo z NPO, kar je razlika 20, 9% [95% IZ:
No difference was seen in overall survival.
Razlike v celotnem preživetju niso ugotovili.
This may be due to patients receiving panitumumab after progression among those randomized to BSC.
To gre morda na račun bolnikov, randomiziranimi na NPO, ki so po napredovanju dobivali panitumumab.
Tumour response according to modified-RECIST criteria was determined by central review.
Odziv tumorja so po modificiranih merilih RECIST določili s centralnim pregledom.
Overall, 9.5% [95% CI:
Objektiven odziv (delen odziv) je bil v celoti potrjen pri 9, 5% [95% IZ:
6.1, 14.1] Vectibix plus BSC patients, and 0% [95% CI:
6, 1, 14, 1] bolnikov, ki so dobivali Vectibix in NPO, in pri 0% [95% IZ:
0.0, 1.6] BSC alone patients had a confirmed objective response (partial response), with stable disease in 26% and 10% patients, respectively.
0, 0, 1, 6] bolnikov, ki so dobivali samo NPO; stabilno bolezen je imelo 26% prvih in 10% drugih.
Among the 176 patients who received Vectibix after progression on BSC alone, the response rate (investigator assessment) was 11.4% (95% CI:
Med 176 bolniki, ki so dobili Vectibix po napredovanju med zdravljenjem s samo NPO, je bil delež odziva (po raziskovalčevi oceni) 11, 4% (95% IZ:
100%
Preživetje brez napredovanja – vsi bolniki 100%
90%
90% Median Treatment Group Terapevtska skupina Events / NDogodki/ n (%) Mediana v tednih
Vectibix+BSC
in Weeks
Events / N (%) in Weeks 193 / 231 (84) 8.0
Vectibix+BSCNPO193 / 231 (193/ 231 (84)
Proportion Event-Free
208 / 232 (208/ 232 (90)
208 / 232 (90) 8.0
90)
50% 40%
8. 0
(95% CI:
60% Razmerje ogroženosti = 0, 60 50% (95% IZ:
0.49, 0.74) Stratified log-rank test p < 0.0001
0, 49- 0, 74) stratificirani log- rang test: p < 0, 0001 40%
0%
0% 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 tednov tedni OgroženiOgroženi preiskovanci: preiskovanci:
Subjects at risk:
Vectibix+NPO
Vectibix+BSC
Vectibix+NPO
BSC Alone
Samo NPO NPO
Unscheduled tumour assessments were moved to the nearest scheduled timepoint
Nenačrtovana ocenjevanja tumorja so bila premaknjena na najbližji načrtovani čas
The relationship between KRAS mutation status determined in archived paraffin embedded tumour tissue and clinical outcome was evaluated in a retrospective analysis.
Retrospektivna analiza je ocenila razmerje med mutacijskim statusom KRAS (določenim v arhiviranem tumorskem tkivu, vloženem v parafin) in kliničnim izidom.
Tumour samples obtained from the primary resection of colorectal cancer were analysed for the presence of the seven most common activating mutations in the codon 12 and 13 (Gly12Asp, Gly12Ala, Gly12Val, Gly12Ser, Gly12Arg, Gly12Cys, and Gly13Asp) of the KRAS gene by using an
8 Vzorce tumorjev, dobljene pri primarni resekciji kolorektalnega raka, so z verižno polimerizacijo, specifično za alele, analizirali glede prisotnosti sedmih najpogostejših aktivacijskih mutacij v kodonih 12 in 13 (Gly12Asp, Gly12Ala, Gly12Val, Gly12Ser, Gly12Arg, Gly12Cys in Gly13Asp) gena KRAS.
427 (92%) patients were evaluable for KRAS status of which 184 had mutations.
Za oceno statusa KRAS je bilo primernih 427 (92%) bolnikov; 184 od teh je imelo eno ali več mutacij.
In an analysis adjusting for potential bias from unscheduled assessments the hazard ratio for PFS was 0.49 (95% CI:
V analizi, ki je uporabila korekcijo možne pristranosti zaradi nenačrtovanih ocenjevanj, je bilo razmerje ogroženosti za preživetje brez napredovanja 0, 49 (95% IZ:
0.37-0.65) in favour of panitumumab in the KRAS wild-type group and 1.07 (95% CI:
0, 37- 0, 65) v korist panitumumaba v skupini z divjim tipom KRAS in 1, 07 (95% IZ:
0.77-1.48) in the KRAS mutant group.
0, 77- 1, 48) v skupini z mutantnim KRAS.
The difference in median PFS in the KRAS wild-type group was 8 weeks.
Razlika v medianem preživetju brez napredovanja v skupini z divjim tipom KRAS je bila 8 tednov.
The progression-free survival rates at the first scheduled visit (week 8) in the KRAS wild-type group were 59.7% on Vectibix plus BSC and 21.0% on BSC alone, a difference of 38.7% [95% CI:
Deleža preživetja brez napredovanja na prvem načrtovanem pregledu (8. teden) v skupini z divjim tipom KRAS sta bila 59, 7% z Vectibixom in NPO in 21, 0% samo z NPO, kar je razlika 38, 7% [95% IZ:
27.4, 50.0].
27, 4, 50, 0].
The difference in median PFS in the KRAS mutant group was 0 weeks.
Razlika v medianem preživetju brez napredovanja v skupini z mutantnim KRAS je bila 0 tednov.
The progression-free survival rates at the first scheduled visit (week 8) in the KRAS mutant group were 21.4% on Vectibix plus BSC and 28.0% on BSC alone, a difference of -6.6% [95% CI: -19.0, 5.9].
Deleža preživetja brez napredovanja na prvem načrtovanem pregledu (8. teden) v skupini z mutantnim KRAS sta bila 21, 4% z Vectibixom in NPO in 28, 0% samo z NPO, kar je razlika - 6, 6% [95% IZ: - 19, 0, 5, 9].
There were no differences in overall survival seen in either group.
V nobeni skupini niso ugotovili razlik v celotnem preživetju.
In the KRAS wild-type group the response rate was 17% for panitumumab and 0% for BSC.
V skupini z divjim tipom KRAS je bil delež odziva na panitumumab 17% in na najboljšo podporno oskrbo 0%.
In the KRAS mutant group there were no responses in either treatment arm.
V skupini z mutiranim KRAS ni bilo odziva ne v enem ne v drugem kraku.
Stable disease rates in the KRAS wild-type group were 34% for panitumumab and 12% for BSC.
Delež stabilne bolezni je bil v skupini z divjim tipom KRAS s panitumumabom 34% in z najboljšo podporno oskrbo 12%.
The stable disease rates in the KRAS mutant group were 12% for panitumumab and 8% for BSC.
V skupini z mutiranim KRAS pa je bil delež stabilne bolezni s panitumumabom 12% in z najboljšo podporno oskrbo 8%.
Response rate (investigator assessment) in patients that crossed over to panitumumab after progression on BSC alone was 22% (95% CI:
Delež odziva (raziskovalčeva ocena) pri bolnikih, ki so po napredovanju ob uporabi NPO prešli v skupino s panitumumabom, je bil 22% (95% IZ:
14.0, 31.9) for those with KRAS wild-type tumours and 0% (95% CI:
14, 0, 31, 9) pri tistih z divjim tipom KRAS in 0% (95% IZ:
0.0, 4.3) for those with mutant KRAS tumours.
0, 0, 4, 3) pri tistih z mutiranim KRAS.
PFS – Patients with mutant and wild type KRAS Wild Type KRAS
Preživetje brez napredovanja – bolniki z mutiranim in divjim tipom KRAS
Treatment Group
Vectibix+BSCNPO 115 / 124 115/ 124 (93)
Median
Vectibix +
Events / N (%) in Weeks
(93) 16. 0 16, 0
Vectibix+BSC
Samo NPO
115 / 124 (93)
114 / 119 114/ 119 (96) 8. 0 8, 0
114 / 119 (96)
(96)
Proportion Event-Free
Delež brez dogodkov
Hazard ratio = 0.49
Razmerje ogroženosti = 0, 49
(95% CI:
(95% IZ:
0.37, 0.65) Stratified log-rank test p < 0.0001 60%
0, 37- 0, 65) 60% Stratificirani log- rang test: p < 0, 0001 50%
0%
0% 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 tedni Weeks Ogroženi Subjects at risk: preiskovanci:
Subjects at risk:
Vectibix+NPO Samo NPO
2
Vectibix+BSC Alone
8 10 12 14 16 18 20 22 24 26 28 30 32 34
24 122 11
20 20 20
20
124 122 116 114 114 69 69 58 58 45 44 44 44 24 20 20 20 13 13 13 12
13 12
BSC Alone
BSC
5 15 11 11 9 9 6 6 6 6 5 4 3 3 2
5 15 11 11 9 9 6 6 6 6 5 4 3 3 2
9 Mutant KRAS
9 Mutantni KRAS
Events / N (%) in Weeks
Terapevtska skupina Events /
90%
Dogodki/ n N (%)
Vectibix+BSC
(%) Mediana v tednih in Weeks
76 / 84 (90)
Vectibix+BSC Vectibix + NPO 76 / 84 76/ 84) (90 (90) 8. 0 8, 0
80%
90% 80%
BSC Alone
BSC Alone Samo NPO