natgillin/translations-raw huggingface dataset:
Immune related adverse reaction
Imunsko pogojeni neželeni učinek
How to store Tecentriq
Kako uporabljati zdravilo Tecentriq
Stratifiedǂ hazard ratio (95% CI) 12-month OS (%)**
Mediani čas do dogodkov (meseci) 95-% IZ Stratificiranoǂ razmerje ogroženosti (95-% IZ) p-vrednost** 12-mesečno OS (%)*** 18-mesečno OS (%)***
Treatment with atezolizumab should be permanently discontinued for Grade 4, or any grade of recurrent pancreatitis.
V primeru pankreatitisa 4. stopnje ali ponovnega pankreatitisa ne glede na stopnjo je treba zdravljenje z atezolizumabom trajno ukiniti.
Common hypokalaemia, hyponatraemia, hyperglycaemia hypokalaemia, hyponatraemia, hypomagnesaemia
Presnovne in prehranske motnje zelo pogosti zmanjšan apetit zmanjšan apetit pogosti hipokaliemija, hiponatriemija, hiperglikemija hipokaliemija, hiponatriemija, hipomagneziemija
Use of atezolizumab in combination with bevacizumab, paclitaxel and carboplatin
Uporaba atezolizumaba v kombinaciji z bevacizumabom, paklitakselom in karboplatinom
Clear, colourless to slightly yellowish liquid.
koncentrat za raztopino za infundiranje bistra, brezbarvna do rahlo rumenkasta tekočina
Pneumonitis requiring the use of corticosteroids occurred in 1.6% (51/3,178) of patients receiving atezolizumab monotherapy.
Pnevmonitis, zaradi katerega je bilo treba uporabiti kortikosteroide, se je pojavil pri 1,6 % (51/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Colitis led to discontinuation of atezolizumab in 8 (0.3%) patients.
Zaradi kolitisa je zdravljenje z atezolizumabom prenehalo 8 (0,3 %) bolnikov.
≤ Grade 1 within 12 weeks, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day.
0. ali 1. stopnjo in je odmerek kortikosteroidov zmanjšan na ≤ 10 mg prednizona (ali ekvivalenta) na dan.
Figure 13: Kaplan-Meier curve for progression-free survival (IMpower133)
Slika 13: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni (IMpower133)
95% CI Stratified hazard ratio (95% CI)
Stratificirano razmerje ogroženosti (95-% IZ)
Common abdominal pain, colitiss, dysphagia, oropharyngeal paint stomatitis, dysgeusia
disfagija, orofaringealna bolečinat stomatitis, disgevzija občasni pankreatitis u
The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq followed by bevacizumab, is administered by intravenous infusion every three weeks.
Uvodni fazi zdravljenja sledi faza vzdrževanja brez kemoterapije, med katero se na tri tedne uporabi zdravilo Tecentriq v odmerku 1200 mg v intravenski infuziji, ki mu sledi bevacizumab.
Österreich Roche Austria GmbH
Roche Registration GmbH
If symptoms improve to ≤ Grade 1, corticosteroids should be tapered over ≥ 1 month.
Če se simptomi izboljšajo na ≤ 1. stopnjo, je treba odmerek kortikosteroidov postopoma zmanjševati v obdobju ≥ 1 meseca.
The demographic and baseline disease characteristics of the study population were well balanced between the treatment arms.
Demografske in izhodiščne značilnosti raziskovane populacije so bile med terapevtskima skupinama dobro uravnotežene.
Dose delay or discontinuation (see also sections 4.4 and 4.8) Table 1: Dose modification advice for Tecentriq
Zapoznitev odmerka ali prenehanje uporabe (glejte tudi poglavji 4.4 in 4.8)
For the recommended dose of 1680 mg: twenty-eight mL of Tecentriq concentrate should be withdrawn from two vials of Tecentriq 840 mg and diluted into a 250 mL polyvinyl chloride (PVC), polyolefin (PO), polyethylene (PE), or polypropylene (PP) infusion bag containing sodium chloride
Za priporočeni 1680-mg odmerek: 28 ml koncentrata zdravila Tecentriq je treba vzeti iz dveh vial zdravila Tecentriq 840 mg in ga razredčiti v 250-ml infuzijski vrečki iz polivinilklorida (PVC), poliolefina (PO), polietilena (PE) ali polipropilena (PP), ki vsebuje 0,9 % (9 mg/ml) raztopino natrijevega klorida za injiciranje.
Maintenance (21-day cycles)
(21-dnevni cikli)
Hypophysitis Hypophysitis occurred in < 0.1% (2/3,178) of patients who received atezolizumab monotherapy.
Hipofizitis se je pojavil pri < 0,1 % (2/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Colitis occurred in 1.1% (34/3,178) of patients who received atezolizumab monotherapy.
Kolitis se je pojavil pri 1,1 % (34/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Myocarditis has been observed in clinical trials with atezolizumab (see section 4.8).
V kliničnih preskušanjih z atezolizumabom so opazili miokarditis (glejte poglavje 4.8).
3 weeks until disease progression.
- še 5 mesecev po zadnjem odmerku.
This study excluded patients who had a history of autoimmune disease; active or corticosteroid-dependent brain metastases; administration of a live, attenuated vaccine within 28 days prior to enrolment; and administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal product within 2 weeks prior to enrolment.
V to študijo niso bili vključeni bolniki, ki so imeli avtoimunsko bolezen v anamnezi; simptomatske ali od kortikosteroidov odvisne zasevke v možganih; ki so prejeli živo, oslabljeno cepivo v 28 dneh pred vključitvijo, ki so uporabljali sistemska imunostimulatorna sredstva v 4 tednih pred vljučitvijo ali sistemska imunosupresivna zdravila v 2 tednih pred vključitvijo.
Pancreatitis requiring the use of corticosteroids occurred in 0.1% (4/3,178) of patients receiving atezolizumab monotherapy.
Pankreatitis, zaradi katerega je bilo treba uporabiti kortikosteroide, se je pojavil pri 0,1 % (4/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
The study met its co-primary endpoints in Cohort 2, demonstrating statistically significant ORRs per IRF-assessed RECIST v1.1 and investigator-assessed mRECIST
Študija je dosegla soprimarne opazovane dogodke v 2. kohorti in je pokazala statistično značilno boljše deleže objektivnih odgovorov po oceni IRF v skladu z merili RECIST v1.1 ter po oceni raziskovalcev v skladu z merili mRECIST v primerjavi z vnaprej opredeljenim 10-odstotnim kontrolnim historičnim deležem odgovora.
The rate of infusion should be reduced or treatment should be interrupted in patients with Grade 1 or 2 infusion-related reactions.
Pri bolnikih, ki imajo z infundiranjem povezane reakcije 1. ali 2. stopnje, je treba hitrost infundiranja zmanjšati ali zdravljenje prekiniti.
Secondary and exploratory endpoints Investigator-assessed ORR (RECIST 1.1)
Stratificirano razmerje ogroženosti‡ (95-% IZ) Sekundarni in eksploratorni dogodki učinkovitosti ORR po oceni raziskovalca (RECIST 1.1)
Includes reports of oropharyngeal pain, oropharyngeal discomfort, throat irritation.
t Vključuje poročila o orofaringealni bolečini, orofaringealnem nelagodju, draženju žrela.
Cohort 2.
Preglednica 2.
Myasthenic syndrome/myasthenia gravis or Guillain-Barré syndrome, which may be life threatening, were observed in patients receiving atezolizumab.
V primeru miastenijskega sindroma/miastenije gravis ali Guillain-Barréjevega sindroma je treba zdravljenje z atezolizumabom trajno prekiniti ne glede na njihovo stopnjo.
Secondary efficacy endpoints evaluated per investigator-assessed Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 are objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR).
Sekundarni opazovani dogodki učinkovitosti po oceni raziskovalca so delež objektivnega odgovora (ORR, objective response rate), preživetje brez napredovanja bolezni (PFS, progression-free survival) in trajanje odgovora (DOR, duration of response) po merilih RECIST (Response Evaluation Criteria in Solid Tumors) v1.1.
95% CI Stratifiedǂ hazard ratio (95% CI)
Stratificiranoǂ razmerje ogroženosti (95% IZ)
Hepatitis requiring the use of corticosteroids occurred in 0.6% (18/3,178) of patients receiving atezolizumab monotherapy.
Hepatitis, zaradi katerega je bilo treba uporabiti kortikosteroide, se je pojavil pri 0,6 % (18/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Diabetes mellitus occurred in 0.3% (11/3,178) of patients who received atezolizumab monotherapy.
Sladkorna bolezen se je pojavila pri 0,3 % (11/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
• underactive thyroid gland (hypothyroidism)
• premajhno delovanje žleze ščitnice (hipotiroidizem)
Table 2: Summary of adverse reactions occurring in patients treated with atezolizumab Atezolizumab monotherapy
Povzetek neželenih učinkov pri bolnikih, zdravljenih z atezolizumabom
Figure 4: Kaplan-Meier curve for PFS in the ITT population (IMpower150)
Slika 4: Kaplan-Meierjeva krivulja celokupnega preživetja v populaciji ITT (IMpower150)
Treatment with atezolizumab must be permanently discontinued for Grade 3 or Grade 4 events (ALT or AST > 5.0 x ULN or blood bilirubin > 3 x ULN).
V primeru učinkov 3. ali 4. stopnje (ALT ali AST > 5,0-kratna ZNM ali bilirubin v krvi > 3-kratna ZNM) je treba zdravljenje z atezolizumabom trajno ukiniti.
Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 myocarditis.
V primeru miokarditisa 3. ali 4. stopnje je treba zdravljenje z atezolizumabom trajno ukiniti.
Immune-related neuropathies
Imunsko pogojene nevropatije
should also have received targeted therapies before receiving Tecentriq (see section 5.1).
Bolniki z EGFR mutiranim ali ALK pozitivnim NDRP morajo pred uvedbo zdravila Tecentriq prejeti tudi tarčna zdravljenja (glejte poglavje 5.1).
Investigator-assessed DOR (RECIST v1.1)
DOR po oceni raziskovalca (RECIST v1.1)
IMpower130 (GO29537): Randomised phase III trial in chemotherapy-naïve patients with metastatic non-squamous NSCLC, in combination with nab-paclitaxel and carboplatin
IMpower130 (GO29537): randomizirano preskušanje faze III atezolizumaba v kombinaciji z nab paklitakselom in karboplatinom pri bolnikih z razsejanim neploščatoceličnim NDRP, predhodno še nezdravljenih s kemoterapijo
Adrenal insufficiency requiring the use of corticosteroids occurred in 0.3% (9/3,178) of patients receiving atezolizumab monotherapy.
Insuficienca nadledvičnih žlez, zaradi katere je bilo treba uporabiti kortikosteroide, se je pojavila pri 0,3 % (9/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Kaplan-Meier curves for OS in the ITT population are presented in Figure 2.
Kaplan-Meierjevi krivulji celokupnega preživetja v populaciji ITT sta prikazani na sliki 2.
METHOD OF ADMINISTRATION For intravenous use after dilution.
POSTOPEK UPORABE za intravensko uporabo po razredčenju
Myasthenia gravis occurred in < 0.1% (1/3,178) of patients who received atezolizumab monotherapy.
Miastenija gravis se je pojavila pri < 0,1 % (1/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Placebo + nab-paclitaxel
nab-paklitaksel placebo +
Immune system disorders Common infusion-related reactionf Endocrine disorders Very common hypothyroidismg
Bolezni imunskega sistema pogosti z infundiranjem povezane reakcijef
Median (months) (95% CI)
Mediani čas do dogodka (meseci) 95-% IZ
The Kaplan-Meier curve for OS in the all comer population is presented in Figure 1.
Kaplan-Meierjeva krivulja za celokupno preživetje v populaciji vseh neselekcioniranih bolnikov je predstavljena na sliki 1.
In Cohort 1, 119 patients were treated with atezolizumab 1,200 mg by intravenous infusion every
V 1. kohorto je bilo z atezolizumabom v odmerku 1200 mg v intravenski infuziji na 3 tedne do napredovanja bolezni zdravljenih 119 bolnikov.
Arm A (Atezolizumab + Paclitaxel + Carboplatin)
Skupina A (atezolizumab + paklitaksel + karboplatin)
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Ime in naslov izdelovalca biološke učinkovine
Stratified hazard ratio‡ (95% CI) p-value
Stratificiranoǂ razmerje ogroženosti (95-% IZ) p-vrednost**
Atezolizumab should be permanently discontinued in patients with Grade 3 or 4 infusion-related reactions.
Pri bolnikih, ki imajo z infundiranjem povezane reakcije 3. ali 4. stopnje, je treba zdravljenje z atezolizumabom trajno ukiniti.
Immune-related myositis
Imunsko pogojeni miozitis
A phase II, multi-centre, international, two-cohort, single-arm clinical trial, IMvigor210, was conducted in patients with locally advanced or metastatic UC (also known as urothelial bladder cancer).
Pri bolnikih z lokalno napredovalim ali razsejanim urotelijskim karcinomom (imenovanim tudi urotelijski rak sečnega mehurja) so izvedli multicentrično mednarodno preskušanje faze II z eno skupino in dvema kohortama (IMvigor210).
Meningoencephalitis occurred in 0.4% (13/3,178) of patients who received atezolizumab monotherapy.
Meningoencefalitis se je pojavil pri 0,4 % (13/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Treatment may be resumed when serum amylase and lipase levels improve to Grade 0 or Grade 1 within 12 weeks, or symptoms of pancreatitis have resolved, and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day
Zdravljenje se lahko znova začne, ko se raven serumske amilaze in lipaze v 12 tednih zniža na 0. ali 1. stopnjo ali ko simptomi pankreatitisa minejo, odmerek kortikosteroidov pa je zmanjšan na
Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment; systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal products within 2 weeks prior to study entry were excluded from clinical trials.
Prav tako v klinična preskušanja niso bili vključeni bolniki, ki so bili v obdobju 28 dni pred vključitvijo v študijo cepljeni z živim oslabljenim cepivom, ki so v obdobju 4 tednov pred vključitvijo v študijo dobili sistemska imunostimulacijska sredstva ali v obdobju 2 tednov sistemska imunosupresivna zdravila.
Treatment with atezolizumab should be withheld for Grade 2 myocarditis, and treatment with systemic corticosteroids at a dose of 1 to 2mg/kg/day of prednisone or equivalent should be started.
V primeru miokarditisa 2. stopnje je treba zdravljenje z atezolizumabom odložiti in uvesti zdravljenje s sistemskimi kortikosteroidi v odmerku 1 do 2 mg/kg/dan prednizona (ali ekvivalenta).
95% CI Stratified hazard ratio‡ (95% CI)
Stratificirano razmerje ogroženosti‡ (95-% IZ)
Myositis occurred in 0.4% (12/3178) of patients who received atezolizumab monotherapy.
Miozitis se je pojavil pri 0,4 % (12/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 pneumonitis.
V primeru pnevmonitisa 3. ali 4. stopnje je treba zdravljenje z atezolizumabom trajno ukiniti.
The Kaplan-Meier curve for OS in the ITT population is presented in Figure 2.
Kaplan-Meierjeva krivulja celokupnega preživetja v populaciji ITT je prikazana na sliki 2.
Patients should be monitored for signs and symptoms of myositis.
Bolnike je treba nadzorovati glede znakov in simptomov, ki kažejo na miozitis.
Cases of hepatitis, some leading to fatal outcomes have been observed in clinical trials with atezolizumab (see section 4.8).
V kliničnih preskušanjih atezolizumaba so opazili primere hepatitisa, nekatere s smrtnim izidom (glejte poglavje 4.8).
Patients were excluded if they had active or untreated CNS metastases; history of autoimmune disease; administration of live, attenuated vaccine within 4 weeks prior to randomisation; administration of systemic immunosuppressive medications within 1 week prior to randomisation.
V študijo niso bili vključeni bolniki, ki so imeli aktivne ali nezdravljene zasevke v osrednjem živčevju, anamnezo avtoimunske bolezni, so bili v 4 tednih pred randomizacijo cepljeni z živim oslabljenim cepivom, ali so v enem tednu pred randomizacijo prejemali sistemska imunosupresivna zdravila.
Nephritis has been observed in clinical trials with atezolizumab (see section 4.8).
V kliničnih preskušanjih z atezolizumabom so opazili nefritis (glejte poglavje 4.8).
CI = confidence interval; DOR = duration of response; NE = not estimable; ORR = objective response rate; OS = overall survival; PFS = progression-free survival; RECIST = Response Evaluation Criteria in Solid Tumours v1.1.
IZ = interval zaupanja; DOR = trajanje odgovora; NO = ni ocenljivo; ORR = delež objektivnega odgovora; OS = celokupno preživetje; PFS = preživetje brez napredovanja bolezni; RECIST = merila RECIST (Response
A phase III, open-label, multi-center, international, randomised study, (IMvigor211), was conducted to evaluate the efficacy and safety of atezolizumab compared with chemotherapy (investigator's choice of vinflunine, docetaxel, or paclitaxel) in patients with locally advanced or metastatic UC who progressed during or following a platinum-containing regimen.
Pri bolnikih z lokalno napredovalim ali razsejanim urotelijskim karcinomom, ki je napredoval med ali po zdravljenju s kemoterapijo na osnovi platine, so za oceno učinkovitosti in varnosti atezolizumaba v primerjavi s kemoterapijo (raziskovalčeva izbira vinflunina, docetaksela ali paklitaksela) izvedli odprto, multicentrično, mednarodno, randomizirano študijo faze III (IMvigor211).
• blood tests showing low levels of potassium (hypokalaemia) or sodium (hyponatremia)
• znižana koncentracija kalija (hipokaliemija) ali natrija (hiponatriemija) v krvi, kar pokažejo preiskave krvi
Treatment with atezolizumab should be withheld for Grade 2 pneumonitis, and 1 to 2 mg/kg/day prednisone or equivalent should be started.
V primeru pnevmonitisa 2. stopnje je treba zdravljenje z atezolizumabom odložiti in uvesti prednizon v odmerku 1 do 2 mg/kg/dan (ali ekvivalenta).
Patients with ECOG performance status ≥ 2 were excluded from the clinical trials in NSCLC, TNBC
Stanje zmogljivosti po ECOG (Eastern Cooperative Oncology Group) ≥ 2 Bolniki s stanjem zmogljivosti po ECOG ≥ 2 niso bili vključeni v klinična preskušanja pri NDRP, TNRD in pri 2. liniji zdravljenja urotelijskega karcinoma (glejte poglavji 4.4 in 5.1).
b etoposide (100 mg/m2)b,c atezolizumab (1,200 mg)
2)b,c + karboplatin (AUC 6)c (100 mg/m atezolizumab (1200 mg)a
• 1,680 mg administered intravenously every four weeks.
• 840 mg intravensko na vsaka dva tedna ali • 1680 mg intravensko na vsake štiri tedne.
Cases of pneumonitis, including fatal cases, have been observed in clinical trials with atezolizumab (see section 4.8).
V kliničnih preskušanjih atezolizumaba so opažali primere pnevmonitisa, vključno s smrtnimi primeri (glejte poglavje 4.8).
Treatment with atezolizumab should be withheld for Grade 2 nephritis, and treatment with systemic corticosteroids at a dose of 1 to 2mg/kg/day of prednisone or equivalent should be started.
V primeru nefritisa 2. stopnje je treba zdravljenje z atezolizumabom odložiti in uvesti zdravljenje s sistemskimi kortikosteroidi v odmerku 1 do 2 mg/kg/dan prednizona (ali ekvivalenta).
For all treated patients, the median duration of treatment was 2.1 months for the docetaxel arm and 3.4 months for the atezolizumab arm.
2,1 meseca v skupini z docetakselom in 3,4 meseca v skupini z atezolizumabom.
Patients were excluded if they had a history of autoimmune disease, administration of live, attenuated vaccine within 28 days prior to randomisation, administration of immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomisation, and active or untreated CNS metastases.
V študijo niso bili vključeni bolniki, ki so imeli anamnezo avtoimunske bolezni, so bili v 28 dneh pred randomizacijo cepljeni z živim oslabljenim cepivom, so v 4 tednih pred randomizacijo prejemali imunostimulacijska sredstva, so v 2 tednih pred randomizacijo prejemali sistemska imunosupresivna zdravila, ali so imeli aktivne ali nezdravljene zasevke v osrednjem živčevju.
No. of partial response (%) 95% CI
Št. delnih odgovorov (%) 95-% IZ
aStratified HR for ITT and TC or IC ≥ 1%.
aStratificirano razmerje ogroženosti za populacijo z namenom zdraviti (ITT) in tumorske celice (TC) ali celice imunskega sistema, ki infiltrirajo tumor (IC) ≥ 1%.
Treatment may be resumed when the symptoms improve to Grade 0 or Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day
Zdravljenje se lahko znova začne, ko se neželeni učinek v 12 tednih izboljša na 0. ali 1. stopnjo in je odmerek kortikosteroidov zmanjšan na ≤ 10 mg prednizona (ali ekvivalenta) na dan.
This study excluded patients who had a history of autoimmune disease, active or corticosteroid-dependent brain metastases, administration of a live, attenuated vaccine within 28 days prior to enrolment, administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medicinal product within 2 weeks prior to enrolment.
V študijo niso bili vključeni bolniki z anamnezo avtoimunske bolezni, z aktivnimi ali od kortikosteroidov odvisnimi zasevki v možganih, prav tako vanjo niso bili vključeni bolniki, ki so v 28 dneh pred vstopom v študijo dobili živo oslabljeno cepivo, sistemska imunostimulacijska sredstva v 4 tednih pred vključitvijo ali sistemska imunosupresivna zdravila v 2 tednih pred vključitvijo.
Meningoencephalitis has been observed in clinical trials with atezolizumab (see section 4.8).
V kliničnih preskušanjih z atezolizumabom so opažali meningoencefalitis (glejte poglavje 4.8).
No. of complete response (%) No. of partial response (%) No. of stable disease (%)
Število popolnih odgovorov (%) Število delnih odgovorov (%) Število stabilne bolezni (%) DOR po oceni raziskovalca (RECIST v1.1)
• inflammation of the pancreas (pancreatitis): symptoms may include abdominal pain, nausea and vomiting
• vnetje trebušne slinavke (pankreatitis): med simptomi so lahko bolečine v trebuhu, slabost (siljenje na bruhanje) in bruhanje;
Physicians should carefully consider the combined risks of the four-drug regimen of atezolizumab bevacizumab, paclitaxel, and carboplatin before initiating treatment (see section 4.8).
Uporaba atezolizumaba v kombinaciji z bevacizumabom, paklitakselom in karboplatinom pri razsejanem neploščatoceličnem nedrobnoceličnem raku pljuč Zdravniki morajo pred začetkom zdravljenja natančno pretehtati skupna tveganja kombiniranega zdravljenja s štirimi zdravili: z atezolizumabom, bevacizumabom, paklitakselom in karboplatinom (glejte poglavje 4.8).
The confirmed ORRs per IRF-RECIST v1.1 were 21.9% (95% CI:
ORR po oceni raziskovalca (RECIST v1.1) Št. bolnikov z odgovorom (%) 95-% IZ
Tecentriq in combination with carboplatin and etoposide
Zdravilo Tecentriq v kombinaciji z bevacizumabom, paklitakselom in karboplatinom
Table 3: Summary of efficacy in all comers (IMvigor211)
Povzetek učinkovitosti pri vseh neselekcioniranih bolnikih (IMvigor211) Opazovani dogodek učinkovitosti atezolizumab (n = 467)
Infusion-related reactions have been observed with atezolizumab (see section 4.8).
Pri zdravljenju z atezolizumabom so opažali z infundiranjem povezane reakcije (glejte poglavje 4.8).
Adrenal insufficiency occurred in 0.4% (12/3,178) of patients who received atezolizumab monotherapy.
Insuficienca nadledvičnih žlez se je pojavila pri 0,4 % (12/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Colitis requiring the use of corticosteroids occurred in 0.6% (19/3,178) of patients receiving atezolizumab monotherapy.
Kolitis, zaradi katerega je bilo treba uporabiti kortikosteroide, se je pojavil pri 0,6 % (19/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Secondary Endpoints Investigator-assessed PFS (RECIST v1.1)*
12-mesečno OS (%) PFS po oceni raziskovalca (RECIST v1.1)**
Posology
Izražanje
expression < 1% in TC and IC.
95-% IZ ‡ stratificirani glede na spol in izražanje PD-L1 na TC in IC
Treatment with atezolizumab must be permanently discontinued for Grade 3 or 4 nephritis.
V primeru nefritisa 3. ali 4. stopnje je treba zdravljenje z atezolizumabom trajno ukiniti.
Myasthenia Gravis) - Immune-Related Meningoencephalitis - Immune-Related Myocarditis - Immune-Related Nephritis - Immune-Related Myositis - Infusion-Related Reactions
- imunsko pogojeni hepatitis - imunsko pogojeni pnevmonitis - imunsko pogojeni kolitis - imunsko pogojeni pankreatitis - imunsko pogojene endokrinopatije (sladkorna bolezen tipa 1, hipotiroidizem,
9.3, 40.0) in patients with PD-L1 expression ≥ 5%, 18.8% (95% CI: 10.9, 29.0) in patients with PD-L1 expression ≥ 1%, and 19.3% (95% CI: 12.7, 27.6) in all comers.
Potrjeni delež objektivnega odgovora s strani IRF po merilih RECIST v1.1 so bili 21,9 % (95-% IZ: 9,3; 40,0) pri bolnikih z izražanjem PD-L1 ≥ 5 %, 18,8 % (95-% IZ: 10,9; 29,0) pri bolnikih z izražanjem PD-L1 ≥ 1 % in 19,3 % (95-% IZ: 12,7; 27,6) pri neselekcioniranih bolnikih.