natgillin/translations-raw huggingface dataset:
No. of confirmed responders (%)
Št. bolnikov s potrjenim odgovorom (%)
IMvigor211 (GO29294): Randomised trial in locally advanced or metastatic UC patients previously treated with chemotherapy
IMvigor211 (GO29294): Randomizirano preskušanje pri bolnikih z lokalno napredovalim ali razsejanim urotelijskim karcinomom, ki so bili predhodno zdravljeni s kemoterapijo
Patients with PD-L1 expression <1% did not show improved PFS when atezolizumab was added to nab-paclitaxel (HR of 0.94, 95% CI 0.78, 1.13).
Bolnikom z izražanjem PD-L1 < 1 % se PFS po dodatku atezolizumaba nab-paklitakselu ni izboljšalo (RO 0,94; 95-% IZ 0,78, 1,13).
Patients with event (%)
Št. bolnikov z odgovorom (%)
After dilution, one mL of solution should contain approximately 6.0 mg of Tecentriq (1680 mg/278 mL).
Po razredčenju vsebuje en mililiter raztopine približno 6,0 mg zdravila Tecentriq (1680 mg/278 ml).
The median time to onset 7.2 months (range: 24 days to 13.7 months).
Mediani čas do pojava je bil 7,2 meseca (razpon: od 24 dni do 13,7 meseca).
• a cancer that arises from the breast, called triple negative breast cancer.
• rakom dojk, imenovanim trojno negativni rak dojk.
Uncommon Guillain-Barré syndromem, meningoencephalitisn
Guillain-Barréjev sindromm, meningoencefalitisn redki miastenijski sindromo
• inflammation of the lung (pneumonitis): symptoms may include new or worsening cough,
• vnetje pljuč (pnevmonitis): med simptomi so lahko novonastal kašelj ali poslabšanje kašlja,
It is used if: the lung cancer has spread to other parts of the body (extensive-stage) you have not received any prior chemotherapy for extensive-stage SCLC.
Pri tem raku ga uporabljamo, če: - se je razširil v druge dele telesa (razsejana oblika), - za zdravljenje razsejanega drobnoceličnega raka pljuč predhodno še niste prejeli kemoterapije.
What Tecentriq contains
Kaj vsebuje zdravilo Tecentriq
Tecentriq used alone The following side effects have been reported in clinical trials with Tecentriq used alone:
Ko so v kliničnih preskušanjih uporabljali samo zdravilo Tecentriq, so poročali o naslednjih neželenih učinkih:
• inflammation of the membrane around the spinal cord and brain
• vnetje open, ki obdajajo hrbtenjačo in možgane
Hepatitis led to discontinuation of atezolizumab in 6 (< 0.2%) patients.
Zaradi hepatitisa je zdravljenje z atezolizumabom prenehalo 6 (< 0,2 %) bolnikov.
To treat extensive-stage SCLC, Tecentriq will be given to you in combination with carboplatin and etoposide.
Za zdravljenje razsejanega drobnoceličnega raka pljuč boste prejeli zdravilo Tecentriq v kombinaciji s karboplatinom in etopozidom.
Hyperthyroidism, Adrenal Insufficiency and Hypophysitis) - Immune-Related Neuropathies (Guillain-Barre Syndrome, Myasthenic Syndrome /
hipertiroidizem, insuficienca nadledvičnih žlez, hipofizitis) - imunsko pogojene nevropatije (Guillain-Barréjev sindrom, miastenijski sindrom/miastenija gravis) - imunsko pogojeni meningoencefalitis - imunsko pogojeni miokarditis - imunsko pogojeni nefritis
• inflammation of the liver (hepatitis): symptoms may include yellowing of skin or eyes, nausea, vomiting, bleeding or bruising, dark urine, and stomach pain
• vnetje jeter (hepatitis): med simptomi so lahko porumenelost kože ali oči, slabost (siljenje na bruhanje), bruhanje, krvavitve ali podplutbe, temen urin in bolečine v trebuhu;
Each 14 mL vial of concentrate contains 840 mg atezolizumab After dilution, 1 mL of solution contains approximately 3.2 mg of atezolizumab for 840 mg dose and 6.0 mg of atezolizumab for 1680 mg dose.
Ena 14-ml viala s koncentratom vsebuje 840 mg atezolizumaba Po redčenju 1 ml raztopine vsebuje približno 3,2 mg atezolizumaba v 840-mg odmerku in približno 6 mg atezolizumaba v 1680-mg odmerku
The confirmed ORRs per IRF-RECIST v1.1 were 28.0% (95% CI: 19.5, 37.9) in patients with PD-L1 expression ≥ 5%, 19.3% (95% CI: 14.2, 25.4) in patients with PD-L1 expression ≥ 1%, and 15.8% (95% CI: 11.9, 20.4) in all comers.
Potrjeni deleži objektivnih odgovorov po oceni IRF glede na merila RECIST v1.1 so bili 28,0 % (95% IZ: 19,5; 37,9) pri bolnikih z izražanjem PD-L1 ≥ 5 %, 19,3 % (95-% IZ: 14,2, 25,4) pri bolnikih izražanjem PD-L1 ≥ 1 % in 15,8 % (95-% IZ: 11,9; 20,4) pri vseh neselekcioniranih bolnikih.
d Includes reports of neutropenia, neutrophil count decreased, febrile neutropenia, neutropenic sepsis, granulocytopenia.
d Vključuje poročila o nevtropeniji, zmanjšanju števila nevtrofilcev, febrilni nevtropeniji, nevtropenični sepsi,
Patients should be monitored for symptoms of motor and sensory neuropathy.
Bolnike je treba spremljati glede znakov in simptomov motorične in senzorične nevropatije.
Administration of atezolizumab could cause foetal harm, including embryo-foetal lethality.
Pričakovati je mogoče, da uporaba atezolizumaba lahko škoduje plodu, vključno s smrtjo zarodka ali ploda.
QUALITATIVE AND QUANTITATIVE COMPOSITION One 20 mL vial of concentrate contains 1,200 mg atezolizumab*.
Ena 20-ml viala s koncentratom vsebuje 1200 mg atezolizumaba*.
Figure 5: Forest plot of progression free survival by PD-L1 expression in the ITT population, Arm B vs. C (IMpower150)
Slika 5: Drevesni diagram preživetja brez napredovanja bolezni glede na izražanje PD-L1 v populaciji ITT, skupina B glede na skupino C (IMpower150)
Vinflunine was administered 320 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
Vinflunin so dajali v odmerku 320 mg/m z intravensko infuzijo 1. dan vsakega 3-tedenskega cikla do napredovanja bolezni ali nesprejemljive toksičnosti.
The median time to onset was 4.7 months (range 15 days to 17.2 months).
Mediani čas do pojava je bil 4,7 mesece (razpon: od 15 dni do 17,2 meseca).
• a cancer that affects the bladder and the urinary system, called urothelial carcinoma.
• rakom, ki prizadene sečni mehur ali druga sečila in ga imenujemo urotelijski karcinom.
Guillain-Barré syndrome requiring the use of corticosteroids occurred in < 0.1% (2/3,178) of patients receiving atezolizumab monotherapy.
Guillain-Barréjev sindrom, zaradi katerega je bilo treba uporabiti kortikosteroide, se je pojavil pri < 0,1 % (2/3178) bolnikov, ki so prejemali atezolizumab v monoterapiji.
Treatment may be resumed if the event improves to ≤ Grade 1 within 12 weeks and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day and the patient is stable on replacement therapy (if required).
Zdravljenje se lahko znova začne, če se neželeni učinek v 12 tednih izboljša na ≤ 1. stopnjo in je odmerek kortikosteroidov zmanjšan na ≤ 10 mg prednizona (ali ekvivalenta) na dan, bolnik pa je stabilen na nadomestnem zdravljenju (če je potrebno).
After dilution, one mL of solution should contain approximately 4.4 mg of Tecentriq (1,200 mg/270 mL).
Po razredčenju vsebuje en mililiter raztopine približno 4,4 mg zdravila Tecentriq (1200 mg/270 ml).
For Grade 2 diarrhoea or colitis, if symptoms persist > 5 days or recur, treatment with 1 to 2 mg/kg/day prednisone or equivalent should be started.
Če simptomi diareje ali kolitisa 2. stopnje trajajo > 5 dni ali se ponovijo, je treba uvesti zdravljenje s prednizonom v odmerku 1 do 2 mg/kg/dan (ali ekvivalenta).
Adrenal insufficiency
Insuficienca naledvičnih žlez
During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion, followed by bevacizumab, paclitaxel, and then carboplatin every three weeks for four or six cycles.
Med uvodno fazo je priporočeni odmerek zdravila Tecentriq 1200 mg v intravenski infuziji, čemur sledijo bevacizumab, paklitaksel in nato karboplatin na tri tedne, skupno štiri ali šest ciklov.
Baseline ECOG performance status was 0 (37%) or 1 (63%).
Izhodiščno stanje zmogljivosti po ECOG je bilo 0 (37 %) ali 1 (63 %).
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy.
Zdravilo Tecentriq je kot monoterapija indicirano za zdravljenje odraslih bolnikov z lokalno napredovalim ali razsejanim NDRP, ki so bili predhodno zdravljeni s kemoterapijo.
1-year OS rate (%)
1-letno celokupno preživetje (%)
Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC):
Zdravilo Tecentriq je kot monoterapija indicirano za zdravljenje odraslih bolnikov z lokalno napredovalim ali razsejanim urotelijskim karcinomom, ki:
Treatment with atezolizumab may be resumed if metabolic control is achieved on insulin replacement therapy.
Zdravljenje z atezolizumabom se lahko znova začne, če je presnova urejena z insulinskim zdravljenjem.
22 months showed a median OS of 12.6 months in patients treated with atezolizumab, vs. 9.7 months in patients treated with docetaxel (HR of 0.69, 95% CI: 0.52, 0.92).
Posodobljena analiza po skupno 200 zabeleženih smrtih in z medianim spremljanjem preživetja 22 mesecev je pokazala mediano celokupno preživetje 12,6 meseca pri prejemnikih atezolizumaba in 9,7 meseca pri prejemnikih docetaksela (RO 0,69, 95-% IZ: 0,52; 0,92).
Treatment with atezolizumab must be permanently discontinued for Grade 4 (life threatening; urgent intervention indicated) diarrhoea or colitis.
V primeru diareje ali kolitisa 4. stopnje (življenje ogrožujoče stanje; potrebno je nujno ukrepanje) je treba zdravljenje z atezolizumabom trajno ukiniti.
The induction phase is followed by a maintenance phase without chemotherapy in which 1,200 mg Tecentriq is administered by intravenous infusion every three weeks.
Uvodni fazi zdravljenja sledi faza vzdrževanja brez kemoterapije, med katero se zdravilo Tecentriq v odmerku 1200 mg v intravenski infuziji aplicira na tri tedne.
NSCLC patients (hazard ratio [HR] of 0.73, 95% CI: 0.60, 0.89; median OS of 15.6 vs. 11.2 months for atezolizumab and docetaxel, respectively) and squamous NSCLC patients (HR of 0.73, 95% CI: 0.54, 0.98; median OS of 8.9 vs. 7.7 months for atezolizumab and docetaxel, respectively).
Celokupno preživetje se je z atezolizumabom v primerjavi z docetakselom izboljšalo tako pri bolnikih z neploščatoceličnim NDRP (razmerje ogroženosti [RO] 0,73, 95-% IZ: 0,60; 0,89; mediano celokupno preživetje 15,6 meseca z atezolizumabom in 11,2 meseca z docetakselom) kot pri bolnikih s ploščatoceličnim NDRP (RO 0,73; 95-% IZ: 0,54; 0,98; mediano celokupno preživetje 8,9 meseca z atezolizumabom in 7,7 z docetakselom).
Small cell lung cancer
Drobnocelični rak pljuč
Patients with previously untreated UC and TNBC should be selected for treatment based on the tumour expression of PD-L1 confirmed by a validated test (see section 5.1).
Testiranje PD-L1 pri bolnikih z urotelijskim karcinomom in TNRD Bolnike s predhodno nezdravljenim urotelijskim karcinomom in TNRD je treba za zdravljenje izbrati na podlagi tumorskega izražanja PD-L1, potrjenega z validirano preiskavo (glejte poglavje 5.1).
Treatment with atezolizumab should be withheld if Grade 2 event (ALT or AST > 3 to 5 x ULN or blood bilirubin > 1.5 to 3 x ULN) persists for more than 5 to 7 days, and 1 to 2 mg/kg/day of prednisone or equivalent should be started.
Če hepatitis 2. stopnje (ALT ali AST > 3- do 5-kratna ZNM ali bilirubin v krvi > 1,5- do 3-kratna ZNM) traja več kot 5 do 7 dni, je treba zdravljenje z atezolizumabom zadržati, in uvesti prednizon v odmerku 1 do 2 mg/kg/dan (ali ekvivalent).
Patients should be monitored for signs and symptoms of myocarditis.
Bolnike je treba nadzorovati glede znakov in simptomov, ki kažejo na miokarditis.
b Includes reports of pneumonia, bronchitis, lung infection, lower respiratory tract infection, infective exacerbation of COPD, infectious pleural effusion, tracheobronchitis, atypical pneumonia, lung abscess, pyopneumothorax.
b Vključuje poročila o pljučnici, bronhitisu, okužbi pljuč, okužbi spodnjih dihal, poslabšanju KOPB zaradi okužbe, infekcijskem plevralnem izlivu, traheobronhitisu, atipični pljučnici, pljučnem abscesu, piopnevmotoraksu.
• inflammation of the lung (pneumonitis): symptoms may include new or worsening cough, shortness of breath, and chest pain
• vnetje pljuč (pnevmonitis): med simptomi so lahko novonastal kašelj ali poslabšanje kašlja, težko dihanje in bolečine v prsih;
Tecentriq in combination with nab-paclitaxel in 1L mTNBC The recommended dose of Tecentriq is 840 mg administered by intravenous infusion, followed by 100 mg/m2 nab-paclitaxel.
Priporočeni odmerek zdravila Tecentriq je 840 mg v intravenski infuziji, ki ji sledi 100 mg/m nab-paklitaksela.
Tumour assessments were conducted every 6 weeks for the first 48 weeks following Cycle 1, Day 1 and then every 9 weeks thereafter.
Ocene tumorjev so izvedli na vsakih 6 tednov po 1. dnevu 1. cikla v prvih 48 tednih in nato na vsakih 9 tednov.
Prognostic risk factors included time from prior chemotherapy of < 3 months,
Napovedni dejavniki tveganja so vključevali čas od predhodne kemoterapije < 3 mesece, stanje zmogljivosti po ECOG > 0 in hemoglobin < 10 g/dl.
During the induction phase, the recommended dose of Tecentriq is 1,200 mg administered by intravenous infusion, followed by nab-paclitaxel and carboplatin every three weeks for four or six cycles.
Med uvodno fazo je priporočeni odmerek zdravila Tecentriq 1200 mg v intravenski infuziji, čemur sledita nab-paklitaksel in nato karboplatin na vsake tri tedne, skupno štiri ali šest ciklov.
Investigator-assessed DOR (RECIST 1.1)** ^
DOR po oceni raziskovalca (RECIST 1.1)** ^
How Tecentriq is given
Kako se daje zdravilo Tecentriq
After dilution, one mL of solution should contain approximately 3.2 mg of Tecentriq (840 mg/264 mL).
Po razredčenju vsebuje en mililiter raztopine približno 3,2 mg zdravila Tecentriq (840 mg/264 ml).
QUALITATIVE AND QUANTITATIVE COMPOSITION One 14 mL vial of concentrate contains 840 mg of atezolizumab*.
Ena 14-ml viala s koncentratom vsebuje 840 mg atezolizumaba*.
After dilution (see section 6.6), one mL of solution contains approximately 3.2 mg of atezolizumab for the 840 mg dose and approximately 6.0 mg of atezolizumab for the 1680 mg dose.
Po razredčenju (glejte poglavje 6.6) 1 ml raztopine vsebuje približno 3,2 mg atezolizumaba v 840-mg odmerku in približno 6 mg atezolizumaba v 1680-mg odmerku.
Atezolizumab (1,200 mg)a
atezolizumab (1200 mg)a + nab-paklitaksel
Induction (Four 21-Day Cycles)
Uvodno zdravljenje (štirje 21-dnevni cikli)
IMpassion130 (WO29522): Randomised phase III trial in locally advanced or metastatic TNBC patients previously untreated for metastatic disease
Preskušanje IMpassion130 (WO29522): randomizirano preskušanje faze III pri bolnikih z lokalno napredovalim ali razsejanim TNRD, predhodno še nezdravljenih zaradi razsejane bolezni
Hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis and type 1 diabetes mellitus, including diabetic ketoacidosis have been observed in clinical trials with atezolizumab (see section
V kliničnih preskušanjih atezolizumaba so opažali hipotiroidizem, hipertiroidizem, insuficienco nadledvičnih žlez, hipofizitis in sladkorno bolezen tipa 1, vključno z diabetično ketoacidozo (glejte poglavje 4.8).
The median time to onset was 1.5 months (range 6 days to 18.8
Mediani čas do pojava je bil 1,5 meseca (razpon: od 6 dni do 18,8 meseca).
Carboplatin and etoposide were administered until completion of 4 cycles, or progressive disease or unacceptable toxicity, whichever occurs first c
b Karboplatin in etopozid so uporabljali do dokončanja 4 ciklov, napredovanja bolezni ali nesprejemljivih toksičnih učinkov,
POPLAR (GO28753): Randomised phase II trial in locally advanced or metastatic NSCLC patients previously treated with chemotherapy
POPLAR (GO28753): Randomizirano preskušanje faze II pri bolnikih z lokalno napredovalim ali razsejanim NDRP, ki so bili predhodno zdravljeni s kemoterapijo
Tecentriq 840 mg concentrate for solution for infusion atezolizumab
Tecentriq 840 mg koncentrat za raztopino za infundiranje atezolizumab
IMpower150 (GO29436): Randomised phase III trial in chemotherapy-naïve patients with metastatic non-squamous NSCLC, in combination with paclitaxel and carboplatin with or without bevacizumab
IMpower150 (GO29436): Randomizirano preskušanje faze III pri bolnikih z razsejanim neploščatoceličnim NDRP, predhodno še nezdravljenih s kemoterapijo, v kombinaciji s paklitakselom in karboplatinom (z bevacizumabom ali brez njega)
Respiratory, thoracic, and mediastinal disorders Very common cough, dyspnoea dyspnoea, cough
Bolezni dihal, prsnega koša in mediastinalnega prostora zelo pogosti kašelj, dispneja dispneja, kašelj pogosti pnevmonitisq, hipoksija,
Figure 9: Forest plot of progression free survival by PD-L1 expression (IMpower130)
Slika 9: Drevesni diagram preživetja brez napredovanja bolezni glede na izražanje PD-L1 (IMpower130)
Tumour assessments were conducted every 6 weeks for the first 36 weeks, and every 9 weeks thereafter.
Ocenjevanje odgovora tumorja so prvih 36 tednov izvajali na 6 tednov, nato pa vsakih 9 tednov.
Tecentriq 1,200 mg concentrate for solution for infusion atezolizumab
Tecentriq 1200 mg koncentrat za raztopino za infundiranje atezolizumab
A Phase I/III, randomised, multicentre, double-blind, placebo-controlled study, IMpower133, was conducted to evaluate the efficacy and safety of atezolizumab in combination with carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC).
Randomizirano, multicentrično, dvojno slepo, s placebom kontrolirano študijo faze I/III IMpower133 so izvedli z namenom ovrednotenja učinkovitosti in varnosti atezolizumaba v kombinaciji s karboplatinom in etopozidom pri bolnikih z razsejanim drobnoceličnim rakom pljuč (angl. extensivestage small cell lung cancer), ki predhodno še niso prejemali kemoterapije.
Treatment may be resumed when rash is resolved and corticosteroids have been reduced to ≤ 10 mg prednisone or equivalent per day
Zdravljenje se lahko znova začne, ko izpuščaj mine in je odmerek kortikosteroidov zmanjšan na ≤ 10 mg prednizona (ali ekvivalenta) na dan.
The median duration was 26 days (range 6 days to 14.5+ months; + denotes a censored value).
Mediano trajanje je bilo 26 dni (razpon: od 6 dni do 14,5+ meseca; + označuje krnjeno vrednost).
• mouth and throat pain
• bolečina v ustih in žrelu
Other endpoints Investigator-assessed ORR (RECIST 1.1)** ^
ORR po oceni raziskovalca (RECIST 1.1)** ^
Cardiac disorders Rare myocarditisp Vascular disorders Common hypotension
Srčne bolezni redki miokarditisp
The median time to onset was 2.1 months (range 21 days to 15.7 months).
Mediani čas do pojava je bil 2,1 meseca (razpon: od 21 dni do 15,7 meseca).
• inflammation of the intestines (colitis): symptoms may include diarrhoea (watery, loose or soft stools), blood in stools, and stomach pain
• vnetje črevesa (kolitis): med simptomi so lahko driska (vodeno, redko ali mehko blato), kri v blatu in bolečine v trebuhu;
Grade 4 or any grade of recurrent pancreatitis
Pankreatitis 4. stopnje ali ponovitev pankreatitisa ne glede na stopnjo
Figure 2: Kaplan-Meier curve for overall survival in the ITT population (IMpower150)
Slika 2: Kaplan-Meierjeva krivulja celokupnega preživetja v populaciji ITT (IMpower150)
(creatinine level > 1.5 to 3.0 x baseline or > 1.5 to 3.0 x ULN)
2. stopnja: koncentracija kreatinina > 1,5 do 3,0kratna izhodiščna vrednost ali > 1,5 do 3,0-kratna ZNM)
What Tecentriq is used for
Za kaj uporabljamo zdravilo Tecentriq
Pneumonitis led to discontinuation of atezolizumab in 12 (0.4%) patients.
Zaradi pnevmonitisa je zdravljenje z atezolizumabom končalo 12 (0,4 %) bolnikov.
Meningoencephalitis requiring the use of corticosteroids occurred in 0.2% (6/3,178) of patients receiving atezolizumab and four patients discontinued atezolizumab.
Meningoencefalitis, zaradi katerega je bilo treba uporabiti kortikosteroide, se je pojavil pri 0,2 % (6/3178) bolnikov, ki so prejemali atezolizumab; štirje bolniki so prenehali z atezolizumabom.
Baseline ECOG performance status was 0 (43%) or 1 (57%).
Izhodiščno stanje zmogljivosti po ECOG je bilo 0 (43 %) ali 1 (57 %).
Table 8: Intravenous treatment regimens (IMpower130) Treatment
Intravenski shemi zdravljenja (IMpower130)
Arm A Atezolizumab + nab-paclitaxel + carboplatin
Skupina A atezolizumab + nab-paklitaksel + karboplatin
Docetaxel was administered 75 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression.
Docetaksel so uporabljali v odmerku 75 mg/m v intravenski infuziji 1. dan vsakega 3-tedenskega cikla do napredovanja bolezni.
No overall differences in safety were observed between patients ≥ 65 years of age and younger patients receiving atezolizumab monotherapy.
Med bolniki, starimi ≥ 65 let, in mlajšimi bolniki, ki so prejemali monoterapijo z atezolizumabom, niso opazili razlik v varnosti.
Investigator-assessed PFS (RECIST v1.1) - Primary analysis
PFS po oceni raziskovalca (RECIST v1.1) - primarna analiza Število dogodkov (%)
Hypothyroidism:
Tecentriq:
No overall differences in efficacy were observed between patients ≥ 65 years of age and younger patients receiving atezolizumab monotherapy.
Med bolniki, starimi ≥ 65 let, in mlajšimi bolniki, ki so prejemali atezolizumab, niso opazili razlik v učinkovitosti.
For the description of Tecentriq trials, refer to the Tecentriq 1,200 mg concentrate for solution for infusion Summary of Product Characteristics (SmPC) section 5.1.
Za opis preskušanj zdravila Tecentriq glejte poglavje 5.1 Povzetka glavnih značilnosti zdravila (SmPC) zdravila Tecentriq 1200 mg koncentrat za raztopino za infundiranje.
• a cancer that affects the lungs, called small cell lung cancer (SCLC).
• rakom, ki prizadene pljuča in ga imenujemo drobnocelični rak pljuč.
musculoskeletal painx arthralgia, musculoskeletal painx, back pain
Bolezni mišično-skeletnega sistema in vezivnega tkiva zelo pogosti artralgija, bolečina v hrbtu, mišično-skeletna bolečinax artralgija, mišično-skeletna bolečinax, bolečina v hrbtu občasni miozitisy
• After dilution, one mL of solution contains approximately 3.2 mg of atezolizumab for 840 mg dose and 6.0 mg of atezolizumab for 1680 mg dose.
• Po razredčenju 1 ml raztopine za injiciranje vsebuje približno 3,2 mg atezolizumaba v 840-mg odmerku in približno 6,0 mg atezolizumaba v 1680-mg odmerku.
Baseline ECOG performance status was 0 (35%) or 1 (65%).
Izhodiščno stanje zmogljivosti po ECOG je bilo 0 (35 %) ali 1 (65 %).
Tumour specimens were evaluated prospectively for PD-L1 expression on tumour cells (TC) and tumour-infiltrating immune cells (IC).
Vzorce tumorjev so prospektivno ocenili glede izražanja PD-L1 na tumorskih celicah in celicah imunskega sistema, ki infiltrirajo tumor.
Tecentriq monotherapy
Zdravilo Tecentriq v monoterapiji
CI = confidence interval; DOR=duration of response; IC = tumour-infiltrating immune cells; IRF = independent review facility; NE = not estimable; ORR = objective response rate; OS = overall survival;
IZ = interval zaupanja, DOR = trajanje odgovora, IC = celice imunskega sistema, ki infiltrirajo tumor, IRF = skupina za neodvisni pregled, NO = ni ocenljivo, ORR = delež objektivnega odgovora, OS = celokupno preživetje, PFS = preživetje brez napredovanja bolezni; RECIST = merila RECIST (Response Evaluation
The primary analysis of study IMvigor211 did not meet its primary endpoint of OS. Atezolizumab did not demonstrate a statistically significant survival benefit compared to chemotherapy in patients with previously treated, locally advanced or metastatic urothelial carcinoma.
Za atezolizumab niso dokazali statistično značilne koristi za preživetje v primerjavi s kemoterapijo pri bolnikih s predhodno zdravljenim, lokalno napredovalim ali razsejanim urotelijskim karcinomom.
Figure 10: Kaplan-Meier curve for overall survival in the primary analysis population (all comers) (OAK)
Slika 10: Kaplan-Meierjeva krivulja celokupnega preživetja v populaciji za primarno analizo (neselekcionirani bolniki) (OAK)
95% CI: 0.63, 1.72 for OS, respectively).
% IZ: 0,59; 1,47 za PFS in RO 1,04, 95-% IZ: 0,63; 1,72 za OS).
Figure 11 summarises the results of OS in the ITT and PD-L1 subgroups, demonstrating OS benefit with atezolizumab in all subgroups, including those with PD-L1
Slika 11 povzema rezultate celokupnega preživetja v podskupini ITT in podskupinah PD-L1; rezultati kažejo korist atezolizumaba za celokupno preživetje v vseh podskupinah, tudi tistih z izražanjem PD-L1 < 1 % v tumorskih celicah in imunskih celicah, ki infiltrirajo tumor.