natgillin/translations-raw huggingface dataset:
Approximately half the patients had received a taxane (51%) or anthracycline (54%) in the (neo)adjuvant setting.
Približno polovica bolnikov je (neo)adjuvantno prejemala nek taksan (51 %) ali antraciklin (54 %).
The recommended dose is 1,200 milligrams (mg) every three weeks.
Priporočeni odmerek je 1200 miligramov (mg) na tri tedne.
There were 24.2% of patients who received only prior platinum-containing adjuvant or neoadjuvant therapy and progressed within 12 months.
24,2 % bolnikov je predhodno prejemalo le adjuvantno ali neoadjuvantno zdravljenje na osnovi platine in jim je bolezen napredovala v 12 mesecih.
In addition, nab-paclitaxel is administered on days 8 and 15.
Dodatno se nab-paklitaksel aplicira še 8. in 15. dan.
Hypersensitivity to atezolizumab or to any of the excipients listed in section 6.1.
Preobčutljivost na atezolizumab ali katero koli pomožno snov, navedeno v poglavju 6.1.
An analysis was also performed with a median duration of survival follow-up of 21.1 months for
Za 2. kohorto je bila opravljena tudi analiza z medianim trajanjem spremljanja preživetja 21,1 meseca.
It is unknown whether atezolizumab is excreted in human milk.
Ni znano, ali se atezolizumab pri človeku izloča v materino mleko.
A population pharmacokinetic analysis indicates that central compartment volume of distribution is 3.28 L and volume at steady-state is 6.91 L in the typical patient.
Populacijska farmakokinetična analiza kaže, da sta pri tipičnem bolniku volumen centralnega prostora 3,28 l in volumen v stanju dinamičnega ravnovesja 6,91 l.
• low levels of magnesium, which can cause weakness and muscle cramping, numbness and pain in the arms and legs
• nizka vrednost magnezija, ki lahko povzroči šibkost in mišične krče kot tudi omrtvičenost in bolečine v rokah in nogah
Myocarditis occurred in < 0.1% (2/8,000) of patients across all atezolizumab clinical trials in multiple tumour types and treatment combinations.
Miokarditis se je pojavil pri < 0,1 % (2/8000) bolnikov v vseh kliničnih preskušanjih z atezolizumabom in kombiniranim zdravljenjem pri več vrstah tumorjev.
In addition, no incompatibilities have been observed with in-line filter membranes composed of polyethersulfone or polysulfone, and infusion sets and other infusion aids composed of PVC, PE, polybutadiene, or polyetherurethane.
Poleg tega niso opazili nobenih inkompatibilnosti z vmesnim filtrom membrane, sestavljene iz polietersulfona ali polisulfona, infuzijskimi seti in drugimi infuzijskimi pripomočki, izdelanimi iz PVC, PE, polibutadiena ali polieteruretana.
If the first infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.
Če bolnik prvo infuzijo dobro prenese, je mogoče vse nadaljnje infuzije dati v 30 minutah.
Atezolizumab is administered as an intravenous infusion.
Atezolizumab se daje z intravensko infuzijo.
• Delay giving your next dose of Tecentriq.
• odloži dajanje naslednjega odmerka zdravila Tecentriq,
From the PD-L1+/BRCA1/2 mutant subgroup, 19 patients received atezolizumab plus nabpaclitaxel and 26 placebo plus nab-paclitaxel.
Iz podskupine z mutacijo PD-L1+/BRCA1/2 je 19 bolnikov prejemalo atezolizumab in nab-paklitaksel, 26 pa placebo in nab-paklitaksel.
• have been given medicines to stimulate your immune system
• ste dobili zdravila za spodbudo imunskega sistema,
Includes reports of diabetes mellitus, type 1 diabetes mellitus, diabetic ketoacidosis, ketoacidosis.
Vključuje poročila o sladkorni bolezni, sladkorni bolezni tipa 1, diabetični ketoacidozi, ketoacidozi.
What Tecentriq is and what it is used for
Kaj je zdravilo Tecentriq in za kaj ga uporabljamo
Each vial contains 1,200 mg of atezolizumab (in 20 mL).
Ena viala vsebuje 1200 mg atezolizumaba (v 20 ml).
Chemotherapy (n = 464)
kemoterapija (n = 464)
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
V primeru prevelikega odmerjanja je treba bolnike skrbno nadzorovati glede znakov in simptomov neželenih učinkov in uvesti je treba ustrezno simptomatsko zdravljenje.
Randomisation was stratified by sex, presence of liver metastases and PD-L1 expression on TC and IC.
Randomizacija je bila stratificirana po spolu, prisotnosti zasevkov v jetrih in izražanju PD-L1 na TC in IC.
12-month OS (%)*** 18-month OS (%)***
12-mesečno OS (%)*** 18-mesečno OS (%)***
Incudes reports of hypophysitis and temperature regulation disorder.
Vključuje poročila o hipofizitisu in motnji regulacije temperature.
There are insufficient data for the subgroup of patients that would be unfit for any chemotherapy; therefore atezolizumab should be used with caution in these patients, after careful consideration of the potential balance of risks and benefits on an individual basis.
Za podskupino bolnikov, neprimernih za katero koli kemoterapijo, ni dovolj podatkov, zato je treba atezolizumab pri njih uporabljati previdno, po temeljitem pretehtanju razmerja med možnimi tveganji in koristmi za vsakega posameznega bolnika.
Kaplan-Meier curves for OS and PFS are presented in Figures 12 and 13.
Kaplan-Meierjevi krivulji OS in PFS sta prikazani na slikah 12 in 13.
• high blood sugar
• visok krvni sladkor • prehlad
PD-L1 expression of ≥ 5% in IC
PD-L1 ≥ 5 % v IC
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying unique identifier included.
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako
Etoposide is also administered by intravenous infusion on days 2 and 3.
Etopozid v intravenski infuziji se aplicira tudi 2. in 3. dan.
The educational programme is aimed at increasing awareness and providing information concerning the signs and symptoms of certain important identified risks of atezolizumab, including immunerelated pneumonitis, hepatitis, colitis, hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, neuropathies, meningoencephalitis, pancreatitis, and infusion related reactions, and how to manage them.
Izobraževalni program je namenjen povečanju ozaveščenosti in zagotavljanju informacij o znakih in simptomih nekaterih pomembnih ugotovljenih tveganj atezolizumaba, vključno z imunsko pogojenim pnevmonitisom, hepatitisom, kolitisom, hipotiroidizmom, hipertiroidizmom, insuficienco nadledvičnih žlez, hipofizitisom, sladkorno boleznijo tipa I, nevropatijami, meningoencefalitisom, pankreatitisom in z infundiranjem povezanimi reakcijami ter njihovem obvladovanju.
The schedule of administration must be adjusted to maintain a 3-week interval between doses.
Urnik dajanja zdravila je treba nato prilagoditi 3-tedenskemu presledku med odmerki.
Includes reports of musculoskeletal pain and myalgia.
x Vključuje poročila o mišično-skeletni bolečini in mialgiji.
Tecentriq is for intravenous use.
Zdravilo Tecentriq je namenjeno za intravensko uporabo.
A population pharmacokinetic analysis suggests that steady-state is obtained after 6 to 9 weeks (2 to 3 cycles) of repeated dosing.
Populacijska farmakokinetična analiza kaže, da je stanje dinamičnega ravnovesja doseženo po 6 do 9 tednih (2 do 3 ciklih) ponavljajoče se uporabe.
Reminder to distribute the patient alert card to all patients receiving treatment with Tecentriq and to advise them to show it to any healthcare professional who may treat them.
Opomnik za razdeljevanje opozorilne kartice za bolnika vsem bolnikom, ki prejemajo zdravljenje z zdravilom Tecentriq, in nasvet, da jo pokažejo vsem zdravstvenim delavcem,
Most immune-related adverse reactions occurring during treatment with atezolizumab were reversible with interruptions of atezolizumab and initiation of corticosteroids and/or supportive care.
Večina imunsko pogojenih neželenih učinkov, ki so se pojavili med zdravljenjem z atezolizumabom, je bila po prekinitvi atezolizumaba in uvedbi kortikosteroidov in/ali podpornega zdravljenja reverzibilna.
Since atezolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected.
Ker se atezolizumab odstrani iz obtoka s katabolizmom, ni pričakovati presnovnih medsebojnih delovanj med zdravili.
Atezolizumab is an Fc-engineered, humanised immunoglobulin G1 (IgG1) monoclonal antibody that directly binds to PD-L1 and provides a dual blockade of the PD-1 and B7.1 receptors, releasing PD-L1/PD-1 mediated inhibition of the immune response, including reactivating the antitumour immune response without inducing antibody-dependent cellular cytotoxicity.
Atezolizumab je humanizirano G1-imunoglobulinsko (IgG1) monoklonsko protitelo z inženirsko obdelano domeno Fc, ki se neposredno veže na PD-L1 in povzroči dvojno blokado receptorjev PD-1 in B7-1, odpravi s PD-L1/PD-1 posredovano zavrtje imunskega odziva in reaktivira protitumorski imunski odziv brez indukcije celične citotoksičnosti, odvisne od protiteles.
‡ Stratified by presence of liver metastases, and by prior taxane treatment.
‡ stratificirani glede na prisotnost zasevkov v jetrih in predhodno zdravljenje s taksanom.
• low oxygen levels, which may cause shortness of breath as a consequence of inflamed lungs
• nizka raven kisika, ki lahko povzroči težko dihanje, kar je posledica vnetja pljuč (hipoksija)
The key results of this study with a median survival follow-up of 21 months are summarised in Table 5.
Ključni rezultati te študije z medianim spremljanjem preživetja 21 mesecev so povzeti v preglednici 5.
The prescriber must discuss the risks of Tecentriq therapy with the patient.
Zdravnik, ki predpiše zdravilo, se mora z bolnikom pogovoriti o tveganjih zdravljenja z zdravilom Tecentriq.
p-value1
p-vrednost1
6.6 Special precautions for disposal and other handling Tecentriq does not contain any antimicrobial preservative or bacteriostatic agents and should be prepared by a healthcare professional using aseptic technique to ensure the sterility of prepared solutions.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo Tecentriq ne vsebuje protimikrobnega konzervansa ali bakteriostatikov; da se zagotovi sterilnosti pripravljenih raztopin, ga mora pripraviti zdravstveni delavec z upoštevajem aseptičega postopka.
In studies IMpower150 and IMpower133, data for patients ≥75 years of age are too limited to draw conclusions on this population.
Podatkov iz študij IMpower150 in IMpower133 je za bolnike, stare ≥ 75 let, premalo, da bi lahko sklepali o tej populaciji.
If you stop receiving Tecentriq
Če ste prenehali dobivati zdravilo Tecentriq
i.e. excluding patients with EGFR mutations or ALK rearrangements.
brez bolnikov z dokazanimi mutacijami EGFR ali preureditvami ALK.
The European Medicines Agency has deferred the obligation to submit the results of studies with atezolizumab in all subsets of the paediatric population in the treatment of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms) (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z atezolizumabom za vse skupine pediatrične populacije za zdravljenje malignih novotvorb (razen tumorjev osrednjega živčevja ter novotvorb hematopoetskega in limfnega tkiva) (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The infusions must not be administered as an intravenous push or bolus.
Infuzij se ne sme dajati kot hiter intravenski odmerek ali bolus.
Details for the significant adverse reactions for atezolizumab when given in combination are presented if clinically relevant differences were noted in comparison to atezolizumab monotherapy.
Podrobnosti o pomembnih neželenih učinkih atezolizumaba v kombinaciji so prikazani, če so bile ugotovljene klinično pomembne razlike v primerjavi z atezolizumabom v monoterapiji.
An updated analysis was performed with a median duration of survival follow-up of 17.2 months for Cohort 1 and is summarised in Table 4.
Za 1. kohorto je bila opravljena posodobljena analiza z medianim trajanjem spremljanja preživetja 17,2 meseca; povzeta je v preglednici 4.
Grade 3 or 4: (ALT or AST > 5 x ULN
3. ali 4. stopnja: (ALT ali AST > 5-kratna ZNM
Instructions for dilution
Navodila za razredčenje
The bag should be gently inverted to mix the solution in order to avoid foaming.
Vrečko z raztopino je treba previdno obračati, da bi preprečili penjenje raztopine.
The median number of treatment cycles was 7 for atezolizumab and 6 for nab-paclitaxel in each treatment arm.
Mediano število ciklov zdravljenja je bilo v vsaki zdravljeni skupini 7 za atezolizumab in 6 za za nab-paklitaksel.
PD-L1 expression of ≥ 1% in IC
PD-L1 ≥ 1 % v IC
Across multiple phase III studies, 13.1% to 36.4% of patients developed treatment-emergent anti-drug antibodies (ADAs).
V več študijah faze III so se pri 13,1 % do 36,4 % bolnikov pojavila z zdravljenjem povzročena protitelesa proti zdravilu (anti-drug antibodies - ADA).
j Includes reports of adrenal insufficiency and primary adrenal insufficiency.
j Vključuje poročila o insuficienci nadledvičnih žlez in primarni insuficienci nadledvičnih žlez.
No fertility studies have been conducted with atezolizumab; however assessment of the cynomolgus monkey male and female reproductive organs was included in the chronic toxicity study.
Z atezolizumabom študij o sposobnosti razmnoževanja niso izvedli, toda študija kronične toksičnosti je vključevala oceno vpliva na reproduktivne organe samcev in samic opic cynomolgus.
This means the lung cancer has: - spread to other parts of the body - come back after previous treatment.
To pomeni, da: - se je razširil v druge dele telesa, - se je ponovil po predhodnem zdravljenju.
Clinically relevant IRF-assessed ORRs per RECIST v1.1 were shown; however, when compared to a pre-specified historical control response rate of 10%, statistical significance was not reached for the primary endpoint.
Prikazani so bili klinično relevantni deleži objektivnih odgovorov po oceni IRF v skladu z merili RECIST v1.1, toda v primerjavi z vnaprej opredeljenim 10-odstotnim kontrolnim historičnim deležem odgovora primarni opazovani dogodek ni bil statistično značilen.
• feeling very tired with no energy (fatigue)
• občutek hude utrujenosti in pomanjkanja energije (izčrpanost)
• changes to sense of taste (dysgeusia)
• spremembe zaznavanja okusa (disgevzija)
Hepatic impairment was defined by the National Cancer Institute (NCI) criteria of hepatic dysfunction (see section 4.2).
Okvara jeter je bila opredeljena po merilih NCI (National Cancer Institute) za moteno delovanje jeter (glejte poglavje 4.2).
Patient alert card
Opozorilna kartica za bolnika
It is not known if Tecentriq gets into breast milk.
Dojenje Ni znano, če zdravilo Tecentriq prehaja v materino mleko.
Randomisation was stratified by sex, ECOG performance status, and presence of brain metastases.
Randomizacija je bila stratificirana po spolu, stanju zmogljivosti po ECOG in prisotnosti zasevkov v možganih.
Human immunoglobulins G1 (IgG1) are known to cross the placental barrier and atezolizumab is an IgG1; therefore, atezolizumab has the potential to be transmitted from the mother to the developing foetus.
Znano je, da humani imunoglobulini G1 (IgG1) prehajajo skozi placentno pregrado, atezolizumab pa je IgG1 in tako obstaja možnost njegovega prenosa od matere v razvijajoči se plod.
Of the 87 patients, one experienced a fatal event.
Pri enem od teh 87 bolnikov se je končal s smrtjo.
The release of Tecentriq in the environment should be minimised.
Odlaganje zdravila Tecentriq v okolje je treba omejiti na najmanjšo mero.
• inflammation of muscles (myositis)
• vnetje mišic (miozitis)
The patient will be provided with the patient alert card and instructed to carry the card at all times.
Bolniku je treba dati Opozorilno kartico za bolnika in mu naročiti, naj jo ima vedno pri sebi.
Urothelial carcinoma
Urotelijski karcinom
• 1,680 milligrams (mg) every four weeks.
• 1680 miligramov (mg) na štiri tedne.
• blocked nose (nasal congestion)
• zamašen nos (nazalna kongestija)
m Includes reports of Guillain-Barré syndrome and demyelinating polyneuropathy.
m Vključuje poročila o Guillain-Barréjevem sindromu in demielinizacijski polinevropatiji.
Grade 4 Diarrhoea or Colitis (life threatening; urgent intervention indicated)
Driska ali kolitis 4. stopnje (življenje ogrožujoče stanje; potrebno je nujno ukrepanje)
No clinically important difference was observed in the pharmacokinetics of atezolizumab among patients < 65 years (n=274), patients between 65−75 years (n=152) and patients > 75 years (n=46) (see section 4.2).
Farmakokinetika atezolizumaba se ni klinično pomembno razlikovala med bolniki, starimi < 65 let (n = 274), bolniki, starimi od 65 do 75 let (n = 152), in bolniki, starimi > 75 let (n = 46) (glejte poglavje 4.2).
Patients with the following conditions were excluded from clinical trials: a history of autoimmune disease, history of pneumonitis, active brain metastasis, HIV, hepatitis B or hepatitis C infection, significant cardiovascular disease and patients with inadequate hematologic and end-organ function.
V klinična preskušanja niso bili vključeni bolniki z naslednjimi stanji: z anamnezo avtoimunske bolezni, anamnezo pnevmonitisa, simptomatskimi možganskimi zasevki, okužbo z virusom HIV, s hepatitisom B ali hepatitisom C, pomembnimi srčno-žilnimi boleznimi ter bolniki z nezadostnim hematološkim delovanjem in delovanjem končnih organov.
Based on an independent Data Monitoring Committee (iDMC) recommendation following an early review of survival data, accrual of patients on the atezolizumab monotherapy treatment arm whose tumours have a low PD-L1 expression (less than 5% of immune cells staining positive for PD-L1 by immunohistochemistry) was stopped after observing decreased overall survival for this subgroup.
V skladu s priporočili neodvisnega Odbora za spremljanje podatkov (independent Data Monitoring Committee - iDMC) po zgodnjem pregledu podatkov o preživetju je bilo vključevanje bolnikov, katerih tumorji imajo nizko raven izražanja PD-L1 (manj kot 5 % PD-L1-pozitivno obarvanih imunskih celic z imunohistokemično metodo), v skupino, ki prejema monoterapijo z atezolizumabom, ustavljeno po ugotovitvi, da je celokupno preživetje pri tej podskupini krajše.
In the absence of data, atezolizumab should be used with caution in these populations after careful evaluation of the balance of benefits and risks for the patient.
Pri teh skupinah je treba zaradi pomanjkanja podatkov atezolizumab uporabljati previdno in po skrbni oceni razmerja med koristmi in tveganji zdravila za bolnika.
Treatment beyond disease progression may be considered at the discretion of the physician (see section 5.1).
Odločitev o zdravljenju po napredovanju bolezni je v pristojnosti zdravnika (glejte poglavje 5.1).
Elderly Based on a population pharmacokinetic analysis, no dose adjustment of Tecentriq is required in patients ≥ 65 years of age (see sections 4.8 and 5.1).
Glede na populacijsko farmakokinetično analizo bolnikom v starosti ≥ 65 let odmerka zdravila Tecentriq ni treba prilagoditi (glejte poglavji 4.8 in 5.1).
12-month OS (%)**
12-mesečno OS (%)**
However, systemic corticosteroids or other immunosuppressants can be used to treat immune-related adverse reactions after starting atezolizumab (see section 4.4).
Vendar pa se sistemske kortikosteroide ali druge imunosupresive lahko uporabi po začetku zdravljenja z atezolizumabom za zdravljenje imunsko pogojenih neželenih učinkov (glejte poglavje 4.4).
or blood bilirubin > 1.5 to 3 x ULN)
ali bilirubin v krvi > 1,5- do 3-kratna ZNM)
The systemic accumulation in area under the curve, maximum concentration and trough concentration was 1.91, 1.46 and 2.75-fold, respectively.
Sistemsko kopičenje v površini pod krivuljo je bilo 1,91-kratno, maksimalna koncentracija je bila 1,46-kratna, najnižja koncentracija pred naslednjim odmerkom pa 2,75-kratna.
At the time of the primary analysis, patients had a median survival follow up time of 13.9 months.
V času primarne analize je bil mediani čas spremljanja preživetja bolnikov 13,9 meseca.
Binding of PD-L1 to the PD-1 and B7.1 receptors found on T-cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine production.
Vezava PD-L1 na receptorje PD-1 in B7-1 na celicah T in celicah, ki predstavijo antigene, zavre citotoksično dejavnost celic T, proliferacijo celic T in nastajanje citokinov.
Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to immune-related rejection of the developing foetus resulting in foetal death.
Študije na živalih so pokazale, da lahko zavrtje poti PD-L1/PD-1 povzroči imunsko zavrnitev razvijajočega se ploda in povzroči smrt ploda.
Includes reports of diarrhoea, defaecation urgency, frequent bowel movements, gastrointestinal hypermotility.
Vključuje poročila o diareji, nujnem iztrebljanju, pogostem odvajanju blata, gastrointestinalni hipermotiliteti.
Chemical and physical in-use stability has been demonstrated for up to 24 hours at ≤ 30 °C and for up to 30 days at 2°C to 8°C from the time of preparation.
Kemijska in fizikalna stabilnost med uporabo sta dokazani za največ 24 ur pri temperaturi ≤ 30 °C in do 30 dni pri temperaturi od 2 do 8 °C od časa priprave.
Table 4: Summary of updated efficacy (IMvigor210 Cohort 1)
Povzetek posodobljenih rezultatov učinkovitosti študije (IMvigor210, 1. kohorta)
Other clinically significant adverse events which were observed more frequently in the atezolizumab, bevacizumab, paclitaxel, and carboplatin arm were epistaxis, haemoptysis, cerebrovascular accident, including fatal events.
Drugi klinično pomembni neželeni učinki, ki so jih opazili pogosteje v skupini z atezolizumabom, bevacizumabom, paklitakselom in karboplatinom, so bili epistaksa, hemoptiza, cerebrovaskularni dogodek, vključno s smrtnim izidom.
• type 1 diabetes
• sladkorna bolezen tipa 1
8.1 months).
5,3 meseca).
OS comparisons between treatment arms in patients with PD-L1 expression ≥1% were not formally tested, as per the pre-specified analysis hierarchy.
2. primerjave celokupnega preživetja med skupinama pri bolnikih z izražanjem PD-L1 ≥ 1 % še niso formalno preskusili v skladu s predhodno določeno hierarhijo analiz;
Permanently discontinue Tecentriq (except endocrinopathies controlled with replacement hormones)
Trajno prenehajte uporabljati zdravilo Tecentriq (razen pri endokrinopatijah,
A total of 287 patients were randomised 1:1 to receive either atezolizumab (1,200 mg by intravenous infusion every 3 weeks until loss of clinical benefit) or docetaxel (75 mg/m2 by intravenous infusion on day 1 of each 3-week cycle until disease progression).
Skupno 287 bolnikov je bilo v razmerju 1:1 randomiziranih ali na atezolizumab (1200 mg v intravenski infuziji na 3 tedne do izgube klinične koristi) ali na docetaksel (75 mg/m v intravenski infuziji 1. dan vsakega 3-tedenskega cikla do napredovanja bolezni).
• who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).
• niso primerni za zdravljenje s cisplatinom in katerih tumorji izražajo PD-L1 v ≥ 5 % (glejte poglavje 5.1).
and PFS by PD-L1 expression are summarised in Figures 7 and 9, respectively.
Eksploratorni rezultati OS in PFS glede na izražanje PD-L1 so povzeti na slikah 7 in 9.
Cohort 1 included 45 patients (38%) with ECOG performance status of 0, 50 patients (42%) with ECOG performance status of 1 and 24 patients (20%) with ECOG performance status of 2, 35 patients (29%) with no Bajorin risk factors (ECOG performance status ≥ 2 and visceral metastasis), 66 patients (56%) with one Bajorin risk factor and 18 patients (15 %) with two Bajorin risk factors, 84 patients (71%) with impaired renal function (glomerular filtration rate [GFR] < 60 mL/min), and 25 patients (21%) with liver metastasis.
V 1. kohorto je bilo vključenih 45 bolnikov (38 %) s stanjem zmogljivosti po ECOG 0, 50 bolnikov (42 %) s stanjem zmogljivosti po ECOG 1, 24 bolnikov (20 %) s stanjem zmogljivosti po ECOG 2, 35 bolnikov (29 %) brez Bajorinovih dejavnikov tveganja (stanje zmogljivosti po ECOG ≥ 2 in visceralne zasevke), 66 bolnikov (56 %) z enim Bajorinovim dejavnikom tveganja in 18 bolnikov (15 %) z dvema Bajorinovima dejavnikoma tveganja, 84 bolnikov (71 %) z okvarjenim delovanjem ledvic (hitrost glomerulne filtracije [GFR] < 60 ml/min) in 25 bolnikov (21 %) z zasevki v jetrih.