natgillin/translations-raw huggingface dataset:
Hypothyroidism may develop during treatment.
Med zdravljenjem se lahko pojavi hipotiroidizem.
The risk of cardiac adverse drug reactions appeared to be higher in paediatric patients with previous exposure to cardiac irradiation or anthracycline compared to those paediatric patients without previous exposure.
Tveganje za pojav s srcem povezanih neželenih učinkov zdravila je bilo večje pri pediatričnih bolnikih s predhodno izpostavljenostjo obsevanju srca ali antraciklinu v primerjavi s pediatričnimi bolniki brez predhodne izpostavljenosti.
Systemic exposures after a single dose of sunitinib were similar in subjects with severe renal impairment (CLcr < 30 ml/min) compared to subjects with normal renal function (CLcr > 80 ml/min).
Sistemske izpostavljenosti po enkratnem odmerku sunitiniba so podobne pri bolnikih s hudo ledvično okvaro (CLcr < 30 ml/min) v primerjavi z osebami z normalnim delovanjem ledvic (CLcr > 80 ml/min).
A total of 59 out of 85 patients (69.4%) from the placebo arm crossed over to open-label sunitinib following disease progression or unblinding at study closure.
Skupno 59 od 85 bolnikov (69,4 %) iz skupine, ki je prejemala placebo, se je ob napredovanju bolezni ali razkritju šifre ob koncu študije vključilo v odprto študijo s sunitinibom.
Secondary endpoints included TTP, duration of response (DR) and OS.
Med sekundarnimi opazovanimi dogodki so bili TTP, trajanje odziva (DR - duration of response) in celokupno preživetje (OS).
Other possible dermatological effects may include dryness, thickness or cracking of the skin, blisters, or rash on the palms of the hands and soles of the feet.
Drugi možni dermatološki učinki lahko vključujejo suho, zadebeljeno ali razpokano kožo, mehurje ali izpuščaj na dlaneh in podplatih.
Increases in lipase activities were transient and were generally not accompanied by signs or symptoms of pancreatitis in subjects with various solid tumours (see section
Zvečanje aktivnosti lipaze je bilo prehodno in ga pri preskušancih z različnimi čvrstimi tumorji praviloma niso spremljali znaki ali simptomi pankreatitisa (glejte poglavje
Sunitinib treatment was associated with longer survival compared to IFN-α.
Zdravljenje s sunitinibom je bilo v primerjavi z IFN- povezano z daljšim preživetjem.
How to take Sutent
Kako jemati zdravilo Sutent
In this study the ORR was 35.8% (95% CI: 26.8% , 47.5 %).
ORR v tej študiji je znašal 35,8 % (95 % IZ: 26,8 %; 47,5 %).
• Abnormal changes in the brain that can cause a collection of symptoms including headache, confusion, seizures, and vision loss (reversible posterior leukoencephalopathy syndrome).
• nenormalne spremembe v možganih, ki lahko povzročijo več simptomov, vključno z glavobolom, zmedenostjo, epileptičnimi krči in izgubo vida (sindrom reverzibilne posteriorne levkoencefalopatije)
Additionally, 49% of sunitinib patients had nonfunctioning tumours versus 52% of placebo patients and 92% of patients in both arms had liver metastases.
Poleg tega je 49 % bolnikov, ki so prejemali sunitinib, imelo nedelujoče tumorje v primerjavi z 52 % bolnikov, ki so prejemali placebo, 92 % bolnikov v obeh skupinah pa je imelo jetrne metastaze.
While you are on this medicine "pyoderma gangrenosum" (painful skin ulceration) or “necrotising fasciitis” (rapidly spreading infection of the skin/soft tissue that may be life-threatening) may occur.
Med uporabo tega zdravila se vam lahko pojavi ''gangrenozna pioderma'' (boleče razjede na koži) ali ''nekrotizirajoči fasciitis'' (okužba kože/mehkih tkiv, ki se hitro širi in je lahko življenjsko ogrožajoča).
QTc interval prolongation was investigated in a trial in 24 patients, ages 20-87 years, with advanced malignancies.
Podaljšanje intervala QTc so preučevali v študiji pri 24 bolnikih z napredovalim rakom, starih od 20 do 87 let.
Sutent can cause heart problems.
Zdravilo Sutent lahko povzroči težave s srcem.
A population pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) analysis was conducted with the scope to extrapolate the PK and key safety and efficacy endpoints of sunitinib in paediatric patients with GIST (aged: 6 years to 17 years).
Izvedena je bila analiza populacijske farmakokinetike (FK) in farmakokinetike/farmakodinamike (FK/FD) z namenom ekstrapolacije FK in ključnih opazovanih dogodkov glede varnosti in učinkovitosti sunitiniba pri pediatričnih bolnikih z GIST (starih od 6 let do 17 let).
Severe cutaneous reactions have been reported, including cases of erythema multiforme (EM), cases suggestive of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some of which were fatal.
Poročali so o hudih kožnih reakcijah, vključno s primeri multiformnega eritema (EM), primeri, ki so nakazovali Stevens-Johnsonov sindrom (SJS) in toksično epidermalno nekrolizo (TEN), od katerih jih je bilo nekaj smrtnih.
ORR (%)
ORR (%) Vmesni ni ustrezno
It is available in plastic bottles of 30 capsules and in perforated unit dose blisters containing 28 x 1 capsules.
Zdravilo je na voljo v plastenkah s 30 kapsulami ter v perforiranih enoodmernih pretisnih omotih z 28 kapsulami.
The primary efficacy endpoint was ORR, based on Response Evaluation Criteria in Solid Tumours (RECIST).
Primarni opazovani dogodek učinkovitosti je bil objektivni odziv na zdravljenje (ORR), ocenjen po merilih RECIST (Response Evaluation Criteria in Solid Tumours).
Serious infections, with or without neutropenia, including some with a fatal outcome, have been reported.
Poročali so o resnih okužbah z ali brez nevtropenije, vključno z nekaterimi s smrtnim izidom.
Subject did not progress or die [n (%)] Subject observed to have progressed or died [n (%)]
Pri preskušancu bolezen ni napredovala ali ni umrl [n (%)] Pri preskušancu je bolezen napredovala ali je umrl [n (%)] PFS (tedni)
Patients receiving concomitant treatment with anticoagulants (e.g., warfarin, acenocoumarole) may be periodically monitored by complete blood counts (platelets), coagulation factors (PT/INR), and physical examination.
Pri bolnikih, ki se sočasno zdravijo z antikoagulanti (npr. varfarin, acenokumarol), se lahko redno spremlja celotna krvna slika (trombociti), koagulacijski faktorji (PČ/INR) in opravi telesni pregled.
• Abnormal blood tests including pancreatic and liver enzymes.
• nenormalni izvidi krvnih preiskav, vključno z encimi trebušne slinavke in jeter
Population PK analyses indicated that sunitinib apparent clearance (CL/F) was not affected by creatinine clearance (CLcr) within the range evaluated (42-347 ml/min).
Analize populacijske FK so pokazale, da se navidezni očistek sunitiniba v območju ocenjevanega delovanja ledvic (očistek kreatinina (CLcr) od 42 do 347 ml/min) ne spremeni.
Sunitinib was not permanently discontinued in any of these patients.
Pri nobenem od teh bolnikov zdravljenja s sunitinibom niso trajno prekinili.
Bleeding.
Krvavitve.
• Abnormally coloured urine.
• nenormalno obarvan urin
Changes in the uterus (endometrial atrophy) and bone growth plate (physeal thickening or dysplasia of cartilage) are thought to be related to the pharmacological action of sunitinib.
Spremembe na maternici (atrofija endometrija) in kostni rastni ploščici (zadebelitev fize ali displazija hrustanca) so domnevno povezane s farmakološkim delovanjem sunitiniba.
Reduced offspring body weights were observed during the preweaning and postweaning periods at 3 mg/kg/day.
Zmanjšano telesno maso mladičev so opazili v času pred in po odstavitvi pri odmerku 3 mg/kg/dan.
After the interim analysis of efficacy and safety, at the recommendation of the independent Data and Safety Monitoring Board (DSMB), the study was unblinded and patients on the placebo arm were offered open-label sunitinib treatment.
Po vmesni analizi učinkovitosti in varnosti, je bila na priporočilo neodvisnega odbora za spremljanje podatkov o varnosti (DSMB - data safety monitoring board) študija razkrita in bolnikom v skupini s placebom so ponudili odprto zdravljenje s sunitinibom.
One hundred and 6 patients received at least one 50 mg dose of sunitinib on Schedule 4/2.
Sto šest (106) bolnikov je dobilo vsaj en 50 mg odmerek sunitiniba po shemi 4/2.
• Influenza-like syndrome.
• gripi podobni znaki bolezni
A total of 255 patients received sunitinib in the open-label treatment phase of the study, including 99 patients who were initially treated with placebo.
V fazi odprtega zdravljenja je skupaj 255 bolnikov prejelo sunitinib, vključno z 99 bolniki, ki so bili prvotno zdravljeni s placebom.
Summary of progression-free survival
Povzetek pri preživetju brez napredovanja bolezni
Thyroid function was monitored prospectively in 2 studies in patients with breast cancer; Sutent is not approved for use in breast cancer.
Delovanje ščitnice so opazovali prospektivno v 2 študijah pri bolnicah z rakom dojk; zdravilo Sutent ni odobreno za uporabo pri raku dojk.
Metastatic renal cell carcinoma (MRCC) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.
Metastatski karcinom ledvičnih celic (MRCC - metastatic renal cell carcinoma) Zdravilo Sutent je indicirano za zdravljenje napredovalega/metastatskega karcinoma ledvičnih celic (MRCC) pri odraslih.
Sunitinib is metabolised primarily by CYP3A4, the CYP isoform which produces its primary active metabolite, desethyl sunitinib, which is then further metabolised by the same isoenzyme.
Sunitinib se presnavlja predvsem preko CYP3A4, izooblike CYP, ki tvori njegov primarni aktivni presnovek, desetil sunitinib; ta se potem presnavlja naprej preko istega izoencima.
Cases of serious infection (with or without neutropenia), including cases with fatal outcome, have been reported.
Poročali so o primerih resnih okužb (z nevtropenijo ali brez nje), vključno s primeri s smrtnim izidom.
Following oral administration in healthy volunteers, the elimination half-lives of sunitinib and its primary active desethyl metabolite are approximately 40-60 hours and 80-110 hours, respectively.
Razpolovni čas izločanja sunitiniba po peroralni uporabi pri zdravih prostovoljcih je približno 40-60 ur, njegovega primarnega aktivnega desetil-presnovka pa približno 80-110 ur.
Nine of these patients had pulmonary embolisms; 1 was Grade 2 and 8 were Grade 4.
Devet od teh bolnikov je imelo pljučno embolijo: pri 1 bolniku je bila 2. stopnje in pri 8 bolnikih 4. stopnje.
Sunitinib was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), VEGF receptors (VEGFR1, VEGFR2, and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET).
Ugotovili so, da sunitinib zavira receptorja rastnega faktorja iz trombocitov (PDGFRα in PDGFRβ), receptorje VEGF (VEGFR1, VEGFR2 in VEGFR3), receptor faktorja matičnih celic (KIT), Fms-ju podobno tirozin-kinazo-3 (FLT3), receptor kolonijo stimulirajočega faktorja (CSF-1R) in receptor nevrotrofičnega faktorja iz celic glije (RET).
The active substance is sunitinib.
Učinkovina je sunitinib.
If signs or symptoms of SJS, TEN, or EM (e.g., progressive skin rash often with blisters or mucosal lesions) are present, sunitinib treatment should be discontinued.
Če so prisotni znaki SJS, TEN ali EM (npr. napredujoč kožni izpuščaj, pogosto z mehurji ali lezijami na sluznicah), je treba zdravljenje s sunitinibom prekiniti.
Patients should be advised that they may experience dizziness during treatment with sunitinib.
Bolnikom je treba svetovati, da jih med zdravljenjem s sunitinibom lahko obide omotica.
Sutent contains the active substance sunitinib, which is a protein kinase inhibitor.
Zdravilo Sutent vsebuje učinkovino sunitinib, ki je zaviralec protein kinaze.
One hundred six patients (61 patients in the treatment-naïve cohort and 45 patients in the later-line cohort) received treatment with sunitinib orally at 37.5 mg once a day on a continuous daily dosing (CDD) schedule.
Sto šest bolnikov (61 bolnikov v predhodno nezdravljeni kohorti in 45 bolnikov v kohorti z zdravljenjem kasnejše izbire) je prejemalo peroralno zdravljenje s sunitinibom v odmerku 37,5 mg enkrat na dan po shemi neprekinjenega dnevnega odmerjanja (CDD - Continuous Daily Dosing).
The clinical safety and efficacy of sunitinib has been studied in the treatment of patients with GIST who were resistant to imatinib (i.e., those who experienced disease progression during or following treatment with imatinib) or intolerant to imatinib (i.e., those who experienced significant toxicity during treatment with imatinib that precluded further treatment), the treatment of patients with MRCC, and the treatment of patients with unresectable pNET.
Klinično varnost in učinkovitost sunitiniba so raziskali pri zdravljenju bolnikov z GIST, ki so bili odporni proti imatinibu (tj. jim je bolezen med zdravljenjem z imatinibom ali po njem napredovala) ali imatiniba niso prenašali (tj. so med zdravljenjem z njim imeli pomembne toksične učinke, ki so preprečili nadaljnjo zdravljenje), zdravljenju bolnikov z MRCC in zdravljenju bolnikov s pNET.
In patients who received sunitinib in Phase 3 registrational studies, pulmonary events (i.e. dyspnoea, pleural effusion, pulmonary embolism, or pulmonary oedema) were reported in approximately 17.8% of patients with GIST, in approximately 26.7% of patients with MRCC and in 12% of patients with pNET.
Pri bolnikih, ki so prejemali sunitinib v registracijskih študijah 3. faze, so o pljučnih dogodkih (tj. dispneji, plevralnem izlivu, pljučni emboliji ali pljučnem edemu) poročali pri približno 17,8 % bolnikov z GIST, pri približno 26,7 % bolnikov z MRCC in pri 12 % bolnikov s pNET.
In some cases of suspected EM, patients tolerated the reintroduction of sunitinib therapy at a lower dose after resolution of the reaction; some of these patients also received concomitant treatment with corticosteroids or antihistamines (see section 4.8).
V nekaterih primerih suma na EM so bolniki po izginotju reakcije prenašali ponovno uvedbo zdravljenja s sunitinibom v manjših odmerkih; nekateri od teh bolnikov so sočasno prejemali tudi kortikosteroide in antihistaminike (glejte poglavje 4.8).
Quartile (95% CI)
Kvartil (95 % IZ)
In addition, the publications reported the following Grade 3 adverse drug reactions experienced by 5 patients: fatigue (2), gastrointestinal adverse drug reactions (including diarrhoea) (2), haematologic adverse drug reactions (including anaemia) (2), cholecystitis (1), hyperthyroidism (1), and mucositis (1).
Poleg tega so v objavah poročali o naslednjih neželenih učinkih zdravila 3. stopnje, ki so se pojavili pri 5 bolnikih: utrujenost (2), gastrointestinalni neželeni učinki zdravila (vključno z diarejo) (2), hematološki neželeni učinki zdravila (vključno z anemijo) (2), holecistitis (1), hipertiroidizem (1) in mukozitis (1).
- Pancreatic neuroendocrine tumours (pNET) (tumours of the hormone-producing cells in the pancreas) that have progressed or cannot be removed with surgery.
- Nevroendokrini tumorji trebušne slinavke (pNET) (tumorji celic trebušne slinavke, ki izločajo hormone), ki so napredovali ali jih ni mogoče odstraniti z operacijo.
• High level of uric acid in the blood.
• visoka raven sečne kisline v krvi
In a pancreatic islet cell tumour cohort of 66 patients, the primary endpoint of response rate was 17%.
V kohorti 66 bolnikov s tumorjem otočkov trebušne slinavke je primarni opazovani dogodek odziva na zdravljenje znašal 17 %.
• Damage to the smallest blood vessels known as thrombotic microangiopathy (TMA).
• poškodbe najmanjših krvnih žil, znane kot trombotična mikroangiopatija (TMA)
Among age and bodysize related covariates tested, age was a significant covariate on apparent clearance of sunitinib (the younger the age of the paediatric patient, the lower the apparent clearance).
Med testiranimi sospremenljivkami, povezanimi s starostjo in velikostjo telesa, je bila starost pomembna sospremenljivka navideznega očistka sunitiniba (nižja kot je bila starost pediatričnega bolnika, manjši je bil navidezni očistek).
For pNET, the recommended dose of Sutent is 37.5 mg taken orally once daily without a scheduled rest period.
Pri pNET priporočeni odmerek zdravila Sutent znaša 37,5 mg peroralno enkrat na dan, brez načrtovanega premora.
In clinical trials, tumour haemorrhage was reported in approximately 2% of patients with GIST.
V kliničnih preskušanjih so o krvavitvah tumorjev poročali pri približno 2 % bolnikov z GIST.
Safety and tolerability
Varnost in prenašanje
Four of these 7 GIST patients discontinued treatment following first observation of DVT.
Pri 4 od teh 7 bolnikov z GIST so zdravljenje prekinili po prvih znakih globoke venske tromboze.
• Painful skin ulceration (pyoderma gangrenosum).
• boleče razjede na koži (gangrenozna pioderma)
- If you have or have had blood disease, bleeding problems, or bruising.
- Če imate ali ste imeli krvno bolezen, težave s krvavitvami ali modrice.
Kaplan-Meier plot of PFS in the pNET Phase 3 study
Slika 1 - Kaplan-Meierjev graf preživetja brez napredovanja bolezni (PFS) v študiji 3. faze pri pNET
In the second part of the study, including patients with prior anticancer therapy but without risk factors for cardiac toxicity, sunitinib was generally tolerable and clinically manageable at the dose of 15 mg/m daily (MTD) on Schedule 4/2.
V drugem delu študije, ki je vključevala bolnike, ki so predhodno prejemali zdravila za zdravljenje raka in niso imeli dejavnikov tveganja za kardiotoksičnost, so bolniki sunitinib na splošno dobro prenašali in je bil klinično obvladljiv v odmerku 15 mg/m2 na dan (MTD) pri shemi 4/2.
Adverse reactions that were reported in GIST, MRCC, and pNET patients in a pooled dataset of 7,115 patients are listed below, by system organ class, frequency and grade of severity (NCI-CTCAE).
Neželeni učinki, opisani pri bolnikih z GIST, MRCC in pNET s skupnim naborom 7.115 bolnikov, so našteti spodaj po organskih sistemih, pogostnosti in stopnji izraženosti (po merilu NCI-CTCAE).
• Deficiency of blood supply to the heart muscle, due to obstruction or constriction of the coronary arteries.
• oviran dotok krvi v srčno mišico zaradi zamašitve ali zožitve srčnih arterij
Ninety-seven patients were enrolled at various doses and schedules; 55 patients received 50 mg at the recommended treatment Schedule 4 weeks on /2 weeks off (“Schedule 4/2”).
Vključenih je bilo 97 bolnikov z različnimi odmerki in shemami; 55 bolnikov je prejemalo 50 mg po priporočeni terapevtski shemi 4 tedne da / 2 tedna ne (''shema 4/2'').
Cases of ONJ have been reported in patients treated with Sutent, most of which occurred in patients who had identified risk factors for ONJ, in particular, exposure to intravenous bisphosphonates and/or a history of dental disease requiring invasive dental procedures (see also section 4.4).
Pri bolnikih, zdravljenih z zdravilom Sutent, so poročali o primerih osteonekroze čeljustnic, večinoma pri bolnikih s prisotnimi znanimi dejavniki tveganja za osteonekrozo čeljustnic, zlasti izpostavljenost intravenskim bisfosfonatom in/ali anamneza zobne bolezni, ki je zahtevala invazivne zobozdravstvene posege (glejte tudi poglavje 4.4).
In this analysis, the placebo arm included those patients randomised to placebo who subsequently received open-label sunitinib treatment.
V tej analizi skupina s placebom vključuje tudi tiste randomizirane bolnike s placebom, ki so v odprti študiji naknadno prejeli zdravljenje s sunitinibom.
What Sutent looks like and contents of the pack
Izgled zdravila Sutent in vsebina pakiranja
Cases of arterial thromboembolic events (ATE), sometimes fatal, have been reported in patients treated with sunitinib.
Poročali so o primerih arterijskih trombemboličnih dogodkov (ATE - arterial thromboembolic events), včasih s smrtnim izidom, pri bolnikih, ki so se zdravili s sunitinibom.
Sunitinib and its primary metabolite are mainly metabolised by the liver.
Sunitinib in njegov primarni presnovek se pretežno presnavljata v jetrih.
Patients should be carefully monitored for clinical signs and symptoms of CHF while receiving sunitinib especially patients with cardiac risk factors and/or history of coronary artery disease.
Bolnike je treba med zdravljenjem s sunitinibom skrbno spremljati glede kliničnih znakov in simptomov CHF, zlasti bolnike s srčnimi dejavniki tveganja in/ali anamnezo koronarne bolezni.
There were 9 deaths in the sunitinib arm and 21 deaths in the placebo arm.
V skupini, ki je prejemala sunitinib, je bilo 9 primerov smrti, 21 primerov smrti pa je bilo v skupini, ki je prejemala placebo.
The long-term safety of sunitinib in patients with MRCC was analysed across 9 completed clinical studies conducted in the first-line, bevacizumab-refractory, and cytokine-refractory treatment settings in 5,739 patients, of whom 807 (14%) were treated for ≥ 2 years up to 6 years.
Dolgoročno varnost sunitiniba pri bolnikih z MRCC so analizirali v 9 dokončanih kliničnih študijah, izvedenih v okviru prve linije zdravljenja MRCC, odpornega proti bevacizumabu, in zdravljenja MRCC, odpornega proti citokinom, pri 5.739 bolnikih, od katerih se je 807 (14 %) zdravilo ≥ 2 leti do največ 6 let.
OS observed after 5 years of follow-up in the extension study showed a hazard ratio of 0.730 (95% CI: 0.504, 1.057).
Celokupno preživetje, opaženo po 5-letnem spremljanju bolnikov v razširjeni študiji, je pokazalo razmerje ogroženosti 0,730 (95 % IZ: 0,504, 1,057).
High-density polyethylene (HDPE) bottle with a polypropylene closure containing 30 hard capsules.
Plastenka iz polietilena visoke gostote (HDPE) s polipropilensko zaporko, ki vsebuje 30 trdih kapsul.
At approximately twice therapeutic concentrations, sunitinib has been shown to prolong the QTcF interval (Fridericia corrected QT interval).
Dokazali so, da sunitinib v približno dvakratni terapevtski koncentraciji podaljša interval QTcF (interval QT s popravkom Fridericia).
Medicinal products that may decrease sunitinib plasma concentrations Effect of CYP3A4 inducers
Zdravila, ki lahko zmanjšajo koncentracijo sunitiniba v plazmi Učinek induktorjev CYP3A4
Call your doctor immediately if you get symptoms such as chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness while on treatment with Sutent.
Nemudoma obvestite zdravnika, če dobite simptome, kot so bolečine v prsnem košu ali pritisk, bolečine v rokah, hrbtu, vratu ali čeljusti, zasoplost, odrevenelost ali šibkost na 1 strani telesa, težave z govorom, glavobol ali vrtoglavico med zdravljenjem z zdravilom Sutent.
Risk factors for TLS include high tumour burden, pre-existing chronic renal insufficiency, oliguria, dehydration, hypotension, and acidic urine.
Med dejavnike tveganja za TLS sodijo velika tumorska masa, obstoječa kronična ledvična insuficienca, oligurija, dehidracija, hipotenzija in kisel urin.
The difference in overall survival (OS) was statistically in favour of sunitinib [hazard ratio (HR): 0.491; (95% CI: 0.290, 0.831)]; the risk of death was 2 times higher in patients in the placebo arm compared to the sunitinib arm.
Razlika v celokupnem preživetju je bila statistično v prid sunitinibu [razmerje ogroženosti (HR - hazard ratio): 0,491; 95 % IZ: 0,290-0,831]; tveganje za smrt je bilo v skupini s placebom 2-krat večje kot v skupini s sunitinibom.