natgillin/translations-raw huggingface dataset:
An updated OS analysis was performed when patients had a median follow-up of 16.6 months (range: 0.1 to 26.3 months).
Posodobljena analiza celokupnega preživetja je bila izvedena, ko je mediani čas spremljanja bolnikov znašal 16,6 meseca (v razponu od 0,1 do 26,3 meseca).
KEYTRUDA, in combination with carboplatin and either paclitaxel or nab-paclitaxel, is indicated for the first-line treatment of metastatic squamous NSCLC in adults.
Zdravilo KEYTRUDA je v kombinaciji s karboplatinom in bodisi paklitakselom bodisi nab-paklitakselom indicirano za prvo linijo zdravljenja metastatskega ploščatoceličnega NSCLC pri odraslih.
Table 13 summarises key efficacy measures.
Preglednica 13 povzema ključna merila učinkovitosti.
Translucent to white proteinaceous particles may be seen in diluted solution.
V razredčeni raztopini so lahko vidni prosojni do beli beljakovinski delci.
The 23 patients had a median follow-up from subsequent allogeneic HSCT of 5.1 months (range: 0-26.2 months).
Pri teh 23 bolnikih je spremljanje od naslednje alogenske HSCT trajalo mediano 5,1 meseca (v razponu: od 0 do 26,2 meseca).
Patients in the placebo arm were offered pembrolizumab as a single agent at the time of disease progression.
Bolnikom v skupini s placebom so v času napredovanja bolezni ponudili pembrolizumab kot samostojno zdravilo.
Response: Best objective response as confirmed complete response or partial response
Odgovor: najboljši objektivni odgovor, potrjen kot popolni oziroma delni odgovor
Grade 3 or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)
3. stopnja ali v primeru suma na Stevens-Johnsonov sindrom (SJS) ali toksično epidermalno nekrolizo (TEN)
The median number of prior lines of therapy administered for the treatment of cHL was 5 (range 2 to 15).
Mediano število predhodnih linij zdravljenja cHL je bilo 5 (v razponu: od 2 do 15).
The pembrolizumab monotherapy arm remains open only to patients whose tumours express PD-L1 with a CPS ≥ 10.
Skupina z monoterapijo s pembrolizumabom ostaja odprta samo za bolnike, pri katerih tumorji izražajo PD-L1 s CPS ≥ 10.
erythema, dry skin, vitiligo t, eczema, alopecia, dermatitis acneiform severe skin reactions s,
eritem, suha koža, vitiligo t, ekcem, alopecija, akneiformni dermatitis hude kožne reakcije s,
A total of 57 NSCLC patients aged ≥ 75 years were enrolled in study KEYNOTE-189 (35 in the pembrolizumab combination and 22 in the control).
Skupno 57 bolnikov z NSCLC, starih ≥ 75 let, je bilo vključenih v študijo KEYNOTE-189 (35 bolnikov v skupino kombiniranega zdravljenja s pembrolizumabom in 22 bolnikov v kontrolno skupino).
Common hypertension hypertension
Pogosti hipertenzija hipertenzija
Eighty-six percent had a primary tumour in the lower tract and 14% had a primary tumour in the upper tract.
Šestinosemdeset odstotkov jih je imelo primarni tumor v spodnjem traktu in 14 % v zgornjem traktu.
Patients with ECOG performance status score ≥ 2 were excluded from the clinical trials of melanoma, NSCLC, cHL, and HNSCC (see sections 4.4 and 5.1).
Ocena zmogljivosti ≥ 2 po ECOG (Eastern Cooperative Oncology Group) lestvici Bolniki z oceno zmogljivosti ≥ 2 po ECOG lestvici so bili izključeni iz kliničnih preskušanj melanoma, NSCLC, cHL in HNSCC (glejte poglavji 4.4 in 5.1).
Breast-feeding - If you are breast-feeding, tell your doctor.
Dojenje - Če dojite, morate to povedati zdravniku.
Table 15 summarises key efficacy measures.
Preglednica 15 povzema ključna merila učinkovitosti.
Patients with BRAF V600E mutant melanoma were not required to have received prior BRAF inhibitor therapy.
Pri bolnikih, ki so imeli melanom z mutacijo BRAF V600E, ni bilo zahtevano predhodno zdravljenje z zaviralcem BRAF.
No dose adjustment is necessary in patients ≥ 65 years (see section 5.1).
Pri bolnikih, starih ≥ 65 let, odmerka ni treba prilagoditi (glejte poglavje 5.1).
PD-L1 expression was tested retrospectively by immunohistochemistry assay with the 22C3 anti-PD-L1 antibody.
Testiranje izraženosti PD-L1 je bilo opravljeno retrospektivno z imunohistokemičnim preizkusom s protitelesom 22C3 proti PD-L1.
Patients must have undergone lymph node dissection, and if indicated, radiotherapy within 13 weeks prior to starting treatment.
Bolniki so morali imeti kirurško odstranjene bezgavke in so se morali zdraviti z obsevanjem, če je bilo le-to indicirano, v 13 tednih pred začetkom zdravljenja.
Thirty-one percent had an ECOG Performance Status of 1, 69% had ECOG Performance Status of 0 and 32% had elevated LDH.
Enaintrideset odstotkov bolnikov je imelo oceno zmogljivosti po ECOG lestvici 1, 69 % je imelo oceno zmogljivosti po ECOG lestvici 0 in 32 % jih je imelo zvišan LDH.
PD-L1 testing for patients with NSCLC, urothelial carcinoma, or HNSCC Testing for PD-L1 tumour expression using a validated test is recommended for patients with NSCLC.
Testiranje PD-L1 pri bolnikih z NSCLC, urotelijskim rakom ali HNSCC Pri bolnikih z NSCLC je priporočljivo opraviti testiranje izraženosti PD-L1 tumorja z validirano preiskavo.
All patients with BRAF mutant tumours were previously treated with a BRAF inhibitor.
Vsi bolniki, ki so imeli tumorje z mutacijo BRAF, so bili predhodno zdravljeni z zaviralcem BRAF.
Seventy percent had at least two and 35% of patients had three or more prior systemic therapies for advanced melanoma.
Sedemdeset odstotkov bolnikov je predhodno prejelo vsaj dve in 35 % bolnikov tri ali več sistemskih zdravljenj za napredovali melanom.
Common pain in extremity, myositis w, arthritis myositis w, pain in extremity, arthritis myositis w, arthritis x,
Pogosti bolečine v okončini, miozitis w, artritis miozitis w, bolečine v okončini, artritis miozitis w, artritis x,
Seventy-six percent of patients received prior cisplatin, 23% had prior carboplatin, and 1% was treated with other platinum-based regimens.
Šestinsedemdeset odstotkov bolnikov je predhodno prejemalo cisplatin, 23 % je predhodno prejemalo karboplatin in 1 % druge sheme na podlagi platine.
A direct comparison of pembrolizumab when used in combination with chemotherapy to pembrolizumab monotherapy is not available.
Neposredna primerjava pembrolizumaba v kombinaciji s kemoterapijo in samostojnega zdravljenja s pembrolizumabom ni na voljo.
For patients with Grade 3 or Grade 4 hyperthyroidism that improved to Grade 2 or lower, continuation of pembrolizumab may be considered, after corticosteroid taper, if needed (see sections 4.2 and 4.8).
Pri bolnikih s hipertiroidizmom 3. ali 4. stopnje, ki se izboljša na 2. ali nižjo stopnjo, se po postopnem zmanjševanju odmerka kortikosteroida (če je potrebno) lahko razmisli o nadaljevanju uporabe pembrolizumaba (glejte poglavji 4.2 in 4.8).
In addition, no safety and efficacy data are available in frailer patients (e.g., ECOG performance status 3) considered not eligible for chemotherapy.
Poleg tega pri bolnikih šibkejšega zdravja (npr. ocena zmogljivosti 3 po ECOG lestvici), ki niso primerni za zdravljenje s kemoterapijo, podatkov o varnosti in učinkovitosti ni na voljo.
Incidences of Grades 3-5 adverse reactions were 76% for pembrolizumab combination therapy and 71% for sunitinib alone.
Pojavnost neželenih učinkov 3. do 5. stopnje je bila med kombiniranim zdravljenjem s pembrolizumabom 76 % in pri zdravljenju s sunitinibom samim 71 %.
The concentrate is a clear to slightly opalescent, colourless to slightly yellow solution.
Koncentrat je bistra ali nekoliko opalescentna, brezbarvna do rahlo rumenkasta raztopina.
The following additional clinically significant, immune-related adverse reactions have been reported in clinical trials or in post-marketing experience: uveitis, arthritis, myositis, myocarditis, pancreatitis, Guillain-Barré syndrome, myasthenic syndrome, haemolytic anaemia, sarcoidosis and encephalitis (see sections 4.2 and 4.8).
V kliničnih preskušanjih in v obdobju trženja zdravila so poročali o naslednjih klinično pomembnih imunsko pogojenih neželenih učinkih: uveitisu, artritisu, miozitisu, miokarditisu, pankreatitisu, Guillain-Barréjevem sindromu, miasteničnem sindromu, hemolitični anemiji, sarkoidozi in encefalitisu (glejte poglavji 4.2 in 4.8).
Of the 834 patients, 60% were male, 44% were ≥ 65 years (median age was 62 years [range 18-89]) and 98% were white.
Od 834 bolnikov je bilo 60 % moških, 44 % starih ≥ 65 let (mediana starost je bila 62 let [razpon 18-89]) in 98 % je bilo belcev.
Based on the severity of the adverse reaction, pembrolizumab should be withheld and corticosteroids administered.
Glede na izrazitost neželenega učinka je treba zadržati uporabo pembrolizumaba in uporabiti kortikosteroide.
Ninety percent of patients were treatment naïve, and 10% received prior adjuvant or neoadjuvant platinum-based chemotherapy.
Devetdeset odstotkov bolnikov predhodno še ni bilo zdravljenih, 10 % pa jih je predhodno prejemalo adjuvantno ali neoadjuvantno kemoterapijo na osnovi platine.
KEYTRUDA 200 mg every 3 weeks n=514
KEYTRUDA 200 mg vsake 3 tedne n = 514
A subgroup analysis was performed as part of the final analysis of KEYNOTE-002 in patients who were PD-L1 positive (PD-L1 expression in ≥ 1% of tumour and tumour-associated immune cells relative to all viable tumour cells - MEL score) vs. PD-L1 negative.
V okviru končne analize v študiji KEYNOTE-002 je bila opravljena analiza podskupin bolnikov, ki so bili PD-L1 pozitivni (izraženost PD-L1 pri ≥ 1 % tumorskih in s tumorjem povezanih imunskih celic v primerjavi z vsemi razpoložljivimi tumorskimi celicami - ocena po lestvici MEL), in PD-L1 negativni.
Of the patients who recovered, 92 (84%) were rechallenged with either pembrolizumab (3%) or axitinib (31%) monotherapy or with both (50%).
Med bolniki, ki so okrevali, so pri 92 (84 %) ponovno uporabili ali pembrolizumab (3 %) ali aksitinib (31 %) kot samostojni zdravljenji ali kombinacijo obeh (50 %).
Secondary efficacy outcome measures were ORR and response duration.
Sekundarni merili izida učinkovitosti sta bila ORR in trajanje odgovora.
The effect of renal impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild or moderate renal impairment compared to patients with normal renal function.
Vpliv okvare ledvic na očistek pembrolizumaba so ocenili s populacijskimi farmakokinetičnimi analizami pri bolnikih z blago ali zmerno okvaro ledvic v primerjavi z bolniki z normalnim delovanjem ledvic.
Pembrolizumab has not been studied in patients with moderate or severe hepatic impairment (see section 4.2).
Pembrolizumaba niso raziskali pri bolnikih z zmerno ali hudo okvaro jeter (glejte poglavje 4.2).
Pembrolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reaction toxicity, except for endocrinopathies that are controlled with replacement hormones (see sections 4.2 and 4.8).
Pembrolizumab je treba trajno ukiniti, če se kateri koli imunsko pogojeni neželeni učinek 3. stopnje znova pojavi oziroma če se pojavi toksičen imunsko pogojeni neželeni učinek 4. stopnje, razen v primeru endokrinopatij, ki so obvladljive z nadomeščanjem hormonov (glejte poglavji 4.2 in 4.8).
The efficacy of pembrolizumab in combination with carboplatin and either paclitaxel or nabpaclitaxel was investigated in Study KEYNOTE-407, a randomised, double-blind, multicentre, placebo-controlled study.
Učinkovitost pembrolizumaba v kombinaciji s karboplatinom in bodisi paklitakselom bodisi nab-paklitakselom so raziskali v študiji KEYNOTE-407, randomizirani, dvojno slepi, multicentrični, s placebom nadzorovani študiji.
Patients on chemotherapy who experienced independently-verified progression of disease were able to crossover and receive pembrolizumab.
Bolniki na kemoterapiji, pri katerih je prišlo do neodvisno potrjenega napredovanja bolezni, so lahko prešli na zdravljenje s pembrolizumabom.
The safety of pembrolizumab in combination with axitinib has been evaluated in a clinical study of 429 patients with advanced RCC receiving 200 mg pembrolizumab every 3 weeks and 5 mg axitinib twice daily.
Varnost pembrolizumaba v kombinaciji z aksitinibom so ocenili v klinični študiji pri 429 bolnikih z napredovalim rakom ledvičnih celic, ki so prejemali 200 mg pembrolizumaba na 3 tedne in 5 mg aksitiniba dvakrat na dan.
Table 11 summarises efficacy results by PD-L1 expression and BRAF mutation status.
Preglednica 11 prikazuje povzetek rezultatov učinkovitosti glede na izraženost PD-L1 in status mutacij BRAF.
The diluted solution must not be frozen.
Razredčene raztopine ne smete zamrzniti.
th edition classification, a total of 82 subjects were classified as stage IIIA; 42 in the pembrolizumab arm and 40 in the placebo arm; with a total of 13 RFS events; 6 in the pembrolizumab arm and 7 in the placebo arm.
Po razvrstitvi po 8. izdaji kriterijev AJCC je bil melanom pri skupno 82 bolnikih klasificiran kot stadij IIIA: pri 42 bolnikih v skupini s pembrolizumabom in 40 bolnikih v skupini s placebom; s skupno 13 RFS dogodki: 6 dogodki v skupini s pembrolizumabom in 7 dogodki v skupini s placebom.
Common aspartate aminotransferase increased, alanine aminotransferase increased, hypercalcaemia, blood alkaline phosphatase increased, blood bilirubin increased, blood creatinine increased hypercalcaemia, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased
Pogosti zvišana aspartat-aminotransferaza, zvišana alaninaminotransferaza, hiperkalciemija, zvišana alkalna fosfataza v krvi, zvišan bilirubin v krvi, zvišan kreatinin v krvi hiperkalciemija, zvišana alanin-aminotransferaza, zvišana aspartataminotransferaza, zvišana alkalna fosfataza v krvi zvišana alkalna fosfataza v krvi, hiperkalciemija, zvišan bilirubin v krvi
Common hyponatraemia, hypokalaemia, hypocalcaemia hyponatraemia, hypocalcaemia hypokalaemia, hyponatraemia, hypocalcaemia
Pogosti hiponatriemija, hipokaliemija, hipokalciemija hiponatriemija, hipokalciemija hipokaliemija, hiponatriemija, hipokalciemija
ORR difference, % (95% CI)
razlika ORR, % (95 % IZ)
KEYNOTE-054: Placebo-controlled trial for the adjuvant treatment of patients with completely resected melanoma
KEYNOTE-054: S placebom nadzorovano preskušanje adjuvantnega zdravljenja bolnikov s popolnoma kirurško odstranjenim melanomom
- If you are a woman who could become pregnant, you must use adequate birth control while you are being treated with KEYTRUDA and for at least 4 months after your last dose.
- Če ste ženska v rodni dobi, morate med zdravljenjem z zdravilom KEYTRUDA in vsaj še
Hypothyroidism is more frequently reported in patients with HNSCC with prior radiation therapy.
O hipotiroidizmu so pogosteje poročali pri bolnikih s HNSCC, ki so se predhodno zdravili z obsevanjem.
KEYNOTE-361 is an ongoing Phase III, randomised, controlled, open-label clinical trial of pembrolizumab with or without platinum-based combination chemotherapy versus chemotherapy as first-line treatment in subjects with advanced or metastatic urothelial carcinoma.
KEYNOTE-361 je potekajoče, randomizirano, kontrolirano, odprto klinično preskušanje III. faze pembrolizumaba s kombinirano kemoterapijo na osnovi platine ali brez takšne kemoterapije v primerjavi s kemoterapijo kot prvo linijo zdravljenja pri bolnikih z napredovalim ali metastatskim urotelijskim rakom.
In patients with ALT ≥ 3 times ULN (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%.
Pri bolnikih z vrednostjo ALT ≥ 3-kratno ZNM (2. do 4. stopnja, n = 116) se je vrednost ALT v 94 % znižala na 0. ali 1. stopnjo.
• Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL.
• Potrebno količino do 4 ml (100 mg) koncentrata povlecite iz viale in jo prenesite v intravensko vrečko, ki vsebuje natrijev klorid 9 mg/ml (0,9 %) ali glukozo 50 mg/ml (5 %), da pripravite razredčeno raztopino s končno koncentracijo od 1 do 10 mg/ml.
Sixty-one percent of patients had received Auto-SCT, 38% were transplant ineligible; 17% had no prior brentuximab vedotin use; and 36% of patients had prior radiation therapy.
Enainšestdeset odstotkov bolnikov je prejelo avto-SCT, 38 % jih ni bilo primernih za presaditev, 17 % jih predhodno ni prejemalo brentuksimaba vedotina in 36 % bolnikov je predhodno prejelo radioterapijo.
Pembrolizumab is most commonly associated with immune-related adverse reactions.
Pembrolizumab je najpogosteje povezan z imunsko pogojenimi neželenimi učinki.
Among 370 patients with urothelial carcinoma who were not eligible for cisplatin-containing chemotherapy baseline characteristics were: median age 74 years (82% age 65 or older); 77% male; and 89% White and 7% Asian.
Pri 370 bolnikih z urotelijskim rakom, ki niso primerni za zdravljenje s kemoterapijo, ki vsebuje cisplatin, so bile izhodiščne značilnosti: mediana starost 74 let (82 % starih 65 let ali več), 77 % moških ter 89 % belcev in 7 % Azijcev.
In this patient population, the most frequent adverse reactions were diarrhoea (54%), hypertension (45%), fatigue (38%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysaesthesia syndrome (28%), nausea (28%), ALT increased (27%), AST increased (26%), dysphonia (25%), cough (21%), and constipation (21%).
V tej populaciji bolnikov so bili najpogostejši neželeni učinki diareja (54 %), hipertenzija (45 %), utrujenost (38 %), hipotiroidizem (35 %), zmanjšan apetit (30 %), sindrom palmarno-plantarne eritrodisestezije (28 %), navzea (28 %), zvišanje vrednosti ALT (27 %), zvišanje vrednosti AST (26 %), disfonija (25 %), kašelj (21 %) in zaprtost (21 %).
There is no information on overdose with pembrolizumab.
Informacij o prevelikem odmerjanju pembrolizumaba ni.
• If ALT or AST ≥ 3 times ULN but < 10 times ULN without concurrent total bilirubin ≥ 2 times ULN, both KEYTRUDA and axitinib should be withheld until these adverse reactions recover to Grades 0-1.
• Če je ALT ali AST ≥ 3-krat nad ZNM, a < 10-krat nad ZNM, in celokupni bilirubin ob tem ni ≥ 2-krat nad ZNM, je treba zadržati uporabo tako zdravila KEYTRUDA kot aksitiniba, dokler se neželeni učinki ne zmanjšajo na stopnjo 0-1.
Eighty-four percent were refractory to at least one prior therapy, including 35% who were refractory to first line therapy.
Štiriinosemdeset odstotkov jih je bilo neodzivnih na vsaj eno predhodno zdravljenje, vključno s 35 %, ki so bili neodzivni na zdravljenje prve linije.
In patients with HNSCC treated with pembrolizumab in combination with platinum and 5-FU chemotherapy (n=276), the incidence of hypothyroidism was 15.2%, all of which were Grade 1 or 2.
Pri bolnikih s HNSCC, ki so prejemali pembrolizumab v kombinaciji s kemoterapijo s platino in 5-fluorouracilom (n = 276), je bila pojavnost hipotiroidizma 15,2 %, vsi primeri so bili 1. ali 2. stopnje.
The Kaplan-Meier curve based on the final analysis for OS is shown in Figure 12.
Kaplan-Meierjeva krivulja na podlagi končne analize za OS je prikazana na sliki 12.
Of the 540 patients, 61% were male, 43% were ≥ 65 years (median age was 62 years [range 15-89]) and 98% were white.
Od 540 bolnikov je bilo 61 % moških, 43 % starih ≥ 65 let (mediana starost je bila 62 let [razpon 15-89]) in 98 % je bilo belcev.
Adverse reactions known to occur with pembrolizumab or chemotherapies given alone may occur during treatment with these medicinal products in combination, even if these reactions were not reported in clinical trials with combination therapy.
Pri kombiniranem zdravljenju se lahko pojavijo neželeni učinki, za katere je znano, da se lahko pojavijo pri samostojnem zdravljenju s pembrolizumabom ali kemoterapijo, čeprav o teh neželenih učinkih v kliničnih preskušanjih kombiniranega zdravljenja morda niso poročali.
Reasons for cisplatin ineligibility included: baseline creatinine clearance of < 60 mL/min (50%), ECOG performance status of 2 (32%), ECOG performance status of 2 and baseline creatinine clearance of < 60 mL/min (9%), and other (Class III heart failure, Grade 2 or greater peripheral neuropathy, and Grade 2 or greater hearing loss; 9%).
Med razlogi, zaradi katerih bolniki niso bili primerni za zdravljenje s cisplatinom, so bili: izhodiščni očistek kreatinina < 60 ml/min (50 %), ocena zmogljivosti po ECOG lestvici 2 (32 %), ocena zmogljivosti po ECOG lestvici 2 in izhodiščni očistek kreatinina < 60 ml/min (9 %) in drugo (srčno popuščanje v razredu III, periferna nevropatija 2. stopnje ali več in izguba sluha 2. stopnje ali več; 9 %).
The effect of hepatic impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild hepatic impairment (as defined using the US National Cancer Institute criteria of hepatic dysfunction) compared to patients with normal hepatic function.
Vpliv okvare jeter na očistek pembrolizumaba so ocenili s populacijskimi farmakokinetičnimi analizami pri bolnikih z blago okvaro jeter (opredeljeno po merilih ameriškega Nacionalnega onkološkega inštituta za moteno delovanje jeter) v primerjavi z bolniki z normalnim delovanjem jeter.
The primary efficacy outcome measures were progression free survival (PFS; as assessed by Integrated Radiology and Oncology Assessment [IRO] review using Response Evaluation Criteria in Solid Tumours [RECIST], version 1.1) and overall survival (OS).
Primarni merili izida učinkovitosti sta bili preživetje brez napredovanja bolezni (PFS - progression free survival, ocenjeno po integrirani radiološki in onkološki presoji [IRO] na podlagi meril RECIST, različica 1.1) ter celokupno preživetje (OS - overall survival).
For severe infusion reactions, infusion should be stopped and pembrolizumab permanently discontinued (see section 4.2).
V primeru hudih z infuzijo povezanih reakcij je treba infundiranje ustaviti in pembrolizumab trajno ukiniti (glejte poglavje 4.2).
#) of patients with duration ≥ 12 months
#) bolnikov s trajanjem ≥ 12 mesecev
Chemotherapy (n=137)
kemoterapija (n = 137)
• If ALT or AST ≥ 10 times ULN or > 3 times ULN with concurrent total bilirubin ≥ 2 times ULN, both KEYTRUDA and axitinib should be permanently discontinued and corticosteroid therapy may be considered.
• Če je ALT ali AST ≥ 10-krat nad ZNM, ali če je > 3-krat nad ZNM, in je ob tem celokupni bilirubin ≥ 2-krat nad ZNM, je treba trajno ukiniti tako zdravilo KEYTRUDA kot aksitinib in razmisliti o zdravljenju s kortikosteroidi.
Based on a recommendation by an external Data Monitoring Committee, the accrual in the pembrolizumab monotherapy arm was stopped for patients whose tumours express PD-L1 with a CPS < 10.
Na podlagi priporočila zunanjega Odbora za spremljanje podatkov (Data Monitoring Committee) se je v skupino z monoterapijo s pembrolizumabom ustavilo vključevanje bolnikov, pri katerih tumorji izražajo PD-L1 s CPS < 10.
Other medicines and KEYTRUDA Tell your doctor - If you are taking other medicines that make your immune system weak.
Zdravniku povejte: - če jemljete druga zdravila, ki lahko oslabijo imunski sistem.
An analysis was performed in KEYNOTE-052 in patients who had tumours that expressed PD-L1 with a CPS < 10 (n=251; 68%) or ≥ 10 (n=110; 30%) based on the PD-L1 IHC 22C3 pharmDx
V študiji KEYNOTE-052 je bila narejena analiza pri bolnikih, ki so imeli tumorje z izraženostjo PD-L1 s CPS < 10 (n = 251; 68 %) ali ≥ 10 (n = 110; 30 %) na podlagi testa PD-L1, opravljenega z IHC 22C3 pharmDx
Safety data of pembrolizumab in the adjuvant melanoma setting in patients ≥ 75 years are limited.
Podatkov o varnosti pembrolizumaba pri bolnikih, starih ≥ 75 let, ki so zdravilo prejemali zaradi adjuvantnega zdravljenja melanoma, je malo.
Of 23 patients with cHL who proceeded to allogeneic HSCT after treatment with pembrolizumab, 6 patients (26%) developed GVHD, one of which was fatal, and 2 patients (9%) developed severe hepatic VOD after reduced-intensity conditioning, one of which was fatal.
Zapleti alogenske HSCT pri klasičnem Hodgkinovem limfomu Med 23 bolniki s cHL, pri katerih je bila po zdravljenju s pembrolizumabom opravljena alogenska HSCT, se je pri 6 bolnikih (26 %) razvila GVHD, v enem primeru s smrtnim izidom, pri 2 bolnikih (9 %) pa se je razvila huda VOD jeter (po pripravi bolnika za presaditev z zmanjšano intenzivnostjo), v enem primeru s smrtnim izidom.