natgillin/translations-raw huggingface dataset:
While the analysis in patients with PD-L1 positive tumours was a co-primary endpoint, pre-defined subgroup analyses were performed in patients whose tumours were PD-L1 negative, BRAF mutation positive or negative.
Medtem ko je bila analiza pri bolnikih s PD-L1 pozitivnimi tumorji sočasni primarni opazovani dogodek, so bile izvedene tudi vnaprej predvidene analize po podskupinah pri bolnikih s PD-L1 negativnimi tumorji ter pozitivno ali negativno mutacijo BRAF.
Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab.
Bolniki, pri katerih se je po postopku presaditve razvila GVHD, imajo lahko povečano tveganje za pojav GVHD po zdravljenju s pembrolizumabom.
Patients underwent imaging every 12 weeks after the first dose of pembrolizumab for the first two years, then every 6 months from year 3 to 5, and then annually.
Pri bolnikih so slikovne preiskave opravljali vsakih 12 tednov po prvem odmerku pembrolizumaba prvi dve leti, nato pa vsakih 6 mesecev od 3. do 5. leta in nato enkrat na leto.
A total of 67 patients in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab at the time of disease progression and 18 additional patients received a checkpoint inhibitor as subsequent therapy.
Skupno 67 bolnikov v skupini s placebom in kemoterapijo je v času napredovanja bolezni prešlo na samostojno zdravljenje s pembrolizumabom, še dodatnih 18 bolnikov pa je pri nadaljnjem zdravljenju prejelo zaviralca kontrolnih točk.
Table 22: ORR and OS by PD-L1 Expression
Preglednica 22: ORR in OS glede na izraženost PD-L1
Each vial contains an excess fill of 10 mg (0.4 mL) to ensure the recovery of 50 mg of KEYTRUDA per vial.
Vsaka viala vsebuje prekomerno polnitev 10 mg (0,4 ml) za zagotovitev dobljene količine 50 mg zdravila KEYTRUDA na vialo.
These medicines may interfere with the effect of KEYTRUDA.
Ta zdravila lahko medsebojno delujejo z zdravilom KEYTRUDA.
Note: toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4).
Opomba: Stopnje toksičnosti so navedene v skladu z verzijo 4.0 Terminološko poenotenih meril neželenih učinkov Nacionalnega onkološkega inštituta (NCI-CTCAE v4; “National Cancer Institute Common Terminology Criteria for Adverse Events.
Common colitis n, dry mouth colitis n, dry mouth colitis n, dry mouth
Pogosti kolitis n, suha usta kolitis n, suha usta kolitis n, suha usta
Among patients who were evaluable for PD-L1 expression (98%), 82% were PD-L1 positive and 18% were PD-L1 negative.
Med bolniki, ki jih je bilo mogoče oceniti glede izraženosti PD-L1 (98 %), je bilo 82 % PD-L1 pozitivnih in 18 % PD-L1 negativnih.
Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA.
Bolniki s pozitivnimi tumorskimi mutacijami EGFR ali ALK so pred prejemom zdravila KEYTRUDA morali prejeti tudi tarčno zdravljenje.
Table 29: Efficacy Results in KEYNOTE-426 by IMDC Risk Category
Preglednica 29: Rezultati učinkovitosti v študiji KEYNOTE-426 po kategoriji tveganja IMDC
AstraZeneca Pharmaceuticals LP, Frederick Manufacturing Center (FMC) 633 Research Court
AstraZeneca Pharmaceuticals LP, Frederick Manufacturing Center (FMC) 633 Research Court Frederick, Maryland (MD) 21703 ZDA
No findings of toxicological significance were observed and the no observed adverse effect level (NOAEL) in both studies was ≥ 200 mg/kg, which produced exposure multiples of 19 and 94 times the exposure in humans at doses of 10 and 2 mg/kg, respectively.
Toksikološko pomembnih ugotovitev ni bilo, koncentracija, pri kateri niso opazili neželenih učinkov (no observed adverse effect level - NOAEL), je bila v obeh študijah ≥ 200 mg/kg, kar je 19-kratnik izpostavljenosti pri človeku ob odmerku 10 mg/kg oziroma 94-kratnik izpostavljenosti pri človeku ob odmerku 2 mg/kg.
Hypothyroidism may be managed with replacement therapy without treatment interruption and without corticosteroids.
Hipotiroidizem je mogoče urejati z nadomestnim zdravljenjem brez prekinitve osnovnega zdravljenja in brez kortikosteroidov.
Following administration of pembrolizumab 200 mg every 3 weeks in patients with cHL, the observed median Cmin at steady-state was up to 40% higher than that in other tumour types treated with the same dosage; however, the range of trough concentrations is similar.
Po uporabi pembrolizumaba 200 mg na 3 tedne pri bolnikih s cHL je opažena mediana Cmin v stanju dinamičnega ravnovesja do 40 % višja kot pri drugih vrstah tumorjev, zdravljenih z enakim odmerkom, vendar pa je razpon glede na koncentracije podoben.
Pembrolizumab is administered via the intravenous route and therefore is immediately and completely bioavailable.
Absorpcija Pembrolizumab se uporablja intravensko, zato je njegova biološka uporabnost takojšnja in popolna.
Complications, including graft-versus-host-disease (GVHD), in people with bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).
Zapleti, vključno z boleznijo presadka proti gostitelju, pri ljudeh s presadkom kostnega mozga (matičnih celic) z uporabo donorskih matičnih celic (alogenska presaditev).
There are no notable differences in median Cmax between cHL and other tumour types.
Glede mediane Cmax med cHL in drugimi vrstami tumorjev ni opaznih razlik.
Corticosteroids to treat adrenal insufficiency and other hormone replacement should be administered as clinically indicated, and pembrolizumab should be withheld for adrenal insufficiency or symptomatic hypophysitis until the event is controlled with hormone replacement.
Za zdravljenje adrenalne insuficience je treba uporabiti kortikosteroide in drugo nadomeščanje hormonov, kot je klinično indicirano; uporabo pembrolizumaba je treba v primeru adrenalne insuficience ali simptomatskega hipofizitisa prekiniti, dokler stanje ni urejeno z nadomeščanjem hormonov.
However, once you are treated with KEYTRUDA, your doctor may give you corticosteroids to reduce the side-effects that you may have with KEYTRUDA.
Vendar pa vam tekom zdravljenja z zdravilom KEYTRUDA zdravnik lahko predpiše kortikosteroide za zmanjšanje neželenih učinkov, ki bi jih lahko imeli zaradi zdravila KEYTRUDA.
If rechallenging with axitinib, dose reduction as per the axitinib SmPC may be considered.
V primeru ponovne uporabe aksitiniba se lahko razmisli o zmanjšanju odmerka v skladu s SmPC aksitiniba.
In patients with cHL (n=241) the incidence of hypothyroidism was 14.1% (all Grades) with 0.4% Grade 3.
Pri bolnikih s cHL (n = 241) je bila pojavnost hipotiroidizma 14,1 % (vse stopnje) z 0,4 % 3. stopnje.
% with duration ≥ 6 months % with duration ≥ 9 months
% s trajanjem ≥ 6 mesecev % s trajanjem ≥ 9 mesecev
People get KEYTRUDA after they have had surgery to remove melanoma to help prevent their cancer from coming back (adjuvant therapy).
Bolniki prejmejo zdravilo KEYTRUDA po kirurški odstranitvi melanoma za preprečevanje ponovitve bolezni (adjuvantno zdravljenje).
There are limited data on the safety and efficacy of KEYTRUDA in patients with ocular melanoma (see section 5.1).
Podatkov o varnosti in učinkovitosti zdravila KEYTRUDA pri bolnikih z očesnim melanomom je malo (glejte poglavje 5.1).
Randomisation to the chemotherapy and the chemotherapy-pembrolizumab arms remains open.
Randomizacija v skupini s kemoterapijo in s kemoterapijo-pembrolizumabom ostaja odprta.
Patients with EGFR activation mutation or ALK translocation also had disease progression on approved therapy for these mutations prior to receiving pembrolizumab.
Pri bolnikih z EGFR aktivirajočo mutacijo ali ALK translokacijo je bolezen napredovala tudi med uporabo odobrenega zdravljenja za primer takšnih mutacij, preden so dobili pembrolizumab.
Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes.
Bolnike je treba spremljati glede hiperglikemije ali drugih znakov in simptomov sladkorne bolezni.
Patients should be monitored for suspected severe skin reactions and other causes should be excluded.
Bolnike je treba spremljati glede hudih kožnih reakcij in izključiti druge vzroke.
Human immunoglobulins G4 (IgG4) are known to cross the placental barrier; therefore, being an IgG4, pembrolizumab has the potential to be transmitted from the mother to the developing foetus.
Znano je, da humani imunoglobulini G4 (IgG4) prehajajo skozi placentno pregrado, in ker je pembrolizumab IgG4, obstaja možnost njegovega prenosa od matere v razvijajoči se plod.
Pembrolizumab concentrations with weight-based dosing at 2 mg/kg every 3 weeks in paediatric patients (2 to 17 years) are comparable to those of adults at the same dose.
Koncentracije pembrolizumaba med odmerjanjem na podlagi telesne mase 2 mg/kg vsake 3 tedne so pri pediatričnih bolnikih (starih od 2 do 17 let) primerljive s tistimi pri odraslih med uporabo enakega odmerka.
Patients with active, non-infectious pneumonitis, an allogeneic transplant within the past 5 years (or > 5 years but with GVHD), active autoimmune disease or a medical condition that required immunosuppression were ineligible for either trial.
Bolniki z aktivnim neinfekcijskim pnevmonitisom, opravljeno alogensko presaditvijo v zadnjih 5 letih (ali > 5 let, toda z GVHD), aktivno avtoimunsko boleznijo ali zdravstvenim stanjem, ki je zahtevalo imunosupresijo, niso bili vključeni v nobeno od raziskav.
The reconstituted vials and/or diluted intravenous bags may be stored for a cumulative time of up to 96 hours in a refrigerator (2°C - 8°C).
Pripravljene viale in/ali vrečke z razredčeno raztopino za intravensko uporabo so lahko shranjene v hladilniku (2 °C - 8 °C) do skupno 96 ur.
Corticosteroids can also be used as premedication, when pembrolizumab is used in combination with chemotherapy, as antiemetic prophylaxis and/or to alleviate chemotherapy-related adverse reactions.
Kortikosteroide je mogoče uporabiti tudi kot premedikacijo, če je pembrolizumab uporabljen v kombinaciji s kemoterapijo, kot antiemetično profilakso in/ali za ublažitev neželenih učinkov, povezanih s kemoterapijo.
Based on the modelling and simulation of dose/exposure relationships for efficacy and safety for pembrolizumab, there are no clinically significant differences in efficacy or safety among the doses of 200 mg every 3 weeks, 2 mg/kg every 3 weeks, and 400 mg every 6 weeks as monotherapy (see section 4.2).
Na podlagi modeliranja in simulacije razmerja odmerek/izpostavljenost za učinkovitost in varnost pembrolizumaba ni klinično pomembnih razlik v učinkovitosti ali varnosti pembrolizumaba pri samostojnem zdravljenju z odmerki 200 mg na 3 tedne, 2 mg/kg na 3 tedne in 400 mg na 6 tednov (glejte poglavje 4.2).
Pembrolizumab is catabolised through non-specific pathways; metabolism does not contribute to its clearance.
Katabolizem pembrolizumaba poteka po nespecifičnih poteh; presnova ne pripomore k njegovemu očistku.
KEYTRUDA as monotherapy is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults.
Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za zdravljenje napredovalega (neoperabilnega ali metastatskega) melanoma pri odraslih.
Hazard ratio* (98% CI) p-Value (stratified log-rank) RFS at 6 months RFS rate RFS at 12 months RFS rate RFS at 18 months RFS rate
razmerje ogroženosti (HR)* (98 % IZ) vrednost p (stratificirani logrank) RFS po 6 mesecih delež RFS RFS po 12 mesecih delež RFS RFS po 18 mesecih delež RFS
Not statistically significant after adjustment for multiplicity Based on patients with a best overall response as confirmed complete or partial response from the final analysis
Ni statistično značilno po prilagoditvi glede multiplikativnosti Na podlagi bolnikov z najboljšim celokupnim odgovorom, potrjenim kot popolni oziroma delni odgovor, v končni analizi
Additional biomarkers other than PD-L1 expression status by Immunohistochemistry (IHC) (e.g. PD-L2, RNA signature, etc.) predictive of pembrolizumab efficacy should be investigated together with more information regarding the pattern of expression of PD-L1 obtained in the ongoing NSCLC studies (P001, P010, P024 and P042) and urothelial carcinoma studies (KN045, KN052), HNSCC study (KN040) and resected Stage II melanoma adjuvant study (KN716):
Raziskati je treba dodatne biomarkerje, ki niso PD-L1 po IHC (Immuno Histo Chemistry) statusu izraženosti (npr. PD-L2, RNA genetski podpis itd.), ki napovedujejo učinkovitost pembrolizumaba, skupaj z informacijami v zvezi z vzorcem izražanja PD-L1, ki je bil pridobljen v potekajočih študijah NSCLC (P001, P010, P024 in P042) in študijah urotelijskega raka (KN045, KN052), študiji HNSCC (KN040) in študiji adjuvantnega zdravljenja melanoma v stadiju II, po kirurški odstranitvi (KN716):
Administer the infusion solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 µm in-line or add-on filter.
Raztopino za infundiranje aplicirajte intravensko v 30 minutah; skozi sterilen, nepirogen, 0,2 do 5 µm linijski ali dodatni filter, ki minimalno veže beljakovine.
KEYTRUDA potentiates T-cell responses, including anti-tumour responses, through blockade of PD-1 binding to PD-L1 and PD-L2, which are expressed in antigen presenting cells and may be expressed by tumours or other cells in the tumour microenvironment.
Zdravilo KEYTRUDA okrepi odziv T celic, vključno s protitumorskim odzivom, tako, da povzroči blokado vezave PD-1 na PD-L1 in PD-L2, ki sta izražena na antigen prezentirajočih celicah in sta lahko izražena na tumorskih ali drugih celicah v mikrookolju tumorja.
Grade ≥ 3 with creatinine > 3 times ULN
≥ 3. stopnja s kreatininom > 3-krat nad ZNM
Subjects whose tumours express PD-L1 CPS < 10 already enrolled into the pembrolizumab monotherapy arm can continue treatment.
Preiskovanci, pri katerih tumorji izražajo PD-L1 s CPS < 10 in so že vključeni v skupino z monoterapijo s pembrolizumabom, lahko nadaljujejo z zdravljenjem.
Patients with active infections occurring during treatment with pembrolizumab were managed with appropriate medical therapy.
Bolniki, pri katerih so se aktivne okužbe pojavile med zdravljenjem s pembrolizumabom, so prejemali ustrezno zdravljenje.
The most serious adverse reactions were immune-related adverse reactions and severe infusion-related reactions (see section 4.4).
Najresnejši neželeni učinki so bili imunsko pogojeni neželeni učinki in hude z infuzijo povezane reakcije (glejte poglavje 4.4).
NR (1.5+, 38.9+)
ND (1,5+; 38,9+)
Do not drive or use machines after you have been given KEYTRUDA unless you are sure you are feeling well.
Potem, ko prejmete zdravilo KEYTRUDA, ne upravljajte vozil ali strojev, če niste povsem prepričani, da se dobro počutite.
Based on best response of stable disease or better Based on Kaplan-Meier estimates; includes 84 patients with response of 6 months or longer
Na podlagi najboljšega odgovora "stabilna bolezen" ali boljšega Na podlagi Kaplan-Meierjevih ocen; vključuje 84 bolnikov, ki so imeli odgovor 6 mesecev ali več
The efficacy of pembrolizumab was investigated in KEYNOTE-087 and KEYNOTE-013, two multicentre, open-label studies for the treatment of 241 patients with cHL.
Učinkovitost pembrolizumaba so raziskali v študijah KEYNOTE-087 in KEYNOTE-013, ki sta bili multicentrični, odprti študiji zdravljenja 241 bolnikov s cHL.
Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies.
V primeru imunsko pogojenih endokrinopatij bo morda potrebno dolgotrajno hormonsko nadomestno zdravljenje.
Disease characteristics were squamous (18%) and non-squamous (82%); M1 (99%); and brain metastases (9%).
Značilnosti bolezni so bile: ploščatocelična (18 %) in neploščatocelična (82 %), M1 (99 %) in metastaze v možganih (9 %).
Table 29 summarises the efficacy measures by IMDC risk category from the pre-specified interim analysis.
Preglednica 29 povzema ključna merila učinkovitosti po kategoriji tveganja IMDC iz vnaprej določene vmesne analize.
Sixty-five percent of patients had M1c stage, 9% had a history of brain metastases, 66% had no and 34% had one prior therapy.
Petinšestdeset odstotkov bolnikov je imelo M1c stadij, 9 % jih je imelo v anamnezi metastaze v možganih, 66 % jih predhodno ni prejemalo zdravljenja, 34 % pa jih je predhodno prejemalo eno zdravljenje.
Overall, 20 cHL patients ≥ 65 years were treated with pembrolizumab in studies KEYNOTE-087 and KEYNOTE-013.
Skupno 20 bolnikov s cHL, starih 65 let ali več, je bilo zdravljenih s pembrolizumabom v študijah KEYNOTE-087 in KEYNOTE-013.
• a kind of cancer called classical Hodgkin lymphoma
• vrste raka, imenovane klasični Hodgkinov limfom,
Pembrolizumab was administered prior to chemotherapy on Day 1.
Pembrolizumab je bil 1. dan uporabljen pred kemoterapijo.
Among patients who were evaluable for PD-L1 expression (79%), 69% (n=294) were PD-L1 positive and 31% (n=134) were PD-L1 negative.
Med bolniki, ki jih je bilo mogoče oceniti glede izraženosti PD-L1 (79 %), je bilo 69 % (n = 294) PD-L1 pozitivnih in 31 % (n = 134) PD-L1 negativnih.
The prescriber must discuss the risks of KEYTRUDA therapy with the patient.
Predpisovalec zdravila se mora o tveganjih, povezanih z zdravljenjem z zdravilom KEYTRUDA, pogovoriti z bolnikom.
You may experience more than one side effect at the same time.
Hkrati se vam lahko pojavi več neželenih učinkov.
In the Hodgkin lymphoma population, the ORR was 50.0%, 2 patients (11.1%) had a complete response and 7 patients (38.9%) had a partial response.
V populaciji s Hodgkinovim limfomom je bil ORR 50,0 %, pri 2 bolnikih (11,1 %) je prišlo do popolnega odgovora in pri 7 bolnikih (38,9 %) do delnega odgovora.
In this patient population, the median observation time was 7.3 months (range: 1 day to 31 months) and the most frequent adverse reactions with pembrolizumab were fatigue (32%), nausea (20%), and diarrhoea (20%).
V tej populaciji bolnikov je mediani čas opazovanja znašal 7,3 mesece (v razponu od 1 dneva do 31 mesecev), najpogostejši neželeni učinki zdravljenja s pembrolizumabom pa so bili utrujenost (32 %), navzea (20 %) in diareja (20 %).
PD-L1 expression was tested retrospectively by immunohistochemistry assay with the 22C3 anti-PD-L1 antibody; 84% of patients had PD-L1-positive melanoma (PD-L1 expression in ≥ 1% of tumour and tumour-associated immune cells relative to all viable tumour cells).
Izraženost PD-L1 so testirali retrospektivno z imunohistokemičnim testom s protitelesom 22C3 proti PD-L1; 84 % bolnikov je imelo PD-L1-pozitivni melanom (izraženost PD-L1 pri ≥ 1 % tumorskih in s tumorjem povezanih imunskih celic v primerjavi z vsemi razpoložljivimi tumorskimi celicami).
Sixtynine (44.8%) patients had 1 or more Grades 3 to 5 adverse reactions of which 6 (3.9%) patients had 1 or more adverse reactions that resulted in death.
Devetinšestdeset (44,8 %) bolnikov je imelo enega ali več neželenih učinkov od 3. do 5. stopnje, 6 od teh bolnikov (3,9 %) je imelo enega ali več neželenih učinkov, ki so povzročili smrt.
Pembrolizumab has not been studied in patients with severe renal impairment.
Pembrolizumaba niso raziskali pri bolnikih s hudo okvaro ledvic.
Patients should be monitored for changes in thyroid function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and clinical signs and symptoms of thyroid disorders.
Bolnike je treba spremljati glede sprememb delovanja ščitnice (na začetku zdravljenja, periodično med zdravljenjem in kot je indicirano glede na klinično oceno) ter kliničnih znakov in simptomov motenj delovanja ščitnice.
10.3 (6.7, NA)
10,3 (6,7; NP)
Tables 23 and 24 summarise key efficacy results for pembrolizumab in patients whose tumours expressed PD-L1 with a CPS ≥ 1 in KEYNOTE-048 at the final analysis performed at a median follow-up of 13 months for pembrolizumab in combination with chemotherapy and at a median follow-up of 11.5 months for pembrolizumab monotherapy.
Preglednici 23 in 24 povzemata ključna merila učinkovitosti za pembrolizumab v študiji KEYNOTE-048 pri bolnikih, ki imajo tumorje z izraženostjo PD-L1 s CPS ≥ 1, ob času končne analize, ki je bila opravljena po medianem času spremljanja 13 mesecev za pembrolizumab v kombinaciji s kemoterapijo in po medianem času spremljanja 11,5 meseca za samostojno zdravljenje s pembrolizumabom.
Among patients with BRAF mutant tumours, 139 (46%) were previously treated with a BRAF inhibitor.
Med bolniki, ki so imeli tumorje z mutacijo BRAF, jih je bilo 139 (46 %) predhodno zdravljenih z zaviralcem BRAF.
Table 18: Efficacy results in KEYNOTE-087 and KEYNOTE-013
Preglednica 18: Rezultati učinkovitosti v študijah KEYNOTE-087 in KEYNOTE-013
Seventy-four percent of patients had received Auto-SCT, 26% were transplant ineligible, and 45% of patients had prior radiation therapy.
Štiriinsedemdeset odstotkov bolnikov je prejelo avto-SCT, 26 % jih ni bilo primernih za presaditev in 45 % bolnikov je predhodno prejelo radioterapijo.
Secondary efficacy outcome measures were overall response rate (ORR) and response duration.
Sekundarni merili izida učinkovitosti sta bili celokupni delež odgovora (ORR - overall response rate) in trajanje odgovora.
The Kaplan-Meier curves for OS and PFS are shown in Figures 9 and 10.
Kaplan-Meierjevi krivulji za OS in PFS sta prikazani na slikah 9 in 10.
Animal reproduction studies have not been conducted with pembrolizumab; however, in murine models of pregnancy blockade of PD-L1 signaling has been shown to disrupt tolerance to the foetus and to result in an increased foetal loss (see section 5.3).
Podatkov o uporabi pembrolizumaba pri nosečnicah ni. S pembrolizumabom niso izvedli študij vpliva na sposobnost razmnoževanja na živalih, vendar pa so v modelih brejosti pri miših ugotovili, da zaviranje signalizacije PD-L1 okvari toleranco na plod in povzroči večjo izgubo plodov (glejte poglavje 5.3).
Blood and lymphatic system disorders Very common anaemia anaemia, neutropaenia, thrombocytopaenia
Bolezni krvi in limfatičnega sistema Zelo pogosti anemija anemija, nevtropenija, trombocitopenija
The Kaplan-Meier curve for OS for the TPS ≥ 50% population is shown in Figure 15.
Kaplan-Meierjeva krivulja celokupnega preživetja (OS) za TPS ≥ 50 % populacijo je prikazana na sliki 15.
Common pneumonitis pneumonitis pneumonitis
Pogosti pnevmonitis pnevmonitis pnevmonitis
Table 2: Adverse reactions in patients treated with pembrolizumab*
Preglednica 2: Neželeni učinki pri bolnikih, zdravljenih s pembrolizumabom*
% with duration ≥ 6 months
% s trajanjem ≥ 6 mesecev
Use of pembrolizumab for adjuvant treatment of patients with melanoma A trend toward increased frequency of severe and serious adverse reactions in patients ≥ 75 years was observed.
Uporaba pembrolizumaba pri adjuvantnem zdravljenju bolnikov z melanomom Pri bolnikih, starih ≥ 75 let, so opazili nagnjenost k povečani pogostnosti hudih in resnih neželenih učinkov.
Sixteen percent (16%) had disease progression following platinum-containing neoadjuvant or adjuvant chemotherapy, and 84% had received 1-2 prior systemic regimens for metastatic disease.
Pri šestnajstih odstotkih (16 %) bolnikov je bolezen napredovala po neoadjuvantnem ali adjuvantnem zdravljenju s kemoterapijo, ki je vključevala platino, 84 % bolnikov pa se je predhodno zdravilo z 1-2 režimoma sistemskega zdravljenja za metastatsko bolezen.
Preliminary data from an early review showed a reduced survival with pembrolizumab monotherapy in patients whose tumours express PD-L1 with a CPS < 10 compared with standard chemotherapy.
Preliminarni podatki iz zgodnjega pregleda so pokazali zmanjšano preživetje pri monoterapiji s pembrolizumabom pri bolnikih, pri katerih tumorji izražajo PD-L1 s CPS < 10, v primerjavi s standardno kemoterapijo.
Pneumonitis occurred more frequently in patients with a history of prior thoracic radiation (8.1%) than in patients who did not receive prior thoracic radiation (3.4%).
Pnevmonitis se je pojavil pogosteje pri bolnikih, ki so se predhodno zdravili z obsevanjem v predelu prsnega koša (8,1 %), kot pri bolnikih, ki se predhodno niso zdravili z obsevanjem v predelu prsnega koša (3,4 %).
Forty-five percent had no prior therapies for advanced melanoma.
Petinštirideset odstotkov jih predhodno ni bilo zdravljenih zaradi napredovalega melanoma.