natgillin/translations-raw huggingface dataset:
Patients receiving placebo plus chemotherapy who experienced independently-verified progression of disease were offered pembrolizumab as monotherapy.
Bolnikom, ki so prejemali placebo in kemoterapijo, pri katerih je bolezen po neodvisni presoji napredovala, je bilo ponujeno samostojno zdravljenje s pembrolizumabom.
RFS Hazard ratio* (95% CI) RFS rate at 6 months
RFS razmerje ogroženosti* (95 % IZ) delež RFS po 6 mesecih
The median time to onset of nephritis was 5.0 months (range 12 days to 21.4 months).
Mediani čas do pojava nefritisa je bil 5,0 meseca (v razponu od 12 dni do 21,4 meseca).
Standard Treatment* n=133
standardno zdravljenje* n = 133
Patients were randomised (1:1) to receive either KEYTRUDA 200 mg every 3 weeks (n=270) or investigator's choice of any of the following chemotherapy regimens all given intravenously every 3 weeks (n=272): paclitaxel 175 mg/m
Bolnike so randomizirali (v razmerju 1:1) na zdravljenje bodisi z 200 mg zdravila KEYTRUDA na 3 tedne (n = 270) ali (po raziskovalčevi izbiri) z eno od naslednjih shem kemoterapije, ki so bile vse uporabljene intravensko na 3 tedne (n = 272): paklitaksel 175 mg/m (n = 84), docetaksel 75 mg/m
KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations.
Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za prvo linijo zdravljenja metastatskega nedrobnoceličnega pljučnega raka (NSCLC - non-small cell lung carcinoma) pri odraslih, ki imajo tumorje z ≥ 50 % izraženostjo PD-L1 (TPS - tumour proportion score) in brez pozitivnih tumorskih mutacij EGFR ali ALK.
Kaplan Meier curves for OS based on the final analysis are shown in Figures 13 and 14.
Kaplan-Meierjeve krivulje celokupnega preživetja na podlagi končne analize so prikazane na slikah 13 in 14.
The efficacy of pembrolizumab was evaluated in KEYNOTE-054, a multicentre, randomised, doubleblind, placebo-controlled trial in patients with completely resected stage IIIA (> 1 mm lymph node metastasis), IIIB or IIIC melanoma.
To je bilo multicentrično, randomizirano, dvojno slepo, s placebom nadzorovano preskušanje pri bolnikih s popolnoma kirurško odstranjenim melanomom v stadiju IIIA (> 1 mm metastaze v bezgavkah), IIIB ali IIIC.
Uncommon amylase increased blood bilirubin increased, amylase increased amylase increased
Občasni zvišana amilaza zvišan bilirubin v krvi, zvišana amilaza zvišana amilaza
The primary efficacy outcome measures were investigator-assessed recurrence-free survival (RFS) in the whole population and in the population with PD-L1 positive tumours, where RFS was defined as the time between the date of randomisation and the date of first recurrence (local, regional, or distant metastasis) or death, whichever occurs first.
RFS je bilo opredeljeno kot čas med datumom randomizacije in datumom prve ponovitve (lokalno, regionalno ali oddaljene metastaze) ali nastopa smrti, kar koli se je zgodilo prej.
Table 15: Efficacy Results in KEYNOTE-407
Preglednica 15: Rezultati učinkovitosti v študiji KEYNOTE-407
In patients with non-squamous NSCLC treated with pembrolizumab in combination with pemetrexed and platinum chemotherapy (n=488), the incidence of nephritis was 1.4% (all Grades) with 0.8% Grade 3 and 0.4% Grade 4.
Pri bolnikih z neploščatoceličnim NSCLC, ki so se zdravili s pembrolizumabom v kombinaciji s pemetreksedom in kemoterapijo na osnovi platine (n = 488), je pojavnost nefritisa znašala 1,4 % (vse stopnje).
Uncommon tenosynovitis tenosynovitis
Občasni tendosinovitis tendosinovitis
*Based on the stratified Cox proportional hazard model
*Na podlagi stratificiranega Coxovega modela sorazmernih ogroženosti
Guillain-Barré syndrome g,
Guillain-Barréjev sindrom g, miastenični sindrom h, meningitis (aseptični)
Based on the stratified Cox proportional hazard model Based on stratified log-rank test
Na podlagi stratificiranega Coxovega modela sorazmernih ogroženosti Na podlagi stratificiranega log-rank testa
Psychiatric disorders Common insomnia insomnia insomnia
Psihiatrične motnje Pogosti nespečnost nespečnost nespečnost
The median time to onset of hypothyroidism was 3.5 months (range 1 day to 19.6 months).
Mediani čas do pojava hipotiroidizma je bil 3,5 meseca (v razponu od 1 dneva do 19,6 meseca).
Favourable
ugodna
Figure 10: Kaplan-Meier Curve for Progression-Free Survival in KEYNOTE-407
Slika 10: Kaplan-Meierjeva krivulja preživetja brez napredovanja bolezni v študiji KEYNOTE-407
It is unknown whether pembrolizumab is secreted in human milk.
Ni znano, ali se pembrolizumab izloča v materino mleko.
Patients with the following conditions were excluded from clinical trials: active CNS metastases; ECOG PS ≥ 2 (except for urothelial carcinoma and RCC); HIV, hepatitis B or hepatitis C infection; active systemic autoimmune disease; interstitial lung disease; prior pneumonitis requiring systemic corticosteroid therapy; a history of severe hypersensitivity to another monoclonal antibody; receiving immunosuppressive therapy and a history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent) for greater than 12 weeks.
Bolniki, ki niso bili vključeni v klinična preskušanja V klinična preskušanja niso bili vključeni bolniki z: aktivnimi metastazami v osrednjem živčevju, oceno zmogljivosti ≥ 2 po ECOG lestvici (razen pri urotelijskem raku in raku ledvičnih celic), okužbo s HIV, hepatitisom B ali hepatitisom C, aktivno sistemsko avtoimunsko boleznijo, intersticijsko boleznijo pljuč, predhodnim pnevmonitisom, ki je zahteval sistemsko zdravljenje s kortikosteroidi, anamnezo hude preobčutljivosti za drugo monoklonsko protitelo, ki se zdravijo z imunosupresivi in z anamnezo hudih imunsko pogojenih neželenih učinkov med zdravljenjem z ipilimumabom, opredeljenih kot toksičnost 4. ali 3. stopnje, ki je zahtevala več kot 12 tedensko zdravljenje s kortikosteroidi (> 10 mg/dan prednizona ali ekvivalenta).
The recommended dose of KEYTRUDA as monotherapy is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes.
Priporočeni odmerek zdravila KEYTRUDA za samostojno zdravljenje je bodisi 200 mg na 3 tedne ali 400 mg na 6 tednov, apliciran z intravensko infuzijo v 30 minutah.
The median follow-up time was 12.8 months (range: 0.1 to 21.5 months).
Mediani čas spremljanja je znašal 12,8 meseca (v razponu od 0,1 do 21,5 meseca).
The diluted solution may be stored for up to 96 hours in a refrigerator (2°C - 8°C).
Razredčeno raztopino lahko shranjujete v hladilniku (2 °C - 8 °C) do skupno 96 ur.
Pituitary function and hormone levels should be monitored to ensure appropriate hormone replacement.
Za zagotovitev ustreznega nadomeščanja hormonov je treba spremljati delovanje ščitnice in vrednosti hormonov.
Patients were randomised (1:1) to one of the following treatment arms via intravenous infusion:
Bolnike so randomizirali (v razmerju 1:1) v eno od naslednjih terapevtskih skupin z uporabo intravenskega infundiranja:
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).
Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za zdravljenje lokalno napredovalega ali metastatskega urotelijskega raka pri odraslih, ki niso primerni za zdravljenje s kemoterapijo, ki vsebuje cisplatin, in imajo tumorje z izraženostjo PD-L1 ≥ 10, ocenjeno s kombinirano pozitivno oceno (CPS) (glejte poglavje 5.1).
The median duration was 1.8 months (range 4 days to 29.2+ months).
Njegovo mediano trajanje je bilo 1,8 meseca (v razponu od 4 dni do 29,2+ meseca).
Response: Best objective response as confirmed complete response or partial response Based on Miettinen and Nurminen method stratified by ECOG (0 vs. 1), HPV status (positive vs. negative) and PD-L1 status (strongly positive vs. not strongly positive)
Odgovor: najboljši objektivni odgovor, potrjen kot popolni oziroma delni odgovor Na podlagi Miettinenove in Nurminenove metode, stratificirane na podlagi ocene zmogljivosti po ECOG lestvici (0 v prim.
Combination with axitinib
Kombinirano zdravljenje z aksitinibom
The study population characteristics were: median age of 65 years (range: 29 to 88); 55% age 65 or older; 81% male; 77% White; ECOG performance status of 0 (29%) and 1 (71%); and 8% with treated brain metastases at baseline.
Značilnosti raziskovane populacije so bile: mediana starost 65 let (razpon: od 29 do 88), 55 % starih 65 let ali več, 81 % moških, 77 % belcev, ocena zmogljivosti po ECOG lestvici 0 (29 %) in 1 (71 %) in 8 % z izhodiščno že zdravljenimi metastazami v možganih.
Table 3 summarises key efficacy measures in patients naïve to treatment with ipilimumab at the final analysis performed after a minimum of 21 months of follow-up.
Preglednica 3 povzema ključna merila učinkovitosti končne analize, opravljene po najmanj 21 mesecih spremljanja, pri bolnikih, ki predhodno niso bili zdravljeni z ipilimumabom.
12-month OS rate, % (95% CI)
12-mesečni delež celokupnega preživetja (OS), % (95 % IZ)
The median trough concentrations (Cmin) at steady-state were approximately 22 mcg/mL at a dose of 2 mg/kg every 3 weeks and 29 mcg/mL at a dose of 200 mg every 3 weeks.
Mediana najmanjša koncentracija v stanju dinamičnega ravnovesja (Cmin) je bila ob odmerku 2 mg/kg na 3 tedne približno 22 µg/ml in ob odmerku 200 mg na 3 tedne 29 µg/ml.
Number (%) of patients with event Median in months (95% CI)
število (%) bolnikov z dogodkom mediana v mesecih (95 % IZ)
KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued for Grade 4 or recurrent Grade 3 immune-related adverse reactions, unless otherwise specified in Table 1.
Če v preglednici 1 ni navedeno drugače, je treba zdravilo KEYTRUDA, bodisi kot samostojno bodisi kot kombinirano zdravljenje, trajno ukiniti v primeru imunsko pogojenih neželenih učinkov 4. stopnje ali ponovitve takšnih neželenih učinkov 3. stopnje.
Ipilimumab 3 mg/kg every 3 weeks n=278
ipilimumab 3 mg/kg na 3 tedne n = 278
An analysis was performed in KEYNOTE-045 in patients who had PD-L1 CPS < 10 [pembrolizumab: n=186 (69%) vs. chemotherapy: n= 176 (65%)] or ≥ 10 [pembrolizumab: n=74 (27%) vs. chemotherapy: n= 90 (33%)] in both pembrolizumab- and chemotherapy-treated arms (see Table 20).
V študiji KEYNOTE-045 je bila narejena analiza pri bolnikih, ki so imeli PD-L1 CPS < 10 [pembrolizumab: n = 186 (69 %), kemoterapija: n = 176 (65 %)] ali ≥ 10 [pembrolizumab: n = 74 (27 %), kemoterapija: n = 90 (33 %)], v obeh skupinah - s pembrolizumabom in s kemoterapijo (glejte preglednico 20).
Pembrolizumab Monotherapy n=124
samostojno zdravljenje s pembrolizumabom n = 124
Among the 616 patients in KEYNOTE-189, baseline characteristics were: median age of 64 years (49% age 65 or older); 59% male; 94% White and 3% Asian; 43% and 56% ECOG performance status of 0 or 1 respectively; 31% PD-L1 negative (TPS < 1%); and 18% with treated or untreated brain metastases at baseline.
Pri 616 bolnikih v študiji KEYNOTE-189 so bile izhodiščne značilnosti naslednje: mediana starost 64 let (49 % bolnikov starih 65 let ali starejših), 59 % bolnikov moškega spola, 94 % bolnikov belcev in 3 % bolnikov Azijcev, 43 % bolnikov z oceno zmogljivosti 0 ter 56 % bolnikov z oceno zmogljivosti 1 po ECOG lestvici, 31 % bolnikov PD-L1 negativnih (TPS < 1 %) in 18 % bolnikov z zdravljenimi ali nezdravljenimi metastazami v možganih v izhodišču.
KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy (see section 5.1).
Zdravilo KEYTRUDA je kot samostojno zdravljenje indicirano za zdravljenje lokalno napredovalega ali metastatskega urotelijskega raka pri odraslih, predhodno zdravljenih s kemoterapijo, ki je vključevala platino (glejte poglavje 5.1).
Table 27: Efficacy of pembrolizumab 200 mg every 3 weeks in HNSCC patients with TPS ≥ 50% who were previously treated with platinum chemotherapy in KEYNOTE-040
Preglednica 27: Učinkovitost pembrolizumaba v odmerku 200 mg vsake 3 tedne pri bolnikih s HNSCC s TPS ≥ 50 %, ki so se predhodno zdravili s kemoterapijo, ki je vključevala platino, v študiji KEYNOTE-040
KEYNOTE-040: Controlled trial in HNSCC patients previously treated with platinum-containing chemotherapy
KEYNOTE-040: kontrolirano preskušanje pri bolnikih s HNSCC, ki so se predhodno zdravili s kemoterapijo, ki je vključevala platino
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Za navodila glede priprave in redčenja zdravila pred dajanjem glejte poglavje 6.6.
Eighty-one percent had a primary tumour in the lower tract, and 19% of patients had a primary tumour in the upper tract.
Enainosemdeset odstotkov jih je imelo primarni tumor v spodnjem traktu in 19 % v zgornjem traktu.
No dose adjustment is needed for patients with mild hepatic impairment.
Pri bolnikih z blago okvaro jeter prilagoditev odmerka ni potrebna.
OS HR (95% CI)
OS HR* (95 % IZ)
KEYTRUDA has not been studied in patients with severe renal impairment (see sections 4.4 and 5.2).
Pri bolnikih s hudo okvaro ledvic zdravilo KEYTRUDA ni raziskano (glejte poglavji 4.4 in 5.2).
The study excluded patients with autoimmune disease or a medical condition that required immunosuppression.
V študijo niso bili vključeni bolniki z avtoimunsko boleznijo in boleznimi, ki so zahtevale imunosupresijo.
EU/1/15/1024/001 (1 vial)
EU/1/15/1024/001 (1 viala)
Subgroup analyses by enrollment were performed in KEYNOTE-426 in patients with PD-L1 CPS ≥ 1 [pembrolizumab/axitinib combination: n=243 (56%) vs. sunitinib: n=254 (59%)]; CPS < 1 [pembrolizumab/axitinib combination: n=167 (39%) vs. sunitinib: n=158 (37%)], and in patients with IMDC risk categories of favourable [pembrolizumab/axitinib combination: n=138 (32%) vs. sunitinib: n=131 (31%)]; intermediate [pembrolizumab/axitinib combination: n=238 (55%) vs. sunitinib: n=246 (57%)]; and poor [pembrolizumab/axitinib combination: n=56 (13%) vs. sunitinib: n=52 (12%)].
V študiji KEYNOTE-426 so analize podskupin glede na vključitev izvedli pri bolnikih s PD-L1 CPS ≥ 1 [kombinacija pembrolizumab/aksitinib: n = 243 (56 %) v primerjavi s sunitinibom: n = 254 (59 %)], CPS < 1 [kombinacija pembrolizumab/aksitinib: n = 167 (39 %) v primerjavi s sunitinibom: n = 158 (37 %)] ter pri bolnikih s kategorijo tveganja IMDC ugodna [kombinacija pembrolizumab/aksitinib: n = 138 (32 %) v primerjavi s sunitinibom: n = 131 (31 %)], srednja [kombinacija pembrolizumab/aksitinib: n = 238 (55 %) v primerjavi s sunitinibom: n = 246 (57 %)] in slaba [kombinacija pembrolizumab/aksitinib: n = 56 (13 %) v primerjavi s sunitinibom: n = 52 (12 %)].
Patients were treated with pembrolizumab until unacceptable toxicity or disease progression.
Bolnike so s pembrolizumabom zdravili do nesprejemljivih toksičnih učinkov ali napredovanja bolezni.
• a kind of lung cancer called non-small cell lung cancer
• vrste pljučnega raka, imenovanega nedrobnocelični pljučni rak,
% (95% CI)
% (95 % IZ)
Patients were treated with pembrolizumab until disease progression or unacceptable toxicity.
Bolnike so s pembrolizumabom zdravili do napredovanja bolezni ali nesprejemljivih toksičnih učinkov.
The median duration was 0.9 months (range 1 day to 8.7+ months).
Njegovo mediano trajanje je bilo 0,9 meseca (v razponu od 1 dneva do 8,7+ meseca).
Not reached (NA, NA)
ni dosežena (NP; NP)
The primary efficacy outcome was OS in the ITT population.
Primarno merilo izida učinkovitosti je bilo celokupno preživetje (OS) v populaciji z-namenomzdravljenja (ITT - intent to treat).
Patients were randomised (2:1) to receive one of the following regimens:
Bolnike so randomizirali (v razmerju 2:1) na zdravljenje z enim od naslednjih režimov zdravljenja:
Rare myocarditis myocarditis k, pericarditis
Redki miokarditis miokarditis k,
Best Overall Response* by IRO ORR %, (95% CI) Complete response Partial response Disease Control Rate % Response Duration Median in months (range) % ongoing at 24 months PFS Median in months (95% CI) PFS rate at 12 months OS Median in months (95% CI)
najboljši celokupni odgovor* po IRO ORR %, (95 % IZ) popolni odgovor delni odgovor delež nadzora nad boleznijo % trajanje odgovora mediana v mesecih (razpon) % še trajajočih po 24 mesecih preživetje brez napredovanja bolezni (PFS) mediana v mesecih (95 % IZ) delež preživetja brez napredovanja bolezni po 12 mesecih celokupno preživetje (OS) mediana v mesecih (95 % IZ)
EU/1/15/1024/002 (1 vial)
EU/1/15/1024/002 (1 viala)
Use of pembrolizumab in urothelial carcinoma patients who have received prior platinum-containing chemotherapy
Uporaba pembrolizumaba pri bolnikih z urotelijskim rakom, predhodno zdravljenih s kemoterapijo, ki je vključevala platino
Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving pembrolizumab (see section 4.8).
Pri bolnikih, ki so prejemali pembrolizumab, so poročali o primerih Stevens-Johnsonovega sindroma (SJS) in toksične epidermalne nekrolize (TEN) (glejte poglavje 4.8).
* Based on the stratified Cox proportional hazard model Based on stratified log-rank test
* Na podlagi stratificiranega Coxovega modela sorazmernih ogroženosti Na podlagi stratificiranega log-rank testa
Hypophysitis resolved in 17 patients, 8 with sequelae.
Izzvenel je pri 17 bolnikih, pri 8 je pustil posledice.
• KEYTRUDA 200 mg every 3 weeks, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m2 every 3 weeks, and 5-FU 1,000 mg/m2/d 4 days continuous every
• zdravilo KEYTRUDA 200 mg na 3 tedne, karboplatin z AUC 5 mg/ml/min na 3 tedne ali cisplatin 100 mg/m2 na 3 tedne ter 5-fluorouracil 1.000 mg/m2/dan 4 dni zapored na 3 tedne
Use of pembrolizumab for first-line treatment of patients with HNSCC In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see section 4.8).
Uporaba pembrolizumaba za prvo linijo zdravljenja bolnikov s HNSCC Na splošno je bila pri kombiniranem zdravljenju s pembrolizumabom opažena večja pogostnost neželenih učinkov kot pri samostojnem zdravljenju s pembrolizumabom ali pri zdravljenju samo s kemoterapijo, kar odraža vpliv vsake od teh komponent zdravljenja (glejte poglavje 4.8).
• Placebo with pemetrexed 500 mg/m 2 and investigator's choice of cisplatin 75 mg/m or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by placebo and pemetrexed 500 mg/m intravenously every 3 weeks (n=206)
• placebo s pemetreksedom v odmerku 500 mg/m 2 in, po izbiri raziskovalca, s cisplatinom v odmerku 75 mg/m ali s karboplatinom (AUC 5 mg/ml/min) intravensko na vsake 3 tedne 4 cikle nato pa s placebom in pemetreksedom v odmerku 500 mg/m 2 intravensko na vsake
Table 6: Efficacy results by BRAF mutation status in KEYNOTE-002
Preglednica 6: Rezultati učinkovitosti glede na status mutacij BRAF v študiji KEYNOTE-002
Use of pembrolizumab for first-line treatment of patients with NSCLC In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see sections 4.2 and 4.8).
Uporaba pembrolizumaba za prvo linijo zdravljenja bolnikov z NSCLC Na splošno je bila pri kombiniranem zdravljenju s pembrolizumabom opažena večja pogostnost neželenih učinkov kot pri samostojnem zdravljenju s pembrolizumabom ali pri zdravljenju samo s kemoterapijo, kar odraža vpliv vsake od teh komponent zdravljenja (glejte poglavji 4.2 in 4.8).
Pneumonitis resolved in 138 patients, 2 with sequelae.
Izzvenel je pri 138 bolnikih, pri 2 je pustil posledice.
The median time to onset of hypophysitis was 5.9 months (range 1 day to 17.7 months).
Mediani čas do pojava hipofizitisa je bil 5,9 meseca (v razponu od 1 dneva do 17,7 meseca).
Standard Treatment* n=122
standardno zdravljenje* n = 122
Grade 4 or recurrent Grade 3
3. ali 4. stopnja trajno ukinite
The primary efficacy outcome measure was ORR as assessed by independent review using RECIST 1.1.
Primarno merilo izida učinkovitosti je bil ORR, ocenjen po neodvisni presoji na podlagi RECIST 1.1.
KEYNOTE-052: Open label trial in urothelial carcinoma patients ineligible for cisplatin-containing chemotherapy
KEYNOTE-052: odprto preskušanje pri bolnikih z urotelijskim rakom, ki niso primerni za zdravljenje s kemoterapijo, ki vključuje cisplatin
Table 7: Efficacy results by BRAF mutation status in KEYNOTE-006
Preglednica 7: Rezultati učinkovitosti glede na status mutacij BRAF v študiji KEYNOTE-006
There were no notable effects in the male and female reproductive organs in monkeys based on 1-month and 6-month repeat dose toxicity studies (see section 5.3).
V 1- in 6-mesečnih študijah toksičnosti ponavljajočih se odmerkov pri opicah niso zaznali opaznih učinkov na spolne organe samcev in samic (glejte poglavje 5.3).
Table 14: Efficacy results by PD-L1 Expression in KEYNOTE-189
Preglednica 14: Rezultati učinkovitosti glede na izraženost PD-L1 v študiji KEYNOTE-189
Table 16: Efficacy results by PD-L1 Expression in KEYNOTE-407
Preglednica 16: Rezultati učinkovitosti glede na izraženost PD-L1 v študiji KEYNOTE-407
• a kind of cancer called bladder cancer (urothelial carcinoma)
• vrste raka, imenovane rak sečnega mehurja (urotelijski rak),
Renal cell carcinoma KEYNOTE-426: Controlled trial of combination therapy in RCC patients naïve to treatment The efficacy of pembrolizumab in combination with axitinib was investigated in KEYNOTE-426, a randomised, multicentre, open-label, active-controlled trial conducted in patients with advanced RCC with clear cell component, regardless of PD-L1 tumour expression status and International Metastatic RCC Database Consortium (IMDC) risk group categories.
Učinkovitost pembrolizumaba v kombinaciji z aksitinibom so preučevali v študiji KEYNOTE-426, to je randomiziranem, multicentričnem, odprtem, z učinkovino nadzorovanem preskušanju pri bolnikih z napredovalim rakom ledvičnih celic s svetlocelično komponento, ne glede na izraženost PD-L1 tumorja in ne glede na kategorijo tveganja po IMDC (International Metastatic RCC Database Consortium).
Gastrointestinal disorders Very common diarrhoea, abdominal pain m, nausea, vomiting, constipation diarrhoea, nausea, vomiting, constipation, abdominal pain diarrhoea, abdominal pain m, nausea, vomiting, constipation
Bolezni prebavil Zelo pogosti diareja, bolečine v trebuhu m, navzea, bruhanje, zaprtost diareja, navzea, bruhanje, zaprtost, bolečine v trebuhu diareja, bolečine v trebuhu m, navzea, bruhanje, zaprtost
Assessment of tumour status was performed at 9 weeks after the first dose, then every 6 weeks through the first year, followed by every 12 weeks thereafter.
Stanje tumorja so ocenili 9 tednov po prvem odmerku, potem na 6 tednov prvo leto, pozneje pa na 12 tednov.
Secondary efficacy outcome measures were OS and ORR (as assessed by BICR using RECIST 1.1).
Sekundarni merili izida učinkovitosti sta bili OS in ORR (po oceni BICR z uporabo RECIST 1.1).
IIIC ≥ 4 positive lymph nodes) and geographic region (North America, European countries, Australia and other countries as designated).
Randomizacija je bila stratificirana glede na stadije po 7. izdaji kriterijev Ameriškega združenja za zdravljenje raka (AJCC - American Joint Committee on Cancer) (IIIA v primerjavi s IIIB v primerjavi s IIIC (1-3 pozitivne bezgavke) v primerjavi s IIIC (≥ 4 pozitivne bezgavke)) in geografsko področje (Severna Amerika, evropske države, Avstralija in druge države, kot je bilo določeno).