natgillin/translations-raw huggingface dataset:
OS benefit was observed regardless of tumour PD-L1 expression level.
Korisni učinci na OS bili su opaženi neovisno o razini tumorske ekspresije PD-L1.
Figure 10: Kaplan-Meier curves of OS (CA209025)
Slika 10: Kaplan-Meierove krivulje za OS (CA209025)
PD-L1 expression < 1%
Ekspresija PD-L1 < 1%
The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of patients with locally advanced or metastatic urothelial carcinoma was evaluated in a phase 2, multicentre, openlabel, single-arm study (CA209275).
Sigurnost i djelotvornost nivolumaba u dozi od 3 mg/kg kao monoterapije za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom urotela ocjenjivale su se u multicentričnom, otvorenom ispitivanju faze 2 s jednom skupinom bolesnika (CA209275).
Resolution occurred in 31 patients (91.2%) with a median time to resolution of 6.1 weeks (range: 0.7-85.9+).
Nuspojave su se povukle u 31 bolesnika (91,2%), a medijan vremena do njihova povlačenja iznosio je 6,1 tjedan (raspon: 0,7-85,9+).
The majority of cases were Grade 1 or 2 in severity reported in 1.6% (41/2578) and 0.7% (18/2578) of patients respectively.
Većina slučajeva bila je 1. ili 2. stupnja težine, a prijavljeni su u 1,6% (41/2578) odnosno 0,7% (18/2578) bolesnika.
Median time to onset was 2.6 months (range: 0.7-12.6).
Medijan vremena do nastupa iznosio je 2,6 mjeseci (raspon: 0,7-12,6).
Objective response (95% CI) Odds ratio (95% CI) p-value
Objektivan odgovor (95% CI) Omjer vjerojatnosti (95% CI) p-vrijednost
For Grade 2 (symptomatic) pneumonitis, nivolumab or nivolumab in combination with ipilimumab should be withheld and corticosteroids initiated at a dose of 1 mg/kg/day methylprednisolone equivalents.
U slučaju (simptomatskog) pneumonitisa 2. stupnja, potrebno je odgoditi primjenu nivolumaba ili nivolumaba u kombinaciji s ipilimumabom i uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 1 mg/kg/dan metilprednizolona.
Intestinal perforation, inflammation of the stomach (gastritis), inflammation of the duodenum Skin disease with thickened patches of red skin, often with silvery scales (psoriasis), severe condition of the skin that causes red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body (erythema multiforme) Severe and possibly fatal peeling of the skin (Stevens-Johnson syndrome) Chronic disease of joints (spondyloarthropathy), disease in which the immune system attacks the glands that make moisture for the body, such as tears and saliva (Sjogren's syndrome), aching muscles, muscle tenderness of weakness, not caused by exercise (myopathy), inflammation of the muscles (myositis), stiffness in muscles and joints, muscle spasm (rhabdomyolysis), inflammation of the muscles causing pain or stiffness (polymyalgia rheumatica) Inflammation of the kidney
nalik na osip kod ospica, koja se prvo javlja na udovima, a ponekad i na licu te drugim dijelovima tijela (multiformni eritem) teško i moguće smrtonosno ljuštenje kože (Stevens-Johnsonov sindrom) kronična bolest zglobova (spondiloartropatija), bolest kod koje imunosni sustav napada žlijezde koje proizvode tekućine za vlaženje tijela, poput suza ili sline (Sjögrenov sindrom), bol u mišićima, osjetljivost mišića na dodir ili mišićna slabost koja nije uzrokovana tjelovježbom (miopatija), upala mišića (miozitis), ukočenost mišića i zglobova, grčenje mišića (rabdomioliza), upala mišića koja uzrokuje bol ili ukočenost (reumatska polimialgija) upala bubrega
Nivolumab+Ipilimumab (events: 29/68), median and 95% CI: N.A. (9.72, N.A.) ──Δ─── Nivolumab (events: 38/80), median and 95% CI: 21.95 (8.90, N.A.) Ipilimumab (events: 57/75), median and 95% CI: 3.94 (2.79, 4.21)
Nivolumab + ipilimumab (događaji: 29/68), medijan i 95% CI: N.D. (9,72; N.D.) ──Δ─── Nivolumab (događaji: 38/80), medijan i 95% CI: 21,95 (8,90; N.D.)
No Grade 5 cases were reported in these studies.
U tim ispitivanjima nije bio prijavljen nijedan slučaj 5. stupnja.
Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.39 (0.28, 0.54) Nivolumab vs. Ipilimumab - hazard ratio: 0.65 (0.48, 0.88) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.60 (0.43, 0.84)
Nivolumab + ipilimumab naspram ipilimumaba - omjer hazarda: 0,39 (0,28; 0,54) Nivolumab naspram ipilimumaba - omjer hazarda: 0,65 (0,48; 0,88) Nivolumab + ipilimumab naspram nivolumaba - omjer hazarda: 0,60 (0,43; 0,84)
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of rash was 65.0% (291/448).
U bolesnika s melanomom liječenih nivolumabom u dozi od 1 mg/kg u kombinaciji s ipilimumabom u dozi od 3 mg/kg, incidencija osipa iznosila je 65,0% (291/448).
Monitoring of thyroid function should continue to ensure appropriate hormone replacement is utilised.
Potrebno je nastaviti pratiti funkciju štitnjače kako bi se osigurala primjena odgovarajuće hormonske nadomjesne terapije.
The majority of cases were Grade 1 or 2 in severity reported in 3.5% (91/2578) and 1.2% (32/2578) of patients respectively.
Većina slučajeva bila je 1. ili 2. stupnja težine, a prijavljeni su u 3,5% (91/2578) odnosno 1,2% (32/2578) bolesnika.
Nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg**
Nivolumab u dozi od 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg**
Resolution occurred in 63 patients (72.4%) with a median time to resolution of 6.1 weeks (range: 0.1+-96.7+); + denotes a censored observation.
Nuspojave su se povukle u 63 bolesnika (72,4%), a medijan vremena do njihova povlačenja iznosio je 6,1 tjedan (raspon: 0,1+-96,7+); +
Grade 2 and Grade 3 hypopituitarism occurred in 0.4% (2/448) and 0.7% (3/448) of patients, respectively.
Hipopituitarizam 2. stupnja prijavljen je u 0,4% (2/448) bolesnika, a hipopituitarizam 3. stupnja u 0,7% (3/448) bolesnika.
Nephritis and Renal Dysfunction
Nefritis i bubrežna disfunkcija
Nivolumab+Ipilimumab (events: 59/123), median and 95% CI: N.A. (26.45, N.A.) ──Δ─── Nivolumab (events: 71/117), median and 95% CI: 23.46 months (13.01, 36.53) Ipilimumab (events: 77/113), median and 95% CI: 18.56 months (13.67, 23.20)
Nivolumab + ipilimumab (događaji: 59/123), medijan i 95% CI: N.D. (26,45; N.D.) ──Δ─── Nivolumab (događaji: 71/117), medijan i 95% CI: 23,46 mjeseci (13,01; 36,53) Ipilimumab (događaji: 77/113), medijan i 95% CI: 18,56 mjeseci (13,67; 23,20)
Nivolumab+Ipilimumab vs. Ipilimumab - hazard ratio: 0.42 (0.33, 0.54) Nivolumab vs. Ipilimumab - hazard ratio: 0.57 (0.45, 0.72) Nivolumab+Ipilimumab vs. Nivolumab - hazard ratio: 0.74 (0.58, 0.96)
Nivolumab + ipilimumab naspram ipilimumaba - omjer hazarda: 0,42 (0,33; 0,54) Nivolumab naspram ipilimumaba - omjer hazarda: 0,57 (0,45; 0,72) Nivolumab + ipilimumab naspram nivolumaba - omjer hazarda: 0,74 (0,58; 0,96)
Depending on your dose, the appropriate amount of OPDIVO will be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for injection before use.
Ovisno o Vašoj dozi, odgovarajuća količina lijeka OPDIVO će se prije primjene razrijediti otopinom natrijeva klorida za injekciju od 9 mg/ml (0,9%) ili otopinom glukoze za injekciju od 50 mg/ml (5%).
PD-L1 expression < 5%
Ekspresija PD-L1 < 5%
Nivolumab+Ipilimumab (events: 63/123), median and 95% CI: 11.24 (6.93, 23.03) ──Δ─── Nivolumab (events: 77/117), median and 95% CI: 2.83 (2.76, 5.13) Ipilimumab (events: 87/113), median and 95% CI: 2.79 (2.66, 2.96)
Nivolumab + ipilimumab (događaji: 63/123), medijan i 95% CI: 11,24 (6,93; 23,03) ──Δ─── Nivolumab (događaji: 77/117), medijan i 95% CI: 2,83 (2,76; 5,13) Ipilimumab (događaji: 87/113), medijan i 95% CI: 2,79 (2,66; 2,96)
Table 6: Adverse reactions with nivolumab in combination with ipilimumab Nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg*
Tablica 6: Nuspojave kod primjene nivolumaba u kombinaciji s ipilimumabom Nivolumab u dozi od 1 mg/kg u kombinaciji s ipilimumabom u dozi od
Resolution occurred in 428 patients (63.8%) with a median time to resolution of 17.1 weeks
Nuspojave su se povukle u 428 bolesnika (63,8%), a medijan vremena do njihova povlačenja iznosio je 17,1 tjedan (0,1-150,0+).
For symptomatic hyperthyroidism, nivolumab or nivolumab in combination with ipilimumab should be withheld and antithyroid medication should be initiated as needed.
U slučaju simptomatske hipertireoze, potrebno je odgoditi primjenu nivolumaba ili nivolumaba u kombinaciji s ipilimumabom i po potrebi uvesti antitireoidni lijek.
Patients with baseline performance score of 2, treated leptomeningeal metastases, ocular/uveal melanoma, autoimmune disease and patients who have had a Grade 3-4 adverse reaction that was related to prior anti-CTLA-4 therapy were included in study CA209172 (see section 5.1).
U ispitivanje CA209172 bili su uključeni bolesnici s početnim funkcionalnim statusom 2, liječenim leptomeningealnim metastazama, očnim/uvealnim melanomom, autoimunom bolešću i nuspojavom 3. - 4. stupnja povezanom s prethodnom anti-CTLA-4 terapijom (vidjeti dio 5.1).
Single-arm phase 2 study (CA209172)
Ispitivanje faze 2 sa samo jednom skupinom (CA209172)
The improvement in OS was similar between nivolumab in combination with ipilimumab and nivolumab monotherapy in patients with high tumour PD-L1 expression (PD-L1 ≥ 1%).
Poboljšanje OS-a u bolesnika s visokom razinom tumorske ekspresije PD-L1 (PD-L1 ≥ 1%) bilo je slično uz nivolumab u kombinaciji s ipilimumabom i nivolumab u monoterapiji.
In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of diarrhoea or colitis was 28.2% (154/547).
U bolesnika s RCC-om liječenih nivolumabom u dozi od 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg, incidencija proljeva ili kolitisa iznosila je 28,2% (154/547).
Grade 3 and 4 cases were reported in 0.4% (11/2578) and <0.1% (1/2578) of patients, respectively.
Slučajevi 3. stupnja prijavljeni su u 0,4% (11/2578) bolesnika, a slučajevi 4. stupnja u < 0,1% (1/2578) bolesnika.
To further investigate the value of biomarkers other than PD-L1 expression status at tumour cell membrane level by IHC (e.g., other genomic-based methods/ assays, and associated cut offs, that might prove more sensitive and specific in predicting response to treatment based on PD-L1, PD-L2, tumour infiltrating lymphocytes with measurement of CD8+T density, RNA signature, expression of components of antigen-presentation complexes and/or other inhibitory checkpoint receptors/ligands within tumour, etc.) as predictive of nivolumab + ipilimumab combination therapy efficacy in the context of melanoma studies CA209038, CA209067, or CA209069.
Dodatno istražiti vrijednost drugih bioloških biljega osim statusa ekspresije PD-L1 na razini tumorske stanične membrane koji se utvrđuje imunohistokemijom (npr. druge metode /testove utemeljene na genomici i pridružene granične vrijednosti, koje bi se mogle pokazati osjetljivijima i specifičnijima u predviđanju odgovora na liječenje na temelju PD-L1, PD-L2, limfocita koji infiltriraju tumore uz određivanje gustoće CD8+ T-stanica, RNK potpisa, ekspresije sastavnica antigen prezentirajućih kompleksa i/ili drugih inhibicijskih receptora/liganda koji služe kao kontrolne točke za imunosni sustav [engl. immune checkpoints] itd.)
In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 3.0% for anaemia (all Grade 3), 0.7% for thrombocytopaenia, 0.6% for leucopoenia, 5.1% for lymphopaenia, 1.1% for neutropaenia, 2.0% for increased alkaline phosphatase, 4.8% for increased AST, 6.5% for increased ALT, 1.1% for increased total bilirubin, 2.1% for increased creatinine, 7.2% for hyperglycaemia, 1.8% for hypoglycemia, 12.2% for increased amylase, 20.1% for increased lipase, 0.4% for hypocalcaemia, 1.3% for hypercalcaemia, 2.4% for hyperkalemia, 1.1% for hypermagnesaemia, 0.4% for hypomagnesaemia 1.9% for hypokalaemia, and 9.9% for hyponatraemia.
U bolesnika s RCC-om liječenih nivolumabom u dozi od 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg, udio bolesnika kod kojih je došlo do pogoršanja početnih laboratorijskih vrijednosti do 3. ili 4. stupnja bio je sljedeći: 3,0% za anemiju (svi slučajevi bili su 3. stupnja), 0,7% za trombocitopeniju, 0,6% za leukopeniju, 5,1% za limfopeniju, 1,1% za neutropeniju, 2,0% za povišene razine alkalne fosfataze, 4,8% za povišene razine AST-a, 6,5% za povišene razine ALT-a, 1,1% za povišene razine ukupnog bilirubina, 2,1% za povišene razine kreatinina, 7,2% za hiperglikemiju, 1,8% za hipoglikemiju, 12,2% za povišene razine amilaze, 20,1% za povišene razine lipaze, 0,4% za hipokalcijemiju,1,3% za hiperkalcijemiju, 2,4% za hiperkalijemiju, 1,1% za hipermagnezijemiju, 0,4% za hipomagnezijemiju, 1,9% za hipokalijemiju i 9,9% za hiponatrijemiju.
Inspect the OPDIVO concentrate for particulate matter or discoloration.
Provjerite sadrži li koncentrat lijeka OPDIVO čestice i je li promijenio boju.
Inflammation of the liver
Oštećenje funkcije jetre ili bubrega
The median age was 61 years (range: 21-85) with 38% ≥ 65 years of age and 8% ≥ 75 years of age.
Medijan dobi iznosio je 61 godinu (raspon: 21-85), uz 38% bolesnika u dobi od ≥ 65 godina i 8% u dobi od ≥ 75 godina.
The trial demonstrated a statistically significant improvement in RFS for patients randomised to the nivolumab arm compared with the ipilimumab 10 mg/kg arm. RFS benefit was consistently demonstrated across subgroups, including tumour PD-L1 expression, BRAF status, and stage of disease.
Korisni učinci na RFS bili su dosljedno primijećeni u svim podskupinama bolesnika, uključujući podskupine prema tumorskoj ekspresiji PD-L1, BRAF statusu i stadiju bolesti.
Median time to onset was 2.6 months (range: 0.2520.6).
Medijan vremena do nastupa iznosio je 2,6 mjeseci (raspon: 0,25-20,6).
Events Hazard ratioa
Ukupno preživljenje Događaji Omjer hazardaa
PD-L1 ≥ 1%, PD-L1+ TAIC abundantd
PD-L1 ≥ 1%, PD-L1+ TAIC obilnad (61 nivolumab, 47 izbor ispitivača)
In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of rash was 48.8% (267/547).
U bolesnika s RCC-om liječenih nivolumabom u dozi od 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg, incidencija osipa iznosila je 48,8% (267/547).
Median time to onset was 1.8 months (range: 0.0-26.6).
Medijan vremena do nastupa iznosio je 1,8 mjeseci (raspon: 0,0-26,6).
The majority of cases were Grade 1 or 2 in severity reported in 0.8% (21/2578) and 1.7% (44/2578) of patients respectively.
Većina slučajeva bila je 1. ili 2. stupnja težine, a prijavljeni su u 0,8% (21/2578) odnosno 1,7% (44/2578) bolesnika.
Randomised phase 3 study vs. chemotherapy (CA209037)
Randomizirano ispitivanje faze 3 naspram kemoterapije (CA209037)
The Kaplan-Meier curves for OS are shown in Figure 9.
Kaplan-Meierove krivulje za OS prikazane su na Slici 9.
Nivolumab 1 mg/kg in Combination with Ipilimumab 3 mg/kg
Nivolumab u dozi od 1 mg/kg u kombinaciji s ipilimumabom u dozi od 3 mg/kg
OPDIVO infusion
Infuzija lijeka OPDIVO
Treatment beyond initial investigator-assessed RECIST, version 1.1-defined progression was permitted if the patient had a clinical benefit, did not have rapid disease progression, and was tolerating study drug as determined by the investigator.
Liječenje nakon početne progresije koju je utvrdio ispitivač sukladno verziji 1.1 RECIST kriterija bilo je dopušteno ako je bolesnik prema ocjeni ispitivača ostvarivao kliničku korist, nije doživio brzu progresiju bolesti te je dobro podnosio ispitivani lijek.
In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of thyroid disorders was 27.2% (149/547).
U bolesnika s RCC-om liječenih nivolumabom u dozi od 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg, incidencija poremećaja štitnjače iznosila je 27,2% (149/547).
Patients with active autoimmune disease, symptomatic interstitial lung disease, or active brain metastases were excluded
U ispitivanje nisu bili uključeni bolesnici s aktivnom autoimunom bolešću, simptomatskom intersticijskom plućnom bolešću ili aktivnim metastazama u mozgu.
Grade 2, Grade 3, and Grade 4 cases were reported in 6.7% (30/448), 15.4% (69/448), and 1.8% (8/448) of patients, respectively.
Slučajevi 2. stupnja prijavljeni su u 6,7% (30/448) bolesnika, slučajevi 3. stupnja u 15,4% (69/448) bolesnika, a slučajevi 4. stupnja u 1,8% (8/448) bolesnika.
The Kaplan-Meier curves for OS are shown in Figure 12.
Kaplan-Meierove krivulje za OS prikazane su na Slici 12.
In patients treated with nivolumab 3 mg/kg in combination with ipilimumab 1 mg/kg in RCC, the incidence of nephritis or renal dysfunction was 8.8% (48/547).
U bolesnika s RCC-om liječenih nivolumabom u dozi od 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg, incidencija nefritisa ili bubrežne disfunkcije iznosila je 8,8% (48/547).
The Kaplan-Meier curves for OS are shown in Figure 10.
Kaplan-Meierove krivulje za OS prikazane su na Slici 10.
The prescribed dose for the patient is 240 mg or 480 mg given regardless of body weight depending on indication.
Nivolumab u monoterapiji: Propisana doza za bolesnika ovisi o indikaciji, a iznosi 240 mg ili 480 mg, neovisno o tjelesnoj težini.
Median time to onset was 1.4 months (range: 0.027.9).
Medijan vremena do nastupa iznosio je 1,4 mjeseca (raspon: 0,0-27,9).
or after diluting according to the following instructions: the final infusion concentration should range between 1 and 10 mg/mL.
Konačna koncentracija infuzije mora biti u rasponu od 1 do 10 mg/ml.
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the proportion of patients who experienced a worsening from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 2.8% for anaemia (all Grade 3), 1.2% for thrombocytopaenia, 0.5% for leucopoenia, 6.7% for lymphopaenia, 0.7% for neutropaenia, 4.3% for increased alkaline phosphatase, 12.4% for increased AST, 15.3% for increased ALT, 1.2% for increased total bilirubin, 2.4% for increased creatinine, 5.3% for hyperglycaemia, 8.7% for increased amylase, 19.5% for increased lipase, 1.2% for hypocalcaemia, 0.2% each for hypernatraemia and hypercalcaemia, 0.5% for hyperkalemia, 0.3% for hypermagnesaemia, 4.8% for hypokalaemia, and 9.5% for hyponatraemia.
U bolesnika s melanomom liječenih nivolumabom u dozi od 1 mg/kg u kombinaciji s ipilimumabom u dozi od 3 mg/kg, udio bolesnika kod kojih je došlo do pogoršanja početnih laboratorijskih vrijednosti do 3. ili 4. stupnja bio je sljedeći: 2,8% za anemiju (svi slučajevi bili su 3. stupnja), 1,2% za trombocitopeniju, 0,5% za leukopeniju, 6,7% za limfopeniju, 0,7% za neutropeniju, 4,3% za povišene razine alkalne fosfataze, 12,4% za povišene razine AST-a, 15,3% za povišene razine ALT-a, 1,2% za povišene razine ukupnog bilirubina, 2,4% za povišene razine kreatinina, 5,3% za hiperglikemiju, 8,7% za povišene razine amilaze, 19,5% za povišene razine lipaze, 1,2% za hipokalcijemiju, 0,2% za hipernatrijemiju i hiperkalcijemiju, 0,5% za hiperkalijemiju, 0,3% za hipermagnezijemiju, 4,8% za hipokalijemiju i 9,5% za hiponatrijemiju.
Renal Cell Carcinoma
Karcinom bubrežnih stanica
Symptomatic Grade 2 or 3 hypothyroidism, hyperthyroidism, hypophysitis,
Simptomatska hipotireoza, hipertireoza, hipofizitis 2. ili 3. stupnja Insuficijencija nadbubrežne žlijezde 2. stupnja
Confirmed objective response (95% CI) Odds ratio (95% CI) p-value
Potvrđen objektivan odgovor (95% CI) Omjer izgleda (95% CI) p-vrijednost
The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of patients with completely resected melanoma were evaluated in a phase 3, randomised, double-blind study (CA209238).
Sigurnost i djelotvornost monoterapije nivolumabom u dozi od 3 mg/kg za liječenje bolesnika nakon potpune resekcije melanoma ispitivane su u randomiziranom, dvostruko slijepom ispitivanju faze 3 (CA209238).
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of nephritis or renal dysfunction was 5.1% (23/448).
U bolesnika s melanomom liječenih nivolumabom u dozi od 1 mg/kg u kombinaciji s ipilimumabom u dozi od 3 mg/kg, incidencija nefritisa ili bubrežne disfunkcije iznosila je 5,1% (23/448).
Progression-free survival Rate (95% CI) at 60 months
Preživljenje bez progresije bolesti Stopa (95% CI) nakon 60 mjeseci
Median time to onset was 2.1 months (range: 0.0-16.1).
Medijan vremena do nastupa iznosio je 2,1 mjesec (raspon: 0,0-16,1).
At the time of this analysis, the hazard ratio was 0.66; (99.8% CI 0.48-0.91) with 166/425 events in the combination arm and 209/422 events in the sunitinib arm. At 18 months, the OS rate was 74.3 (95% CI 69.8-78.2) for nivolumab in combination with ipilimumab and 59.9 (95% CI 54.9-64.5) for sunitinib.
U trenutku provedbe te analize omjer hazarda iznosio je 0,66 (99,8% CI: 0,48-0,91), uz 166/425 događaja u skupini liječenoj kombiniranom terapijom i 209/422 događaja u skupini liječenoj sunitinibom.
8.7,22.2%), a median OS of 8.21 months (95% CI: 6.05,10.9), and a median PFS of 1.87 months (95% CI 1.77,3.15).
Nivolumab u dozi od 3 mg/kg ostvario je stopu ukupnog odgovora (engl. overall response rate, ORR) od 14,5% (95% CI: 8,7-22,2%), medijan OS-a od 8,21 mjeseca (95% CI: 6,05-10,9) i medijan PFS-a od 1,87 mjeseci (95% CI: 1,77-3,15).
Median time to onset was 1.2 months (range: 0.0-24.7).
Medijan vremena do nastupa iznosio je 1,2 mjeseca (raspon: 0,0-24,7).
Signs and symptoms may include muscle pain, stiffness, weakness, chest pain, or severe fatigue.
Znakovi i simptomi mogu uključivati bol, ukočenost i slabost mišića, bol u prsnom košu ili jak umor. odbacivanje presađenog solidnog organa (unutarnjeg organa čvrste građe). reakcija presatka protiv primatelja
Median (95% CI) months Rate (95% CI) at 12 months
Medijan (95% CI) (mjeseci) Stopa (95% CI) nakon 12 mjeseci
In patients treated with nivolumab 1 mg/kg in combination with ipilimumab 3 mg/kg in melanoma, the incidence of thyroid disorders was 25.2% (113/448).
U bolesnika s melanomom liječenih nivolumabom u dozi od 1 mg/kg u kombinaciji s ipilimumabom u dozi od 3 mg/kg, incidencija poremećaja štitnjače iznosila je 25,2% (113/448).
For Grade 2 or 3 serum creatinine elevation, nivolumab or nivolumab in combination with ipilimumab should be withheld, and corticosteroids should be initiated at a dose of 0.5 to 1 mg/kg/day methylprednisolone equivalents.
U slučaju povišenja razine kreatinina 2. ili 3. stupnja, potrebno je odgoditi primjenu nivolumaba ili nivolumaba u kombinaciji s ipilimumabom i uvesti liječenje kortikosteroidima u dozi ekvivalentnoj 0,5 do 1 mg/kg/dan metilprednizolona.
Grade 2 diarrhoea or colitis
Proljev ili kolitis 2. stupnja
Nivolumab 3 mg/kg in Combination with Ipilimumab 1 mg/kg
Nivolumab u dozi od 3 mg/kg u kombinaciji s ipilimumabom u dozi od 1 mg/kg
The safety and efficacy of nivolumab 3 mg/kg for the treatment of advanced (unresectable or metastatic) melanoma were evaluated in a phase 3, randomised, open-label study (CA209037).
Sigurnost i djelotvornost nivolumaba u dozi od 3 mg/kg za liječenje uznapredovalog (neresektabilnog ili metastatskog) melanoma ispitivane su u randomiziranom, otvorenom ispitivanju faze 3 (CA209037).
b 25/100 (25%) of the patients in CA209205 Cohort C presented B-Symptoms at baseline.
a18/80 (22,5%) bolesnika iz kohorte B u ispitivanju CA209205 pokazivalo je B-simptome na početku ispitivanja. b25/100 (25%) bolesnika iz kohorte C u ispitivanju CA209205 pokazivalo je B-simptome na početku ispitivanja.
The median age was 62 years (range: 21 to 85) with 34% ≥65 years of age and 7% ≥75 years of age.
Medijan dobi iznosio je 62 godine (raspon: 21-85), uz 34% bolesnika u dobi od ≥ 65 godina i 7% u dobi od ≥ 75 godina.
Grade 3 and 4 cases were reported in 0.7% (19/2578) and <0.1% (1/2578) of patients respectively.
Slučajevi 3. stupnja prijavljeni su u 0,7% (19/2578) bolesnika, a slučajevi 4. stupnja u < 0,1% (1/2578) bolesnika.