natgillin/translations-raw huggingface dataset:
There are limited data in patients with malignant pleural mesothelioma treated with ALIMTA alone.
O bolnikih z malignim plevralnim mezoteliomom, zdravljenih samo z ALIMTO, so na voljo le omejeni podatki.
ALIMTA at a dose of 500 mg/ m2 was studied as a single-agent in 64 chemonaive patients with malignant pleural mesothelioma.
ALIMTO kot edino učinkovino so preučevali v odmerku 500 mg/ m2 pri 64 bolnikih z malignim plevralnim mezoteliomom, ki predhodno še niso prejemali kemoterapije.
The overall response rate was 14.1%.
Povprečna stopnja odzivnosti je bila 14, 1%.
A multicentre, randomised, open label phase 3 study of ALIMTA versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treated with ALIMTA (Intent To Treat population n = 283) and 7.9 months for patients treated with docetaxel (ITT n = 288).
Multicentrična, randomizirana študija faze 3 z znanim zdravilom, kjer so preskušali ALIMTO v primerjavi z docetakselom pri bolnikih z lokalno napredovalim ali metastatskim NSCLC po predhodni kemoterapiji, je pokazala mediano časa preživetja 8, 3 mesece pri bolnikih, zdravljenih z ALIMTO (Populacija z namenom zdraviti n = 283), in 7, 9 mesecev pri bolnikih, zdravljenih z docetakselom (NZ n = 288).
An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of ALIMTA versus docetaxel for other than predominantly squamous histologies (n=399, 9.3 versus 8.0 months, adjusted HR = 0.78; 95% CI =0 .61-1.00, p =0.047) and was in favour of docetaxel for squamous cell carcinoma histology (n=172, 6.2 versus 7.4 months, adjusted HR = 1.56; 95% CI =1.08-2.26, p =0.018).
Analiza vpliva histologije NSCLC glede učinka zdravljenja na skupno preživetje je bila prednostna za ALIMTO proti docetakselu pri tistih, ki nimajo pretežno luskaste histologije (n = 399, 9, 3 proti 8, 0 mesecev, prilagojen RT = 0, 78; 95% IZ = 0, 61- 1, 00, p = 0, 047) in je bila prednostna za docetaksel za luskasto celično histologijo karcinoma (n = 172, 6, 2 proti 7, 4 mesecev, prilagojen RT = 1, 56; 95% IZ = 1, 08- 2, 26, p = 0, 018).
There were no clinically relevant differences observed for the safety profile of ALIMTA within the histology subgroups.
Za varnostni profil ALIMTE niso opazili nobenih klinično pomembnih razlik znotraj histoloških podskupin.
Limited clinical data from a separate randomized, Phase 3, controlled trial, suggest that efficacy data (overall survival, progression free survival) for pemetrexed are similar between patients previously pre treated with docetaxel (n=41) and patients who did not receive previous docetaxel treatment (n=540).
Omejeni klinični podatki iz ločeno randomiziranih, kontroliranih preskušanj faze 3, nakazujejo, da so podatki o učinkovitosti (skupno preživetje, preživetje brez napredovanja) za pemetreksed podobni med
Efficacy of ALIMTA vs docetaxel in NSCLC - ITT Population
13 bolniki, ki so bili predhodno zdravljeni z doksatakselom (n = 41) in bolniki, ki niso prejeli predhodnega zdravljenja z doksatakselom (n = 540).
Survival Time (months) Median (m) 95% CI for median HR
Učinkovitost ALIMTE v primerjavi z docetakselom pri NSCLC - Populacija NZ Čas preživetja (meseci)
(n = 288) 7.9 (6.3 - 9.2)
Docetaksel (n = 288)
95% CI for HR Non-inferiority p-value (HR)
95% IZ za mediano
(.82 - 1.20) .226
(6, 3 - 9, 2)
Progression free survival (months) Median HR (95% CI)
95% IZ za RT Prednostna p- vrednost (RT)
0.97 (.82 – 1.16)
(0, 82 - 1, 20) 0, 226 (n = 288)
Time to treatment failure (TTTF – months) Median HR (95% CI)
RT (95% IZ)
Response rate (%) (95% CI) Stable disease (%)
Stopnja odzivnosti (%) (95% IZ)
9.1 (5.9 - 13.2) 45.8
9, 1 (5, 9 - 13, 2)
8.8 (5.7 - 12.8) 46.4
8, 8 (5, 7 - 12, 8)
CI = confidence interval; HR = hazard ratio; ITT = intent to treat; n = total population size.
IZ = interval zaupanja; RT = razmerje tveganja; NZ = namen zdraviti; n = velikost populacije.
14 A multicentre, randomised, open-label, Phase 3 study of ALIMTA plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that ALIMTA plus cisplatin (Intent-To-Treat [ITT] population n = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n = 863) in overall survival (adjusted hazard ratio 0.94; 95% CI 0.84-1.05).
Multicentrična, randomizirana, odprta študija faze 3 ALIMTE skupaj s cisplatinom proti gemcitabinu skupaj s cisplatinom pri bolnikih, ki v preteklosti še niso prejemali kemoterapije, z lokalno napredovalim ali metastatskim (stopnja IIIb ali IV) nedrobnoceličnim karcinomom pljuč (NSCLC), je pokazala, da je ALIMTA skupaj s cisplatinom (Populacija z namenom zdraviti, [NZ] populacija n = 862) dosegla prvotno končno točko in pokazala podobno klinično učinkovitost, kot gemcitabin skupaj s cisplatinom (NZ n = 863) v skupnem preživetju (prilagojeno razmerje tveganja 0, 94; 95% IZ = 0, 84- 1, 05).
Sensitivity analyses of main efficacy endpoints were also assessed on the Protocol Qualified (PQ) population.
Analize občutljivosti glavne končne točke učinkovitosti so ocenili tudi s s protokolom kvalificirano (PK) populacijo.
Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for ALIMTA plus cisplatin versus 5.1 months for gemcitabine plus cisplatin (adjusted hazard ratio 1.04; 95% CI 0.94-1.15), and overall response rate was 30.6% (95% CI 27.3- 33.9) for ALIMTA plus cisplatin versus 28.2% (95% CI 25.0-31.4) for gemcitabine plus cisplatin.
Preživetje brez napredovanja (PBN) in celokupno razmerje odziva sta bila podobna med vejama zdravljenja: mediana PBN je bila 4, 8 mesecev za ALIMTO skupaj s cisplatinom proti 5, 1 mesecev za gemcitabin skupaj s cisplatinom (prilagojeno razmerje tveganja 1, 04; 95% IZ 0, 94- 1, 15) in celokupno razmerje odziva je bilo 30, 6% (95% IZ 27, 3- 33, 9) za ALIMTO skupaj s cisplatinom proti 28, 2% (95% IZ 25, 0- 31, 4) za gemcitabin skupaj s cisplatinom.
PFS data were partially confirmed by an independent review (400/ 1725 patients were randomly selected for review).
PBN podatki so bili delno potrjeni z neodvisnim pregledom (400/ 1725 bolnikov je bilo naključno izbranih za pregled).
ITT Population
Učinkovitost ALIMTE skupaj s cisisplatinom proti gemcitabinu skupaj s cisplatinom pri prvem izboru nedrobnoceličnega carcinoma pljuč – NZ populacija in histološke podskupine
Median Overall Survival in Months
14 Mediana skupnega preživetja v mesecih Prilagojeno NZ populacija
Hazard Ratio Superiority (HR) p-value
in histološke
Subgroups
tveganja
Gemcitabine + Cisplatin
Gemcitabin + Cisplatin
(95% CI) a
(95% IZ) NZ populacija
ITT Population
N = 862 10, 3 N = 863 0, 94
10.3 N=862
10, 3 N = 862 10, 3
10.3 N=863
N = 863
(9.8 – 11.2)
(9, 8– 11, 2)
(9.6 – 10.9)
(9, 6– 10, 9)
0.84
(0, 84– 1, 05)
(10.7 – 13.6)
Adenokarcinom
(10.2
12, 6
– 11.9)
N = 436
(0.71– 0.99)
10, 9
N=77
N = 411
0.67
0, 84
0.027
0, 033
(N=153)
(N = 847)
(8.6
(10, 7– 13, 6)
– 14.1)
(10, 2– 11, 9)
(5.5 – 9.0)
(0, 71– 0, 99)
(0.48– 0.96)
Velike celice (N = 153)
Other
10, 4 (8, 6– 14, 1)
8.6
N = 76
N=106
6, 7 (5, 5– 9, 0)
9.2
N = 77
N=146
0, 67 (0, 48– 0, 96)
1.08
0, 027
0.586
Drugo (N = 252)
(N=252)
8, 6 (6, 8– 10, 2)
(6.8
N = 106
– 10.2)
9, 2 (8, 1– 10, 6)
(8.1 – 10.6)
N = 146
(0.81– 1.45)
1, 08 (0, 81– 1, 45)
Squamous Cell (N=473)
0, 586
(8.4
Luskaste celice (N = 473)
9.4 – 10.2)
9, 4 (8, 4– 10, 2)
10.8 (9.5 – 12.1)
10, 8 (9, 5– 12, 1)
CI = confidence interval; ITT = intent-to-treat; N = total population size. a Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p < 0.001).
IZ = interval zaupanja; NZ = namen zdraviti; N = velikost populacije. aStatistično pomembna za prednost, s celotnim intervalom zaupanja za RT znatno pod 1, 17645 mejo prednosti (p < 0, 001).
15 Kaplan Meier Plots of Overall Survival by Histology
Kaplan Meier- jeva grafa skupnega preživetja glede na histologijo
1.0
A+C
Large Cell Carcinoma
Karcinom velikih celic
0.9
A+C
Survival Probability Survival Probability
Survival Probability Verjetnost preživetja
Survival Time (months)
Survival Time (meseci)
Survival Time (months)
Survival Time (months) Čas preživetja (meseci)
There were no clinically relevant differences observed for the safety profile of ALIMTA plus cisplatin within the histology subgroups.
Za varnostni profil ALIMTE niso opazili nobenih klinično pomembnih razlik znotraj histoloških podskupin.
Patients treated with ALIMTA and cisplatin required fewer transfusions (16.4% versus 28.9%, p < 0.001), red blood cell transfusions (16.1% versus 27.3%, p < 0.001) and platelet transfusions (1.8% versus 4.5%, p=0.002).
Bolniki zdravljeni z ALIMTO in cisplatinom so potrebovali manj transfuzij (16, 4% proti 28, 9%, p < 0, 001), transfuzij rdečih krvničk (16, 1% proti 27, 3%, p < 0, 001) in transfuzij krvnih ploščic (1, 8% proti 4, 5%, p = 0, 002).
Patients also required lower administration of erythropoietin/ darbopoietin (10.4% versus 18.1%, p < 0.001), G-CSF/ GM-CSF (3.1% versus 6.1%, p=0.004), and iron preparations (4.3% versus 7.0%, p=0.021).
Bolniki so potrebovali tudi nižje odmerjanje eritropoetin/ darbopoetina (10, 4% proti 18, 1%, p < 0, 001), G- CSF/ GM- CSF (3, 1% proti 6, 1%, p = 0, 004) in pripravkov z železom (4, 3% proti 7, 0%, p = 0, 021).
The pharmacokinetic properties of pemetrexed following single-agent administration have been evaluated in 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/ m2 infused over a 10-minute period.
Farmakokinetične lastnosti pemetrekseda po dajanju ene učinkovine so vrednotili pri 426 bolnikih z različnimi malignimi trdnimi tumorji v razponu odmerkov od 0, 2 do 838 mg/ m2, infundiranih v 10 minutah.
Pemetrexed has a steady-state volume of distribution of 9 l/ m2.
Pemetreksed ima volumen porazdelitve v stanju dinamičnega ravnovesja 9 l/ m2.
In vitro studies indicate that pemetrexed is approximately 81% bound to plasma proteins.
Študije in vitro kažejo, da se pemetreksed približno 81% veže na plazemske beljakovine.
Pemetrexed is primarily eliminated in the urine, with 70% to 90% of the administered dose being recovered unchanged in urine within the first 24 hours following administration.
Celotni sistemski očistek pemetrekseda je 91, 8 ml/ min, razpolovni čas izločanja iz plazme je 3, 5 ur pri bolnikih z normalnim ledvičnim
Pemetrexed total systemic clearance is 91.8 ml/ min and the elimination half-life from plasma is 3.5 hours in patients with normal renal function (creatinine clearance of 90 ml/ min).
15 delovanjem (očistek kreatinina 90 ml/ min).
Between patient variability in clearance is moderate at 19.3%.
Variabilnost med bolniki v očistku je zmerna, 19, 3%.
In a study conducted in beagle dog by intravenous bolus injection for 9 months, testicular findings (degeneration/ necrosis of the seminiferous epithelium) have been observed.
V 9- mesečni študiji, ki so jo izvedli na psih pasme beagle tako, da so jim dajali intravenske injekcije v bolusu, so opazovali spremembe na testisih (degeneracija/ nekroza seminifernega epitelija).
16 Pemetrexed was not mutagenic in either the in vitro chromosome aberration test in Chinese hamster ovary cells, or the Ames test.
Pemetreksed ni bil mutagen niti v testu kromosomskih aberacij in vitro na celicah jajčnika kitajskih hrčkov niti v testu Ames.
Pemetrexed is physically incompatible with diluents containing calcium, including lactated Ringer’ s Injection and Ringer’ s Injection.
Pemetreksed je fizikalno neskladen z razredčili, ki vsebujejo kalcij, vključujoč raztopino Ringerjevega laktata ter Ringerjevo raztopino.
In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti tega zdravila ne smemo mešati z drugimi zdravili.
Reconstituted and Infusion Solutions:
Pripravljene raztopine in raztopine za infundiranje:
When prepared as directed, reconstituted and infusion solutions of ALIMTA contain no antimicrobial preservatives.
Po pripravi, skladni z navodili, pripravljene raztopine in raztopine ALIMTE za infundiranje ne vsebujejo nobenih protimikrobnih konzervansov.
Chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature or 25°C.
Kemijsko in fizikalno obstojnost za uporabo pripravljenih raztopin pemetrekseda in raztopin pemetrekseda za infundiranje so pokazali za 24 ur v hladilniku ali pri temperaturi 25 °C.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution / dilution has taken place in controlled and validated aseptic conditions.
Če zdravila, pripravljenega za uporabo, ne uporabimo takoj, je za čase shranjevanja in pogoje pred uporabo odgovoren uporabnik, in naj bi običajno ne presegali 24 ur pri 2 do 8 °C, v kolikor nismo priprave/ redčenja opravili v nadzorovanih in validiranih aseptičnih pogojih.
Unopened vial:
Neodprta viala:
For storage conditions of the reconstituted medicinal product see section 6.3.
16 Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6. 3.
Powder in Type I glass vial.
Prašek v stekleni viali tipa I.
Rubber stopper.
Gumijasta zaporka.
17 6.6 Special precautions for disposal and other handling
6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Use aseptic technique during the reconstitution and further dilution of pemetrexed for intravenous infusion administration.
Pri pripravi in nadaljnjemu redčenju pemetrekseda za intravensko infundiranje uporabljajte aseptično metodo.
Calculate the dose and the number of ALIMTA vials needed.
Izračunajte odmerek in število potrebnih vial ALIMTE.
Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection, without preservative, resulting in a solution containing 25 mg/ ml pemetrexed.
100 mg viale pripravite s 4, 2 ml natrijevega klorida 9 mg/ ml (0, 9%) raztopine za injiciranje brez konzervansa, tako dobite raztopino, ki vsebuje 25 mg/ ml pemetrekseda.
The pH of the reconstituted solution is between 6.6 and 7.8.
Raztopina, ki jo dobite, je bistra, brezbarvna do rumena ali zeleno- rumena, barve v tem razponu ne vplivajo na kakovost zdravila. pH pripravljene raztopine je med 6, 6 in 7, 8.
The appropriate volume of reconstituted pemetrexed solution should be further diluted to 100 ml with sodium chloride 9 mg/ ml (0.9%) solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Ustrezno prostornino pripravljene raztopine pemetrekseda moramo še nadalje redčiti do 100 ml z 9 mg/ ml (0, 9%) raztopino za injiciranje natrijevega klorida brez konzervansa, damo jo kot intravensko infuzijo, ki teče 10 minut.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Videz parenteralnih zdravil je treba pred dajanjem vizualno pregledati, da ne vsebujejo trdnih delcev ali da niso razbarvane.
Eli Lilly Nederland B. V., Grootslag 1-5, NL-3991 RA, Houten, The Netherlands.
Eli Lilly Nederland B. V., Grootslag 1- 5, NL- 3991 RA, Houten, Nizozemska.
Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Vsaka viala vsebuje 500 mg pemetrekseda (v obliki dinatrijevega pemetrekseda).
Each vial must be reconstituted with 20 ml of sodium chloride 9 mg/ ml (0.9%) solution for injection resulting in 25 mg/ ml of solution.
Vsako vialo moramo pripraviti z 20 ml natrijevega klorida 9 mg/ ml (0, 9%) raztopine za injiciranje, da dobimo raztopino s koncentracijo 25 mg/ ml.
19 ALIMTA as single agent:
19 ALIMTA kot samostojno zdravilo:
20 Table 2 - Dose Modification Table for ALIMTA (as single agent or in combination) and Cisplatin– Non-haematologic Toxicities a, b
(National Cancer Institute Common Toxicity Criteria, CTC v2. 0; NCI 1998), definiciji za ≥ CTC stopnjo krvavitve 2
Dose of ALIMTA 2 (mg/ m)
Z zdravljenjem nadaljujemo skladno s smernicami v Preglednici 2.
Any Grade 3 or 4 toxicities except mucositis
20
National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) b Excluding neurotoxicity
Merila pogostih toksičnosti Nacionalnega inštituta za rakava obolenja (CTC v2. 0; NCI 1998) b Brez nevrološke toksičnosti
CTCa Grade
Stopnja CTC a *
Breast-feeding must be discontinued during pemetrexed therapy (see section 4.6).
Med zdravljenjem s pemetreksedom je treba dojenje prekiniti (glejte poglavje 4. 6).
21 Concomitant yellow fever vaccine (see section 4.5).
Sočasno cepljenje proti rumeni mrzlici (glejte poglavje 4. 5).
22 recommended.
22 Pemetreksed lahko ima gensko škodljive učinke.
Women of childbearing potential must use effective contraception during treatment with pemetrexed (see section 4.6).
Ženske v rodni dobi morajo v času zdravljenja s pemetreksedom uporabljati učinkovito kontracepcijo (glejte poglavje 4. 6).
Use an inactivated vaccine where it exists (poliomyelitis) (see section 4.4).
Tveganje je povečano
23 4.6 Pregnancy and lactation
23 pri ljudeh, ki imajo že zaradi svoje osnovne bolezni oslabljeno delovanje imunskega sistema.
There are no data from the use of pemetrexed in pregnant women but pemetrexed, like other anti-metabolites, is suspected to cause serious birth defects when administered during pregnancy.
Podatkov o uporabi pemetrekseda pri nosečnicah ni, a za pemetreksed, kot za druge anti- metabolite, sumimo, da povzroča resne prirojene okvare, če ga dajemo med nosečnostjo.
24 System Organ
24 Organski
*Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “ creatinine clearance decreased” ** which is derived from the term “ renal/ genitourinary other”. *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
* Glejte CTC Nacionalnega inštituta za rakava obolenja, različico 2, za vsako stopnjo toksičnosti, razen izraza “ znižan očistek kreatinina ”. **, ki izhaja iz izraza “ ledvični/ sečila drugo ”. *** V skladu z CTC Nacionalnega inštituta za rakava obolenja (v2. 0; NCI 1998), motnje okusa in alopecija morata biti poročana kot stopnja 1 ali 2.
25 Very common ≥ 10%; Common is normally defined as ≥ 1% and < 10%.
Zelo pogosto > 10%; Pogosto so običajno definirani kot > 1% in < 10%.
Clinically relevant CTC toxicities that were reported in ≥ 1% and < 5% (common) of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
25 Klinično pomembne CTC toksičnosti, o katerih so poročali pri > 1% in < 5% (pogosto) bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala cisplatin in pemetreksed, vključujejo: odpoved ledvic, okužbo, pireksijo, febrilno nevtropenijo, povišane AST, ALT in GGT, koprivnico in bolečino v prsnem košu.
Very Common
Bolezni kože Zelo in podkožja pogosto
Very common ≥ 10%; Common is normally defined as ≥ 1% and < 10%.
26 Zelo pogosto > 10%; Pogosto so običajno definirani kot > 1% in < 10%.
26 Clinically relevant CTC toxicities that were reported in ≥ 1% and < 5% (common) of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/ hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Klinično pomembne CTC toksičnosti, o katerih so poročali pri > 1% in < 5% (pogosto) bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: okužbo brez nevtropenije, febrilno nevtropenijo, alergijsko reakcijo/ preobčutljivost, povišan kreatinin, motorično nevropatijo, senzorično nevropatijo, multiformni eritem in bolečino v trebuhu.
27 System Organ Class
Organski sistem
Diarrhea without colostomy
Diareja brez kolostomije
44.9
27
28 Clinically relevant toxicity that was reported in < 1% (uncommon) of the patients that were randomly assigned to receive cisplatin and pemetrexed include:
Klinično pomembne toksičnosti, o katerih so poročali pri < 1% (občasno) bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: povišanje GGT, bolečino v prsnem košu, aritmijo in motorično nevropatijo.
During post marketing surveillance, the following adverse reactions have been reported in patients treated with pemetrexed:
28 V nadzoru po uvedbi zdravila na trg so pri bolnikih, ki so jih zdravili s pemetreksedom, poročali o naslednjih neželenih učinkih:
Cases of radiation pneumonitis have been reported in patients treated with radiation either prior, during or subsequent to their pemetrexed therapy (see section 4.4) Cases of radiation recall have been reported in patients who have received radiotherapy previously (see section 4.4).
Poročali so o primerih radiacijske pljučnice pri bolnikih, ki so jih zdravili z radiacijo pred, med ali po njihovem zdravljenju s pemetreksedom (glejte poglavje 4. 4).
Cases of peripheral ischemia leading sometimes to extremity necrosis have been reported.
Poročali so o radiacijskem izpuščaju pri bolnikih, ki so se v preteklosti zdravili z radioterapijo (glejte poglavje 4. 4).
(7.8 - 10.7) (11.4 - 14.9) 0.051
(7, 8 - 10, 7) (11, 4 - 14, 9) 0, 051
(8.4 - 11.9)
(8, 4 - 11, 9)
(4.9 – 6.5) 0.001
(4, 9 - 6, 5) 0, 001
(2.8 - 4.4) (5.3 - 7.0) 0.008
(2, 8 - 4, 4) (5, 3 - 7, 0) 0, 008
4.5 (3.9 – 4.9) 0.001
4, 5 (3, 9 - 4, 9) 0, 001
2.7 4.7 (2.1 - 2.9) (4.3 - 5.6) 0.001
2, 7 4, 7 (2, 1 - 2, 9) (4, 3 - 5, 6) 0, 001
16.7% 45.5%
16, 7% 45, 5%
(34.8 - 48.1)
(34, 8 - 48, 1)
(12.0 - 22.2) (37.8 - 53.4)
(12, 0 - 22, 2) (37, 8 - 53, 4)
Fisher’ s exact p-value* Abbreviation:
Fisherjeva točna p- vrednost * Okrajšava:
CI = confidence interval * p-value refers to comparison between arms.
IZ = interval zaupanja
** In the ALIMTA/ cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
* p- vrednost se nanaša na primerjavo med vejama zdravljenja. ** V veji zdravljenja z ALIMTO/ cisplatinom, randomizirani in zdravljeni (N = 225) ter s popolnim dopolnjevanjem (N = 167).
Efficacy of ALIMTA vs docetaxel in NSCLC - ITT Population
30 bolniki, ki so bili predhodno zdravljeni z doksatakselom (n = 41) in bolniki, ki niso prejeli predhodnega zdravljenja z doksatakselom (n = 540).
(.82 - 1.20) .226
(7, 0 - 9, 4)
Progression free survival (months) Median
(6, 3 - 9, 2)
(n
RT
(n
(0, 82 - 1, 20) 0, 226 (n = 288)
= 288) 2.9
Mediana
HR (95% CI)
RT (95% IZ)
Time to treatment failure (TTTF – months) Median
Čas do neuspeha zdravljenja (Time to treatment failure, TTTF – meseci)
31 A multicentre, randomised, open-label, Phase 3 study of ALIMTA plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that ALIMTA plus cisplatin (Intent-To-Treat [ITT] population n = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n = 863) in overall survival (adjusted hazard ratio 0.94; 95% CI 0.84-1.05).
Multicentrična, randomizirana, odprta študija faze 3 ALIMTE skupaj s cisplatinom proti gemcitabinu skupaj s cisplatinom pri bolnikih, ki v preteklosti še niso prejemali kemoterapije, z lokalno napredovalim ali metastatskim (stopnja IIIb ali IV) nedrobnoceličnim karcinomom pljuč (NSCLC), je pokazala, da je ALIMTA skupaj s cisplatinom (Populacija z namenom zdraviti, [NZ] populacija n = 862) dosegla prvotno končno točko in pokazala podobno klinično učinkovitost, kot gemcitabin skupaj s cisplatinom (NZ n = 863) v skupnem preživetju (prilagojeno razmerje tveganja 0, 94; 95% IZ = 0, 84- 1, 05).
Median Overall Survival in Months
31 Mediana skupnega preživetja v mesecih Prilagojeno NZ populacija
32 Kaplan Meier Plots of Overall Survival by Histology
Kaplan Meier- jeva grafa skupnega preživetja glede na histologijo
Pemetrexed total systemic clearance is 91.8 ml/ min and the elimination half-life from plasma is 3.5 hours in patients with normal renal function (creatinine clearance of 90 ml/ min).
32 delovanjem (očistek kreatinina 90 ml/ min).