natgillin/translations-raw huggingface dataset:
Many of the patients in whom these occurred had underlying risk factors for the development of renal events including dehydration or pre-existing hypertension or diabetes.
Mnogi bolniki, pri katerih so se le- ti pojavili, so imeli v osnovi dejavnike tveganja za razvoj ledvičnih primerov, vključno z dehidracijo ali že prej obstoječo hipertenzijo ali diabetesom.
The effect of third space fluid, such as pleural effusion or ascites, on pemetrexed is unknown.
Učinek tekočine tretjega prostora, denimo plevralnega izliva ali ascitesa, na pemetreksed ni znan.
In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to pemetrexed administration.
Pri bolnikih s klinično pomembno tekočino tretjega prostora moramo razmisliti o drenaži izliva pred dajanjem pemetrekseda.
Therefore, patients should receive adequate antiemetic treatment and appropriate hydration prior to and/ or after receiving treatment.
Zato moramo bolnike pred prejemanjem terapije in/ ali po njej ustrezno hidrirati, prejeti morajo zadostno antiemetično zdravljenje.
Most of the patients in whom these events have been observed had pre- existing cardiovascular risk factors (see section 4.8).
Večina bolnikov, pri katerih so take dogodke opažali, je imela v preteklosti srčnožilne dejavnike tveganja (glejte poglavje 4. 8).
As a result, concomitant use of live attenuated vaccines (except yellow fever which is contraindicated) is not recommended (see section 4.3 and 4.5).
Zato odsvetujemo uporabo živih oslabljenih cepiv (razen za rumeno mrzlico, kar je kontraindicirano) (glejte poglavje 4. 3 in 4. 5).
5 Pemetrexed can have genetically damaging effects.
Pemetreksed lahko ima gensko škodljive učinke.
Women of childbearing potential must use effective contraception during treatment with pemetrexed (see section 4.6).
5 Ženske v rodni dobi morajo v času zdravljenja s pemetreksedom uporabljati učinkovito kontracepcijo (glejte poglavje 4. 6).
Concomitant administration of nephrotoxic drugs (e. g. aminoglycoside, loop diuretics, platinum compounds, cyclosporin) could potentially result in delayed clearance of pemetrexed.
Sočasno dajanje nefrotoksičnih zdravil (denimo, aminoglikozidov, diuretikov zanke, spojin platine, ciklosporina) lahko potencialno povzroči zakasnjeni očistek pemetrekseda.
Concomitant administration of substances that are also tubularly secreted (e. g. probenecid, penicillin) could potentially result in delayed clearance of pemetrexed.
Sočasno dajanje snovi, ki se tudi izločajo s tubulno sekrecijo (denimo, probenecid, penicilin), lahko potencialno povzroči zakasnjeni očistek pemetrekseda.
In patients with normal renal function (creatinine clearance > 80 ml/ min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1600 mg/ day) and aspirin at higher dosage (> 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Pri bolnikih z normalnim delovanjem ledvic (očistek kreatinina ≥ 80 ml/ min) lahko visoki odmerki nesteroidnih protivnetnih zdravil (NSAID- i, denimo, ibuprofen > 1600 mg dnevno) in acetilsalicilna kislina v visokih odmerkih (≥ 1, 3 g dnevno) zmanjšajo eliminacijo pemetrekseda in tako lahko povečajo pojavnost neželenih učinkov pemetrekseda.
Therefore, caution should be made when administering higher doses of NSAIDs or aspirin at higher dosage, concurrently with pemetrexed to patients with normal function (creatinine clearance > 80 ml/ min).
Zato je pri dajanju visokih odmerkov NSAID- ov ali acetilsalicilne kisline sočasno s pemetreksedom bolnikom z normalnim delovanjem ledvic (očistek kreatinina ≥ 80 ml/ min) potrebna previdnost.
In patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/ min), the concomitant administration of pemetrexed with NSAIDs (e. g. ibuprofen) or aspirin at higher dosage should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
Pri bolnikih z blagim do zmernim popuščanjem delovanja ledvic (očistek kreatinina 45 - 79 ml/ min) se moramo izogibati sočasnemu dajanju pemetrekseda z NSAID- i (denimo, ibuprofenom) ali acetilsalicilno kislino v visokih odmerkih 2 dni pred dajanjem pemetrekseda, na dan dajanja in še 2 dni po dajanju pemetrekseda (glejte poglavje 4. 4).
In the absence of data regarding potential interaction with NSAIDs having longer half-lives as piroxicam or rofecoxib, the concomitant administration with pemetrexed should be avoided for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.4).
Ker ni podatkov o možnem medsebojnem delovanju pemetrekseda in NSAID- ov z daljšimi razpolovnimi časi, denimo, piroksikama ali rofekoksiba, se moramo sočasnemu dajanju s pemetreksedom izogibati vsaj 5 dni pred dajanjem pemetrekseda, na dan dajanja in še vsaj 2 dni po dajanju pemetrekseda (glejte poglavje 4. 4).
Concomitant use contraindicated:
Kontraindicirana sočasna uporaba:
Yellow fever vaccine: risk of fatal generalised vaccinale disease (see section 4.3).
Cepivo proti rumeni mrzlici: tveganje za smrtno generalizirano bolezen po cepljenju (glejte poglavje 4. 3).
Concomitant use not recommended:
Odsvetovana sočasna uporaba:
The risk is increased in
Uporabite inaktivirano cepivo, če to obstaja (poliomielitis) (glejte poglavje 4. 4).
6 subjects who are already immunosuppressed by their underlying disease.
4. 6 Nosečnost in dojenje
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.
6 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.
Animal studies have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale reproduktivno toksičnost (glejte poglavje 5. 3).
Pemetrexed should not be used during pregnancy unless clearly necessary, after a careful consideration of the needs of the mother and the risk for the foetus (see section 4.4).
Pemetrekseda med nosečnostjo ne smemo uporabljati, če to ni neobhodno potrebno, uporabimo pa ga le po skrbni preučitvi potreb matere in tveganja za plod (glejte poglavje 4. 4).
Breast-feeding must be discontinued during pemetrexed therapy (see section 4.3).
Dojenje je treba med zdravljenjem s pemetreksedom prekiniti (glejte poglavje 4. 3).
The table below provides the frequency and severity of undesirable effects that have been reported in > 5% of 168 patients with mesothelioma who were randomised to receive cisplatin and pemetrexed and 163 patients with mesothelioma randomised to receive single agent cisplatin.
Spodnja preglednica navaja pogostnost in hudost neželenih učinkov, o katerih so poročali pri > 5% 168 bolnikov z mezoteliomom, ki so jih naključno razporedili, da so prejemali cisplatin in pemetreksed, ter pri 163 bolnikov z mezoteliomom, ki so jih naključno dodelili v skupino, ki je prejemala le eno učinkovino, cisplatin.
Very common (≥ 1/ 10), Common (≥ 1/ 100 and < 1/ 10), Uncommon (≥ 1/ 1000 and < 1/ 100), Rare (≥ 1/ 10,000 and < 1/ 1000), Very Rare (<  1/ 10,000) and Not known (cannot be estimated from available data-spontaneous reports)
Neželene reakcije Pogostnosti so določene kot: zelo pogosto (≥ 1/ 10), pogosto (≥ 1/ 100 in < 1/ 10), občasno (≥ 1/ 1000 in < 1/ 100), redko (≥ 1/ 10. 000 in < 1/ 1000), zelo redko (< 1/ 10. 000) in ni znano (ocena ni možna iz danih podatkov- spontanih poročil).
7 System Organ
7 Organski
Frequency
Cisplatin
Event*
sistem
Class
Toksičnost Toksičnost Toksičnost Toksičnost
All
vseh
Grade All
stopnje vseh
All Grade All
vseh stopnje vseh
Grades
stopnje
Grades 3-4 Grades
stopenj (%)
Toxicity Toxicity (%) (%)
3- 4 stopenj (%) (%)
Toxicity Toxicity (%) (%)
3- 4 (%)
Blood and Lymphatic System
Bolezni krvi in limfatičnega
56.0 23.2
23, 2 13, 5
13.5 3.1
3, 1
Disorders
sistema
53.0 14.9
14, 9
26.2 4.2
26, 2
Eye Disorders
Očesne bolezni
Gastrointestinal Disorders
Bolezni prebavil
Diarrhoea Vomiting Stomatitis/ Pharyngitis
Diareja Bruhanje Stomatitis / Faringitis
Nausea Anorexia Constipation
Slabost Anoreksija Zaprtje
82.1 11.9 20.2 1.2 11.9 0.6
11, 9 1, 2 0, 6
General Disorders
Splošne težave
Nervous System Disorders
Bolezni živčevja
Neuropathy- Sensory
Nevropatija - senzorična
Renal and Urinary Disorders
Bolezni sečil
Creatinine clearance decreased**
Znižan očistek kreatinina **
Skin and Subcutaneous
Bolezni kože
Very Common
Zelo
Rash
Izpuščaj
Tissue Disorders
in podkožja
*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 ”. ** 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.
8 Very common - ≥ 10%; Common is normally defined as - ≥ 1% and < 10%.
Zelo pogosto > 10%; Pogosto so običajno definirani kot > 1% in < 10%.
For the purpose of this table a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed and cisplatin.
Za namen te preglednice smo uporabili » cut off « 5% za vključitev vseh dogodkov, kjer je poročevalec upošteval možno povezavo s pemetreksedom ali cisplatinom.
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.
8 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.
Clinically relevant CTC toxicities that were reported in < 1% (uncommon) of the patients that were randomly assigned to receive cisplatin and pemetrexed include arrhythmia and motor neuropathy.
Klinično pomembne CTC toksičnosti, o katerih so poročali pri < 1% (občasno) bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala cisplatin in pemetreksed, vključujejo aritmijo in motorično nevropatijo.
The table below provides the frequency and severity of undesirable effects that have been reported in > 5% of 265 patients randomly assigned to receive single agent pemetrexed with folic acid and vitamin B12 supplementation and 276 patients randomly assigned to receive single agent docetaxel.
Spodnja preglednica podaja pogostnost in hudost neželenih učinkov, o katerih so poročali pri > 5% od 265 bolnikov, ki so jih naključno razporedili, da so prejemali eno učinkovino pemetreksed z dopolniloma folno kislino in vitaminom B12, ter pri 276 bolnikih, ki so jih naključno dodelili v skupino, ki je prejemala le eno učinkovino, docetaksel.
Event*
Dogodek *
All Grades Grade 3 – Toxicity 4 Toxicity (%) (%)
Toksičnost Toksičnost vseh stopnje stopenj 3– 4 (%) (%)
10.9 5.3
10, 9 5, 3
12.1 4.2
45, 3 40, 2
34.1 27.2
sistema
Haemoglobin decreased
Znižani levkociti
19.2 4.2
19, 2 4, 2
22.1 4.3
22, 1 4, 3
1.1 0.4
1, 1 0, 4
12.8 0.4 16.2 1.5 14.7 1.1
12, 8 0, 4 16, 2 1, 5 14, 7 1, 1
24.3 2.5 12.0 1.1 17.4 1.1
24, 3 2, 5 12, 0 1, 1 17, 4 1, 1
Nausea Anorexia
Slabost Anoreksija
30.9 2.6 21.9 1.9
30, 9 2, 6 21, 9 1, 9
16.7 1.8 23.9 2.5
16, 7 1, 8 23, 9 2, 5
Constipation
Zaprtje
5.7 0.0
5, 7 0, 0
4.0 0.0
4. 0 0, 0
34.0 5.3
34, 0 5, 3
35.9 5.4
35, 9 5, 4
Fever
Povišana telesna temperatura
8.3 0.0
8, 3 0, 0
7.6 0.0
7, 6 0, 0
Hepatobilliary Disorders
Bolezni jeter, žolčnika in
7.9 1.9
7, 9 1, 9
1.4 0.0
1, 4 0, 0
6.8 1.1
6, 8 1, 1
0.7 0.0
0, 7 0, 0
Skin and Sub- cutaneous
Bolezni kože Zelo in podkožja pogosto
Very Common
Izpuščaj / luščenje
Rash/ desquamation
14, 0
Tissue Disorders Common
Pogosto
*Refer to National Cancer Institute CTC version 2 for each grade of toxicity. **According to National Cancer Institute CTC (v2.0; NCI 1998), alopecia should only be reported as Grade 1 or 2.
* Glejte CTC Nacionalnega inštituta za rakava obolenja, različico 2, za vsako stopnjo toksičnosti. ** V skladu z CTC Nacionalnega inštituta za rakava obolenja (v2. 0; NCI 1998), alopecija mora biti poročana kot stopnja 1 ali 2.
Very common ≥ 10%; Common is normally defined as ≥ 1% and < 10%.
9 Zelo pogosto > 10%; Pogosto so običajno definirani kot > 1% in < 10%.
For the purpose of this table a cut off of 5% was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed.
Za namen te preglednice smo uporabili » cut off « 5% za vključitev vseh dogodkov, kjer je poročevalec upošteval možno povezavo s pemetreksedom.
9 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.
Clinically relevant CTC toxicities that were reported in < 1% (uncommon) of the patients that were randomly assigned to pemetrexed include supraventricular arrhythmias.
Klinično pomembne CTC toksičnosti, o katerih so poročali pri < 1% (občasno) bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo supraventrikularne aritmije.
Clinically relevant Grade 3 and Grade 4 laboratory toxicities were similar between integrated Phase 2 results from three single agent pemetrexed studies (n = 164) and the Phase 3 single agent pemetrexed study described above, with the exception of neutropenia (12.8% versus 5.3%, respectively) and alanine transaminase elevation (15.2% versus 1.9%, respectively).
Klinično pomembne laboratorijske toksičnosti stopenj 3 in 4 so bile podobne pri integriranih rezultatih faze 2 treh študij pemetrekseda kot edine učinkovine (n = 164) in faze 3 študije pemetrekseda kot edine učinkovine, opisane zgoraj, z izjemo nevtropenije (12, 8% oziroma 5, 3%) in povišanja alaninske transaminaze (15, 2% oziroma 1, 9%).
These differences were likely due to differences in the patient population, since the Phase 2 studies included both chemonaive and heavily pre-treated breast cancer patients with pre-existing liver metastases and/ or abnormal baseline liver function tests.
Te razlike so bile verjetno posledica različnih populacij bolnikov, saj so v študijah faze 2 sodelovali bolniki, ki še niso prejemali kemoterapije, in tudi bolnice s karcinomom dojke, ki so v preteklosti prejemale kemoterapijo, s predhodno obstoječimi metastazami v jetrih in/ ali nenormalnimi izhodiščnimi vrednostmi testov jetrnega delovanja.
The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5% of 839 patients with NSCLC who were randomized to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomized to receive cisplatin and gemcitabine.
Spodnja preglednica podaja pogostnost in resnost neželenih učinkov, ki so jih ocenili kot možno povezane s študijskim zdravilom, o katerih so poročali pri > 5% od 839 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so naključno prejemali cisplatin in pemetreksed in 830 bolnikov z nedrobnoceličnim karcinomom pljuč, ki so naključno prejemali cisplatin in gemcitabin.
10 System Organ Class
Organski sistem
Event**
Dogodek **
Pemetrexed/ cisplatin (N = 839)
Pemetreksed/ cisplatin N = 839
Gemcitabine/ cisplatin (N = 830)
Gemcitabin/ cisplatin N = 830
Toxicity Toxicity (%) (%)
Toksičnost Toksičnost vseh stopnje stopenj 3– 4 (%) (%)
Blood and Lymphatic
Bolezni krvi in
33.0* 5.6*
33, 0 * 5, 6 *
45.7* 9.9*
45, 7 * 9, 9 *
System Disorders
limfatičnega sistema
29.0* 15.1*
29, 0 * 15, 1 *
38.4* 26.7*
38, 4 * 26, 7 *
Nausea Vomiting Anorexia Constipation Stomatitis/ pharyngitis
Slabost Bruhanje Anoreksija Zaprtje Stomatitis / Faringitis
Dyspepsia/ heartburn
Dispepsija / Zgaga
General Disorders and Administration Site Conditions
Splošne težave in
6.7
44, 9 4, 9
44.9
10
Nervous System
Nevropatija -
Common
Bolez ni
Neuropathy- sensory
senzorična
Disorders
živče vja
Skin and Subcutaneous
Bolezni kože in podkožja
21.4*
0, 0 ***
0.5***
21, 4 *
Common
0, 5 ***
*P-values < 0.05 comparing pemetrexed/ cisplatin to gemcitabine/ cisplatin, using Fisher Exact test. **Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity. ***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
* P- vrednosti < 0, 05 v primerjavi pemetreksed/ cisplatin proti gemcitabin/ cisplatin, z uporabo Fisherjevega Exact testa. ** Glejte CTC Nacionalnega inštituta za rakava obolenja (v2. 0; NCI 1998), za vsako stopnjo toksičnosti. *** V skladu z CTC Nacionalnega inštituta za rakava obolenja (v2. 0; NCI 1998), alopecija mora biti poročana kot stopnja 1 ali 2.
Very common ≥ 10%; common is normally defined as ≥ 1% and < 10%.
Zelo pogosto > 10%; Pogosto so običajno definirani kot > 1% in < 10%.
For the purpose of this table, a cut-off of 5% was used for inclusion of all events where the reporter considered a possible relationship to pemetrexed and cisplatin).
Za namen te preglednice smo uporabili » cut off « 5% za vključitev vseh dogodkov, kjer je poročevalec upošteval možno povezavo s pemetreksedom.
AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Klinično pomembne toksičnosti, o katerih so poročali pri > 1% in < 5% (pogosto) bolnikov, ki so jih naključno dodelili v skupino, ki je prejemala pemetreksed, vključujejo: povišanje AST, povišanje ALT, okužbo, febrilno nevtropenijo, odpoved ledvic, pireksijo, dehidracijo, konjuktivitis in znižanje očistka kreatinina.
11 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:
11 V nadzoru po uvedbi zdravila na trg so pri bolnikih, ki so jih zdravili s pemetreksedom, poročali o naslednjih neželenih učinkih:
Cases of acute renal failure have been reported with pemetrexed alone or in association with other chemotherapeutic agents (see section 4.4).
Poročali so o primerih akutne odpovedi ledvic s pemetreksedom samim ali v povezavi z drugimi kemoterapevtiki (glejte poglavje 4. 4).
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).
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 radiation recall have been reported in patients who have received radiotherapy previously (see section 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).
In addition, infection with or without fever, diarrhoea, and/ or mucositis may be seen.
Poleg tega lahko opazimo okužbo s povišano telesno temperaturo ali brez nje, diarejo in/ ali vnetje sluznic.
Folic acid analogues, ATC code:
Analogi folne kisline, Oznaka ATC:
Clinical Efficacy:
Klinična učinkovitost:
EMPHACIS, a multicentre, randomised, single-blind phase 3 study of ALIMTA plus cisplatin versus cisplatin in chemonaive patients with malignant pleural mesothelioma, has shown that patients treated with ALIMTA and cisplatin had a clinically meaningful 2.8-month median survival advantage over patients receiving cisplatin alone.
EMPHACIS, multicentrična, randomizirana, enojno slepa študija faze 3 ALIMTE skupaj s cisplatinom v primerjavi s cisplatinom pri bolnikih z malignim plevralnim mezoteliomom, ki v preteklosti še niso prejemali kemoterapije, je pokazala, da so imeli bolniki, zdravljeni z ALIMTO in cisplatinom, klinično pomembno prednost 2, 8- mesečne mediane preživetja pred bolniki, ki so prejemali samo cisplatin.
The primary analysis of this study was performed on the population of all patients randomly assigned to a treatment arm who received study drug (randomised and treated).
Primarno analizo te študije so opravili na populaciji vseh bolnikov, ki so bili naključno dodeljeni v vejo zdravljenja, kjer so prejemali zdravilo v preskušanju (randomizirani
Cisplatin in Malignant Pleural Mesothelioma
Učinkovitost ALIMTE skupaj s cisplatinom v primerjavi s cisplatinom pri malignem plevralnem mezoteliomu
Randomized and Treated Patients
Randomizirani in zdravljeni bolniki
Fully Supplemented Patients
Bolniki s popolnim dopolnjevanjem
ALIMTA/ cisplatin
ALIMTA / cisplatin
Cisplatin ALIMTA/ cisplatin
Cisplatin ALIMTA / cisplatin
Median Overall Survival (months)
Mediana skupnega preživetja (meseci)
= 226) 12.1
= 226) 12, 1
= 222) 9.3
= 222) 9, 3
= 163) 10.0
= 163) 10, 0
(95% CI) Log Rank p-value*
(95% IZ) Log Rank p- vrednost *
(10.0 - 14.4) 0.020
(10, 0 - 14, 4) 0, 020
(7.8 - 10.7)
(7, 8 - 10, 7) (11, 4 - 14, 9) 0, 051
- 11.9)
(8, 4 - 11, 9)
Median Time to tumour progression (months)
Mediana časa do napredovanja tumorja (meseci)
0.001
(4, 9 - 6, 5) 0, 001
(5.3 - 7.0)
(2, 8 - 4, 4) (5, 3 - 7, 0) 0, 008
(2.8 - 4.5)
(2, 8 - 4, 5)
Time to Treatment Failure (months) (95% CI) Log Rank p-value*
Čas do neuspeha zdravljenja (meseci) (95% IZ) Log Rank p- vrednost *
4.5 (3.9 - 4.9)
4, 5 (3, 9 - 4, 9) 0, 001
4.7 (4.3 - 5.6)
2, 7 4, 7 (2, 1 - 2, 9) (4, 3 - 5, 6) 0, 001
2.7 (2.2 - 3.1)
2, 7 (2, 2 - 3, 1)
Overall response rate**
Skupna stopnja odziva **
16.7%
16, 7% 45, 5%
(12.0 - 22.2)
(34, 8 - 48, 1)
(37.8 - 53.4)
(12, 0 - 22, 2) (37, 8 - 53, 4)
(13.8 - 26.6)
(13, 8 - 26, 6)
Fisher’ s exact p-value*
Fisherjeva točna p- vrednost * Okrajšava:
13 ** 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).
A statistically significant improvement of the clinically relevant symptoms (pain and dyspnoea) associated with malignant pleural mesothelioma in the ALIMTA/ cisplatin arm (212 patients) versus the cisplatin arm alone (218 patients) was demonstrated using the Lung Cancer Symptom Scale.
Z uporabo Lestvice simptomov pljučnega raka (Lung Cancer Symptom Scale) so pokazali statistično značilno izboljšanje klinično pomembnih simptomov (bolečina in dispneja), povezanih z malignim plevralnim mezoteliomom v veji zdravljenja z ALIMTO/ cisplatinom (212 bolnikov) v primerjavi z vejo zdravljenja s cisplatinom samim (218 bolnikov).
The separation between the treatment arms was achieved by improvement in lung function in the ALIMTA/ cisplatin arm and deterioration of lung function over time in the control arm.
Razlikovanje med vejama zdravljenja je bilo doseženo z izboljšanjem delovanja pljuč v veji zdravljenja z ALIMTO/ cisplatinom in poslabšanjem pljučnega delovanja s časom v kontrolni veji preskušanja.