natgillin/translations-raw huggingface dataset:
* Se National Cancer Institute CTC version 2 for hver grad af toksicitet, undtagen udtrykket "nedsat kreatinin- clearance", ** som stammer fra udtrykket "andre renale/ genitourinære faktorer". *** I henhold til National Cancer Institute CTC (v2. 0; NCI 1998), bør smagsforstyrrelser og alopeci kun rapporteres som grad 1 eller 2.
*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.
8 Meget almindelige - > 10%; Almindelige ≥ 1% og < 10% (til denne tabel blev der anvendt en afskæringsværdi på 5% til inkludering af alle hændelser, hvor indberetteren anså, at bivirkningen muligvis var forbundet med pemetrexed og cisplatin).
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.
De klinisk relevante CTC- toksiciteter, som blev rapporteret hos ≥ 1% og < 5% (almindelige) af de patienter, der var randomiseret til cisplatin og pemetrexed, omfattede: nyresvigt, infektion, pyreksi, febril neutropeni, forhøjet ASAT, ALAT og GGT, nældefeber og brystsmerter.
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.
De klinisk relevante CTC- toksiciteter, som blev rapporteret hos < 1% (ikke almindelig) af de patienter, der var randomiseret til cisplatin og pemetrexed, omfattede arytmi og motorisk neuropati.
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.
Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger, der blev rapporteret hos > 5% af 265 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed og tilskud af folsyre og B12- vitamin, og 276 patienter, som var randomiseret til enkeltstofbehandling med docetaxel.
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.
Organsystem - klasse
System Organ Class
Toksicitet i Toksicitet i alle grader grad 3- 4 (%) (%)
All Grades Grade 3 – Toxicity 4 Toxicity (%) (%)
Toksicitet i Toksicitet alle grader i grad 3- 4 (%) (%)
All Grades Grade 3 – Toxicity 4 Toxicity (%) (%)
Nedsat neutrofiler / granulocytter
Neutrophils/ Granulocytes decreased
Kvalme Anoreksi
Nausea Anorexia
Almene symptomer og
General Disorders
Lever og galdeveje
Hepatobilliary Disorders
SGPT (ALAT) SGOT (ASAT)
SGPT (ALT) elevation
7, 9 1, 9 6, 8 1, 1
SGOT (AST) elevation
1, 4 0, 0 0, 7 0, 0
0.7 0.0
Hud og subkutane væv
Skin and Sub- cutaneous
Udslæt/ skel - dannelse
Rash/ desquamation
14, 0 0, 0
14.0 0.0
6, 2 0, 0
6.2 0.0
Almindelig
Tissue Disorders Common
Kløe Alopeci
Alopecia
6, 8 0, 4 6, 4 0, 4 **
0.4**
1, 8 0, 0 37, 7 2, 2 **
2.2**
* Se National Cancer Institute CTC version 2 for hver grad af toksicitet. ** I henhold til National Cancer Institute CTC (v2. 0; NCI 1998), bør alopeci kun rapporteres som grad 1 eller 2.
*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.
Meget almindelige > 10%; Almindelige ≥ 1% og < 10% (til denne tabel blev der anvendt en afskæringsværdi på 5% til inkludering af alle hændelser, hvor indberetteren anså, at bivirkningen muligvis var forbundet med pemetrexed).
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.
9 De klinisk relevante CTC- toksiciteter, som blev rapporteret hos ≥ 1% og < 5% (almindelige) af de patienter, der var randomiseret til pemetrexed, omfattede: infektion uden neutropeni, febril neutropeni, allergisk reaktion/ overfølsomhed, forhøjet kreatinin, motorisk neuropati, sensorisk neuropati, erythema multiforme og mavesmerter.
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.
De klinisk relevante CTC- toksiciteter, som blev rapporteret hos < 1% (ikke almindelig) af de patienter, der var randomiseret til pemetrexed, omfattede supraventrikulær arytmi.
Clinically relevant CTC toxicities that were reported in < 1% (uncommon) of the patients that were randomly assigned to pemetrexed include supraventricular arrhythmias.
De klinisk relevante laboratorierelaterede toksiciteter af grad 3 og 4 var ensartede mellem de integrerede fase 2- resultater fra tre forsøg med pemetrexed som enkeltstofbehandling (n = 164) og det fase 3- enkeltstofforsøg med pemetrexed, som er beskrevet ovenfor, med undtagelse af neutropeni (12, 8% versus 5, 3%) og forhøjet alaninaminotransferase (15, 2% versus 1, 9%).
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).
Disse forskelle skyldtes sandsynligvis forskelle i patientpopulationen, eftersom fase 2- forsøgene både omfattede patienter, som ikke tidligere havde modtaget kemoterapi, og intensivt forbehandlede brystcancer - patienter med eksisterende levermetastaser og/ eller unormale leverfunktionsanalyser ved baseline.
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.
Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger, der blev vurderet som muligt relateret til studiesubstans, og som blev rapporteret hos > 5% af de 839 patienter med NSCLC, der blev randomiseret til at få cisplatin og pemetrexed, samt de 830 patienter med NSCLC, som blev randomiseret til at få cisplatin og gemcitabin.
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.
Alle patienter fik studiebehandling som initial behandling for lokalt fremskreden eller metastatisk NSCLC, og patienterne i begge behandlingsgrupper fik fuldstændigt dækkende tilskud af folsyre og vitamin B 12.
All patients received study therapy as initial treatment for locally advanced or metastatic NSCLC and patients in both treatment groups were fully supplemented with folic acid and vitamin B12.
Organsystem - klasse
10 System Organ Class
Bivirkning **
Event**
Pemetrexed / cisplatin (N = 839)
Pemetrexed/ cisplatin (N = 839)
Gemcitabin / cisplatin (N = 830)
Gemcitabine/ cisplatin (N = 830)
Blod og lymfesystem
Blood and Lymphatic
Nedsat hæmoglobin Nedsat neutrofiler / granulocytter
Hemoglobin decreased
33, 0 * 5, 6 * 29, 0 * 15, 1 *
System Disorders
45, 7 * 9, 9 * 38, 4 * 26, 7 *
Neutrophils/ Granulocytes decreased
17, 8 4, 8 *
17.8 4.8*
20, 6 7, 6 *
20.6 7.6*
10, 1 * 4, 1 *
10.1* 4.1*
26, 6 * 12, 7 *
26.6* 12.7*
Kvalme Opkastning Anoreksi Forstoppelse Stomatitis / pharyngitis
Nausea Vomiting Anorexia Constipation Stomatitis/ pharyngitis
56, 1 7, 2 * 39, 7 6, 1 26, 6 2, 4 * 21, 0 0, 8 13, 5 0, 8
56.1 39.7 26.6 21.0 13.5
53, 4 3, 9 * 35, 5 6, 1 24, 2 0, 7 * 19, 5 0, 4 12, 4 0, 1
53.4 35.5 24.2 19.5 12.4
Diarré uden kolostomi
3.9* 6.1 0.7* 0.4 0.1
12, 4 1, 3
12.4
12, 8 1, 6
12.8
Dyspepsi / halsbrand
Dyspepsia/ heartburn
5, 2 0, 1
5.9
5, 9 0, 0
0.0
Almene symptomer og reaktioner på administra - tionsstedet
General Disorders and Administration Site Conditions
42, 7 6, 7
42.7
44, 9 4, 9
44.9
10
4.9
Organsystem - klasse
Nervous System
Bivirkning **
Neuropathy- sensory
Pemetrexed / cisplatin (N = 839) Toksicitet i Toksicitet i alle grader grad 3- 4 (%) (%)
8.5*
Gemcitabin / cisplatin (N = 830) Toksicitet i Toksicitet alle grader i grad 3- 4 (%) (%)
0.0*
Nervesystemet
12.4*
Almindelig
0.6*
Sensorisk neuropati
Disorders
8, 5 * 0, 0 *
Taste disturbance
12, 4 * 0, 6 *
8.1
Smagsforstyr - relser
0.0***
8, 1 0, 0 ***
8.9
8, 9 0, 0 ***
0.0***
10, 1 * 0, 8
10.1*
6, 9 * 0, 5
6.9*
Hud og subkutane væv
Skin and Subcutaneous
11, 9 * 0 ***
0.5***
21, 4 * 0, 5 ***
Tissue Disorders
Hududslæt / hudafskalning
Rash/ desquamation
6, 8 0, 1
8.0
8, 0 0, 5
0.5
* P- værdier < 0. 05 sammenligning af pemetrexed/ cisplatin med gemcitabin/ cisplatin, ved brug af Fisher Exact test. ** Se National Cancer Institute CTC (v2. 0; NCI 1998) for hver toksicitetsgrad. *** I henhold til National Cancer Institute CTC (v2. 0; NCI 1998), smagsforstyrrelser og alopeci bør kun rapporteres som grad 1 eller 2.
*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.
Meget almindelig ≥ 10%; almindelig ≥ 1% og < 10%.
Very common ≥ 10%; common is normally defined as ≥ 1% and < 10%.
Til denne tabel blev anvendt en afskæringsværdi på 5% til inkludering af alle hændelser, hvor indberetteren vurderede, at bivirkningen muligvis var forbundet med pemetrexed og cisplatin.
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).
Klinisk relevant toksicitet, som blev rapporteret hos ≥ 1% og ≤ 5% (almindelig) af de patienter, der var randomiseret til cisplatin og pemetrexed, omfattede: forhøjet AST, forhøjet ALT, infektion, febril neutropeni, nyresvigt, pyreksi, dehydrering, konjunktivitis og nedsat kreatininclearance.
AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Klinisk relevant toksicitet, som blev rapporteret hos < 1% (ikke almindelig) af de patienter, som blev randomiseret til at få cisplatin og pemetrexed, omfattede: forhøjet GGT, brystsmerter, arytmier og motorisk neuropati.
GGT increase, chest pain, arrhythmia, and motor neuropathy.
Alvorlige kardiovaskulære og cerebrovaskulære bivirkninger, herunder myokardieinfarkt, angina pectoris, cerebrovaskulære hændelser og forbigående iskæmisk anfald er ikke almindeligt rapporteret under kliniske forsøg med pemetrexed, sædvanligvis når pemetrexed gives i kombination med et andet cytotoksisk lægemiddelstof.
Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident and transient ischaemic attack have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
Potentielt alvorlige tilfælde af hepatitis er sjældent rapporteret under kliniske forsøg med pemetrexed.
Rare cases of hepatitis, potentially serious, have been reported during clinical studies with pemetrexed.
Pancytopeni er sjældent rapporteret under kliniske forsøg med pemetrexed.
Pancytopenia has been uncommonly reported during clinical trials with pemetrexed.
Tilfælde af colitis (inklusive intestinal og rektal blødning, sommetider fatal, intestinal nekrose og typhliitis) er ikke almindeligt rapporteret hos patienter behandlet med pemetrexed i kliniske forsøg.
In clinical trials, cases of colitis (including intestinal and rectal bleeding, sometimes fatal, intestinal perforation, intestinal necrosis and typhlitis) have been reported uncommonly in patients treated with pemetrexed.
Tilfælde af pnemonia interstitialis med respiratorisk insufficiens, sommetider fatalt, er ikke almindeligt rapporteret hos patienter behandlet med pemetrexed i kliniske forsøg.
In clinical trials, cases of interstitial pneumonitis with respiratory insufficiency, sometimes fatal, have been reported uncommonly in patients treated with pemetrexed.
4. 4).
Cases of acute renal failure have been reported with pemetrexed alone or in association with other chemotherapeutic agents (see section 4.4).
Hos patienter i strålebehandling, enten før, under eller efter behandling med pemetrexed, har der været rapporteret om tilfælde af strålingspneumonitis (se pkt.
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).
Tilfælde af perifer iskæmi, som af og til medfører ekstremitetsnekroser, er rapporteret.
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.
Derudover kan der optræde infektion med eller uden feber, diarré og/ eller mucositis.
In addition, infection with or without fever, diarrhoea, and/ or mucositis may be seen.
Til afhjælpning af en overdosering af pemetrexed bør det overvejes at anvende kalciumfolinat/ folsyre.
The use of calcium folinate / folinic acid in the management of pemetrexed overdose should be considered.
Farmakoterapeutisk klassifikation:
Folic acid analogues, ATC code:
Folsyreanaloger, ATC- kode L01BA04
L01BA04
ALIMTA (pemetrexed) er et bredspektret anti- cancer- antifolat, som virker ved at forstyrre de centrale folatafhængige metaboliske processer, der er afgørende for celledannelsen.
ALIMTA (pemetrexed) is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
In vitro- forsøg har vist, at pemetrexed fungerer som et bredspektret anti- folat ved at hæmme thymidylatsyntase (TS), dihydrofolatreduktase (DHFR) og glycinamidribonucleotidformyltransferase (GARFT), som er folatafhængige nøgleenzymer i forbindelse med de novo- biosyntesen af thymidin og purinnukleotider.
In vitro studies have shown that pemetrexed behaves as a multitargeted antifolate by inhibiting thymidylate synthase (TS), dihydrofolate reductase (DHFR), and glycinamide ribonucleotide formyltransferase (GARFT), which are key folate-dependent enzymes for the de novo biosynthesis of thymidine and purine nucleotides.
Polyglutamation er en tids - og koncentrationsafhængig proces, som primært finder sted i tumorceller og i mindre grad i normalt væv.
Polyglutamation is a time- and concentration-dependent process that occurs in tumour cells and, to a lesser extent, in normal tissues.
Klinisk effekt:
Clinical Efficacy:
EMPHACIS, et randomiseret, enkeltblindet, fase 3- multicenterforsøg med ALIMTA sammen med cisplatin versus cisplatin alene til patienter, der ikke tidligere havde fået kemoterapi, og som led af malignt pleura mesotheliom, viste, at de patienter, som blev behandlet med ALIMTA og cisplatin, havde en klinisk meningsfuld længere median- levetid på 2, 8 måneder end patienter, som kun blev behandlet med cisplatin.
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.
I løbet af forsøget blev patienternes behandling suppleret med et lavdosistilskud af folsyre og B12 - vitamin for at mindske toksiciteten.
During the study, low-dose folic acid and vitamin B12 supplementation was introduced to patients’ therapy to reduce toxicity.
Den primære analyse af dette forsøg blev udført på en population bestående af alle de patienter, som var randomiseret til en behandlingsarm, og som modtog forsøgs - lægemidlet (randomiseret og behandlet).
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).
Der blev udført en undergruppeanalyse af de patienter, som fik et folsyre - og B12- vitamintilskud under hele forsøgsforløbet (fuldt tilskud).
A subgroup analysis was performed on patients who received folic acid and vitamin B12 supplementation during the entire course of study therapy (fully supplemented).
12 Effekt af ALIMTA sammen med cisplatin versus cisplatin alene til patienter med malignt pleura mesotheliom
Cisplatin in Malignant Pleural Mesothelioma
Randomiseret og behandlet Patienter
Randomized and Treated Patients
Fuldt tilskud Patienter
Fully Supplemented Patients
ALIMTA / cisplatin
ALIMTA/ cisplatin
Cisplatin ALIMTA / cisplatin
Cisplatin ALIMTA/ cisplatin
Cisplatin
Cisplatin
Median- overlevelse (måneder)
Median Overall Survival (months)
(n
(N
= 226) 12, 1
= 226) 12.1
(n = 222) 9, 3
= 222) 9.3
= 168) 13, 3
= 168) 13.3
= 163) 10, 0
= 163) 10.0
(95% - CI) Log- rank- p- værdi *
(95% CI) Log Rank p-value*
(10, 0- 14, 4)
(7.8 - 10.7)
0, 020
(11.4
(7, 8- 10, 7) (11, 4- 14, 9)
- 14.9)
0, 051
0.051
(8, 4- 11, 9)
(8.4
Median- tid til tumorprogression (måneder)
Median Time to tumour progression (months)
5, 7
3.9
3, 9 6, 1
6.1
(4, 9- 6, 5)
(4.9 - 6.5)
(2, 8- 4, 4) (5, 3- 7, 0)
(2.8 - 4.4)
(2, 8- 4, 5)
(5.3 - 7.0)
(95% - CI) Log- rank- p- værdi *
Time to Treatment Failure (months) (95% CI) Log Rank p-value*
(3, 9- 4, 9)
4.5 (3.9 - 4.9)
(2, 1- 2, 9) (4, 3- 5, 6)
4.7 (4.3 - 5.6)
(2, 2- 3, 1)
2.7 (2.2 - 3.1)
Samlet responsrate **
Overall response rate**
(95% - CI)
(95% CI)
(34, 8- 48, 1)
(34.8 - 48.1)
(12, 0- 22, 2) (37, 8- 53, 4)
(12.0 - 22.2)
(13, 8- 26, 6)
(37.8 - 53.4)
Fishers eksakte p- niveau * Forkortelse:
(13.8 - 26.6)
CI = konfidensinterval
Fisher’ s exact p-value*
* p- værdi henviser til sammenligning mellem arme. ** I ALIMTA/ cisplatin- armen, randomiseret og behandlet (n = 225) og fuldt tilskud (n = 167)
13 ** In the ALIMTA/ cisplatin arm, randomized and treated (N = 225) and fully supplemented (N = 167)
Ved hjælp af lungecancersymptomskalaen blev der påvist en statistisk signifikant bedring af de klinisk relevante symptomer (smerte og dyspnø) i forbindelse med malignt pleura mesotheliom i ALIMTA/ cisplatin- armen (212 patienter) versus armen med cisplatin alene (218 patienter).
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.
Spredningen mellem behandlings - armene viste sig ved en forbedring af lungefunktionen i ALIMTA/ cisplatin- armen og en med tiden dårligere lungefunktion i kontrolarmen.
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.
Der foreligger en begrænset mængde data for de patienter med malignt pleura mesotheliom, som blev behandlet med ALIMTA alene.
There are limited data in patients with malignant pleural mesothelioma treated with ALIMTA alone.
ALIMTA i en dosis på 500 mg/ m2 blev undersøgt som enkeltstof - behandling til 64 patienter med malignt pleura mesotheliom, som ikke tidligere havde modtaget kemoterapi.
ALIMTA at a dose of 500 mg/ m2 was studied as a single-agent in 64 chemonaive patients with malignant pleural mesothelioma.
Den samlede responsrate var 14, 1%.
The overall response rate was 14.1%.
Et åbent, randomiseret fase 3- multicenterforsøg med ALIMTA versus docetaxel til patienter med lokalt fremskreden eller metastatisk NSCLC (ikke- småcellet lungekræft), der tidligere var behandlet med kemoterapi, har vist en median- overlevelsestid på 8, 3 måneder for patienter, som blev behandlet med ALIMTA (intent- to- treat- population n = 283), og 7, 9 måneder for patienter, som blev behandlet med docetaxel (ITT n = 288).
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).
En analyse af virkningen på NSCLCs histologi for behandlingens virkning på samlet overlevelse var til fordel for ALIMTA versus docetaxel bortset fra cancerformer hovedsageligt bestående af pladeepitelceller (n=399; 9, 3 versus 8, 0 måneder, justeret HR= 0, 78; 95% CI= 0, 61- 1, 00, p= 0, 047) og til fordel for docetaxel for carcinom af pladeepitelceller (n= 172; 6, 2 versus 7, 4 måneder, justeret HR 1, 56; 95% CI= 1, 08- 2, 26, p= 0, 0018).
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).
De begrænsede kliniske data fra et enkelt randomiseret fase 3 kontrolleret studie tyder på, at effektdata (samlet overlevelse, progression free survival) for pemetrexed er lignende for patienter, som tidligere er behandlet med docetaxel (n=41) og patienter, som ikke tidligere har fået behandling med docetaxel (n=540).
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).
Effekt af ALIMTA versus docetaxel mod NSCLC – ITT- population
Efficacy of ALIMTA vs docetaxel in NSCLC - ITT Population
Overlevelsestid (måneder)
Survival Time (months) Median (m) 95% CI for median HR
(n = 283)
(n = 283) 8.3 (7.0 - 9.4)
(n = 288)
(n = 288) 7.9 (6.3 - 9.2)
95% - CI for median HR
95% CI for HR Non-inferiority p-value (HR)
(0, 82- 1, 20) 0, 226
(.82 - 1.20) .226
Overlevelse uden progression (måneder) Median HR (95% - CI)
Progression free survival (months) Median HR (95% CI)
(n
(n = 283) 2.9
= 283) 2, 9 0, 97 (0, 82- 1, 16)
0.97 (.82 – 1.16)
= 288) 2, 9
= 288) 2.9
Tid til behandlingssvigt (TTTF – måneder) Median HR (95% - CI)
Time to treatment failure (TTTF – months) Median HR (95% CI)
(n = 283) 2, 3 0, 84 (0, 71- 0, 997)
0.84 (.71 - .997)
Responsrate (%) (95% - CI) Stabil sygdom (%)
Response rate (%) (95% CI) Stable disease (%)
9, 1 (5, 9- 13, 2) 45, 8
9.1 (5.9 - 13.2) 45.8
8, 8 (5, 7- 12, 8) 46, 4
8.8 (5.7 - 12.8) 46.4
CI = konfidensinterval; HR = hazard- ratio; ITT = intent to treat; n = samlet populationsstørrelse.
CI = confidence interval; HR = hazard ratio; ITT = intent to treat; n = total population size.