natgillin/translations-raw huggingface dataset:
47 Voksne og børn fra 3 år med tilbagevendende eller progressivt malignt gliom:
Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma:
Til patienter, som ikke tidligere er behandlet med kemoterapi, indgives TMZ oralt i en dosis på 200 mg/ m2 én gang dagligt i de første 5 dage efterfulgt af en 23 - dages behandlingspause (i alt 28 dage).
In patients previously untreated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m2 once daily for the first 5 days followed by a 2 3 day treatment interruption (total of 28 days).
På baggrund af en analyse af populationsfarmakokinetikken for patienter mellem 19- 78 år er TMZ clearance ikke afhængig af alder.
Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age.
4. 4).
49 Severe myelosuppression (see section 4.4).
48 Der kan være en højere forekomst af PCP, når TMZ anvendes i et længere dosisregime.
There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen.
Mandlige patienter
50 Male patients
49 I et separat fase I- studie resulterede indtagelse af TMZ sammen med ranitidin ikke i ændringer i absorptionsgraden af temozolomid eller eksponeringen over for dets aktive metabolit monomethyltriazenoimidazolcarboxamid (MTIC).
In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
51 4.7 Effects on ability to drive and use machines
Bivirkninger fremkommet hos patienter med ny diagnosticeret glioblastoma multiforme under konkomitant - og monoterapi behandlingsfaserne Systemorganklasse
Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme
Almindelige:
52 Psychiatric disorders Common:
Almindelige:
53 Common:
52
Uncommon:
Disse bivirkninger var oftest grad 1 eller 2, (0- 5 opkastninger inden for 24 timer) og ophørte af sig selv eller kunne let kontrolleres med kvalmestillende standard behandling.
These reactions were usually Grade 1 or 2 (0 – 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Køn
55 Gender
54 Erfaring efter markedsføring:
Post-Marketing Experience
TMZ blev givet som salvage- behandling i opfølgningsfasen hos 161 patienter af 282 (57%) i armen med strålebehandling alene, og 62 patienter af 277 (22%) i armen med TMZ + strålebehandling.
56 TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57%) in the RT alone arm, and 62 patients of the 277 (22%) in the TMZ + RT arm.
10%) er højere for gruppen med strålebehandling + TMZ.
The estimated probability of surviving 2 years or more (26% vs 10%) is higher for the R T + TMZ arm.
55 ITT Population:
H R (9 5% C .I.) = 1 .5 9 (1 .3 3 – 1 .9 1) lo g -ra n k p -va lu e < .0 0 0 1
Median- tiden til progression af disse endpoints varierede fra at være 0, 7 til 2, 1 måneder længere for TMZ end for procarbazin (log rank p = < 0, 01 til 0, 03).
57 median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p = < 0.01 to 0.03).
56 6- måneders hændelses- frie overlevelse for ITT populationen var 44% med en median event- fri overlevelse på 4, 6 måneder, hvilket var i lighed med resultaterne for den progressionsfri overlevelse.
The 6-month event-free survival for the ITT population was 44% with a median event-free survival of 4.6 months, which was similar to the results for the progression-free survival.
Særlige patientgrupper
58 Special populations
57 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
Kapselskal: gelatine, titandioxid (E 171), natriumlaurilsulfat, indigo carmin (E 132),
Capsule shell: gelatin, titanium dioxide (E 171), sodium lauril sulfate, indigo carmine (E 132),
58 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
Hver hård kapsel indeholder 316, 3 mg vandfri lactose.
Each hard capsule contains 316.3 mg of anhydrous lactose.
De hårde kapsler har en uigennemsigtig hvid bund, en uigennemsigtig orange hætte og bærer et tryk med sort tryksværte.
Hard capsule The hard capsules have an opaque white body, an opaque orange cap, and are imprinted with black ink.
Bunden bærer et tryk med ” 180 mg ”, Schering- Plough- logoet og to striber.
The body is imprinted with "180 mg", the Schering-Plough logo and two stripes.
61 • common toxicity criteria (CTC, kriterium for gradering af bivirkninger) ikke- hæmatologisk toksicitet ≤ Grad 1 (undtagen for alopeci, kvalme og opkastning) Under behandling bør en komplet blodundersøgelse foretages ugentlig.
- common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea
Tabel 3.
63 Table 3.
62 Voksne og børn fra 3 år med tilbagevendende eller progressivt malignt gliom:
Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma:
4. 4).
64 Severe myelosuppression (see section 4.4).
63 Der kan være en højere forekomst af PCP, når TMZ anvendes i et længere dosisregime.
There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen.
Mandlige patienter
65 Male patients
64 I et separat fase I- studie resulterede indtagelse af TMZ sammen med ranitidin ikke i ændringer i absorptionsgraden af temozolomid eller eksponeringen over for dets aktive metabolit monomethyltriazenoimidazolcarboxamid (MTIC).
In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
66 4.7 Effects on ability to drive and use machines
Almindelige:
67 Psychiatric disorders Common:
Almindelige:
68 Common:
67
Uncommon:
Køn
70 Gender
69 Erfaring efter markedsføring:
Post-Marketing Experience
L01A X03.
L01 A X03
TMZ blev givet som salvage- behandling i opfølgningsfasen hos 161 patienter af 282 (57%) i armen med strålebehandling alene, og 62 patienter af 277 (22%) i armen med TMZ + strålebehandling.
71 TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57%) in the RT alone arm, and 62 patients of the 277 (22%) in the TMZ + RT arm.
70 ITT Population:
H R (9 5% C .I.) = 1 .5 9 (1 .3 3 – 1 .9 1) lo g -ra n k p -va lu e < .0 0 0 1
Hos patienter med tidligere kemoterapi, blev en forbedring registreret hos patienter med en KPS ≥ 80.
In p atients with prior chemotherapy a benefit was indicated in those with a KPS ≥ 80.
Median- tiden til progression af disse endpoints varierede fra at være 0, 7 til 2, 1 måneder længere for TMZ end for procarbazin (log rank p = < 0, 01 til 0, 03).
72 median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p = < 0.01 to 0.03).
I en multicenter, prospektiv fase II undersøgelse, der vurderede sikkerhed og effekt af oral TMZ i behandlingen af patienter med anaplastisk astrocytoma ved første relaps, var 6 måneders PFS 46%.
In a multicentre, prospective phase II trial evaluating the safety and efficacy of oral TMZ in the treatment of patients with anaplastic astrocytoma at first relapse, the 6 month PFS was 46%.
71 6- måneders hændelses- frie overlevelse for ITT populationen var 44% med en median event- fri overlevelse på 4, 6 måneder, hvilket var i lighed med resultaterne for den progressionsfri overlevelse.
The 6-month event-free survival for the ITT population was 44% with a median event-free survival of 4.6 months, which was similar to the results for the progression-free survival.
Særlige patientgrupper
73 Special populations
72 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
Tryk: shellac, propylenglycol, renset vand, ammoniumhydroxid, kaliumhydroxid, sort jernoxid (E 172).
Printing ink: shellac, propylene glycol, purified water, ammonium hydroxide, potassium hydroxide,
73 3 år
3 years
EU/ 1/ 98/ 096/ 011 EU/ 1/ 98/ 096/ 012 EU/ 1/ 98/ 096/ 019 EU/ 1/ 98/ 096/ 020 74 9.
EU/1/98/096/011 EU/1/98/096/012 EU/1/98/096/019 EU/1/98/096/020
Hver hård kapsel indeholder 154, 3 mg vandfri lactose.
Each hard capsule contains 154.3 mg of anhydrous lactose.
De hårde kapsler har en uigennemsigtig hvid bund og hætte og bærer et tryk med sort tryksværte.
The hard capsules have an opaque white body and cap and are imprinted with black ink.
Bunden bærer et tryk med ” 250 mg ”, Schering- Plough- logoet og to striber.
The body is imprinted with "250 mg", the Schering -Plough logo and two stripes.
Voksne med nydiagnosticeret glioblastoma multiforme
Adult patients with newly -diagnosed glioblastoma multiforme
76 • common toxicity criteria (CTC, kriterium for gradering af bivirkninger) ikke- hæmatologisk toksicitet ≤ Grad 1 (undtagen for alopeci, kvalme og opkastning) Under behandling bør en komplet blodundersøgelse foretages ugentlig.
- common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea
Tabel 3.
78 Table 3.
77 Voksne og børn fra 3 år med tilbagevendnde eller progressivt malignt gliom:
Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma:
4. 4).
79 Severe myelosuppression (see section 4.4).
Pneumocystis carini- lungebetændelse
Pneumocystis carinii pneumonia
78 Malignitet
Malignancies
Mandlige patienter
80 Male patients
79 I et separat fase I- studie resulterede indtagelse af TMZ sammen med ranitidin ikke i ændringer i absorptionsgraden af temozolomid eller eksponeringen over for dets aktive metabolit monomethyltriazenoimidazolcarboxamid (MTIC).
In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
4. 7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner
81 4.7 Effects on ability to drive and use machines
Ikke almindelig:
Metabolism and nutrition
Almindelige:
82 Psychiatric disorders Common:
81 Almindelige:
Common:
Øre og labyrint
Uncommon:
Almindelige:
83 Common:
82
Uncommon:
Køn
85 Gender
84 Erfaring efter markedsføring:
Post-Marketing Experience
TMZ blev givet som salvage- behandling i opfølgningsfasen hos 161 patienter af 282 (57%) i armen med strålebehandling alene, og 62 patienter af 277 (22%) i armen med TMZ + strålebehandling.
86 TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57%) in the RT alone arm, and 62 patients of the 277 (22%) in the TMZ + RT arm.
85 ITT Population:
H R (9 5% C .I.) = 1 .5 9 (1 .3 3 – 1 .9 1) lo g -ra n k p -va lu e < .0 0 0 1
Median- tiden til progression af disse endpoints varierede fra at være 0, 7 til 2, 1 måneder længere for TMZ end for procarbazin (log rank p = < 0, 01 til 0, 03).
87 median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p = < 0.01 to 0.03).
86 6- måneders hændelses- frie overlevelse for ITT populationen var 44% med en median event- fri overlevelse på 4, 6 måneder, hvilket var i lighed med resultaterne for den progressionsfri overlevelse.
The 6-month event-free survival for the ITT population was 44% with a median event-free survival of 4.6 months, which was similar to the results for the progression-free survival.
Særlige patientgrupper
88 Special populations
Ved analyse af populationsbaseret farmakokinetik for TMZ blev det fundet, at plasma TMZ- clearance var uafhængig af alder, nyrefunktion og tobaksforbrug.
Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
6. 2 Uforligeligheder
89 6.2 Incompatibilities
88 Flaske
Bottle presentation
8.
90 8.
90 1.
91 1.
Temodal 2, 5 mg/ ml pulver til infusionsvæske, opløsning.
Temodal 2.5 mg/ml powder for solution for infusion
Efter rekonstitution indeholder 1 ml infusionsvæske, opløsning, 2, 5 mg temozolomid.
After reconstitution, 1 ml solution for infusion contains 2.5 mg temozolomide.
Hvert hætteglas indeholder 2, 4 mmol natrium.
Each vial contains 2.4 mmol sodium.
Temodal 2, 5 mg/ ml er indiceret til behandling af:
Temodal 2.5 mg/ ml is indicated for the treatment of:
Temodal 2, 5 mg/ ml bør kun ordineres af læger, der har erfaring med onkologisk behandling af hjernetumorer.
Temodal 2.5 mg/ml should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Temodal 2, 5 mg/ ml anvendes konkomitant med fokal strålebehandling (konkomitant fase) efterfulgt af op til 6 serier af temozolomid (TMZ) - monoterapi (monoterapi fase).
Temodal 2.5 mg/ml is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Konkomitant fase TMZ indgives i en dosis på 75 mg/ m2 dagligt i 42 dage konkomitant med fokal strålebehandling (60 Gy indgivet i 30 fraktioner).
TMZ is administered at a dose of 75 mg/m2 daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
Det anbefales ikke at foretage dosisreduktioner, men udskydelse eller seponering af TMZ- indgift bør overvejes hver uge i henhold til hæmatologiske og ikke- hæmatologiske toksicitetskriterier.
No dose reductions are recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non- haematological toxicity criteria.
Indgift af TMZ kan fortsættes under den konkomitante periode på 42 dage (i op til 49 dage), hvis alle de følgende betingelser er opfyldt: • absolut antal neutrofile (ANC) ≥ 1, 5 x 109/ l • trombocyttal ≥ 100 x 109/ l • Common Toxicity Criteria (CTC, kriterium for gradering af bivirkninger) ikke- hæmatologisk toksicitet ≤ Grad 1 (undtagen for alopeci, kvalme og opkastning)
- common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia,
91 Under behandling bør en komplet blodundersøgelse foretages ugentlig.
During treatment a complete blood count should be obtained weekly.
Trombocyttal CTC ikke- hæmatologisk toksicitet (undtagen for alopeci, kvalme,
Thrombocyte count CTC non-h aematological toxicity
TMZ dosis 2 (mg/ m / dag)
TMZ dose (mg/m2/day)
Tabel 3.
93 Table 3.
92 En behandlingsserie består af 28 dage.
A treatment cycle comprises 28 days.
Til patienter, som ikke tidligere er behandlet med kemoterapi, indgives TMZ i en dosis på 200 mg/ m2 én gang dagligt i de første 5 dage efterfulgt af en 23- dages behandlingspause (i alt 28 dage).
In patients previously untreated with chemotherapy, TMZ is administered at a dose of 200 mg/m2 once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
Baseret på TMZ’ s farmakokinetiske egenskaber er det usandsynligt, at dosisreduktion er påkrævet hos patienter med svær leverinsufficiens eller hvilken som helst grad af nyreinsufficiens.
Based on the pharmacokinetic properties of TMZ, it is unlikely that dose reductions are required in patients with severe hepatic impairment or any degree of renal impairment.
Temodal 2, 5 mg/ ml pulver til infusionsvæske, opløsning, må kun anvendes til intravenøs infusion.
Temodal 2.5 mg/ ml powder for solution for infusion must be administered only by intravenous infusion.
Som for andre lignende kemoterapeutiske lægemidler anbefales det at undgå udsivning.
94 As with other similar chemotherapeutic agents, caution is recommended to avoid extravasation.
Bivirkninger relateret til det lokale injektionssted, som for det meste var milde og kortvarige, blev rapporterede hos patienter, der modtog Temodal 2, 5 mg/ ml pulver til infusionsvæske, opløsning.
Local injection site adverse reactions, which were mostly mild and short-lived were reported in patients receiving Temodal 2.5 mg/ml powder for solution for infusion.
4. 8 og 5. 3).
Preclinical studies did not show permanent tissue damage (see sections 4.8 and 5.3).
5. 2).
Temodal 2.5 mg/ml powder for solution for infusion, given as an intravenous infusion over 90 minutes, is bioequivalent to the hard capsule formulation (see section 5.2).
Overfølsomhed over for det aktive stof, over for et eller flere af hjælpestofferne.
Hypersensitivity to the active substance or to any of the excipients.
93 Patienter, som fik konkomitant TMZ og strålebehandling i en pilotundersøgelse af det længerevarende 42 dages- program, viste sig at have særlig risiko for at udvikle Pneumocystis carinii lungebetændelse (PCP).
Patients who received concomitant TMZ and RT in a pilot trial for the prolonged 42-day schedule were shown to be at particular risk for developing Pneumocystis carinii pneumonia (PCP).
Hvis ANC falder til < 1, 0 x 109/ l, eller trombocyttallet er < 50 x 109/ l i en behandlingsserie, skal næste behandlingsserie reduceres med et dosisniveau (se pkt.
If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x 109/l during any cycle, the next cycle should be
4. 2).
95 reduced one dose level (see section 4.2).
4. 6).
Men being treated with TMZ should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment (see section 4.6).
94 Dette lægemiddel indeholder 2, 4 mmol natrium pr. hætteglas.
This medicinal product contains 2.4 mmol sodium per vial.
I et separat fase I- studie resulterede indtagelse af TMZ sammen med ranitidin ikke i ændringer i absorptionsgraden af temozolomid eller eksponeringen over for dets aktive metabolit monomethyltriazenoimidazolcarboxamid (MTIC).
In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
Temodal 2, 5 mg/ ml bør ikke anvendes til gravide kvinder.
Temodal 2.5 mg/ml should not be administered to pregnant women.
Det vides ikke, om TMZ udskilles i modermælk; amning bør derfor afbrydes, mens behandling med TMZ modtages.
96 It is not known whether TMZ is excreted in human milk; thus, breast-feeding should be discontinued while receiving treatment with TMZ.
Hos de nyligt diagnosticerede patienter med glioblastom multiforme, der modtog monoterapi, blev kramper rapporteret som værende meget almindeligt.
In patients treated with TMZ, whether used in combination with RT or as monotherapy following RT for newly-diagnosed glioblastoma multiforme, or as monotherapy in patients with recurrent or progressive glioma, the reported very common adverse reactions were similar: nausea, vomiting, constipation, anorexia, headache and fatigue.
De fleste hæmatologiske bivirkninger blev rapporteret som værende almindelige eller meget almindelige for begge indikationer (Tabel 4 og 5); hyppighed af grad 3- 4 laboratoriefund er angivet efter hver tabel.
Most haematological adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5); the frequency of grade 3-4 laboratory findings is presented after each table.
Ikke almindelig:
97 Endocrine disorders Uncommon:
96 Nervesystemet
Nervous system disorders Very common:
Hovedpine Kramper, bevidsthedssvækkelse, døsighed, afasi, nedsat balanceevne, svimmelhed, forvirring, nedsat hukommelse, nedsat koncentrationsevne, neuropati, parestesi, taleforstyrrelse, tremor
Headache Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
Kramper, hovedpine Hemiparese, afasi, nedsat balanceevne, døsighed, forvirring, svimmelhed, nedsat hukommelse, nedsat koncentrationsevne, dysfasi, neurologisk lidelse (NOS), neuropati, perifer neuropati, parestesi, taleforstyrrelse, tremor
Convulsions, headache Hemiparesis, aphasia, balance impaired, somnolence, confusion, dizziness, memory impairment, concentration impaired, dysphasia, neurological disorder (NOS), neuropathy, peripheral neuropathy, paresthesia, speech disorder, tremor
Øjne
Uncommon:
Luftveje, thorax og mediastinum
98 Respiratory, thoracic and mediastinal disorders Common:
Meget almindelige:
Skin and subcutaneous tissue disorders
97 Almindelige:
Common:
Dermatitis, tør hud, erythem, kløe Hudeksfoliering, lysoverfølsomhedsreaktion, unormal pigmentering
Dermatitis, dry skin, erythema, pruritus
Tør hud, kløe Erythem, unormal pigmentering, øget svedtendens
Dry skin, pruritus
Undersøgelser
Uncommon:
Almindelig:
99 Common:
Når unormale laboratorieværdier og bivirkninger blev slået sammen på tværs af konkomitante og monoterapi behandlingsfaser, blev Grad 3 - eller Grad 4- neutrofilabnormaliteter inklusive neutropeni- bivirkninger set hos 8% af patienterne.
When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8% of the patients.
98 Tabel 5.
Table 5.
Hovedpine Søvnighed, svimmelhed, parestesier
Headache Somnolence, dizziness, paresthesia
Træthed Feber, asteni, rigor, alment ubehag, smerte, smagsforstyrrelser
Fatigue Fever, asthenia, rigors, malaise, pain, taste perversion
0% af de mandlige forsøgspersoner i det første terapiforløb.
In a study of 288 subjects with newly– diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3% of female vs 0% of male subjects and Grade 4 thrombocytopenia in 1% of female vs 0% of male subjects in the first cycle of therapy.
Erfaringer fra klinisk undersøgelser med IV
Clinical trial experience with IV
Temodal 2, 5 mg/ ml pulver til infusionsvæske, opløsning, leverer TMZ doser samt udsættelse for både TMZ og den aktive metabolit MTIC ækvivalent med den tilsvarende Temodal hårde kapsel (se pkt.
Temodal 2.5 mg/ml powder for solution for infusion delivers equivalent TMZ dose and exposure to both TMZ and its active metabolite MTIC as the corresponding Temodal hard capsules (see section 5.2).
De bivirkninger, der blev rapporterede under de to studier med den intravenøs formulering (n=35) men ikke i studier med de hårde kapsler, var reaktioner i forbindelse med infusionsstedet: smerte, irritation, pruritus, varme, hævelse og erythema såvel som hæmatom.
Adverse reactions reported during the two studies with the intravenous formulation (n=35) but not in studies using hard capsules, were infusion site reactions: pain, irritation, pruritus, warmth, swelling, and erythema, as well as haematoma.
Erfaring efter markedsføring:
Post -Marketing Experience
Én patient har taget en overdosis på 10. 000 mg (total dosis i en enkelt serie over 5 dage) og de rapporterede bivirkninger var pancytopeni, pyreksi, multiorgansvigt og dødsfald.
An overdose of 10,000 mg (total dose in a single cycle, over 5 days) was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi-organ failure and death.
5. 1 Farmakodynamiske egenskaber
101 5.1 Pharmacodynamic properties
Pneumocystis carinii
Pneumocystis carinii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Total overlevelse
The addition of concomitant TMZ to RT, followed by TMZ monotherapy in the treatment of patients with newly-diagnosed glioblastoma multiforme demonstrated a statistically significant improvement in overall survival (OS) compared with RT alone (Figure 1).
Strålebehandling + TMZ 26%
Kaplan-Meier curves for overall survival (Intent to Treat population)
10% Strålebehandling alene
H R (9 5% C .I.) = 1 .5 9 (1 .3 3 – 1 .9 1) lo g -ra n k p -va lu e < .0 0 0 1
12, 1
26% RT+TM Z
14, 6
10% R T O n ly
Tid fra randomisering (måneder)
1 2 .1
Figur 1
1 4 .6
Data for klinisk effekt hos patienter med glioblastoma multiforme (Karnofsky performance status [KPS] ≥ 70), der progredierer eller recidiverer efter kirurgi og strålebehandling, var baseret på to kliniske undersøgelser med oral TMZ.
102 Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS] ≥ 70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral TMZ.