natgillin/translations-raw huggingface dataset:
Docetaxels kinetiske profil er dosis- uafhængig og i overensstemmelse med en 3 - compartment farmakokinetisk model, med halveringstider for α, β og γ faserne på henholdsvis 4 min., 36 min. og 11, 1 time.
The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and 11.1 h, respectively.
Efter administration af docetaxel 100 mg/ m2 givet som infusion over 1 time, fandtes den gennemsnitlige maksimale plasmakoncentration at være 3, 7 mg/ ml med et AUC på 4, 6 h. μg/ ml.
Following the administration of a 100 mg/ m2 dose given as a one-hour infusion a mean peak plasma level of 3.7 µg/ ml was obtained with a corresponding AUC of 4.6 h. µg/ ml.
Gennemsnitsværdierne for den totale clearence og steady- state distributionsvolumen var henholdsvis 21 l/ h/ m2 og 113 l.
Mean values for total body clearance and steady-state volume of distribution were 21 l/ h/ m2 and 113 l, respectively.
Den interindividuelle variation i totalclearance var ca 50%.
Inter individual variation in total body clearance was approximately 50%.
Docetaxels plasmaproteinbinding er > 95%.
Docetaxel is more than 95% bound to plasma proteins.
Der er gennemført en undersøgelse med 14C- mærket docetaxel på 3 kræftpatienter.
A study of 14C-docetaxel has been conducted in three cancer patients.
Inden for 7 dage udgjorde ekskretion i urin og fæces henholdsvis 6% og 75% af radioaktivtiteten.
Docetaxel was eliminated in both the urine and faeces following cytochrome P450-mediated oxidative metabolism of the tert-butyl ester group, within seven days, the urinary and faecal excretion accounted for about 6% and 75% of the administered radioactivity, respectively.
Ca 80% af radioaktiviteten i fæces er udskilt efter 48 timer i form af en større inaktiv og tre mindre inaktive metabolitter samt meget lave koncentrationer af uomdannet lægemiddel.
About 80% of the radioactivity recovered in faeces is excreted during the first 48 hours as one major inactive metabolite and 3 minor inactive metabolites and very low amounts of unchanged medicinal product.
De farmakokinetiske parametre i modellen lå tæt på det, der blev observeret i fase I- studier.
Pharmacokinetic parameters estimated by the model were very close to those estimated from phase I studies.
Hos et beskedent antal patienter (n = 23) med en klinisk kemi, der tydede på en let til moderat nedsat leverfunktion (ASAT og ALAT ≥ 1, 5 gange øvre normalværdi og basisk fosfatase ≥ 2, 5 gange øvre normalværdi), var clearance nedsat med gennemsnitlig 27%.
In a small number of patients (n = 23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥ 1.5 times the ULN associated with alkaline phosphatase ≥ 2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2).
4. 2).
Docetaxel clearance was not
Docetaxels clearance var ikke påvirket hos patienter med let til moderat væskeretention, og der findes ingen data for clearance hos patienter med svær væskeretention.
33 modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
34 Docetaxel influerer ikke på clearence af doxorubicin eller plasmaniveauet af doxorubicinol (en doxorubicinmetabolit), når det anvendes i kombination.
When used in combination, docetaxel does not influence the clearance of doxorubicin and the plasma levels of doxorubicinol (a doxorubicin metabolite).
Den samtidige administration af docetaxel, doxorubicin og cyclophosfamid påvirkede ikke deres farmakokinitik.
The pharmacokinetics of docetaxel, doxorubicin and cyclophosphamide were not influenced by their coadministration.
Fase I- studier, som evaluerede capecitabins effekt på docetaxels farmakokinetik og vice versa, viste ingen effekt af capecitabin på docetaxels farmakokinetik (Cmax og AUC) og ingen effekt af docetaxel på capecitabins hovedmetabolit 5 ’ - DFUR’ s farmakokinetik.
Phase I study evaluating the effect of capecitabine on the pharmacokinetics of docetaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel (Cmax and AUC) and no effect by docetaxel on the pharmacokinetics of a relevant capecitabine metabolite 5’ -DFUR.
Den kombinerede administration af docetaxel, cisplatin og 5- fluorouracil hos 12 patienter med massive tumorer havde ingen indflydelse på farmakokinetikken for hvert af de individuelle lægemidler.
The combined administration of docetaxel, cisplatin and 5-fluorouracil in 12 patients with solid tumors had no influence on the pharmacokinetics of each individual medicinal product.
Docetaxel har vist sig at være mutagent in vitro i mikronucleus - og kromosom- aberrationstesten i CHO- K1 celler, samt in vivo i mikronucleustesten i mus.
Docetaxel has been shown to be mutagenic in the in vitro micronucleus and chromosome aberration test in CHO-K1 cells and in the in vivo micronucleus test in the mouse.
Derimod induceredes ingen mutationer i Ames test eller i en CHO/ HGPRT gen mutation assay.
However, it did not induce mutagenicity in the Ames test or the CHO/ HGPRT gene mutation assay.
Det må derfor formodes, at også den mandlige fertilitet påvirkes af docetaxel.
Undesirable effects on the testis observed in rodent toxicity studies suggest that docetaxel may impair male fertility.
Koncentrat hætteglas: polysorbat 80.
Concentrate vial: polysorbate 80.
Solvens hætteglas: ethanol 95% vand til injektionsvæsker.
Solvent vial: ethanol 95% water for injections.
6. 3 Opbevaringstid
34 6.3 Shelf-life
• 2 år. • Præmix- opløsning:
• 2 years. • Premix solution:
Præmix- opløsningen indeholder 10 mg/ ml docetaxel og skal bruges straks efter tilberedning.
The premix solution contains 10 mg/ ml docetaxel and should be used immediately after preparation.
Infusionsopløsningen skal bruges inden for 4 timer ved stuetemperatur (under 25°C).
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2 °C and 8 °C or at room temperature (below 25 °C). • Infusion solution: the infusion solution should be used within 4 hours at room temperature (below 25 °C).
35 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
Må ikke opbevares over 25ºC eller under 2ºC.
Do not store above 25 °C or below 2 °C.
Hver blisterpakning indeholder: • et enkeltdosis hætteglas med koncentrat og, • et enkeltdosis hætteglas med solvens
Each blister pack contains: • one single-dose vial of concentrate and, • one single-dose vial of solvent.
Docetaxel Winthrop 20 mg koncentrat til infusionsvæske, opløsning hætteglas:
Docetaxel Winthrop 20 mg concentrate for solution for infusion vial
7 ml klart Type I- hætteglas med en grøn afrivningshætte.
7 ml clear glass Type I vial with a green flip-off cap.
Hætteglasset indeholder en docetaxel- opløsning i 0, 5 ml polysorbat 80 med en koncentration på 40 mg/ ml (indhold:
This vial contains 0.5 ml of a 40 mg/ ml solution of docetaxel in polysorbate 80 (fill volume:
24, 4 mg/ 0, 61 ml).
24.4 mg/ 0.61 ml).
Dette tab skyldes skumdannelse, væske, der klæber til siderne af glasset, og et restvolumen, som ikke kan udtages.
This fill volume has been established during the development of Docetaxel Winthrop to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
Dette overskud sikrer, at der efter fortynding med hele indholdet af den medfølgende solvens til Docetaxel Winthrop udtages et præmixvolumen på mindst 2 ml, som indeholder 10 mg/ ml docetaxel, hvilket svarer til den mængde, der er angivet på pakningen med 20 mg per hætteglas.
This overfill ensures that after dilution with the entire contents of the accompanying solvent for Docetaxel Winthrop vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ ml docetaxel which corresponds to the labelled amount of 20 mg per vial.
Hætteglasset indeholder 1, 5 ml af en 13% ethanol opløsning i vand til injektionsvæsker (indhold:
Solvent vial contains 1.5 ml of a 13% w/ w solution of ethanol 95% in water for injections (fill volume:
1, 98 ml).
1.98 ml).
Tilsætning af hele indholdet fra hætteglasset med solvens til indholdet i hætteglasset med Docetaxel Winthrop 20 mg, koncentrat il infusionsvæske, opløsning, sikrer en præmixkoncentration på 10 mg/ ml docetaxel.
The addition of the entire contents of the solvent vial to the contents of the Docetaxel Winthrop 20 mg concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ ml docetaxel.
Docetaxel Winthrop er et antineoplastisk stof, og ligesom andre potentielle toksiske stoffer skal det behandles med forsigtighed ved håndtering og tilberedning af Docetaxel Winthrop- opløsningerne.
Docetaxel Winthrop is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Docetaxel Winthrop solutions.
Hvis Docetaxel Winthrop infusionskoncentrat, præmix- opløsning eller infusionsvæske skulle komme på huden, så vask omgående og grundigt med sæbe og vand.
If Docetaxel Winthrop concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Hvis Docetaxel Winthrop infusionskoncentrat, præmix- opløsning eller infusionsvæske skulle komme i kontakt med slimhinderne, så vask omgående og grundigt med vand.
If Docetaxel Winthrop concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Tilberedning af infusionsvæsken:
35 Preparation for the intravenous administration
a) Tilberedning af Docetaxel Winthrop præmix (10 mg docetaxel/ ml)
a) Preparation of the Docetaxel Winthrop premix solution (10 mg docetaxel/ ml)
Hvis hætteglassene opbevares i køleskab, skal det nødvendige antal Docetaxel Winthrop- æsker stå i stuetemperatur (under 25°C) i 5 minutter før brug.
If the vials are stored under refrigeration, allow the required number of Docetaxel Winthrop boxes to stand at room temperature (below 25 °C) for 5 minutes.
Med en sprøjte udtages hele indholdet aseptisk fra hætteglasset med opløsningsmiddel til Docetaxel Winthrop ved at holde hætteglasset på skrå.
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for Docetaxel Winthrop vial by partially inverting the vial.
Injicer hele indholdet af sprøjten i det tilsvarende hætteglas med Docetaxel Winthrop.
Inject the entire contents of the syringe into the corresponding Docetaxel Winthrop vial.
36 Fjern sprøjten, og bland miksturen manuelt ved at vende hætteglasset gentagne gange i mindst 45 sekunder.
Remove the syringe and needle and mix manually by repeated inversions for at least 45 seconds.
(Skumdannelse er normalt, selv efter 5 minutter på grund af polysorbat 80 i opløsningen).
Allow the premix vial to stand for 5 minutes at room temperature (below 25 °C) and then check that the solution is homogenous and clear (foaming is normal even after 5 minutes due to the presence of polysorbate 80 in the formulation).
Præmixen indeholder 10 mg/ ml docetaxel og skal bruges straks efter tilberedning.
The premix solution contains 10 mg/ ml docetaxel and should be used immediately after preparation.
Dog har præmixopløsningen vist fysisk og kemisk stabilitet i en periode på 8 timer, både når den blev opbevaret mellem +2°C og +8°C, og når den blev opbevaret ved stuetemperatur (under 25°C).
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2 °C and 8 °C or at room temperature (below 25 °C).
I henhold til den beregnede dosis udtrykt i mg udtages det tilsvarende volumen præmix indeholdende 10 mg/ ml docetaxel aseptisk med en gradueret sprøjte.
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding premix volume containing 10 mg/ ml docetaxel from the appropriate number of premix vials using graduated syringes fitted with a needle.
Injicer derefter den beregnede mængde Docetaxel Winthrop- præmix i en 250 ml infusionspose med enten 5% glucose eller 0, 9% NaCl.
Inject the required premix volume into a 250 ml infusion bag or bottle containing either 5% glucose solution or 0.9% sodium chloride solution.
Hvis den beregnede dosis er større end 200mg docetaxel, skal der bruges et større volumen af infusionsvæsken, så man ikke overstiger en koncentration på 0, 74 mg/ ml.
If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ ml docetaxel is not exceeded.
Docetaxel Winthrop infusionsopløsning skal bruges inden for 4 timer og anvendes under aseptiske forhold som en 1- times infusion ved stuetemperatur (under 25°C) og under normale lysforhold.
The Docetaxel Winthrop infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25 °C) and normal lighting conditions.
Som ved alle andre parenterale produkter, skal både Docetaxel Winthrop præmix og infusionsvæske kontrolleres for uklarheder, og opløsninger med udfældning skal i givet fald kasseres.
As with all parenteral products, Docetaxel Winthrop premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
20 avenue Raymond Aron 92165 Antony Cedex Frankrig
Aventis Pharma S. A., 20 avenue Raymond Aron, 92165 Antony Cedex, France
XX
20 April 2007
Docetaxel Winthrop 80 mg koncentrat og solvens til infusionsvæske, opløsning.
Docetaxel Winthrop 80 mg concentrate and solvent for solution for infusion
Hvert enkeltdosis- hætteglas med Docetaxel Winthrop 80 mg koncentrat indeholder docetaxel som trihydrat, svarende til 80 mg docetaxel (vandfri).
Each single-dose vial of Docetaxel Winthrop 80 mg concentrate contains docetaxel which is a trihydrate corresponding to 80 mg of docetaxel (anhydrous).
38 Prostatakræft
38 Prostate cancer
For behandling efter forudgående svigt af platinbaseret kemoterapi, er den anbefalede dosis 75 mg/ m2 givet som enkeltstof.
39 after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/ m² as a single agent.
40 havde denne reaktion, skulle forblive på G- CSF og have deres docetaxel- dosis reduceret til 60 mg/ m2.
40 However, in clinical practice neutropenia could occur earlier.
41 Specielle patientgrupper:
41 Special populations
42 Hos de patienter, der blev behandlet med docetaxel i kombination med cisplatin og 5- fluorouracil (TCF), opstod der febril neutropeni og neutropenisk infektion i mindre grad, når patienterne fik profylaktisk G- CSF.
42 In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
43 Nervesystemet
43 Cardiac toxicity
44 4. 5 Interaktion med andre lægemidler og andre former for interaktion
44 4.5 Interaction with other medicinal products and other forms of interaction
De bivirkninger, som sandsynligvis er relateret til anvendelsen af docetaxel, er set hos: • 1312 og 121 patienter som fik henholdsvis 100 mg/ m2 og 75 mg/ m2 af Docetaxel Winthrop som enkeltstof. • 258 patienter som fik docetaxel i kombinationsbehandling med doxorubicin. • 406 patienter som fik docetaxel i kombination med cisplatin. • 92 patienter som fik docetaxel i kombination med trastuzumab. • 255 patienter som fik docetaxel i kombination med capecitabin.
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in: • 1312 and 121 patients who received 100 mg/ m² and 75 mg/ m² of docetaxel as a single agent respectively. • 258 patients who received docetaxel in combination with doxorubicin. • 406 patients who received docetaxel in combination with cisplatin.
45 • 332 patienter som fik docetaxel i kombination med prednison eller prednisolon (klinisk relevante behandlingsrelaterede bivirkninger er medtaget). • 744 patienter som fik docetaxel i kombination med doxorubicin og cyclophosphamid (bivirkninger til klinisk vigtig behandling er præsenteret). • 300 gastrisk adenocarcinoma- patienter (221 patienter i fase III- delen af undersøgelsen og 79 patienter i fase II- delen af undersøgelsen), som blev behandlet med docetaxel i kombination med cisplatin og 5- fluorouracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt). • 174 og 251 hoved - og hals- kræft- patienter, som blev behandlet med docetaxel i kombination med cisplatin og 5- fluorouracil (klinisk vigtige behandlingsrelaterede bivirkninger er nævnt).
45 • 92 patients treated with docetaxel in combination with trastuzumab. • 255 patients who received docetaxel in combination with capecitabine. • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented). • 744 patients who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented). • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented). • 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented).
46 Der er rapporter om tilfælde af væskeretention såsom perifert ødem og sjældnere pleura- og perikardieekssudat, ascites og vægtøgning.
Fluid retention includes events such as peripheral oedema and less frequently pleural effusion, pericardial effusion, ascites and weight gain.
Det perifere ødem starter sædvanligvis i underekstremiteterne og kan blive generaliseret med vægtstigning på 3 kg eller mere.
46 extremities and may become generalised with a weight gain of 3 kg or more.
48 Docetaxel Winthrop 75 mg/ m² enkeltstof:
48 Docetaxel Winthrop 75 mg/ m² single agent
49 Docetaxel Winthrop 75 mg/ m² i kombination med doxorubicin:
49 Docetaxel Winthrop 75 mg/ m² in combination with doxorubicin
50 Docetaxel Winthrop 75 mg/ m2 i kombination med cisplatin:
50 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin
51 Docetaxel Winthrop 100 mg/ m² i kombination med trastuzumab:
51 Docetaxel Winthrop 100 mg/ m² in combination with trastuzumab
52 Docetaxel Winthrop 75 mg/ m² i kombination med capecitabin:
52 Docetaxel Winthrop 75 mg/ m² in combination with capecitabine
53 Docetaxel Winthrop 75 mg/ m² i kombination med prednison eller prednisolon:
53 Docetaxel Winthrop 75 mg/ m² in combination with prednisone or prednisolone
54 Docetaxel Winthrop 75 mg/ m² i kombination med doxorubicin og cyclophosphamid:
54 Docetaxel Winthrop 75 mg/ m² in combination with doxorubicin and cyclophosphamide
Vaskulære sygdomme Almene symptomer og reaktioner på administrationsstedet
Vascular disorders
0, 9%) 0%) Asteni (G3/ 4:
0.9%) 0%)
55 Systemorganklasser i henhold til MedDRA - databasen Det reproduktive system og mammae
55 MedDRA System Organ classes General disorders and administration site conditions
Meget almindelige bivirkninger ≥ 10% af patienterne Amenorré
11%); Fever (G3/ 4:
56 Docetaxel Winthrop 75 mg/ m² i kombination med cisplatin og 5- fluorouracil til gastrisk adenocarcinoma- kræft:
56 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin and 5-fluorouracil for gastric adenocarcinoma cancer
Hjerte Blod og lymfesystem
Cardiac disorders Blood and lymphatic system disorders
2, 3%); Perifer motorisk neuropati (G3/ 4:
2.3%); Peripheral motor neuropathy (G3/ 4:
Øjne Øre og labyrint
Eye disorders
0%) Nedsat hørelse (G3/ 4:
0%)
Diarré (G3/ 4:
Diarrhoea (G3/ 4:
19, 7%); Kvalme (G3/ 4:
19.7%); Nausea (G3/ 4:
23, 7%); Opkastning (G3/ 4:
23.7%); Vomiting (G3/ 4:
Konstipation (G3/ 4:
Constipation (G3/ 4:
1, 0%); Gastrointestinale smerter (G3/ 4:
1.0%); Gastrointestinal pain (G3/ 4:
1, 0%); Oesophagitis/ dysfagi/ odynofagi (G3/ 4:
1.0%); Oesophagitis/ dysphagia/ odynop hagia (G3/ 4:
Kløende udslæt (G3/ 4:
Rash pruritus (G3/ 4:
Infektioner og parasitære sygdomme Almene symptomer og reaktioner på administrationsstedet
Infections and infestations
Neutropenisk infektion; Infektion (G3/ 4:
11.7%)
11, 7%) Lethargi (G3/ 4:
Lethargy (G3/ 4:
57 Docetaxel Winthrop 75 mg/ m² i kombination med cisplatin og 5- fluorouracil (til hoved - og halskræft):
57 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin and 5-fluorouracil for Head and Neck cancer
58 • Induktions kemoterapi efterfulgt af kemo - og stråleterapi (TAX 324)
58 • Induction chemotherapy followed by chemoradiotherapy (TAX 324)
Vaskulære lidelser Almene symptomer og reaktioner på administrationsstedet
Vascular disorders General disorders and administration site conditions
59 Erfaringer efter markedsføring:
59 Post-marketing experience
Ved behandlig med docetaxel er der rapporteret om sclerodermi- lignende forandringer, som ofte går forud for perifer lymfødem.
Sclerodermal-like changes usually preceded by peripheral lymphedema have been reported with docetaxel.
60 Hovedsagelig hos patienter med præ- eksisterende leversygdomme er der rapporter om meget sjældne tilfælde af hepatitis, nogle gange fatale.
60 Hepatobiliary disorders Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
61 En interim- analyse blev udført med et median- opfølgning ved 55 måneder.
61 An interim analysis was performed with a median follow up of 55 months.
Der blev vist signifikant længere sygdomsfri overlevelse i TAC- armen end FAC- armen.
Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Forekomsten af tilbagefald ved 5 år var reduceret hos de patienter som fik TAC, sammenlignet med dem, som fik FAC (henholdsvis 25% versus 32%).
Incidence of relapses at 5 years was reduced in patients receiving TAC compared to those who received FAC (25% versus 32%, respectively) i. e. an absolute risk reduction by 7% (p = 0.001).
Total overlevelse ved 5 år var også signifikant forøget med TAC i forhold til FAC / henholdsvis 87% versus 81%).
Overall survival at 5 years was also significantly increased with TAC compared to FAC (87% versus 81%, respectively) i. e. an absolute reduction of the risk of death by 6% (p = 0.008).
62 Docetaxel forlængede median- tiden til progression (24, 6 uger vs 15, 6 uger; p < 0, 01) og median - overlevelse (15, 3 måneder vs 12, 7 måneder; p = 0, 03) uden at påvirke det primære endepunkt (32% vs 25%, p = 0, 10), samlet respons rate (32% vs 25%, p = 0, 10).
Without affecting the primary endpoint, overall response rate (32% vs 25%, p = 0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p < 0.01) and median survival (15.3 months vs 12.7 months; p = 0.03).
Flere grad 3/ 4 bivirkninger blev observeret for Docetaxel Winthrop monoterapi (55, 4%) sammenlignet med paclitaxel (23, 0%).
More grade 3/ 4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Docetaxel Winthrop i kombination med doxorubicin
62 Docetaxel Winthrop in combination with doxorubicin
63 1 Fuldt analysesæt (intent to treat) 2 Estimeret median overlevelse.
1 Full analysis set (intent-to-treat) 2 Estimated median survival
Data fra et randomiseret, kontrolleret, klinisk fase 3- multicenterstudie understøtter anvendelsen af capecitabin i kombination med docetaxel til behandling af patienter med lokal fremskreden eller metastatisk brystkræft hos hvem cytotoksisk kemoterapi med et anthracyklin, har været uden effekt.
Data from one multicenter, randomised, controlled phase III clinical trial support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast
Sekundære endepunkter inkluderede forandring i smerter, global rating af livskvalitet med EuroQoL - 5D, lungekræft- symptom skala, og forandringer i karnosfkys performance status.
64 Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.