natgillin/translations-raw huggingface dataset:
Forekomsten af tilbagefald i år ti var reduceret hos patienter, som fik TAC sammenlignet med dem, som fik FAC (hhv. 39% og 45%), dvs. en absolut reduktion i risiko med 6% (p=0,0043). 
Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC (39% versus 45%, respectively) i.e. an absolute risk reduction by 6% (p = 0.0043).
G¬CSF blev indgivet som sekundær profylakse til patienter som oplevede kompliceret neutropeni (febril neutropeni, prolongeret neutropeni eller infektion). 
G-CSF was administered as secondary prophylaxis to patients who experienced complicated neutropenia (febrile neutropenia, prolonged neutropenia, or infection).
For behandling efter svigt af forudgående platinbaseret kemoterapi, er den anbefalede dosis 75 mg/m² givet som enkeltstof. 
For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent.
Hovedpine (G3/4: < 1%); Perifer neuropati 
Headache (G3/4: < 1%); Neuropathy peripheral
- Ved behandling af tidlig brystkræft med eller uden spredning til lymfeknuder kan docetaxel anvendes i kombination med doxorubicin eller cyclophosphamid. 
- For the treatment of early breast cancer with or without lymph node involvement, docetaxel could be administered in combination with doxorubicin and cyclophosphamide.
Til patienter, som i SCCHN pivotalstudiet udviklede kompliceret neutropeni (inklusiv prolongeret neutropeni, febril neutropeni eller infektion), blev G¬CSF anbefalet som profylakse (f.eks. dag 6-15) i alle efterfølgende cyklusser. 
In the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 6-15) in all subsequent cycles.
Som alle andre parenterale præparater bør Docetaxel Mylan koncentrat til infusionsvæske eller fortyndet opløsning til infusionsvæske inspiceres visuelt inden brug, og opløsninger med udfældning skal kasseres. 
As with all parenteral products, Docetaxel Mylan concentrate for solution or diluted solution for infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
• 174 og 251 hoved-halscancer-patienter, som blev behandlet med docetaxel i kombination med cisplatin og 5-fluoruracil (klinisk relevante behandlingsrelaterede bivirkninger er nævnt). 
• 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).
Blandt de patienter, der fik docetaxel hver tredje uge, var hyppigheden af relaterede negleforandringer ≥ 10% højere i patientgruppen på 65 år og derover, end i gruppen af yngre patienter. 
In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate ≥ 10% higher in patients who were 65 years of age or greater compared to younger patients.
Se også afsnittet ”Docetaxel Mylan indeholder ethanol (alkohol)”. 
See also section “Docetaxel Mylan contains ethanol” below.
Overlevelse var bedre i kombinationsarmen med docetaxel + carpecitabin (p = 0,0126). 
Survival was superior in the docetaxel + capecitabine combination arm (p = 0.0126).
De anbefalede dosis-justeringer for toksicitet hos patienter behandlet med docetaxel i kombination med cisplatin og 5-fluoruracil (5-FU): 
Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
På baggrund af den dosis, der er nødvendig for patienten udtrykt i mg, udtages den tilsvarende mængde af 20 mg/ml docetaxel aseptisk fra det passende antal hætteglas med en gradueret sprøjte med påsat 21G-kanyle. 
Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume of concentrate for solution containing 20 mg/ml docetaxel from the appropriate number of vials using graduated syringes fitted with a 21G needle.
Docetaxel har vist sig at være mutagent i in vitro mikronucleus- og kromosomaborrationstest i CHOK1-celler samt i in vivo mikronucleustest med 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.
Effekten af docetaxel i behandlingen af patienter med gastrisk adenokarcinom 
Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
I tilfælde af efterfølgende episoder med kompliceret neutropeni, bør dosis af docetaxel reduceres fra 60 mg/m² til 45 mg/m². 
If subsequent episodes of complicated neutropenia occur the docetaxel dose should be reduced from 60 to 45 mg/m².
Immunsystemet Metabolisme og ernæring Nervesystemet neuropati (G3: 4,1%); Perifer motorisk neuropati (G3/4: 4%); Dysgeusi (alvorlig: 
Immune system disorders Metabolism and nutrition disorders Nervous system disorders neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
• Docetaxel 30 mg/m² indgivet ugentlig de første 5 uger i en cyklus på 6 uger i 5 cyklusser. 
• Docetaxel 30 mg/m² administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles.
• Efter den anbefalede tilsætning til infusionsposen er docetaxelinfusionsopløsningen stabil i 6 timer, hvis den opbevares under 25°C. 
• Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours.
Medianantallet af cyklusser indgivet pr. patient var 6 (et interval på 1-16) for TCFarmen sammenlignet med 4 (et interval på 1-12) for CF-armen. 
The median number of cycles administered per patient was 6 (with a range of 1-16) for the TCF arm compared to 4 (with a range of 1-12) for the CF arm. Time to progression (TTP) was the primary endpoint.
Uden at påvirke det primære endepunkt, total responsrate (32% mod 25%, p = 0,10), forlængede docetaxel mediantiden til progression (24,6 uger mod 15,6 uger, p < 0,01) og medianoverlevelse (15,3 måneder mod 12,7 måneder, p = 0,03). 
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).
• Docetaxel 75 mg/m² hver 3. uge i 10 cyklusser. 
• Docetaxel 75 mg/m² every 3 weeks for 10 cycles.
Efter tilsætning til infusionpose 
Once added to the infusion bag
Den kombinerede administration af docetaxel, cisplatin og 5-floururacil hos 12 patienter med massive tumorer påvirkede ikke farmakokinetikken for hvert enkelt lægemiddel. 
The combined administration of docetaxel, cisplatin and 5-fluorouracil in 12 patients with solid tumours had no influence on the pharmacokinetics of each individual medicinal product.
I tidligere kemoterapi skal antracyklin eller et alkylerende stof have været anvendt. 
Previous chemotherapy should have included an anthracycline or an alkylating agent.
Reaktionerne ved infusionsstedet var almindeligvis milde og bestod af hyperpigmentering, inflammation, rødmen eller tørhed i huden, flebititis eller blodudtrækninger og hævelse af venen. 
Infusion site reactions were generally mild and consisted of hyper pigmentation, inflammation, redness or dryness of the skin, phlebitis or extravasation and swelling of the vein.
Injicer den nødvendige mængde koncentrat til infusionsvæske i en 250 ml infusionspose eller -flaske indeholdende enten 5% glukoseinfusionsvæske eller 9 mg/ml (0,9%) natriumkloridinfusionsvæske. 
Inject the required volume of concentrate for solution into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Et open-label, multicenter, randomiseret fase III-studie blev udført med henblik på at sammenligne docetaxel som monoterapi og paclitaxel til behandling af fremskreden brystcancer hos patienter, hvis tidligere behandling skulle have omfattet et antracyklin. 
An open-label, multicenter, randomized phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
To randomiserede, fase III, komparative studier med hhv. 326 patienter og 392 patienter med metastatisk brystcancer, der tidligere uden effekt havde fået behandling med hhv. alkylerende stoffer eller antracykliner, blev udført med docetaxel ved det anbefalede dosisregime på 100 mg/m² hver 3. uge. 
Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m² every 3 weeks.
Begge regimer blev indgivet på første dagen hver tredje uge. 
Both regimens were administered on day 1 every 3 weeks.
Total medianoverlevelse var også signifikant længere til fordel for TPF-armen (median for total overlevelse: 18,6 mod 14,5 måneder) med en 28% reduktion i risikoen for mortalitet, p = 0,0128. 
Median overall survival was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
Et stort randomiseret fase III-studie med 429 tidligere ubehandlede patienter med metastatisk sygdom blev udført med doxorubicin (50 mg/m²) i kombination med docetaxel (75 mg/m²) (AT-arm) sammenlignet med doxorubicin (60 mg/m²) i kombination med cyclophosphamid (600 mg/m²) (ACarm). 
One large randomized phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/m²) in combination with docetaxel (75 mg/m²) (AT arm) versus doxorubicin (60 mg/m²) in combination with cyclophosphamide (600 mg/m²) (AC arm).
Patienter med svær væskeretention i form af pleuralekssudat og perikardieekssudat samt ascites skal observeres nøje. 
Patients with severe fluid retention such as pleural effusion, pericardial effusion and ascites should be monitored closely.
Følgende allergiske reaktioner (kan forekomme hos flere end 1 ud af 10 patienter) kan optræde under infusionen på hospitalet: 
During the infusion at the hospital the following allergic reactions (may affect more than 1 in 10 people) may occur:
Der var en forøget forekomst af meget alvorlige bivirkninger (40% mod 31%) og grad 4 alvorlige bivirkninger (34% mod 23%) i kombinationsarmen trastuzumab sammenlignet med docetaxel enkeltbehandling. 
There was an increased incidence of SAEs (40% vs. 31%) and Grade 4 AEs (34% vs. 23%) in the trastuzumab combination arm compared to docetaxel monotherapy.
Adjuverende behandling til brystcancer 
Adjuvant therapy for breast cancer
Toksicitet Diarré grad 3 
Diarrhoea grade 3
For patienter, behandlet med docetaxel, doxorubicin og cyclophosphamid (TAC), kræver risikoen for forsinket myelodysplasi eller myeloid leukæmi hæmatologisk opfølgning. 
In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukaemia requires haematological follow-up.
Hos patienter, som tidligere havde fået antracyklin uden effekt, blev docetaxel sammenlignet med kombinationen af Mitomycin C og Vinblastin (12 mg/m² hver 6. uge og 6 mg/m² hver 3. uge). 
In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks).
Hjælpestoffer: polysorbat 80, ethanol, vandfri og citronsyre. 
LIST OF EXCIPIENTS Excipients: polysorbate 80, ethanol anhydrous and citric acid.
• Hos patienter, der første gang udvikler grad 2-toksicitet, der vedvarer til tidspunktet for den næste docetaxel/capecitabin-behandling skal behandlingen udsættes, til der er grad 0-1-toksicitet. 
• For patients developing the first appearance of a Grade 2 toxicity, which persists at the time of the next docetaxel/capecitabine treatment, delay treatment until resolved to Grade 0-1, and resume at 100% of the original dose.
Der er begrænsede tilgængelige data vedrørende anvendelse af docetaxel i kombination med doxorubicin og cyclophosphamid til patienter over 70 år. 
There are limited available data in patients > 70 years of age on docetaxel use in combination with doxorubicin and cyclophosphamide.
- Ved behandling af lungekræft kan docetaxel enten indgives alene eller i kombination med cisplatin. 
- For the treatment of lung cancer, docetaxel could be administered either alone or in combination with cisplatin.
Data fra et multicenter open-label randomiseret studie støtter anvendelsen af docetaxel til adjuverende behandling af patienter med operabel lymfeknude-positiv brystcancer og KPS ≥ 80% i alderen 18 til 70 år. 
Data from a multicenter open label randomized study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Som førstebehandling indgives 75 mg/m² doxetaxel i kombinationsbehandling med doxorubicin (50 mg/m²). 
In first-line treatment, docetaxel 75 mg/m² is given in combination therapy with doxorubicin (50 mg/m²).
Docetaxel kan gives, når neutrofiltallet er ≥ 1.500 celler/mm3. 
Docetaxel should be administered when the neutrophil count is ≥ 1,500 cells/mm3.
Data fra et multicenter, randomiseret, kontrolleret fase-III klinisk studie understøtter brugen af docetaxel i kombination med capecitabin til behandling af patienter med lokalt fremskreden eller metastatisk brystcancer efter manglende effekt af cytotoksisk kemoterapi, herunder et antracyklin. 
Data from one multicenter, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
• vægtforøgelse eller vægttab 
• weight gain or loss.
Asteni persisterede ind i followup-perioden (median followup-tid var 10 år og 5 måneder) og blev fortsat observeret hos 12 patienter (2,3%) i TAC-armen og hos 4 patienter (0,8%) i FAC-armen. 
Asthenia persisted into the follow-up period (median follow-up time of 10 years and 5 months) and was observed to be ongoing in 12 patients (2.3 %) in TAC arm and 4 patients (0.8 %) in FAC arm.
I alt 449 patienter blev randomiseret til enten monoterapi med 100 mg/m² docetaxel som en infusion over 1 time eller 175 mg/m² paclitaxel som en infusion over 3 timer. 
A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion.
I kombination med capecitabin anbefales det at reducere startdosis af capecitabin til 75% hos patienter på 60 år eller ældre (Se: Produktresumé for capecitabin). 
In combination with capecitabine, for patients 60 years of age or more, a starting dose reduction of capecitabine to 75% is recommended (see capecitabine summary of product characteristics).
Begge regimer blev indgivet hver 3. uge. 
Both regimens were administered every 3 weeks.
I tilfælde af grad 4-trombocytopeni bør dosis af docetaxel reduceres fra 75 mg/m² til 60 mg/m². 
In case of Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m².
Hvis det ikke anvendes straks, er opbevaringstider og -forhold brugerens ansvar. 
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Gennemsnitsværdierne for den samlede kropsclearance og steady-state-distributionsvolumen var henholdsvis 21 l/h/m² og 113 l. Variationen fra person til person i den samlede kropsclearance var ca. 50%. 
Mean values for total body clearance and steady-state volume of distribution were 21 l/h/m² and 113 l, respectively.
Adjuverende stråleterapi blev ordineret i henhold til gældende retningslinjer hos de deltagende institutioner og blev givet til 69% af patienterne i TAC-armen og 72% af patienterne i FAC-armen. 
Adjuvant radiation therapy was prescribed according to guidelines in place at participating institutions and was given to 69% of patients who received TAC and 72% of patients who received FAC.
Alle patienter undtagen en patient i hver arm blev diagnosticeret med CHF mere end 30 dage efter behandlingsperioden.To patienter i TAC-armen og 4 patienter i FAC-armen døde af hjertesvigt. 
All except one patient in each arm were diagnosed with CHF more than 30 days after the treatment period.
Begge regimer blev administreret en gang hver 3. uge i 6 cyklusser. 
Both regimens were administered once every 3 weeks for 6 cycles.
95% CI p-værdi 
95% CI p-value
• Udtag den ønskede mængde af Docetaxel, koncentrat til infusionsvæske, opløsning aseptisk med en kalibreret sprøjte. 
• Aseptically withdraw the required amount of concentrate for solution for infusion with a calibrated syringe.
Koncentratet er lysgul til brunlig gul. 
The concentrate is pale yellow to brownish-yellow.
Endvidere er den fysiske og kemiske stabilitet af infusionsvæsken tilberedt som anbefalet i PVC-frie infusionsposer påvist at være op til 48 timer ved opbevaring mellem 2°C og 8°C. 
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.
Fase I-studier har undersøgt docetaxels farmakokinetik hos cancerpatienter efter indgift af 20-115 mg/m². 
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m² in phase I studies.
For patienter, der ikke tidligere er behandlet med kemoterapi, der behandles for ikke-småcellet lungecancer, er den anbefalede dosis af docetaxel 75 mg/m², straks efterfulgt af cisplatin 75 mg/m² givet over 30-60 minutter. 
In chemotherapy naïve patients treated for non-small cell lung cancer, the recommended dose regimen is docetaxel 75 mg/m² immediately followed by cisplatin 75 mg/m² over 30-60 minutes.
Docetaxel influerer ikke på clearance af doxorubicins eller plasmaniveauet af doxorubicinol (en doxorubicinmetabolit), når det anvendes i kombinations. 
When used in combination, docetaxel does not influence the clearance of doxorubicin and the plasma levels of doxorubicinol (a doxorubicin metabolite).
Et multicenter, open-label, randomiseret studie blev udført for at evaluere sikkerheden og virkningen af docetaxel i behandlingen af patienter med metastatisk gastrisk adenokarcinom, herunder adenokarcinom i den gastroøsofageale overgang, som ikke tidligere havde fået kemoterapi for en metastatisk sygdom. 
A multicenter, open-label, randomized study was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Infektion associeret med G4-neutropeni (G3/4: 4,6%) 
Infection associated with G4 neutropenia (G3/4: 4.6%)
- Ved behandling af prostatakræft indgives docetaxel i kombination med prednison eller prednisolon. 
- For the treatment of prostate cancer, docetaxel is administered in combination with prednisone or prednisolone.
Koncentrationen af docetaxel i Docetaxel Mylan er 20 mg/ml. 
In Docetaxel Mylan, the concentration of docetaxel is 20 mg/ml.
• Induktionskemoterapi efterfulgt af strålebehandling (TAX 323) Sikkerheden og effektiviteten af docetaxel ved induktionsbehandling af patienter med pladecellekarcinom i hoved og hals (SCCHN) blev evalueret i et fase III, multicenter, open-label, randomiseret studie (TAX 323). 
• Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Den fysiske og kemiske stabilitet af infusionsvæsken tilberedt som anbefalet i PVC-frie infusionsposer er påvist at være op til 48 timer ved opbevaring mellem 2°C og 8°C. 
Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.
Første episode: Reducer 5-FU-dosis med 20%. 
First episode: reduce 5-FU dose by 20%.
Docetaxel Mylan koncentrat til infusionsvæske, opløsning er lysgul til brunlig gul. 
Docetaxel Mylan concentrate for solution for infusion is a pale yellow to brownish-yellow solution.
Median TTP var 37,3 uger (95% CI: 33,4-42,1) i AT-armen og 31,9 uger (95% CI: 27,4-36,0) i AC-armen. 
The median TTP was 37.3 weeks (95% CI: 33.4-42.1) in AT arm and 31.9 weeks (95% CI: 27.4-36.0) in AC arm.
Docetaxel Mylan i kombination med prednison eller prednisolon er indiceret til behandling af patienter med hormonrefraktær metastatisk prostatacancer. 
Docetaxel Mylan in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
5 hætteglas á 10 ml 
5 vials of 10 ml
• Fra et mikrobiologisk synspunkt skal fortynding foretages under kontrollerede og aseptiske forhold og lægemidlet bør anvendes umiddelbart herefter. 
• From a microbiological point of view, dilution must take place in controlled and aseptic conditions and the infusion solution should be used immediately.
I alt 445 patienter med KPS > 70 blev behandlet med enten docetaxel (T) (75 mg/m² på førstedagen) i kombination med cisplatin (C) (75 mg/m² på førstedagen) og 5-fluoruracil (F) (750 mg/m² pr. dag i 5 dage) eller cisplatin (100 mg/m² på førstedagen) og 5-fluoruracil (1.000 mg/m² pr. dag i 5 dage). 
A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/m² on day 1) in combination with cisplatin (C) (75 mg/m² on day 1) and 5-fluorouracil (F) (750 mg/m² per day for 5 days) or cisplatin (100 mg/m² on day 1) and 5-fluorouracil (1000 mg/m² per day for 5 days).
I studiet GEICAM9805 udviklede 3 patienter (0,6%) i TAC-armen og 3 patienter (0,6%) i FAC-armen kongestivt hjertesvigt i followup-perioden. 
In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period.
Almene symptomer og reaktioner på administrationsstedet Der er i sjældne tilfælde rapporteret recallfænomener i forbindelse med strålebehandling. 
General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
5 hætteglas á 1 ml 
5 vials of 1 ml
Hos de patienter, der blev behandlet med docetaxel i kombination med cisplatin og 5-fluoruracil (TCF), opstod der febril neutropeni og neutropenisk infektion i mindre grad, når patienterne fik profylaktisk G¬CSF. 
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.
Medianoverlevelse (mdr.) 
Median survival (months)
Infektion (G3/4: 3,6%) Neutropenisk infektion 
Infection (G3/4: 3.6%) Neutropenic infection
Den totale responsrate var 59,3% (95% CI: 52,8-65,9) i AT-armen og 46,5% (95% CI: 39,8-53,2) i AC-armen. 
The ORR was 59.3% (95% CI: 52.8-65.9) in AT arm versus 46.5% (95% CI: 39.8-53.2) in AC arm.
Dette regime administreres hver 3. uge i 4 cyklusser. 
This regimen is administered every 3 weeks for 4 cycles.
Der blev observeret flere grad 3/4-bivirkninger ved monoterapi med docetaxel (55,4%) end paclitaxel 
More grade 3/4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
PSA** responsrate (%) 95% CI p-value* 
PSA** response rate (%) 95% CI p-value*
I dette studie blev 255 patienter randomiseret til behandling med docetaxel (75 mg/m² som intravenøs infusion over 1 time hver 3. uge) og capecitabin (1.250 mg/m² 2 gange dagligt i 2 uger efterfulgt af 1 uges pause). 
In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m² as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/m² twice daily for 2 weeks followed by 1-week rest period).