natgillin/translations-raw huggingface dataset:
Almindelige bivirkninger ≥ 1 til < 10% af patienterne Vægtstigning
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Ikke almindelige bivirkninger ≥ 0, 1 til < 1% af patienterne
Weight increased
Arytmi (G3/ 4:
Arrhythmia (G3/ 4:
Nervesystemet
5.2%) Nervous system disorders
Dysgeusi/ parosmi Perifer sensorisk neuropati (G3/ 4:
Dysgeusia/ Parosmia; Peripheral sensory neuropathy (G3/ 4:
0, 6%); Stomatitis (G3/ 4:
0.6%); Stomatitis (G3/ 4:
4, 0%); Diarré (G3/ 4:
4.0%); Diarrhea (G3/ 4:
2, 9%); Opkastning (G3/ 4:
2.9%); Vomiting (G3/ 4:
Konstipation; Oesophagitis/ dysfagi / odynofagi (G3/ 4:
Constipation; Esophagitis/ dysphagia/ odynophagia (G3/ 4:
0, 6%); Gastrointestinale smerter; Dyspepsi; Gastrointestinale blødninger (G3/ 4:
0.6%); Abdominal pain; Dyspepsia; Gastrointestinal haemorrhage (G3/ 4:
Kløende udslæt; Tør hud; Hudafskalning (G3/ 4:
Rash pruritic; Dry skin; Skin exfoliative (G3/ 4:
Infektioner og parasitære sygdomme
Infections and infestations Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infektion (G3/ 4:
Infection (G3/ 4:
6, 3%); Neutropenisk infektion
6.3%); Neutropenic infection
Kræftsmerter (G3/ 4:
Cancer pain (G3/ 4:
Venesygdomme (G3/ 4:
Venous disorder (G3/ 4:
3, 4%); Pyreksi (G3/ 4:
3.4%); Pyrexia (G3/ 4:
0, 6%); Væskeretention; Ødem
0.6%); Fluid retention; Oedema
22 • Induktions kemoterapi efterfulgt af kemo - og stråleterapi (TAX 324)
22 • Induction chemotherapy followed by chemoradiotherapy (TAX 324)
Undersøgelser Hjerte Blod og lymfesystem
Investigations Cardiac disorders
Vægttab Neutropeni (G3/ 4:
Arrhythmia (G3/ 4:
83, 5%); Anæmi (G3/ 4:
2.0%)
12, 4%); Thrombocytopeni (G3/ 4:
Neutropenia (G3/ 4:
4, 0%); Febril neutropeni
83.5%); Anemia (G3/ 4:
Arytmi (G3/ 4:
12.4%); Thrombocytopenia (G3/ 4:
2, 0%)
4.0%); Febrile neutropenia
Dysgeusi/ parosmi (G3/ 4:
Dysgeusia/ Parosmia (G3/ 4:
0, 4%); Perifer sensorisk neuropati (G3/ 4:
0.4%); Peripheral sensory neuropathy (G3/ 4:
2, 0%); Perifer motorisk neuropati (G3/ 4:
2.0%); Peripheral motor neuropathy (G3/ 4:
Øjne Øre og labyrint
Eye disorders Ear and labyrinth disorders
20, 7%); Opkastning (G3/ 4:
20.7%); Vomiting (G3/ 4:
8, 4%) Diarré (G3/ 4:
8.4%); Diarrhea (G3/ 4:
6, 8%); Esophagitis/ dysphagi/ o dynophagi (G3/ 4:
6.8%); Esophagitis/ dysphagia/ odynophagia (G3/ 4:
12, 0%) Konstipation (G3/ 4:
12.0%); Constipation (G3/ 4:
Dyspepsi (G3/ 4:
Dyspepsia (G3/ 4:
0, 8%) Gastrointestinal smerte (G3/ 4:
0.8%); Gastrointestinal pain (G3/ 4:
1, 2%) Gastrointestinal blødning (G3/ 4:
1.2%); Gastrointestinal haemorrhage (G3/ 4:
Hud og subkutane væv
Skin and subcutaneous tissue disorders Musculoskeletal, connective tissue bone disorders
4, 0%) Kløende udslæt
4.0%); Rash pruritic
Myalgi (G3/ 4:
Dry skin; Desquamation Myalgia (G3/ 4:
Cancersmerter (G3/ 4:
Neutropenic infection Cancer pain (G3/ 4:
4, 0%); Febril tilstand (G3/ 4:
4.0%); Pyrexia (G3/ 4:
3, 6%) Væskeretention G3/ 4:
3.6%); Fluid retention (G3/ 4:
1, 2%) Ødemer (G3/ 4:
1.2%); Oedema (G3/ 4:
23 Erfaringer efter markedsføring:
23 Post-marketing experience
Sjældne tilfælde af myokardieinfarkt er rapporteret.
Cardiac disorders Rare cases of myocardial infarction have been reported.
Blod og lymfesystem Der er rapporter om knoglemarvsdepression og andre hæmatologiske bivirkninger.
Blood and lymphatic system disorders Bone marrow suppression and other hematologic adverse reactions have been reported.
Der er rapporter om dissemineret intravaskulær koagulation (DIC), ofte i forbindelse med sepsis eller multiorgan- svigt.
Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported.
Der er observeret sjældne tilfælde af kramper eller forbigående tab af bevidstheden under administration af docetaxel.
Nervous system disorders Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
Der er observeret meget sjældne tilfælde af forbigående synsforstyrrelser (glimt, lysglimt, pletter i synsfeltet) typisk forekommende under infusion med lægemidlet og i forbindelse med hypersensivitets- reaktioner.
Eye disorders Very rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during infusion of the medicinal product and in association with hypersensitivity reactions have been reported.
Der er rapporter om sjældne tilfælde af ototoksicitet, nedsat hørelse og/ eller tab af hørelse.
Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/ or hearing loss have been reported.
Der er sjældne rapporter om akut respiratorisk åndedrætsbesvær, interstitial pneumoni og pulmonar fibrosis.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome, interstitial pneumonia and pulmonary fibrosis have rarely been reported.
Der er rapporter om sjælden forekomst af dehydrering som en konsekvens af gastrointestinale lidelser, gastrointestinal perforation, iskæmisk colitis, colitis og neutropenisk enterocolitis.
Gastrointestinal disorders Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Med docetaxel er der rapporter om meget sjældne tilfælde af bulløst udslæt, såsom erythema multiforme, Stevens- Johnson syndrom og toksisk epidermal nekrolyse.
Skin and subcutaneous tissue disorders Very rare cases of cutaneous lupus erythematosus and bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Ved behandling 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.
Cyster og polypper) Der er rapporter om meget sjældne tilfælde af akut myeloid leukemi og myelodyplasisk syndrom, når docetaxel blev administreret i kombination med andre kemoterapeutiske stoffer og/ eller radioterapi.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Very rare cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/ or radiotherapy.
Venøse tromboemboliske tilfælde er sjældent rapporteret.
Vascular disorders Venous thromboembolic events have rarely been reported.
Almene symptomer og reaktioner på administrationsstedet Der er sjældne rapporter om radiation recall- fænomen.
General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Der er rapporter om tilfælde af anafylaktisk chok, nogle gange fatale.
Immune system disorders Some cases of anaphylactic shock, sometimes fatal, have been reported.
Hovedsagelig hos patienter med præ- eksisterende leversygdomme er der rapporter om meget sjældne tilfælde af hepatitis, nogle gange fatale.
24 Hepatobiliary disorders Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
24 4. 9 Overdosering
4.9 Overdose
Patienter bør modtage terapeutisk G- CSF så snart som muligt efter overdosering er erkendt.
Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose.
Antineoplastisk stof, ATC kode:
Antineoplastic agents, ATC Code:
L01CD 02
L01CD 02
In vitro- forsøg har vist, at Docetaxel ødelægger det mikrotubulære netværk i celler, som er essentielle for mitosen og cellulære funktioner i interfasen.
Docetaxel has been shown in vitro to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions.
Docetaxel fandtes ydermere at være aktivt over for nogle, men ikke alle cellelinjer, der udviste overekspression af p- glycoprotein, hvis tilstedeværelse er bestemt af "multidrug resistance" - genet (MDR- genet).
In addition, docetaxel was found to be active on some but not all cell lines over expressing the p-glycoprotein which is encoded by the multidrug resistance gene.
Adjuverende behandling
Docetaxel Winthrop in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Data fra et multicenter åbent randomiseret forsøg støtter anvendelsen af den adjuverende behandling til patienter med operabel lymfeknude- positiv brystkræft og KPS > 80% i alderen mellem 18 og 70 år.
Data from a multicenter open label randomized trial 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.
Efter stratificering i henhold til antallet af positive lymfeknuder (1- 3, 4+), blev 1491 patienter randomiseret til enten at få enten docetaxel 75 mg/ m2 administreret en time efter doxorubicin 50 mg/ m2 og cyclophosfamid 500 mg/ m2 (TAC arm), eller doxorubicin 50 mg/ m2, fulgt af fluorouracil 500 mg / m2 og cyclophosfamid 500 mg/ m2 (FAC arm).
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomized to receive either docetaxel 75 mg/ m2 administered 1-hour after doxorubicin 50 mg/ m2 and cyclophosphamide 500 mg/ m2 (TAC arm), or doxorubicin 50 mg/ m2 followed by fluorouracil 500 mg/ m2 and cyclosphosphamide 500 mg/ m2 (FAC arm).
G- CSF blev administreret som sekundær profylakse til patienter, som fik kompliceret neutropeni (febril neutropeni, forlænget neutropen eller infektion).
G-CSF was administered as secondary prophylaxis to patients who experienced complicated neutropenia (febrile neutropenia, prolonged neutropenia, or infection).
Patienter på TAC- armen fik antibiotisk profylakse med ciprofloxacin 500 mg oralt 2 gange daglig i 10 dage, startende på dag 5 af hver periode, eller lignende.
Patients on the TAC arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Efter den sidste cyklus af kemoterapi, fik patienter i begge arme, der havde positive østrogen - og/ eller progesteron receptorer tamoxifen 20 mg daglig i op til 5 år.
In both arms, after the last cycle of chemotherapy, patients with positive estrogen and/ or progesterone receptors received tamoxifen 20 mg daily for up to 5 years.
Adjuverende stråleterapi blev givet i henhold til eksisterende vejledninger på de deltagende centre og blev givet til 69% af patienterne, som fik TAC, og 72% af patienterne som fik FAC.
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.
En interim- analyse blev udført med et median- opfølgning ved 55 måneder.
25 An interim analysis was performed with a median follow up of 55 months.
Forekomsten af tilbagefald ved 5 år
Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Det betyder en absolut risikoreduktion på 7% (p = 0, 001).
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).
Det betyder en absolut reduktion i risikoen for død på 6% (p = 0, 008).
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).
Patient
Patient subset No of positive nodes
Antal
Number of patients
Hazard
Hazard ratio*
p= Hazard
p=
95% CI p= Hazard 95% CI
Hazard 95% CI ratio*
fordeling Antal positive lymfeknuder
0.72
patienter
0.59-0.88
ratio *
0.001
ratio *
0.008
I alt 1- 3 4+
1-3 4+
0, 72 0, 61 0, 83
0.61 0.83
0, 59- 0, 88 0, 46- 0, 82 0, 63- 1, 08
0.46-0.82 0.0009 0.63-1.08 0.17
Den gavnlige effekt af TAC blev ikke bevist hos patienter med 4 eller flere positive lymfeknuder (37% af patienterne) ved tidspunktet for interim- analyse.
The beneficial effect of TAC was not proven in patients with 4 and more positive nodes (37% of the population) at the interim analysis stage.
Effekten synes mindre end hos patienter med 1- 3 positive lymfeknuder.
The effect appears to be less pronounced than in patients with 1-3 positive nodes.
Fordelingen af fordele/ ulemper blev ikke fuldt ud defineret hos patienter med 4 eller flere positive lymfeknuder på dette analysestadie.
The benefit/ risk ratio was not defined fully in patients with 4 and more positive nodes at this analysis stage.
Der indgik henholdvis 326 patienter, som tidligere havde fået behandling med alkylerende stoffer uden effekt, og 392 patienter, som tidligere havde fået behandling med anthracyclin uden effekt.
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.
Hos de patienter, der tidligere havde fået behandling med alkylerende stoffer uden effekt, blev docetaxel sammenlignet med doxorubicin (75 mg/ m2 hver 3. uge).
In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/ m² every 3 weeks).
Uden at påvirke overlevelsestiden (docetaxel 15 måneder mod doxorubicin 14 måneder, p = 0, 38) eller tiden til progression (docetaxel 27 uger mod doxorubicin 23 uger, p = 0, 54), øgede docetaxel responsraten (52% mod 37%, p = 0, 01) og gav hurtigere respons (12 uger mod 23 uger, p = 0, 007).
23 weeks, p = 0.007).
3 patienter (2%), der fik docetaxel, ophørte med behandlingen grundet væskeretention, hvorimod 15 patienter (9%), der fik doxorubicin, stoppede behandlingen grundet hjertetoksicitet (3 tilfælde af fatal hjerteinsufficiens).
Three docetaxel patients (2%) discontinued the treatment due to fluid retention, whereas 15 doxorubicin patients (9%) discontinued due to cardiac toxicity (three cases of fatal congestive heart failure).
Hos de patienter, der tidligere havde fået behandling med anthracyclin uden effekt, blev docetaxel sammenlignet med kombinationsbehandling med mitomycin C og vinblastine (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).
Docetaxel øgede responsraten (33% mod 12%, p < 0, 0001), forlængede tiden til progression (19 uger mod 11 uger, p = 0, 0004), samt forlængede overlevelsen (11 måneder mod 9 måneder, p = 0, 01).
9 months, p = 0.01).
4. 8).
During these two phase III studies, the safety profile of docetaxel was consistent with the safety profile observed in phase II studies (see section 4.8).
Et åbent multicenter randomiseret fase III- studie blev udført for at sammenligne docetaxel monoterapi med paclitaxel i behandlingen af fremskreden brystkræft hos patienter, hvis tidligere behandling havde inkluderet 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.
449 patienter blev randomiseret til enten at modtage docetaxel monoterapi 100 mg/ m2 givet som 1 times infusion eller paclitaxel 175 mg/ m2 givet 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.
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).
26 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
26 Docetaxel Winthrop in combination with doxorubicin
Et stort randomiseret fase III- studie, med 429 tidligere ubehandlede patienter med metastatisk sygdom, er blevet udført med doxorubicin (50 mg/ m2) i kombination med docetaxel (75 mg/ 2) (AT arm) versus doxorubicin (60 mg/ m2) i kombination med cyclophosfamid (600 mg/ m2) (AC arm).
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).
• Tiden til progression (TTP) var signifikant længere i AT- armen i forhold til AC- armen, p = 0, 0138.
• Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
TTP- medianen var 37, 3 uger (95% CI:
The median TTP was 37.3 weeks (95% CI:
33, 4 – 42, 1) i AT- armen og 31, 9 uger (95% CI:
33.4 - 42.1) in AT arm and 31.9 weeks (95% CI:
27, 4 – 36, 0) i AC- armen. • Den totale responshyppighed var signifikant højere i AT- armen i forhold til AC- armen, p = 0, 009.
27.4 - 36.0) in AC arm. • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
Total responshyppighed var 59, 3% (95% CI:
The ORR was 59.3% (95% CI:
52, 8 – 65, 9) I AT armen i forhold til 46, 5% (95% CI:
52.8 - 65.9) in AT arm versus 46.5% (95% CI:
39, 8 – 53, 2) i AC armen.
39.8 - 53.2) in AC arm.
I dette forsøg viste AT- armen en hyppigere forekomst af alvorlig neutropeni (90% versus 68, 6%), febril neutropeni (33, 3% versus 10%), infektion (8% vesus 2, 4%), diarré (7, 5% versus 1, 4%), asteni (8, 5% vesus 2, 4%) og smerter ((2, 4% versus 0%) end AC- armen.
In this trial, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm.
Hjerteinsufficiens (3, 8% versus 2, 8%), total LVEF - nedsættelse > 20% (13, 1% versus 6, 1%), total LVEF- nedsættelse > 30% (6, 2% versus 1, 1%).
On the other hand, AC arm showed a higher incidence of severe anemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease ≥ 20% (13.1% versus 6.1%), absolute LVEF decrease ≥ 30% (6.2% versus 1.1%).
Toksisk død forekom hos 1 patient i AT- armen (hjerteinsufficiens) og i 4 patienter i AC- armen (1 på grund af septisk shock og 3 på grund af hjerteinsufficiens).
Toxic deaths occurred in 1 patient in the AT arm (congestive heart failure) and in 4 patients in the AC arm (1 due to septic shock and 3 due to congestive heart failure).
I begge arme var livskvaliteten målt via et EORTC- spørgeskema sammenlignelig og stabil under behandling og opfølgning.
In both arms, quality of life measured by the EORTC questionnaire was comparable and stable during treatment and follow-up.
Docetaxel i kombination med trastuzumab blev undersøgt til behandling af patienter med metastatisk brystkræft, hvis tumorer var HER2- positive, og som ikke tidligere havde fået kemoterapi for metastatisk sygdom.
Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2, and who previously had not received chemotherapy for metastatic disease.
186 patienter blev randomiseret til at få docetaxel (100 mg/ m2) med eller uden trastuzumab.
One hundred eighty six patients were randomized to receive docetaxel (100 mg/ m2) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy.
60% af patienter fik først anthracyclinbaseret adjuverende kemoterapi. docetaxel + trastuzumab var effektivt til patienterne, uanset om de havde fået adjuverende anthracyclin eller ikke.
Docetaxel plus trastuzumab was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Den primære testmetode, som blev anvendt til at bestemme HER2- positivitet i dette pivotal- studie var immunohistokemi (IHC).
The main test method used to determine HER2 positivity in this pivotal trial was immunohistochemistry (IHC).
I dette forsøg havde 87% af patienterne sygdom, som var IHC 3+, og 95% af de inkluderede patienter havde sygdom, som var IHC3+ og/ eller patienterne var FISH positive.
In this trial, 87% of patients had disease that was IHC 3+, and 95% of patients entered had disease that was IHC 3+ and/ or FISH positive.
Response rate (95% CI) Gennemsnitlig varighed af respons
Response rate (95% CI) Median Duration of response
(måneder) (95% CI) Gennemsnitlig TTP (måneder) (95% CI) Gennemsnitlig overlevelse (måneder) (95% CI)
(95% CI) Median TTP (months) (95% CI) Median Survival (months)
11, 4 (9, 2- 15, 0) 10, 6 (7, 6- 12, 9) 30, 52 (26, 8- ne)
(9.2-15.0) 10.6 (7.6-12.9) 30.52
5, 1 (4, 4- 6, 2) 5, 7 (5, 0- 6, 5) 22, 11 (17, 6- 28, 9)
(4.4-6.2) 5.7 (5.0-6.5) 22.12
TTP = tid til progression. ” ne ” indikerer at dette ikke kunne estimeres eller ikke blev nået.
TTP = time to progression; “ ne” indicates that it could not be estimated or it was not yet reached.
1 Fuldt analysesæt (intent to treat) 2 Estimeret median overlevelse.
1 Full analysis set (intent-to-treat) 2 Estimated median survival
27 Docetaxel Winthrop i kombination med capecitabin
27 cancer after failure of cytotoxic chemotherapy, including an anthracycline.
I dette kliniske forsøg randomiseredes 255 patienter til behandling med docetaxel (75 mg/ m² som en 1 - times intravenøs infusion hver 3. uge) og capecitabin (1250 mg/ m2 to gange daglig i 2 uger efterfulgt af en uges pause).
In this trial, 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).
256 patienter blev randomiseret til behandling med docetaxel alene (100 mg / m2 som 1 times intravøs infusion hver 3. uge).
256 patients were randomised to treatment with docetaxel alone (100 mg/ m2 as a 1 hour intravenous infusion every 3 weeks).
Overlevelsen var bedre i kombinationsarmen med docetaxel + capecitabin (p = 0, 0126).
Survival was superior in the docetaxel + capecitabine combination arm (p = 0.0126).
De objektive responsrater i den randomiserede population (investigators vurdering) var 41, 6% (docetaxel+capecitabin) vs.
The overall objective response rates in the all-randomised population (investigator assessment) were 41.6% (docetaxel + capecitabine) vs.
29, 7% (docetaxel alene); p = 0, 0058.
29.7% (docetaxel alone); p = 0.0058.
Tid indtil progressiv sygdom var længere i kombinationsarmen med Xeloda + docetaxel (p < 0, 0001).
Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p < 0.0001).
Ikke- småcellet lungekræft.
Non-small cell lung cancer
7 uger) og den samlede overlevelse signifikant længere for docetaxel ved doseringen 75 mg/ m2 end for bedste palliative behandling.
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/ m² compared to Best Supportive Care.
Den 1- årige overlevelsesrate var signifikant længere med docetaxel (40%) end for bedste palliative behandling (16%).
The 1-year survival rate was also significantly longer in docetaxel (40%) versus BSC (16%).
Der var mindre brug af smertestillende morfika (p < 0, 01), smertestillende ikke- morfika (p < 0, 01), anden ikke- sygdomsrelateret medicin (p = 0, 06) og strålebehandling (p < 0, 01) hos de patienter, der fik behandling med docetaxel ved doseringen 75 mg/ m2 end hos patienterne, der fik bedste palliative behandling.
There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medications (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/ m² compared to those with BSC.