natgillin/translations-raw huggingface dataset:
En metaanalyse af 13 kliniske studier med data fra mere end 3800 patienter, som er blevet behandlet med capecitabin- monoterapi eller capecitabin i kombination med forskellige kemoterapiregimer indenfor flere indikationer (kolonkræft, kolorektalkræft, ventrikelkræft og brystkræft) viste, at hand - foot syndrom (alle grader) forekom hos 1788 (47%) patienter gennemsnitligt 155 [95% konfidensinterval 135, 187] dage efter behandlingsstart med capecitabin.
A meta-analysis of 13 clinical trials with data from over 3800 patients treated with capecitabine monotherapy or capecitabine in combination with different chemotherapy regimens in multiple indications (colon, colorectal, gastric and breast cancer) showed that HFS (all grades) occurred in 1788 (47%) patients after a median time of 155 [95% CI 135, 187] days after starting treatment with capecitabine.
I alle studierne kombineret var følgende kovarianter statistisk signifikant associeret med en øget risiko for udviklingen af hand - foot syndrom: stigende capecitabin- startdosis (gram), faldende kumulativ capecitabin- dosis (0, 1 * kg), stigende relativ dosisintensitet i de første seks uger, længere behandlingsvarighed (uger), stigende alder (ved 10- års forøgelse), kvindeligt køn og med en god ECOG performancestatus ved baseline (0 versus ≥1).
In all studies combined, the following covariates were statistically significantly associated with an increased risk of developing HFS: increasing capecitabine starting dose (gram), decreasing cumulative capecitabine dose (0.1*kg), increasing relative dose intensity in the first six weeks, increasing duration of study treatment (weeks), increasing age (by 10 year increments), female gender, and good ECOG performance status at baseline (0 versus ≥ 1).
4. 4):
Diarrhoea (see section 4.4):
Xeloda kan inducere forekomsten af diarré, hvilket er observeret i op til 50% af patienterne.
Xeloda can induce the occurrence of diarrhoea, which has been observed in up to 50% of patients.
En metaanalyse af 13 kliniske studier med data fra mere end 3800 patienter, som er blevet behandlet med capecitabin, viste i alle studier kombineret at følgende kovarianter var statistisk signifikant associeret med en øget risiko for udviklingen af diarré: stigende capecitabin- startdosis (gram), længere behandlingsvarighed (uger), stigende alder (ved 10- års forøgelse) samt kvindeligt køn.
The results of a meta-analysis of 13 clinical trials with data from over 3800 patients treated with capecitabine showed that in all studies combined, the following covariates were statistically significantly associated with an increased risk of developing diarrhea: increasing capecitabine starting dose (gram), increasing duration of study treatment (weeks), increasing age (by 10 year increments), and female gender.
Følgende kovarianter var statistisk signifikant associeret med en faldende risiko for udviklingen af diarré: øget kumulativ capecitabin- dosis (0, 1 * kg) og med stigende relativ dosisintensitet i de første seks uger.
The following covariates were statistically significantly associated with a decreased risk of developing diarrhea: increasing cumulative capecitabine dose (0.1*kg) and increasing relative dose intensity in the first six weeks.
4. 4):
Cardiotoxicity (see section 4.4):
Bivirkningerne er baseret på en samlet analyse af kliniske sikkerhedsdata fra 7 kliniske studier med 949 patienter (2 fase III - og 5 fase II - kliniske studier i metastatisk kolorektalkræft og metastatisk brystkræft) og omfatter: kardiomyopati, hjerteinsufficiens, dødsfald og ventrikulære ekstrasystoler.
In addition to the ADRs described in Tables 4 and 5, the following ADRs with an incidence of less than 0.1% were associated with the use of Xeloda monotherapy based on a pooled analysis from clinical safety data from 7 clinical trials including 949 patients (2 phase III and 5 phase II clinical trials in metastatic colorectal cancer and metastatic breast cancer): cardiomyopathy, cardiac failure, sudden death, and ventricular extrasystoles.
Encephalopati:
Encephalopathy:
14 Baseret på en samlet analyse af kliniske sikkerhedsdata fra 7 kliniske studier, blev der ud over de bivirkninger, som er anført i tabel 4 og 5, observeret encephalopati som værende forbundet med anvendelsen af Xeloda- monoterapi med en hyppighed på mindre end 0, 1%.
In addition to the ADRs described in Tables 4 and 5, and based on the above pooled analysis from clinical safety data from 7 clinical trials, encephalopathy was also associated with the use of Xeloda monotherapy with an incidence of less than 0.1%.
4. 2):
Elderly patients (see section 4.2):
En analyse af sikkerhedsdata fra patienter ≥ 60 år, som behandledes med Xeloda- monoterapi og en analyse af patienter, som behandledes med Xeloda plus docetaxel, viste en stigning i incidensen af behandlingsrelaterede bivirkninger af grad 3 og 4 og af behandlingsrelaterede alvorlige bivirkninger, sammenlignet med patienter < 60 år.
An analysis of safety data in patients ≥ 60 years of age treated with Xeloda monotherapy and an analysis of patients treated with Xeloda plus docetaxel combination therapy showed an increase in the incidence of treatment-related grade 3 and 4 adverse reactions and treatment-related serious adverse
Der var flere patienter ≥ 60 år, som behandledes med Xeloda plus docetaxel, som måtte stoppe behandlingen tidligt på grund af bivirkninger, sammenlignet med patienter < 60 år.
Patients ≥ 60 years of age treated with Xeloda plus docetaxel also had more early withdrawals from treatment due to adverse reactions compared to patients < 60 years of age.
Resultaterne fra en metaanalyse af 13 kliniske studier med data fra mere end 3800 patienter, som er blevet behandlet med capecitabin, viste at i alle studier kombineret, var stigende alder (ved 10- års forøgelse) statistisk signifikant associeret med en øget risiko for udviklingen af hand- foot syndrom og diarré og med en faldende risiko for at udvikle neutropeni.
The results of a meta-analysis of 13 clinical trials with data from over 3800 patients treated with capecitabine showed that in all studies combined, increasing age (by 10 year increments) was statistically significantly associated with an increased risk of developing HFS and diarrhea and with a decreased risk of developing neutropenia.
Køn Resultaterne fra en metaanalyse af 13 kliniske studier med data fra mere end 3800 patienter, som er blevet behandlet med capecitabin, viste at i alle studier kombineret, var kvindeligt køn statistisk signifikant associeret med en øget risiko for udviklingen af hand- foot syndrom og diarré og med en faldende risiko for at udvikle neutropeni.
Gender The results of a meta-analysis of 13 clinical trials with data from over 3800 patients treated with capecitabine showed that in all studies combined, female gender was statistically significantly associated with an increased risk of developing HFS and diarrhea and with a decreased risk of developing neutropenia.
4. 2, 4. 4 og 5. 2):
Patients with renal impairment (see section 4.2, 4.4, and 5.2):
En analyse af sikkerhedsdata fra patienter, som fik Xeloda- monoterapi (kolorektalkræft) og som havde nyreinsufficiens ved baseline, viste, at der var en stigning i hyppigheden af behandlingsrelaterede bivirkninger, grad 3 og 4, sammenlignet med patienter med normal nyrefunktion (36% hos patienter uden nyreinsufficiens n=268 vs. henholdsvis 41% hos patienter med let nyreinsufficiens n=257 og 54% hos patienter med moderat nyreinsufficiens n=59) (se pkt.
41% in mild n=257 and 54% in moderate n=59, respectively) (see section 5.2).
Patienter med moderat nyreinsufficiens fik hyppigere dosis reduceret (44%) vs.
Patients with moderately impaired renal function show an increased rate of dose reduction (44%) vs.
33% og 32% hos patienter med ingen eller let nyreinsufficiens og havde flere tidlige behandlingsophør (21% behandlingsophør i de første to serier) vs.
33% and 32% in patients with no or mild renal impairment and an increase in early withdrawals from treatment (21% withdrawals during the first two cycles) vs.
5% og 8% hos patienter med ingen eller let nyreinsufficiens.
5% and 8% in patients with no or mild renal impairment.
Cytostatikum (antimetabolit), ATC kode:
Pharmacotherapeutic group: cytostatic (antimetabolite), ATC code:
L01B- C06
L01BC06
Capecitabin er et non- cytotoksisk fluorpyrimidincarbamat, som virker som en oral administreret prækursor for det cytotoksiske 5 - fluorouracil (5- FU).
Capecitabine is a non-cytotoxic fluoropyrimidine carbamate, which functions as an orally administered precursor of the cytotoxic moiety 5-fluorouracil (5-FU).
5. 2).
Capecitabine is activated via several enzymatic steps (see section 5.2).
Enzymet thymidinfosforylase (ThyPase), som er involveret i den endelige omdannelse til 5- FU, findes i tumorvæv, men også i normalt væv, om end i lavere koncentrationer.
The enzyme involved in the final conversion to 5-FU, thymidine phosphorylase (ThyPase), is found in tumour tissues, but also in normal tissues, albeit usually at lower levels.
15 Der er holdepunkter for at metabolismen af 5- FU i den anabolske pathway blokerer metyleringen af desoxyuridylsyre til thymidylssyre og derved interfererer med desoxyribonukleinsyresyntesen (DNA).
There is evidence that the metabolism of 5-FU in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid, thereby interfering with the synthesis of deoxyribonucleic acid (DNA).
Inkorporeringen af 5- FU medfører hæmning af RNA og proteinsyntesen.
The incorporation of 5-FU also leads to inhibition of RNA and protein synthesis.
Da DNA og RNA er nødvendige for celledelingen og cellevæksten, virker 5- FU muligvis ved at skabe et thymidindeficit, som provokerer ubalanceret vækst og død af en celle.
Since DNA and RNA are essential for cell division and growth, the effect of 5-FU may be to create a thymidine deficiency that provokes unbalanced growth and death of a cell.
Virkningen af DNA og RNA deprivation er tydeligst på de celler, som prolifererer hurtigst, og som metaboliserer 5- FU hurtigere.
The effects of DNA and RNA deprivation are most marked on those cells which proliferate more rapidly and which metabolise 5-FU at a more rapid rate.
Kolon - og kolorektalkræft:
15 Colon and colorectal cancer:
Adjuverende behandling med Xeloda af kolonkræft Data fra et randomiseret, kontrolleret, klinisk fase III- multicenterstudie hos patienter med kolonkræft i stadium III (Dukes ’ stadium C) støtter anvendelsen af Xeloda som adjuverende behandling af patienter med kolonkræft (XACT- Studie; M66001).
Adjuvant Therapy with Xeloda in colon cancer Data from one multicentre, randomised, controlled phase III clinical trial in patients with stage III (Dukes’ C) colon cancer supports the use of Xeloda for the adjuvant treatment of patients with colon cancer (XACT Study; M66001).
I dette studie blev 1987 patienter randomiseret til behandling med Xeloda (1250 mg/ m2 to gange dagligt i 2 uger, efterfulgt af en uges pause, givet som 3- ugers serier i 24 uger) eller til behandling med 5- FU og leucovorin (Mayo Clinic- regime:
In this trial, 1987 patients were randomised to treatment with Xeloda (1250 mg/ m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3-week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen:
20 mg/ m2 leucovorin i. v., efterfulgt af 425 mg/ m2 5- FU i. v. som bolus på dag 1 til 5, hver 28. dag i 24 uger).
20 mg/ m2 leucovorin IV followed by 425 mg/ m2 IV bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks).
Xeloda var mindst ækvivalent med 5- FU/ LV i. v. mht. sygdomsfri overlevelse i protokolpopulationen (hazard ratio 0, 92; 95% konfidensinterval 0, 80- 1, 06).
Xeloda was at least equivalent to IV 5-FU/ LV in disease-free survival in per protocol population (hazard ratio 0.92; 95% CI 0.80- 1.06).
0, 88 (95% konfidensinterval 0, 77 – 1, 01; p = 0, 068) og 0, 86 (95% konfidensinterval 0, 74 – 1, 01; p = 0, 060).
In the all-randomised population, tests for difference of Xeloda vs 5-FU/ LV in disease-free and overall survival showed hazard ratios of 0.88 (95% CI 0.77 – 1.01; p = 0.068) and 0.86 (95% CI 0.74 – 1.01; p = 0.060), respectively.
Den mediane tid for follow/ up på analysetidspunktet var 6, 9 år.
The median follow up at the time of the analysis was 6.9 years.
I en forudplanlagt multivariat Cox- analyse blev det vist, at Xeloda er bedre sammenlignet med bolus 5- FU/ LV.
In a preplanned multivariate Cox analysis, superiority of Xeloda compared with bolus 5-FU/ LV was demonstrated.
Alder, tid fra operation til randomisering, køn, CEA- værdier ved baseline, lymfeknuder ved baseline samt land.
The following factors were pre-specified in the statistical analysis plan for inclusion in the model: age, time from surgery to randomization, gender, CEA levels at baseline, lymph nodes at baseline, and country.
I den samlede randomiseringspopulation blev Xeloda vist at være bedre end 5 - FU/ LV mht. sygdomsfri overlevelse (hazard ratio 0, 849; 95% konfidensinterval 0, 739 - 0, 976; p = 0, 0212) og mht. samlet overlevelse (hazard ratio 0, 828; 95% konfidensinterval 0, 705 - 0, 971; p = 0, 0203).
In the all-randomised population, Xeloda was shown to be superior to 5FU/ LV for disease-free survival (hazard ratio 0.849; 95% CI 0.739 - 0.976; p = 0.0212), as well as for overall survival (hazard ratio 0.828; 95% CI 0.705 - 0.971; p = 0.0203).
På nuværende tidspunkt er der ingen data tilgængelig for anvendelsen af Xeloda i kombination med andre kemoterapeutika ved adjuverende behandling af kolonkræft.
Currently, data on the use of Xeloda in combination with other chemotherapeutic agents in adjuvant therapy of colon cancer is not available.
Monoterapi med Xeloda ved metastatisk kolorektalkræft Data fra to identisk designede, randomiserede, kontrollerede, kliniske multicenterstudier i fase III (SO14695; SO14796) støtter anvendelsen af Xeloda til 1. linjebehandling af metastatisk kolorektalkræft.
Monotherapy with Xeloda in metastatic colorectal cancer Data from two identically-designed, multicentre, randomised, controlled phase III clinical trials (SO14695; SO14796) support the use of Xeloda for first line treatment of metastatic colorectal cancer.
I studierne blev 603 patienter randomiserede til behandling med Xeloda (1250 mg/ m2 to gange dagligt i 2 uger, efterfulgt af en uges pause, og givet som 3- ugers serier).
In these trials, 603 patients were randomised to treatment with Xeloda (1250 mg/ m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3-week cycles).
604 patienter randomiseredes til behandling med 5- FU og leucovirin (Mayo regime:
604 patients were randomised to treatment with 5-FU and leucovorin (Mayo regimen:
20 mg/ m2 leucovirin i. v. efterfulgt af en 5- FU bolus på 425 mg/ m2 i. v. på dag 1 til 5, hver 28. dag).
20 mg/ m2 leucovorin IV followed by 425 mg/ m2 IV bolus 5-FU, on days 1 to 5, every 28 days).
De totale objektive responsrater i den totale randomiserede population var (investigators vurdering) 25, 7% (Xeloda) vs.
The overall objective response rates in the all- randomised population (investigator assessment) were 25.7% (Xeloda) vs.
16, 7% (Mayo regime), p < 0, 0002.
16.7% (Mayo regimen); p < 0.0002.
Den mediane tid til progression var 140 dage (Xeloda) vs.
The median time to progression was 140 days (Xeloda) vs.
Den mediane overlevelse var 392 dage (Xeloda) vs.
Median survival was 392 days (Xeloda) vs.
Der er for tiden ingen data om Xeloda- monoterapi af kolorektalkræft sammenlignet med 1. linjekombinationsbehandlinger.
Currently, no comparative data are available on Xeloda monotherapy in colorectal cancer in comparison with first line combination regimens.
Kombinationsterapi i 1. linjebehandling af metastatisk kolorektalkræft Data fra et multicenter, randomiseret, kontrolleret klinisk fase III- studie (NO16966) understøtter anvendelsen af Xeloda i kombination med oxaliplatin eller i kombination med oxaliplatin og bevacizumab til 1. linjebehandling af metastatisk kolorektalkræft.
16 Combination therapy in first-line treatment of metastatic colorectal cancer Data from a multicentre, randomised, controlled phase III clinical study (NO16966) support the use of Xeloda in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab for the first-line treatment of metastatic colorectal cancer.
En initial 2- arms del, i hvilken 634 patienter blev randomiseret i to forskellige behandlingsgrupper, inkluderende XELOX eller FOLFOX- 4, og efterfølgende 2* 2 design, i hvilken 1401 patienter blev randomiseret til 4 forskellige behandlingsgrupper, inkluderende XELOX plus placebo, FOLFOX- 4 plus placebo, XELOX plus bevacizumab og FOLFOX- 4 plus bevacizumab.
The study contained two parts: an initial 2-arm part in which 634 patients were randomised to two different treatment groups, including XELOX or FOLFOX-4, and a subsequent 2x2 factorial part in which 1401 patients were randomised to four different treatment groups, including XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab, and FOLFOX-4 plus bevacizumab.
Se tabel 6 vedrørende behandlingsregimer.
See Table 6 for treatment regimens.
16 Tabe1 6
Table 6
Behandlingsregimer i Studie NO16966 (mCRC) Behandling Startdosis 2
Treatment Regimens in Study NO16966 (mCRC) Treatment Starting Dose
FOLFOX- 4 eller
FOLFOX-4 or
Oxaliplatin Leucovorin
Oxaliplatin Leucovorin
85 mg/ m i. v.
85 mg/ m2 200 mg/ m
2 timer 2
IV 2 hr 2 IV 2 hr
Oxaliplatin på dag 1, hver 2. uge
weeks
FOLFOX- 4 + Bevacizumab
Bevacizumab
5- Fluorouracil
5-Fluorouracil
200 mg/ m i. v.
400 mg/ m2 IV bolus,
2 timer 400 mg/ m2 i. v. bolus, efterfulgt af 600 mg / m2 i. v.
5-fluorouracil IV bolus/ infusion,
22 timer
followed by 600 mg/ m2 IV 22 hr
Leucovorin på dag 1 og 2, hver 2. uge 5- fluorouracil i. v. bolus/ infusion, hver på dag 1 og 2, hver 2. uge
each on Days 1 and 2, every 2 weeks
Dag 1, før FOLFOX- 4, hver 2. uge
Day 1, prior to FOLFOX-4, every 2 weeks
XELOX eller XELOX+ Bevacizumab
XELOX or
130 mg/ m2 i. v.
130 mg/ m2 IV 2 hr 2 1000 mg/ m oral
2 timer 1000 mg/ m2 oral 2 gange daglig
Oxaliplatin on Day 1, every 3 weeks Capecitabine oral twice daily for 2
Oxaliplatin på dag 1, hver 3. uge Capecitabin oral to gange daglig i 2 uger (efterfulgt af 1 uge uden behandling)
weeks (followed by 1 week off- treatment)
30- 90 min
7.5 mg/ kg IV 30-90 mins
i. v. bolus injektion umiddelbart efter leucovorin
IV bolus injection immediately after leucovorin
I den egnede patientpopulation og intent- to- treat- populationen blev der demonstreret non- inferioritet af XELOX- armen, sammenlignet med FOLFOX- 4- armen, med hensyn til progressionsfri overlevelse (se tabel 7).
Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival in the eligible patient population and the intent-to-treat population (see Table 7).
Resultaterne indikerer, at XELOX er ækvivalent med FOLFOX- 4 med hensyn til den samlede overlevelse (se tabel 7).
The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see Table 7).
En sammenligning af XELOX plus bevacizumab versus FOLFOX- 4 plus bevacizumab var en præspecificeret eksplorativ analyse.
A comparison of XELOX plus bevacizumab versus FOLFOX-4 plus bevacizumab was a pre-specified exploratory analysis.
Sammenligningen viste, at XELOX plus bevacizumab svarede til FOLFOX- 4 plus bevacizumab med hensyn til progressionsfri overlevelse (hazard ratio 1, 01; 97, 5% konfidensinterval 0, 84 - 1, 22).
In this treatment subgroup comparison, XELOX plus bevacizumab was similar compared to FOLFOX-4 plus bevacizumab in terms of progression-free survival (hazard ratio 1.01; 97.5% CI 0.84 - 1.22).
Den mediane follow- up- tid på tidspunktet for de primære analyser i intent- to- treat- populationen var 1, 5 år; data fra analyser efter yderligere et års follow- up fremgår også af tabel 7.
The median follow up at the time of the primary analyses in the intent-to-treat population was 1.5 years; data from analyses following an additional 1 year of follow up are also included in Table 7.
Hazard ratioen for XELOX versus FOLFOX- 4 var 1, 24 med 97, 5% konfidensinterval 1, 07 - 1, 44.
However, the on-treatment PFS analysis did not confirm the results of the general PFS and OS analysis: the hazard ratio of XELOX versus FOLFOX-4 was 1.24 with 97.5% CI 1.07 - 1.44.
Selvom sensitivitetsanalyser viser, at forskelle i behandlingsskemaer og tidspunkt for tumorvurdering påvirker analysen for progressionsfri overlevelse on- treatment, er der ikke fundet en fyldestgørende forklaring på dette fund.
Although sensitivity analyses show that differences in regimen schedules and timing of tumor assessments impact the on- treatment PFS analysis, a full explanation for this result has not been found.
17 Tabel 7
17 Table 7
Nøgleresultaterne for effekt af non- inferioritetsanalysen af studie NO16966 PRIMÆRE ANALYSE XELOX/ XELOX+P / FOLFOX- 4/ FOLFOX- 4+P / XELOX+BV FOLFOX- 4+BV (EPP *:
XELOX/ XELOX+P/ XELOX+BV
(97, 5% KI)
(97.5% CI)
1, 05 (094; 1, 18) 1, 04 (0, 93; 1, 16)
1.05 (0.94; 1.18) 1.04 (0.93; 1.16)
577 581 ET ÅRS YDERLIGERE FOLLOW UP
577 581 ADDITIONAL 1 YEAR OF FOLLOW UP
0, 97 (0, 84; 1, 14) 0, 96 (0, 83; 1, 12) HR
0.97 (0.84; 1.14) 0.96 (0.83; 1.12) HR
* EPP=egnet patientpopulation; ** ITT=intent- to- treat population
*EPP=eligible patient population; **ITT=intent-to-treat population
Data fra et randomiseret, kontrolleret fase III- forsøg (CAIRO) støtter anvendelsen af en initial Xeloda - dosis på 1000 mg/ m2 i 2 uger hver 3. uge i kombination med irinotecan som 1. linjebehandling af patienter med metastatisk kolorektalkræft.
Data from a randomised, controlled phase III study (CAIRO) support the use of Xeloda at a starting dose of 1000 mg/ m2 for 2 weeks every 3 weeks in combination with irinotecan for the first-line treatment of patients with metastatic colorectal cancer.
820 patienter blev randomiseret til at få enten sekventiel behandling (n = 410) eller kombinationsbehandling (n = 410).
820 Patients were randomized to receive either sequential treatment (n=410) or combination treatment (n=410).
Den sekventielle behandling bestod af 1. linjebehandling med Xeloda (1250 mg/ m2 to gange daglig i 14 dage), 2. linjebehandling med irinotecan (350 mg/ m2 på dag 1) og 3. linjebehandling en kombination af capecitabin (1000 mg/ m2 2 gange dagligt i 14 dage) med oxaliplatin (130 mg/ m2 på dag 1).
Sequential treatment consisted of first-line treatment with Xeloda (1250 mg/ m2 twice daily for 14 days), second-line irinotecan (350 mg/ m2 on day 1), and third-line combination of capecitabine (1000 mg/ m2 twice daily for 14 days) with oxaliplatin (130 mg/ m2 on day 1).
Kombinationsbehandlingen bestod af 1. linjebehandling med Xeloda (1000 mg/ m2 to gange daglig i 14 dage) kombineret med irinotecan (250 mg/ m2 på dag 1) (XELIRI) og 2. linjebehandling med capecitabine (1000 mg/ m2 to gange dagligt i 14 dage) plus oxaliplatin (130 mg/ m2 på dag 1).
Combination treatment consisted of first-line treatment of Xeloda (1000 mg/ m2 twice daily for 14 days) combined with irinotecan (250 mg / m2 on day 1) (XELIRI) and second-line capecitabine (1000 mg/ m2 twice daily for 14 days) plus oxaliplatin (130 mg/ m2 on day 1).
I 1. linjebehandlingen var den mediane progressionsfri overlevelse i intent- to- treat - populationen 5, 8 måneder (95% konfidensinterval 5, 1 – 6, 2 måneder) for Xeloda monoterapi og 7, 8 måneder (95% konfidensinterval 7, 0 - 8, 3 måneder; p = 0, 0002) for XELIRI.
In first-line treatment the median progression-free survival in the intent-to-treat population was 5.8 months (95%CI 5.1 - 6.2 months) for Xeloda monotherapy and 7.8 months (95%CI 7.0 - 8.3 months; p=0.0002) for XELIRI.
Data fra en interimanalyse af et randomiseret, kontrolleret fase II- multicenterforsøg (AIO KRK 0604) støtter anvendelsen af en initial Xeloda- dosis på 800 mg/ m2 i 2 uger hver 3. uge i kombination med irinotecan og bevacizumab som 1. linjebehandling af patienter med metastatisk kolorektalkræft.
Data from an interim analysis of a multicentre, randomised, controlled phase II study (AIO KRK 0604) support the use of Xeloda at a starting dose of 800 mg/ m2 for 2 weeks every 3 weeks in combination with irinotecan and bevacizumab for the first-line treatment of patients with metastatic colorectal cancer.