natgillin/translations-raw huggingface dataset:
Tilsvarende værdier for XELOX subgruppen var:
The median overall survival was 20.3 months in placebo and 21.2 months in bevacizumab treated patients in the FOLFOX treatment subgroup, HR=0.94, 97.5% CI = [0.75; 1.16]; p-value = 0.4937, the corresponding results in the XELOX, treatment subgroup being 19.2 vs.
19, 2 vs 21, 4 måneder, HR=0, 84; 97, 5%, konfidensinterval = [0, 68; 1, 04]; p- værdien = 0, 0698.
21.4 months, HR = 0.84, 97.5% CI = [0.68; 1.04]; p-value = 0.0698.
ECOG E3200 Dette var et fase III, randomiseret, aktivt- kontrolleret, ublindet studie, som undersøgte Avastin 10 mg/ kg i kombination med leucovorin og 5- fluorouracil bolus efterfulgt af 5 - fluorouracil infusion med iv oxaliplatin (FOLFOX- 4), administreret hver 2. uge til tidligere behandlede (2. linje) patienter med fremskreden kolorektal kræft.
ECOG E3200 This was a phase III randomised, active-controlled, open-label study investigating Avastin 10 mg/ kg in combination with leucovorin with 5-fluorouracil bolus and then 5-fluorouracil infusional, with IV oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule in previously-treated patients (second line) with advanced colorectal cancer.
I kemoterapiarmene anvendtes et FOLFOX- 4 regime med samme dosering og frekvens som vist i tabel 5 for studie NO16966.
In the chemotherapy arms, the FOLFOX-4 regimen used the same doses and schedule as shown in Table 5 for Study NO16966.
Den primære effektparameter for studiet var samlet overlevelse, defineret som tid fra randomisering til død, uanset årsag.
The primary efficacy parameter of the trial was overall survival, defined as the time from randomization to death from any cause.
829 blev randomiseret (292 FOLFOX- 4, 293 Avastin +FOLFOX- 4 og 244 Avastin monoterapi).
Eight hundred and twenty-nine patients were randomised (292 FOLFOX-4, 293 Avastin +_FOLFOX-4 and 244 Avastin monotherapy).
Tillæg af Avastin til FOLFOX- 4 gav en statistisk signifikant forlængelse af overlevelse.
The addition of Avastin to FOLFOX-4 resulted in a statistically significant prolongation of survival.
Statistisk signifikante forbedringer i den progressionsfrie overlevelse og objektive responsrate sås også (se tabel 7).
Statistically significant improvements in progression-free survival and objective response rate were also observed (see Table 7).
17 Table 7
17 Table 7
Effektresultater for studie E3200
Efficacy Results for Study E3200
Antal patienter
Number of Patients Overall Survival
95% konfidensinterval b
95% confidence
0, 751
0.751
(p- værdi = 0, 0012)
(p-value = 0.0012) Progression-Free Survival
Median (måneder) Hazard ratio
Median (months) Hazard ratio
(p- værdi < 0, 0001) Objektiv responsrate
(p-value < 0.0001) Objective Response Rate
(p- værdi < 0. 0001)
(p-value < 0.0001)
a 10 mg/ kg hver 2. uge b I forhold til kontrolarmen
a 10 mg/ kg every 2 weeks b Relative to control arm
Der blev ikke observeret nogen signifikant forskel i varighed af overlevelse hos patienter, der modtog Avastin monoterapi i forhold til patienter, som blev behandlet med FOLFOX- 4.
No significant difference was observed in the duration of overall survival between patients who received Avastin monotherapy compared to patients treated with FOLFOX-4.
Progressionsfri overlevelse og objektiv responsrate var inferior i Avastin monoterapiarmen i forhold til FOLFOX- 4 armen.
Progression-free survival and objective response rate were inferior in the Avastin monotherapy arm compared to the FOLFOX-4 arm.
Effekten af genbehandling med Avastin hos patienter med metastatisk kolorektal kræft, som tidligere har fået behandling med Avastin, er ikke undersøgt i randomiserede kliniske forsøg.
The benefit of Avastin re-treatment in metastatic colorectal cancer patients who were exposed to Avastin in previous therapies has not been addressed in randomized clinical trials.
Studie E2100 var et åbent, randomiseret, aktivt kontrolleret, multicenter klinisk studie til evaluering af Avastin i kombination med paclitaxel af lokalt recidiverende eller metastatisk brystkræft hos patienter, som ikke tidligere havde modtaget kemoterapi for lokalt recidiverende og metastatisk sygdom.
Study E2100 was an open-label, randomised, active controlled, multicentre clinical trial evaluating Avastin in combination with paclitaxel for locally recurrent or metastatic breast cancer in patients who had not previously received chemotherapy for locally recurrent and metastatic disease.
Patienterne blev randomiseret til paclitaxel alene (90 mg/ m2 indgivet intravenøst som 1- times infusion i tre ud af fire uger) eller i kombination med Avastin (10 mg/ kg legemsvægt, indgivet som intravenøs infusion hver 14. dag).
Patients were randomised to paclitaxel alone (90 mg/ m2 IV over 1 hour once weekly for three out of four weeks) or in combination with Avastin (10 mg/ kg IV infusion every two weeks).
Adjuvant taxanbehandling var kun tilladt, hvis den var afsluttet mindst 12 måneder før inklusion i studiet.
Adjuvant taxane therapy was allowed only if it was completed at least 12 months prior to study entry.
Af de 722 patienter i studiet havde hovedparten HER2- negativ sygdom (90%), mens der var et lille antal patienter med ukendt (8%) eller bekræftet HER2- positiv status (2%), som tidligere var blevet behandlet med eller som blev betragtet som uegnede til trastuzumab- terapi.
Of the 722 patients in the study, the majority of patients had HER2-negative disease (90%), with a small number of patients with unknown (8%) or confirmed HER2-positive status (2%), who had previously been treated with or were considered unsuitable for trastuzumab therapy.
Desuden havde 65% af patienterne modtaget adjuvant kemoterapi, herunder 19% forudgående taxaner og 49% forudgående antracykliner.
Furthermore, 65% of patients had received adjuvant chemotherapy including 19% prior taxanes and 49% prior anthracyclines.
Patienter med metastaser til centralnervesystemet, herunder tidligere behandlede eller resekterede hjernelæsioner, blev ekskluderet.
Patients with central nervous system metastasis, including previously treated or resected brain lesions, were excluded.
I studie E2100 blev patienterne behandlet indtil sygdomsprogression.
In Study E2100, patients were treated until disease progression.
Patientkarakteristika var sammenlignelige på tværs af armene i studiet.
The patient characteristics were similar across the study arms.
Det primære endpoint for dette studie var progressionsfri overlevelse (PFS), baseret på studieinvestigatorernes vurdering af sygdomsprogression.
The primary endpoint of this trial was progression free survival (PFS), based on study investigators’ assessment of disease progression.
En uafhængig gennemgang af det primære endpoint blev også udført.
In addition, an independent review of the primary endpoint was also conducted.
Resultaterne af dette studie vises i tabel 8.
The results of this study are presented in Table 8.
18 Tabel 8
18 Table 8
Studie E2100 resultater for effekt:
Study E2100 Efficacy Results:
Investigators vurdering *
Investigator Assessment*
IRF vurdering
IRF Assessment
Paclitaxel (n=354)
Paclitaxel (n=354)
Paclitaxel/ Avastin Paclitaxel (n=368) (n=354)
Paclitaxel/ Avastin Paclitaxel (n=368) (n=354)
Paclitaxel/ Avastin (n=368)
Paclitaxel/ Avastin (n=368)
(95% konfidensinterval) p- værdi Responsrater (for patienter med målbar
(95% CI) p-value
(0, 343; 0, 516) < 0, 0001 sygdom)
(0.343; 0.516) < 0.0001
Investigator vurdering
Investigator Assessment
Paclitaxel (n=243)
Paclitaxel (n=243)
Paclitaxel/ Avastin Paclitaxel (n=229) (n=243)
Paclitaxel/ Avastin Paclitaxel (n=229) (n=243)
Paclitaxel/ Avastin (n=229)
Paclitaxel/ Avastin (n=229)
% af pt med objektivt respons
% pts with objective response
Samlet overlevelse (OS)
Overall Survival
Median OS (måneder) HR
Median OS (months) HR
(95% konfidensinterval) p- værdi
(95% CI) p-value
Den kliniske effekt af Avastin, som målt som PFS, blev observeret hos alle testede præ- specificerede subgrupper (herunder sygdomsfrit interval, antal metastatiske foci, tidligere adjuverende kemoterapi og østrogenreceptorstatus (ER)).
The clinical benefit of Avastin as measured by PFS was seen in all pre-specified subgroups tested (including disease-free interval, number of metastatic sites, prior receipt of adjuvant chemotherapy and estrogen receptor (ER) status).
Sikkerheden og effekten af Avastin, i kombination med platinbaseret kemoterapi, til 1. linjebehandling af patienter med ikke- planocellulært ikke- småcellet lungekræft (NSCLC), blev undersøgt i studierne E4599 og BO17704.
The safety and efficacy of Avastin, in addition to platinum-based chemotherapy, in the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC), was investigated in studies E4599 and BO17704.
Samlet overlevelse er vist i studie E4599 med en dosering af bevacizumab på 15 mg/ kg legemsvægt hver 3. uge.
An overall survival benefit has been demonstrated in study E4599 with a 15 mg/ kg/ q3wk dose of bevacizumab.
Forsøg BO17704 har vist, at bevacizumab givet som både 7, 5 mg/ kg legemsvægt hver 3. uge og 15 mg/ kg legemsvægt hver 3. uge øger progressionsfri overlevelse og responsraten.
Study BO17704 has demonstrated that both 7.5 mg/ kg/ q3wk and 15 mg/ kg/ q3wk bevacizumab doses increase progression free survival and response rate.
Da opfølgningsperioden for BO17704 var kort, kan der ikke drages konklusioner om en forøgelse af den samlede overlevelse.
Due to the short duration of follow-up in study BO17704 no conclusions can be drawn regarding a benefit in overall survival.
Studie E4599 var et åbent, randomiseret, aktivt kontrolleret, multicenter klinisk studie til evaluering af Avastin som 1. liniebehandling af patienter med lokal fremskreden (stadie IIIb med malignt pleural effusion), metastatisk eller recidiverende NSCLC, der ikke har dominerende pladecellehistologi.
E4599 was an open-label, randomised, active-controlled, multicentre clinical trial evaluating Avastin as first-line treatment of patients with locally advanced (stage IIIb with malignant pleural effusion), metastatic or recurrent NSCLC other than predominantly squamous cell histology.
Patienter blev randomiseret til platinbaseret kemoterapi (paclitaxel 200 mg/ m2 og carboplatin AUC = 6, 0, begge som i. v. - infusion) (PC) på dag 1 af hver 3- ugers serie i op til 6 serier eller PC i kombination med Avastin med en dosis på 15 mg/ kg i. v. - infusion på dag 1 af hver 3- ugers serie.
Patients were randomized to platinum-based chemotherapy (paclitaxel 200 mg/ m2 and carboplatin AUC = 6.0, both by IV infusion) (PC) on day 1 of every 3-week cycle for up to 6 cycles or PC in combination with Avastin at a dose of 15 mg/ kg IV infusion day 1 of every 3-week cycle.
Efter afslutning af 6 serier kemoterapi med carboplatin- paclitaxel eller efter for tidlig seponering af kemoterapi, fortsatte patienter, der fik Avastin + carpoplatin- paclitaxel, med at få Avastin som enkeltstofbehandling hver 3. uge indtil sygdomsprogression.
After completion of six cycles of carboplatin-paclitaxel chemotherapy or upon premature discontinuation of chemotherapy, patients on the Avastin + carboplatin– paclitaxel arm continued to receive Avastin as a single agent every 3 weeks until disease progression.
Af de patienter, der i løbet af studiet modtog studiebehandling, modtog 32, 2% (136/ 422) af patienterne 7- 12 administrationer af Avastin og 21, 1% (89/ 422) af patienterne modtog 13 eller flere administrationer af Avastin.
During the study, of the patients who received trial treatment, 32.2% (136/ 422) of patients received 7-12 administrations of Avastin and 21.1% (89/ 422) of patients received 13 or more administrations of Avastin.
19 Det primære endepunkt var varigheden af overlevelse.
19 The primary endpoint was duration of survival.
Effektresultater fra studie E4599
Efficacy results for study E4599
Arm 1
Arm 1
Arm 2
Arm 2
Carboplatin / Paclitaxel
Carboplatin/ Paclitaxel
Carboplatin / Paclitaxel + Avastin
Carboplatin/ Paclitaxel + Avastin
15 mg/ kg hver 3. uge Antal patienter Samlet overlevelse
15
Median (måneder) Hazard ratio
Median (months)
95% konfidensinterval (0, 69; 0, 93) Progressionfri overlevelse
95% CI (0.69, 0.93) Progression-Free Survival
95% konfidensinterval (0, 56; 0, 76) Samlet Responsrate
95% CI (0.56, 0.76) Overall Response Rate
I en eksplorativ analyse var omfanget af fordelene ved Avastin på den samlede overlevelse mindre udtalt i undergruppen af patienter, som ikke havde adenocarcinom- histologi.
In an exploratory analysis, the extent of Avastin benefit on overall survival was less pronounced in the subgroup of patients who did not have adenocarcinoma histology.
Det blev udført på patienter med lokalt fremskreden (stadie IIIb med supraklaviculær lymfekirtelmetastaser eller med malignt pleural eller perikardial effusion), metastatisk eller recidiverende ikke- planocellulært NSCLC, som ikke tidligere havde fået kemoterapi.
Study BO17704 was a randomised, double-blind phase III study of Avastin in addition to cisplatin and gemcitabine versus placebo, cisplatin and gemcitabine in patients with locally advanced (stage IIIb with supraclavicular lymph node metastases or with malignant pleural or pericardial effusion), metastatic or recurrent non-squamous NSCLC, who had not received prior chemotherapy.
Det primære endepunkt var progressionsfri overlevelse (PFS).
The primary endpoint was progression free survival (PFS).
Patienter, der blev randomiseret til platinbaseret kemoterapi, cisplatin 80 mg/ m2 i. v. - infusion på dag 1 og gemcitabin 1250 mg/ m2 i. v. - infusion på dag 1 og 8 af hver 3- ugers serie i op til 6 serier (CG) med placebo eller CG i kombination med Avastin med en dosis på 7, 5 eller 15 mg/ kg i. v. - infusion på dag 1 af hver 3- ugers serie.
Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/ m2 i. v. infusion on day 1 and gemcitabine 1250 mg/ m2 i. v. infusion on days 1 and 8 of every 3-week cycle for up to 6 cycles (CG) with placebo or CG with Avastin at a dose of 7.5 or 15 mg/ kg IV infusion day 1 of every 3-week cycle.
I Avastinarmen kunne patienter modtage Avastin som enkeltstofbehandling hver 3. uge indtil sygdomsprogression eller indtil uacceptabel toksicitet.
In the Avastin-containing arms, patients could receive Avastin as a single-agent every 3 weeks until disease progression or unacceptable toxicity.
Studieresultaterne viser, at 94% (277/ 296) af de kvalificerede patienter kom i enkeltstofbehandling med bevacizumab ved serie 7.
Study results show that 94% (277 / 296) of eligible patients went on to receive single agent bevacizumab at cycle 7.
Effektresultaterne er præsenteret i tabel 10.
The efficacy results are presented in Table 10.
20 Tabel 10
20 Table 10
Effektresultater fra studie BO17704
Efficacy results for study BO17704
Cisplatin/ Gemcitabin +
Cisplatin/ Gemcitabine
Cisplatin/ Gemcitabin
Cisplatin/ Gemcitabine
Cisplatin/ Gemcitabin + placebo
Cisplatin/ Gemcitabine + placebo
Avastin 7. 5 mg/ kg 3 uger
+ Avastin 7.5 mg/ kg q 3 weeks
+ Avastin 15 mg/ kg 3 uger
+ Avastin 15 mg/ kg q 3 weeks
Antal patienter
Number of
347
Patients 347
345
345
Progressionfri overlevelse
Progression-Free Survival
6, 7
(p =
6, 5
6.7 0.0026)
(p=0, 0026)
(p =
(p=0, 0301)
6.5 0.0301)
0, 75 [0, 62; 0, 91]
0.75
Bedste
0.82
samlede
[0.62; 0.91]
20, 1%
[0.68; 0.98]
34, 1%
Best Overall Response Rate a
Fremskreden og/ eller metastaserende renalcellecarcinom
Advanced and/ or metastatic Renal Cell Cancer (mRCC)
Avastin i kombination med interferon alfa- 2a til 1. linjebehandling af patienter med fremskreden og/ eller metastaserende renalcellecarcinom (BO17705).
Avastin in Combination with Interferon alfa-2a for the First-Line Treatment of Advance and/ or Metastatic Renal Cell Cancer (BO17705)
Dette var et fase III, randomiseret, dobbeltblindet studie, der blev udført for at undersøge effekt og sikkerhed ved Avastin i kombination med interferon (IFN) alfa- 2a (Roferon) versus IFN alfa- 2a alene som 1. linjebehandling af mRCC.
This was a phase III randomised double-blind trial conducted to evaluate the efficacy and safety of Avastin in combination with interferon (IFN) alfa-2a (Roferon®) versus IFN alfa-2a alone as first-line treatment in mRCC.
De 649 randomiserede patienter (641 behandlede) havde Karnofsky Performance Status (KPS) på ≥ 70%, ingen CNS metastaser og tilstrækkelig organfunktion.
The 649 randomized patients (641 treated) had Karnofsky Performance Status (KPS) of ≥ 70%, no CNS metastases and adequate organ function.
Patienterne blev nefrektomeret grundet primær renalcellecarcinom.
Patients were nephrectomised for primary renal cell carcinoma.
Der blev givet Avastin 10 mg/ kg hver anden uge indtil sygdomsprogession.
Avastin 10 mg/ kg was given every 2 weeks until disease progression.
Denne dosis kunne reduceres til 3 MIE tre gange ugentligt ad to omgange.
IFN alfa-2a was given up to 52 weeks or until disease progression at a recommend starting dose of 9 MIU three times a week, allowing a dose reduction to 3 MIU three times a week in 2 steps.
Patienterne blev stratificeret i forhold til land og Motzer score og behandlingsarmene viste at være velafbalancerede i forhold til prognostiske faktorer.
Patients were stratified according to country and Motzer score and the treatment arms were shown to be well balanced for the prognostic factors.
Ved data cut- off havde 505 tilfælde af sygdomsprogression indtruffet, 111 patienter var stadig i behandling, 287 patienter havde afbrudt behandlingen (afbrydelse af behandlingen på grund af uønskede hændelser skete for 12% i IFN alfa- 2a- armen mod 28% i IFN alfa- 2a+ Avastin- armen), og 251 patienter var døde.
At the data cut-off, 505 progression events had occurred, 111 patients remained on treatment, 287 had discontinued (discontinuations of trial treatment due to AEs were 12% with IFN alfa-2a vs.
Syvoghalvfems (97) patienter i IFN alfa- 2a- armen og 131 patienter i Avastin - armen reducerede dosis af IFN alfa- 2a fra 9 MIE til enten 6 eller 3 MIE tre gange ugentlig, som anført i protokollen.
28% with IFN alfa-2a +Avastin), and 251 died.
Reduktion af dosis af IFN alfa- 2a syntes ikke at påvirke effekten af kombinationen af Avastin og IFN alfa- 2a.
Ninety seven (97) patients in the IFN alfa-2a arm and 131 patients in the Avastin arm reduced the dose of IFN alfa-2a from 9 MIU to either 6 or 3 MIU three times a week as pre-specified in the protocol.
Dette baseres på subgruppeanalyser af andelen af patienter uden progression over tid.
Dose-reduction of IFN alfa-2a did not appear to affect the efficacy of the combination of Avastin and IFN alfa-2a based on PFS event free rates over time, as shown by a sub-group analysis.
De 131 patienter i Avastin + IFN alfa- 2a- armen, som reducerede og fastholdt dosis af IFN alfa- 2a på enten 6 eller 3 MIE gennem studiet, udviste ved 6, 12 og 18 måneder en andel uden progression på henholdsvis 73, 52 og 21% sammenlignet med 61, 43 og 17% i den totale population, som fik Avastin og IFN alfa- 2a.
The 131 patients in the Avastin + IFN alfa-2a arm who reduced and maintained the IFN alfa-2a dose at 6 or 3 MIU during the study, exhibited at 6, 12 and 18 months PFS event free rates of 73, 52 and 21% respectively, as compared to 61, 43 and 17% in the total population of patients receiving Avastin + IFN alfa-2a.
Tillæg af Avastin til IFN alfa- 2a forøgede den progressionsfri overlevelse og den objektive tumorrespons signifikant (tabel 11).
The addition of Avastin to IFN alfa-2a significantly increased PFS and objective tumour response rate (Table 11).
Data for den samlede overlevelse var ikke modne ved interimanalysen.
The overall survival (OS) data were not mature at the time of the interim analysis.
21 Tabel 11
21 Table 11
Effektresultater for studie BO17705
Efficacy Results for Study BO17705
Antal af patienter
Number of Patients
(p- value < 0, 0001) Objektiv responsrate (%) for patienter med målelig sygdom
(p-value < 0.0001) Objective Response Rate (%) in Patients with Measurable Disease n
(p- value < 0, 0001)
(p-value < 0.0001)
Interferon alfa- 2a 9 MIE 3x/ ugentlig b Bevacizumab 10 mg/ kg hver anden uge
Interferon alfa-2a 9 MIU 3x/ week b Bevacizumab 10 mg/ kg q 2 wk
Dette var et randomiseret, dobbelt- blindet, fase II klinisk studie, som undersøgte Avastin 10 mg/ kg hver anden uge i forhold til Avastin i samme dosis i kombination med 150 mg erlotinib dagligt til patienter med metastaserende clear cell RCC.
This was a randomised, double-blind, phase II clinical study investigating Avastin 10 mg/ kg in a 2 weekly schedule with the same dose of Avastin in combination with 150 mg daily erlotinib, in patients with metastatic clear cell RCC.
I alt blev 104 patienter randomiseret til behandling i dette studie; 53 til Avastin 10 mg/ kg hver anden uge plus placebo og 51 til Avastin 10 mg/ kg hver anden uge plus erlotinib 150 mg dagligt.
A total of 104 patients were randomised to treatment in this study, 53 to Avastin 10 mg/ kg every 2 weeks plus placebo and 51 to Avastin 10 mg/ kg every 2 weeks plus erlotinib 150 mg daily.
Analysen af primært endepunkt viste ingen forskel mellem Avastin- placebo armen og Avastin– erlotinib armen (median progressionsfri overlevelse 8, 5 vs 9, 9 måneder).
The analysis of the primary endpoint showed no difference between the Avastin + Placebo arm and the Avastin + Erlotinib arm (median PFS 8.5 versus 9.9 months).
Tillæg af erlotinib til bevacizumab resulterede ikke i forbedring af den samlede overlevelse (HR=1, 764; p=0, 1789), varighed af objektiv respons (6, 7 vs 9, 1 måneder) eller tid til progession af symptomer (HR= 1, 172; p=0, 5076).
The addition of erlotinib to bevacizumab did not result in an improvement in OS (HR = 1.764; p=0.1789), duration of objective response (6.7 vs 9.1 months) or time to symptom progression (HR = 1.172; p = 0.5076).
Dette var et randomiseret fase II studie, der blev udført for at sammenligne effekt og sikkerhed af bevacizumab vs. placebo.
This was a randomised phase II trial conducted to compare the efficacy and safety of bevacizumab versus placebo.
Et samlet antal på 116 patienter blev randomiseret til at modtage bevacizumab 3 mg/ kg hver anden uge (n=39); 10 mg/ kg hver anden uge (n=37) eller placebo (n=40).
A total of 116 patients were randomized to receive bevacizumab 3 mg/ kg every 2 weeks (n=39), 10 mg/ kg every 2 weeks; (n=37), or placebo (n=40).
En interim analyse viste, at der var signifikant forlængelse af tid til progression af sygdom for 10 mg/ kg gruppen i forhold til placebo- gruppen (hazard ratio, 2, 55; p < 0, 001).
An interim analysis showed there was a significant prolongation of the time to progression of disease in the 10 mg/ kg group as compared with the placebo group (hazard ratio, 2.55; p < 0.001).
Der var en lille forskel, med ubetydelige signifikans, mellem tid til progression af sygdom i gruppen behandlet med 3 mg/ kg i forhold til placebo- gruppen (hazard ratio, 1, 26; p=0, 0053).
There was a small difference, of borderline significance, between the time to progression of disease in the 3 mg/ kg group and that in the placebo group (hazard ratio, 1.26; p=0.053).
Fire patienter viste objektiv (partiel) respons og alle de patienter modtog 10 mg/ kg bevacizumab; samlet responsrate for 10 mg/ kg var 10%.
Four patients had objective (partial) response, and all of these had received the 10 mg/ kg dose bevacizumab; the ORR for the 10 mg/ kg dose was 10%.
De farmakokinetiske data for bevacizumab stammer fra 8 kliniske studier hos patienter med solide tumorer.
The pharmacokinetic data for bevacizumab are available from eight clinical trials in patients with solid tumours.
I det første fase I studie var bevacizumabs farmakokinetik lineær i dosisområdet 1 til 10 mg/ kg.
The pharmacokinetics of bevacizumab was linear at doses ranging from 1 to 10 mg/ kg.
Absorption Ikke relevant.
Absorption Not applicable.
22 Distribution Baseret på en farmakokinetiske populationsanalyse af 491 patienter, som fik Avastin ugentlig, hver 2. eller 3. uge i doser fra 1 til 20 mg/ kg var volumenet af den centrale kompartment (Vc) 2, 92 l.
22 Distribution Based on a population pharmacokinetic analysis of 491 subjects receiving Avastin weekly, every 2 weeks, or every 3 weeks, in doses ranging from 1 to 20 mg/ kg, the volume of the central compartment (Vc) was 2.92 l.