natgillin/translations-raw huggingface dataset:
• Hvert 16 ml hætteglas indeholder 400 mg bevacizumab svarende til 16,5 mg/ml efter foreskreven fortynding.
• Each 16 mL vial contains 400 mg of bevacizumab, corresponding to 16.5 mg/mL when diluted as recommended.
(p-værdi5 < 0,0001)
(p-value5 < 0.0001)
Data for det sekundære endepunkt, den samlede overlevelse, er ikke tilgængelige endnu.
The secondary endpoint of overall survival was not mature.
Sammenlignet med 5-FU/FA-kemoterapi alene medførte tillæg af bevacizumab 5 mg/kg hver 2. uge til 5-FU/FA en højere, objektiv responsrate, længere progressionsfri overlevelse og en tendens til længere overlevelse (se tabel 5).
The addition of bevacizumab 5 mg/kg every two weeks to 5-FU/FA resulted in higher objective response rates, longer progression-free survival, and a trend in longer survival, compared with 5-FU/FA chemotherapy alone (see table 5).
Når lægemidlet anvendes til voksne patienter med fremskreden kræft i æggestokkene, kræft i æggeledere eller primær bughindekræft, hvor sygdommen er kommet igen tidligere end 6 måneder efter sidste kemoterapi, som indeholdt platin, vil MVASI blive givet sammen med paclitaxel eller topotecan eller pegyleret liposomal doxorubicin.
When used for those adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back before 6 months after the last time they were treated with a chemotherapy regimen containing a platinum agent, MVASI will be administered in combination with paclitaxel, or topotecan, or pegylated liposomal doxorubicin.
I FOLFOX undergruppen var den mediane PFS 8,6 måneder i placebogruppen vs 9,4 måneder for bevacizumab-behandlede patienter, HR = 0,89, 97,5 % konfidensinterval = [0,73-1,08]; p-værdi = 0,1871.
In the FOLFOX treatment subgroup, the median PFS was 8.6 months in placebo and 9.4 months in bevacizumab-treated patients, HR = 0.89, 97.5% CI = [0.73; 1.08]; p-value = 0.1871, the corresponding results in the XELOX treatment subgroup being 7.4 vs. 9.3 months, HR = 0.77, 97.5% CI = [0.63; 0.94]; p-value = 0.0026.
Sekundært endepunkt Progressionsfri overlevelse
Secondary endpoint Progression-free survival (PFS)
Hvert hætteglas med 4 ml koncentrat indeholder 100 mg bevacizumab.
Each vial of 4 mL of concentrate contains 100 mg of bevacizumab.
Kongestivt hjertesvigtb,d Supraventrikulær takykardi
Congestive heart failureb,d, Supraventricular tachycardia
85 mg/m i.v.
85 mg/m2 IV 2 h
Nogle af bivirkningerne er almindelige ved behandling med kemoterapi, men bevacizumab kan forværre disse bivirkninger, når det gives i kombination med kemoterapi, f.eks. palmoplantar erytrodysæstesisyndrom med pegyleret liposomal doxorubicin eller capecitabin, perifer sensorisk neuropati med paclitaxel eller oxaliplatin, negleproblemer og alopeci med paclitaxel og paronykie med erlotinib.
Examples include palmar-plantar erythrodysaesthesia syndrome with pegylated liposomal doxorubicin or capecitabine, peripheral sensory neuropathy with paclitaxel or oxaliplatin, nail disorders or alopecia with paclitaxel and paronychia with erlotinib.
Patienter med ubehandlede CNS-metastaser, verificeret ved billeddiagnostik eller tegn og symptomer, er rutinemæssigt blevet udeladt af kliniske studier med bevacizumab.
Patients with untreated CNS metastases were routinely excluded from clinical trials with bevacizumab, based on imaging procedures or signs and symptoms.
Fistlerb,d Muskelsvaghed Rygsmerter
Dyspnoea, Rhinitis, Epistaxis, Cough
I begge behandlingsarme var der ingen bivirkninger som resulterede i dødsfald.
No adverse events leading to death occurred in either treatment arm; all deaths were attributed to disease progression.
Objektiv responsrate5
p-value3,4 Objective response rate5
Effektresultater er præsenteret i tabel 14.
The efficacy results are presented in table 14.
Den mediane, samlede overlevelse var 20,3 måneder for placebogruppen vs 21,2 måneder for bevacizumab-behandlede patienter i FOLFOX undergruppen, HR = 0,94, 97,5 % konfidensinterval = [0,75-1,16]; p-værdi = 0,4937.
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. 21.4 months, HR = 0.84, 97.5% CI = [0.68; 1.04]; p-value = 0.0698.
Kemoterapi (n = 182)
CT (n = 182)
• CPB arm: Carboplatin (AUC 5) og paclitaxel (175 mg/m i.v.)
• CPB arm: Carboplatin (AUC5) and paclitaxel (175 mg/m2 IV) and concurrent bevacizumab
Størstedelen af patienterne i de 2 behandlingsarme (74 % og 71 %) havde lavt differentierede (grad 3) (NCI-CTCAE v. 3) primære tumorer ved baseline.
The majority of the patients in each treatment arm (74% and 71%) had poorly differentiated (grade 3)
Patienter med målbar sygdom ved baseline.
Patients with measurable disease at baseline.
MVASI er medicin, som anvendes hos voksne til behandling af fremskreden kræft i tyktarmen eller endetarmen.
MVASI is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum.
(14,9 vs 11,9 måneder; p =
(14.9 vs. 11.9 months; p = 0.1061)
Den samlede seponeringsfrekvens på grund af bivirkninger var 8,8 % i kemoterapi-armen og 43,6 % i kemoterapi + bevacizumab-armen (hovedsagelig på grund af bivirkninger af grad 2-3).
The overall rates of discontinuation due to adverse events were 8.8% in the CT arm and 43.6% in the CT + BV arm (mostly due to grade 2-3 adverse events) and the median time to discontinuation in the CT + BV arm was 5.2 months compared with 2.4 months in the CT arm.
Samlet overlevelse -Followupanalyse2 Hazard ratio (95 % konfidensinterval)
Overall survival - Follow-up analysis2 Hazard ratio (95% CI)
• Bevacizumab-armene var bedre med hensyn til progressionsfri overlevelse i ITT (intent-to-treat) populationen (tabel 7) i forhold til behandlingsarmene, der kun indeholdt kemoterapi.
• Superiority of the bevacizumab-containing arms versus the chemotherapy alone arms in the overall comparison was demonstrated in terms of progression-free survival in the ITT population (Table 7).
hver 2. uge (eller bevacizumab 15 mg/kg hver 3. uge, hvis det anvendes i kombination med topotecan 1,25 mg/m2 på dag 1-5 hver 3. uge).
• The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV every 2 weeks (or bevacizumab 15 mg/kg every 3 weeks if used in combination with topotecan 1.25 mg/m2 on days 1-5 every 3 weeks).
Sammenlignet med 5-FU/FA-kemoterapi alene medførte tillæg af bevacizumab 5 mg/kg hver 2. uge til 5-FU/FV en højere, objektiv responsrate, signifikant længere progressionsfri overlevelse og en tendens til længere overlevelse.
The addition of bevacizumab 5 mg/kg every two weeks to 5-FU/FA resulted in higher objective response rates, significantly longer progression-free survival, and a trend in longer survival as compared to 5-FU/FA chemotherapy alone.
4.4 og Post-marketing erfaring nedenfor)
Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below)
29 % af patienterne i CPP- og CPB15-armene og 26 % i CPB15+-armen var over 65 år.
The majority of patients included in the study were white (87% in all three arms); the median age was 60 years in CPP and CPB15 arms and 59 years in CPB15+ arm; and 29% of patients in CPP or CPB15 and 26% in CPB15+ were over 65 years of age.
Den anbefalede dosis af MVASI administreres som intravenøs infusion og administreres enten som 5 mg/kg eller 10 mg/kg legemsvægt en gang hver 2. uge eller som 7,5 mg/kg eller 15 mg/kg legemsvægt en gang hver 3. uge.
Metastatic carcinoma of the colon or rectum (mCRC) The recommended dose of MVASI, administered as an intravenous infusion, is either 5 mg/kg or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks.
Median PFS (måneder) Hazard ratio (95 % konfidensinterval)4 Randomiserede patienter med stadie III sub-optimalt tumorreduceret sygdom CP (n = 154)
Median PFS (months) Hazard ratio (95% CI)4 Randomised patients with stage III suboptimally debulked disease3 CP (n = 154)
MVASI er, i kombination med platinbaseret kemoterapi, indiceret til 1.-linjebehandling af voksne patienter med ikke-operabel fremskreden, metastatisk eller recidiverende, ikke-småcellet lungekræft.
MVASI, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.
Median PFS (måneder) Hazard ratio (95 % konfidensinterval)4 Randomiserede patienter med stadie III sub-optimalt tumorreduceret sygdom CPP (n = 253)
Median PFS (months) Hazard ratio (95% CI)4 Randomised patients with stage III suboptimally debulked disease3 CPP (n = 253)
4.4 og Proteinuri i pkt.
For further information on proteinuria see section 4.4 and Proteinuria in section 4.8
Resultater vises i tabel 21.
Results are presented in table 21.
• Kemoterapi-arm (kemoterapi alene): • Paclitaxel 80 mg/m som 1-times i.v.-infusion på dag 1, 8, 15 og 22 hver 4. uge.
• Paclitaxel 80 mg/m2 as a 1-hour IV infusion on days 1, 8, 15, and 22 every 4 weeks
Hos patienter med målbar sygdom ved baseline.
In patients with measurable disease at baseline.
a p-værdi
P-value
Gastrointestinale perforationer og fistler (se pkt.
Gastrointestinal (GI) perforations and Fistulae (see section 4.4)
I studie BO25041 blev bevacizumab føjet til post-operativ strålebehandling med samtidig adjuverende temozolomidbehandling hos pædiatriske patienter med nyligt diagnosticeret supratentorielt, infratentorielt, cerebellært eller pedunkulært høj-grads-gliom.
In study BO25041 of bevacizumab added to post-operative radiation therapy (RT) with concomitant and adjuvant temozolomide in paediatric patients with newly diagnosed supratentorial, infratentorial, cerebellar, or peduncular high-grade glioma, the safety profile was comparable with that observed in other tumour types in adults treated with bevacizumab.
Median PFS (i behandling)** Hazard ratio (97,5 % konfidensinterval) Samlet responsrate (Investigators vurdering)**
Secondary endpoints Median PFS (on treatment)** Hazard ratio (97.5% CI) Overall response rate (invest.
Pulmonal blødning/ hæmoptysea,b Lungeemboli Epistaxis
Pulmonary haemorrhage/ Haemoptysisa,b, Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia
Andre bivirkninger ved behandling med bevacizumab, der blev set med en højere frekvens hos patienter over 65 år versus patienter ≤ 65 år, var grad 3-4 leukopeni og trombocytopeni (NCI-CTCAE v. 3) samt neutropeni (alle grader), diarré, kvalme, hovedpine og træthed (se pkt.
Other reactions with a higher frequency seen in patients over 65 were grade 3-4 leucopenia and thrombocytopenia (NCI-CTCAE v.3); and all grade neutropenia, diarrhoea, nausea, headache and fatigue as compared to those aged ≤ 65 years when treated with bevacizumab (see sections 4.4 and 4.8 under Thromboembolism).
Progressionfri overlevelse Median (måneder) Hazard ratio (95 % konfidensinterval)
Progression-free survival Median (months) Hazard ratio (95% confidence interval)
• Den protokolspecificerede analyse af investigatorvurderet PFS (uden censurering for CA-125 progressioner eller non-protokolleret terapi (NPT)) viser en stratificeret hazard ratio på 0,71 (95 % konfidensinterval: 0,61-0,83, ensidig log-rank p-værdi < 0,0001), når CPB15+ sammenlignes med CPP, med en median PFS på 10,4 måneder i CPP-armen og 14,1 måned i CPB15+-armen.
• The protocol-specified analysis of investigator assessed PFS (without censoring for CA-125 progression or non-protocol therapy [NPT]) shows a stratified hazard ratio of 0.71 (95% CI: 0.61-0.83, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 10.4 months in the CPP arm and 14.1 months in the CPB15+ arm.
• AVF4095g evaluerede bevacizumabs virkning og sikkerhed i kombination med carboplatin og gemcitabin, efterfulgt af bevacizumab som monoterapi, hos patienter med platinfølsom, recidiverende epitelial ovariecancer, tubacancer eller primær peritonealcancer.
• AVF4095g evaluated the efficacy and safety of bevacizumab in combination with carboplatin and gemcitabine followed by bevacizumab as a single agent in patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Disse klinisk signifikante bivirkninger blev rapporteret i kliniske studier, men grad 3-5 bivirkningerne opfyldte ikke grænsen på mindst 2 % forskel i forhold til kontrolarmen.
These clinically significant adverse reactions were reported in clinical trials but the grade 3-5 reactions did not meet the threshold of at least a 2% difference compared to the control arm. Table 2 also includes clinically significant adverse reactions that were observed only in the post-marketing setting, therefore, the frequency and NCI-CTCAE grade is not known.
• CPP-arm: Fem serier af placebo (startende i serie 2) i kombination med carboplatin (AUC 6) og paclitaxel (175 mg/m2) i 6 serier, efterfulgt af placebo alene, i op til sammenlagt 15 måneders behandling.
• CPP arm: Five cycles of placebo (started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by placebo alone, for a total of up to 15 months of therapy
Træthed Pyreksi Smerte Slimhindeinflammation
Lethargy, Mucosal inflammation
Arm 2 Carboplatin/ Paclitaxel + bevacizumab 15 mg/kg hver 3. uge
Carboplatin/ Paclitaxel + bevacizumab 15 mg/kg q 3 weeks
Den anbefalede dosis af MVASI, når det anvendes sammen med erlotinib, er 15 mg/kg legemsvægt en gang hver 3. uge som intravenøs infusion.
The recommended dose of MVASI when used in addition to erlotinib is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
I et klinisk studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer (studie GOG-0240) blev infektioner af grad 3-5 rapporteret hos op til 24 % af patienterne, behandlet med bevacizumab i kombination med paclitaxel og topotecan, sammenlignet med hos op til 13 % af patienterne, behandlet med paclitaxel og topotecan.
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 infections have been reported in up to 24% of patients treated with bevacizumab in combination with paclitaxel and topotecan compared with up to 13% of patients treated with paclitaxel and topotecan.
• tilstand i hjernen (posteriort reversibelt encefalopati syndrom) med symptomer såsom kramper, hovedpine, forvirring og synsforstyrrelser,
• a brain condition with symptoms including seizures (fits), headache, confusion, and changes in vision (Posterior Reversible Encephalopathy Syndrome or PRES),
• en blodprop i lungerne,
• a blood clot in the blood vessels of your lungs,
Studiet var et randomiseret, dobbeltblindet, aktivt kontrolleret, klinisk fase III-studie, som evaluerede bevacizumab i kombination med IFL som 1.-linjebehandling af metastatisk kolorektalkræft.
This was a phase III randomised, double-blind, active-controlled clinical trial evaluating bevacizumab in combination with IFL as first-line treatment for metastatic carcinoma of the colon or rectum.
Effektresultater for studiet er vist i tabel 13.
The efficacy results of the study are presented in table 13.
I et klinisk studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer (studie GOG-0240) blev blødninger af grad 3-5 rapporteret hos op til 8,3 % af patienterne, som blev behandlet med bevacizumab i kombination med paclitaxel og topotecan, sammenlignet med hos op til 4,6 % af patienterne, som blev behandlet med paclitaxel og topotecan.
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 bleeding reactions have been reported in up to 8.3% of patients treated with bevacizumab in combination with paclitaxel and topotecan compared with up to 4.6% of patients treated with paclitaxel and topotecan.
95 % konfidensinterval for responsrate3
Difference in response rates 95% CI for difference in response rates4
I et klinisk studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer (studie GOG-0240) blev venøs tromboemboli af grad 3-5 rapporteret hos op til 15,6 % af patienterne, som blev behandlet med bevacizumab i kombination med paclitaxel og cisplatin, sammenlignet med hos op til 7,0 % af patienterne, som blev behandlet med paclitaxel og cisplatin.
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 venous thromboembolic events have been reported in up to 15.6% of patients treated with bevacizumab in combination with paclitaxel and cisplatin compared with up to 7.0% of patients treated with paclitaxel and cisplatin.
Febril neutropeni Leukopeni Neutropenia Trombocytopeni
Febrile neutropenia, Leucopenia, Neutropeniaa, Thrombocytope nia
Kemoterapi (n = 144)
CT (n = 144)
(17,5 vs 15,0 måneder: p =
(17.5 vs.15.0 months; p = 0.0584)
Perifer sensorisk neuropatib Dysartri
Peripheral sensory neuropathyb, Dysarthria, Headache, Dysguesia
MVASI er, i kombination med carboplatin og paclitaxel, indiceret til frontlinjebehandling af voksne patienter med fremskreden (International Federation of Gynecology and Obstetrics (FIGO) stadie III B, III C og IV) epitelial ovariecancer, tubacancer eller primær peritonealcancer (se pkt.
MVASI, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO)
MVASI administreres sammen med platinbaseret kemoterapi i op til 6 behandlingsserier, efterfulgt af behandling med MVASI som monoterapi indtil sygdomsprogression.
First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy MVASI is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by MVASI as a single agent until disease progression.
Ovariesvigta,b
Ovarian failurea,b
Asteni Træthed
Asthenia, Fatigue
MVASI bruges også hos voksne til behandling af fremskreden kræft i æggestokkene, kræft i æggeledere eller primær bughindekræft.
MVASI is also used for the treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
* primær analyse
Primary analysis Overall survival
Antallet af infusioner, som du skal have, afhænger af, hvordan du reagerer på behandlingen.
The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until MVASI fails to stop your tumour growing.
Hætteglas (uåbnet)
Gall bladder perforation (not known)
• Den primære analyse af investigatorvurderet PFS (censureret for CA-125-progressioner og NPT) viser en stratificeret hazard ratio på 0,62 (95 % konfidensinterval: 0,52-0,75, ensidig log rank pværdi < 0,0001), når CPB15+ sammenlignes med CPP, med en median PFS på 12,0 måneder i CPP-armen og 18,2 måneder i CPB15+-armen.
• The primary analysis of investigator assessed PFS (censoring for CA-125 progressions and NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.52-0.75, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 12.0 months in the CPP arm and 18.2 months in the CPB15+ arm.
Resultaterne af dette studie vises i tabel 10.
The results of this trial are presented in table 10.
I et studie hos patienter med persisterende, recidiverende eller metastatisk cervixcancer var forekomsten af gastrointestinale-vaginale fistler 8,3 % hos bevacizumab-behandlede patienter og 0,9 % i kontrolgruppen.
In a trial of patients with persistent, recurrent or metastatic cervical cancer, the incidence of GI-vaginal fistulae was 8.3% in bevacizumab-treated patients and 0.9% in control patients, all of whom had a history of prior pelvic radiation.
Effekten og sikkerheden af bevacizumab i frontlinjebehandling af patienter med epitelial ovariecancer, tubacancer eller primær peritonealcancer blev undersøgt i to fase III-studier (GOG-0218 og BO17707).
The safety and efficacy of bevacizumab in the front-line treatment of patients with epithelial ovarian, fallopian tube or primary peritoneal cancer were studied in two phase III trials (GOG-0218 and BO17707) that evaluated the effect of the addition of bevacizumab to carboplatin and paclitaxel compared to the chemotherapy regimen alone.
Antal patienter Samlet overlevelse Median (måneder) Hazard ratio (95 % konfidensinterval)
Number of patients Overall survival Median (months) Hazard ratio (95% confidence interval)
Median PFS (måneder)2 Hazard ratio [95 % konfidensinterval]2
Median PFS (months)2 Hazard ratio [95% CI]2
Hypertensiv encefalopati (meget sjælden) (se også pkt.
Nervous system disorders Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8)
• CPB15-arm: Fem serier af bevacizumab (15 mg/kg hver 3. uge startende i serie 2) i kombination med carboplatin (AUC 6) og paclitaxel (175 mg/m2) i 6 serier, efterfulgt af placebo alene, i op til sammenlagt 15 måneders behandling.
• CPB15 arm: Five cycles of bevacizumab (15 mg/kg q3w started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by placebo alone, for a total of up to 15 months of therapy
Median PFS (måneder) Hazard ratio (95 % konfidensinterval) Median OS (måneder) Hazard ratio (95 % konfidensinterval)
Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI)
Den anbefalede dosis af MVASI er 7,5 mg/kg eller 15 mg/kg legemsvægt en gang hver 3. uge administreret som intravenøs infusion.
The recommended dose of MVASI is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
(14,9 vs 17,5 måneder; p =
(14.9 vs. 17.5 months; p = 0.4146)
Det primære endepunkt var progressionsfri overlevelse baseret på vurdering af en ufhængig evalueringskomité.
The primary endpoint was progression-free survival (PFS) based on independent review assessment.
Resultater fra studiet er opsummeret i tabel 19.
The results of this study are summarised in table 19.
Median OS (måneder) Hazard ratio (95 % konfidensinterval) Topotecan n = 120
Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI) Topotecan n = 120
Samlet overlevelse Median (måneder) Hazard ratio 95 % konfidensinterval
Overall survival Median (months) Hazard ratio 95% CI
Den anbefalede dosis af MVASI er 10 mg/kg legemsvægt en gang hver 2. uge eller 15 mg/kg legemsvægt en gang hver 3. uge administreret som intravenøs infusion.
The recommended dose of MVASI is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Leucovorin på dag 1 og 2 5-fluoruracil i.v.
Leucovorin on day 1 and 2
Osteonekrose af kæbenb,c
Osteonecrosis of the jawb,c
over 24 timer på dag 1 og cisplatin 50 mg/m i.v på dag 2, hver 3. uge;
• Paclitaxel 135 mg/m2 IV over 24 hours on day 1 and cisplatin 50 mg/m2 IV on day 2, every 3 weeks (q3w); or
• næseblod.
• nose bleeds.
200 mg/m2 i.v.
200 mg/m2 IV 2 h
HOLLAND
NETHERLANDS
Hazard ratio (95 % konfidensinterval) p-værdi
Hazard ratio (95% CI) p-value
stadie I eller IIA (grad 3 eller clear cell histologi alene, n = 142) eller FIGO-stadie IIB-IV (alle grader ogalle histologiske typer, n = 1.386) epitelial ovariecancer, tubacancer eller primær peritonealcancer efter operation (NCI-CTCAE v. 3).
BO17707 was a phase III, two-arm, multicentre, randomised, controlled, open-label study comparing the effect of adding bevacizumab to carboplatin plus paclitaxel in patients with FIGO stage I or IIA (grade 3 or clear cell histology only; n = 142), or FIGO stage IIB-IV (all grades and all histological types, n = 1,386) epithelial ovarian, fallopian tube or primary peritoneal cancer following surgery (NCI-CTCAE v.3).
Tromboemboli (venøs)a,b
Haemorrhagea,b, Thromboembolis m (venous)a,b,
Galdeblæreperfora tionb,c
Gallbladder perforationb,c
Fistlera,b Myalgi
Arthralgia, Myalgia