natgillin/translations-raw huggingface dataset:
If you have headache, vision changes, confusion or seizure with or without high blood pressure, please contact your doctor.
spremembe vida, ste zmedeni ali imate epileptični napad z visokim krvnim pritiskom ali brez njega, obvestite svojega zdravnika.
• AVF2107g: A weekly schedule of irinotecan/bolus 5-fluorouracil/folinic acid (IFL) for a total of 4 weeks of each 6 week-cycle (Saltz regimen).
· AVF2107g: tedenska shema irinotekana/bolusa 5-fluorouracila/folinske kisline (IFL), ki jo bolnik prejema 4 tedne zapored v 6-tedenskih ciklih (shema Saltz).
Clear to slightly opalescent, colourless to pale brown liquid.
Bistra do rahlo motna, brezbarvna do svetlo rjava tekočina.
2 Patients and percentage of patients with best overall response of confirmed CR or PR; percentage calculated on patients with measurable disease at baseline
Bolnice in odstotek bolnic z najboljšim celokupnim odgovorom, ocenjenim kot popolni odgovor ali delni odgovor, odstotek izračunan pri bolnicah z merljivo boleznijo ob izhodišču.
Caution should be exercised when treating patients with clinically significant cardiovascular disease such as pre-existing coronary artery disease, or congestive heart failure with Avastin.
Pri zdravljenju z zdravilom Avastin je pri bolnikih s klinično pomembno kardiovaskularno boleznijo, kot je predhodno obstoječa bolezen koronarnih arterij ali kongestivno srčno popuščanje, potrebna previdnost.
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.
Sedemindevetdesetim (97) bolnikom iz skupine, ki je prejemala interferon alfa-2a, in 131 bolnikom iz skupine, ki je prejemala zdravilo Avastin, so v skladu s protokolom zmanjšali odmerek interferona alfa-2a z 9 mio i.e. na 6 ali 3 mio i.e. trikrat na teden.
Recurrent ovarian cancer
Ponovitev raka jajčnikov
Overall Survival - Follow-up analysis Median (months)
Celokupno preživetje - analiza po spremljanju Mediana (meseci)
Most of the patients who experienced CHF had metastatic breast cancer and had received previous treatment with anthracyclines, prior radiotherapy to the left chest wall or other risk factors for CHF were present.
Večina bolnikov, pri katerih se je pojavilo kongestivno srčno popuščanje, je imela metastatski rak dojk in je predhodno prejela zdravljenje z antraciklini, radioterapijo na levi strani prsnega koša ali je imela druge dejavnike tveganja za kongestivno srčno popuščanje.
Major or massive pulmonary haemorrhage/haemoptysis has been observed primarily in trials in patients with non-small cell lung cancer (NSCLC).
Večjo ali masivno krvavitev v pljučih/hemoptizo so opazili predvsem v kliničnih preskušanjih pri bolnikih z nedrobnoceličnim rakom pljuč.
New cases of ovarian failure were reported in 2.6% patients in the mFOLFOX-6 group compared to 39% in the mFOLFOX-6 + bevacizumab group.
O novih primerih okvare jajčnikov so poročali pri 2,6 % bolnic v skupini mFOLFOX-6, v skupini, ki je prejemala mFOLFOX-6 in bevacizumab, pa je bila okvara jajčnikov opažena pri 39 % bolnic.
● Periodic Safety Update Reports
Redno posodobljena poročila o varnosti zdravila (PSUR)
In Avastin clinical trials, gastrointestinal fistulae (all grade) have been reported with an incidence of up to 2% in patients with metastatic colorectal cancer and ovarian cancer, but were also reported less commonly in patients with other types of cancer.
V kliničnih preskušanjih zdravila Avastin so fistule prebavil (vseh stopenj) pri bolnikih z metastatskim kolorektalnim rakom in rakom jajčnikov zabeležili z incidenco do 2 %, pri bolnikih z drugimi vrstami raka pa so bile zabeležene redkeje.
How to use Avastin
Kako uporabljati zdravilo Avastin
Grade 3 hypertension was 60.0% in patients treated with Avastin in combination with erlotinib compared to 11.7% in patients treated with erlotinib alone.
Hipertenzijo stopnje 3 so opazili pri 60,0 % bolnikov, zdravljenih z zdravilom Avastin v kombinaciji z erlotinibom, v primerjavi z 11,7 % bolnikov, zdravljenih samo z erlotinibom.
In clinical trials, with the exception of study JO25567, the overall incidence of hypertension (all grades) ranged up to 42.1% in the Avastin containing arms compared with up to 14% in the control arms.
V kliničnih preskušanjih, z izjemo študije JO25567, je bila celokupna incidenca hipertenzije (vseh stopenj) pri skupinah bolnikov, zdravljenih z zdravilom Avastin, do 42,1 % v primerjavi z do 14 % pri bolnikih, zdravljenih v primerjalnih skupinah.
In study BO20924 of Avastin with current standard of care in rhabdomyosarcoma and nonrhabdomyosarcoma soft tissue sarcoma, the safety profile of Avastin treated children was comparable with that observed in adults treated with Avastin.
V študiji BO20924 z zdravilom Avastin v kombinaciji s trenutnim standardnim zdravljenjem metastatskega rabdomiosarkoma in ostalih mehkotkivnih sarkomov je bil varnostni profil zdravila Avastin pri zdravljenih otrocih primerljiv s tistim pri odraslih, zdravljenih z zdravilom Avastin.
• abnormal urine test (protein in the urine),
· oviranje pretoka v črevesju ali mehurju, · nenormalen urinski test (beljakovine v seču),
The use of diuretics to manage hypertension is not advised in patients who receive a cisplatin-based chemotherapy regimen.
Uporaba diuretikov za uravnavo hipertenzije pri bolnikih, ki prejemajo kemoterapijo s cisplatinom, ni priporočljiva.
However, somnolence and syncope have been reported with Avastin use (see table 1 in section 4.8).
Vendar pa so pri uporabi zdravila Avastin poročali o pojavu somnolence in sinkope (glejte preglednico 1 v poglavju 4.8).
Results from the randomised phase III studies, PACCE and CAIRO-2, in patients with mCRC suggest that the use of anti-EGFR monoclonal antibodies panitumumab and cetuximab, respectively, in combination with bevacizumab plus chemotherapy, is associated with decreased PFS and/or OS, and with increased toxicity compared with bevacizumab plus chemotherapy alone.
Rezultati randomiziranih študij faze III, PACCE in CAIRO-2, pri bolnikih z metastatskim rakom debelega črevesa in danke kažejo, da je uporaba monoklonskih protiteles proti EGFR, panitumumaba in cetuksimaba, v kombinaciji s kemoterapijo in bevacizumabom povezana s skrajšanjem preživetja brez napredovanja bolezni in/ali celokupnega preživetja ter s povečano toksičnostjo v primerjavi samo z bevacizumabom in kemoterapijo.
No trials have been conducted to investigate the pharmacokinetics of bevacizumab in patients with hepatic impairment since the liver is not a major organ for bevacizumab metabolism or excretion.
Preskušanj za proučevanje farmakokinetike bevacizumaba pri bolnikih z okvaro jeter niso opravili, ker jetra niso glavni organ za presnovo ali izločanje bevacizumaba.
Observed effects included decreases in maternal and foetal body weights, an increased number of foetal resorptions and an increased incidence of specific gross and skeletal foetal malformations.
Opazili so zmanjšanje telesne mase tako matere kot ploda, povečanje števila reabsorbiranih fetusov, povečanje incidence določenih skeletnih nepravilnosti ploda in anomalij velikosti ploda.
In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years treated with Avastin.
V literaturi so bili objavljeni primeri osteonekroze izven spodnje čeljustnice pri bolnikih, ki so se zdravili z zdravilom Avastin in so bili mlajši od 18 let.
LIST OF EXCIPIENTS Trehalose dihydrate, sodium phosphate, polysorbate 20, water for injections.
SEZNAM POMOŽNIH SNOVI Trehaloza dihidrat, natrijev fosfat, polisorbat 20, voda za injekcije.
Adjustment for these baseline factors resulted in a treatment hazard ratio of 0.78 (95% CI [0.63; 0.96], p=0.0219), indicating a 22% reduction in the risk of death for patients in the Avastin + IFN alfa-2a arm compared to IFN alfa-2a arm.
Po prilagoditvi glede na izhodiščne dejavnike je bilo razmerje ogroženosti 0,78 (95-% interval zaupanja [0,63; 0,96], p = 0,0219), kar je pomenilo 22 % zmanjšanje tveganja za smrt za bolnike, ki so prejemali zdravilo Avastin in interferon alfa-2a, v primerjavi z bolniki, ki so prejemali interferon alfa2a.
The choices of chemotherapy included capecitabine, taxane (protein-bound paclitaxel, docetaxel), and anthracycline-based agents (doxorubicin/ cyclophosphamide, epirubicin/ cyclophosphamide, 5-fluorouracil/ doxorubicin/ cyclophosphamide, 5-fluorouracil/epirubicin/cyclophosphamide) given every three weeks (q3w).
Med kemoterapevtiki, ki so bili na izbiro, so bili kapecitabin, taksan (na beljakovine vezan paklitaksel, docetaksel), zdravila na osnovi antraciklinov (doksorubicin/ciklofosfamid, epirubicin/ciklofosfamid, 5-fluorouracil/doksorubicin/ciklofosfamid, 5-fluorouracil/epirubicin/ciklofosfamid); dajali so jih vsake 3 tedne.
Neutropenia and infections (see section 4.8)
Nevtropenija in okužbe (glejte poglavje 4.8)
• The other ingredients are trehalose dihydrate, sodium phosphate, polysorbate 20 and water for injections.
· Pomožne snovi so trehaloza dihidrat, natrijev fosfat, polisorbat 20 in voda za injekcije.
The majority of patients included in the study were White (87% in all three arms); the median age was
Večina bolnic, vključenih v študijo, je bila belk (96 %), mediana starosti je v obeh skupinah bila 57
p-value (Chi-squared Test) Kaplan-Meier estimates
1 Ocena po metodi Kaplan-Meier
In the post-marketing setting, cases of foetal abnormalities in women treated with bevacizumab alone or in combination with known embryotoxic chemotherapeutics have been observed (see section 4.8).
V obdobju po prihodu zdravila na trg so opazili primere nenormalnosti pri plodu, če je nosečnica jemala bevacizumab sam ali v kombinaciji s kemoterapijo, za katero je znano, da je embriotoksična (glejte poglavje 4.8).
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 Avastin (see sections 4.4 and 4.8 under Thromboembolism).
Druge reakcije, ki so jih pri bolnikih, starejših od 65 let, opazili z višjo pogostnostjo v primerjavi z bolniki, starimi 65 let ali manj, so bile levkopenija in trombocitopenija stopnje 3 do 4 (NCI-CTCAE v.3), vse stopnje nevtropenije, diareja, navzea, glavobol in utrujenost (glejte poglavji 4.4 in 4.8 pod
In the Avastin-containing arms, patients could receive Avastin as a single-agent every 3 weeks until disease progression or unacceptable toxicity.
V skupinah, ki sta prejemali zdravilo Avastin, so bolniki lahko prejemali zdravilo Avastin samostojno vsake 3 tedne do napredovanja bolezni ali do nesprejemljive toksičnosti.
Treatment of platinum-resistant recurrent disease: Avastin is administered in combination with one of the following agents - paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin.
Zdravljenje ponovitve bolezni, ki je rezistentna na platino: zdravilo Avastin dajemo v kombinaciji z enim od naslednjih zdravil: paklitakselom, topotekanom (s tedenskim odmerjanjem) ali pegiliranim liposomalnim doksorubicinom.
Epithelial ovarian, fallopian tube and primary peritoneal cancer
Epitelijski rak jajčnikov, karcinom jajcevodov in primarni peritonealni karcinom
Laboratory abnormalities
Laboratorijske nepravilnosti
(p-value = 0.3113)
(p-vrednost = 0,3113)
For patients in study AVF3694g who received anthracyclines concomitantly with bevacizumab, the incidences of Grade 3 or higher CHF for the respective bevacizumab and control arms were similar to those in the other studies in metastatic breast cancer: 2.9% in the anthracycline + bevacizumab arm and 0% in the anthracycline + placebo arm.
V študiji AVF3694g je bila pri bolnikih, ki so prejemali antracikline sočasno z bevacizumabom, incidenca kongestivnega srčnega popuščanja stopnje 3 ali več v skupini z bevacizumabom in v kontrolni skupini podobna kot v drugih preskušanjih pri metastatskemu raku dojk: 2,9 % v skupini z antraciklinom in bevacizumabom ter 0 % v skupini z antraciklinom in placebom.
In this trial arterial thromboembolic reactions were observed in 11% (11/100) of patients compared to 5.8% (6/104) in the chemotherapy control group.
V tem preskušanju so opazili arterijske trombembolične neželene učinke pri 11 % bolnikov (11/100) v primerjavi s kontrolno skupino, ki je prejemala le kemoterapijo, kjer so te neželene učinke opazili pri 5,8 % bolnikov (6/104).
Venous thromboembolic reactions include deep venous thrombosis, pulmonary embolism and thrombophlebitis.
Venski trombembolični neželeni učinki so vključevali globoko vensko trombozo, pljučni embolizem in tromboflebitis.
If the 60-minute infusion is well tolerated, all subsequent infusions may be administered over 30 minutes.
Če je bolnik tudi 60-minutno infuzijo dobro prenesel, lahko vse naslednje infuzije dajemo 30 minut.
If you have high blood pressure which is not well controlled with blood pressure medicines, please consult your doctor as it is important to make sure that your blood pressure is under control before starting Avastin treatment.
Če imate visok krvni tlak, ki ni dobro uravnan z zdravili proti zvišanemu krvnemu tlaku, se posvetujte s svojim zdravnikom.
Table 8 Efficacy results for trial E3200
Rezultati učinkovitosti za preskušanje E3200
The clinical presentation of PRES is often nonspecific, and therefore the diagnosis of PRES requires confirmation by brain imaging, preferably MRI.
Klinična slika sindroma posteriorne reverzibilne encefalopatije je pogosto nespecifična, zato diagnoza tega sindroma zahteva potrditev s slikanjem možganov, po možnosti z magnetnoresonančnim slikanjem (Magnetic resonance imaging, MRI).
5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks
a 5,0 mg/kg vsaka 2 tedna ali 7,5 mg/kg vsake 3 tedne
p-Value Hazard ratio (95% CI) (registration form)b
p-vrednost razmerje ogroženosti (95-% IZ) (registracijski obrazec)b
Clinical safety data suggest that the incidence of hypertension is likely to be dose-dependent.
Podatki o klinični varnosti zdravila Avastin kažejo, da je incidenca hipertenzije najverjetneje odvisna od odmerka zdravila.
Effect of bevacizumab on the pharmacokinetics of other antineoplastic agents No clinically relevant interaction of bevacizumab was observed on the pharmacokinetics of coadministered interferon alpha 2a, erlotinib (and its active metabolite OSI-420), or the chemotherapies irinotecan (and its active metabolite SN38), capecitabine, oxaliplatin (as determined by measurement of free and total platinum), and cisplatin.
Klinično pomembnega medsebojnega delovanja bevacizumaba na farmakokinetiko sočasno danega interferona alfa-2a, erlotiniba (in njegovega aktivnega presnovka OSI-420), kemoterapevtika irinotekana (in njegovega aktivnega presnovka SN38), kapecitabina, oksaliplatina (kot je dokazano z merjenjem proste in celokupne platine) in cisplatina niso opazili.
Contents of the pack and other information
Shranjevanje zdravila Avastin Vsebina pakiranja in dodatne informacije
The results of this trial are presented in Table 10.
Rezultati tega preskušanja so predstavljeni v preglednici 10.
This does not necessarily mean that these side effects were strictly caused by Avastin.
To pa ne pomeni, da je neželene učinke povzročilo le zdravilo Avastin.
Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 30°C in sodium chloride 9 mg/ml (0.9%) solution for injection.
Kemijska in fizikalna stabilnost v 0,9-% (9 mg/ml) raztopini natrijevega klorida za injiciranje pred uporabo je bila dokazana do 48 ur pri temperaturi 2 °C do 30 °C.
Topotecan+ Paclitaxel
Topotekan + paklitaksel
Patients treated with Avastin have an increased risk of haemorrhage, especially tumour-associated haemorrhage.
Bolnike, zdravljene z zdravilom Avastin, spremlja večje tveganje za krvavitev, še posebej za krvavitev, povezano s tumorjem.
Clinical safety data suggest that the incidence of minor mucocutaneous haemorrhage (e.g. epistaxis) may be dose-dependent.
Klinični podatki o varnosti nakazujejo, da je incidenca manjših krvavitev iz kože in sluznic (na primer epistaksa) lahko odvisna od odmerka.
MARKETING AUTHORISATION NUMBER(S) EU/1/04/300/002
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU1/04/300/002
Gastrointestinal perforations have been reported in clinical trials with an incidence of less than 1% in patients with non-squamous non-small cell lung cancer, up to 1.3% in patients with metastatic breast cancer, up to 2.0% in patients with metastatic renal cell cancer or in patients with ovarian cancer, and up to 2.7% (including gastrointestinal fistula and abscess) in patients with metastatic colorectal cancer.
O perforacijah prebavil so v kliničnih preskušanjih pri bolnikih z neskvamoznim nedrobnoceličnim rakom pljuč poročali z incidenco, manjšo od 1 %, pri bolnikih z metastatskim rakom dojk z incidenco do 1,3 %, pri bolnikih z metastatskim rakom ledvičnih celic ali pri bolnicah z rakom jajčnikov z incidenco do 2,0 % ter pri bolnikih z metastatskim rakom debelega črevesa in danke do 2,7 % (vključno z gastrointestinalno fistulo in abscesom).
Pulmonary haemorrhage/haemoptysis
Krvavitev v pljučih/hemoptiza
The percentage of patients who received Avastin in the open-label phase was 62.1% in the capecitabine + placebo arm and 49.9% in the capecitabine + Avastin arm.
Odstotek bolnikov, ki so odprto prejemali zdravilo Avastin, je bil v skupini, ki je prejemala kapecitabin in placebo, 62,1 %, v skupini, ki je prejemala kapecitabin in zdravilo Avastin, pa 49,9 %.
3 95% CI for one sample binomial using Pearson-Clopper method Approximate 95% CI for difference of two rates using Hauck-Anderson method 5 log-rank test (stratified)
4 Približni 95-% interval zaupanja za razliko dveh deležev z uporabo Hauck-Andersonove metode.
Overall response rate Rate (percent)
Celokupni odgovor delež (odstotki)
Binding of the IgG to the FcRn receptor results in protection from cellular metabolism and the long terminal half-life.
Z vezavo na receptor FcRn se IgG zaščiti pred celično presnovo, zato se podaljša njegov končni razpolovni čas.
Stopping your treatment with Avastin may stop the effect on tumour growth.
Če ste prenehali jemati zdravilo Avastin Prenehanje zdravljenja z zdravilom Avastin lahko ustavi učinek na rast tumorja.
The primary endpoint was progression-free survival (PFS) based on independent review assessment.
Primarni cilj študije je bil preživetje brez napredovanja bolezni (PFS), ki je temeljilo na oceni neodvisnega pregleda.
If this is well-tolerated the second infusion may be given over 60 minutes.
Če jo boste dobro prenesli, boste drugo infuzijo prejeli v 60 minutah.
• tiredness,
pireksija,
The primary endpoint of this trial was progression free survival (PFS), based on trial investigators' assessment of disease progression.
Primarni cilj tega preskušanja je bilo preživetje brez napredovanja bolezni (PFS), osnovano na oceni napredovanja bolezni s strani raziskovalcev.
Avastin will be administered together with a chemotherapy regimen containing platinum.
Zdravilo Avastin boste prejeli skupaj s kemoterapijo, ki vsebuje platino.
An unstratified analysis of PFS (investigator assessed) was performed that did not censor for nonprotocol therapy prior to disease progression.
Izvedli so nestratificirano analizo preživetja brez napredovanja bolezni (po oceni raziskovalca), v kateri niso krnili zdravljenja pred napredovanjem bolezni, ki ni bilo v skladu s protokolom.
Patients receiving Avastin plus chemotherapy, with a history of arterial thromboembolism, diabetes or age greater than 65 years have an increased risk of developing arterial thromboembolic reactions during therapy.
Bolniki, ki prejemajo zdravilo Avastin skupaj s kemoterapijo in imajo arterijske trombembolične neželene učinke v anamnezi, sladkorno bolezen ali so stari nad 65 let, imajo med zdravljenjem povečano tveganje za razvoj arterijskih trombemboličnih neželenih učinkov.
Pre-existing hypertension should be adequately controlled before starting Avastin treatment.
Obstoječo hipertenzijo je treba pred začetkom zdravljenja z zdravilom Avastin ustrezno uravnati.
Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.
Bevacizumab je v kombinaciji z interferonom alfa-2a indiciran za prvo linijo zdravljenja odraslih bolnikov z napredovalim in/ali metastatskim rakom ledvičnih celic.
GI-vaginal Fistulae in study GOG-0240
Fistule med prebavili in nožnico v študiji GOG-0240
In some cases underlying intra-abdominal inflammation was present, either from gastric ulcer disease, tumour necrosis, diverticulitis, or chemotherapy-associated colitis.
V nekaterih primerih je bilo prisotno spremljajoče vnetje znotraj trebušne votline zaradi ulkusne bolezni želodca, nekroze tumorja, divertikulitisa ali kolitisa, povezanega s kemoterapijo.
The majority of patients in both arms had an ECOG Performance Status (PS) of 0 (CT: 56.4% vs. CT + BV: 61.2%).
Večina bolnic v obeh skupinah je imela stanje zmogljivosti po ECOG 0 (kemoterapija: 56,4 % v primerjavi s kemoterapijo in bevacizumabom: 61,2 %).
1 Final Analysis 2 Tumour assessments and response evaluations were determined by the investigators using the GOG
1 Končna analiza; 2 Ocene tumorjev in vrednotenje odzivov so določili raziskovalci z uporabo kriterijev GOG RECIST (revidiranih smernic RECIST (verzija 1.1).
In a study of platinum-resistant recurrent ovarian cancer patients, alopecia, mucosal inflammation, peripheral sensory neuropathy, proteinuria and hypertension were also reported and occurred at a rate at least 5% higher in the CT + BV arm for bevacizumab-treated patients ≥ 65 years of age compared with bevacizumab-treated patients aged < 65 years.
V študiji pri bolnicah s ponovitvijo raka jajčnikov, rezistentnega na platino, so poročali tudi o alopeciji, vnetju sluznice, periferni senzorični nevropatiji, proteinuriji in hipertenziji, ki so se pojavili z najmanj 5 % večjo pogostnostjo pri starejših bolnicah ³ 65 let v primerjavi z bolnicami, mlajšimi od 65 let, v skupini, ki je prejemala kemoterapijo in bevacizumab.
Detailed information about these post-marketing reactions are provided in Table 3.
Natančnejše informacije o teh neželenih učinkih so v preglednici 3.
Fistulaa,b,
fistulab,d,
A third group of 33 patients received bolus 5-FU/FA + Avastin (10 mg/kg every 2 weeks).
Tretja skupina 33-ih bolnikov je prejela bolus 5-FU/FA + Avastin (10 mg/kg vsaka dva tedna).
The study compared the effect of adding Avastin to carboplatin and gemcitabine chemotherapy and continuing Avastin as a single agent to progression, to carboplatin and gemcitabine alone.
Študija je primerjala učinek dodajanja zdravila Avastin h kemoterapiji, ki je vsebovala karboplatin in gemcitabin, ter se je nadaljevala s samim zdravilom Avastin do napredovanja bolezni, z dajanjem samo karboplatina in gemcitabina.
Results are presented in Table 23.
Rezultati so prikazani v preglednici 23.
Compared to patients treated with chemotherapy (paclitaxel, topotecan or PLD) alone in the recurrent platinum-resistant setting, patients who received bevacizumab at a dose of 10 mg/kg every 2 weeks (or 15 mg/kg every 3 weeks if used in combination with 1.25 mg/m2 topotecan on Days 1-5 every 3 weeks) in combination with chemotherapy and continued to receive bevacizumab until disease progression or unacceptable toxicity, had a statistically significant improvement in PFS.
V primerjavi z bolnicami, zdravljenimi samo s kemoterapijo (paklitakselom, topotekanom ali PLD), pri ponovitvi bolezni, rezistentni na platino, so imele bolnice, ki so prejemale bevacizumab v odmerku 10 mg/kg vsaka 2 tedna (ali 15 mg/kg vsake 3 tedne, če so ga uporabljali v kombinaciji z 1,25 mg/m2 topotekana od 1. do 5. dne vsake 3 tedne) v kombinaciji s kemoterapijo in nadaljevale z njegovim jemanjem do napredovanja bolezni ali nesprejemljive toksičnosti, statistično pomembno izboljšanje preživetja brez napredovanja bolezni.