natgillin/translations-raw huggingface dataset:
In clinical trials, the overall incidence of arterial thromboembolic reactions ranged up to 3.8% in the bevacizumab-containing arms compared with up to 2.1% in the chemotherapy control arms.
U kliničkim je ispitivanjima ukupna incidencija arterijskih tromboembolijskih reakcija dosezala do 3,8% u skupinama čija je terapija obuhvaćala bevacizumab te do 2,1% u kontrolnim skupinama liječenima kemoterapijom.
Death of bone tissue (osteonecrosis) in bones other than the jaw have been reported in patients under 18 years old when treated with bevacizumab.
U bolesnika mlađih od 18 godina prijavljeno je odumiranje koštanog tkiva (osteonekroza) u drugim kostima osim čeljusti kada su liječeni bevacizumabom.
The results of this study are summarised in table 15.
Rezultati ovog ispitivanja sažeti su u Tablici 15.
MVASI, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
MVASI je u kombinaciji s karboplatinom i gemcitabinom ili u kombinaciji s karboplatinom i paklitakselom indiciran za liječenje odraslih bolesnica s prvim recidivom epitelnog karcinoma jajnika, karcinoma jajovoda ili primarnog peritonealnog karcinoma osjetljivih na platinu, koje prethodno nisu bile liječene bevacizumabom, drugim VEGF inhibitorima niti lijekovima koji djeluju na VEGF receptore.
Most patients had EOC (82% in CPP and CPB15, 85% in CPB15+) followed by PPC (16% in CPP, 15% in CPB15, 13% in CPB15+) and FTC (1% in CPP, 3% in CPB15, 2% in CPB15+).
CPP, 15% u skupini CPB15, 13% u skupini CPB15+) te karcinom jajovoda (1% u skupini CPP, 3% u skupini CPB15, 2% u skupini CPB15+).
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.
U ispitivanju u bolesnica s perzistentnim, recidivirajućim ili metastatskim karcinomom cerviksa, incidencija gastrointestinalno-vaginalnih fistula iznosila je 8,3% u bolesnica liječenih bevacizumabom te 0,9% u kontrolnoj skupini, a u svih njih prethodno je provedeno zračenje zdjelice.
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.
MVASI je u kombinaciji s kemoterapijom na bazi spojeva platine indiciran za prvu liniju liječenja odraslih bolesnika s neresektabilnim uznapredovalim, metastatskim ili recidivirajućim karcinomom pluća nemalih stanica u kojemu histološki ne prevladavaju skvamozne stanice.
Each vial of 4 mL of concentrate contains 100 mg of bevacizumab.
Jedna bočica koncentrata od 4 ml sadrži 100 mg bevacizumaba.
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.
Dodavanjem bevacizumaba u dozi od 5 mg/kg protokolu 5-FU/FA svaka dva tjedna povećala se stopa objektivnog odgovora, statistički značajno je produljeno preživljenje do progresije bolesti uz tendenciju poboljšanja preživljenja u usporedbi s primjenom samo kemoterapije 5-FU/FA.
• NO16966: bevacizumab 7.5 mg/kg of body weight every 3 weeks in combination with oral capecitabine and intravenous oxaliplatin (XELOX) or bevacizumab 5 mg/kg every 2 weeks in combination with leucovorin plus 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4).
• NO16966: bevacizumab u dozi od 7,5 mg/kg tjelesne težine svaka 3 tjedna u kombinaciji s peroralno primijenjenim kapecitabinom i intravenski primijenjenim oksaliplatinom (XELOX), ili bevacizumab u dozi od 5 mg/kg svaka 2 tjedna u kombinaciji s leukovorinom i bolusom 5fluorouracila te zatim infuzijom 5-fluorouracila i intravenski primijenjenim oksaliplatinom (FOLFOX-4).
Congestive heart failureb,d, Supraventricular tachycardia
Srčani poremećaji kongestivno zatajenje srcab,d, supraventrikularna tahikardija
Necrotising fasciitis, including fatal cases, has rarely been reported in patients treated with bevacizumab.
U bolesnika liječenih bevacizumabom rijetko je prijavljen nekrotizirajući fasciitis, uključujući slučajeve sa smrtnim ishodom.
(p-value5 < 0.0001)
(p-vrijednost5 < 0,0001)
The results of this study are summarised in table 19.
Rezultati ovog ispitivanja sažeti su u Tablici 19.
Testing for proteinuria is recommended prior to start of MVASI therapy.
Prije početka liječenja lijekom MVASI preporučuje se testiranje na proteinuriju.
Limited information is available on the continued use of bevacizumab in patients with other fistulae.
Podaci o nastavku primjene bevacizumaba u bolesnika s drugim fistulama su ograničeni.
difference compared to the control arm for NCI-CTCAE grade 3-5 reactions),
3-5 prema NCI-CTCAE),
Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/m2 intravenous infusion on day 1 and gemcitabine 1,250 mg/m2 intravenous infusion on days 1 and 8 of every 3-week cycle for up to 6 cycles (CG) with placebo or CG with bevacizumab at a dose of 7.5 or 15 mg/kg IV infusion day 1 of every 3-week cycle.
Bolesnici su randomizirani ili u skupinu koja je primala kemoterapiju na bazi platine, i to cisplatin u dozi od 80 mg/m2 primijenjen intravenskom infuzijom 1. dana i gemcitabin u dozi od 1250 mg/m2 primijenjen intravenskom infuzijom 1. i 8. dana svakog trotjednog ciklusa u trajanju do najviše 6 ciklusa (CG) i placebo ili u skupine koje su primale CG u kombinaciji s lijekom bevacizumab u dozi od 7,5 ili 15 mg/kg, primijenjenim i.v. infuzijom 1. dana svakog trotjednog ciklusa.
• E3200: bevacizumab 10 mg/kg of body weight every 2 weeks in combination with leucovorin and 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4) in bevacizumab-naïve patients.
• E3200: bevacizumab u dozi od 10 mg/kg tjelesne težine svaka 2 tjedna u kombinaciji s leukovorinom i bolusom 5-fluorouracila te zatim infuzijom 5-fluorouracila i intravenski primijenjenim oksaliplatinom (FOLFOX-4) u bolesnika koji prethodno nisu bili liječeni bevacizumabom.
MVASI in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer.
MVASI je u kombinaciji s paklitakselom indiciran za prvu liniju liječenja odraslih bolesnika s metastatskim karcinomom dojke.
stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section
IIIB, IIIC i IV) epitelnim karcinomom jajnika, karcinomom jajovoda i primarnim peritonealnim karcinomom.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MVASI 25 mg/mL sterile concentrate bevacizumab
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA MVASI 25 mg/ml sterilni koncentrat bevacizumab i.v.
• blocking of the blood vessels of the lungs by a blood clot,
• začepljenje krvnih žila u plućima zbog krvnog ugruška,
Each vial of 16 mL of concentrate contains 400 mg of bevacizumab.
Jedna bočica koncentrata od 16 ml sadrži 400 mg bevacizumaba.
These results demonstrate robustness of the analysis of PFS as shown in table 15.
Ti rezultati pokazuju robusnost analize preživljenja bez progresije bolesti koja je prikazana u Tablici 15.
(17.5 vs.14.3 months; p = 0.0609)
(17,5 naspram 14,3 mjeseci; p = 0,0609)
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.
Kada se koristi za odrasle bolesnice s uznapredovalim epitelnim rakom jajnika, rakom jajovoda ili primarnim peritonealnim rakom u kojih se bolest vratila manje od 6 mjeseci nakon posljednje primjene kemoterapije koja je sadržavala platinu, MVASI će se davati u kombinaciji s paklitakselom ili topotekanom ili pegiliranim liposomalnim doksorubicinom.
In locally recurrent and metastatic breast cancer trials, grade 3-5 wound healing complications were observed in up to 1.1% of patients receiving bevacizumab compared with up to 0.9% of patients in the control arms (NCI-CTCAE v.3).
U ispitivanjima lokalno recidivirajućeg ili metastatskog karcinoma dojke, komplikacije pri zacjeljivanju rana stupnja 3-5 primijećene su u 1,1% bolesnika koji su primali bevacizumab, u usporedbi s 0,9% bolesnika u kontrolnoj skupini (NCI-CTCAE v.3).
Arterial thromboembolism: An increased incidence of arterial thromboembolic reactions was observed in patients treated with bevacizumab across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.
U bolesnika liječenih bevacizumabom u svim je indikacijama opažena povećana incidencija arterijskih tromboembolijskih reakcija, uključujući cerebrovaskularne incidente, infarkt miokarda, tranzitorne ishemijske atake i druge arterijske tromboembolijske reakcije.
• 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).
• Skupina KT+BV (kemoterapija i bevacizumab): odabrana kemoterapija kombinirana je s bevacizumabom primijenjenim u dozi od 10 mg/kg i.v. svaka 2 tjedna (ili s bevacizumabom u dozi od 15 mg/kg svaka 3 tjedna ako se radilo o kombinaciji s topotekanom u dozi od 1,25 mg/m2 od 1. do 5. dana svaka 3 tjedna).
The addition of bevacizumab to IFN alfa-2a significantly increased PFS and objective tumour response rate.
Dodavanjem bevacizumaba interferonu alfa-2a značajno se produljilo preživljenje bez progresije bolesti i stopa objektivnog odgovora tumora.
One hundred and five patients were randomised to 5-FU/FA + placebo arm and 104 patients to 5-FU/FA + bevacizumab (5 mg/kg every 2 weeks) arm. All treatments were continued until disease progression.
Randomizirano je 105 bolesnika u skupinu 5-FU/FA + placebo, a 104 bolesnika u skupinu 5-FU/FA + bevacizumab (5 mg/kg svaka 2 tjedna).
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.
Te su klinički značajne nuspojave bile prijavljene u kliničkim ispitivanjima, ali nuspojave stupnja 3-5 nisu prešle zadani prag od barem 2% razlike u odnosu na kontrolnu skupinu.
XELOX + bevacizumab
XELOX + bevacizumab oksaliplatin
Sepsis, Cellulitis, Abscessa,b, Infection, Urinary tract infection
Infekcije i infestacije sepsa, celulitis, apscesa,b, infekcija, infekcija mokraćnih putova nekrotizirajući fasciitisc
The primary analysis of investigator assessed PFS with a data cut-off date of 28 February 2010 shows an unstratified hazard ratio of 0.79 (95% CI: 0.68-0.91, 2-sided log-rank p-value 0.0010) with a median PFS of 16.0 months in the CP arm and 18.3 months in the CPB7.5+ arm.
Primarna analiza preživljenja bez progresije bolesti prema procjeni ispitivača i na temelju podataka prikupljenih do 28. veljače 2010. pokazuje nestratificirani omjer rizika od 0,79 (95% CI: 0,68-0,91; p-vrijednost dvostranog log-rang testa = 0,0010), uz medijan preživljenja bez progresije bolesti od 16,0 mjeseci u skupini CP te 18,3 mjeseca u skupini CPB7,5+.
In clinical trials of ovarian cancer, grade 3-5 wound healing complications were observed in up to 1.8% of patients in the bevacizumab arm versus 0.1% in the control arm (NCI-CTCAE v.3).
U kliničkim ispitivanjima karcinoma jajnika, komplikacije pri zacjeljivanju rana stupnja 3-5 zabilježene su u 1,8% bolesnica u skupini koja je primala bevacizumab u odnosu na 0,1% u kontrolnoj skupini (NCI-CTCAE v.3).
MVASI in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents (see section 5.1).
MVASI je u kombinaciji s paklitakselom, topotekanom ili pegiliranim liposomalnim doksorubicinom indiciran za liječenje odraslih bolesnica s recidivom epitelnog karcinoma jajnika, karcinoma jajovoda ili primarnog peritonealnog karcinoma rezistentnih na platinu, koje prethodno nisu primile više od dva kemoterapijska protokola i koje prethodno nisu bile liječene bevacizumabom, drugim VEGF inhibitorima niti lijekovima koji djeluju na VEGF receptore (vidjeti dio 5.1).
In some clinical trials anaphylactic and anaphylactoid-type reactions were reported more frequently in patients receiving bevacizumab in combination with chemotherapy than with chemotherapy alone.
U nekim su kliničkim ispitivanjima anafilaktičke i anafilaktoidne reakcije prijavljene češće u bolesnika koji su u kombinaciji s kemoterapijom primali bevacizumab nego u bolesnika koji su primali samo kemoterapiju.
Each single use vial contains 100 mg of bevacizumab in 4 mL of concentrate.
Jedna bočica za jednokratnu primjenu sadrži 100 mg bevacizumaba u 4 ml koncentrata.
• Each 16 mL vial contains 400 mg of bevacizumab, corresponding to 16.5 mg/mL when diluted as recommended.
- Jedna bočica od 16 ml sadrži 400 mg bevacizumaba, što odgovara 16,5 mg/ml kada se razrijedi sukladno preporuci.
Compared to patients treated with chemotherapy (carboplatin and paclitaxel) alone in the front-line setting, patients who received bevacizumab at a dose of 15 mg/kg q3w in combination with chemotherapy and continued to receive bevacizumab alone (CPB15+), had a clinically meaningful and statistically significant improvement in PFS.
U usporedbi s bolesnicama liječenima samo kemoterapijom (karboplatin i paklitaksel) u prvoj liniji liječenja, bolesnice koje su dobivale 15 mg/kg bevacizumaba svaka tri tjedna u kombinaciji s kemoterapijom te nastavile primati samo bevacizumab (CPB15+) imale su klinički i statistički značajno poboljšano preživljenje bez progresije bolesti.
Overall survival - Primary analysis1 Hazard ratio (95% CI)
Ukupno preživljenjePrimarna analiza1 Omjer hazarda (95% CI)
A third group of 110 patients received bolus 5-FU/FA + bevacizumab (Arm 3).
Treća skupina sa 110 bolesnika primala je bolus 5FU/FA
This was a phase III randomised, controlled, open-label trial investigating bevacizumab 5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in combination with fluoropyrimidine-based chemotherapy versus fluoropyrimidine-based chemotherapy alone in patients with mCRC who have progressed on a first-line bevacizumab-containing regimen.
Riječ je o randomiziranom, kontroliranom, otvorenom ispitivanju faze III u kojemu se ispitivao bevacizumab u dozi od 5,0 mg/kg svaka 2 tjedna ili 7,5 mg/kg svaka 3 tjedna u kombinaciji s kemoterapijom na bazi fluoropirimidina u usporedbi s primjenom samo kemoterapije na bazi fluoropirimidina u bolesnika s metastatskim karcinomom kolona ili rektuma u kojih je došlo do progresije bolesti nakon prve linije liječenja koja je obuhvaćala bevacizumab.
• Carboplatin (AUC 4, day 1) and gemcitabine (1,000 mg/m2 on days 1 and 8) and concurrent bevacizumab (15 mg/kg day 1) every 3 weeks for 6 and up to 10 cycles followed by bevacizumab (15 mg/kg every 3 weeks) alone until disease progression or unacceptable toxicity.
• karboplatin (AUC 4, 1. dan) i gemcitabin (1000 mg/m2, 1. i 8. dan) uz bevacizumab (15 mg/kg, 1. dan) svaka 3 tjedna tijekom 6, a najviše 10 ciklusa, a zatim samo bevacizumab (15 mg/kg svaka 3 tjedna) do progresije bolesti ili razvoja neprihvatljive toksičnosti.
Infusion reactionsa,b,c
Poremećaji imunološkog sustava preosjetljivost, infuzijske reakcijea,b,c
This was a phase III randomised, active-controlled, open-label trial investigating bevacizumab 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.
Riječ je o randomiziranom, aktivno kontroliranom, otvorenom kliničkom ispitivanju faze III u kojemu se ispitivao bevacizumab u dozi od 10 mg/kg svaka 2 tjedna u kombinaciji s leukovorinom i bolusom 5-fluororuracilom, a zatim infuzijom 5-fluorouracila uz intravensku primjenu oksaliplatina (FOLFOX-4) u prethodno liječenih bolesnika (druga linija) s uznapredovalim kolorektalnim karcinomom.
PFS subgroup analyses by disease stage and debulking status are summarised in table 18.
Analize preživljenja bez progresije bolesti po podskupinama prema stadiju bolesti i statusu smanjenja tumorske mase sažeti su u Tablici 18.
difference compared to the control arm for NCI-CTCAE grade 1-5 reactions or at least a 2%
NCI-CTCAE ili s razlikom od barem 2% u odnosu na kontrolnu skupinu za nuspojave stupnja
Recurrent ovarian cancer
Rekurentni karcinom jajnika
Patients may be at risk of developing venous thromboembolic reactions, including pulmonary embolism under bevacizumab treatment.
U bolesnika koji se liječe bevacizumabom postoji rizik za razvoj venskih tromboembolijskih reakcija, uključujući plućnu emboliju.
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.
U kliničkom ispitivanju u bolesnica s perzistentnim, recidivirajućim ili metastatskim karcinomom cerviksa (ispitivanje GOG-0240), venski tromboembolijski događaji stupnja 3-5 prijavljeni su u do 15,6% bolesnica liječenih bevacizumabom u kombinaciji s paklitakselom i cisplatinom u usporedbi s do7,0% bolesnica liječenih paklitakselom i cisplatinom.
Efficacy results1,2 from study GOG-0213
Tablica 21. Rezultati djelotvornosti1,2 za ispitivanje GOG-0213 Primarna mjera ishoda
Trial BO17704 has demonstrated that both 7.5 mg/kg/q3wk and 15 mg/kg/q3wk bevacizumab doses increase progression-free survival and response rate.
Ispitivanje BO17704 pokazalo je da bevacizumab i u dozi od 7,5 mg/kg svaka 3 tjedna i u dozi od 15 mg/kg svaka 3 tjedna produljuje preživljenje bez progresije bolesti te povećava stopu odgovora na liječenje.
• Paclitaxel 175 mg/m2 IV over 3 hours on day 1 and topotecan 0.75 mg/m2 IV over 30 minutes on days 1-3 (q3w)
• paklitaksel u dozi od 175 mg/m2 i.v. tijekom 3 sata 1. dana i topotekan u dozi od 0,75 mg/m2 i.v. tijekom 30 minuta od 1. do 3. dana (svaka 3 tjedna)
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.
MVASI se primjenjuje uz kemoterapiju na bazi spojeva platine do najviše 6 ciklusa liječenja, nakon čega se MVASI primjenjuje sam do progresije bolesti.
• a blood clot in the blood vessels of your lungs,
• u slučaju krvnog ugruška u venama u plućima,
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.
Preporučena doza lijeka MVASI kada se primjenjuje kao dodatak erlotinibu je 15 mg/kg tjelesne težine, a primjenjuje se jednom svaka 3 tjedna u obliku intravenske infuzije.
This was a randomised, double-blind, phase II clinical trial investigating bevacizumab 10 mg/kg in a 2 weekly schedule with the same dose of bevacizumab in combination with 150 mg daily erlotinib, in patients with metastatic clear cell RCC. A total of 104 patients were randomised to treatment in this trial, 53 to bevacizumab 10 mg/kg every 2 weeks plus placebo and 51 to bevacizumab 10 mg/kg every 2 weeks plus erlotinib 150 mg daily.
U ovom su ispitivanju ukupno 104 bolesnika randomizirana u dvije terapijske skupine: 53 za liječenje bevacizumabom u dozi od 10 mg/kg svaka 2 tjedna u kombinaciji s placebom, a 51 za liječenje bevacizumabom u dozi od 10 mg/kg svaka 2 tjedna u kombinaciji s erlotinibom u dozi od 150 mg na dan.
PFS subgroup analyses by disease stage and debulking status are summarised in table 16.
Analize preživljenja bez progresije bolesti po podskupinama prema stadiju bolesti i statusu smanjenja tumorske mase sažeti su u Tablici 16.
• MO22224 evaluated the efficacy and safety of bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
• U ispitivanju MO22224 ocijenjene su djelotvornost i sigurnost bevacizumaba u kombinaciji s paklitakselom, topotekanom ili pegiliranim liposomalnim doksorubicinomu u bolesnica s recidivom epitelnog karcinoma jajnika, karcinoma jajovoda ili primarnog peritonealnog karcinoma rezistentnih na platinu.
This was a phase II randomised, active-controlled, open-labelled clinical trial investigating bevacizumab in combination with 5-FU/FA as first-line treatment of metastatic colorectal cancer.
Riječ je o randomiziranom, aktivno kontroliranom, otvorenom kliničkom ispitivanju faze II, u kojemu se ispitivala primjena bevacizumaba u kombinaciji s protokolom 5-FU/FA u prvoj liniji liječenja metastatskog kolorektalnog karcinoma.
• clogging of a very small blood vessel(s) in the kidney,
• začepljenje vrlo malih krvnih žila u bubregu,
In patients with NSCLC excluding predominant squamous histology, all grade reactions were seen with a frequency of up to 9.3% when treated with bevacizumab plus chemotherapy compared with up to 5% in the patients treated with chemotherapy alone.
U bolesnika s karcinomom pluća nemalih stanica, osim u slučaju prevladavajuće histologije skvamoznih stanica, krvarenja svih stupnjeva zabilježena su s učestalošću do 9,3% kada su liječeni bevacizumabom i kemoterapijom, u usporedbi s najviše 5% u bolesnika liječenih samo kemoterapijom.
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.
U kliničkom ispitivanju u bolesnica s perzistentnim, recidivirajućim ili metastatskim karcinomom cerviksa (ispitivanje GOG-0240), reakcije krvarenja stupnja 3-5 prijavljene su u do 8,3% bolesnica liječenih bevacizumabom u kombinaciji s paklitakselom i topotekanom u usporedbi s do 4,6% bolesnica liječenih paklitakselom i topotekanom.
The percentage of patients with an ECOG PS of 1 or ≥ 2 was 38.7% and 5.0% in the CT arm, and 29.8% and 9.0% in the CT + BV arm. Information on race exists for 29.3% of patients and nearly all patients were white.
Postotak bolesnica s ECOG funkcionalnim statusom 1 odnosno ≥ 2 iznosio je 38,7% odnosno 5,0% u skupini koja je primala KT te 29,8% odnosno 9,0% u skupini koja je primala KT+BV.
Patients were randomised 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 bevacizumab at a dose of 15 mg/kg IV infusion day 1 of every 3-week cycle.
Bolesnici su randomizirani u skupinu koja je primala kemoterapiju na bazi platinskog spoja (paklitaksel 200 mg/m2) i karboplatin AUC = 6,0, oba i.v. infuzijom (PK) 1. dana svakog trotjednog ciklusa u trajanju do najviše šest ciklusa, ili u skupinu koja je primala isti kemoterapijski protokol na bazi platine (PK) uz bevacizumab u dozi od 15 mg/kg primijenjen intravenskom infuzijom 1. dana svakog trotjednog ciklusa.