natgillin/translations-raw huggingface dataset:
Prespecified PFS analyses were conducted, all with a cut-off date of 29 September 2009.
Narejene so bile vnaprej določene analize preživetja brez napredovanja bolezni, vse s podatki zbranimi do 29. septembra 2009.
The efficacy results are presented in Table 13.
Rezultati učinkovitosti so predstavljeni v preglednici 13.
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.
Po zaključku 6 ciklov kemoterapije s karboplatinom in paklitakselom ali po predčasnem zaključku kemoterapije so bolniki v skupini, ki je prejemala zdravilo Avastin s karboplatinom in paklitakselom, do napredovanja bolezni prejemali samo zdravilo Avastin vsake 3 tedne.
A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI).
Diagnozo sindroma posteriorne reverzibilne encefalopatije potrdimo s slikovnimi preiskavami možganov, po možnosti s slikanjem z magnetno resonanco (MRS).
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 trials E4599 and BO17704.
Varnost in učinkovitost zdravila Avastin v prvi liniji zdravljenja bolnikov z neskvamoznim nedrobnoceličnim rakom pljuč so v preskušanjih E4599 in BO17704 proučevali skupaj z dodano kemoterapijo na osnovi platine.
Across clinical trials, 8 cases of PRES have been reported.
V kliničnih preskušanjih so poročali o 8 primerih sindroma posteriorne reverzibilne encefalopatije.
3 5.8% of the overall randomised patient population had Stage IIIB disease.
5,8 % celotne populacije randomiziranih bolnic je imelo bolezen stadija III B. 4 Glede na kontrolno skupino.
The 649 randomised patients (641 treated) had Karnofsky Performance Status (KPS) of ≥ 70%,
V klinično preskušanje je bilo randomiziranih 649 bolnikov (641 pa zdravljenih), njihovo stanje zmogljivosti po Karnofskem je bilo
The primary endpoint was progression free survival, secondary endpoints for the trial included the duration of overall survival.
Primarni končni cilj preskušanja je bilo preživetje brez napredovanja bolezni, sekundarni končni cilji preskušanja so vključevali trajanje celokupnega preživetja.
● If you have any further questions, ask your doctor, pharmacist or nurse.
· Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
As maternal IgG is excreted in milk and bevacizumab could harm infant growth and development (see section 5.3), women must discontinue breast-feeding during therapy and not breast-feed for at least six months following the last dose of Avastin.
Ker se materini IgG izločajo v mleko in ker bevacizumab lahko negativno vpliva na rast in razvoj otroka (glejte poglavje 5.3), morajo ženske med zdravljenjem dojenje prekiniti.
Of the 452 patients randomized at baseline, the majority of patients were white (80.0% in the Chemo alone group and 75.3% in the Chemo+Avastin group), had squamous cell carcinoma (67.1% in the Chemo alone group and 69.6% in the Chemo+Avastin group), had persistent/recurrent disease (83.6% in the Chemo alone group and 82.8% in the Chemo+Avastin group), had 1-2 metastatic sites (72.0% in the Chemo alone group and 76.2% in the Chemo+Avastin group), had lymph node involvement (50.2% in the Chemo alone group and 56.4% in the Chemo+Avastin group), and had a platinum free interval ≥ 6 months (72.5% in the Chemo alone group and 64.4% in the Chemo+Avastin group).
75,3 % v skupini s kemoterapijo in zdravilom Avastin), večina je imela skvamozni karcinom (67,1 % v skupini s samo kemoterapijo in 69,6 % v skupini s kemoterapijo in zdravilom Avastin), večina je imela prisotno bolezen tudi po zaključenem primarnem zdravljenju/ponovitev bolezni (83,6 % v skupini s samo kemoterapijo in 82,8 % v skupini s kemoterapijo in zdravilom Avastin), večina je imela metastaze na 1 do 2 mestih (72,0 % v skupini s samo kemoterapijo in 76,2 % v skupini s kemoterapijo in zdravilom Avastin), večina je imela prizadete bezgavke (50,2 % v skupini s samo kemoterapijo in 56,4 % v skupini s kemoterapijo in zdravilom Avastin) in večina je imela ³ 6-mesečni interval brez platine (72,5 % v skupini s samo kemoterapijo in 64,4 % v skupini s kemoterapijo in zdravilom Avastin).
These results demonstrate robustness of the analysis of PFS as shown in Table 16.
Ti rezultati prikazujejo robustnost analize preživetja brez napredovanja bolezni, ki je prikazana v preglednici 16.
Posterior Reversible Encephalopathy Syndrome (PRES) (see section 4.8) There have been rare reports of Avastin-treated patients developing signs and symptoms that are consistent with PRES, a rare neurologic disorder, which can present with the following signs and symptoms among others: seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
povezanih s sindromom posteriorne reverzibilne encefalopatije (PRES, Posterior Reversible Encephalopathy Syndrome), redko nevrološko motnjo, ki se lahko kaže tudi z naslednjimi znaki in simptomi: epileptični napad, glavobol, spremenjeni mentalni status, motnje vida ali kortikalna slepota s sočasno hipertenzijo ali brez nje.
16 ml solution in a vial (Type I glass) with a stopper (butyl rubber) containing 400 mg of bevacizumab.
16 ml raztopine v viali (steklo tipa I) z zamaškom (butilna guma), ki vsebuje 400 mg bevacizumaba.
Table 10 Trial E2100 efficacy results
Rezultati učinkovitosti preskušanja E2100
PFS subgroup analyses depending on recurrence since last platinum therapy are summarised in Table 21.
Analize preživetja brez napredovanja bolezni v podskupinah, glede na ponovitev bolezni od zadnjega zdravljenja, ki je vsebovalo platino, so povzete v preglednici 21.
Chemotherapy was chosen at the investigator's discretion prior to randomisation in a 2:1 ratio to receive either chemotherapy plus Avastin or chemotherapy plus placebo.
Kemoterapijo je po lastni presoji izbral raziskovalec pred randomizacijo, ki je potekala v razmerju 2:1 v skupino, ki je prejemala kemoterapijo in zdravilo Avastin, ali skupino, ki je prejemala kemoterapijo in placebo.
There is no information on the safety profile of Avastin in patients with congenital bleeding diathesis, acquired coagulopathy or in patients receiving full dose of anticoagulants for the treatment of thromboembolism prior to starting Avastin treatment, as such patients were excluded from clinical trials.
Varnostni profil zdravila Avastin pred njegovo uvedbo pri bolnikih, ki imajo kongenitalno hemoragično diatezo ali pridobljeno koagulopatijo ali če prejemajo polni odmerek antikoagulantov za zdravljenje trombembolije, ni poznan, ker le-ti niso bili vključeni v klinična preskušanja.
Number of Patients Overall Survival Median (months)
Število bolnikov Celokupno preživetje mediana časa (meseci)
Eligible patients had epithelial ovarian, fallopian tube or primary peritoneal cancer that progressed within <6 months of previous platinum therapy consisting of a minimum of 4 platinum therapy cycles.
Za vključitev v študijo so bile primerne bolnice, ki so imele epitelijski rak jajčnikov, karcinom jajcevodov ali primarni peritonealni karcinom, ki je napredoval v manj kot 6 mesecih od prejšnjega zdravljenja s platino, ki je vključevalo najmanj 4 cikluse zdravljenja z njo.
Avastin (15 mg/kg Day 1) every 3 weeks for 6 and up to 10 cycles followed by Avastin (15 mg/kg every 3 weeks) alone until disease progression or unacceptable toxicity
Avastin (15 mg/kg, dan 1) vsake 3 tedne, od 6 do največ 10 ciklov, nato je sledilo samo zdravilo Avastin (15 mg/kg vsake 3 tedne) do napredovanja bolezni ali nesprejemljive toksičnosti.
Secondary efficacy endpoints included progression-free survival and objective response rate.
Med sekundarnimi opazovanimi dogodki sta bila preživetje brez napredovanja bolezni in objektivni delež odgovora.
The metabolism and elimination of bevacizumab is similar to endogenous IgG i.e. primarily via proteolytic catabolism throughout the body, including endothelial cells, and does not rely primarily on elimination through the kidneys and liver.
To poteka v glavnem s proteolitično razgradnjo po celem telesu, tudi v endotelijskih celicah, ni pa predvsem odvisno od izločanja preko ledvic in jeter.
Patients who develop GI-vaginal fistulae may also have bowel obstructions and require surgical intervention as well as diverting ostomies.
Bolnice, ki se jim pojavijo fistule med prebavili in nožnico, imajo lahko tudi obstrukcijo črevesa in potrebujejo kirurško posredovanje in preusmeritvene stome.
Study AVF3694g was a Phase III, multicentre, randomised, placebo-controlled trial designed to evaluate the efficacy and safety of Avastin in combination with chemotherapy compared to chemotherapy plus placebo as first-line treatment for patients with HER2-negative metastatic or locally recurrent breast cancer.
AVF3694g AVF3694g je bilo multicentrično, randomizirano, s placebom primerjano preskušanje faze III, ki je proučevalo učinkovitost in varnost zdravila Avastin v kombinaciji s kemoterapijo v primerjavi s kemoterapijo in placebom, v prvi liniji zdravljenja bolnikov s HER2 negativnim metastatskim ali lokalno recidivnim rakom dojk.
There is no information on the effect of Avastin in patients with uncontrolled hypertension at the time of initiating therapy.
O učinku zdravila Avastin pri bolnikih, ki so imeli neurejeno hipertenzijo ob pričetku zdravljenja z njim, ni podatkov.
MAHA is a haemolytic disorder which can present with red cell fragmentation, anaemia, and thrombocytopenia.
Mikroangiopatična hemolitična anemija je hemolitična motnja, ki se lahko kaže s fragmentacijo rdečih krvničk, anemijo in trombocitopenijo.
(p-value = 0.0185)
(p-vrednost = 0,0185)
Avastin may impair female fertility (see sections 4.6 and 4.8).
Okvara jajčnikov/plodnost Zdravilo Avastin lahko zmanjša plodnost žensk (glejte poglavji 4.6 in 4.8).
In randomised clinical trials, age > 65 years was associated with an increased risk of developing arterial thromboembolic reactions, including cerebrovascular accidents (CVAs), transient ischaemic attacks (TIAs) and myocardial infarctions (MIs).
V randomiziranih kliničnih preskušanjih je bila starost nad 65 let pri zdravljenju z zdravilom Avastin povezana s povečanjem tveganja za razvoj arterijskih trombemboličnih neželenih učinkov, vključno s cerebrovaskularnimi dogodki, tranzitornimi ishemičnimi atakami in miokardnimi infarkti.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Zdravila za parenteralno dajanje je treba pred uporabo vizualno pregledati, saj ne smejo vsebovati delcev ali biti obarvana.
The results of this study are summarised in Table 20.
Rezultati te študije so povzeti v preglednici 20.
(16.2 vs 17.5 months; p = 0.3769)
(16,2 proti 17,5 meseca; p = 0,3769)
The primary efficacy endpoint was overall survival.
Primarni opazovani dogodek učinkovitosti je bil celokupno preživetje.
• Study AVF3694g (capecitabine) • Median PFS increase 2.9 months, HR 0.69 (p = 0.0002, 95% CI 0.56; 0.84)
· študija AVF3694g (kapecitabin) · mediana podaljšanja PFS 2,9 meseca, razmerje ogroženosti 0,69 (p = 0,0002, 95-% interval zaupanja 0,56; 0,84) Dodatne podrobnosti o vsakem preskušanju in rezultati so navedeni spodaj.
The results of this study are summarised in Table 16.
Rezultati te študije so povzeti v preglednici 16.
The incidence of these reactions in some clinical trials of Avastin is common (up to 5% in bevacizumabtreated patients).
Incidenca teh reakcij pri nekaterih kliničnih preskušanjih zdravila Avastin je pogosta (do
In four phase III trials (AVF2119g, E2100, BO17708 and AVF3694g) in patients with metastatic breast cancer CHF Grade 3 (NCI-CTCAE v.3) or higher was reported in up to 3.5% of patients treated with Avastin in combination with chemotherapy compared with up to 0.9% in the control arms.
V štirih preskušanjih faze III (AVF2119g, E2100, BO17708 in AVF3694g) so pri bolnikih z metastatskim rakom dojk o kongestivnem srčnem popuščanju stopnje 3 ali več (NCI
In locally recurrent and metastatic breast cancer trials, Grade 3-5 wound healing complications were observed in up to 1.1% of patients receiving Avastin compared with up to 0.9% of patients in the control arms (NCI-CTCAE v.3).
V preskušanjih lokalno recidivnega in metastatskega raka dojk so zaplete pri celjenju ran stopnje 3 do 5 opazili pri do 1,1 % bolnikov, ki so prejemali zdravilo Avastin, v primerjavi z do 0,9 % bolnikov v kontrolnih skupinah (NCI-CTCAE v.3).
Front-line treatment: Avastin is administered in addition to carboplatin and paclitaxel for up to 6 cycles of treatment followed by continued use of Avastin as single agent until disease progression or for a maximum of 15 months or until unacceptable toxicity, whichever occurs earlier.
Prvo zdravljenje: zdravilo Avastin dodajamo karboplatinu in paklitakselu do 6 ciklov, nato pa dajemo zdravilo Avastin samostojno do napredovanja bolezni ali do največ 15 mesecev oziroma do nesprejemljive toksičnosti, kar od tega nastopi prej.
Adverse foetal outcomes were observed at all tested doses, of which the lowest dose resulted in average serum concentrations approximately 3 times larger than in humans receiving 5 mg/kg every 2 weeks.
Od teh je najnižji odmerek sprožil približno 3-krat višje povprečne serumske koncentracije kot odmerek 5 mg/kg pri ljudeh, ki so ga prejemali vsaka dva tedna.
Across clinical trials, the following Grade 3 and 4 (NCI-CTCAE v.3) laboratory abnormalities occurred in patients treated with Avastin with at least a 2% difference compared to the corresponding control groups: hyperglycaemia, decreased haemoglobin, hypokalaemia, hyponatraemia, decreased white blood cell count, increased international normalised ratio (INR).
Naslednje laboratorijske nepravilnosti stopnje 3 in 4 (NCI-CTCAE v.3) so se v kliničnih preskušanjih pri bolnikih, ki so se zdravili z zdravilom Avastin, v primerjavi z ustreznimi kontrolnimi skupinami pojavile z najmanj 2-% razliko: hiperglikemija, zmanjšana koncentracija hemoglobina, hipokaliemija,
Eight hundred and twenty-nine patients were randomised (292 FOLFOX-4, 293 Avastin + FOLFOX-4 and 244 Avastin monotherapy).
Randomizirali so 829 bolnikov (zdravljenje po shemi FOLFOX-4 je prejemalo 292 bolnikov, zdravilo Avastin in zdravljenje po shemi FOLFOX-4
Severe side effects, which may be common (affects 1 to 10 users in 100), include:
Hudi neželeni učinki, ki so lahko pogosti (pojavijo se pri 1 do 10 bolnikih od 100 bolnikov),
This was a phase II randomised, double-blind, active-controlled clinical trial evaluating the efficacy and safety of Avastin in combination with 5-FU/FA as first-line treatment for metastatic colorectal cancer in patients who were not optimal candidates for first-line irinotecan treatment.
To je bilo randomizirano, aktivno kontrolirano, dvojno slepo klinično preskušanje faze II, v katerem so proučevali učinkovitost in varnost zdravila Avastin v kombinaciji s kemoterapevtsko shemo 5-FU/FA v prvi liniji zdravljenja bolnikov z metastatskim rakom debelega črevesa in danke, ki niso bili najprimernejši kandidati za prvo linijo zdravljenja z irinotekanom.
The safety and efficacy of Avastin 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 Avastin to carboplatin and paclitaxel compared to the chemotherapy regimen alone.
karcinomom jajcevodov ali primarnim peritonealnim karcinomom so proučevali v dveh preskušanjih faze III (GOG-0218 in BO17707), kjer so ocenjevali vpliv dodajanja zdravila Avastin karboplatinu in paklitakselu v primerjavi s kemoterapijo samo.
Venous thromboembolism: The incidence of venous thromboembolic reactions in clinical trials was similar in patients receiving Avastin in combination with chemotherapy compared to those receiving the control chemotherapy alone.
Venska trombembolija: Incidenca venskih trombemboličnih neželenih učinkov v kliničnih preskušanjih je bila pri bolnikih, ki so prejemali zdravilo Avastin v kombinaciji s kemoterapijo in bolnikih v kontrolni skupini, ki so prejemali le kemoterapijo, podobna.
These results demonstrate robustness of the primary analysis of PFS as shown in Table 18.
Ti rezultati prikazujejo robustnost analize preživetja brez napredovanja bolezni, ki je prikazana v preglednici 18.
Cases of ONJ have been reported in cancer patients treated with Avastin, the majority of whom had received prior or concomitant treatment with intravenous bisphosphonates, for which ONJ is an identified risk.
Pri bolnikih z rakom, ki so se zdravili z zdravilom Avastin, so poročali o primerih osteonekroze čeljustnic; večina teh bolnikov je bila predhodno ali sočasno zdravljena z intravenskimi difosfonati, za katere je osteonekroza čeljustnic znano tveganje.
• In a single-arm study (PBTC-022), 18 children with recurrent or progressive non-pontine high-grade glioma (including 8 with glioblastoma [WHO Grade IV], 9 with anaplastic astrocytoma [Grade III] and 1 with anaplastic oligodendroglioma [Grade III]) were treated with bevacizumab (10 mg/kg) two weeks apart and then with bevacizumab in combination with CPT-11 (125-350 mg/m²) once every two weeks until progression.
· V študiji (PBTC-022), ki je vključevala eno skupino, je 18 otrok s ponavljajočim se ali napredovalim gliomom visoke stopnje malignosti, ki se ni nahajal v možganskem deblu, bilo zdravljenih z bevacizumabom (10 mg/kg) v razmiku dveh tednov in nato z bevacizumabom v kombinaciji s CPT-11 (125-350 mg/m2) enkrat na dva tedna do napredovanja bolezni (8 otrok je imelo glioblastom [stopnje IV po lestvici SZO], 9 anaplastični astrocitom [stopnje III po lestvici SZO] in 1 anaplastični oligodenrogliom [stopnje III po lestvici SZO]).
(p-value = 0.0188)
(p-vrednost = 0,0188)
Avastin will be administered in combination with chemotherapy treatment containing a fluoropyrimidine medicine.
Prejeli ga boste v kombinaciji z zdravljenjem s kemoterapijo, ki vsebuje zdravilo na osnovi fluoropirimidina.
The results of this study are summarised in Table 18.
Rezultati te študije so povzeti v preglednici 18.
% pts with objective response p-value * primary analysis Overall survival
% bolnikov z objektivnim odgovorom p-vrednost * primarna analiza; **IRF - Ustanova za neodvisni pregled (Independent Review Facility)
Trial BO17704 was a randomised, double-blind phase III trial 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.
Preskušanje BO17704 je bilo randomizirano, dvojno slepo preskušanje faze III, v katerem so primerjali zdravilo Avastin v kombinaciji s cisplatinom in gemcitabinom s placebom, cisplatinom in gemcitabinom pri bolnikih z lokalno napredovalim (stadij IIIB z zasevki v supraklavikularnih bezgavkah ali maligno plevralnim ali perikardialnim izlivom), metastatskim ali ponavljajočem se neskvamoznim nedrobnoceličnim rakom pljuč.
Table 21 Progression-free survival by time from last platinum therapy to recurrence Investigator Assessment
Preživetje brez napredovanja bolezni prikazano glede na čas od zadnjega zdravljenja, ki je vsebovalo platino, do ponovitve bolezni Ocena raziskovalca
Hypertensionb,d, Thrombo-embolism (venous)b,d
Žilne bolezni hipertenzijab,d, (venska) trombembolijab,d
Bevacizumab addition to multimodal standard of care treatment seemed to be tolerated in this paediatric population.
Zdi se, da je bil pri tej pediatrični populaciji bevacizumab kot dodatek multimodalnemu standardnemu zdravljenju dobro prenosljiv.
IFN alfa-2a was given up to 52 weeks or until disease progression at a recommended starting dose of 9 MIU three times a week, allowing a dose reduction to 3 MIU three times a week in 2 steps.
52 tednov ali do napredovanja bolezni, priporočeni začetni odmerek je bil 9 mio i.e. trikrat na teden,
● The risk of developing blood clots in your arteries (a type of blood vessel) can increase if you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries.
· tveganje za pojav krvnih strdkov v arterijah (tip krvne žile) je lahko povečano, če ste starejši od
Chemotherapy + Avastin (n=227)
Kemoterapija + Avastin (n = 227)
Avastin is also used for the treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Zdravilo Avastin uporabljamo tudi za zdravljenje odraslih bolnic z napredovalim epitelijskim rakom jajčnikov, karcinomom jajcevodov ali primarnim rakom potrebušnice.
5 Patients with measurable disease at baseline.
5 Bolnice z merljivo boleznijo na začetku zdravljenja.
Caution should be taken when treating these patients with Avastin.
Pri zdravljenju teh bolnikov je zato potrebna previdnost.
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 trial, 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.
Pri 131 bolnikih iz skupine, ki je prejemala zdravilo Avastin in interferon alfa-2a, pri katerih so zmanjšali in vzdrževali odmerek interferona alfa-2a med preskušanjem na 6 ali 3 mio i.e., so deleži preživetja brez napredovanja bolezni znašali: po 6 mesecih 73 %, po 12 mesecih 52 % in po 18 mesecih 21 %.
Grade 4 hypertension (hypertensive crisis) occurred in up to 1.0% of patients treated with Avastin and chemotherapy compared to up to 0.2% of patients treated with the same chemotherapy alone.
Hipertenzija stopnje 4 (hipertenzivna kriza) se je pojavila pri do 1,0 % bolnikov, ki so se zdravili z zdravilom Avastin in kemoterapijo, v primerjavi z do 0,2 % bolnikov, ki so se zdravili z enako kemoterapijo brez zdravila Avastin.
Table 19 PFS1 results by disease stage and debulking status from study BO17707 (ICON7) Randomised patients stage III optimally debulked disease 2,3 CP (n = 368)
Rezultati preživetja brez napredovanja bolezni1, glede na stadij bolezni in stopnjo citoredukcije iz študije BO17707 (ICON7) Randomizirane bolnice z optimalno citoredukcijo, stadija III
Intestinal perforation, Ileus, Intestinal obstruction, Recto-vaginal fistulaec,d,
ileus, intestinalna obstrukcija, rektovaginalne fistulec,d,
This is consistent with results in patients in other studies of metastatic breast cancer who did not receive concurrent anthracycline treatment (NCI-CTCAE v.3) (see section 4.8).
To je skladno z rezultati pri bolnikih v drugih preskušanjih pri metastatskemu raku dojk, ki niso prejemali sočasnega zdravljenja z antraciklini (NCI
(16.2 vs. 12.0 months; p = 0.1342)
(16,2 proti 12,0 meseca; p = 0,1342)
Investigations Weight decreased
Preiskave zmanjšanje telesne mase
Median OS (months) Hazard ratio (95% CI) (eCRF)a
mediana OS (meseci) razmerje ogroženosti (95-% IZ) (eCRF)a
Additional endpoints included objective response, duration of response, overall survival and safety.
Ostali cilji so vključevali objektiven odgovor, trajanje odgovora,
was initiated prior to documented progression; data from those patients were censored at the last tumour assessment prior to starting NPT.
Podatke teh bolnikov so krnili ob času zadnje ocene tumorja pred začetkom zdravljenja, ki ni bilo v skladu s protokolom.
The HR for PFS was 0.47 (95% CI: 0.35, 0.62) and 0.45 (95% CI: 0.31, 0.67) for the < 65 and ≥ 65 subgroups, respectively.
Razmerje ogroženosti za preživetje brez napredovanja bolezni je bilo 0,47 (95-% interval zaupanja: 0,35; 0,62) za mlajše od 65 let in 0,45 (95-% interval zaupanja: 0,31; 0,67) za bolnice, stare 65 let ali več.
(11.9 vs.14.3 months; p = 0.4825)
(11,9 proti 14,3 meseca; p = 0,4825)
The addition of Avastin to IFN-alpha-2a significantly increased PFS and objective tumour response rate.
Dodatek zdravila Avastin k interferonu alfa-2a je pomembno podaljšal preživetje brez napredovanja bolezni in pomembno povečal objektivni odgovor na zdravljenje.