natgillin/translations-raw huggingface dataset:
Based on the results of the population pharmacokinetic analysis, pertuzumab exposure in patients with mild (creatinine clearance [CLcr] 60 to 90 ml/min, N=200) and moderate renal impairment (CLcr 30 to 60 ml/min, N=71) was similar to that in patients with normal renal function (CLcr greater than 90 ml/min, N=200).
Na osnovi rezultatov farmakokinetične populacijske analize je bila izpostavljenost pertuzumabu pri bolnikih z blago okvaro ledvic (očistek kreatinina [Clcr] = 60 do 90 ml/min, n = 200) ter bolnikih z zmerno okvaro ledvic (Clcr = 30 do 60 ml/min, n = 71) podobna kot pri bolnikih z normalno funkcijo ledvic(Clcr večji kot
HR= hazard ratio; CI= confidence interval; Pla= placebo; Ptz= pertuzumab (Perjeta); T= trastuzumab (Herceptin); D= docetaxel.
HR = razmerje ogroženosti; Pla = placebo; Ptz = pertuzumab (zdravilo Perjeta); T = trastuzumab (zdravilo Herceptin); D = docetaksel
• NEOSPHERE (n=309) and TRYPHAENA (n=218), in which neoadjuvant Perjeta was given in combination with trastuzumab and chemotherapy to patients with locally advanced, inflammatory, or early breast cancer
• NEOSPHERE (n = 309) in TRYPHAENA (n = 218), kjer so zdravilo Perjeta dajali kot neoadjuvantno zdravljenje v kombinaciji s trastuzumabom in kemoterapijo bolnicam z lokalno napredovalim, vnetnim ali zgodnjim rakom dojk;
Based on the population pharmacokinetic analysis, no significant difference was observed in the pharmacokinetics of pertuzumab between patients < 65 years (n=306) and patients ≥ 65 years (n=175).
Na osnovi populacijske farmakokinetične analize niso ugotovili pomembnih farmakokinetičnih razlik za pertuzumab med bolniki, ki so bili mlajši od 65 let (n = 306), in bolniki, ki so bili stari 65 let ali več (n = 175).
It is given by a drip into a vein (intravenous infusion) once every three weeks.
• Dobili ga boste v obliki infuzije v žilo (intravenske infuzije) vsake 3 tedne.
The pCR rates were lower in the subgroup of patients with hormone receptor positive tumours (range 46.2% to 50.0%) than in patients with hormone receptor-negative tumours (range 65.0% to 83.8%).
Deleži pCR so bili nižji v podskupini bolnic s hormonsko odvisnimi tumorji (razpon 46,2 % do 50,0 %) v primerjavi z bolnicami s hormonsko neodvisnimi tumorji (razpon vrednosti 65,0 % do 83,8 %).
On the first day when only Perjeta was administered, the overall frequency of infusion reactions was 9.8% in the placebo-treated group and 13.2% in the Perjeta-treated group, with the majority of infusion reactions being mild or moderate.
Prvi dan, ko je bilo uporabljeno le zdravilo Perjeta, je bila celotna pogostnost infuzijskih reakcij v skupini, ki je prejemala placebo, 9,8 %, in v skupini, ki je prejemala zdravilo Perjeta, 13,2 %; večina teh reakcij je bila blagih ali zmernih.
As Perjeta was used with trastuzumab and chemotherapy in these trials, it is difficult to ascertain the causal relationship of an adverse event to a particular medicinal product.
Ker so v teh preskušanjih zdravilo Perjeta uporabljali skupaj s trastuzumabom in kemoterapijo, je težko ugotoviti vzročno povezanost neželenega učinka s posameznim zdravilom.
The difference in pCR rate is considered likely to translate into a clinically meaningful difference in long term outcomes and is supported by positive trends in PFS (HR 0.69, 95% CI 0.34, 1.40) and DFS (HR 0.60, 95% CI 0.28, 1.27).
Razlika v deležu pCR se bo verjetno odrazila v klinično pomembno razliko v dolgoročnih izidih; podprta je s pozitivnimi trendi v PFS (razmerje ogroženosti 0,69, 95-% interval zaupanja 0,34; 1,40) in DFS (razmerje ogroženosti 0,60, 95-% interval zaupanja 0,28; 1,27).
Following surgery all patients received 3 cycles of 5fluorouracil (600 mg/m2), epirubicin (90 mg/m2), cyclophosphamide (600 mg/m2) (FEC) given intravenously every three weeks, and trastuzumab administered intravenously every three weeks to complete one year of therapy.
Po operaciji so vse bolnice prejele 3 cikle kombinacije 5-fluorouracila (600 mg/m2), epirubicina (90 mg/m2) in ciklofosfamida (600 mg/m2) (FEC) intravensko vsake tri tedne in trastuzumab intravensko vsake tri tedne do zaključka enoletnega zdravljenja.
Therefore, there is no need to adjust the dosage of pertuzumab based on these covariates.
Zato odmerka pertuzumaba ni treba prilagajati glede na ti sospremenljivki.
Figure 1 IRF-assessed PFS by patient subgroup
IRF-ova ocena preživetja brez napredovanja bolezni po podskupinah bolnikov
When administered with Perjeta in the adjuvant setting, the recommended dose of paclitaxel is 80 mg/m2 once weekly for 12 weekly cycles.
Priporočeni odmerek paklitaksela ob zdravilu Perjeta v adjuvantnem zdravljenju je 80 mg/m2 enkrat na teden v 12-tedenskih ciklih.
If you forget to have Perjeta
Če ste pozabili na zdravilo Perjeta
Patients considered suitable for neoadjuvant treatment with trastuzumab plus anthracycline/taxane-based chemotherapy were allocated to receive one of the two following regimens prior to surgery as follows:
Bolnike, za katere so menili, da so primerni za neoadjuvantno zdravljenje s trastuzumabom in kemoterapijo na osnovi antraciklinov/taksanov, so pred operacijo dodelili na prejemanje ene od naslednjih dveh spodaj navedenih shem:
In conclusion, administration of Pertuzumab may cause Infusion Related Reactions (IRR) and hypersensitivity/anaphylaxis reactions that can be associated with fatal outcome and the Product Information should be updated to reflect such outcome.
Zaključili so, da dajanje pertuzumaba lahko povzroči infuzijske reakcije in reakcije preobčutljivosti/anafilaksije, ki so lahko povezane s smrtnim izidom, informacije o zdravilu pa je treba posodobiti, da bo iz njih to razvidno.
• the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)
• adjuvantno zdravljenje odraslih bolnikov z zgodnjim rakom dojk z visokim tveganjem za ponovitev (glejte poglavje 5.1).
However sensitivity analyses performed at the recommended dose and schedule of Perjeta showed that at the extreme values of these two covariates, there was no significant impact on the ability to achieve target steady-state concentrations identified in preclinical tumour xenograft models.
Toda v analizah občutljivosti ob priporočenem odmerjanju in razporedu uporabe zdravila Perjeta ti sospremenljivki niti pri svojih skrajnih vrednostih nista pomembno vplivali na sposobnost za doseganje ciljnih koncentracij v stanju dinamičnega ravnovesja, ugotovljenih v predkliničnih ksenotransplantacijskih tumorskih modelih.
What Perjeta looks like and contents of the pack Perjeta is a concentrate for solution for infusion.
Izgled zdravila Perjeta in vsebina pakiranja Zdravilo Perjeta je koncentrat za raztopino za infundiranje.
In cynomolgus monkeys, weekly intravenous administration of pertuzumab at doses up to 150 mg/kg/dose was generally well tolerated.
Opice cynomolgus so na splošno dobro prenesle intravensko uporabo pertuzumaba vsak teden v odmerkih do 150 mg/kg/odmerek.
The majority of cases of symptomatic heart failure reported in the adjuvant setting were in patients who received anthracyclinebased chemotherapy (see section 4.8).
Večino primerov simptomatskega srčnega popuščanja v okviru adjuvantnega zdravljenja so zabeležili pri bolnikih, zdravljenih s kemoterapijo na osnovi antraciklina (glejte poglavje 4.8).
Following surgery all patients received trastuzumab to complete one year of therapy.
Po operaciji so vse bolnice prejemale trastuzumab do zaključka enoletnega zdravljenja.
Assess LVEF prior to initiation of Perjeta and at regular intervals during treatment with Perjeta (e.g. once during neoadjuvant treatment and every 12 weeks in the adjuvant or metastatic setting) to ensure that LVEF is within normal limits.
Pred uvedbo zdravila Perjeta je treba oceniti vrednost LVEF in jo nato med zdravljenjem z zdravilom Perjeta tudi redno spremljati (npr. enkrat med neoadjuvantnim zdravljenjem in vsakih 12 tednov med adjuvantnim zdravljenjem ali pri metastatski bolezni) ter zagotoviti, da LVEF ostaja znotraj normalnih vrednosti.
Investigators selected one of the following anthracyclinebased or non-anthracycline-based chemotherapy regimens for individual patients:
Raziskovalci so za posamezne bolnike izbrali eno od naslednjih shem kemoterapije (na osnovi antraciklina ali brez):
Perjeta is unlikely to affect you being able to drive or use machines.
Malo je verjetno, da bi zdravilo Perjeta vplivalo na vaše sposobnosti za upravljanje vozil in strojev.
Thereafter in both arms physical function and global health status scores returned to baseline levels during targeted treatment.
Zatem sta se oceni telesne zmogljivosti in splošnega zdravstvenega stanja med ciljnim zdravljenjem v obeh skupinah vrnili na izhodiščno raven.
There is no relevant use of Perjeta in the paediatric population in the indication of breast cancer.
Uporaba zdravila Perjeta pri indikaciji rak dojk za pediatrično populacijo ni smiselna.
Patients treated with Perjeta must have HER2-positive tumour status, defined as a score of 3+ by immunohistochemistry (IHC) and/or a ratio of ≥ 2.0 by in situ hybridisation (ISH) assessed by a validated test.
Bolniki, zdravljeni z zdravilom Perjeta, morajo imeti HER2-pozitivni tumor, imunohistokemično opredeljen kot 3+ in/ali razmerje pri in situ hibridizaciji (ISH) > 2,0, opredeljeno z validiranim testom.
Based on the pharmacological actions of HER2-targeted agents and anthracyclines, the risk of cardiac toxicity might be expected to be higher with concomitant use of Perjeta and anthracyclines than with sequential use.
Z upoštevajnjem farmakološkega delovanja zdravil, usmerjenih proti HER2, in antraciklinov je med sočasno uporabo zdravila Perjeta in antraciklinov mogoče pričakovati večje tveganje za kardiotoksičnost kot med zaporedno uporabo.
Figure 3 Kaplan-Meier Curve of Invasive Disease Free Survival
Kaplan-Meierjeva krivulja preživetja brez invazivne bolezni
Pertuzumab exposure was reported in offspring from all treated groups, at levels of 29% to 40% of maternal serum levels at
O izpostavljenosti pertuzumabu so poročali pri mladičih vseh zdravljenih skupin, v razponu od 29- do 40 % vrednosti v serumu samic pri GD 100.
If the LVEF has declined as indicated in section 4.2 and has not improved, or has declined further at the subsequent assessment, discontinuation of Perjeta and trastuzumab should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Če se LVEF poslabša, kot je opisano v poglavju 4.2, in se ob naslednjem preverjanju ne izboljša ali se še dodatno poslabša, je treba resno razmisliti o prenehanju zdravljenja z zdravilom
In patients receiving an anthracycline-based regimen, Perjeta and trastuzumab should be administered following completion of the entire anthracycline regimen (see section 4.4).
Bolniki, ki prejemajo shemo na osnovi antraciklina, morajo zdravilo Perjeta in trastuzumab dobiti po koncu celotne sheme antraciklina (glejte poglavje 4.4).
FEC (5-fluorouracil [500 mg/m2], epirubicin [100 mg/m2], cyclophosphamide [600 mg/m2]) were given intravenously every three weeks for 3 cycles.
FEC (5-fluorouracil [500 mg/m2], epirubicin [100 mg/m2], ciklofosfamid [600 mg/m2])
Table 5 Overall Efficacy: ITT Population
Celokupna učinkovitost: populacija z namenom zdravljenja
For further information on dosing of trastuzumab and chemotherapy (which can cause side effects as well), please refer to the package leaflet for these products.
Za dodatne informacije o odmerjanju trastuzumaba in kemoterapije (vsi imajo prav tako lahko neželene učinke) glejte navodili za uporabo teh zdravil.
In the adjuvant setting, based on data from the APHINITY study, HER2-positive early breast cancer patients at high risk of recurrence are defined as those with lymph node-positive or hormone receptornegative disease.
V okviru adjuvantnega zdravljenja, ki temelji na podatkih iz študije APHINITY, so kot bolniki z zgodnjim rakom dojk z visokim tveganjem za ponovitev opredeljeni tisti z boleznijo s pozitivnimi bezgavkami ali negativnimi hormonskimi receptorji.
A population pharmacokinetic analysis was performed with data from 481 patients across different clinical trials (phase I, II and III) with various types of advanced malignancies who had received Perjeta as a single agent or in combination at pertuzumab doses ranging from 2 to 25 mg/kg administered every 3 weeks as a 30-60 minutes intravenous infusion.
Populacijsko farmakokinetično analizo so izvedli iz podatkov 481 bolnikov, ki so sodelovali v različnih kliničnih preskušanjih (faze I, II in III) z različnimi oblikami napredovalih rakov in so prejeli pertuzumab samostojno ali v kombinaciji v odmerku od 2 do 25 mg/kg, danih v obliki 30 do 60 minutne infuzije vsake 3 tedne.
Perjeta should be administered by a healthcare professional prepared to manage anaphylaxis and in an environment where full resuscitation facilities are immediately available.
Zdravilo Perjeta lahko daje samo zdravstveni delavec, ki zna ukrepati v primeru anafilaksije, in ga daje v okolju, kjer je na voljo vsa nujno potrebna medicinska oprema za oživljanje.
[95% CI]
[95-% IZ]
The fixed dose of 600mg trastuzumab SC should be administered as soon as possible.
Čim prej je treba dati fiksni 600-mg subkutani odmerek trastuzumaba.
The metabolism of pertuzumab has not been directly studied.
Presnove pertuzumaba niso neposredno proučevali.
In the neoadjuvant setting, locally advanced and inflammatory breast cancers are considered as highrisk irrespective of hormone receptor status.
V okviru neoadjuvantnega zdravljenja smatramo lokalno napredovali in vnetni rak dojk kot visoko tvegana, neodvisno od statusa hormonskih receptorjev.
However, if you get any infusion reactions, allergic or anaphylactic reactions, wait until these have gone away before driving or using machines.
Če se pri vas razvije alergijska ali anafilaktična reakcija, prosimo, počakajte, da vsi simptomi izzvenijo, preden začnete voziti ali upravljati stroje.
Patients treated with Perjeta, trastuzumab and docetaxel are at increased risk of febrile neutropenia compared with patients treated with placebo, trastuzumab and docetaxel, especially during the first 3 cycles of treatment (see section 4.8).
Pri bolnikih, ki se zdravijo z zdravilom Perjeta, trastuzumabom in docetakselom, obstaja večje tveganje za nastanek febrilne nevtropenije v primerjavi z bolniki, ki se zdravijo s placebom, trastuzumabom in docetakselom, še posebej med prvimi 3 cikli zdravljenja (glejte poglavje 4.8).
No relationship between CLcr and pertuzumab exposure was observed over the range of CLcr (27 to 244 ml/min).
Med očistkom kreatinina in izpostavljenostjo pertuzumabu niso našli povezave pri razponu očistka kreatinina od 27 do 244 ml/min.
Perjeta has been associated with infusion reactions, including events with a fatal outcome (see section 4.8).
Uporabo zdravila Perjeta so spremljale infuzijske reakcije, vključno z dogodki s smrtnim izidom (glejte poglavje 4.8).
The safety of Perjeta has been evaluated in more than 6,000 patients in Phase I, II, and III trials in patients with various malignancies and predominantly treated with Perjeta in combination with other antineoplastic agents.
Varnost zdravila Perjeta so ocenili pri več kot 6000 bolnikih v preskušanjih faze I, II in III, v katera so bili vključeni bolniki z različnimi malignimi boleznimi, ki so bili pretežno zdravljeni z zdravilom
Secondary efficacy endpoints were pCR rate in the breast (ypT0/is), DFS, PFS and OS.
Sekundarni končni cilji učinkovitosti so bili deleži pCR v dojki (ypT0/is), DFS in OS.
In addition, in the population PK analysis, no evidence of a drug-drug interaction has been shown between pertuzumab and trastuzumab or between pertuzumab and docetaxel.
Tudi farmakokinetična populacijska analiza ni pokazala medsebojnega delovanja med pertuzumabom in trastuzumabom ali med pertuzumabom in docetakselom.
However, only limited safety data are available on concurrent use of Perjeta and an anthracycline.
O varnosti sočasne uporabe zdravila Perjeta in antraciklina pa je na voljo le malo podatkov.
The addition of Perjeta to trastuzumab plus chemotherapy did not affect patients' overall role function over the course of the study.
Dodatek zdravila Perjeta kombinaciji trastuzumaba in kemoterapije med potekom študije ni vplival na družbeno in družinsko vlogo bolnikov.
Perjeta is for single use only.
Zdravilo Perjeta je za enkratno uporabo.
Perjeta and trastuzumab may be resumed if the LVEF has recovered to > 45%, or to 40-45% associated with a difference of < 10% points below pre-treatment values.
Zdravili Perjeta in trastuzumab lahko znova uvedemo, če se vrednost LVEF dvigne na > 45 % ali 40 do 45 %, pri čemer je padec manjši od 10 odstotnih točk glede na vrednosti pred zdravljenjem.
Close observation of the patient during and for 60 minutes after the first infusion and during and for 30-60 minutes after subsequent infusions of Perjeta is recommended.
Priporoča se skrbno opazovanje bolnika med prvo infuzijo in še 60 minut po njej ter med vsako naslednjo infuzijo zdravila Perjeta in še 30 do 60 minut po njej.
In BERENICE, 4.1% (16/392) of the patients treated with Perjeta tested positive for ADA.
V preskušanju BERENICE so pri 4,1 % (16/392) bolnikov, zdravljenih z zdravilom Perjeta, ugotovili prisotnost protiteles proti zdravilu.
Febrile neutropenia (Low white blood cells with fever) When Perjeta is given with other cancer treatments (trastuzumab and chemotherapy), the number of white blood cells may drop and fever (raised temperature) may develop.
Ko zdravilo Perjeta dajemo skupaj z drugimi zdravili za zdravljenje raka (trastuzumab in kemoterapija), lahko število belih krvnih celic pade, razvije se lahko vročina (zvišana telesna temperatura).
An increased incidence of febrile neutropenia was observed among Asian patients in both treatment groups compared with patients of other races and from other geographic regions.
Pri obeh zdravljenih skupinah so večjo incidenco febrilne nevtropenije opažali pri azijski populaciji v primerjavi z bolniki drugih ras in geografskih področij.
Randomisation was stratified by breast cancer type (operable, locally advanced, or inflammatory) and ER or PgR positivity.
Randomizacija je bila stratificirana glede na tip raka dojk (operabilen, lokalno napredovali ali vnetni) in glede na pozitivnost ER in PR.
The safety and efficacy of Perjeta have not been studied in patients with hepatic impairment.
Okvara jeter Varnost in učinkovitost zdravila Perjeta pri bolnikih z okvaro jeter nista raziskani.
The most common infusion reactions (≥ 1.0%) in the Perjeta-treated group were pyrexia, chills, fatigue, headache, asthenia, hypersensitivity and vomiting.
Najpogostejše infuzijske reakcije (≥ 1,0 %) v skupini, ki je prejemala zdravilo Perjeta, so bile pireksija, mrzlica, utrujenost, glavobol, astenija, preobčutljivost in bruhanje.
On the basis of the scientific conclusions for pertuzumab the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing pertuzumab is unchanged subject to the proposed changes to the product information
Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za pertuzumab odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo pertuzumab, nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
The primary endpoint of the BERENICE trial is cardiac safety in the neoadjuvant period of the trial.
Primarni cilj preskušanja BERENICE je kardiološka varnost med neoadjuvantnim obdobjem preskušanja.
Reproductive toxicology studies have been conducted in pregnant cynomolgus monkeys (Gestational Day (GD) 19 through to GD 50) at initial doses of 30 to 150 mg/kg followed by bi-weekly doses of 10 to 100 mg/kg.
Toksikološke študije o sposobnosti razmnoževanja so bile opravljene pri brejih opicah cynomolgus (19. do 50. gestacijski dan (GD)) z začetnimi odmerki od 30 do 150 mg/kg in vzdrževalnimi odmerki na dva tedna 10 do 100 mg/kg.
Allergic and anaphylactic (more severe allergic) reactions with symptoms that may include swelling of your face and throat, with difficulty in breathing.
• alergijske in anafilaktične (hujše alergijske) reakcije s simptomi, ki se lahko kažejo kot oteklina obraza in žrela z oteženim dihanjem.
Chest symptoms such as a dry cough or breathlessness (possible signs of interstitial lung disease, a condition of damage to the tissues around the air sacs in the lungs) Fluid around the lungs causing difficulty in breathing
• simptomi v prsnem košu, kot je suh kašelj ali zasoplost (to so lahko znaki intersticijske pljučne bolezni, stanja poškodbe tkiva, ki se nahaja okoli pljučnih mešičkov) • zadrževanje vode okrog pljuč, kar povzroča težko dihanje.
The mean decrease from baseline at that time for physical function was -10.7 (95% CI-11.4, -10.0) in the Perjeta arm and -10.6 (95% CI -11.4, -9.9) in the placebo arm; global health status was -11.2 (95% CI -12.2, -10.2) in the Perjeta arm and -10.2
Za telesno zmogljivost je bilo takrat povprečno zmanjšanje od izhodišča -10,7 (95-% IZ -11,4, -10,0) v skupini z zdravilom Perjeta in -10,6 (95-% IZ11,4, -9,9) v skupini s placebom ter za splošno zdravstveno stanje -11,2 (95-% IZ -12,2, -10,2) v skupini z zdravilom Perjeta in -10,2 (95-% IZ -11,1,-9,2) v skupini s placebom.
Nodal status Positive
Stanje bezgavk pozitivno negativno
The higher incidence of febrile neutropenia in Perjeta-treated patients was associated with the higher incidence of mucositis and diarrhoea in these patients.
Večja incidenca febrilne nevtropenije pri bolnikih, ki so prejemali zdravilo Perjeta, je bila povezana z večjo incidenco mukozitisa in driske pri teh bolnikih.
In the neoadjuvant and adjuvant trials, hypersensitivity/anaphylaxis events were consistent with those observed in CLEOPATRA.
V preskušanjih neoadjuvantnega in adjuvantnega zdravljenja so bili preobčutljivostni/anafilaktični dogodki skladni z že opaženimi v preskušanju CLEOPATRA.
In early stage breast cancer, tumor size, grade, hormone receptor status and lymph node metastases should be taken into account in the risk assessment.
Pri oceni tveganja pri zgodnjem raku dojk je treba upoštevati velikost tumorja, stadij, status hormonskih receptorjev in metastaze v bezgavkah.
The infusion should be discontinued immediately and permanently if the patient experiences a NCICTCAE Grade 4 reaction (anaphylaxis), bronchospasm or acute respiratory distress syndrome (see section 4.4).
Infundiranje je treba nemudoma in dokončno ukiniti, če se razvije reakcija stopnje 4 po merilih NCICTCAE (anafilaksija), bronhospazem ali akutni respiratorni distresni sindrom (glejte poglavje 4.4).
Table 2 summarizes the ADRs from the Perjeta-treated groups of the following pivotal clinical trials:
Preglednica 2 povzema neželene učinke tistih skupin bolnikov, ki so prejemali zdravilo Perjeta v naslednjih ključnih kliničnih preskušanjih:
(vs Perjeta+ Trastuzumab+ Docetaxel)
(vs. Perjeta + trastuzumab + docetaksel)
A statistically significant improvement in pCR rate (ypT0/is) was observed in patients receiving Perjeta plus trastuzumab and docetaxel compared to patients receiving trastuzumab and docetaxel (45.8% vs 29.0%, p value = 0.0141).
Statistično pomembno izboljšanje v deležu pCR (ypT0/is) je bilo opaženo pri bolnicah, ki so prejemale zdravilo Perjeta, trastuzumab in docetaksel, v primerjavi z bolnicami, ki so prejemale trastuzumab in docetaksel (45,8 % v primerjavi z 29,0 %, p vrednost = 0,0141).
Docetaxel was given as an initial dose of 75 mg/m2 as an intravenous infusion every three weeks for at least 6 cycles.
Docetaksel je bil dan v začetnem odmerku 75 mg/m2 v intravenski infuziji vsake 3 tedne vsaj 6 ciklov.
no. of patients with an event Median months
Št. bolnikov z dogodkom
Among Asian patients, the incidence of febrile neutropenia was higher in the Perjeta-treated group (25.8%) compared with the placebo-treated group (11.3%).
Med bolniki azijske rase je bila incidenca febrilne nevtropenije večja v skupini, ki je prejemala zdravilo Perjeta (25,8 %) v primerjavi s skupino, ki je prejemala placebo (11,3 %).
The dose of docetaxel could be escalated to 100 mg/m2 at the investigator's discretion if the initial dose was well tolerated.
Odmerek docetaksela se je po presoji raziskovalca lahko povečal na 100 mg/m2, če je bolnik začetni odmerek dobro prenesel.