natgillin/translations-raw huggingface dataset:
If LVEF has not improved, or has declined further, or if symptomatic congestive heart failure (CHF) has developed, discontinuation of Herceptin should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks.
Ako se LVEF ne poboljša ili se još više smanji, ili ako se razvije simptomatsko kongestivno zatajenje srca (CHF), potrebno je ozbiljno razmotriti mogućnost prekida liječenja lijekom Herceptin, osim u slučaju kada koristi za pojedinog bolesnika nadmašuju rizike.
The reconstituted Herceptin solution contains 21 mg/mL of trastuzumab.
Rekonstituirana otopina lijeka Herceptin sadrži 21 mg/ml trastuzumaba.
If other medicines for subcutaneous use are used during the treatment course with Herceptin, a different injection site should be used.
Ako se tijekom ciklusa liječenja lijekom Herceptin primjenjuju i drugi lijekovi za potkožnu primjenu, njih treba primijeniti na neko drugo mjesto.
For subcutaneous use only
Samo za supkutanu primjenu
Causing excessive foaming during reconstitution or shaking the reconstituted solution may result in problems with the amount of Herceptin that can be withdrawn from the vial.
Stvaranje prevelike pjene tijekom rekonstitucije ili prejako protresanje rekonstituirane otopine može uzrokovati poteškoće s izvlačenjem odgovarajuće količine lijeka Herceptin iz bočice.
One 6 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film containing 5 mL of solution (600 mg of trastuzumab).
Jedna prozirna staklena bočica od 6 ml (staklo tipa I) s butilnim gumenim čepom presvučenim fluoro-rezinskim filmom sadrži 5 ml otopine (600 mg trastuzumaba).
Congestive heart failure (NYHA Class II-IV) is a common adverse reaction to Herceptin.
Kongestivno zatajenje srca (NYHA klase II-IV) česta je nuspojava kod primjene lijeka Herceptin.
- intravenous cyclophosphamide, at 600 mg/ m2 over 30 minutes, given every 3 weeks for 4
- intravenski ciklofosfamid u dozi od 600 mg/m2 kroz 30 minuta, svaka 3 tjedna u 4 ciklusa
The mean Ctrough during the neoadjuvant treatment phase, at the pre dose Cycle 8 time point, was higher in the Herceptin subcutaneous arm (78.7 µg/mL) than the Herceptin intravenous arm
Srednja vrijednost Ctrough tijekom neoadjuvantne faze liječenja, u trenutku prije primjene doze u 8. ciklusu, bila je viša u skupini koja je primala Herceptin u supkutanoj formulaciji (78,7 µg/ml) nego u skupini koja je primala intravensku formulaciju lijeka Herceptin (57,8 µg/ml).
Symptoms may include kidney problems (weakness, shortness of breath, fatigue and confusion), heart problems (fluttering of the heart or a faster or slower heartbeat), seizures, vomiting or diarrhoea and tingling in the mouth, hands or feet
Simptomi mogu uključivati bubrežne tegobe (slabost, nedostatak zraka, umor i smetenost), srčane tegobe (lepršanje srca te ubrzani ili usporeni otkucaji srca), napadaje, povraćanje ili proljev te trnce u ustima, šakama ili stopalima.
Study MO22982 investigated switching between the Herceptin intravenous and Herceptin subcutaneous formulation with a primary objective to evaluate patient preference for either the intravenous or the subcutaneous route of trastuzumab administration.
U ispitivanju MO22982 istraživao se prelazak s intravenske formulacije lijeka Herceptin na supkutanu formulaciju lijeka Herceptin i obrnuto, a primarni je cilj bio ocijeniti daju li bolesnici prednost intravenskom ili supkutanom putu primjene trastuzumaba.
Detection of HER2 overexpression or HER2 gene amplification in breast cancer Herceptin should only be used in patients whose tumours have HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
Određivanje povećane ekspresije HER2 ili genske amplifikacije HER2 kod raka dojke Herceptin se smije primjenjivati samo u onih bolesnika s tumorima čije stanice pokazuju povećanu ekspresiju HER2 ili HER2 gensku amplifikaciju utvrđenu preciznom i validiranom metodom.
1 Year N = 1693
N = 1693
Median TTP (months) (95 %CI)
Medijan TTP (mjeseci) (95%CI)
Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with Herceptin treatment, although the risk is lower than with concurrent use of Herceptin and anthracyclines.
U bolesnika s metastatskim rakom dojke koji su prethodno primali antracikline je također povećan rizik od disfunkcije srca pri liječenju lijekom Herceptin, premda je on manji od rizika u bolesnika koji istodobno primaju Herceptin i antracikline.
Patients who receive anthracyclines after stopping Herceptin may possibly be at increased risk of cardiac dysfunction.
U bolesnika koji nakon prestanka liječenja lijekom Herceptin počnu uzimati antracikline postoji povećan rizik disfunkcije srca.
- intravenous docetaxel - 75 mg/m2 as an intravenous infusion over 1 hour, given every 3 weeks for 6 cycles (day 2 of cycle 1, then day 1 of each subsequent cycle) which was followed by: - carboplatin - at target AUC = 6 mg/mL/min administered by intravenous infusion over 3060 minutes repeated every 3 weeks for a total of six cycles
- intravenski docetaksel - 75 mg/m2 u intravenskoj infuziji tijekom 1 sata, svaka 3 tjedna u 6 ciklusa (2. dan 1. ciklusa, a potom 1. dan svakog sljedećeg ciklusa) nakon čega je slijedio: - karboplatin - s ciljnom AUC = 6 mg/ml/min, primijenjen u intravenskoj infuziji tijekom 30-60 minuta, svaka 3 tjedna u ukupno 6 ciklusa
In this trial, 2 cohorts (one using subcutaneous formulation in vial and one using subcutaneous formulation in administration system) were investigated using a 2-arm, cross-over design with 488 patients being randomized to one of two different three-weekly Herceptin treatment sequences (IV [Cycles 1-4]→ SC [Cycles 5-8], or SC [Cycles 1-4]→ IV [Cycles 5-8]).
Radilo se o ukriženom ispitivanju s dvije skupine, u kojem je 488 bolesnika bilo randomizirano da prima jedan od dvaju različitih trotjednih sljedova liječenja lijekom Herceptin (i.v. [1.-4. ciklus] → s.c. [5.-8. ciklus] ili s.c. [1.-4. ciklus] → i.v. [5.-8. ciklus]).
At 8 years, the survival rate was estimated to be 86.9% in the AC→PH arm and 79.4% in the AC→P arm, an absolute benefit of 7.4% (95% CI 4.9%, 10.0%).
Procijenjena stopa preživljenja nakon 8 godina iznosila je 86,9% u skupini liječenoj AC→PH kemoterapijom te 79,4% u skupini koja je primala AC→P kemoterapiju, što ukazuje na apsolutnu korist od 7,4% (95% CI 4,9%, 10,0%).
Only patients with a large amount of HER2 will be treated with Herceptin.
Lijekom Herceptin će biti liječeni samo bolesnici s visokom razinom HER2.
Table 6 Efficacy Results from Study BO16348
Tablica 6 Rezultati djelotvornosti iz ispitivanja BO16348
The results of this substudy suggested that the exposure to the bioactive metabolites (e.g. 5-FU) of capecitabine was not affected by concurrent use of cisplatin or by concurrent use of cisplatin plus Herceptin.
Rezultati ovog podispitivanja ukazali su da istodobna primjena cisplatina ili istodobna primjena cisplatina i lijeka Herceptin ne utječe na izloženost bioaktivnim metabolitima (npr. 5-FU) kapecitabina.
However, capecitabine itself showed higher concentrations and a longer half-life when combined with Herceptin.
Međutim, kod istodobne primjene s lijekom Herceptin koncentracije samog kapecitabina bile su povećane, a njegov poluvijek produljen.
Other symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired.
Ostale nuspojave su: mučnina, povraćanje, bol, povećana napetost mišića i drhtanje, glavobolja, omaglica, otežano disanje, piskanje, visok ili nizak krvni tlak, poremećaji srčanog ritma (osjećaj lupanja srca, lepršanje srca ili nepravilni otkucaji srca), oticanje lica i usana, osip i umor.
Herceptin plus paclitaxel2
Herceptin s paklitakselom2
The population predicted PK exposure values (median with 5th - 95th Percentiles) and PK parameter values at clinically relevant concentrations (Cmax and Cmin) for MBC, EBC and AGC patients treated with the approved q1w and q3w dosing regimens are shown in Table 14 (Cycle 1), Table 15 (steadystate), and Table 16 (PK parameters).
Vrijednosti farmakokinetičke izloženosti predviđene za populaciju (medijan i 5. do 95. percentil) i vrijednosti farmakokinetičkih parametara pri klinički značajnim koncentracijama (Cmax i Cmin) za bolesnike s metastatskim rakom dojke, ranim rakom dojke i uznapredovalim rakom želuca koji se liječe odobrenim režimima doziranja jedanput na tjedan i jedanput svaka 3 tjedna prikazane su u nastavku, u Tablici 14 (1. ciklus), Tablici 15 (stanje dinamičke ravnoteže) i Tablici 16 (farmakokinetički parametri).
Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC):
Herceptin je indiciran u liječenju odraslih bolesnika s HER2 pozitivnim metastatskim rakom dojke:
The recommended dose is 600 mg. Herceptin is given as a subcutaneous injection (under the skin) over 2 to 5 minutes every three weeks.
Herceptin se primjenjuje supkutanom injekcijom (injekcijom pod kožu) tijekom 2 do 5 minuta svaka tri tjedna.
Patients should be observed for ARRs for six hours after the first injection and for two hours after subsequent injections.
Bolesnike treba motriti šest sati nakon prve injekcije te dva sata nakon svake sljedeće injekcije zbog moguće pojave reakcija povezanih s primjenom lijeka.
Administration-related reactions/hypersensitivity
Reakcije povezane s primjenom lijeka/preosjetljivost
In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1 % (30/296) of patients treated with Herceptin intravenous developed antibodies against trastuzumab.
U sklopu ispitivanja neoadjuvantnog-adjuvantnog liječenja ranog raka dojke (BO22227), nakon medijana praćenja od više od 70 mjeseci, u 10,1% (30/296) bolesnika liječenih lijekom Herceptin za intravensku primjenu razvila su se protutijela na trastuzumab.
- Study BCIRG 006 study was designed to investigate combining Herceptin treatment with docetaxel either following AC chemotherapy or in combination with docetaxel and carboplatin in patients with HER2 positive EBC following surgery.
- Ispitivanje BCIRG 006 s ciljem istraživanja kombiniranog liječenja lijekom Herceptin i docetakselom nakon AC kemoterapije ili u kombinaciji s docetakselom i karboplatinom u bolesnica s HER2 pozitivnim ranim rakom dojke nakon kirurškog zahvata.
All candidates for treatment with Herceptin, but especially those with prior anthracycline and cyclophosphamide exposure, should undergo baseline cardiac assessment including history and physical examination and electrocardiogram (ECG), echocardiogram, and/or multigated acquisition (MUGA) scan or magnetic resonance imaging.
Svi bolesnici koji su kandidati za liječenje lijekom Herceptin, osobito oni prethodno liječeni antraciklinima i ciklofosfamidom, prije početka liječenja moraju obaviti osnovni kardiološki pregled koji uključuje uzimanje anamneze, fizikalni pregled i elektrokardiogram (EKG), ultrazvuk srca i/ili radionuklidnu ventrikulografiju (MUGA) ili magnetsku rezonanciju.
Cycle 1 297 Cycle 7 (steady state)
7. ciklus (stanje dinamičke ravnoteže)
In the BCIRG 006 study HER2 positive, EBC was defined as either lymph node positive or high risk node negative patients with no (pN0) lymph node involvement, and at least 1 of the following factors: tumour size greater than 2 cm, estrogen receptor and progesterone receptor negative, histological and/or nuclear grade 2-3, or age < 35 years.
U ispitivanju BCIRG 006 HER2 pozitivni rani rak dojke bio je definiran bilo kao tumor s pozitivnim limfnim čvorovima ili visokorizični tumor s negativnim limfnim čvorovima (pN0) te barem jednim od sljedećih čimbenika: tumor veći od 2 cm, negativni estrogenski i progesteronski receptori, histološki i/ili nuklearni gradus 2-3 ili dob < 35 godina.
No reductions in the dose of Herceptin were made during clinical trials.
Tijekom kliničkih ispitivanja doza lijeka Herceptin nije bila smanjivana.
Very common side effects of Herceptin: may affect more than 1 in 10 people
Vrlo česte nuspojave lijeka Herceptin: mogu se javiti u više od 1 na 10 osoba
Weak to moderate complete, basolateral or lateral membranous reactivity in ≥ 10 % of tumour cells
Slaba do umjereno potpuna, bazolateralna ili lateralna membranska reaktivnost u ≥ 10 % tumorskih stanica
In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1% (30/296) of patients treated with Herceptin intravenous and 15.9 % (47/295) of patients receiving Herceptin subcutaneous vial developed antibodies against trastuzumab.
U sklopu ispitivanja neoadjuvantnog-adjuvantnog liječenja ranog raka dojke (BO22227), nakon medijana praćenja od više od 70 mjeseci, u 10,1% (30/296) bolesnika liječenih lijekom Herceptin za intravensku primjenu te 15,9% (47/295) bolesnika liječenih lijekom Herceptin za supkutanu primjenu u bočici razvila su se protutijela na trastuzumab.
Table 12 Efficacy Results from MO16432
Tablica 12 Rezultati djelotvornosti iz ispitivanja MO16432
Study BO22227 was designed to demonstrate non-inferiority of treatment with Herceptin subcutaneous formulation versus Herceptin intravenous formulation based on co-primary PK and efficacy endpoints (trastuzumab Ctrough at pre-dose Cycle 8, and pCR rate at definitive surgery, respectively).
Ispitivanje BO22227 bilo je dizajnirano tako da dokaže neinferiornost liječenja supkutanom formulacijom lijeka Herceptin u odnosu na intravensku formulaciju lijeka Herceptin na temelju dviju primarnih mjera ishoda - za farmakokinetiku i djelotvornost (Ctrough trastuzumaba prije primjene doze u 8. ciklusu odnosno pCR pri definitivnom kirurškom zahvatu).
In the pivotal trial BO22227, there were more than twice as many patients reporting all grade hypertension with the Herceptin subcutaneous formulation (4.7 % versus 9.8 % in the intravenous and subcutaneous formulations respectively), with a greater proportion of patients with severe events (NCI
U pivotalnom ispitivanju BO22227 hipertenziju je prijavio više nego dvostruko veći broj bolesnica koje su primale Herceptin u supkutanoj formulaciji (4,7% uz intravensku formulaciju naspram 9,8% uz supkutanu formulaciju), a pritom je i veći udio bolesnica prijavio teške događaje (NCI CTCAE stupnja ≥ 3), < 1% uz intravensku formulaciju naspram 2,0% uz supkutanu formulaciju.
In the pivotal trial BO22227, Herceptin was administered concurrently with neoadjuvant chemotherapy that contained four cycles of epirubicin (cumulative dose 300 mg/m2); at a median follow-up exceeding 70 months, the incidence of cardiac failure/congestive cardiac failure was 0.3% in the Herceptin intravenous arm.
U pivotalnom ispitivanju BO22227, Herceptin se primjenjivao istodobno s neoadjuvantnom kemoterapijom koja se sastojala od četiri ciklusa epirubicina (kumulativna doza: 300 mg/m2); nakon medijana praćenja od više od 70 mjeseci, incidencija zatajenja srca/kongestivnog zatajenja srca iznosila je 0,3% u skupini koja je primala Herceptin za intravensku primjenu.
Table 10 Overview of Efficacy Analyses BCIRG 006 AC→D versus DCarbH Parameter
Tablica 10 Pregled analize djelotvornosti u ispitivanju BCIRG 006; AC→D u odnosu na DcarbH
The analysis of the efficacy co-primary endpoint, pCR, defined as absence of invasive neoplastic cells in the breast, resulted in rates of 40.7 % (95 % CI: 34.7, 46.9) in the Herceptin intravenous arm and 45.4 % (95 % CI: 39.2 %, 51.7 %) in the Herceptin subcutaneous arm, a difference of 4.7 percentage points in favour of the Herceptin subcutaneous arm.
Rezultati analize primarne mjere ishoda za djelotvornost, potpunog patološkog odgovora (pCR), koji je definiran kao nepostojanje invazivnih neoplastičnih stanica u dojci, pokazali su stopu od 40,7% (95% CI: 34,7; 46,9) u skupini koja je primala intravensku formulaciju lijeka Herceptin i 45,4%
In one of the 3 pivotal studies conducted in which a median follow-up of 5.5 years was available (BCIRG006) a continuous increase in the cumulative rate of symptomatic cardiac or LVEF events was observed in patients who were administered Herceptin concurrently with a taxane following anthracycline therapy up to 2.37% compared to approximately 1% in the two comparator arms (anthracycline plus cyclophosphamide followed by taxane and taxane, carboplatin and Herceptin).
U jednom od 3 provedena pivotalna ispitivanja s medijanom vremena praćenja od 5,5 godina (BCIRG006), u bolesnica koje su nakon anatraciklinske terapije Herceptin primale istodobno s taksanima zabilježen je kontinuirani porast kumulativne stope simptomatskih srčanih događaja ili događaja povezanih s LVEF-om (do 2,37%) u odnosu na oko 1% u dvije usporedne skupine (antraciklin plus ciklofosfamid uz nastavak liječenja taksanima te kombinacija taksana, karboplatina i lijeka Herceptin).
No. patients with event p=0.0275
Broj bolesnica s događajem p=0,0275
As a three-weekly regimen the recommended initial loading dose of Herceptin is 8 mg/kg body weight.
U trotjednim ciklusima preporučena početna udarna doza lijeka Herceptin iznosi 8 mg/kg tjelesne težine.
In patients with EBC an increase in the incidence of symptomatic and asymptomatic cardiac events was observed when Herceptin was administered after anthracycline-containing chemotherapy compared to administration with a non-anthracycline regimen of docetaxel and carboplatin and was more marked when Herceptin was administered concurrently with taxanes than when administered sequentially to taxanes.
U bolesnika s ranim rakom dojke zabilježeno je povećanje incidencije simptomatskih i asimptomatskih srčanih događaja pri primjeni lijeka Herceptin nakon kemoterapije antraciklinima, u odnosu na njegovu primjenu nakon neantraciklinskog protokola s docetakselom i karboplatinom, a taj je porast incidencije bio izraženiji kada se Herceptin primjenjivao istodobno s taksanima nego kada se primjenjivao nakon terapije taksanima.
In 3 pivotal EBC clinical trials of adjuvant intravenous Herceptin given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic congestive heart failure) was similar in patients who were administered chemotherapy alone (ie did not receive Herceptin) and in patients who were administered Herceptin sequentially after a taxane (0.3-0.4 %).
U 3 pivotalna klinička ispitivanja adjuvantnoga liječenja ranog raka dojke primjenom intravenske formulacije lijeka Herceptin u kombinaciji s kemoterapijom, incidencija disfunkcije srca stupnja 3/4 (osobito simptomatsko kongestivno zatajenje srca) bila je podjednaka u bolesnica kojima je primijenjena samo kemoterapija (tj. koji nisu primale Herceptin) i bolesnika koje su primile Herceptin nakon taksana (0,3-0,4%).
AC→D = doxorubicin plus cyclophosphamide, followed by docetaxel; DCarbH = docetaxel, carboplatin and trastuzumab; CI = confidence interval
AC→D = doksorubicin i ciklofosfamid nakon kojih slijedi docetaksel; DCarbH = docetaksel, karboplatin i trastuzumab; CI = interval pouzdanosti
All candidates for treatment with Herceptin, but especially those with prior anthracycline and cyclophosphamide (AC) exposure, should undergo baseline cardiac assessment including history and physical examination, electrocardiogram (ECG), echocardiogram, and/or multigated acquisition (MUGA) scan or magnetic resonance imaging.
Svi bolesnici koji su kandidati za liječenje lijekom Herceptin, osobito oni prethodno liječeni antraciklinima i ciklofosfamidom (AC protokol), prije početka liječenja moraju obaviti osnovni kardiološki pregled koji uključuje uzimanje anamneze, fizikalni pregled, elektrokardiogram (EKG), ultrazvuk srca i/ili radionuklidnu ventrikulografiju (MUGA) ili magnetsku rezonanciju.
A population PK model with parallel linear and nonlinear elimination from the central compartment was constructed using pooled Herceptin SC and Herceptin IV PK data from the phase III study BO22227 to describe the observed PK concentrations following Herceptin IV and Herceptin SC administration in EBC patients.
Populacijski farmakokinetički model s paralelnom linearnom i nelinearnom eliminacijom iz središnjeg odjeljka izrađen je na temelju objedinjenih farmakokinetičkih podataka za supkutanu formulaciju lijeka Herceptin i intravensku formulaciju lijeka Herceptin iz ispitivanja faze III (BO22227) kako bi se opisale farmakokinetičke koncentracije primijećene nakon primjene intravenske formulacije lijeka Herceptin i supkutane formulacije lijeka Herceptin u bolesnika s ranim rakom dojke.
Ejection fraction decreased*
1 undulacija srca smanjena ejekcijska frakcija*
In patients with EBC an increase in the incidence of symptomatic and asymptomatic cardiac events was observed when Herceptin (intravenous formulation) was administered after anthracyclinecontaining chemotherapy compared to administration with a non-anthracycline regimen of docetaxel and carboplatin and was more marked when Herceptin (intravenous formulation) was administered concurrently with taxanes than when administered sequentially to taxanes.
U bolesnika s ranim rakom dojke zabilježeno je povećanje incidencije simptomatskih i asimptomatskih srčanih događaja pri primjeni lijeka Herceptin (intravenska formulacija) nakon kemoterapije antraciklinima, u odnosu na njegovu primjenu nakon neantraciklinskog protokola s docetakselom i karboplatinom, a taj je porast incidencije bio izraženiji kada se Herceptin (intravenska formulacija) primjenjivao istodobno s taksanima nego kada se primjenjivao nakon terapije taksanima.
- intravenous paclitaxel - 175 mg/m2 as a continuous intravenous infusion, given every 3 weeks for 4 cycles (day 1 of each cycle).
- intravenski paklitaksel - 175 mg/m2 u kontinuiranoj intravenskoj infuziji svaka 3 tjedna u 4 ciklusa (1. dan svakog ciklusa)
Pharmacokinetic data from studies BO15935 and M77004 in women with HER2-positive MBC suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-α hydroxyl paclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab (8 mg/kg or
Farmakokinetički podaci iz ispitivanja BO15935 i M77004 u žena s HER2-pozitivnim metastatskim rakom dojke ukazali su da prisutnost trastuzumaba (intravenska udarna doza od 8 mg/kg odnosno 4 mg/kg, nakon koje slijedi intravenska doza od 6 mg/kg svaka 3 tjedna odnosno 2 mg/kg jedanput tjedno) nije promijenila izloženost paklitakselu i doksorubicinu (i njihovim glavnim metabolitima 6-α hidroksil-paklitakselu, POH, i doksorubicinolu, DOL).
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 600 mg/5 mL trastuzumab.
TVARI Jedna bočica sadrži 600 mg/5 ml trastuzumaba.
Herceptin plus docetaxel3
Herceptin s docetakselom3
Herceptin IV is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Herceptin za intravensku primjenu dolazi u sterilnim, nepirogenim bočicama za jednokratnu uporabu koje ne sadrže konzervanse.
Herceptin in the control arm, the addition of Herceptin to paclitaxel chemotherapy resulted in a 52 % decrease in the risk of disease recurrence.
Unatoč prijelazu na liječenje lijekom Herceptin u kontrolnoj skupini, dodavanje lijeka Herceptin kemoterapiji paklitakselom rezultiralo je smanjenjem rizika od ponovne pojave bolesti za 52 %.
Herceptin should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result.
Herceptin treba davati samo onim bolesnicima s metastatskim rakom želuca čije tumorske stanice pokazuju povećanu ekspresiju HER2 određenu imunohistokemijski kao 2+ i potvrđenu SISH-om ili FISH-om, ili određenu imunohistokemijski kao 3+.