FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has waived the obligation to submit the results of studies with trastuzumab in all subsets of the paediatric population in breast and gastric cancer (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja trastuzumaba u svim podskupinama pedijatrijske populacije za rak dojke i želuca (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: For early breast cancer, metastatic breast cancer and metastatic gastric cancer, KANJINTI is given every 3 weeks.
Croatian: Za rani rak dojke, metastatski rak dojke i metastatski rak želuca, KANJINTI se primjenjuje svaka 3 tjedna.
English: Such methods must clearly be precise and accurate enough to demonstrate overexpression of HER2 and must be able to distinguish between moderate (congruent with 2+) and strong (congruent with 3+) overexpression of HER2.
Croatian: Takve metode moraju biti dovoljno precizne i točne u procjeni povećane ekspresije HER2 te moraju biti u stanju razlikovati umjereno (2+) i izrazito (3+) povećanu ekspresiju HER2.
English: Study H0648g: IHC3+ patient subset
Croatian: Ispitivanje H0648g: IHC3+ podskupina bolesnica
English: The effects may be moderate to severe and could cause death.
Croatian: Učinci mogu biti umjereni do teški te mogu dovesti do smrti.
English: As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during KANJINTI therapy and for 7 months after the last dose.
Croatian: Budući da se humani IgG1 izlučuje u majčino mlijeko u ljudi, a nema spoznaja o mogućem štetnom učinku na novorođenče, žene ne bi smjele dojiti tijekom liječenja lijekom KANJINTI ni 7 mjeseci nakon posljednje doze lijeka.
English: What KANJINTI is and what it is used for What you need to know before you are given KANJINTI How KANJINTI is given
Croatian: Što je KANJINTI i za što se koristi Što morate znati prije nego počnete primati KANJINTI Kako primjenjivati KANJINTI Moguće nuspojave
English: Very rarely, patients with severe breathing difficulties before treatment have died when they were given trastuzumab.
Croatian: Vrlo rijetko su bolesnici koji su i prije liječenja imali znatne poteškoće s disanjem preminuli nakon primjene trastuzumaba.
English: The bag should be gently inverted to mix the solution in order to avoid foaming.
Croatian: Vrećicu treba lagano okretati kako bi se otopina izmiješala bez stvaranja pjene.
English: As animal reproduction studies are not always predictive of human response, KANJINTI should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus.
Croatian: Budući da se na temelju ispitivanja provedenih na životinjama ne može pouzdano predvidjeti odgovor kod ljudi, primjenu lijeka KANJINTI u trudnoći treba izbjegavati osim ako je moguća korist za majku veća od moguće opasnosti za fetus.
English: +Cardiac failure (congestive)
Croatian: +zatajenje srca (kongestivno)
English: The exploratory analyses of covariates with information in only a subset of patients suggested that patients with greater shed HER2-ECD level had faster non-linear clearance (lower Km) (p < 0.001).
Croatian: Eksploracijske analize kovarijanti na temelju podataka prikupljenih samo u jednoj podskupini bolesnika pokazali su da su bolesnici s višom razinom odcjepljivanja HER2-ECD-a imali brži nelinearni klirens (niži Km) (P < 0,001).
English: Aseptic reconstitution and dilution:
Croatian: Aseptička rekonstitucija i razrjeđivanje:
English: • Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section 6.1
Croatian: • Preosjetljivost na trastuzumab, mišje proteine ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: The efficacy results from the interim efficacy analysis crossed the protocol pre-specified statistical boundary for the comparison of 1-year of trastuzumab versus observation.
Croatian: Rezultati djelotvornosti iz privremene analize djelotvornosti nadmašili su prethodno definiranu statističku graničnu vrijednost za usporedbu skupine liječene trastuzumabom tijekom 1 godine naspram opservacija.
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite was unclear.
Croatian: D7D niti klinički značaj povećanih koncentracija toga metabolita.
English: In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is KANJINTI (trastuzumab) and not trastuzumab emtansine.
Croatian: U svrhu sprečavanja medikacijskih pogrešaka, važno je provjeriti naljepnice na bočicama kako biste bili sigurni da je lijek koji se priprema i primjenjuje KANJINTI (trastuzumab), a ne trastuzumab emtanzin.
English: Positive
Croatian: Pozitivna
English: On very rare occasions, patients have experienced the onset of infusion symptoms and pulmonary symptoms more than six hours after the start of the trastuzumab infusion.
Croatian: U vrlo rijetkim slučajevima infuzijski i plućni simptomi pojavili su se nakon više od 6 sati od početka infuzije trastuzumaba.
English: SISH technology is however, recommended to allow for the parallel evaluation of tumour histology and morphology.
Croatian: SISH metoda se međutim preporučuje u svrhu istodobne procjene histologije i morfologije tumora.
English: To ensure accurate and reproducible results, the testing must be performed in a specialised laboratory, which can ensure validation of the testing procedures.
Croatian: Da bi se dobili točni i ponovljivi rezultati, ispitivanje se mora provesti u specijaliziranom laboratoriju koji može osigurati primjenu validiranih postupaka ispitivanja.
English: At the time of the analysis a total of 349 randomised patients had died: 182 patients (62.8%) in the control arm and 167 patients (56.8%) in the treatment arm.
Croatian: U vrijeme analize umrlo je 349 od ukupnog broja randomiziranih bolesnika: 182 bolesnika (62,8%) u kontrolnoj skupini i 167 bolesnika (56,8%) u ispitivanoj skupini.
English: The safety of continuation or resumption of trastuzumab in patients who experience cardiac dysfunction has not been prospectively studied.
Croatian: Sigurnost kontinuirane ili ponovne primjene trastuzumaba u bolesnika u kojih se razvila disfunkcija srca nije prospektivno ispitana.
English: Severe anaphylactic reactions requiring immediate additional intervention can occur usually during either the first or second infusion of trastuzumab (see section 4.4) and have been associated with a fatal outcome.
Croatian: Teške anafilaktičke reakcije koje zahtijevaju dodatnu hitnu intervenciju obično se javljaju tijekom 1. ili 2. infuzije trastuzumaba (vidjeti dio 4.4) i mogu završiti smrtnim ishodom.
English: In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of KANJINTI, or longer if a continuous decrease of LVEF is observed.
Croatian: U bolesnika koji primaju kemoterapiju koja sadrži antracikline, preporučuje se daljnje praćenje jednom godišnje do 5 godina od posljednje primjene lijeka KANJINTI ili dulje ako je uočeno daljnje smanjenje LVEF-a.
English: Women of childbearing potential should be advised to use effective contraception during treatment with KANJINTI and for 7 months after treatment has concluded (see section 5.2).
Croatian: Ženama reproduktivne dobi potrebno je preporučiti učinkovitu kontracepciju tijekom terapije lijekom KANJINTI i 7 mjeseci nakon prestanka liječenja (vidjeti dio 5.2).
English: Trastuzumab was administered weekly with chemotherapy and 3-weekly thereafter for a total of 52 weeks.
Croatian: Trastuzumab je primjenjivan tjedno uz kemoterapiju i svaka 3 tjedna nakon toga, ukupno 52 tjedna.
English: If you miss a dose of KANJINTI
Croatian: Ako propustite dozu lijeka KANJINTI
English: There was a correlation between shed antigen and SGOT/AST levels; part of the impact of shed antigen on clearance may have been explained by SGOT/AST levels.
Croatian: Postojala je korelacija između odcijepljenog antigena i razina SGOT-a/AST-a; dio utjecaja odcijepljenog antigena na klirens možda bi se mogao objasniti razinama SGOT-a/AST-a.
English: Monitoring may help to identify patients who develop cardiac dysfunction.
Croatian: Praćenjem je moguće uočiti bolesnike koji razvijaju disfunkciju srca.
English: Infusion solutions should be used immediately after dilution.
Croatian: Infuzijske otopine potrebno je primijeniti odmah nakon razrjeđivanja.
English: Occasionally, symptoms start later than six hours after the infusion begins.
Croatian: Simptomi ponekad mogu početi i više od 6 sati nakon početka infuzije.
English: They include weakening of the heart muscle possibly leading to heart failure, inflammation of the lining around the heart and heart rhythm disturbances.
Croatian: One uključuju slabljenje srčanog mišića, što može uzrokovati zatajivanje srca, upalu srčane ovojnice i poremećaje srčanog ritma.
English: At the time of a safety update after a median of 3.5-3.8 years follow-up, an analysis of DFS reconfirms the magnitude of the benefit shown in the definitive analysis of DFS.
Croatian: U vrijeme kontrole sigurnosti primjene nakon medijana praćenja od 3,5-3,8 godina, analiza preživljenja bez bolesti ponovno je potvrdila značajnu korist prikazanu u konačnoj analizi preživljenja bez bolesti.
English: Do not use KANJINTI if you notice any particulate matter or discolouration prior to administration.
Croatian: KANJINTI se ne smije upotrijebiti ako primijetite bilo kakve čestice ili promjenu boje prije primjene.
English: Reversibility of severe CHF (defined as a sequence of at least two consecutive LVEF values ≥ 50% after the event) was evident for 71.4% of trastuzumab-treated patients.
Croatian: Reverzibilnost teškog kongestivnog zatajenja srca (definirana kao slijed od najmanje dviju uzastopnih vrijednosti LVEF ≥ 50% nakon događaja) bila je primjetna u 71,4% bolesnika liječenih trastuzumabom.
English: Trastuzumab may have a minor influence on the ability to drive or use machines (see section 4.8).
Croatian: Trastuzumab može imati manji utjecaj na sposobnost upravljanja vozilima i rada sa strojevima (vidjeti dio 4.8).
English: A careful risk-benefit assessment should be made before deciding to treat with KANJINTI.
Croatian: Potrebna je pomna procjena rizika i koristi liječenja prije donošenja odluke o liječenju lijekom KANJINTI.
English: Total pathological complete response* (95% CI)
Croatian: Ukupan potpuni patološki odgovor* (95% CI)
English: Effect of antineoplastic agents on trastuzumab pharmacokinetics
Croatian: Učinak antineoplastika na farmakokinetiku trastuzumaba
English: The rate was highest in patients who were administered trastuzumab concurrently with a taxane (2.0%).
Croatian: Učestalost je bila najviša u bolesnika koji su trastuzumab primali istodobno s taksanima (2,0%).
English: The presence of anti-trastuzumab antibodies had no impact on the pharmacokinetics, efficacy (determined by pathological complete response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of trastuzumab intravenous.
Croatian: Prisutnost protutijela na trastuzumab nije utjecala na farmakokinetiku, djelotvornost (određenu potpunim patološkim odgovorom [engl. pathological complete response, pCR] i preživljenjem bez događaja [engl. event-free survival, EFS]) niti sigurnost određenu na temelju nastupa reakcija povezanih s primjenom lijeka trastuzumaba za intravensku primjenu.
English: Trastuzumab 1 Year N = 1,702***
Croatian: Trastuzumab tijekom 1 godine N = 1702***
English: Do not breast-feed your baby during KANJINTI therapy and for 7 months after the last dose as KANJINTI may pass to your baby through your breast milk.
Croatian: Nemojte dojiti dijete za vrijeme terapije lijekom KANJINTI ni 7 mjeseci nakon posljednje doze lijeka jer se KANJINTI preko vašeg mlijeka može prenijeti na vaše dijete.
English: Your doctor will prescribe a dose and treatment regimen that is right for you.
Croatian: Liječnik će Vam propisati dozu i način primjene koji Vama najviše odgovara.
English: Binding of trastuzumab to HER2 inhibits ligand-independent HER2 signalling and prevents the proteolytic cleavage of its extracellular domain, an activation mechanism of HER2.
Croatian: Vezanje trastuzumaba za HER2 inhibira HER2 signalni put neovisan od liganda i sprječava proteolitičko cijepanje njegove ekstracelularne domene, koje predstavlja aktivacijski mehanizam HER2.
English: *Cmin,ss - Cmin at steady-state **Cmax,ss = Cmax at steady-state *** time to 90% of steady-state
Croatian: *Cmin,ss - Cmin u stanju dinamičke ravnoteže **Cmax,ss = Cmax u stanju dinamičke ravnoteže *** vrijeme do postizanja 90% stanja dinamičke ravnoteže
English: AC→DH (vs. AC→D) (BCIRG 006)
Croatian: AC→DH (naspram AC→D) (BCIRG 006)
English: The median duration of follow-up was 2.9 years in the AC→D arm and 3.0 years in each of the AC→DH and DCarbH arms.
Croatian: Medijan praćenja iznosio je 2,9 godina u AC→D skupini i 3,0 godine u skupinama AC→DH i DcarbH.
English: What KANJINTI contains
Croatian: Što KANJINTI sadrži
English: Patients may continue therapy during periods of reversible, chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time.
Croatian: Liječenje se može nastaviti tijekom razdoblja reverzibilne, kemoterapijom izazvane mijelosupresije, ali je bolesnike tijekom tog razdoblja potrebno pažljivo promatrati kako bi se pravodobno opazile komplikacije neutropenije.
English: KANJINTI is for intravenous use only.
Croatian: KANJINTI se koristi samo za intravensku primjenu.
English: The difference was not statistically significant, however more than half of the patients in the anastrozole alone arm crossed over to a trastuzumab containing regimen after progression of disease.
Croatian: Razlika nije bila statistički značajna, no više od polovine bolesnica koje su primale samo anastrozol, nakon progresije bolesti počelo je primati terapiju koja je uključivala trastuzumab.
English: If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30-minute infusion.
Croatian: Ako je bolesnik dobro podnio početnu udarnu dozu, sljedeće se doze mogu primjenjivati u 30-minutnoj infuziji.
English: In all patients cardiac function should be monitored during treatment (e.g. every 12 weeks).
Croatian: Funkciju srca potrebno je pratiti tijekom liječenja (primjerice, svakih 12 tjedana) u svih bolesnika.
English: If you experience any of the above symptoms when your treatment with KANJINTI has finished, you should see your doctor and tell them that you have previously been treated with KANJINTI.
Croatian: Ako se neki od gore navedenih simptoma jave nakon prestanka liječenja lijekom KANJINTI, javite se svojem liječniku i recite mu da ste prethodno bili liječeni lijekom KANJINTI.
English: Study H0649g: IHC3+ patient subset
Croatian: 1. Ispitivanje H0649g: IHC3+ podskupina bolesnica
English: IHC is recommended as the first testing modality and in cases where HER2 gene amplification status is also required, either a silver-enhanced in situ hybridisation (SISH) or a FISH technique must be applied.
Croatian: IHC se preporučuje kao prvi način testiranja, a u slučajevima kod kojih je potreban i status HER2 genske amplifikacije treba primijeniti ili srebrom povećanu in situ hibridizaciju (SISH) ili FISH metodu.
English: The addition of trastuzumab to paclitaxel chemotherapy also resulted in a 37% decrease in the risk of death.
Croatian: Dodavanje trastuzumaba kemoterapiji paklitakselom rezultiralo je i smanjenjem rizika od smrti za 37%.
English: (day)
Croatian: (dani)
English: Patients were treated with trastuzumab until progression of disease.
Croatian: Bolesnice su primale trastuzumab sve do progresije bolesti.
English: No formal drug interaction studies have been performed.
Croatian: Nisu provedena formalna ispitivanja interakcija s drugim lijekovima.
English: which was followed by - CMF on day 1 and 8 every 4 weeks for 3 cycles which was followed after surgery by - additional cycles of adjuvant trastuzumab (to complete 1 year of treatment)
Croatian: a zatim - CMF 1. i 8. dana svaka 4 tjedna u 3 ciklusa a zatim nakon kirurškog zahvata - dodatni ciklusi adjuvantnog trastuzumaba (do dovršetka 1 godine liječenja).
English: Adjuvant treatment
Croatian: Adjuvantno liječenje
English: * Observed with combination therapy following anthracyclines and combined with taxanes.
Croatian: * Opaženo u kombinacijskoj terapiji nakon antraciklina i u kombinaciji s taksanima.
English: As a result, trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2.
Croatian: Kao rezultat toga, trastuzumab je i u pokusima in vitro i na životinjama inhibirao proliferaciju ljudskih tumorskih stanica koje imaju povećanu ekspresiju HER2.
English: Most of the patients (79%) who developed cardiac dysfunction in these trials experienced an improvement after receiving standard treatment for CHF.
Croatian: U većine bolesnica (79%) u kojih se u tim ispitivanjima razvila srčana disfunkcija došlo je do poboljšanja nakon što su primile standardnu terapiju za kongestivno zatajenje srca.
English: • acute accumulation of fluid in the lungs
Croatian: • akutno nakupljanje tekućine u plućima
English: Time to steadystate*** (week)
Croatian: Vrijeme do stanja dinamičke ravnoteže*** (tjedni)
English: The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1% versus 4.6% in the 1-year treatment arm).
Croatian: Stopa asimptomatske disfunkcije srca bila je povećana u skupini liječenoj tijekom 2 godine (8,1% naspram 4,6% u skupini liječenoj tijekom 1 godine).
English: p-value versus AC→P
Croatian: p-vrijednost naspram AC→P
English: Each carton contains one vial.
Croatian: Jedna kutija sadrži jednu bočicu.
English: KANJINTI treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see section 4.4), and should be administered by a healthcare professional only.
Croatian: Liječenje lijekom KANJINTI smije započeti samo liječnik s iskustvom u primjeni citotoksične kemoterapije (vidjeti dio 4.4), a lijek smije primijeniti samo zdravstveni radnik.
English: • Tumour lysis syndrome (a group of metabolic complications occurring after cancer treatment characterised by high blood levels of potassium and phosphate, and low blood levels of calcium).
Croatian: • Sindrom tumorske lize (skup metaboličkih komplikacija koje se javljaju nakon terapije za rak, a očituju se visokim razinama kalija i fosfata te niskim razinama kalcija u krvi).
English: Three-weekly and weekly schedule
Croatian: Trotjedni i tjedni ciklusi
English: Amongst the most serious and/or common adverse reactions reported in trastuzumab usage to date are cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions.
Croatian: Među najozbiljnije i/ili najčešće nuspojave dosad prijavljene pri primjeni trastuzumaba ubrajaju se disfunkcija srca, reakcije povezane s infuzijom, hematotoksičnost (osobito neutropenija) infekcije i plućne nuspojave.
English: A volume overage of 4% ensures that the labelled dose of 150 mg can be withdrawn from each vial.
Croatian: Višak volumena od 4% jamči da se naznačena doza od 150 mg može izvući iz svake bočice.
English: The administration of concomitant anastrozole did not appear to influence the pharmacokinetics of trastuzumab.
Croatian: Čini se da istodobna primjena anastrozola ne utječe na farmakokinetiku trastuzumaba.
English: If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping KANJINTI.
Croatian: Ako je moguće, uputno je izbjegavati primjenu antraciklinske terapije do 7 mjeseci nakon prestanka primjene lijeka KANJINTI.
English: • shock
Croatian: • šok
English: For overall survival, the HR was 0.75 (95% CI 0.51-1.11) in the IHC 2+/FISH+ group and the HR was 0.58 (95% CI 0.41-0.81) in the IHC 3+/FISH+ group.
Croatian: HR za ukupno preživljenje je bio 0,75 (95% CI 0,51-1,11) u skupini IHC 2+/FISH+ i 0,58 (95% CI 0,41-0,81) u skupini IHC 3+/FISH+.
English: Trastuzumab plus docetaxel4 N = 110
Croatian: Trastuzumab plus docetaksel4 N = 110
English: KANJINTI vial
Croatian: KANJINTI bočica
English: 2) Swirl the vial gently to aid reconstitution.
Croatian: 2) Bočicu nježno zaokrećite kako bi se pospješila rekonstitucija.
English: General considerations
Croatian: Opća razmatranja
English: • heartburn (dyspepsia)
Croatian: • žgaravica (dispepsija)
English: The median overall survival was extended by 4.6 months for patients in the combination arm.
Croatian: Medijan ukupnog preživljenja produljen je za 4,6 mjeseci u skupini koja je primala kombiniranu terapiju.
English: The infusion may be continued after the symptoms improve.
Croatian: Infuzija se može nastaviti nakon smanjenja simptoma.
English: • you have severe breathing problems at rest due to your cancer or if you need oxygen treatment.
Croatian: • ako zbog raka imate ozbiljnih poteškoća s disanjem u mirovanju ili Vam je potrebno liječenje kisikom.
English: However, the majority of infusion-related reactions are mild to moderate in intensity (NCI-CTC grading system) and tend to occur earlier in treatment, i.e. during infusions one, two and three and lessen in frequency in subsequent infusions.
Croatian: Međutim, većina infuzijskih reakcija je blagog do umjerenog intenziteta (prema NCI-CTC stupnjevanju) i uglavnom se javlja na početku liječenja tj. za vrijeme 1., 2. i 3. infuzije te im se učestalost smanjuje sa svakom sljedećom infuzijom.
English: Risk factors for a cardiac event identified in four large adjuvant studies included advanced age (> 50 years), low LVEF (< 55%) at baseline, prior to or following the initiation of paclitaxel treatment, decline in LVEF by 10-15 points, and prior or concurrent use of anti-hypertensive medicinal products.
Croatian: Faktori rizika za srčani događaj utvrđeni u četiri velika ispitivanja adjuvantnog liječenja uključivali su stariju dob (> 50 godina), nizak LVEF (< 55%) na početku liječenja, prije ili nakon početka liječenja paklitakselom, pad LVEF-a za 10-15 bodova te prethodnu ili istodobnu primjenu antihipertenziva.
English: The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27%), and was significantly higher than for anthracycline/cyclophosphamide alone (7%-10%).
Croatian: Najviša stopa srčane disfunkcije zabilježena je u bolesnica koje su primale trastuzumab istodobno s antraciklinom/ciklofosfamidom (27%), što je bilo značajno više nego kod primjene samo antraciklina/ciklofosfamida (7% - 10%).
English: Post-hoc subgroup analyses indicate that positive treatment effects are limited to targeting tumours with higher levels of HER2 protein (IHC 2+/FISH+ or IHC 3+).
Croatian: Rezultati post hoc analiza podskupina pokazuju da su pozitivni učinci liječenja ograničeni na tumore s višim razinama HER2 proteina (IHC 2+/FISH+ ili IHC 3+).
English: Patients treated with KANJINTI are at increased risk for developing CHF (New York Heart Association [NYHA] class II-IV) or asymptomatic cardiac dysfunction.
Croatian: U bolesnika liječenih lijekom KANJINTI postoji povećan rizik od razvoja kongestivnog zatajenja srca (engl. congestive heart failure, CHF) (klase II-IV prema New York Heart Association [NYHA]) ili asimptomatske disfunkcije srca.
English: A volume overage of 5% ensures that the labelled dose of 420 mg can be withdrawn from each vial.
Croatian: Višak volumena od 5% jamči da se naznačena doza od 420 mg može izvući iz svake bočice.
English: • You have metastatic gastric cancer with high levels of HER2, when it is in combination with the other cancer medicines capecitabine or 5-fluorouracil and cisplatin.
Croatian: • bolujete od metastatskog raka želuca s visokom razinom proteina HER2, u kombinaciji s drugim lijekovima za liječenje raka, kapecitabinom ili 5-fluorouracilom i cisplatinom.
English: Docetaxel3 N = 94
Croatian: Docetaksel3 N = 94