natgillin/translations-raw huggingface dataset:
In patients who experienced either febrile neutropenia, neutrophil count < 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from 75 to 60 mg/m².
Pri bolnikih, ki so med zdravljenjem z docetakselom doživeli febrilno nevtropenijo, zmanjšanje števila nevtrofilcev na < 500 celic/mm3 za več kot en teden, hude ali kumulativne kožne reakcije ali hudo periferno nevropatijo, je treba odmerek docetaksela zmanjšati s 100 mg/m2 na 75 mg/m2 oz. s 75 na 60 mg/m2.
Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Učinkovitost docetaksela pri zdravljenju bolnikov z adenokarcinomom želodca
• stomach upsets including nausea, vomiting and diarrhoea, constipation
• draženje želodca, vključno s slabostjo, bruhanjem in drisko, zaprtje,
Acute myeloid leukemia and myelodysplastic syndrome have been reported (frequency uncommon) in pivotal clinical studies in breast cancer with TAC regimen.
O akutni mieloični levkemiji in mielodisplastičnem sindromu so (s pogostnostjo "občasno") poročali v ključnih kliničnih študijah pri raku dojke s shemo TAC.
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema:
In addition, dexamethasone did not affect protein binding of docetaxel.
Tudi deksametazon ni vplival na vezavo docetaksela na beljakovine.
Docetaxel is highly protein bound (> 95%).
Docetaksel je v veliki meri (> 95 %) vezan na beljakovine.
• tiredness; or flu-like symptoms
• utrujenost ali gripi podobni simptomi,
Infusion site reaction; Pain
reakcija na mestu infundiranja, bolečine
In first-line treatment, docetaxel 75 mg/m2 is given in combination therapy with doxorubicin (50 mg/m2).
Kot zdravljenje prvega izbora se docetaksel 75 mg/m2 daje v kombinaciji z doksorubicinom (50 mg/m2).
As with all parenteral products, DOCETAXEL KABI infusion solution should be visually inspected prior to use, and solutions containing a precipitate should be discarded.
Tako kot vsa zdravila za parenteralno uporabo je treba tudi raztopino za infundiranje zdravila DOCETAKSEL KABI pred uporabo vizualno pregledati, in če vsebuje precipitat, jo je treba zavreči.
At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (TPF/RT).
Na koncu kemoterapije (z najkrajšim presledkom 4 tedne in najdaljšim presledkom 7 tednov) so bolniki, ki jim bolezen ni napredovala, 7 tednov dobivali radioterapijo (RT) v skladu s smernicami ustanove (TPF/RT).
**un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
*nekorigirani log-rang test **nekorigirani log-rang test, nekorigiran za multiple primerjave ***test hi-kvadrat, nekorigiran za multiple primerjave NP - ni podatka
Second episode: stop 5-FU only, at all subsequent cycles.
Drugi pojav: med vsemi naslednjimi cikli opustite le 5-FU.
• Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
• Celotni delež odziva je bil v kraku AT značilno večji kot v kraku AC, p = 0,009.
Overall survival was also significantly longer (p = 0.0201) in favour of the TCF arm with a risk reduction of mortality of 22.7%.
V kraku s TCF je bilo značilno daljše (p = 0,0201) tudi celotno preživetje, tveganje umrljivosti pa se je zmanjšalo za 22,7 %.
- The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and anhydrous citric acid (for pH adjustment).
- Pomožne snovi so polisorbat 80, brezvodni etanol (glejte poglavje 2) in brezvodna citronska kislina (za uravnavanje pH).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Fresenius Kabi Deutschland GmbH
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Fresenius Kabi Deutschland GmbH
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomised multi-centre phase III study.
Varnost in učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom pri bolnikih z metastatskim hormonsko neodzivnim rakom prostate je bila ocenjena v randominizirani multicentrični študiji faze III.
In patients treated with docetaxel every three weeks, the incidence of related nail changes occurred at a rate ≥ 10% higher in patients who were 65 years of age or greater compared to younger patients.
Pri bolnikih zdravljenih z docetakselom vsake tri tedne, ki so bili starejši od 65 let, je bila incidenca pojavljanja z zdravljenjem povezanih sprememb na nohtih ≥ 10 % večja v primerjavi z mlajšimi bolniki.
Median survival was 442 days (docetaxel + capecitabine) vs. 352 days (docetaxel alone).
Mediana preživetja je bila 442 dni (docetaksel + kapecitabin) v prim.
Without affecting the primary endpoint, overall response rate (32% vs 25%, p = 0.10), docetaxel prolonged median time to progression (24.6 weeks vs 15.6 weeks; p < 0.01) and median survival (15.3 months vs 12.7 months; p = 0.03).
Docetaksel ni vplival na primarno končno točko, celotni delež odziva (32 % v primerjavi s 25 %, p = 0,10), podaljšal pa je mediani čas do napredovanja bolezni (24,6 tedna v primerjavi s 15,6 tedna, p < 0,01) in mediano preživetje (15,3 meseca v primerjavi z 12,7 meseca, p = 0,03).
Pharmacotherapeutic group: antineoplastic agents, plant alkaloids and other natural products, taxanes, ATC Code: L01CD02
Farmakoterapevtska skupina: Zdravila z delovanjem na novotvorbe (citostatiki), Rastlinski alkaloidi in druge naravne učinkovine (zaviralci mitoze), Taksani, oznaka ATC: L01CD02
No statistically significant effect of prednisone on the pharmacokinetics of docetaxel was observed.
Niso opazovali statistično značilnih učinkov prednizona na farmakokinetiko docetaksela.
Each vial is for single use and should be used immediately after opening.
Viala je namenjena za enkratno uporabo in jo je treba uporabiti takoj po odprtju.
First episode: reduce docetaxel and 5-FU doses by 20%.
Prvi pojav: zmanjšajte odmerka docetaksela in 5-FU za 20 %.
61352 Bad Homburg v.d.Höhe Germany
61352 Bad Homburg v.d. Höhe Nemčija
Frequent monitoring of complete blood counts should be conducted on all patients receiving docetaxel.
Vsem bolnikom, ki prejemajo docetaksel, je treba pogosto pregledovati celotno krvno sliko.
The median time to progression was 186 days (docetaxel + capecitabine) vs. 128 days (docetaxel alone).
Mediana časa do napredovanja je bila 186 dni (docetaksel + kapecitabin) v prim.
Patients should not be retreated with subsequent cycles of docetaxel until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3.
Bolniki ne smejo znova dobiti ciklov docetaksela, dokler se število nevtrofilcev ne poveča na > 1.500 celic/mm3 in število trombocitov na > 100.000 celic/mm3.
Women of childbearing potential/ Contraception in males and females Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Ženske v rodni dobi/ Kontracepcija pri moških in ženskah Ženskam v rodni dobi, ki dobivajo docetaksel, je treba odsvetovati nosečnost; če zanosijo, morajo o tem takoj obvestiti lečečega zdravnika.
Preparation for the intravenous administration
Priprava za intravensko aplikacijo
• 406 patients who received docetaxel in combination with cisplatin.
• 406 bolnikih, ki so prejemali docetaksel v kombinaciji s cisplatinom.
Following chemotherapy, patients should receive chemoradiotherapy.
Po kemoterapiji morajo bolniki prejeti še kemoradioterapijo.
If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m2.
Če se kljub uporabi G-CSF pojavi febrilna nevtropenija, dolgotrajna nevtropenija ali nevtropenična okužba, je treba odmerek docetaksela zmanjšati s 75 na 60 mg/m2.
Discuss with your doctor if you suffer from alcohol dependency, epilepsy or liver impairment.
Posvetujte se s svojim zdravnikom, če ste odvisni od alkohola, imate epilepsijo ali okvaro jeter.
The development of severe peripheral neurotoxicity requires a reduction of dose (see section 4.2).
Če se pojavijo hudi periferni nevrotoksični učinki, je treba odmerek zmanjšati (glejte poglavje 4.2).
For prostate cancer, the premedication is oral dexamethasone 8 mg, 12 hours, 3 hours and 1 hour before the docetaxel infusion (see section 4.2).
Pri zdravljenju raka prostate je premedikacija peroralni deksametazon 8 mg, 12 ur, 3 ure in 1 uro pred infuzijo docetaksela (glejte poglavje 4.2).
Two patients in the TAC arm and 4 patients in the FAC arm died because of cardiac failure.
Dve bolnici v kraku s TAC in 4 bolnice v kraku s FAC so zaradi srčnega popuščanja umrle.
Patients treated with TCF should receive prophylactic G-CSF to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Bolniki, ki prejemajo TCF, morajo profilaktično prejemati G-CSF za zmanjšanje tveganja za zapleteno nevtropenijo (febrilno nevtropenijo, dolgotrajno nevtropenijo ali nevtropenično okužbo).
Second primary malignancies (frequency not known), including non-Hodgkin lymphoma have been reported in association with docetaxel when used in combination with other anticancer treatments known to be associated with second primary malignancies.
O drugih primarnih malignomih (pogostnost ni znana), vključno z ne-Hodgkinovim limfomom, so poročali v povezavi z docetakselom, kadar je bil ta uporabljen v kombinaciji z drugimi zdravili proti raku, za katera je znano, da so povezana s pojavom drugih primarnih malignomov.
Following the administration of a 100 mg/m2 dose given as a one-hour infusion a mean peak plasma level of 3.7 μg/ml was obtained with a corresponding AUC of 4.6 h.μg/ml.
Po aplikaciji odmerka 100 mg/m2 v enourni infuziji je bila povprečna največja koncentracija v plazmi 3,7 µg/ml, ustrezna AUC pa 4,6 h.µg/ml.
Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
Učinkovitost zdravila docetaksel za indukcijsko zdravljenje bolnikov z inoperabilnim lokalno napredovanim SCCHN (analiza z namenom zdravljenja)
For example, a dose of 140 mg docetaxel would require 7 ml docetaxel concentrate for solution.
Primer: za odmerek 140 mg docetaksela potrebujete 7 ml koncentrata docetaksela za raztopino.
Fluid retention includes events such as peripheral oedema and less frequently pleural effusion, pericardial effusion, ascites and weight gain.
Zastajanje tekočine je vključevalo pojave, kot so periferni edemi, redkeje plevralni izliv, perikardialni izliv, ascites in povečanje telesne mase.
DOCETAXEL KABI must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Zdravila DOCETAKSEL KABI NE smete dobiti, če ste noseči, razen če vam vaš zdravnik ne odredi drugače.
Patients receiving TCF should be closely monitored (see sections 4.2 and 4.8).
Bolnike, ki prejemajo TCF, je treba natančno nadzirati (glejte poglavji 4.2 in 4.8).
Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p = 0.0121) and a longer time to definitive worsening of Karnofsky performance status (p = 0.0088) compared to patients treated with CF.
Pri bolnikih, zdravljenih s TCF, je bil v primerjavi s tistimi, ki so jih zdravili s CF, daljši tako čas do 5 % trajnega poslabšanja splošnega zdravstvenega stanja po vprašalniku QLQ-C30 (p = 0,0121) kot čas do trajnega poslabšanja stanja zmogljivosti po Karnofskem (p = 0,0088).
In this study, 358 patients with inoperable locally advanced SCCHN, and WHO performance status 0 or 1, were randomised to one of two treatment arms.
V tej študiji so 358 bolnikov z inoperabilnim lokalno napredovalim SCCHN in stanjem zmogljivosti po WHO 0 ali 1 randomizirali v enega od dveh terapevtskih krakov.
Rare occurrences of dehydration have been reported as a consequence of gastrointestinal events including enterocolitis and gastrointestinal perforation.
Opisani so redki primeri dehidracije zaradi dogodkov, povezanih s prebavili, vključno z enterokolitisom in gastrointestinalno perforacijo.
In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomised to one of two arms.
V tej študiji so 501 bolnika z lokalno napredovalim SCCHN in stanjem zmogljivosti 0 ali 1 po WHO randomizirali v enega od dveh krakov.
The 1-year survival rate was also significantly longer in docetaxel (40%) versus BSC (16%).
Tudi enoletni delež preživetja je bil z docetakselom značilno daljši (40 %) kot z najboljšo podporno oskrbo (16 %).
• For patients developing the second appearance of Grade 2 toxicity, or the first appearance of Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1 and then resume treatment with docetaxel 55 mg/m².
• Pri bolnikih, pri katerih se drugič pojavijo toksični učinki 2. stopnje ali prvič učinki 3. stopnje kadarkoli med ciklom zdravljenja, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo od 0 do 1, nato zdravljenje nadaljujte z docetakselom55 mg/m2.
For breast and non-small cell lung cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e.g. 8 mg BID) for 3 days starting 1 day prior to docetaxel administration, unless contraindicated, can reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.
Pri zdravljenju raka dojke in nedrobnoceličnega pljučnega raka lahko 3-dnevna premedikacija s peroralnim kortikosteroidom, npr. deksametazonom 16 mg na dan (npr. 8 mg 2-krat na dan), ki se začne 1 dan pred aplikacijo docetaksela, zmanjša pogostnost in izrazitost zastajanja tekočine ter izrazitost preobčutljivostnih reakcij, če ni kontraindicirana.
Other medicines and DOCETAXEL KABI
Druga zdravila in zdravilo DOCETAKSEL KABI
When patients are candidates for treatment with docetaxel in combination with trastuzumab, they should undergo baseline cardiac assessment.
Pri bolnicah, kandidatkah za zdravljenje z docetakselom v kombinaciji s trastuzumabom, je potrebno opraviti temeljne preiskave za oceno srčne funkcije.
The incidence of febrile neutropenia/neutropenic sepsis was also increased in patients treated with Herceptin plus docetaxel (23% versus 17% for patients treated with docetaxel alone).
Pri bolnikih, zdravljenih s Herceptinom in docetakselom, je bila večja tudi incidenca febrilne nevtropenije/nevtropenične sepse (23 % v primerjavi s 17 % pri bolnikih, ki so dobivali samo docetaksel).
• Docetaxel 75 mg/m2 every 3 weeks for 10 cycles.
• Docetaksel 75 mg/m2 vsake 3 tedne, 10 ciklov.
All patients on the docetaxel-containing arm of the study received prophylactic antibiotics.
Vsi bolniki v kraku z docetakselom so profilaktično dobili antibiotike.
In GEICAM 9805 study, 3 patients (0.6 %) in TAC arm and 3 patients (0.6 %) in FAC arm developed congestive heart failure during the follow-up period.
V študiji GEICAM 9805 se je 3 bolnicam (0,6 %) v kraku TAC in 3 bolnicam (0,6 %) v kraku FAC med obdobjem spremljanja pojavilo kongestivno srčno popuščanje.
Discuss with your doctor if you suffer from alcohol dependency epilepsy or liver impairment.
Posvetujte se s svojim zdravnikom, če ste odvisni od alkohola, imete epilepsijo ali okvaro jeter.
• 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented).
• 332 bolnikih, ki so prejemali docetaksel v kombinaciji s prednizonom ali prednizolonom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).
Hazard ratio (95% CI) **p-value n = 128
Razmerje tveganja (95 % IZ) **p-vrednost n = 128
Docetaxel should be administered when the neutrophil count is ≥ 1,500 cells/mm3.
Docetaksel je treba aplicirati, ko je število nevtrofilcev ≥ 1.500 celic/mm3.
PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial with 160 mg/8 ml METHOD AND ROUTE(S) OF ADMINISTRATION Ready to add to infusion solution.
FARMACEVTSKA OBLIKA IN VSEBINA koncentrat za raztopino za infundiranje 1 viala s 120 mg/6 ml POSTOPEK IN POT(I) UPORABE ZDRAVILA Pripravljeno za dodajanje raztopini za infundiranje.
The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 27.436.0) in AC arm.
Mediana časa do napredovanja je bila v kraku AT 37,3 tedna (95 % IZ: 33,4-42,1) in v kraku AC 31,9 tedna (95 % IZ: 27,4-36,0).
Primary G-CSF prophylaxis should be considered in patients who receive adjuvant therapy with TAC for breast cancer to mitigate the risk of complicated neutropenia (febrile neutropenia, prolonged neutropenia or neutropenic infection).
Primarna profilaksa z G-CSF pride v poštev pri bolnicah, ki prejemajo adjuvantno zdravljenje s TAC za raka dojke, za zmanjšanje tveganja zapletene nevtropenije (febrilne nevtropenije, dolgotrajne nevtropenije ali nevtropenične okužbe).
The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
Če se pojavijo hudi periferni nevrotoksični učinki, je treba odmerek zmanjšati (glejte poglavji 4.2 in 4.4).
Prednisone or prednisolone 5 mg orally twice daily is administered continuously (see section 5.1).
Prednizon ali prednizolon v odmerku 5 mg dvakrat na dan dajemo nepretrgoma (prosimo, glejte poglavje 5.1).
In the adjuvant treatment of operable node-positive and node-negative breast cancer, the recommended dose of docetaxel is 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 every 3 weeks for 6 cycles (TAC regimen) (see also Dose adjustments during treatment).
Pri dopolnilnem zdravljenju operabilnega raka dojke s pozitivnimi in negativnimi bezgavkami je priporočeni odmerek docetaksela 75 mg/m2, apliciran eno uro po doksorubicinu 50 mg/m2 in ciklofosfamidu 500 mg/m2 vsake tri tedne v 6 ciklih (TAC režim) (glejte tudi Prilagajanje odmerka med zdravljenjem).
Diarrhoea grade 3
Prilagoditev odmerka driska 3. stopnje
You must not be given DOCETAXEL KABI:
Zdravila DOCETAKSEL KABI ne smete dobiti:
The most frequently reported symptoms were flushing, rash with or without pruritus, chest tightness, back pain, dyspnoea and fever or chills.
Najpogosteje opisani simptomi so vročinski oblivi, izpuščaj s srbenjem ali brez njega, tiščanje v prsih, bolečine v hrbtu, dispneja ter povišanje telesne temperature ali mrzlica.
Rare cases of enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, have been reported with a potential fatal outcome (frequency not known).
Opisani so redki primeri enterokolitisa, vključno s kolitisom, ishemičnim kolitisom in nevtropeničnim enterokolitisom, s potencialnim smrtnim izidom (pogostnost neznana).
Acute respiratory distress syndrome, interstitial pneumonia/pneumonitis, interstitial lung disease, pulmonary fibrosis and respiratory failure have been reported and may be associated with fatal outcome.
Opisani so bili akutni respiracijski distres sindrom (dihalna stiska), intersticijska pljučnica/pnevmonitis, intersticijska bolezen pljuč, pljučna fibroza in dihalna odpoved, ki so lahko bili usodni.
Less frequently, severe symptoms such as eruptions followed by desquamation which rarely lead to interruption or discontinuation of docetaxel treatment were reported (see sections 4.2 and 4.4).
Redkeje so poročali o hudih simptomih, npr. izpuščajih s poznejšo deskvamacijo, zaradi katerih je bilo treba v redkih primerih zdravljenje z docetakselom prekiniti (glejte poglavji 4.2 in 4.4).
Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m2 (see sections 4.4 and 5.2).
Glede na farmakokinetične podatke o monoterapiji z docetakselom v odmerku 100 mg/m2 je priporočljivi odmerek docetaksela za bolnike, ki imajo transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno zgornjo mejo normalnega območja (ULN) in alkalno fosfatazo nad 2,5-kratno ULN, 75 mg/m2 (glejte poglavji 4.4 in 5.2).
A multi-centre, open-label, randomised study, was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Opravljena je bila multicentrična, odprta, randomizirana študija za oceno varnosti in učinkovitosti docetaksela pri zdravljenju bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki za metastatsko bolezen še niso prejemali kemoterapije.
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m².
Bolnicam, pri katerih se razvije stomatitis 3. ali 4. stopnje, moramo odmerek zmanjšati na 60 mg/m2.
Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays.
In vitro je ugotovljeno, da docetaksel v klonogenih preizkusih deluje citotoksično proti različnim linijam mišjih in človeških tumorskih celic in proti sveže odstranjenim človeškim tumorskim celicam.
• hair loss: in most cases normal hair growth should return.
• izguba las in dlak (večinoma se obnovi njihova normalna rast), v nekaterih primerih (neznana pogostnost) so bili opisani primeri trajne izgube las in dlak,
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic EXPIRY DATE
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOTOKSIČNO ZDRAVILO DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Patients with baseline neutrophil count of < 1,500 cells/mm3.
Bolniki z izhodiščnim številom nevtrofilcev < 1.500 celic/mm3.
Patients should be retreated with docetaxel when neutrophils recover to a level ≥ 1,500 cells/mm3 (see section 4.2).
Bolniki smejo docetaksel spet dobiti, šele ko se število nevtrofilcev znova zveča na vrednost ≥ 1.500 celic/mm3 (glejte poglavje 4.2).
Incidence of relapses at 10 years was reduced in patients receiving TAC compared to those who received FAC (39% versus 45%, respectively) i.e. an absolute risk reduction by 6% (p = 0.0043).
Pogostost recidiva pri 10 letih je bila zmanjšana pri bolnicah, ki so prejemale TAC, v primerjavi s tistimi, ki so prejemale FAC (39 % proti 45 %) t.j.
Pre-Menopausal
Pred menopavzo
These were reversible upon discontinuation of the infusion.
Po prekinitvi infundiranja so bili reverzibilni.
TAC-treated patients had a 32% reduction in the risk of relapse compared to those treated with FAC (hazard ratio = 0.68, 95% CI (0.49-0.93), p = 0.01).
Prejemnice TAC so imele 32 % manjše tveganje za recidiv kot prejemnice FAC (razmerje ogroženosti 0,68, 95 % IZ (0,49-0,93), p = 0,01).
Without affecting overall survival time (docetaxel 15 months vs. doxorubicin 14 months, p = 0.38) or time to progression (docetaxel 27 weeks vs. doxorubicin 23 weeks, p = 0.54), docetaxel increased response rate (52% vs. 37%, p = 0.01) and shortened time to response (12 weeks vs. 23 weeks, p= 0.007).
Docetaksel ni vplival na celotni čas preživetja (docetaksel 15 mesecev, doksorubicin 14 mesecev, p = 0,38) niti na čas do napredovanja (docetaksel 27 tednov, doksorubicin 23 tednov, p = 0,54), je pa zvečal delež odziva (52 % v prim.
Median overall survival was also significantly longer in favour of the TPF arm compared to the PF arm (median OS: 18.6 vs. 14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
Tudi mediano celotno preživetje (OS) je bilo signifikantno daljše na kraku TPF kot na kraku PF (mediano OS: 18,6 proti 14,5 mesecev) z 28 % zmanjšanjem tveganja smrti, p = 0,0128.
• 258 patients who received docetaxel in combination with doxorubicin.
• 258 bolnikih, ki so prejemali docetaksel v kombinaciji z doksorubicinom.
Contraindications for other medicinal products also apply, when combined with docetaxel.
Če se v kombinaciji z docetakselom uporabljajo še druga zdravila, veljajo tudi kontraindikacije zanje.