natgillin/translations-raw huggingface dataset:
Taxespira in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck. 
Zdravilo Taxespira je v kombinaciji s cisplatinom in 5-fluorouracilom indicirano za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu.
In a small number of patients (n = 23) with clinical chemistry data suggestive of mild to moderate liver function impairment (ALT, AST ≥1.5 times the ULN associated with alkaline phosphatase ≥ 2.5 times the ULN), total clearance was lowered by 27% on average (see section 4.2). 
Pri majhnem številu bolnikov (n = 23) z biokemičnimi izvidi, ki so nakazovali blago do zmerno okvaro jetrne funkcije (ALT, AST ≥ 1,5-kratna ULN hkrati z alkalno fosfatazo ≥ 2,5-kratno ULN), se je celotni očistek v povprečju zmanjšal za 27 % (glejte poglavje 4.2).
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately. 
Z mikrobiološkega vidika morata rekonstutucija/redčenje potekati v nadzorovanih in aseptičnih pogojih in je zdravilo treba uporabiti takoj.
Docetaxel is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing its solutions. 
Docetaksel je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem in pripravo raztopin tega zdravila potrebna previdnost.
In patients who experienced either febrile neutropenia, neutrophil count <500 cells/mm 3 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/m 2 to 75 mg/m 2 and/or from 75 to 
Pri bolnikih, ki so med zdravljenjem z docetakselom doživeli febrilno nevtropenijo, zmanjšanje števila nevtrofilcev na < 500 celic/mm 3 za več kot en teden, hude ali kumulativne kožne reakcije ali hudo periferno nevropatijo, je treba odmerek docetaksela zmanjšati s 100 mg/m 2 na 75 mg/m 2 oz. s 75 na 60
Treatment difference: 5.4% [95% CI: -1.1; 12.0] Treatment difference: 6.2% [95% CI: 0.2; 12.3] 
razmerje tveganj: 1,122 [97,2 % IZ: 0,937; 1,342]* razlika zdravljenj: 5,4 % [95 % IZ: -1,1; 12,0] razlika zdravljenj: 6,2 % [95 % IZ: 0,2; 12,3]
Use immediately the medicine once added into the infusion bag. 
Ko je zdravilo dodano v infuzijsko vrečko, ga je treba uporabiti takoj.
• For the treatment of early breast cancer with or without lymph node involvement, Taxespira could be administered in combination with doxorubicin and cyclophosphamide. 
• Za zdravljenje zgodnjega raka dojke brez ali s prizadetostjobezgavk se zdravilo Taxespira lahko aplicira v kombinaciji z doksorubicinom in ciklofosfamidom.
The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm. 
V kraku s TCF je ciklus zdravljenja trajal 3 tedne, v kraku s CF pa 4 tedne.
The ORR was 59.3% (95% CI: 52.8 - 65.9) in AT arm versus 46.5% (95% CI: 39.8 - 53.2) in 
V kraku AT je bil celotni delež odziva 59,3 % (95 % IZ: 52,8-65,9) in v kraku AC 46,5 % (95 % IZ: 39,8-53,2).
3 weeks) and capecitabine (1250 mg/m2 twice daily for 2 weeks followed by 1-week rest period). 
tedne) in kapecitabinom (1.250 mg/m2 dvakrat na dan 2 tedna s sledečim 1-tedenskim premorom).
In this study, 358 patients with inoperable locally advanced SCCHN, and WHO performance status 0 or 1, were randomized 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.
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).
Pack size: 
Velikost pakiranja:
A hazard ratio of less than 1 favours docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumour site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test 
Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5-FU *Model po Cox-u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) **Log-ranktest ***Hi-kvadrattest
A total of 1006 patients with KPS ≥60 were randomized to the following treatment groups: 
V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem ≥ 60:
Once added as recommended into the infusion bag, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours. 
Ko je zdravilo skladno s priporočili dodano v infuzijsko vrečo, je infuzijska raztopina docetaksela pri temperaturi do 25°C stabilna 6 ur.
- The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid monohydrate. 
- Pomožne snovi so polisorbat 80, brezvodni etanol (glejte poglavje 2) in citronska kislina monohidrat.
• swelling of the hands, feet, legs 
• otekanje dlani, stopal, nog
At the median follow-up time of 77 months, significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated. 
Po mediano 77 mesecih spremljanja je bilo dokazano, da je preživetje brez bolezni v kraku TAC značilno daljše kot v kraku FAC.
• Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138. 
• Čas do napredovanjaje bil v kraku AT značilno daljši kot v kraku AC, p = 0,0138.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy. 
Na vsebnost etanola (alkohola) morajo biti pozorne nosečnice in doječe matere, otroci in skupine z velikim tveganjem, kot so bolniki z jetrnimi obolenji ali epilepsijo.
Epistaxis (G3/4: <1%) 
epistaksa (S3/4: < 1 %)
For example, a dose of 140 mg docetaxel would require 7 ml Taxespira 20 mg/1 ml concentrate for solution for infusion. 
Na primer, za odmerek 140 mg docetaksela bi bilo potrebnih 7 ml zdravila Taxespira 20 mg/ 1 ml koncentrat za raztopino za infundiranje.
Taxespira is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Taxespira solutions. 
Zdravilo Taxespira je antineoplastično zdravilo in tako kot pri ravnanju z drugimi potencialno toksičnimi spojinami je tudi med rokovanjem in pripravo raztopin zdravila Taxespira potrebna previdnost.
• sores in the mouth 
• razjede v ustih
If not used immediately, in-use storage times and conditions are the responsibility of the user. 
Če ni uporabljena takoj, je za čas in pogoje hranjenja odgovoren uporabnik.
You must not breast-feed while you are treated with Taxespira. 
Med zdravljenjem z zdravilom Taxespira ne smete dojiti.
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/m 2 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/m 2 vsake tri tedne v 6 ciklih (TAC režim) (glejte tudi Prilagajanje odmerka med zdravljenjem).
• stomach upsets including nausea, vomiting and diarrhoea, constipation 
• draženje želodca, vključno s slabostjo, bruhanjemin drisko, zaprtje
Patients with liver impairment In patients treated with docetaxel at 100 mg/m2 as single agent who have serum transaminase levels (ALT and/or AST) greater than 1.5 times the ULN concurrent with serum alkaline phosphatase levels greater than 2.5 times the ULN, there is a higher risk of developing severe adverse reactions such as toxic deaths including sepsis and gastrointestinal haemorrhage which can be fatal, febrile neutropenia, infections, thrombocytopenia, stomatitis and asthenia. 
Bolniki z okvaro jeter Pri bolnikih, zdravljenih s 100 mg docetaksela/m2 v monoterapiji, ki imajo serumski transaminazi (ALT, AST ali obe) zvišani nad 1,5-kratno ULN in hkrati zvišano serumsko alkalno fosfatazo nad 2,5- kratno ULN, obstaja večja nevarnost hudih neželenih učinkov, kot so smrti zaradi zastrupitve, vključno s sepso in gastrointestinalno krvavitvijo, ki sta lahko usodni, febrilne nevtropenije, okužb, trombocitopenije, stomatitisa in astenije.
• inflammation of the eye or increased tearing of the eyes 
• vnetje oči ali močnejše solzenje
• 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/m 
• Pri bolnikih, pri katerih se drugič pojavijo toksični učinki 2. stopnje ali prvič učinki 3. stopnje kadarkoli med ciklusom zdravljenja, zdravljenje odložite, dokler se ne zmanjšajo na stopnjo od 0 do 1 in nato zdravljenje nadaljujte z docetakselom 55 mg/m
After stratification according to the number of positive lymph nodes (1-3, 4+), 1,491 patients were randomized to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 
Po stratifikaciji glede na število pozitivnih bezgavk (1-3, 4 ali več) je bilo 1.491 bolnic randomiziranih na prejemanje docetaksela 75 mg/m2, apliciranega 1 uro po doksorubicinu 50 mg/m2 (krak TAC), ali na prejemanje doksorubicina 50
Febrile neutropenia and neutropenic infection occurred respectively in 12.1% and 3.4 % of patients when patients received prophylactic G-CSF, in 15.6% and 12.9% of patients without prophylactic G-CSF (see section 4.2). 
Febrilna nevtropenija se je pojavila pri 12,1 % bolnikov, ki so dobivali profilakso z G-CSF, in pri 15,6 % tistih, ki je niso, nevtropenična okužba pa se je pojavila pri 3,4 % ki so dobivali profilakso z GCSF, in pri 12,9 % tistih, ki je niso (glejte poglavje 4.2).
• 174 and 251 head and neck cancer patients who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented). 
• 174 in 251 bolnikih z rakom glave in vratu, ki so prejemali docetaksel v kombinaciji s cisplatinom in 5-fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki).
Docetaxel clearance was not modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention. 
Pri bolnikih z blagim do zmernim zastajanjem tekočine se očistek docetaksela ni spremenil; za bolnike s hudim zastajenjem tekočine podatkov ni.
Aseptically withdraw the required amount of Taxespira concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle. 
Aseptično izvlecite ustrezno količino zdravila Taxespira koncentrat za raztopino za infundiranje in uporabite kalibrirane injekcijske brizge z iglo velikosti 21G.
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m 
Bolnicam, pri katerih se razvije stomatitis 3. ali 4. stopnje, moramo odmerek zmanjšati na 60 mg/m
Docetaxel + Cis + 5-FU n = 177 
Docetaksel+ Cis+5-FU n = 177
As with all parenteral products, infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded. 
Tako kot vsa zdravila za parenteralno uporabo je treba tudi raztopino docetaksela za infundiranje pred uporabo pregledati; če vsebuje precipitat, jo je treba zavreči.
Second episode: stop 5-FU only, at all subsequent cycles. 
Drugi pojav: med vsemi naslednjimi ciklusi opustite le 5-FU.
If the concomitant use of a strong CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) cannot be avoided, a close clinical surveillance is warranted and a dose-adjustment of docetaxel may be suitable during the treatment with the strong CYP3A4 inhibitor (see section 4.4). 
ketokonazola, itrakonazola, klaritromicina, indinavirja, nefazodona, nelfinavirja, ritonavirja, sakvinavirja, telitromicina ali vorikonazola) ni mogoče izogniti, je potreben natančen klinični nadzor in med zdravljenjem z močnim zaviralcem CYP3A4 je lahko primerna prilagoditev odmerka docetaksela (glejte poglavje 4.4).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cases of acute myeloid leukaemia and myelodysplastic syndrome have been reported in association with docetaxel when used in combination with other chemotherapy agents and/or radiotherapy. 
Benigne in maligne neoplazme (vključno s cistami in polipi) Poročali so o primerih akutne mieloične levkemije in mielodisplastičnega sindroma pri uporabi docetaksela v kombinaciji z drugimi kemoterapevtiki in/ali radioterapijo.
• Docetaxel 30 mg/m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles. 
• Docetaksel 30 mg/m 2 aplicirano tedensko prvih 5 tednov 6 tedenskega cikla, ki se ponovi v 5-ih ciklih.
If Taxespira concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. 
Če pride koncentrat ali raztopina za infundiranje Taxespira v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
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.
Nervous system The development of severe peripheral neurotoxicity requires a reduction of dose (see section 4.2). 
Živčevje Če se pojavijo hudi periferni nevrotoksični učinki, je treba odmerek zmanjšati (glejte poglavje 4.2).
Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), citric acid monohydrate. 
Pomožne snovi: polisorbat 80, brezvodni etanol (opozorila so navedena v navodilu za uporabo), citronska kislina monohidrat.
versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months. 
Ob tem so pri shemi z docetakselom ugotovili tudi 30 % zmanjšanje tveganja umrljivosti v primerjavi s PF (razmerje ogroženosti (OR) = 0,70, 95 % interval zaupanja (IZ) = 0,54-0,90); celotni mediani čas spremljanja je bil 41,9 meseca.
Docetaxel is highly protein bound (>95%). 
Docetaksel je v veliki meri (> 95 %) vezan na beljakovine.
The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient. 
Raztopino v infuzijski vrečki je treba uporabiti v 6 urah, če je hranjena pri temperaturi do 25°C, ena ura infundiranja zdravila bolniku je všteta v ta čas.
In case CMO is diagnosed, docetaxel treatment should be discontinued and appropriate treatment initiated (see section 
Če je diagnosticiran CMO, je treba zdravljenje z docetakselom prekiniti in uvesti ustrezno zdravljenje (glejte poglavje 4.8).
Elderly people 
Starejši bolniki
The severity of adverse events of Taxespira may be increased when Taxespira is given in combination with other chemotherapeutic agents. 
Izrazitost neželenih učinkov zdravila Taxespira se lahko poveča, če dobivate zdravilo Taxespira v kombinaciji z drugimi kemoterapevtiki.
• 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).
Data from one multicenter, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline. 
Podatki multicentrične, randomizirane, kontrolirane kliničnega študije III. faze podpirajo uporabo docetaksela v kombinaciji s kapecitabinom za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke po neuspehu citotoksične kemoterapije, ki je vključevala antraciklin.
If it should come into contact with mucous membranes, wash immediately and thoroughly with water. 
Če pride v stik s sluznicami, jih je treba takoj in temeljito umiti z vodo.
• oesophagitis (inflammation of the gullet) 
• ezofagitis (vnetje požiralnika)
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 zardevanje, izpuščaj s srbenjem ali brez njega, tiščanje v prsih, bolečine v hrbtu, dispneja ter zvišanje telesne temperature ali mrzlica.
Median OS 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.
For treatment after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/m² as a single agent. 
Za zdravljenje po neuspehu predhodne, na platini osnovane kemoterapije, je priporočeni odmerek 75 mg/m
The events were spontaneously reversible within 3 months. 
Motnje so spontano izginile v 3
• chest tightness; difficulty in breathing 
• tiščanje v prsih, težko dihanje
Vascular disorders Venous thromboembolic events have rarely been reported. 
Žilne bolezni Redko so poročali o venskih trombembolijah.
Mix the infusion bag or bottle manually using a rocking motion. 
• Infuzijsko vrečko ali steklenico ročno premešajte z nagibanjemsem in tja.
Clear glass (type I) vial with a chlorobutyl rubber stopper and an aluminium seal with a flip-off cap. 
Viala iz prozornega stekal (tipa I) z zamaškom iz klorobutilne gume in aluminijasto dvižno zaporko.
More than one vial of Taxespira concentrate for solution for infusion may be necessary to obtain the required dose for the patient. 
Za odmerek, ki ga potrebuje bolnik, utegne biti potrebna več kot ena viala zdravila Taxespira koncentrat za raztopino za infundiranje.
An open-label, multicenter, randomized phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline. 
Narejena je bila odprta multicentrična randomizirana študija III. faze za primerjavo monoterapije docetaksela in paklitaksela pri zdravljenju napredovalega raka na dojki pri bolnicah, katerih predhodno zdravljenje je moralo vključevati nek antraciklin.
Grade 4 thrombocytopenia the docetaxel dose should be reduced from 75 to 60 mg/m 2. 
V primeru trombocitopenije 4. stopnje je treba odmerek docetaksela zmanjšati s 75 na 60 mg/m2.
In the case of severe neutropenia (<500 cells/mm 
Če se med zdravljenjem z docetakselom pojavi huda nevtropenija (< 500 celic/mm
In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukaemia requires haematological follow-up. 
Pri bolnikih, ki se zdravijo z docetakselom, doksorubicinom in ciklofosfamidom (TAC), je zaradi tveganja mieolodisplazije ali mieloične levkemije potrebno hematološko spremljanje.
The median TTP was 37.3 weeks (95% CI: 33.4 - 42.1) in AT arm and 31.9 weeks (95% CI: 
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).
50 mg/m 2 and cyclophosphamide 500 mg/m 2 (539 patients in TAC arm), or doxorubicin 50 mg/m followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).). 
1060 bolnic je bilo naključno razporejenih na prejemanje zdravila Taxespira 75 mg/m 2 1 -uro po doksorubicinu 50 mg/m 2 in ciklofosfamidu 500 mg/m 2 (539 bolnic v kraku TAC), ali na prejemanje doksorubicina 50 mg/m2, ki sta mu sledila fluorouracil 500 mg/m2 in ciklofosfamid 500 mg/m bolnic v kraku FAC) kot adjuvantnega zdravljenja operabilnega raka dojke z negativnimi bezgavkami pri bolnicah z velikim tveganjem recidiva po St.- Gallenskih merilih 1998 (velikost tumorja > 2 cm in/ali negativni ER in PR in/ali visoka histološka/jedrna stopnja (2. do 3. stopnja) in/ali starost < 35 let).
In first-line treatment, docetaxel 75 mg/m is given in combination therapy with doxorubicin (50 mg/m 
Kot zdravljenje prvega izbora se docetaksel 75 mg/m 2 daje v kombinaciji z doksorubicinom (50 mg/m
In this study, 255 patients were randomised to treatment with docetaxel (75 mg/m2 as a 1 hour intravenous infusion every 
V tem preskušanju so 255 bolnic randomizirali na zdravljenje z docetakselom (75 mg/m2 v 1-urni intravenski infuziji na 3
• Inject the required dose (in mg) via a single injection (one shot) into a 250 ml non-PVC infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion or with 5% glucose solution in a glass bottle. 
• Potrebni odmerek (v mg) naenkrat (z enim pritiskom) vbrizgajte v 250-ml infuzijsko vrečko, katere material ne vsebuje PVC, in ki vsebuje bodisi 5% raztopino glukoze bodisi raztopino natrijevega klorida 9 mg/ml (0,9 %) za infundiranje ali v ali steklenico, v kateri je 5 % raztopina glukoze za infundiranje.
A multicenter, open-label, randomized 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. 
Opravljeno je bilo 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.
Taxespira in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: 
Zdravilo Taxespira je v kombinaciji z doksorubicinom in ciklofosfamidom indicirano za adjuvantno zdravljenje bolnic:
Taxespira in combination with doxorubicin and cyclophosphamide: adjuvant therapy 
Zdravilo Taxespira v kombinaciji z doksorubicinom in ciklofosfamidom: adjuvantno zdravljenje
A total of 449 patients were randomized to receive either docetaxel monotherapy 100 mg/m² as a 1 hour infusion or paclitaxel 175 mg/m² as a 3 hour infusion. 
Skupaj 449 bolnic je bilo randomiziranih bodisi na monoterapijo z docetakselom 100 mg/m2 v 1-urni infuziji bodisi na paklitaksel 175 mg/m2 v 3-urni infuziji.
Patients with baseline neutrophil count of <1,500 cells/mm 
Bolniki z izhodiščnim številom nevtrofilcev < 1.500 celic/mm
Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis) 
Učinkovitost docetaksela v indukcijskem zdravljenju bolnikov z lokalno napredovalim SCCHN (analiza znamenom-zdravljenja)
• For the treatment of advanced breast cancer, Taxespira could be administered either alone or in combination with doxorubicin, or trastuzumab, or capecitabine. 
• Za zdravljenjenapredovalegaraka dojke se lahko zdravilo Taxespira uporablja sam ali v kombinaciji z doksorubicinom ali trastuzumabom ali kapecitabinom.