natgillin/translations-raw huggingface dataset:
Exploratory subgroup analyses for disease-free survival for patients who meet the 2009 St. Gallen chemotherapy criteria - (ITT population) were performed and presented here below: 
Opravljene so bile eksplorativne analize podskupin glede preživetja brez bolezni pri bolnicah, ki izpolnjujejo St.-Gallenska merila 2009 za kemoterapijo (populacija ZNZ); predstavljene so spodaj
It is important that you read the entire contents of this guide prior to the preparation of the Taxespira infusion solution. 
Pomembno je, da pred pripravo zdravila Taxespira v celoti preberete ta navodila.
It should be used within 6 hours (including the one hour 
Porabiti jo je treba v 6 urah (ena ura infundiranja všteta).
The final analysis was performed when all patients had reached their 10-year follow-up visit (unless they had a DFS event or were lost to follow-up before). 
Končna analiza je bila opravljena, ko so vse bolnice prišle na pregled po 10letnem spremljanju (razen če se jim je prej pojavil dogodek DFS ali so se prej izgubile spremljanju).
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (<500 cells/mm 
Najpogosteje opisani neželeni učinki na sam docetaksel so: nevtropenija (ki je bila reverzibilna in ni bila kumulativna; srednji čas do najmanjšega števila je bil 7 dni, srednje trajanje hude nevtropenije (< 500 celic/mm
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.
Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported. 
Poročali so o diseminirani intravaskularni koagulaciji (DIK), pogosto v povezavi s sepso ali multiorgansko odpovedjo.
1,000 mg/m2 per day for 5 days. 
(1000 mg/m2 na dan, 5 dni).
Each vial is for single use and should be used immediately after opening. 
Vsaka viala je namenjena za enkratno uporabo in jo je treba uporabiti takoj po odprtju.
Patients who received docetaxel every three weeks demonstrated significantly longer OS compared to those treated with mitoxantrone. 
Pri bolnikih, ki so prejemali docetaksel vsake tri tedne so prikazali značilno daljše skupno preživetje v primerjavi s tistimi, ki so bili zdravljeni z mitoksantronom.
Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
• fever: if this happens you must tell your doctor immediately 
• zvišana telesna temperatura: če se vam to zgodi, morate nemudoma povedati zdravniku
• Periodic safety update reports 
• Redno posodobljenaporočila o varnosti zdravila (PSUR)
Patients in both treatment arms were to receive 7 weeks of CRT following induction chemotherapy with a minimum interval of 3 weeks and no later than 8 weeks after start of the last cycle (day 22 to day 56 of last cycle). 
Bolniki v obeh terapevtskih krakih so po indukcijski kemoterapiji dobili 7 tednov kemoradioterapije; najkrajši presledek je bil 3 tedne in ne več kot 8 tednov po začetku zadnjega ciklusa (22. do 56. dan zadnjega ciklusa).
Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m2 in all subsequent cycles (see sections 4.4 and 4.8). 
Bolnicam, ki se jim pojavi febrilna nevtropenija in/ali nevtropenična okužba, je treba odmerek docetaksela v vseh nadaljnjih ciklusih zmanjšati na 60 mg/m2 (glejte poglavji 4.4 in 4.8).
• pneumonia (infection of the lungs) 
• pljučnica (okužba pljuč)
95% CI p = 
95 % IZ p =
• haemorrhage (bleeding) 
• hemoragija (krvavitev)
• For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose. 
• V primeru vsakega ponovnega pojava toksičnih učinkov ali pojava toksičnih učinkov 4. stopnje, odmerek docetaksela prekinite.
If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately. 
Če se pojavijo akutne težave s pljuči ali pride do poslabšanja simptomov (povišana telesna temperatura, težko dihanje/kratka sapa ali kašelj), takoj obvestite svojega zdravnika, medicinsko sestro ali bolnišničnega farmacevta.
Acute leukaemia /Myelodysplastic syndrome 
Akutna levkemija / mielodisplastični sindrom
Hormonal receptor status 
Stanje hormonskih receptorjev Negativno
If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded. 
Če je potrebni odmerek večji od 190 mg docetaksela, uporabite več infuzijskega vehikla, tako da končna koncentracija v raztopini za infundiranje ne preseže koncetracije docetaksela 0,74 mg/ml.
In addition, docetaxel was found to be active on some but not all cell lines over expressing the p-glycoprotein which is encoded by the multidrug resistance gene. 
Poleg tega je ugotovljeno, da je docetaksel aktiven na nekaterih, ne pa na vseh celičnih linijah s hipereksprimiranim pglikoproteinom, ki ga kodira gen za rezistenco proti več zdravilom.
Meeting relative indication for chemotherapy No 
Izpolnjena relativna indikacija za kemoterapijo
If you are a man being treated with Taxespira you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because Docetaxel may alter male fertility. 
Če ste moški, ki se zdravi z zdravilom Taxespira je priporočljivo, da ne zaplodite otroka med zdravljenjem in v obdobju 6 mesecev po koncu zdravljenja ter da pred začetkom zdravljenja poiščete nasvet glede ohranitve sperme, ker docetaksel lahko prizadene moško plodnost.
Taxespira must NOT be administered if you are pregnant unless clearly indicated by your doctor. 
Zdravila Taxespira NE smete dobiti, če ste noseči, razen če vam vaš zdravnik ne odredi drugače.
One hundred eighty six patients were randomized to receive docetaxel (100 mg/m2) with or without trastuzumab; 60% of patients received prior anthracycline-based adjuvant chemotherapy. 
Stošestinosemdeset (186) bolnic je bilo randomiziranih na prejemanje docetaksela (100 mg/m2) s trastuzumabom ali brez njega; 60 % bolnic je prej dobilo adjuvantno kemoterapijo na osnovi antraciklinov.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
IME ZDRAVILA IN POT(I) UPORABE ZDRAVILA
Each vial is of single use and should be used immediately. 
Vsaka viala je za enkratno uporabo in jo je treba uporabiti takoj.
If the vials are stored under refrigeration, allow the required number of boxes of Taxespira concentrate for solution for infusion to stand below 25°C for 5 minutes before use. 
Če so viale shranjene v hladilniku, pred uporabo pustite potrebno število škatel zdravila Taxespira koncentrat za raztopino za infundiranje 5 minut stati na sobni temperaturi (do 25°C).
3, or in patients who experience febrile neutropenia, or in patients with serious non-haematologic toxicities, the docetaxel dose in subsequent cycles should be reduced to 65 mg/m2. 
3, bolnikom, ki doživijo febrilno nevtropenijo, in bolnikom z resnimi nehematološkimi toksičnimi učinki je treba odmerek docetaksela v naslednjih ciklusih zmanjšati na 65 mg/m2.
In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours. 
In vivo docetaksel ni odvisen od sheme in ima širok spekter eksperimentalnega protitumorskega delovanja proti napredovalim mišjim in humanim transplantiranim tumorjem.
Taxespira concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution. 
Zdravila Taxespira koncentrat za raztopino za infundiranje predhodno NI potrebno redčiti z vehiklom in je pripravljeno za dodajanje v infuzijsko raztopino.
This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥25% reduction in bidimensionally measured tumour size) was observed after 2 cycles. 
To shemo so uporabljali 4 cikluse vsake 3 tedne, če so po 2 ciklusih opazili vsaj majhen odziv (≥ 25 % zmanjšanje dvodimenzionalno merjene velikosti tumorja).
In non-clinical studies, docetaxel has genotoxic effects and may alter male fertility (see section 5.3). 
V predkliničnih študijah so opazili genotoksične učinke docetaksela in lahko prizadene moško plodnost (glejte poglavje 5.3).
3 for seven days or more) during a course of docetaxel therapy, a reduction in dose for subsequent courses of therapy or the use of appropriate symptomatic measures are recommended (see section 4.2). 
3 sedem dni ali več), je med naslednjimi ciklusi priporočljivo zmanjšati odmerek ali uporabiti ustrezne simptomatske ukrepe (glejte poglavje 4.2).
The European Medicines Agency has waived the obligation to submit the results of studies with Taxespira in all subsets of the paediatric population in breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila (EMA) je odstopila od obveze za predložitev rezultatov študij z zdravilom Taxespira za vse skupine pediatrične populacije za raka dojke, nedrobnoceličnega pljučnega raka, raka prostate, karcinom želodca in raka glave in vratu, ne vključujoč manj diferenciiran nazofaringealni karcinom tipa II oz. III (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval; ER = estrogen receptor PR = progesterone receptor 
TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid IZ = interval zaupanja, ER = estrogenski receptor PR = progesteronski receptor a negativno ER/PR ali 3. stopnja ali velikost tumorja > 5 cm
The incidence of the following adverse events (all grades): lethargy, stomatitis, neutropenic infection occurred at rates ≥ 10% higher in patients who were 65 years of age or older compared to younger patients. 
Incidenca naslednjih neželenih učinkov (vse stopnje) - letargije, stomatitisa in nevtropenične okužbe - je bila pri bolnikih, starih 65 let ali več, ≥ 10 % večja kot pri mlajših bolnikih.
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/m2 in phase I studies. 
Absorpcija Farmakokinetiko docetaksela so ocenili pri onkoloških bolnikih po uporabi 20-115 mg/m2 v študijah I. faze.
Median duration of response to chemotherapy ± radiotherapy (months) (95% CI) 
Mediano trajanje odziva na kemoterapijo radioterapijo(meseci) (95 % IZ)
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions. 
Z mikrobiološkega vidika morata rekonstitucija/redčenje potekati v nadzorovanih in aseptičnih pogojih.
• at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling 
• na mestu injiciranja, kožne reakcije, flebitis (vnetje vene) ali otekanje
If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 6 hours below 25°C including the one hour infusion. 
Če zdravilo ni uporabljeno takoj, je za čas in pogoje hranjenja med uporabo odgovoren uporabnik in ne sme biti daljši kot 6 ur pri temperaturi do 25°C, pri čemer je ena ura infundiranja všteta v ta čas.
• blurred vision due to swelling of the retina within the eye (cystoid macular oedema) 
• zamegljen vid zaradi oteklosti očesne mrežnice (cistoidni makularni edem)
2-year estimate (%) 
2-letno preživetje (%)
• swelling caused by faulty lymphatic drainage 
• otekanje zaradi nepravilnelimfatične drenaže
In combination with trastuzumab the recommended dose of docetaxel is 100 mg/m2 every three weeks, with trastuzumab administered weekly. 
Za kombinacijo s trastuzumabom je priporočeni odmerek docetaksela 100 mg/m2 vsake tri tedne, s tedensko aplikacijo trastuzumaba.
A population pharmacokinetic analysis has been performed with docetaxel in 577 patients. 
Starost in spol Farmakokinetične analize docetaksela na populaciji so opravili pri 577 bolnikih.
Cases of permanent alopecia (frequency not known) have been reported. 
Opisani so bili primeri trajne plešavosti (pogostnost neznana).
• tiredness or flu-like symptoms 
• utrujenost ali gripi podobni simptomi
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/4; grade 4 = G4), the COSTART and the MedDRA terms. 
Neželeni učinki so bili opisani po merilih NCI Common Toxicity Criteria (3. stopnja = S3, 3.-4. stopnja = S3/4, 4. stopnja = S4) in z izrazi COSTART in MedDRA.
For combination with capecitabine, the most frequent treatment-related undesirable effects (≥5%) reported in a phase III study in breast cancer patients failing anthracycline treatment are presented (see capecitabine summary of product characteristics). 
Pri kombinaciji s kapecitabinom so predstavljeni najpogostejši z zdravljenjem povezani neželeni učinki (≥ 5 %), o katerih so poročali v fazi III klinične študije pri bolnicah z rakom dojke z neuspelim zdravljenjem z antraciklini (prosimo, glejte povzetek glavnih značilnosti kapecitabina).
The most commonly reported adverse reactions of Taxespira alone are: decrease in the number of red blood cells or white blood cells, alopecia (hair loss), nausea, vomiting, sores in the mouth, diarrhoea and tiredness. 
Najpogosteje poročani neželeni učinki zdravila Taxespira samega so: zmanjšanje števila rdečih ali belih krvnih celic, alopecija (izguba las), siljenje na bruhanje, bruhanje, razjede v ustih, driska in utrujenost.
• difficulty or painful swallowing 
• težave ali bolečine pri požiranju
PREPARATION GUIDE FOR USE WITH TAXESPIRA CONCENTRATE FOR SOLUTION FOR INFUSION 
NAVODILA ZA UPORABO ZDRAVILA TAXESPIRA KONCENTRAT ZA RAZTOPINO ZA INFUNDIRANJE
The kinetic profile of docetaxel is dose independent and consistent with a three-compartment pharmacokinetic model with half lives for the α, β and γ phases of 4 min, 36 min and 11.1 h, respectively. 
Kinetični profil docetaksela ni odvisen od odmerka in se sklada s trirazdelčnim farmakokinetičnim modelom, pri čemer je razpolovni čas faze α 4 minute, β 36 minut in γ 11,1 ure.
Subset analyses-adjuvant therapy in patients with node-negative breast cancer study (intent-to-treat analysis) 
Analize podskupine - adjuvantno zdravljenje bolnic v študiji raka dojke z negativnimi bezgavkami (analiza z-namenom-zdravljenja)
5-fluorouracil (F) 750 mg/m2 per day as a continuous infusion for 5 days. 
fluorouracil (F) 750 mg/m2 na dan v obliki neprekinjene infuzije 5 dni.
Post-Menopausal *a hazard ratio (TAC/FAC) of less than 1 indicates that TAC is associated with a longer disease free survival compared to FAC. 
Po menopavzi *a razmerje ogroženosti Vrednost (TAC/FAC) manj kot 1 pomeni, da je kombinacija TAC povezana z daljšim preživetjem brez bolezni kot kombinacija FAC.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter 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 the pivotal SCCHN studies patients who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (e.g., day 6-15) in all subsequent cycles. 
V ključnih SCCHN študijah pri bolnikih, pri katerih se je pojavila komplicirana nevtropenija (ki vključuje dolgotrajno nevtropenijo, fibrilno nevtropenijo ali okužbo), je bilo priporočeno, naj se v vseh naslednjih ciklih za profilaktično kritje (na primer med 6. in 15. dnem) uporablja G-CSF.
How to use Taxespira 
Kako uporabljati zdravilo Taxespira
Therefore, men being treated with docetaxel are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment 
Zato je priporočljivo, da moški, ki se zdravijo z docetakselom, ne zaplodijo otroka med zdravljenjem in v obdobju šestih mesecev po koncu zdravljenja ter da pred začetkom zdravljenja poiščejo nasvet glede ohranitve sperme.
Overall 
Celotno
Injection site recall reaction (recurrence of skin reaction at a site of previous extravasation following administration of docetaxel at a different site) has been observed at the site of previous extravasation (frequency not known). 
Na mestu prejšnje ekstravazacije so opažali reakcijo pomnjenja na mestu injiciranja (ponovitev kožne reakcije na mestu predhodne ekstravazacije med dajanjem docetaksela na drugem mestu) (pogostnost ni znana).
The concentrate is a pale yellow to brownish-yellow solution. 
Koncentrat je bledo rumena do rjavo-rumena raztopina.
Taxespira has been prescribed by your doctor for the treatment of breast cancer, special forms of lung cancer (non-small cell lung cancer), prostate cancer, gastric cancer or head and neck cancer: 
Zdravnik vam je zdravilo Taxespira predpisal za zdravljenje raka dojke, posebne vrste pljučnega raka (nedrobnocelični pljučni rak), raka prostate, raka želodca ali raka glave in vratu:
Ready to add to infusion solution. 
Pripravljeno za dodajanje raztopini za infundiranje.
• 1,276 patients (744 and 532 in TAX 316 and GEICAM 9805 respectively) who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented). 
• 1.276 bolnikih (744 pri TAX 316 in 532 GEICAM 9805), ki so prejemali docetaksel v kombinaciji z doksorubicinom in ciklofosfamidom (predstavljeni so klinično pomembni z zdravljenjem povezani neželeni učinki).
The incidence of related fever, diarrhoea, anorexia, and peripheral oedema occurred at rates ≥ 10 % higher in patients who were 75 years of age or greater versus less than 65 years. 
Incidenca z zdravljenjem povezane zvišane telesne temperature, diareje, anoreksije in perifernih edemov se je pojavljala ≥ 10 % večkrat pri bolnikih nad 75 let v primerjavi z mlajšimi od 65 let.
*a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and OS compared to FAC 
*Razmerje tveganj manj kot 1 pomeni, da je TAC povezan z daljšim preživetjem brez bolezni in daljšim celotnim preživetjem kot FAC.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJAZA PROMET Z
Although the possible in vivo interaction of docetaxel with concomitantly administered medicinal product has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel. 
Možna medsebojna delovanja docetaksela s sočasno uporabljanimi zdravili in vivo sicer niso bila formalno raziskana, a medsebojno delovanje z učinkovinami, močno vezanimi na beljakovine - npr. eritromicinom, difenhidraminom, propranololom, propafenonom, fenitoinom, salicilati, sulfametoksazolom in natrijevim valproatom - in vitro ni vplivalo na vezavo docetaksela na beljakovine.
A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable 
Razmerje ogroženosti manj kot 1 pomeni prednost kombinacije docetaksel + cisplatin + fluorouracil *Nekorigirani log-rang test **Nekorigirani log-rang test, nekorigiran za multiple primerjave ***Test hi-kvadrat, nekorigiran za multiple primerjave NP - ni podatka
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
D. POGOJI ALI OMEJITVEV ZVEZI Z VARNO IN UČINKOVITOUPORABO ZDRAVILA
General disorders and administration site conditions The median cumulative dose to treatment discontinuation was more than 1,000 mg/m and the median time to fluid retention reversibility was 16.4 weeks (range 0 to 42 weeks). 
Mediani kumulativni odmerek do prekinitve zdravljenja je bil več kot 1.000 mg/m2 in mediani čas do izginotja zastoja tekočine 16,4 tedna (razpon od 0 do 42 tednov).
The cycles were repeated every 3 weeks for 3 cycles. 
Cikluse so ponavljali 3 cikluse vsake 3 tedne.
In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomized 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.
• if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Taxespira (listed in section 6). 
• če ste alergični na (preobčutljivi za) docetaksel ali katerokoli sestavino zdravila Taxespira
Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p <0.0001). 
Čas do napredovanja bolezni je bil v kraku s kombinacijo docetaksel + kapecitabin boljši (p < 0,0001).
For the treatment of patients with locally advanced or metastatic breast cancer, the recommended dose of docetaxel is 100 mg/m2 in monotherapy. 
Za zdravljenje bolnic z lokalno napredovalim ali metastatskim rakom dojke je priporočeni odmerek docetaksela v monoterapiji 100 mg/m 2.
5.2 Pharmacokinetic properties 
5.2 Farmakokinetičnelastnosti
Disease-free survival (DFS) was the primary efficacy endpoint and OS was the secondary efficacy endpoint. 
Preživetje brez bolezni (DFS) je bilo primarni, celokupno preživetje (OS) pa sekundarni opazovani dogodek učinkovitosti.
Docetaxel infusion solution is supersaturated, therefore may crystallize over time. 
Raztopina docetaksela je supernasičena in sčasoma lahko kristalizira.
Based on a population pharmacokinetic analysis, there are no special instructions for use in the elderly. 
Starejši bolniki Za uporabo pri starejših bolnikih glede na analizo farmakokinetike na populaciji ni posebnih navodil.
There is no relevant use of Taxespira in the paediatric population for the indication of breast cancer, non-small cell lung cancer, prostate cancer, gastric carcinoma and head and neck cancer, not including type II and III less differentiated nasopharyngeal carcinoma. 
Zdravilo Taxespira ni primerno za uporabo pri pediatrični populaciji za indikacije rak dojke, nedrobnocelični pljučni rak, rak prostate, karcinom želodca in rak glave in vratu, ne vključujoč manj diferenciiran nazofaringealni karcinom tipa II oz. III.
Docetaxel has been shown to be both embryotoxic and foetotoxic in rabbits and rats, and to reduce fertility in rats. 
Dokazano je, da je docetaksel pri kuncih in podganah embriotoksičen in fetotoksičen ter da pri podganah zmanjšuje plodnost.
A survival update analysis conducted with a median follow-up time of 41.6 months no longer showed a statistically significant difference although always in favour of the TCF regimen and showed that the benefit of TCF over CF is clearly observed between 18 and 30 months of follow up. 
Analiza podskupin po starosti, spolu in rasi dosledno kaže prednost kraka s TCF pred krakom s CF. Ponovna analiza preživetja, narejena pri medianem času spremljanja 41,6 mesecev, ni več pokazala statistično značilne razlike, čeprav je bila shema s TCF še vedno ugodnejša; pokazala pa je, da so koristi TCF v primerjavi s CF jasno opazne med 18. in 30. mesecem spremljanja.