natgillin/translations-raw huggingface dataset:
Phase I study evaluating the effect of capecitabine on the pharmacokinetics of docetaxel and vice versa showed no effect by capecitabine on the pharmacokinetics of docetaxel (Cmax and AUC) and no effect by docetaxel on the pharmacokinetics of a relevant capecitabine metabolite 5'-DFUR.
U ispitivanju faze I u kojem se evaluirao učinak kapecitabina na farmakokinetiku docetaksela i obrnuto, pokazano je da kapecitabin nema učinka na farmakokinetiku docetaksela (Cmax i AUC) te da nema učinka docetaksela na farmakokinetiku 5'-DFUR-a, relevantnog metabolita kapecitabina.
G3/4 AST increased
G3/4 AST povišen
• if you are allergic (hypersensitive) to docetaxel or any of the other ingredients of Taxespira (listed in section 6).
• ako ste alergični (preosjetljivi) na docetaksel ili neki drugi sastojak ovog lijeka (naveden u dijelu
The use of docetaxel should be confined to units specialised in the administration of cytotoxic chemotherapy and it should only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy (see section 6.6).
Docetaksel se može primjenjivati samo na odjelima specijaliziranim za primjenu citotoksične kemoterapije i to isključivo pod nadzorom liječnika kvalificiranog za primjenu antitumorske kemoterapije (vidjeti dio 6.6).
Hypokalaemia, hypomagnesaemia, and hypocalcaemia were observed, usually in association with gastrointestinal disorders and in particular with diarrhoea.
Hipokalemija, hipomagnezijemija i hipokalcemija su primijećeni, obično povezani s gastrointestinalnim poremećajima,a osobito s proljevom.
When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
Kada se primjenjivala zajedno s docetakselom, klirens karboplatine bio je oko 50% veći u odnosu na vrijednosti koje su ranije zabilježene u monoterapiji karboplatinom.
- The other ingredients are polysorbate 80, ethanol anhydrous (see section 2) and citric acid monohydrate.
Drugi sastojci su polisorbat 80, bezvodni etanol (pogledajte dio 2) i citratna kiselina hidrat.
• ventricular arrhythmia or ventricular tachycardia (manifested as irregular and/or rapid heartbeat,
• ventrikularna aritmija ili ventrikularna tahikardija (koja se manifestira kao nepravilni i/ili ubrzani otkucaji srca, težak nedostatak zraka, omaglica i/ili nesvjestica).
G3/4 Blood alkaline phosphatase increased
G3/4 povećanje alkalne fosfataze u krvi
The development of severe peripheral neurotoxicity requires a reduction of dose (see sections 4.2 and 4.4).
Razvoj teške periferne neurotoksičnosti zahtijeva smanjenje doze (vidjeti dijelove 4.2 i 4.4).
Stratified log rank test *Threshold for statistical significance = 0.0175 **PSA: Prostate-Specific Antigen
95% CI p-vrijednost* † Stratificirani log-rank test * prag statističke značajnosti = 0,0175 ** PSA: prostata specifični antigen
All materials that have been utilised for dilution and administration should be disposed of according to standard procedures.
Sav materijal korišten za razrjeđivanje i primjenu lijeka potrebno je zbrinuti sukladno standardnim procedurama.
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).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Taxespira u svim podskupinama pedijatrijske populacije za karcinom dojke, karcinom nemalih stanica pluća, karcinom prostate, karcinom želuca i karcinom glave i vrata, ne uključujući manje diferencirani nazofaringealni karcinom tipa II i III (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
• blood clots.
• krvni ugrušci.
Taxespira concentrate for solution for infusion is a pale yellow to brownish-yellow solution provided in glass vials.
Taxespira koncentrat za otopinu za infuziju je blijedo žuta do smećkasto-žuta otopina u staklenim bočicama.
• Induction chemotherapy followed by chemoradiotherapy (TAX 324)
• Indukcijska kemoterapija praćena kemoradioterapijom (TAX 324)
Stomatitis/mucositis grade 4 First episode: stop 5-FU only, at all subsequent cycles.
Stomatitis/mukozitis stupnja 4 Prva epizoda: prekinuti samo primjenu 5-FU u svim sljedećim
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
Stoga se muškarcima liječenim docetakselom savjetuje da ne začinju dijete do 6 mjeseci nakon završetka liječenja i da potraže savjet o konzervaciji sperme prije početka liječenja.
This is because Taxespira or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Naime, može se dogoditi da u tom slučaju Taxespira ili neki drugi lijek neće djelovati prema očekivanju te da postoji veća vjerojatnost pojave nuspojava.
OS (Primary end-point):
Ukupno preživljenje (primarni ishod):
• nasal drainage; inflammation of the throat and nose; cough
• curenje iz nosa; upala grla i nosa; kašalj
The concentrate is a pale yellow to brownish-yellow solution.
Koncentrat je blijedo žuta do smećkasto-žuta otopina.
For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer (see section 5.1).
U bolesnika s operabilnim karcinomom dojke i negativnim limfnim čvorovima, adjuvantno liječenje treba ograničiti samo na bolesnike koji su prikladni za primanje kemoterapije prema međunarodno utvrđenim kriterijima za primarnu terapiju ranog karcinoma dojke (vidjeti dio 5.1).
For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
Bolesnicima u kojih se pojavila komplicirana neutropenija (produljena neutropenija, febrilna neutropenija ili infekcija) treba razmotriti primjenu G-CSF i smanjenje doze (vidjeti dio 4.2).
Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p <0.0001).
Vrijeme do progresije bolesti je bilo dulje u skupini koja je primala kombinaciju docetaksel + kapecitabin (p<0,0001).
In both arms, after the last cycle of chemotherapy, patients with positive estrogen and/or progesterone receptors received tamoxifen 20 mg daily for up to 5 years.
U obje su skupine, nakon zadnjeg ciklusa kemoterapije, bolesnici s pozitivnim estrogenskim i/ili progesteronskim receptorima primali tamoksifen 20 mg dnevno u trajanju od 5 godina.
C-docetaxel has been conducted in three cancer patients.
C-docetaksela na tri osobe s karcinomom.
Taxespira was administered as a 1-hour infusion, all other medicinal products were given intravenously on day 1 every three weeks.
Taxespira se primjenjivao u obliku jednosatne infuzije, a svi ostali lijekovi davali su se intravenski na 1. dan svaka tri tjedna.
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.
U ovom je ispitivanju 358 bolesnika s inoperabilnim, lokalno uznapredovalim SCCHN, WHO izvedbenog statusa 0 ili 1, bilo randomizirano u jednu od dvije liječene skupine.
Mild to moderate neuro-sensory signs are characterised by paraesthesia, dysesthesia or pain including burning.
Blagi do umjereni neurosenzorni znaci karakterizirani su parestezijom, dizestezijom ili boli uključujući pečenje.
Hypersensitivity reactions (frequency not known) have been reported with docetaxel in patients who previously experienced hypersensitivity reactions to paclitaxel.
Reakcije preosjetljivosti (nepoznate učestalost) prijavljene su s docetakselom u bolesnika koji su prethodno doživjeli reakcije preosjetljivosti na paklitaksel.
Sclerodermal-like changes usually preceded by peripheral lymphoedema have been reported with docetaxel.
Promjene slične sklerodermiji, kojima obično prethodi periferni limfedem zabilježeni su s docetakselom.
How to use Taxespira
Kako čuvati Taxespira
Contraception in males and females An effective method of contraception should be used during treatment.
Za vrijeme liječenja potrebno je koristiti učinkovitu kontracepciju.
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:
Taxespira Vam je propisao liječnik za liječenje karcinoma dojke, posebnih oblika karcinoma pluća (karcinom nemalih stanica pluća), karcinoma prostate, karcinoma želuca ili karcinoma glave i vrata:
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
Omjer hazarda manji od 1 daje prednost kombinaciji docetaksel + cisplatin + fluorouracil *neprilagođeni log-rank test **neprilagođeni log-rank test, nije prilagođen višestrukim usporedbama
MedDRA System Organ classes
MedDRA klasifikacija organskih sustava
Recommended dose modifications for toxicities in patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (5-FU):
Preporučene modifikacije doziranja u slučajevima toksičnosti u bolesnika liječenih docetakselom u kombinaciji s cisplatinom i 5-fluoruracilom (5-FU):
- The active substance is docetaxel (as trihydrate).
- Djelatna tvar je docetaksel (u obliku docetaksel trihidrata).
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, u bolesnika koji su imali febrilnu neutropeniju ili u bolesnika s ozbiljnim nehematološkim toksičnim učincima, doza docetaksela u sljedećim ciklusima mora se smanjiti na 65 mg/m2.
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).
Incidencija febrilne neutropenije/neutropenijske sepse također je bila povećana u bolesnika koji su liječeni Herceptinom i docetakselom (23% u odnosu na 17% bolesnika koji su liječeni samo docetakselom)
Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported.
Zabilježena je diseminirana intravaskularna koagulacija (DIK), često udružena sa sepsom ili multiorganskim zatajenjem.
More than one vial of Taxespira concentrate for solution for infusion may be necessary to obtain the required dose for the patient.
Ponekad je potrebno upotrijebiti više od jedne bočice Taxespira koncentrata za otopinu za infuziju kako bi se dobila potrebna doza za bolesnika.
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).
Ako se ne može izbjeći istodobna primjena snažnog CYP3A4 inhibitora (npr. ketokonazola, itrakonazola, klaritromicina, indinavira, nefazodona, nelfinavira, ritonavira, sakvinavira, telitromicina i vorikonazola), nužan je poman klinički nadzor, a može biti potrebna i prilagodba doze docetaksela za vrijeme terapije snažnim inhibitorom CYP3A4 (vidjeti dio 4.4).
Taxespira must NOT be administered if you are pregnant unless clearly indicated by your doctor.
Taxespira NE SMIJETE primati ako ste trudni, osim ako to liječnik nije izričito propisao.
Women of childbearing age receiving docetaxel should be advised to avoid becoming pregnant, and to inform the treating physician immediately should this occur.
Žene reproduktivne dobi koje primaju docetaksel treba savjetovati da ne planiraju trudnoću te da odmah obavijeste svog liječnika ako zatrudne.
In particular, please inform your doctor in case of diarrhoea, sores in the mouth, feeling of numbness or pins and needles, fever and give her/him the results of your blood tests.
Osobito je važno obavijestiti liječnika u slučaju proljeva, ranica u ustima, osjećaja utrnulosti ili bockanja u udovima i povišene temperature te mu pokazati rezultate krvnih pretraga.
Disease-free survival (DFS) was the primary efficacy endpoint and OS was the secondary efficacy endpoint.
Preživljenje bez znakova bolesti (DFS) bio je primarni ishod djelotvornosti, a ukupno preživljenje (OS) sekundarni ishod djelotvornosti.
Each vial is for single use and should be used immediately after opening.
Jedna bočica je za jednokratnu primjenu i mora se primijeniti odmah nakon otvaranja.
Excipients: polysorbate 80, ethanol anhydrous (see leaflet for further information), citric acid monohydrate.
Pomoćne tvari: polisorbat 80, bezvodni etanol (za dodatne informacije pogledajte uputu o lijeku), citratna kiselina hidrat.
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.
Randomizirano je 186 bolesnika koji su primali docetaksel (100 mg/m2) s trastuzumabom ili bez trastuzumaba; 60% bolesnika ranije je primalo adjuvantnu terapiju temeljenu na antraciklinima.
Median duration of response to chemotherapy ± radiotherapy (months) (95% CI)
Medijan trajanja odgovora na kemoterapiju ± radioterapiju (mjeseci) (95% CI)
It should be used within 6 hours (including the one hour infusion intravenous administration).
Mora se primijeniti unutar 6 sati (to uključuje i 1 sat primjene intravenske infuzije).
Rare cases of enterocolitis, including colitis, ischemic colitis, and neutropenic enterocolitis, have been reported with a potential fatal outcome (frequency not known).
Zabilježeni su rijetki slučajevi enterokolitisa, uključujući kolitis, ishemijski kolitis i neutropenijski enterokolitis s potencijalno smrtnim ishodom (nepoznata učestalost).
Adjuvant radiation therapy was prescribed according to guidelines in place at participating institutions and was given to 69 % of patients who received TAC and 72% of patients who received FAC.
Adjuvantno radioterapijsko liječenje provođeno je sukladno smjernicama ustanova u kojima je provođeno ispitivanje i provedeno je u 69% bolesnika koji su primili TAC i u 72% bolesnika koji su primili FAC.
In combination with cisplatin and 5-fluorouracil
Kombinacija s cisplatinom i 5-fluoruracilom
The concomitant use of docetaxel with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole) should be avoided (see section 4.5).
Treba izbjegavati istodobnu primjenu docetaksela sa snažnim inhibitorima CYP3A4 (npr. ketokonazolom, itrakonazolom, klaritromicinom, indinavirom, nefazodonom, nelfinavirom, ritonavirom, sakvinavirom, telitromicinom i vorikonazolom) (vidjeti dio 4.5).
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.
Pri medijanu vremena praćenja od 77 mjeseci dokazano je značajno produljenje preživljenja bez znakova bolesti u TAC skupini u usporedbi sa bolesnicima iz FAC skupine.
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).
Rjeđe su zabilježeni teški simptomi poput erupcija praćenih deskvamacijom što je rijetko dovelo do prekida ili prestanka liječenja docetakselom (vidjeti dijelove 4.2 i 4.4).
Disposal
Eliminacija
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).
Bez utjecaja na primarni ishod, ukupnu stopu odgovora (32% prema 25%, p=0,10), docetaksel je produljio medijan vremena do progresije bolesti (24,6 tjedana prema 15,6 tjedana; p<0,01) i medijan vremena preživljenja (15,3 mjeseca prema 12,7 mjeseci; p=0,03).
Pack size:
Veličina pakiranja:
In both arms, after the last cycle of chemotherapy, patients with ER+ and/or PgR+ tumours received tamoxifen 20 mg once a day for up to 5 years.
U obje skupine, nakon posljednjeg ciklusa kemoterapije, bolesnici sa ER+ i/ili PgR+ tumorima, primali su tamoksifen 20 mg jednom dnevno u razdoblju do 5 godina.
Treatment difference: 5.4% [95% CI: -1.1; 12.0] Treatment difference: 6.2% [95% CI: 0.2; 12.3]
Omjer hazarda: 1,122 [97.2% CI: 0.937; 1,342]* Razlika u liječenju: 5,4% [95% CI: -1,1; 12,0] Razlika u liječenju: 6.2% [95% CI: 0,2; 12,3]
Very common: Haematological toxicity was increased in patients receiving trastuzumab and docetaxel, compared with docetaxel alone (32% grade 3/4 neutropenia versus 22%, using NCI-CTC criteria).
Vrlo često: Hematološka toksičnost bila je povećana u bolesnika koji su primali trastuzumab i docetaksel u usporedbi s bolesnicima koji su primali docetaksel u monoterapiji (32% neutropenija stupnja 3/4 u odnosu na 22%, prema kriterijima NCI-CTC).
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.
Nema relevantne primjene lijeka Taxespira u pedijatrijskoj populaciji za indikacije karcinoma dojke, karcinoma nemalih stanica pluća, karcinoma prostate, karcinoma želuca i karcinoma glave i vrata, ne uključujući manje diferencirani nazofaringealni karcinom tipa II i III.
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.
Najčešće prijavljivane nuspojave lijeka Taxespira kada se primjenjuje sam su: pad broja crvenih ili bijelih krvnih stanica, gubitak kose, mučnina, povraćanje, ranice u ustima, proljev i umor.
Patients who experience Grade 3 or 4 stomatitis should have their dose decreased to 60 mg/m
Bolesnicima u kojih se pojavi stomatitis stupnja 3 ili 4 treba smanjiti dozu na 60 mg/m
Taxespira is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing Taxespira solutions.
Taxespira je antineoplastična tvar te se, kao što je slučaj i sa svim ostalim potencijalno toksičnim spojevima, mora s njime oprezno rukovati u pripremi otopine Taxespira.
Neutropenic complications in patients receiving TAC with or without primary G-CSF prophylaxis (GEICAM 9805)
Neutropenijske komplikacije u bolesnika koji su primali TAC terapiju s ili bez profilakse s G-CSF (GEICAM 9805)
Physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2°C to 8°C.
Fizikalna i kemijska stabilnost infuzijske otopine, pripremljene kako je preporučeno, dokazana je tijekom najviše 48 sati u ne-PVC vrećicama uz čuvanje na temperaturi od 2°C do 8°C.
The incidence of Grade 4 neutropenia, febrile neutropenia and neutropenic infection was decreased in patients who received primary G-CSF prophylaxis (see section 4.8).
Incidencija neutropenije stupnja 4, febrilne neutropenije i neutropenijske infekcije smanjena je u bolesnika koji su primali primarnu profilaksu s G-CSF (vidjeti dio 4.8).
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.
Muškarcima koji primaju Taxespira savjetuje se da ne začinju dijete tijekom liječenja i do 6 mjeseci nakon prestanka terapije te da potraže savjet o konzervaciji sperme prije liječenja, jer docetaksel može utjecati na plodnost muškarca.
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.
U bolesnika koji su docetaksel primali svaka tri tjedna, incidencija promjena na noktima povezanih s uzimanjem lijeka bila je ≥ 10% viša u bolesnika u dobi od 65 godina ili starijih u usporedbi s mlađim bolesnicima.
Docetaxel n = 94
Docetaksel n = 94
Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Od 300 bolesnika (221 bolesnik u fazi III ispitivanja i 79 bolesnika u fazi II ispitivanja) liječenih s docetakselom u kombinaciji sa cisplatinom i 5-fluoruracilom u ispitivanju koje je uključivalo bolesnike s karcinomom želuca, njih 74 je bilo u dobi od 65 godina ili starije, a 4 ih je bilo u dobi od 75 godina ili starije.
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.
U pivotalnim SCCHN ispitivanjima bolesnicima u kojih se javila komplicirana neutropenija (uključujući produljenu neutropeniju, febrilnu neutropeniju ili infekciju), preporučeno je primijeniti GCSF u svim sljedećim ciklusima (npr. od 6. do 15. dana), kako bi se osigurala profilaktička zaštita.
The required volume of Taxespira concentrate for solution for infusion must be injected via a single infusion (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Potrebni volumen Taxespira koncentrata za otopinu za infuziju mora se injicirati jednokratnom injekcijom (jedno injiciranje) u infuzijsku vrećicu ili bocu od 250 ml koja sadrži ili 5%-tnu otopinu glukoze ili 0,9%-tnu (9 mg/ml) otopinu natrijevog klorida za infuziju.
In anthracycline-failure patients, docetaxel was compared to the combination of mitomycin C and vinblastine (12 mg/m² every 6 weeks and 6 mg/m² every 3 weeks).
U bolesnika koji su neuspješno liječeni antraciklinima, docetaksel se uspoređivao s kombinacijom mitomicina C i vinblastina (12 mg/m svakih 6 tjedana i 6 mg/m svaka 3 tjedna).
OS at 10 years was also significantly increased with TAC compared to FAC (76% versus 69%, respectively) i.e. an absolute reduction of the risk of death by 7% (p = 0.002).
Sveukupno preživljenje nakon 10 godina bilo je također značajno poboljšano u TAC skupini u usporedbi sa FAC skupinom (76% prema 69%), što znači da je apsolutni rizik od smrti smanjen za 7% (p=0,002).
Docetaxel was administered as a 1-hour infusion, all other medicinal products were given as intravenous bolus on day one.
Docetaksel se primjenjivao u obliku jednosatne infuzije, a svi ostali lijekovi davali su se u intravenskom bolusu na 1. dan.
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.
Incidencija vrućice, proljeva, anoreksije i perifernog edema povezanih s uzimanjem lijeka bila je ≥10% viša u bolesnika u dobi od 75 godina i starijih u odnosu na mlađe od 65 godina.
Adjuvant radiation therapy was administered according to guidelines in place at participating institutions and was given to 57.3 % of patients who received TAC and 51.2 % of patients who received FAC.
Adjuvantna radioterapija provedena je prema važećim smjernicama ustanova u kojima je provođeno ispitivanje u 57,3% bolesnika koji su primali TAC terapiju i 51,2% bolesnika koji su primali FAC terapiju.