natgillin/translations-raw huggingface dataset:
Congestive Heart Failure (CHF) (2.3% at 70 months median follow-up) has also been reported.
Opisano je bilo tudi kongestivno srčno popuščanje (2, 3% pri mediano 70- mesečnem spremljanju).
One patient in each treatment arm died due to cardiac failure.
Zaradi srčnega popuščanja je umrl po en bolnik v vsakem kraku.
Nervous system disorders Peripheral sensory neuropathy was observed to be ongoing at the median follow-up time of 55 months in 9 patients out of the 73 patients with peripheral sensory neuropathy at the end of the chemotherapy.
Še prisotno periferno senzorično nevropatijo so po mediano 55- mesečnem spremljanju zabeležili pri 9 od 73 bolnikov, ki so imeli periferno senzorično nevropatijo ob koncu kemoterapije.
Skin and subcutaneous tissue disorders Alopecia was observed to be ongoing at the median follow-up time of 55 months in 22 patients out of the 687 patients with alopecia at the end of the chemotherapy.
Še prisotno alopecijo so po mediano 55- mesečnem spremljanju zabeležili pri 22 od 687 bolnikov, ki so imeli alopecijo ob koncu kemoterapije.
General disorders and administration site conditions Oedema peripheral was observed to be ongoing at the median follow-up time of 55 months in 18 patients out of the 112 patients with oedema peripheral at the end of the chemotherapy.
Še prisotne periferne edeme so po mediano 55- mesečnem spremljanju zabeležili pri 18 od 112 bolnikov, ki so imeli periferne edeme ob koncu kemoterapije.
Reproductive system and breast disorders Amenorrhoea was observed to be ongoing at the median follow-up time of 55 months in 133 patients out of the 233 patients with amenorrhoea at the end of the chemotherapy.
Še prisotno amenorejo so po mediano 55- mesečnem spremljanju zabeležili pri 133 od 233 bolnic, ki so imele amenorejo ob koncu kemoterapije.
20 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin and 5-fluorouracil for gastric adenocarcinoma cancer
20 Docetaxel Winthrop 75 mg/ m2 v kombinaciji s cisplatinom in 5- fluorouracilom za adenokarcinom želodca
Cardiac disorders Blood and lymphatic system disorders
Organski sistemi po MedDRA Srčne bolezni Bolezni krvi in limfatičnega sistema
Anaemia (G3/ 4:
Zelo pogosti neželeni učinki ≥ 10% bolnikov anemija (S3/ 4:
20.9%); Neutropenia (G3/ 4:
20, 9%), nevtropenija (S3/ 4:
83.2%); Thrombocytopenia (G3/ 4:
83, 2%), trombocitopenija (S3/ 4:
8.8%); Febrile neutropenia
8, 8%), febrilna nevtropenija
Arrhythmia (G3/ 4:
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov aritmija (S3/ 4:
Dizziness (G3/ 4:
omotica (S3/ 4:
2.3%); Peripheral motor neuropathy (G3/ 4:
2, 3%), periferna motorična nevropatija (S3/ 4:
Eye disorders
Očesne bolezni Ušesne bolezni, vključno z motnjami labirinta
0%)
0%) okvara sluha (S3/ 4:
Hearing impaired (G3/ 4:
0%) zaprtje (S3/ 4:
0%)
1, 0%),
Diarrhoea (G3/ 4:
driska (S3/ 4:
19.7%); Nausea (G3/ 4:
19, 7%), navzea (S3/ 4:
16%); Stomatitis (G3/ 4:
16%), stomatitis (S3/ 4:
23.7%); Vomiting (G3/ 4:
23, 7%), bruhanje (S3/ 4:
Constipation (G3/ 4:
bolečine v prebavilih (S3/ 4:
1.0%); Oesophagitis/ dysphagia/ odynop hagia (G3/ 4:
1, 0%), ezofagitis/ disfagija/ odinofagija (S3/ 4:
Alopecia (G3/ 4:
alopecija (S3/ 4:
Rash pruritus (G3/ 4:
pruritični izpuščaj (S3/ 4:
0.7%); Skin exfoliation (G3/ 4:
0, 7%), eksfoliacija kože (S3/ 4:
11.7%)
Presnovne in prehranske motnje anoreksija (S3/ 4:
Infections and infestations
11, 7%) Infekcijske in parazitske bolezni nevtropenična okužba; okužba (S3/ 4:
Neutropenic infection; Infection (G3/ 4:
11, 7%) Splošne težave in spremembe na letargija (S3/ 4:
11.7%)
19, 0%), mestu aplikacije
19.0%); Fever (G3/ 4:
zvišana telesna temperatura (S3/ 4:
2.3%); Fluid retention (severe/ life- threatening:
2, 3%), zastajanje tekočine (hudo/ smrtno nevarno:
Blood and lymphatic system disorders Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Febrilna nevtropenija se je pojavila pri 17, 2% bolnikov, nevtropenična okužba pa pri 13, 5% bolnikov, ne glede na uporabo G- CSF.
G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7% of the cycles).
G- CSF so uporabili za sekundarno profilakso pri 19, 3% bolnikov (10, 7% ciklusov).
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 G- CSF, in pri 12, 9% tistih, ki je niso (glejte poglavje 4. 2).
21 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin and 5-fluorouracil for Head and Neck cancer
21 Docetaxel Winthrop 75 mg/ m² v kombinaciji s cisplatinom in 5- fluorouracilom za rak glave in vratu
Very common adverse reactions ≥ 10% of patients
Zelo pogosti neželeni učinki ≥ 10% bolnikov
Common adverse reactions ≥ 1 to < 10% of patients
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov povečanje telesne mase
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Občasni neželeni učinki ≥ 0, 1 do < 1% bolnikov
Arrhythmia (G3/ 4:
miokardna ishemija (S3/ 4:
Neutropenia (G3/ 4:
aritmija (S3/ 4:
Febrile neutropenia
Bolezni krvi in limfatičnega sistema
Anemia (G3/ 4:
nevtropenija (S3/ 4: 76, 3%); anemija (S3/ 4:
9.2%); Thrombocytopenia (G3/ 4:
9, 2), trombocitopenija (S3/ 4: 5, 2%)
5.2%) Nervous system disorders
Bolezni živčevja
0.6%)
disgevzija/ parozmija, periferna senzorična nevropatija (S3/ 4: 0, 6%):
0.6%); Stomatitis (G3/ 4:
0, 6%),
4.0%); Diarrhea (G3/ 4:
ezofagitis/ disfagija/ odin
2.9%); Vomiting (G3/ 4:
stomatitis (S3/ 4:
Constipation; Esophagitis/ dysphagia/ odynophagia (G3/ 4:
4, 0%), ofagija (S3/ 4: 0, 6%); diareja (S3/ 4:
0.6%)
2, 9%), bolečine v trebuhu; bruhanje (S3/ 4:
Skin and subcutaneous tissue disorders
0, 6%) dispepsija; krvavitev v prebavilih (S3/ 4: 0, 6%) Bolezni kože in podkožja Bolezni mišično - skeletnega sistema in vezivnega tkiva
0.6%)
srbeč izpuščaj; suha koža; luščenje kože (S3/ 4: 0, 6%) mialgija (S3/ 4: 0, 6%)
0.6%)
anoreksija (S3/ 4: 0, 6%)
Infections and infestations Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infekcijske in parazitske okužba (S3/ 4: 6, 3%), bolezni Benigne in maligne neoplazme (vključno s cistami in polipi)
6.3%); Neutropenic infection
nevtropenična okužba
Cancer pain (G3/ 4:
bolečina zaradi raka (S3/ 4:
Venous disorder (G3/ 4:
venska bolezen (S3/ 4:
General disorders and administration site conditions
Splošne težave in spremembe na mestu aplikacije Bolezni imunskega sistema
Lethargy (G3/ 4:
Letargija (G3/ 4:
0.6%); Fluid retention; Oedema
3, 4%) pireksija (S3/ 4: 0, 6%); retenca tekočine; edem
Hypersensitivity (no severe)
preobčutljivost (brez težjih primerov)
22 • Induction chemotherapy followed by chemoradiotherapy (TAX 324)
22 • Indukcijska kemoterapija in nato kemoradioterapija (TAX 324)
Common adverse reactions ≥ 1 to < 10% of patients
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov
Investigations Cardiac disorders
Preiskave
2.0%)
povečanje telesne mase
Blood and lymphatic system disorders
Srčne bolezni Bolezni krvi in limfatičnega sistema
83.5%); Anemia (G3/ 4:
83, 5%), anemija (S3/ 4:
12.4%); Thrombocytopenia (G3/ 4:
aritmija (S3/ 4:
4.0%); Febrile neutropenia
2, 0%),
Dysgeusia/ Parosmia (G3/ 4:
disgevzija/ parozmija (S3/ 4:
0.4%); Peripheral sensory neuropathy (G3/ 4:
0, 4%), periferna senzorična nevropatija (S3/ 4:
Dizziness (G3/ 4:
periferna motorična nevropatija (S3/ 4:
Eye disorders Ear and labyrinth disorders
Očesne bolezni Ušesne bolezni, vključno z motnjami labirinta
Hearing impaired (G3/ 4:
okvara sluha (S3/ 4:
Lacrimation increased
močnejše solzenje dispepsija (S3/ 4:
13.9%); Stomatitis (G3/ 4:
13, 9%), stomatitis (S3/ 4:
20.7%); Vomiting (G3/ 4:
20, 7%), bruhanje (S3/ 4:
8.4%); Diarrhea (G3/ 4:
8, 4%), driska (S3/ 4:
6.8%); Esophagitis/ dysphagia/ odynophagia (G3/ 4:
6, 8%), ezofagitis/ disfagija/ odin ofagija (S3/ 4:
Dyspepsia (G3/ 4:
0, 8%), bolečine v prebavilih (S3/ 4:
0.8%); Gastrointestinal pain (G3/ 4:
1, 2%), gastrointestinalna krvavitev (S3/ 4:
Skin and subcutaneous tissue disorders Musculoskeletal, connective tissue bone disorders
Bolezni kože in podkožja Bolezni mišično - skeletnega sistema in vezivnega tkiva
4.0%); Rash pruritic
4, 0%), pruritičen izpuščaj
Dry skin; Desquamation Myalgia (G3/ 4:
suha koža, luščenje mialgija (S3/ 4:
Infections and infestations Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infekcijske in parazitske bolezni Benigne, maligne in neopredeljene neoplazme (vključno s cistami in polipi)
Neutropenic infection Cancer pain (G3/ 4:
nevtropenična okužba bolečina zaradi raka (S3/ 4:
Vascular disorders General disorders and administration site conditions
Žilne bolezni Splošne težave in spremembe na mestu aplikacije
Lethargy (G3/ 4:
letargija (S3/ 4:
4.0%); Pyrexia (G3/ 4:
4, 0%), pireksija (S3/ 4:
3.6%); Fluid retention (G3/ 4:
3, 6%), zastajanje tekočine (S3/ 4:
1.2%); Oedema (G3/ 4:
1, 2%), edemi (S3/ 4:
23 Post-marketing experience
23 Pomarketinške izkušnje:
Cardiac disorders Rare cases of myocardial infarction have been reported.
Poročali so o redkih primerih miokardnega infarkta.
Blood and lymphatic system disorders Bone marrow suppression and other hematologic adverse reactions have been reported.
Poročali so o supresiji kostnega mozga in drugih neželenih hematoloških učinkih.
Nervous system disorders Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
Ob uporabi docetaksela so opažali redke primere konvulzij ali prehodne izgube zavesti.
Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/ or hearing loss have been reported.
Opisani so bili redki primeri ototoksičnosti, okvar sluha in/ ali poslabšanja sluha.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome, interstitial pneumonia and pulmonary fibrosis have rarely been reported.
V redkih primerih so bili opisani akutni respiracijski distres sindrom, intersticijska pljučnica in pljučna fibroza.
Gastrointestinal disorders Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Opisani so redki primeri dehidracije zaradi prebavnih motenj, gastrointestinalne perforacije, ishemični kolitis, kolitis in nevtropenični enterokolitis.
Skin and subcutaneous tissue disorders Very rare cases of cutaneous lupus erythematosus and bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been reported with docetaxel.
Zelo redko so pri zdravljenju z docetakselom poročali o kožnem eritematoznem lupusu in o buloznih erupcijah, npr. o multiformnem eritemu, Stevens- Johnsonovem sindromu, toksični nekrolizi epidermisa.
Sclerodermal-like changes usually preceded by peripheral lymphedema have been reported with docetaxel.
Pri zdravljenju z docetakselom so poročali o spremembah podobnih sklerodermalnim spremembam.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Very rare 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.
Poročali so o zelo redkih primerih akutne mieloične levkemije in mielodisplastičnega sindroma pri uporabi docetaksela v kombinaciji z drugimi kemoterapevtiki in/ ali radioterapijo.
24 Hepatobiliary disorders Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Opisani so zelo redki primeri hepatitisa, včasih s smrtnim izidom, pri bolnikih z že prej obstoječo boleznijo jeter.
4.9 Overdose
24 4. 9 Preveliko odmerjanje
Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose.
Po odkritju prevelikega odmerjanja mora bolnik čim prej dobiti terapevtski G- CSF.
Antineoplastic agents, ATC Code:
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, oznaka ATC:
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 p- glikoproteinom, ki ga kodira gen za rezistenco proti več zdravilom.
Docetaxel Winthrop in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Docetaxel Winthrop v kombinaciji z doksorubicinom in ciklofosfamidom: adjuvantno zdravljenje
Data from a multicenter open label randomized trial support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Podatki multicentričnega, odprtega randomiziranega preskušanja podpirajo uporabo docetaksela za adjuvantno zdravljenje od 18 do 70 let starih bolnic z operabilnim rakom dojke, pozitivnimi bezgavkami in seštevkom po Karnofskem ≥ 80%.
After stratification according to the number of positive lymph nodes (1-3, 4+), 1491 patients were randomized to receive either docetaxel 75 mg/ m2 administered 1-hour after doxorubicin 50 mg/ m2 and cyclophosphamide 500 mg/ m2 (TAC arm), or doxorubicin 50 mg/ m2 followed by fluorouracil 500 mg/ m2 and cyclosphosphamide 500 mg/ m2 (FAC arm).
Po stratifikaciji glede na število pozitivnih bezgavk (1– 3, 4 ali več) je bilo 1. 491 bolnic randomiziranih na prejemanjedocetaksela 75 mg/ m2, apliciranega 1 uro po doksorubicinu 50 mg/ m2 in ciklofosfamidu 500 mg/ m2 (krak TAC), ali na prejemanje doksorubicina 50 mg/ m2, ki sta mu sledila fluorouracil 500 mg/ m2 in ciklofosfamid 500 mg/ m2 (krak FAC).
Docetaxel was administered as a 1-hour infusion, all other medicinal products were given as intravenous bolus on day one.
Docetaksel so aplicirali v 1- urni infuziji, vsa ostala zdravila pa v intravenskem bolusu prvi dan.
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.
V obeh krakih so bolnice s pozitivnimi estrogenskimi in/ ali progesteronskimi receptorji po zadnjem ciklu kemoterapije do 5 let dobivale tamoksifen 20 mg na dan.
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.
Dobilo jo je 69% bolnic, ki so prejemale TAC, in 72% bolnic, ki so prejemale FAC.
Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
25 preživetje brez bolezni v kraku TAC značilno daljše kot v kraku FAC.
Incidence of relapses at 5 years was reduced in patients receiving TAC compared to those who received FAC (25% versus 32%, respectively) i. e. an absolute risk reduction by 7% (p = 0.001).
Pogostost recidiva pri 5 letih je bila zmanjšana pri bolnicah, ki so prejemale TAC, v primerjavi s tistimi, ki so prejemale FAC (25% proti 32%) t. j. zmanjšanje absolutnega tveganja za 7% (p = 0, 001).
Overall survival at 5 years was also significantly increased with TAC compared to FAC (87% versus 81%, respectively) i. e. an absolute reduction of the risk of death by 6% (p = 0.008).
Tudi celotno preživetje pri 5 letih je bilo značilno povečano pri TAC v primerjavi z FAC (87% proti 81%) t. j. zmanjšanje absolutnega tveganja za smrt za 6% (p = 0, 008).
Disease Free Survival
preživetje brez bolezni
Overall Survival
celotno preživetje
Patient subset No of positive nodes
podskupina bolnic št. pozitivnih bezgavk
Hazard ratio*
razmerje tveganj *
Hazard 95% CI ratio*
razmerje 95% IZ tveganj *
1-3 4+
celotno 1– 3 4+
0.46-0.82 0.0009 0.63-1.08 0.17
0, 59– 0, 88 0, 46– 0, 82 0, 63– 1, 08
0.29-0.70 0.0002 0.66-1.33 0.72
0, 008 0, 0002 0, 72
*a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival compared to FAC
* Razmerje tveganj manj kot 1 pomeni, da je TAC povezan z daljšim preživetjem brez bolezni in daljšim celotnim preživetjem kot FAC.
The beneficial effect of TAC was not proven in patients with 4 and more positive nodes (37% of the population) at the interim analysis stage.
Ugodni učinek TAC ni bil dokazan pri bolnicah s 4 ali več pozitivnimi bezgavkami (37% populacije) na stopnji vmesne analize.
The effect appears to be less pronounced than in patients with 1-3 positive nodes.
Kaže, da je učinek manj izrazit kot pri bolnicah z 1- 3 pozitivnimi bezgavkami.
The benefit/ risk ratio was not defined fully in patients with 4 and more positive nodes at this analysis stage.
Na tej stopnji analize razmerje med koristjo in tveganjem ni bilo povsem definirano pri bolnicah s 4 ali več pozitivnimi bezgavkami.
Docetaxel Winthrop as single agent
Docetaxel Winthrop v monoterapiji
Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/ m² every 3 weeks.
Z docetakselom sta bili v priporočenem odmerku in shemi 100 mg/ m2 na 3 tedne opravljeni dve randomizirani primerjalni študiji III. faze, ki sta vključevali bolnice z metastatskim rakom dojke, in sicer 326 bolnic po neuspešnem alkilirajočem in 392 po neuspešnem antraciklinskem zdravljenju.
In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/ m² every 3 weeks).
Pri bolnicah z neuspelim alkilirajočim zdravljenjem so docetaksel primerjali z doksorubicinom (75 mg/ m2 na 3 tedne).
37%, p = 0.01) and shortened time to response (12 weeks vs.
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. s 37%, p = 0, 01) in skrajšal čas do odziva (12 tednov v prim. s 23 tedni, p = 0, 007).
Three docetaxel patients (2%) discontinued the treatment due to fluid retention, whereas 15 doxorubicin patients (9%) discontinued due to cardiac toxicity (three cases of fatal congestive heart failure).
Tri bolnice (2%), ki so prejemale docetaksel, so zdravljenje prekinile zaradi zastajanja tekočine, 15 prejemnic (9%) doksorubicina pa ga je prekinilo zaradi kardiotoksičnih učinkov (trije primeri usodnega kongestivnega srčnega popuščanja).
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).
Pri bolnicah po neuspelem antraciklinskem zdravljenju so docetaksel primerjali s kombinacijo mitomicina C in vinblastina (12 mg/ m2 na 6 tednov in 6 mg/ m2 na 3 tedne).
9 months, p = 0.01).
Docetaksel je zvečal delež odziva (33% v prim. z 12%, p < 0, 0001), podaljšal čas do napredovanja (19 tednov v prim. z 11 tedni, p = 0, 0004) in podaljšal celotno preživetje (11 mesecev v prim. z 9 meseci, p = 0, 01).
During these two phase III studies, the safety profile of docetaxel was consistent with the safety profile observed in phase II studies (see section 4.8).
Med študijama III. faze se je varnostni profil docetaksela skladal z varnostnim profilom, ugotovljenim v študijah II. faze (glejte poglavje 4. 8).
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.
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).
More grade 3/ 4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Med monoterapijo z docetakselom so zabeležili več neželenih učinkov 3. ali 4. stopnje (55, 4%) kot med terapijo s paklitakselom (23, 0%).
26 Docetaxel Winthrop in combination with doxorubicin
26 Docetaxel Winthrop v kombinaciji z doksorubicinom
One large randomized phase III study, involving 429 previously untreated patients with metastatic disease, has been performed with doxorubicin (50 mg/ m²) in combination with docetaxel (75 mg/ m²) (AT arm) versus doxorubicin (60 mg/ m²) in combination with cyclophosphamide (600 mg/ m²) (AC arm).
Opravljena je bila ena velika randomizirana študija III. faze, ki je vključevala 429 predhodno nezdravljenih bolnic z metastatsko boleznijo; v njej so kombinacijo doksorubicina (50 mg/ m2) in docetaksela (75 mg/ m2) (krak AT) primerjali s kombinacijo doksorubicina (60 mg/ m2) in ciklofosfamida (600 mg/ m2) (krak AC).
• Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
• Čas do napredovanja je bil v kraku AT značilno daljši kot v kraku AC, p = 0, 0138.
The median TTP was 37.3 weeks (95% CI:
Mediana časa do napredovanja je bila v kraku AT 37, 3 tedna (95% IZ:
33.4 - 42.1) in AT arm and 31.9 weeks (95% CI:
33, 4 – 42, 1) in v kraku AC 31, 9 tedna (95% IZ:
27.4 - 36.0) in AC arm. • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
27, 4 – 36, 0). • Celotni delež odziva je bil v kraku AT značilno večji kot v kraku AC, p = 0, 009.
The ORR was 59.3% (95% CI:
V kraku AT je bil celotni delež odziva 59, 3% (95% IZ:
52.8 - 65.9) in AT arm versus 46.5% (95% CI:
52, 8 – 65, 9) in v kraku AC 46, 5% (95% IZ:
In this trial, AT arm showed a higher incidence of severe neutropenia (90% versus 68.6%), febrile neutropenia (33.3% versus 10%), infection (8% versus 2.4%), diarrhea (7.5% versus 1.4%), asthenia (8.5% versus 2.4%), and pain (2.8% versus 0%) than AC arm.
V tem preskušanju so bili v kraku AT pogostejši kot v kraku AC: huda nevtropenija (90% v prim. z 68, 6%), febrilna nevtropenija (33, 3% v prim. z 10%), okužbe (8% v prim. z 2, 4%), driska (7, 5% v prim. z 1, 4%), astenija (8, 5% v prim. z 2, 4%) in bolečine (2, 8% v prim. z 0%).
On the other hand, AC arm showed a higher incidence of severe anemia (15.8% versus 8.5%) than AT arm, and, in addition, a higher incidence of severe cardiac toxicity: congestive heart failure (3.8% versus 2.8%), absolute LVEF decrease ≥ 20% (13.1% versus 6.1%), absolute LVEF decrease ≥ 30% (6.2% versus 1.1%).
Po drugi strani je bila huda anemija pogostejša v kraku AC kot v kraku AT (15, 8% v prim. z 8, 5%); pogostejši so bili tudi hudi kardiotoksični učinki: kongestivno srčno popuščanje (3, 8% v prim. z 2, 8%), absolutno zmanjšanje LVEF ≥ 20% (13, 1% v prim. s 6, 1%), absolutno zmanjšanje LVEF ≥ 30% (6, 2% v prim. z 1, 1%).
Docetaxel Winthrop in combination with trastuzumab
Docetaxel Winthrop v kombinaciji s trastuzumabom
Docetaxel in combination with trastuzumab was studied for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2, and who previously had not received chemotherapy for metastatic disease.
Docetaksel so v kombinaciji s trastuzumabom raziskali za zdravljenje bolnic z metastatskim rakom dojke, ki so imele na tumorju hiperekspresijo HER2 in prej še niso dobivale kemoterapije za metastatsko bolezen.
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.
The main test method used to determine HER2 positivity in this pivotal trial was immunohistochemistry (IHC).
Glavni test za ugotavljanje HER2- pozitivnosti v tem odločilnem preskušanju je bila imunohistokemija (IHK).