natgillin/translations-raw huggingface dataset:
45 • 92 patients treated with docetaxel in combination with trastuzumab. • 255 patients who received docetaxel in combination with capecitabine. • 332 patients who received docetaxel in combination with prednisone or prednisolone (clinically important treatment related adverse events are presented). • 744 patients who received docetaxel in combination with doxorubicin and cyclophosphamide (clinically important treatment related adverse events are presented). • 300 gastric adenocarcinoma patients (221 patients in the phase III part of the study and 79 patients in the phase II part) who received docetaxel in combination with cisplatin and 5-fluorouracil (clinically important treatment related adverse events are presented). • 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).
46 • 300 bolnikov z adenokarcinomom želodca (221 bolnikov v III. fazi študije in 79 bolnikov v II. fazi študije), ki so prejemali docetaksel v kombinaciji s cisplatinom in 5 - fluorouracilom (navedeni so klinično pomembni, z zdravljenjem povezani, neželeni učinki). • 174 bolnikov 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).
46 extremities and may become generalised with a weight gain of 3 kg or more.
Periferni edemi se ponavadi začnejo na nogah in lahko postanejo generalizirani; telesna masa se lahko poveča za 3 kg ali več.
Fluid retention is cumulative in incidence and severity (see section 4.4).
Zastajanje tekočine je kumulativno po incidenci in izrazitosti (glejte poglavje 4. 4).
Immune system disorders
47 Bolezni imunskega sistema:
Docetaxel Winthrop 100 mg/ m² single agent
Docetaxel Winthrop 100 mg/ m2 v monoterapiji:
MedDRA System Organ classes Investigations
Organski sistemi po MedDRA Preiskave
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients G3/ 4 Blood bilirubin increased (< 5%); G3/ 4 Blood alkaline phosphatase increased (< 4%); G3/ 4 AST increased (< 3%); G3/ 4 ALT increased (< 2%)
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov zvečanje bilirubina v krvi S3/ 4 (< 5%), zvečanje alkalne fosfataze v krvi S3/ 4 (< 4%), zvečanje AST S3/ 4 (< 3%), zvečanje ALT S3/ 4 (< 2%)
0.7%)
0, 7%) trombocitopenija (S4:
2.7%)
dispneja (huda 2, 7%)
Gastrointestinal disorders
0, 2%), Bolezni prebavil
4%); Abdominal pain Nausea (G3/ 4:
4%),
4%); (severe:
0, 4%)
1%); Vomiting (G3/ 4:
bruhanje (S3/ 4:
Oesophagitis (severe:
gastrointestinalna krvavitev (huda:
Infections and infestations
okužba, povezana z
Infections (G3/ 4:
Infekcijske in parazitske okužbe (S3/ 4:
5.7%; Infection associated including sepsis and with G4 neutropenia pneumonia, fatal in (G3/ 4:
5, 7%; nevtropenijo S4 (S3/ 4: bolezni
Vascular disorders
48 Organski sistemi po MedDRA Žilne bolezni Splošne težave in spremembe na mestu
Hypotension; Hypertension; Haemorrhage
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov hipotenzija, hipertenzija, krvavitev reakcija na mestu infundiranja,
General disorders and administration site conditions
Občasni neželeni učinki ≥ 0, 1 do < 1% bolnikov
Blood and lymphatic system disorders Rare: bleeding episodes associated with grade 3/ 4 thrombocytopenia.
Redki: krvavitve povezane s trombocitopenijo stopnje 3/ 4
48 Docetaxel Winthrop 75 mg/ m² single agent
49 Docetaxel Winthrop 75 mg/ m2 v monoterapiji:
G3/ 4 Blood bilirubin increased (< 2%)
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov zvečanje bilirubina v krvi S3/ 4 (< 2%)
0.8%) Myalgia
spremembe nohtov (hude 0, 8%)
Metabolism and nutrition disorders
Bolezni mišično- skeletnega sistema in vezivnega tkiva
Anorexia
mialgija
Infections and infestations Vascular disorders General disorders and administration site conditions
Presnovne in prehranske motnje Infekcijske in parazitske bolezni Žilne bolezni Splošne težave in spremembe na mestu aplikacije
Infections (G3/ 4:
anoreksija okužba (S3/ 4:
5%) Asthenia (severe:
5%) astenija (huda:
49 Docetaxel Winthrop 75 mg/ m² in combination with doxorubicin
50 Docetaxel Winthrop 75 mg/ m2 v kombinaciji z doksorubicinom:
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov
G3/ 4 Blood bilirubin increased (< 2.5%); G3/ 4 Blood alkaline phosphatase increased (< 2.5%)
zvečanje bilirubina v krvi S3/ 4 (< 2, 5%), zvečanje alkalne fosfataze v krvi S3/ 4 (< 2, 5%)
G3/ 4 AST increased (< 1%); G3/ 4 ALT increased (< 1%)
(< 1%), zvečanje ALT S3/ 4 (< 1%)
50 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin
51 Docetaxel Winthrop 75 mg/ m2 v kombinaciji s cisplatinom:
G3/ 4 Blood bilirubin increased (2.1%); G3/ 4 ALT increased (1.3%)
Pogosti neželeni učinki ≥ 1 do < 10% bolnikov zvečanje bilirubina v krvi S3/ 4 (2, 1%), zvečanje ALT S3/ 4 (1, 3%)
G3/ 4 AST increased (0.5%); G3/ 4 Blood alkaline phosphatase increased (0.3%)
Občasni neželeni učinki ≥ 0, 1 do < 1% bolnikov zvečanje AST S3/ 4 (0, 5%), zvečanje alkalne fosfataze v krvi S3/ 4 (0, 3%)
0.7%)
0, 7%) febrilna nevtropenija
51 Docetaxel Winthrop 100 mg/ m² in combination with trastuzumab
52 Docetaxel Winthrop 100 mg/ m2 v kombinaciji s trastuzumabom:
Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
O simptomatskem srčnem popuščanju so poročali pri 2, 2% bolnikov, ki so dobivali docetaxel in trastuzumab, in pri 0% bolnikov, ki so dobivali samo docetaxel.
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
V kraku z docetaxel in trastuzumabom je 64% bolnikov predhodno dobivalo antracikline kot adjuvantno terapijo; v kraku, v katerem so bolniki dobivali samo docetaksel, je bil ta delež 55%.
52 Docetaxel Winthrop 75 mg/ m² in combination with capecitabine
53 Docetaxel Winthrop 75 mg/ m2 v kombinaciji s kapecitabinom:
4%); Constipation (G3/ 4:
1%),
1%); Abdominal pain (G3/ 4:
bolečine v trebuhu (S3/ 4:
2%); Dyspepsia
2%), dispepsija Bolezni kože in podkožja
24%); Alopecia (G3/ 4:
24%) dermatitis, alopecija (S3/ 4:
2%)
6%), eritematozen izpuščaj spremembe nohtov (S3/ 4:
Dermatitis; Rash erythematous (G3/ 4: < 1%); Nail discolouration; Onycholysis (G3/ 4:
2%) (S3/ 4: < 1%), obarvanje nohtov, oniholiza (S3/ 4:
Musculoskeletal and connective tissue disorders Metabolism and nutrition disorders Infections and infestations
Bolezni mišično- skeletnega sistema in vezivnega tkiva
2%); Arthralgia (G3/ 4:
2%), bolečine v udih (S3/ 4: < 1%), artralgija (S3/ 4:
1%) Anorexia (G3/ 4:
Presnovne in prehranske motnje anoreksija (S3/ 4:
1%) Dehydration (G3/ 4:
dehidracija (S3/ 4:
Asthenia (G3/ 4:
Infekcijske in parazitske bolezni Splošne težave in spremembe astenija (S3/ 4:
3%); Pyrexia (G3/ 4:
3%), na mestu aplikacije pireksija (S3/ 4:
Lethargy; Pain
oralna kandidoza (S3/ 4: < 1%) letargija, bolečine
53 Docetaxel Winthrop 75 mg/ m² in combination with prednisone or prednisolone
54 Docetaxel Winthrop 75 mg/ m2 v kombinaciji s prednizonom ali prednizolonom:
0.6%)
močnejše solzenje (S3/ 4: 0, 6%) epistaksa (S3/ 4:
Alopecia; Nail disorders (no severe) Anorexia (G3/ 4:
eksfoliacijski izpuščaj (S3/ 4:
54 Docetaxel Winthrop 75 mg/ m² in combination with doxorubicin and cyclophosphamide
55 Docetaxel Winthrop 75 mg/ m2 v kombinaciji z doksorubicinom in ciklofosfamidom:
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients Weight increased or decreased (G3/ 4:
Zelo pogosti neželeni učinki ≥ 10% bolnikov povečanje ali zmanjšanje telesne mase (S3/ 4:
Arrhythmia (G3/ 4:
0, 1%),
0.1%); Congestive heart failure
kongestivno srčno popuščanje
2.0%); Febrile neutropenia
0%)
Lacrimation disorder (G3/ 4:
motnja solzenja (S3/ 4:
0.1%); Conjunctivitis (G3/ 4:
0, 1%), konjunktivitis (S3/ 4:
Cough (G3/ 4:
kašelj (S3/ 4:
5.1%); Abdominal pain (G3/ 4:
7, 1%), bruhanje (S3/ 4:
Colitis/ enteritis/ large intestine perforation
ija debelega črevesa
0.4%)
0, 4%) mialgija (S3/ 4:
Myalgia (G3/ 4:
0, 8%), artralgija (S3/ 4:
0.8%); Arthralgia (G3/ 4:
0, 4%)
Vascular disorders
Žilne bolezni Splošne težave in spremembe na mestu aplikacije
55 MedDRA System Organ classes General disorders and administration site conditions
56 Organski sistemi po MedDRA Bolezni imunskega sistema Motnje reprodukcije in dojk
11%); Fever (G3/ 4:
Zelo pogosti neželeni učinki ≥ 10% bolnikov preobčutljivost (S3/ 4:
1.2%); Oedema peripheral (G3/ 4:
1, 1%) amenoreja
1.1%) Amenorrhoea
Občasni neželeni učinki ≥ 0, 1 do < 1% bolnikov
56 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin and 5-fluorouracil for gastric adenocarcinoma cancer
57 Docetaxel Winthrop 75 mg/ m2 v kombinaciji s cisplatinom in 5- fluorouracilom za adenokarcinom želodca:
Constipation (G3/ 4:
zaprtje (S3/ 4:
1.0%); Gastrointestinal pain (G3/ 4:
1, 0%), bolečine v prebavilih (S3/ 4:
Neutropenic infection; Infection (G3/ 4:
Infekcijske in parazitske bolezni nevtropenična okužba, okužba (S3/ 4:
57 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin and 5-fluorouracil for Head and Neck cancer
58 Docetaxel Winthrop 75mg/ m² v kombinaciji s cisplatinom in 5- fluorouracilom za rak glave in vratu:
MedDRA System Organ classes
Organski sistemi po MeDRA Preiskave
Myocardial ischemia (G3/ 4:1.7%)
miokardna ishemija (S3/ 4: 1, 7%) febrilna nevtropenija
76.3%);
nevtropenija (S3/ 4: 76, 3%), anemija (S3/ 4: 9, 2%), trombocitopenija (S3/ 4: 5, 2%)
Febrile neutropenia
vrtoglavost
0.6%)
disgevzija/ parozmija, periferna senzorična nevropatija (S3/ 4: 0, 6%),
Gastrointestinal disorders
zaprtje, Bolezni prebavil
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
0.6%)
srbeč izpuščaj, suha koža, luščenje kože (S3/ 4: 0, 6%)
Venous disorder (G3/ 4:
letargija (S3/ 4: 3, 4%), pireksija (S3/ 4:
0.6%)
0, 6%), retenca tekočine, edem
3.4%); Pyrexia (G3/ 4:
venska bolezen (S3/ 4: 0, 6%)
58 • Induction chemotherapy followed by chemoradiotherapy (TAX 324)
59 • Indukcijska kemoterapija in nato kemoradioterapija (TAX 324)
Very common adverse reactions ≥ 10% of patients
Zelo pogosti neželeni učinki ≥ 10% bolnikov zmanjšanje telesne mase
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Občasni neželeni učinki ≥ 0, 1 do < 1% bolnikov povečanje telesne mase
Investigations Cardiac disorders
Srčne bolezni Bolezni krvi in limfatičnega sistema
Arrhythmia (G3/ 4:
nevtropenija (S3/ 4:
2.0%)
83, 5%), anemija (S3/ 4:
Weight increased Ischemia myocardial
12, 4%), trombocitopenija (S3/ 4:
Blood and lymphatic system disorders
4, 0%), febrilna nevtropenija
83.5%); Anemia (G3/ 4:
2, 0%) omotica (S3/ 4:
12.4%); Thrombocytopenia (G3/ 4:
2, 0%),
4.0%); Febrile neutropenia
miokardna ishemija
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)
59 Post-marketing experience
60 Pomarketinške izkušnje:
These reactions sometimes appear during the infusion of the medicinal product.
Očesne bolezni:
60 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
61 4. 9 Preveliko odmerjanje
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 prejemanje docetaksela 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, vse ostale medicinske produkte pa v intravenskem bolusu prvi dan.
61 An interim analysis was performed with a median follow up of 55 months.
Narejena je bila vmesna analiza z mediano 55- mesečnim spremljanjem.
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%
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).
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 docetaksel 100 mg/ m2 v 1- urni infuziji bodisi na paklitaksel 175 mg/ m2 v 3 - urni infuziji.
More grade 3/ 4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Med monoterapijo z docetaksel so zabeležili več neželenih učinkov 3. ali 4. stopnje (55, 4%) kot med terapijo s paklitakselom (23, 0%).
62 Docetaxel Winthrop in combination with doxorubicin
63 Docetaxel Winthrop v kombinaciji z doksorubicinom
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 prejemanjedocetaksel (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).
In this trial, 87% of patients had disease that was IHC 3+, and 95% of patients entered had disease that was IHC 3+ and/ or FISH positive.
V tem preskušanju je imelo 87% bolnic bolezen, ki je bila IHK 3+, 95% vključenih bolnic pa je imelo bolezen, ki je bila IHK 3+ in/ ali FISH - pozitivna.
Docetaxel
docetaksel 1
(95% CI) Median TTP (months) (95% CI) Median Survival (months)
(meseci) (95% IZ) mediani ČDN (meseci) (95% IZ) mediano preživetje (meseci)
(9.2-15.0) 10.6 (7.6-12.9) 30.52
11, 4 (9, 2– 15, 0) 10, 6 (7, 6– 12, 9) 30, 52
(4.4-6.2) 5.7 (5.0-6.5) 22.12
5, 1 (4, 4– 6, 2) 5, 7 (5, 0– 6, 5) 22, 12
Docetaxel Winthrop in combination with capecitabine
64 Docetaxel Winthrop v kombinaciji s kapecitabinom
Data from one multicenter, randomised, controlled phase III clinical trial support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast
Podatki multicentričnega, randomiziranega, kontroliranega kliničnega preskušanja 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.
In a phase III trial, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/ m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/ m2 over 30-60 minutes every 3 weeks, docetaxel 75 mg/ m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ ml. min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/ m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/ m2 administered on day 1 of cycles repeated every 4 weeks.
Druga je na 3 tedne dobivala docetaksel 75 mg/ m2 v 1- urni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ ml• min) v 30– 60 minutah, tretja pa na 4 tedne vinorelbin (V) 25 mg/ m2 v 6– 10 minutah 1., 8., 15. in 22. dan, ki mu je 1. dan ciklusov sledil cisplatin 100 mg/ m2.
64 Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
Sekundarne končne točke so vključevale spremembe bolečin, celotno oceno kakovosti življenja z EuroQoL- 5D, Lung Cancer Symptom Scale in spremembe zmogljivostnega stanja po Karnofskem.
For docetaxel/ carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Za kombinacijo docetaksel Winthrop / karboplatin v primerjavi z referenčno terapevtsko kombinacijo VCis ni bilo mogoče dokazati niti enakovredne niti neinferiorne učinkovitosti.
A total of 1006 patients with KPS ≥ 60 were randomized to the following treatment groups: • Docetaxel 75 mg/ m2 every 3 weeks for 10 cycles. • Docetaxel 30 mg/ m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles. • Mitoxantrone 12 mg/ m2 every 3 weeks for 10 cycles.
V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem ≥ 60: • docetaksel 75 mg/ m2 vsake 3 tedne, 10 ciklov. • docetaksel 30 mg/ m2 aplicirano tedensko prvih 5 tednov 6 tedenskega cikla, ki se ponovi v 5- ih ciklih. • Mitoksantron 12 mg/ m2 vsake 3 tedne, 10 ciklov.
Docetaxel every Docetaxel every 3 weeks week
docetaxel vsake docetaxel vsak 3 tedne teden 334
Mitoxantrone every 3 weeks
Mitoksantron vsake 3 tedne 337
Number of patients Median survival (months) 95% CI Hazard ratio 95% CI p-value† * Number of patients PSA** response rate (%) 95% CI p-value* Number of patients Pain response rate (%) 95% CI p-value* Number of patients Tumor response rate (%) 95% CI p-value* † Stratified log rank test
število bolnikov odzivnost na PSA ** (%) 95% IZ p- vrednost * število bolnikov odzivnost na bolečino (%) 95% IZ p - vrednost *
335 334 18.9 17.4 (17.0-21.2) (15.7-19.0) 0.761 0.912 (0.619-0.936) (0.747-1.113) 0.0094 0.3624 291 282 45.4 47.9 (39.5-51.3) (41.9-53.9) 0.0005 < 0.0001 153 154 34.6 31.2 (27.1-42.7) (24.0-39.1) 0.0107 0.0798 141 134 12.1 8.2 (7.2-18.6) (4.2-14.2) 0.1112 0.5853
291 282 45, 4 47, 9 (39, 5- 51, 3) (41, 9- 53, 9) 0, 0005 < 0, 0001 154 153 31, 2 34, 6 (24, 0- 39, 1) (27, 1- 42, 7) 0, 0798 0, 0107
337 16.5 (14.4-18.6) -- -- -- 300 31.7 (26.4-37.3) -- 157 21.7 (15.5-28.9) -- 137 6.6 (3.0-12.1) --
300 31, 7 (26, 4- 37, 3) -- 157 21, 7 (15, 5- 28, 9) --
*Threshold for statistical significance = 0.0175 **PSA:
število bolnikov odzivnost tumorja (%) 95% IZ p - vrednost *
Prostate-Specific Antigen
137 6, 6 (3, 0- 12, 1) --
Given the fact that docetaxel every week presented a slightly better safety profile than docetaxel every 3 weeks, it is possible that certain patients may benefit from docetaxel every week.
Glede na to, da je docetaxel tedensko pokazal nekoliko boljši profil varnosti kot Docetaxel Winthrop vsake tri tedne, je možno, da bi določenim bolnikom koristil docetaxel tedensko.
No statistical differences were observed between treatment groups for Global Quality of Life.
Med skupinami zdravljenja niso opazovali statističnih razlik po oceni globalnega vprašalnika o kvaliteti življenja (» Global Quality of Life «).
65 Gastric adenocarcinoma
Adenokarcinom želodca
A multicenter, open-label, randomized trial, 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 multicentrično, odprto, randomizirano preskušanje za oceno varnosti in učinkovitosti docetaxel pri zdravljenju bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki za metastatsko bolezen še niso prejemali kemoterapije.
A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/ m2 on day 1) in combination with cisplatin (C) (75 mg/ m2 on day 1) and 5-fluorouracil (F) (750 mg/ m2 per day for 5 days) or cisplatin (100 mg/ m2 on day 1) and 5-fluorouracil (1000 mg/ m2 per day for 5 days).
Skupaj je bilo zdravljenih 445 bolnikov z oceno zmogljivosti po Karnofskem > 70; prejemali so bodisi docetaxel (T) (75 mg/ m2 1. dan) v kombinaciji s cisplatinom (C) (75 mg/ m2 1. dan) in 5- fluorouracilom (F) (750 mg/ m2 na dan, 5 dni), bodisi cisplatin (100 mg/ m2 1. dan) in 5 - fluorouracil (1000 mg/ m2 na dan, 5 dni).
Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
67 Učinkovitost docetaxela pri zdravljenju bolnikov z adenokarcinomom želodca
Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p = 0.0121) and a longer time to definitive worsening of Karnofsky performance status (p = 0.0088) compared to patients treated with CF.
Pri bolnikih, zdravljenih s TCF, je bil v primerjavi s tistimi, ki so jih zdravili s CF, daljši tako čas do 5% trajnega poslabšanja splošnega zdravstvenega stanja po vprašalniku QLQ- C30 (p = 0, 0121) kot čas do trajnega poslabšanja stanja zmogljivosti po Karnofskem (p = 0, 0088).
• Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized trial (TAX323).
• Indukcijska kemoterapija in nato radioterapija (TAX 323) Varnost in učinkovitost docetaxel za indukcijsko zdravljenje bolnikov sskvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenjevali v multicentričnem odprtem randomiziranemu preskušanju faze III (TAX323).
Patients on the docetaxel arm received docetaxel (T) 75 mg/ m2 followed by cisplatin (P) 75 mg/ m2 followed by
Bolniki v kraku docetakselom so prejelidocetaxel 75 mg/ m2, ki mu je sledil cisplatin (P) 75 mg/ m2, temu pa 5- fluorouracil (F) 750 mg/ m2 na dan v obliki neprekinjene infuzije 5 dni.
At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (TPF/ RT).
Na koncu kemoterapije (z najkrajšim presledkom 4 tedne in najdaljšim presledkom 7 tednov) so bolniki, ki jim bolezen ni napredovala, 7 tednov dobivali radioterapijo (RT) v skladu s smernicami ustanove (TPF/ RT).
Patients on the comparator arm received cisplatin (P) 100 mg/ m2 followed by 5-fluorouracil (F) 1000 mg/ m2 per day for 5 days.
Bolniki v primerjalnem kraku so dobili ali cisplatin (P) 100 mg/ m2, ki mu je sledil 5- fluorouracil 1000 mg/ m2 (F) na dan 5 dni.
Locoregional therapy with radiation was delivered either with a conventional fraction (1.8 Gy - 2.0 Gy once a day, 5 days per week for a total dose of 66 to 70 Gy), or accelerated/ hyperfractionated regimens of radiation therapy (twice a day, with a minimum interfraction interval of 6 hours, 5 days per week).
Lokoregionalno terapijo z obsevanjem so aplicirali bodisi s konvecionalno frakcijo (1, 8 Gy – 2, 0 Gy enkrat na dan, 5 dni na teden v celotnem odmerku 66 do 70 Gy), ali s pospešenimi/ hiperfrakcioniranimi shemami obsevalnega zdravljenja (dvakrat na dan, z minimalnim intervalom med frakcijama 6 ur, 5 dni na teden).