qanastek/EMEA-V3 huggingface dataset:
3%); Pyrexia (G3/ 4:
3%);
1%); Fatigue/ weakness (G3/ 4:
1%); Għejja/ indeboliment (G3/ 4:
5%); Oedema peripheral (G3/ 4:
5%); Edima periferika (G3/ 4:
17 Docetaxel Winthrop 75 mg/ m² in combination with prednisone or prednisolone
Docetaxel Winthrop 75 mg/ m² użat flimkien ma ’ prednisone jew prednisolone:
Cardiac left ventricular function decrease (G3/ 4:
Insuffiċjenza tal- ventrikolu tax - xellug tal- qalb (G3/ 4:
32%); Anaemia (G3/ 4:
32%); Anemija (G3/ 4:
4.9%)
4. 9%)
0.6%); Febrile neutropenia
0. 6%); Newtropenija bid- deni
1.2%); Dysgeusia (G3/ 4:
1. 2%); Disgewzja (G3/ 4:
Eye disorders
Disturbi fl- għajnejn Disturbi respiratorji, toraċiċi u medjastinali
Lacrimation increased (G3/ 4:
Tidmigħ miżjud (G3/ 4:
Epistaxis (G3/ 4:
0. 6%) Fġir l- imnieħer (G3/ 4:
0%); Dyspnoea (G3/ 4:
0%); Dispneja (G3/ 4:
0.6%); Cough (G3/ 4:
0. 6%); Sogħla (G3/ 4:
2.4%); Diarrhoea (G3/ 4:
2. 4%); Dijarrea (G3/ 4:
1.2%); Stomatitis/ Pharyngitis (G3/ 4:
1. 2%); Stomatite/ Farinġite (G3/ 4:
0.9%); Vomiting (G3/ 4:
0. 9%); Rimettar (G3/ 4:
Skin and subcutaneous tissue disorders Musculoskeletal and connective bone disorders Metabolism and nutrition disorders
Disturbi fil- ġilda u fitt- tessuti ta ’ taħt il - ġilda
0.6%)
Alopeċja; Mard tad- dwiefer (mhux sever)
Exfoliative rash (G3/ 4:
Raxx esfoljattiv (G3/ 4:
0.3%) Arthralgia (G3/ 4:
Artralġja (G3/ 4:
0.3%); Myalgia (G3/ 4:
0. 3%); Majalġja (G3/ 4:
Infections and infestations General disorders and administration site conditions Immune system disorders
Disturbi fil- metaboliżmu u n- nutrizzjoni Infezzjonijiet u infestazzjonijiet
Infection (G3/ 4:
Anorexja (G3/ 4:
3.3%) Fatigue (G3/ 4:
Għejja (G3/ 4:
3.9%); Fluid retention (severe:
3. 9%); Żamm tal- fluwidu (sever:
0.6%)
0. 6%)
18 Docetaxel Winthrop 75 mg/ m² in combination with doxorubicin and cyclophosphamide
Docetaxel Winthrop 75 mg/ m² użat flimkien ma ’ doxorubicin u cyclophosphamide:
MedDRA System Organ classes Investigations
Sistema tal- Klassifika tal - Organi fid- Database MedDRA
0.3%)
Reazzjonijiet Avversi komuni > 1 to < 10% tal- pazjenti
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Reazzjonijiet Avversi mhux komuni > 0. 1 to < 1% tal- pazjenti
0.1%); Congestive heart failure
0. 1%); L- insuffiċjenza konġestiva tal- qalb
Anaemia (G3/ 4:
Anemija (G3/ 4:
4.3%); Neutropenia (G3/ 4:
4. 3%); Newtropenija (G3/ 4:
65.5%); Thrombocytopenia (G3/ 4:
65. 5%); Tromboċitopenija (G3/ 4:
2.0%); Febrile neutropenia
2. 0%); Newtropenija bid- deni
Nervous system disorders
Newropatija periferika tal -
0%) 0.3%); Neurocerebellar (G3/ 4:
Disgewżja (G3/ 4:
0.1%)
0. 7%);
Syncope (G3/ 4:
movimenti (G3/ 4:
Eye disorders
nervuża
Lacrimation disorder (G3/ 4:
0%)
0.1%); Conjunctivitis (G3/ 4:
Newrokortikali( G3/ 4:
Cough (G3/ 4:
Sogħla (G3/ 4:
Nausea (G3/ 4:
5. 1%);
5.1%); Abdominal pain (G3/ 4:
Ugigħ addominali (G3/ 4:
0.5%) 7.1%); Vomiting (G3/ 4:
7. 1%); 0. 5%) Rimettar (G3/ 4:
4.3%); Diarrhoea (G3/ 4:
3. 2%); Stitikezza (G3/ 4:
3.2%); Constipation (G3/ 4:
0. 4%)
Colitis/ enteritis/ large intestine perforation
tal- musrana l- kbira
Skin and subcutaneous tissue disorders
Disturbifil- ġilda u fit - tessuti ta ’ taħt il- ġilda
Alopecia; Skin toxicity (G3/ 4:
Alopeċja; Tossiċità tal- ġilda (G3/ 4:
0.7%); Nail disorders (G3/ 4:
0. 7%); Mard tad- dwiefer (G3/ 4:
Musculoskeletal and connective tissue disorders
Disturbi muskolu- skeletrali u tal- connective tissue
2.2%)
Disturbi fil- metaboliżmu u Anoreksja (G3/ 4:
Infections and infestations
2. 2%) n- nutrizzjoni Infezzjonijiet u infestazzjonijiet
3.2%); Neutropenic infection.
3. 2%); Infezzjoni assoċjata man - newtropenija.
There were no septic deaths.
Ma kienx hemm imwiet bis- sepsis.
Vasodilatation (G3/ 4:
Vasodilatazzjoni (G3/ 4:
0%); Lymphoedema (G3/ 4:
0%); Edima limfatika (G3/ 4:
19 MedDRA System Organ classes General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients Asthenia (G3/ 4:
Astenja (G3/ 4:
11%); Fever (G3/ 4:
11%); Deni (G3/ 4:
Immune system disorders Reproductive system and breast disorders
Disturbi fis- sistema immuni Disturbi fis- sistema riproduttiva u fis- sider
1.1%) Amenorrhoea
1. 1%) Amenorreja
Cardiac disorders
Disturbi fil- qalb:
Congestive Heart Failure (CHF) (2.3% at 70 months median follow-up) has also been reported.
L- insuffiċjenza konġestiva tal- qalb (CHF) (2. 3% fiż- żmien medjan ta ’ 70 xahar fil- perijodu ta ’ osservazzjoni ta ’ wara t- trattament) kienet ukoll innotata.
One patient in each treatment arm died due to cardiac failure.
Pazjent wieħed f’ kull fergħa ta ’ trattament miet minn insuffiċjenza tal- qalb.
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.
In- newropatija periferika tas- sensazzjoni kienet għadha innotata fil- perijodu ta ’ osservazzjoni ta ’ wara t- trattament fiż- żmien medjan ta ’ 55 xahar f’ 9 pazjenti minn 73 pazjent b’ newropatija periferika tas - sensazzjoni li kienet hemm fit- tmiem tal- kimoterapija.
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.
L- alopeċja kienet għadha hemm waqt il- perijodu ta ’ osservazzjoni ta ’ wara t- trattament fi żmien medjan ta ’ 55 xahar f’ 22 pazjent minn 687 pazjent bl- alopeċja fit- tmiem tal- kimoterapija.
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.
L- edima periferika kienet għadha hemm waqt il- perijodu ta ’ osservazzjoni ta ’ wara t- trattament fi żmien medjan ta ’ 55 xahar fi 18- il pazjent minn 112 pazjent bl- edima periferika fit- tmiem tal - kimoterapija.
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.
L- amenorreja kienet ghadha hemm waqt il- perijodu ta ’ osservazzjoni ta ’ wara t- trattament fi żmien medjan ta ’ 55 xahar f’ 133 pazjent minn 233 pazjent b’ amenorreja fit- tmiem tal- kimoterapija.
20 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin and 5-fluorouracil for gastric adenocarcinoma cancer
Docetaxel Winthrop 75 mg/ m² użat flimkien ma ’ cisplatin u 5- fluorouracil għal kanċer tat- tip adenokarċinoma ta ’ l- istonku:
Common adverse reactions ≥ 1 to < 10% of patients
Reazzjonijiet Avversi > 1 to < 10% tal- pazjenti
Cardiac disorders Blood and lymphatic system disorders
Disturbi fil- qalb Disturbi fid- demm u fis- sistema limfatika
20.9%); Neutropenia (G3/ 4:
20. 9%); Newtropenija (G3/ 4:
83.2%); Thrombocytopenia (G3/ 4:
83. 2%); Tromboċitopenija (G3/ 4:
8.8%); Febrile neutropenia
8. 8%); Newtropenija bid- deni
1.0%)
1. 0%).
8.7%)
8. 7%)
Dizziness (G3/ 4:
Sturdament (G3/ 4:
2.3%); Peripheral motor neuropathy (G3/ 4:
2. 3%); Newropatija periferika tal - movimenti (G3/ 4:
1.3%)
1. 3%)
Eye disorders
Disturbi fl- għajnejn Disturbi fil- widnejn u fis- sistema labirintika
Ear and labyrinth disorders
Reazzjonijiet Avversi komuni ħafna ≥ 10% tal- pazjenti
Hearing impaired (G3/ 4:
Reazzjonijiet Avversi > 1 to < 10% tal- pazjenti Stitikezza (G3/ 4:
0%)
1. 0%);
Diarrhoea (G3/ 4:
Dijarrea (G3/ 4:
19.7%); Nausea (G3/ 4:
19. 7%); Tqalligħ (G3/ 4:
23.7%); Vomiting (G3/ 4:
23. 7%); Rimettar (G3/ 4:
14.3%)
14. 3%)
Constipation (G3/ 4:
Ugigħ gastro- intestinali (G3/ 4:
1.0%); Gastrointestinal pain (G3/ 4:
1. 0%); Esofaġite/ disfaġja/ odinofaġja (G3/ 4:
Alopecia (G3/ 4:
Alopeċja (G3/ 4:
4.0%)
4. 0%)
Rash pruritus (G3/ 4:
Raxx bil- ħakk (G3/ 4:
0.7%); Skin exfoliation (G3/ 4:
0. 7%); Esfoljazzjoni tal- ġilda (G3/ 4:
Anorexia (G3/ 4:
Anorexja (G3/ 4:
11.7%)
11. 7%)
Neutropenic infection; Infection (G3/ 4:
Infezzjoni assoċjata man - newtropenija; Infezzjoni (G3/ 4:
Lethargy (G3/ 4:
Letarġija (G3/ 4:
19.0%); Fever (G3/ 4:
19. 0%); Deni (G3/ 4:
2.3%); Fluid retention (severe/ life- threatening:
2. 3%); Żamm tal- fluwidu (sever/ li jpoġġi l- ħajja f’ periklu:
1.7%)
1. 7)
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.
Newtropenija bid- deni u infezzjonijiet assoċjati man- newtropenija ġraw, rispettivament, f’ 17. 2% u 13. 5% tal- pazjenti, u dan irrispettiv jekk intużax G- CSF.
G-CSF was used for secondary prophylaxis in 19.3% of patients (10.7% of the cycles).
G- CSF kien użat ghall- profilassi sekondarja f’ 19. 3% tal- pazjenti (10. 7% taċ- ċikli).
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).
Newtropenija bid- deni u infezzjonijiet assoċjati man - newtropenija ġraw, rispettivament, fi 12. 1% u 3. 4% tal- pazjenti, meta dawn irċevew il- profilassi b’ G - CSF, fil- waqt li 15. 6% u 12. 9% tal- pazjenti ma ngħatawx profilassi b’ G- CSF (ara sezzjoni 4. 2).
21 Docetaxel Winthrop 75 mg/ m² in combination with cisplatin and 5-fluorouracil for Head and Neck cancer
Docetaxel Winthrop 75 mg/ m² użat flimkien ma ’ cisplatin and 5- fluorouracil (għal kanċer tar- ras u ta ’ l- għonq):
• Induction chemotherapy followed by radiotherapy (TAX 323)
• Kimoterapija Induttiva segwita bi radjuterapija (TAX323)
MedDRA System Organ classes
Sistema tal- Klassifika tal- Organi fid - Database MedDRA Investigazzjonijiet
Common adverse reactions ≥ 1 to < 10% of patients
Reazzjonijiet Avversi komuni > 1 to < 10% tal - pazjenti Żieda fil- piż
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Reazzjonijiet Avversi mhux komuni > 0. 1 to < 1% tal - pazjenti
Myocardial ischemia (G3/ 4:1.7%)
Mard iskemiku tal - mijokardju (G3/ 4: 1. 7%) Arritmija Newtropenija bid- deni
Neutropenia (G3/ 4:
Newtropenija (G3/ 4: 76. 3%) Anemija (G3/ 4:
76.3%);
9. 2%); Tromboċitopenija (G3/ 4: 5. 2%)
Febrile neutropenia
Sturdament
5.2%) Nervous system disorders
Disturbi fis- sistema
0.6%)
Disgewżja / Parosmja
Dizziness
nervuża
Lacrimation increased; Conjunctivitis
Tidmigħ miżjud Konġuntivite
Hearing impaired
Reazzjonijiet Avversi komuni > 1 to < 10% tal - pazjenti Nuqqas ta ’ smigħ
Gastrointestinal disorders
Reazzjonijiet Avversi mhux komuni > 0. 1 to < 1% tal - pazjenti
Nausea (G3/ 4:
Stitikezza
0.6%); Stomatitis (G3/ 4:
Disturbi gastro -
4.0%); Diarrhea (G3/ 4:
Tqalligħ (G3/ 4: 0. 6%)
2.9%); Vomiting (G3/ 4:
Esofaġite/ disfaġja /
0.6%)
intestinali
Constipation; Esophagitis/ dysphagia/ odynophagia (G3/ 4:
Stomatite (G3/ 4: 4. 0%) Dijarrea (G3/ 4: 2. 9%) Rimettar (G3/ 4: 0. 6%)
0.6%)
odinofaġja (G3/ 4: 0. 6%) Uġigħ addominali Dispepsja Emoraġija gastrointestinali (G3/ 4: 0. 6%)
10.9%)
Alopeċja (G3/ 4: 10. 9%)
0.6%)
Raxx bil- ħakk Ġilda xotta Ġilda esfoljattiva (G3/ 4: 0. 6%)
Musculoskeletal and connective tissue disorders
Disturbi muskolu - skeletrali u tal - connective tissue
0.6%)
Majalġja (G3/ 4: 0. 6%)
Metabolism and nutrition disorders
Disturbi fil - metaboliżmu u n - nutrizzjoni
0.6%)
Anoreksja (G3/ 4: 0. 6%)
Infections and infestations Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infezzjonijiet u infestazzjonijiet Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
6.3%); Neutropenic infection
Infezzjoni (G3/ 4: 6. 3%) Infezzjoni bin - newtropenija
Cancer pain (G3/ 4:
Uġigh tal- kanċer (G3/ 4:
0.6%)
Disturbi fil- vini (G3/ 4: 0. 6%)
Lethargy (G3/ 4:
Letarġija (G3/ 4: 3. 4%).
0.6%); Fluid retention; Oedema
Deni (G3/ 4: 0. 6%) Żamm tal- fluwidu Edima
22 • Induction chemotherapy followed by chemoradiotherapy (TAX 324)
21 • Kimoterapija Induttiva segwita bi kimoradjuterapija (TAX324)
Common adverse reactions ≥ 1 to < 10% of patients
Reazzjonijiet Avversi komuni ≥ 1 to < 10% tal - pazjenti
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Reazzjonijiet Avversi mhux komuni ≥ 0. 1 to < 1% tal- pazjenti
Investigations Cardiac disorders
Investigazzjonijiet Disturbi fil- qalb
Weight decreased
Tnaqqis fil- piż
2.0%)
2. 0%)
Weight increased Ischemia myocardial
Żieda fil- piż Mard iskemiku tal - mijokardju
83.5%); Anemia (G3/ 4:
83. 5%); Anemija (G3/ 4:
12.4%); Thrombocytopenia (G3/ 4:
12. 4%); Tromboċitopenija (G3/ 4:
4.0%); Febrile neutropenia
4. 0%) Newtropenija bid- deni
Dysgeusia/ Parosmia (G3/ 4:
Sturdament (G3/ 4:
0.4%); Peripheral sensory neuropathy (G3/ 4:
Disgewżja / Parosmja
1.2%)
2. 0%)
Dizziness (G3/ 4:
(G3/ 4:
2.0%); Peripheral motor neuropathy (G3/ 4:
0. 4%);
0.4%)
Newropatija periferika
Eye disorders Ear and labyrinth disorders
0. 4%); 1. 2%) Disturbi fl- għajnejn Disturbi fil- widnejn u fis- sistema labirintika
Hearing impaired (G3/ 4:
Nuqqas ta ’ smigħ (G3/ 4:
1.2%)
1. 2%);
Lacrimation increased
Tidmigħ miżjud; Dispepsja (G3/ 4:
Conjunctivitis
Konġuntivite
Gastrointestinal disorders
Disturbi gastro -
13.9%); Stomatitis (G3/ 4:
13. 9%); Stomatite (G3/ 4:
20.7%); Vomiting (G3/ 4:
20. 7%); Rimettar (G3/ 4:
8.4%); Diarrhea (G3/ 4:
8. 4%) Dijarrea (G3/ 4:
6.8%); Esophagitis/ dysphagia/ odynophagia (G3/ 4:
6. 8%); Esofaġite/ disfaġja / odinofaġja (G3/ 4:
0.4%)
0. 4%);
0.8%); Gastrointestinal pain (G3/ 4:
1. 2%); Emoraġija gastrointestinali (G3/ 4:
Skin and subcutaneous tissue disorders Musculoskeletal, connective tissue bone disorders
Disturbi fil- ġilda u fit - tessuti ta ’ taħt il- ġilda
4.0%); Rash pruritic
4. 0%); Raxx bil- ħakk;
Dry skin; Desquamation Myalgia (G3/ 4:
Majalġja (G3/ 4:
Anorexia (G3/ 4:
Anoreksja (G3/ 4:
12.0%)
12. 0%)
3.6%)
3. 6%);
Neutropenic infection Cancer pain (G3/ 4:
Infezzjoni bin - newtropenija Uġigħ tal- kanċer (G3/ 4:
Vascular disorders General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
4.0%); Pyrexia (G3/ 4:
4. 0%); Deni (G3/ 4:
3.6%); Fluid retention (G3/ 4:
3. 6%); Żamm tal- fluwidu (G3/ 4:
1.2%); Oedema (G3/ 4:
1. 2%); Edima (G3/ 4:
23 Post-marketing experience
L- esperjenza wara li tpoġġa fis- suq:
Cardiac disorders Rare cases of myocardial infarction have been reported.
Każijiet rari ta ’ infart mijokardijaku kienu irrapportati.
Blood and lymphatic system disorders Bone marrow suppression and other hematologic adverse reactions have been reported.
Trażżin tal- mudullun u reazzjonijiet avversi oħra ematoloġiċi kienu irrapportati.
Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported.
Koagulazzjoni intrvasculari mifruxa (DIC), spiss assoċjata ma ’ sepsis u insuffiċjenza ta ’ organi multipli, kienet irrapportata.
Nervous system disorders Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
Każijiet rari ta ’ aċċessjonijiet jew telf temporanju mis- sensi kien innotat fl- ingħatar ta ’ docetaxel.
These reactions sometimes appear during the infusion of the medicinal product.
Dawn ir- reazzjonijiet tfaċċaw x’ imdaqqiet waqt l- infużjoni tas- sustanza.
Eye disorders Very rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during infusion of the medicinal product and in association with hypersensitivity reactions have been reported.
Każijiet rari ħafna ta ’ disturbi viżivi li jgħaddu (leħħiet, dawl ileħħ u skotomata) li tipikament ġraw waqt l- infużjoni tal- prodott mediċinali, u assoċjati flimkien ma ’ reazzjonijiet ta ’ sensittività eċċessiva, kienu irrapportati.
These were reversible upon discontinuation of the infusion.
Dawn kienu riversibbli hekk kif twaqqfet l- infużjoni.
Cases of lacrimation with or without conjunctivitis, as cases of lacrimal duct obstruction resulting in excessive tearing have been rarely reported.
Każijiet rari ta ’ tidmigħ b’ konġuntivite jew mingħajrha, bħal każijiet ta ’ mblokkar tal- pajp tad- dmugħ, li jqattar fl- imnieħer, u b’ hekk irriżulta f’ tidmigħ eċċessiv, kienu rarament irrapportati.
Ear and labyrinth disorders Rare cases of ototoxicity, hearing impaired and/ or hearing loss have been reported.
Każijiet rari ta ’ effetti tossiċi fuq il- widna, nuqqas u/ jew telf tas- smigħ kienu irrapportati.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome, interstitial pneumonia and pulmonary fibrosis have rarely been reported.
Acute respiratory distress syndrome, pulmonite ta ’ l- interstizjum u fibrożi tal- pulmuni kienu rarament irrapportati.
Rare cases of radiation pneumonitis have been reported in patients receiving concomitant radiotherapy.
Każijiet rari ta ’ pneumonite dovut għar- radjazzjoni ġew irrapportati f’ pazjenti li kienu qed jieħdu konkomittantement ir- radjuterapija.
Gastrointestinal disorders Rare occurrences of dehydration as a consequence of gastrointestinal events, gastrointestinal perforation, colitis ischaemic, colitis and neutropenic enterocolitis have been reported.
Okkorrenzi rari ta ’ deidrazzjoni bħala konsegwenza ta ’ ġrajjiet gastro- intestinali, perforament gastro - intestinali, kolite iskemika, kolite u enterokolite newtropenika kienu irrapportati.
Rare cases of ileus and intestinal obstruction have been reported.
Każijiet rari ta ’ ileus u ostruzzjoni ta ’ l- intestin ġew irrapportati.
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.
Każijiet rari ħafna ta ’ lupus erythematosus tal- ġilda u nfafet kbar bħal erythema multiforme, is - sindrome ta ’ Stevens- Johnson, u toxic epidermal necrolysis, kienu ġew irrapportati b’ docetaxel.
In some cases concomitant factors may have contributed to the development of these effects.
F’ xi każijiet, fatturi konkomittanti setgħu taw kontribut għall- iżvilupp ta ’ dawn l- effetti.
Sclerodermal-like changes usually preceded by peripheral lymphedema have been reported with docetaxel.
B’ docetaxel, ġew irrapportati tibdil tat- tip sklerodermali, ħafna drabi wara limfedima periferali.
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.
Każijiet rari ħafna ta ’ lewkimja akuta tat- tip myeloid u s- sindrome myelodysplastic kienu ġew irrapportati, assoċjati ma ’ l- użu ta ’ docetaxel flimkien ma ’ sustanzi kimoterapewtiċi oħra u/ jew ir - radjuterapija.
Vascular disorders Venous thromboembolic events have rarely been reported.
Ġrajjiet tromboemboliċi kienu rarament irrapportati.
General disorders and administration site conditions Radiation recall phenomena have rarely been reported.
Recall phenomena tar- radjazzjoni kienu rarament irrapportati.
Fluid retention has not been accompanied by acute episodes of oliguria or hypotension.
Iż- żamm tal- fluwidu ma kienx akkompanjat ma ’ ġrajjiet akuti ta ’ oliguria jew pressjoni baxxa tad - demm.
Dehydration and pulmonary oedema have rarely been reported.
Id- deidrazzjoni u l- edima pulmonari kienu rarament irrapportati.
Immune system disorders Some cases of anaphylactic shock, sometimes fatal, have been reported.
Xi każijiet ta ’ xokk anafilattiku, x’ imdaqqiet fatali, kienu irrapportati.
24 Hepatobiliary disorders Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Każijiet rari ħafna ta ’ epatite, kultant fatali speċjalment f’ pazjenti li kellhom mard preċedenti tal - fwied, kienu irrapportati.
There were a few reports of overdose.
Kien hemm ftit rapporti ta ’ dożaġġ eċcessiv.
There is no known antidote for docetaxel overdose.
M’ hemmx antidot magħruf kontra doża eċċessiva ta’ docetaxel.
In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored.
F’ każ ta ’ doża eċċessiva, il- pazjent għandu jinżamm f’ ċentru speċjaliżżat u l- funzjoni ta ’ l- organi vitali għandha tkun immoniterjata.
In cases of overdose, exacerbation of adverse events may be expected.
F’ każijiet ta ’ dożaġġ eċċessiv, il- ġrajjiet avversi jistgħu jiġu mistennija li jmorru għall- agħar.
The primary anticipated complications of overdose would consist of bone marrow suppression, peripheral neurotoxicity and mucositis.
Il- kumplikazzjonijiet primarji u antiċipati ta ’ doża eċċessiva jikkonsistu f’ trażżin tal - mudullun ta ’ l- għadam, newrotossiċità periferika u infjammazjoni tal- mukoża.
Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose.
Il- pazjenti għandhom jingħataw il- G- CSF terapewtikament mill- aktar fis possibbli wara li tkun skoperta li ngħatat doża eċċessiva.
Other appropriate symptomatic measures should be taken, as needed.
Miżuri oħra sintomatiċi u xierqa għandhom jittieħdu, skond kif inhu meħtieġ.
Pharmacotherapeutic group:
Kategorija farmako- terapewtika:
Antineoplastic agents, ATC Code:
Klassi ta ’ sustanzi kontra t- tumuri, Kodiċi ATC:
Preclinical data
Tagħrif ta ’ qabel l- użu kliniku
Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin.
Docetaxel huwa sustanza li tintuża kontra t- tumuri, li jaħdem billi jippromwovi is- sintesi tat- tubulin f’ mikrotubuli stabbli u jinibixxi l- ismantellament tagħhom, u b’ hekk, iġib tnaqqis sostanzjali fil- livell tat- tubulin liberu.
The binding of docetaxel to microtubules does not alter the number of protofilaments.
Ir- rabta ta ’ docetaxel mal- mikrotubuli ma jibdilx in- numru tal- protofilamenti.
Docetaxel has been shown in vitro to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions.
Il- mikrotubuli huma essenzjali għall- funzjoni mitotika vitali u għall- funzjoni ċellulari ta ’ bejn il- fażijiet.
Docetaxel was found to be cytotoxic in vitro against various murine and human tumour cell lines and against freshly excised human tumour cells in clonogenic assays.
Docetaxel instab li huwa ċitotossiku in vitro għall- linji ċellulari ta ’ tumuri li huma derivati mill - ġrieden u l- bniedem, u kontra ċelluli umani meħudin minn tumuri hekk kif dawn ikunu tneħħew, fi studji klonoġeniċi fil- laboratorju.
Docetaxel achieves high intracellular concentrations with a long cell residence time.
Docetaxel jinstab f’ livelli għoljin fiċ- ċelluli fejn idum għal tul ta ’ żmien.
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.
Barra minn hekk, docetaxel instab li huwa attiv fuq xi linji ċellulari, iżda mhux kollha, billi jżid il- produzzjoni tal- glikoproteina p, li s- sinteżi tagħha tinsab miktuba fuq il- ġene li tiddetermina r - reżistenza għal sustanzi multipli.
In vivo, docetaxel is schedule independent and has a broad spectrum of experimental antitumour activity against advanced murine and human grafted tumours.
In vivo, docetaxel jaħdem indipendentement mill- iskeda ta ’ kif jingħata u għandu firxa wiesgħa t’ attivita fuq it- tumuri esperimentali, kontra tumuri mlaqqmin u avvanzati derivati mill- ġrieden u mill- bnedmin.
Clinical data
24 Tagħrif kliniku
Breast cancer
Il- kanċer tas- sider
Docetaxel Winthrop in combination with doxorubicin and cyclophosphamide: adjuvant therapy
Docetaxel Winthrop użat flimkien ma ’ doxorubicin u cyclophosphamide: terapija miżjuda
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.
Id- data minn ċentri multipli, fejn kemm il- pazjenti kif ukoll l- investigaturi kienu jafu x’ mediċini qed jintużaw, u l- pazjenti tqassmu mingħajr għażla, isaħħu l- użu ta ’ docetaxel għat- trattament miżjud f’ pazjenti li għandhom kanċer tas- sider li nfirex fil- glandoli limfatiċi u li huwa operabbli b’ KPS ta ’ ≥80%, minn 18 sa 70 sena fl- età.
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).
Wara t- tqassim tal- pazjenti skond in- numru ta ’ glandoli limfatiċi effettwati (1- 3, 4+), 1491 pazjent kienu mqassma mingħajr għażla biex jirċievu jew docetaxel 75 mg/ m2 siegħa wara doxorubicin 50 mg/ m2 u cyclophosphamide 500 mg/ m2 (il- fergħa TAC), jew doxorubicin 50 mg/ m2 segwit minn fluorouracil 500 mg/ m2 u cyclophosphamide 500 mg/ m2 (il- fergħa FAC).
Both regimens were administered once every 3 weeks for 6 cycles.
Iż- żewġ gruppi kienu ngħataw il- kura darba kull 3 ġimgħat għal 6 ċikli.
Docetaxel was administered as a 1-hour infusion, all other medicinal products were given as intravenous bolus on day one.
Docetaxel kien ingħata bħala infużjoni tul siegħa, waqt li l- prodotti mediċinali l- oħra kienu ngħataw bħala bolus fil- vini fl - ewwel jum.
G-CSF was administered as secondary prophylaxis to patients who experienced complicated neutropenia (febrile neutropenia, prolonged neutropenia, or infection).
G- CSF kien ingħata bħala profilassi sekondarja lill- pazjenti li żviluppaw newtropenija komplikata (newtropenija bid- deni, newtropenija fit- tul jew infezzjoni).
Patients on the TAC arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Il- pazjenti fil- fergħa TAC irċevew profilassi bl- antibijotiku ciprofloxacin 500 mg oralment, darbtejn kuljum, ghal 10 ijiem, mibdi f’ jum 5 ta ’ kull ċikli, jew ekwivalenti.
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.
Fiż- żewġ friegħi, wara l- aħħar kors tal- kimoterapija, il - pazjenti li kellhom reċetturi pożittivi għal estrogen u/ jew progesterone ingħataw tamoxifen 20 mg kuljum sa 5 snin.
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.
Ir- radjuterapija miżjuda kienet preskritta skond il- prattiċi awtorevoli fiċ- ċentri li ipparteċipaw fl- istudji u dan ingħata lil 69% tal- pazjenti li ħadu TAC u 72% tal- pazjenti li ħadu FAC.
25 An interim analysis was performed with a median follow up of 55 months.
Sadattant, analiżi nħaddmet fuq perijodu medjan ta ’ 55 xahar.
Significantly longer disease-free survival for the TAC arm compared to the FAC arm was demonstrated.
Is- sopravivenza ikkaratteriżżata minn nuqqas tal- marda kienet b’ mod sinifikattiv itwal fil- fergħa TAC meta kienet imqabbla mal- fergħa 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).
L- inċidenza tar- rikaduta hekk kif għaddew 5 snin tnaqqas fil- pazjenti li rċevew TAC meta mqabbel ma ’ dawk li rċevew FAC (25% kontra 32%, rispettivament) li tfisser riskju assolut imnaqqas b’ 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).
Sopravivenza totali wara 5 snin kienet kibret b’ mod sinifikattiv b’ TAC meta mqabbla ma ’ FAC (87% kontra 81% rispetivament) li tfisser riskju assolut tal- mewt imnaqqas b’ 6% (p = 0. 008).
TAC-treated patient subsets according to prospectively defined major prognostic factors were analyzed:
Il- fergħa tal- pazjenti li ħadu TAC, imqassam fi gruppi żgħar, skond fatturi pronostiċi maġġuri, definiti prospettivament, kien analiżżat:
Disease Free Survival
Sopravivenza Mingħajr Marda
Overall Survival
Sopravivenza Totali
Patient subset No of positive nodes
Il- grupp tal- pazjenti
Number of patients
Numru
Hazard ratio*
Il - 95% CI p= Il -
Hazard 95% CI ratio*
riskju *
p=
riskju *
0.72
0. 70
0.59-0.88
0. 53- 0. 91
0.008
0. 008
0.61 0.83
0. 61 0. 83
0.46-0.82 0.0009 0.63-1.08 0.17
0. 46- 0. 82 0. 63- 1. 08
0.45 0.94
0. 45 0. 94
0.29-0.70 0.0002 0.66-1.33 0.72
0. 29- 0. 70 0. 66- 1. 33
*a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival compared to FAC
* il- proporzjon ta ’ riskju ta ’ anqas minn 1 jindika li TAC hu assoċjat ma ’ sopravivenza mingħajr marda itwal, u sopravivenza totali itwal, meta mqabbel ma ’ 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.
L- effett siewi ta ’ TAC ma ġiex ippruvat f’ pazjenti li kellhom 4 jew aktar glandoli limfatiċi pożittivi (37% tal- popolazzjoni studjata) fl- istadju propriju ta ’ l- analiżi.
The effect appears to be less pronounced than in patients with 1-3 positive nodes.
L- effett jidher li hu anqas immarkat f’ pazjenti li għandhom 1- 3 glandoli pożittivi.
The benefit/ risk ratio was not defined fully in patients with 4 and more positive nodes at this analysis stage.
Il- proporzjon bejn il- benefiċċju u r- riskju ma ntweriex kompletament fil- pazjenti li kellhom 4 jew aktar glandoli pożittivi f’ dan l- istadju ta ’ l- analiżi.
Docetaxel Winthrop as single agent
Docetaxel Winthrop meta jintuża waħdu
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.
Dawn ingħatalhom docetaxel f’ doża u tul ta ’ żmien irrakkomandati, jiġifieri 100 mg/ m2 kull 3 ġimgħat.
In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/ m² every 3 weeks).
25 F’ dawk il- pazjenti li kienu ħadu l- kors bis- sustanza alkylating, li falla, docetaxel kien imqabbel ma ’ doxorubicin (75 mg/ m2 kull 3 ġimgħat).
37%, p = 0.01) and shortened time to response (12 weeks vs.
Mingħajr m’ affettwa iż- żmien totali tas- sopravivenza (għal docetaxel 15- il xahar kontragħal doxorubicin 14- il xahar, p = 0. 38), jew iż- zmien sakemm javvanza t - tumur (b’ docetaxel 27 ġimgħa kontra li d- doxorubicina kien ta ’ 23 ġimgħa, p = 0. 54), docetaxel wera rata ta ’ rispons aktar għolja (52% kontra 37%, p = 0. 01) u qassar iż- żmien għar- rispons (12- il ġimgħa vs 23 ġimgħa, 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).
Tliet pazjenti fuq docetaxel (2%) ma komplewx il- kura minħabba żamm ta ’ fluwidu, waqt li 15- il pazjent fuq id- doxorubicin (9%) waqfu l- kura minħabba tossiċità kardijaka (tliet każijiet fatali ta ’ insuffiċenza konġestiva tal- qalb).
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).
Fil- pazjenti li kienu ħadu t- trattament b’ anthracycline, li kien falla, docetaxel kien ikkomparat ma ’ l - użu ta ’ mitomycin C u l- vinblastine flimkien (12 mg/ m2 kull 6 ġimgħat u 6 mg/ m2 kull 3 ġimgħat).
9 months, p = 0.01).
Docetaxel żied r- rata tar- rispons (33% vs 12%, p < 0. 0001), ittardja l- avvanz tat- tumur (19- il ġimgħa vs 11- il ġimgħa, p = 0. 0004) u tawwal iż- żmien totali tas- sopravivenza (11- il xahar vs 9 xhur, 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).
Waqt dawn iż- żewġ studji fil- fażi III, il- profil ta ’ sigurtà ta ’ docetaxel kien konsistenti mal- profil ta ’ sigurtà osservat fil- fażi II ta ’ l- istudji (ara sezzjoni 4. 8).
An open-label, multicenter, randomized phase III study was conducted to compare docetaxel monotherapy and paclitaxel in the treatment of advanced breast cancer in patients whose previous therapy should have included an anthracycline.
Studju fil- fażi III, magħmul f’ ċentri multipli, fejn kemm il- pazjenti kif ukoll l- investigaturi kienu jafu x’ mediċini qed jintużaw, u li il- pazjenti tqassmu mingħajr għażla, sar biex il- monoterapija b ’ docetaxel titqabbel ma ’ pacilitaxel fit- trattament ta ’ kanċer tas- sider avvanzat, f’ pazjenti li t- terapija preċedenti kellha tinkludi xi anthracycline.
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.
It- total ta ’ 449 pazjenti kienu mqassma, mingħajr għażla, biex jirċievu jew docetaxel 100 mg/ m2 li tingħata bħala infużjoni tul siegha, jew paclitaxel 175 mg/ m2 bħala infużjoni tul ta ’ 3 sigħat.
Both regimens were administered every 3 weeks.
Il- pazjenti fiż- żewġ gruppi ngħataw il- mediċini kull 3 ġimghat.
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).
Mingħajr ma kienet effettwata r- rata totali tar- riżultati u l- punt ewlieni tal- waqfien (32% kontra 25%, p = 0. 10), docetaxel tawwal iż- żmien medjan ghall- avvanz (24. 6 ġimgħat kontra 15. 6 ġimgħat; p < 0. 01) u ż- zmien medjan ta ’ kemm għexu (15. 3 xhur kontra 12. 7 xhur; p = 0. 03).
More grade 3/ 4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Aktar ġrajjiet avversi ta ’ grad 3/ 4 kienu innotati b’ docetaxel bħala monoterapija (55. 4%) meta mqabbel ma ’ paclitaxel (23%).
26 Docetaxel Winthrop in combination with doxorubicin
Docetaxel Winthrop użat flimkien ma ’ doxorubicin
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).
Dawn ingħataw doxorubicin (50 mg/ m2) flimkien ma ’ docetaxel (75 mg/ m2) (il- fergħa AT) kontra doxorubicin (60 mg/ m2) flimkien ma ’ cyclophosphamide (600 mg/ m2) (il- fergħa AC).
Both regimens were administered on day 1 every 3 weeks.
Iż- żewġ sistemi ta ’ trattament ingħataw fl- ewwel jum ta ’ kull 3 ġimgħat.
• Time to progression (TTP) was significantly longer in the AT arm versus AC arm, p = 0.0138.
• Iż- żmien tal- progressjoni (ŻTP) kien sinifikament itwal fil- fergħa AT kontra l- fergħa AC, p = 0. 0138.
The median TTP was 37.3 weeks (95% CI:
Iż- ŻTP medjan kien 37. 3 ġimgħat (95% CI:
33.4 - 42.1) in AT arm and 31.9 weeks (95% CI:
34. 4 - 42. 1) fil- fergħa AT u 31. 9 ġimgħat (95% CI:
27.4 - 36.0) in AC arm. • Overall response rate (ORR) was significantly higher in the AT arm versus AC arm, p = 0.009.
• Ir- rata totali tar- rispons (RTTR) kienet b’ mod sinifikattiv ogħla fil- fergħa AT kontra il- fergħa AC, p = 0. 009.
The ORR was 59.3% (95% CI:
Ir- RTTR kienet 59. 3% (95% CI:
52.8 - 65.9) in AT arm versus 46.5% (95% CI:
52. 8 - 65. 9) fil- fergħa AT versu 46. 5% (95% CI:
39.8 - 53.2) in AC arm.
39. 8 - 53. 2) fil- fergħa AC.
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.
F’ din il- prova, l- fergħa AT uriet inċidenza ogħla ta ’ newtropenija severa (90% kontra 68. 6%), newtropenija bid- deni (33. 3% kontra 10%), infezzjoni (8% kontra 2. 4%), dijareja (7. 5% kontra 1. 4%), astenja (8. 5% kontra 2. 4%) u uġigħ (2. 8% kontra 0%), mill- fergħa AC.
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%).
Minn naħa l- oħra, il- fergħa AC uriet inċidenza ogħla ta ’ anemija severa (15. 8% kontra 8. 5%) mill- fergħa AT, kif ukoll inċidenza ogħla ta ’ tossiċita severa kardijaka: insuffiċenza konġestiva tal- qalb (3. 8% kontra 2. 8%), ir- rata assoluta tal- LVEF tnaqqset ≥ 20% (13. 1% kontra 6. 1%), ir- rata assoluta tal- LVEF tnaqqset ≥ 30% (6. 2% kontra1. 1%).
Toxic deaths occurred in 1 patient in the AT arm (congestive heart failure) and in 4 patients in the AC arm (1 due to septic shock and 3 due to congestive heart failure).
Imwiet minn kawża tossika ġraw f’ pazjent wieħed fil- fergħa AT (insuffiċjenza konġestiva tal- qalb) u f’ 4 pazjenti fil- fergħa AC (1 dovut għal xokk settiku u 3 minħabba insuffiċenza konġestiva tal- qalb).
In both arms, quality of life measured by the EORTC questionnaire was comparable and stable during treatment and follow-up.
Fiż- żewġ friegħi, il- kwalità tal- ħajja imkejjla mil- kwestjonarju tal- EORTC, kienet komparabbli u stabbli waqt it- trattament u l- visti sussegwenti.
Docetaxel Winthrop in combination with trastuzumab
26 Docetaxel Winthrop użat flimkien ma ’ trastuzumab
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.
Docetaxel użat flimkien ma ’ trastuzumab kien studjat fit- trattament ta ’ pazjenti b’ kanċer metastatiku tas- sider, liema tumuri kienu jipproduċu HER 2, u li precedentement ma rċevewx il- kimoterapija għal mard metastatiku.
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.
Mija sitta u tmenin (186) pazjent kienu mqassma mingħajr għażla biex jieħdu docetaxel (100 mg/ m2) bi trastuzumab jew mingħajru; 60% tal- pazjenti rċevew preċedentement kimoterapija miżjuda b’ tip ta ’ anthracycline.
Docetaxel plus trastuzumab was efficacious in patients whether or not they had received prior adjuvant anthracyclines.
Docetaxel flimkien ma ’ trastuzumab kien effettiv fil - pazjenti, kemm dawk li rċevew it- terapija preċedenti u miżjuda bl- anthracyclines, kif ukoll f’ dawk li ma ħadux.
The main test method used to determine HER2 positivity in this pivotal trial was immunohistochemistry (IHC).
It- metodu ewlieni tat- test biex ikun stabbilit ir- reazzjoni pożittiva għall- HER 2 f’ din il - prova pivitali kien l- immuno- kimika fil- ħistoloġija (IHC).
A minority of patients were tested using fluorescence in-situ hybridization (FISH).
Minoranza ta ’ pazjenti kienu ittestjati bl - użu ta ’ fluorescence in- situ hybridization (FISH).
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.
F’ din il- prova, 87% tal- pazjenti kellhom mard li kien IHC 3+, u 95% tal- pazjenti li dahlu fl- istudju kellhom mard li kien IHC 3+ u/ jew FISH pożittiv.
Efficacy results are summarized in the following table:
Ir- riżultati ta ’ effikaċja huma mogħtija fil- qosor fit- tabella murija hawn taħt:
Parameter
Docetaxel1
Docetaxel
Parametru
Response rate (95% CI) Median Duration of response
Rata ta ’ rispons
(months)
(25- 45)
11.4
11. 4
(95% CI) Median TTP (months) (95% CI) Median Survival (months)
(95% CI) Medjan ta ’ TTP (xhur) (95% CI) Medjan ta ’ Sopravivenza
(9.2-15.0) 10.6 (7.6-12.9) 30.52
(9. 2- 15. 0) 10. 6 (7. 6- 12. 9) 30. 52
(4.4-6.2) 5.7 (5.0-6.5) 22.12
(4. 4- 6. 2) 5. 7 (5. 0- 6. 5) 22. 12
(95% CI)
(xhur) (95% CI)
(26.8-ne)
(26. 8- ne)
(17.6-28.9)
(17. 6- 28. 9)
1 Full analysis set (intent-to-treat) 2 Estimated median survival
TTP=iż- żmien għal progressjoni; “ ne ” jindika li ma setax ikun stmat jew li ma kienx għadu milħuq 1 Sett sħiħ ta ’ l- analiżi (bit- tir ta ’ fejqan) 2 Is- sopravivenza medjana u stmata
Docetaxel Winthrop in combination with capecitabine
Docetaxel Winthrop użat flimkien ma ’ capecitabine
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
It- data minn studju wieħed f’ ċentru multipli fil- fażi III, ta’ prova klinika, u li sar mingħajr għażla u li kien ikkontrollat, issostni l- użu ta ’ docetaxel flimkien ma ’ capecitabine għat- trattament ta ’ pazjenti b’ kanċer tas- sider avvanzat lokalment jew dak metastatiku, wara li falliet il- kimoterapija ċitotossika, inkluża anthracycline.
In this trial, 255 patients were randomised to treatment with docetaxel (75 mg/ m2 as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/ m2 twice daily for 2 weeks followed by 1-week rest period).
F’ dan l- istudju, 255 pazjent kienu mqassmin, mingħajr għażla, għall- kura b’ docetaxel (75 mg/ m2 bħala infużjoni fil- vini fuq perijodu ta ’ siegħa, kull 3 ġimgħat) u capecitabine (1250 mg/ m2 darbtejn kuljum għal ġimgħatejn, segwit b’ perijodu ta ’ waqfien għal ġimgħa).
256 patients were randomised to treatment with docetaxel alone (100 mg/ m2 as a 1 hour intravenous infusion every 3 weeks).
256 pazjent kienu mqassmin, mingħajr għażla, għall- kura b’ docetaxel biss (100 mg/ m2 bħala infużjoni fil - vini fuq perjodu ta ’ siegħa kull 3 ġimgħat).
Survival was superior in the docetaxel + capecitabine combination arm (p = 0.0126).
Is- sopravivenza kienet superjuri tal- fergħa fliemkien bit - trattament ta ’ docetaxel + capecitabine flimkien (p = 0. 0126).
352 days (docetaxel alone).
Is- sopravivenza medjana kienet ta ’ 442 jum (docetaxel + capecitabine) kontra 352 jum (docetaxel waħdu).
29.7% (docetaxel alone); p = 0.0058.
Ir- rati totali u oġġettivi ta ’ rispons fil- popolazzjoni mqassma mingħajr għażla (kif stmat mill- investigatur) kienu 41. 6% (docetaxel + capecitabine) kontra 29. 7% (docetaxel waħdu); p = 0. 0058.
Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p < 0.0001).
Iż- żmien biex jintlaħaq il- mard progressiv kien superjuri bid- docetaxel u capecitabine flimkien (p < 0. 0001).
128 days (docetaxel alone).
It- tul ta ’ żmien medjan għal progressjoni kien ta ’ 186 jiem (docetaxel + capecitabine) kontra ta ’ 128 jiem (b’ docetaxel biss).
Non-small cell lung cancer
Kanċer tal- pulmun li mhux ikkaratterizzat b’ ċelluli żgħar
Patients previously treated with chemotherapy with or without radiotherapy
Pazjenti ittrattati preċedentement bil- kimoterapija u bir- radjuterapija jew mingħajrha
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/ m² compared to Best Supportive Care.
F’ studju fil- fażi III, f’ pazjenti ttrattati preċedentement, iż- żmien biex isir il- progressjoni (12. 3 ġimgħat kontra 7 ġimgħat) u s- sopravivenza totali kienu sinifikament itwal b’ docetaxel f’ doża ta ’ 75 mg/ m2 komparati ma ’ l- aqwa kura supportiva (AKS).
The 1-year survival rate was also significantly longer in docetaxel (40%) versus BSC (16%).
Ir- rata ta ’ sopravivenza ta ’ sena kienet b’ mod sinifikattiv itwal b’ docetaxel (40%) kontra l- AKS (16%).
There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medications (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/ m² compared to those with BSC.
27 uġigħ (p < 0. 01), sustanzi ghall- ugigħ mhux tat- tip tal- morfina (p < 0. 01), mediċini oħra relatati mal - marda (p = 0. 06) u r- radjuterapija (p < 0. 01), f’ pazjenti ittrattati b’ docetaxel b’ doża ta ’ 75 mg/ m2, komparat ma dawk fuq l- AKS.
The overall response rate was 6.8% in the evaluable patients, and the median duration of response was 26.1 weeks.
Ir- rata totali tar- rispons kienet ta ’ 6. 8% fil- pazjenti evalwati, u ż- żmien medjan tar - rispons kien ta ’ 26. 1 ġimgħat.
Docetaxel Winthrop in combination with platinum agents in chemotherapy-naïve patients
Docetaxel Winthrop użat flimkien ma ’ sustanzi tal- platinum f’ pazjenti li ma jafux li qed jingħataw l - kura bill- kimoterapija
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.
Fil- prova fil- fażi III, 1218- il pazjent li kellhom tumur li ma jistax jitneħħa kiruġikament, kategorija IIIB jew IV NSCLC, b’ KPS ta ’ 70% jew akbar, u li ma rċevewx kimoterapija preċedenti għal din il - kundizzjoni, kienu mqassmin, mingħajr għażla, jew fi ġrupp li ħa it- docetaxel (T) f’ doża ta ’ 75 mg/ m2 bħala infużjoni tul siegħa, segwita immedjatament b’ cisplatin (Sis) 75 mg/ m2 li ngħata fuq perjodu ta ’ bejn 30 sa 60 minuta kull 3 ġimgħat, jew docetaxel 75 mg/ m2 bħala infużjoni fil vini f’ tul ta ’ siegħa, flimkien ma ’ carboplatin (AUC 6 mg/ ml. minuta) li ngħata f’ 30 sa 60 minuta kull 3 ġimgħat, jew vinorelbine (V) 25 mg/ m2, mogħti tul 6 sa 10 minuti fil- jiem 1, 8, 15 u 22, segwit b’ cisplatin 100 mg/ m2 li ngħata fl- ewwel jum taċ- ċikli tal- kura, repetuti kull 4 ġimgħat.
Survival data, median time to progression and response rates for two arms of the study are illustrated in the following table:
It- tagħrif dwar is- sopravivenza, iż- żmien medjan għall- progressjoni, u r- rati ta ’ rispons f’ żewġ friegħi ta ’ l- istudju huma murija fit- tabella hawn taħt:
Statistical Analysis
Analiżi Statistika
Median Survival (months)
Sopravivenza Medjana (xhur)
11.3
11. 3
1.122
Riskju Proporzjonali:
[97.2% CI:
1. 122 [97. 2% CI:
0.937; 1.342]*
0. 937; 1. 342] *
Treatment difference:
Differenza fit- Trattament:
5.4% [95% CI: -1.1; 12.0]
5. 4% 41 46 Sopravivenza ta ’ Sena (%) [95% CI: - 1. 1; 12. 0] Differenza fit- Trattament:
14
6. 2% 14 21 Sopravivenza ta ’ Sentejn (%) [95% CI:
0.2; 12.3]
0. 2; 12. 3] Il- ħin Medjan Ġhall- Progressjoni
(weeks):
(ġimgħat):
22.0
22. 0
23.0
23. 0
1.032
Riskju Proporzjonali:
[95% CI:
1. 032 [95% CI:
0.876; 1.216]
0. 876; 1. 216]
Overall Response Rate (%):
Ir- Rata Totali tar- Rispons (%)
31.6
31. 6
24.5
24. 5
7.1% [95% CI:
7. 1% [95% CI:
0.7; 13.5]
0. 7; 13. 5]
Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
* Ikkoreġġuti għal paraguni multipli u aġġustati għall- fatturi stratifikanti (stadju tal- marda u l- post tat - trattament), ibbażati fuq il- popolazzjoni ta ’ pazjenti evalwati.
28 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.
L- aħħar stadji sekondarji tal- proċess kienu jinkludu bidla fl- uġigħ, ir- rata globali tal- kwalità tal- ħajja bl- użu tal- EuroQoL- 5D, Skala ta ’ Sintomi għall- Kanċer tal- Pulmun, u bidliet fl- istatus tal- wirja ta ’ Karnosfky.
Results on these end-points were supportive of the primary end-points results.
Ir- riżultati ta ’ dawn l- aħħar stadji tal- proċess kienu supportivi għal dawk ta ’ l- aħħar stadju primarju.
For docetaxel/ carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Għad - docetaxel u carboplatin flimkien, l- effikaċja, li kienet la ekwivalenti u anqas ma kienet inferjuri, ma setgħetx tkun ippruvata meta mqabbla mat- trattament ta ’ referenza, iġifieri VCis.
Prostate cancer
Kanċer tal- prostata
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 trial.
Is- sigurtà u l- effikaċja ta ’ Docetaxel użat flimkien ma ’ prednisone jew prednisolone, f’ pazjenti li qed ibatu minn kanċer metastatiku tal- prostata li mhux sensittiv għall- kura bl- ormoni kienu studjati f’ ċentri multipli, mingħajr għażla tal- pazjenti, fil- prova fażi III.