qanastek/EMEA-V3 huggingface dataset:
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.
Adenokarċinoma ta ’ l- istonku Studju f’ ċentri multipli fejn kemm l- investigatur kif ukoll il- pazjent kienu jafu x’ mediċini kienu qed jintużaw, u li il- pazjenti tqassmu f’ gruppi mingħajr għażla, sar biex ikunu evalwati s- sigurtà u l - effikaċja ta ’ docetaxel għat- trattament ta ’ pazjenti li kellhom adenokarċinoma metastatika ta ’ l - istonku, inklużi dawk li kellhom adenokarċinoma fil- parti fejn l- istonku jagħqad ma ’ l- esofagu, u li ma kienux ħadu qabel kimoterapija għall- mard metastatiku.
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).
Total ta ’ 445 pazjent b’ KPS > 70 kienu ittrattati b ’ docetaxel (T) (75 mg/ m2 fl- ewwel jum) flimkien ma ’ cisplatin (C) (75 mg/ m2 fl- ewwel jum) u 5- fluorouracil (F) (750 mg/ m2 kuljum għal 5 ijiem), jew cisplatin (100 mg/ m2 fl- ewwel jum) u 5- fluorouracil (1000 mg/ m2 kuljum għal 5 ijiem).
Time to progression (TTP) was the primary endpoint.
30 żmien li ħa t- tumur biex avvanza (TTP) kien l- aħħar stadju primarju tal- proċess.
30 Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
L- Effikaċja ta ’ docetaxel fit- trattament ta ’ pazjenti b’ adenokarċinoma ta ’ l- istonku
This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
Pazjenti tal- fergħa ta ’ docetaxel ingħataw docetaxel (T) 75 mg/ m2, segwit minn cisplatin (P) 75 mg/ m2, segwit minn 5- fluorouracil (F) 750 mg/ m2 kuljum bħala infużjoni kontinwa għal 5 ijiem Din is- sistema ta ’ kura ingħatat kull tliet ġimgħat għal 4 ċikli fil - każ li, ta ’ l- anqas, rispons ċkejken kien ikun osservat wara żewġ ċikli (≥ 25% tnaqqis fid- daqs tat - tumur permezz ta ’ kejl f’ żewġ dimensjonijiet).
This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
31 is- sistema ta ’ kura ingħatat kull tliet ġimgħat għal 4 ċikli fil- każ li, ta ’ l- anqas, rispons ċkejken kien ikun osservat wara żewġ ċikli (≥ 25% tnaqqis fid- daqs tat- tumur permezz ta ’ kejl f’ żewġ dimensjonijiet).
Patients on the TPF arm received antibiotic prophylaxis 31 with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Il- pazjenti tal- fergħa ta ’ TPF irċevew il- profilassi bl- antibijotiċi permezz ta ’ ciprofloxacin 500 mg oralment darbtejn kuljum għal 10 ijiem, mibdi fil- hames jum ta ’ kull ċiklu, jew l- ekwivalenti.
Docetaxel + Cis + 5-FU
L- aħħar stadju tal- proċess
+ 5-FU
Docetaxel+ Cis + 5- FU
(95% CI) Adjusted Hazard ratio
javvanza (xhur) (95% CI) Il- proporzjon aġġustat tar- riskju
(7.4-9.1)
(7. 4- 9. 1)
(95% CI) *p-value
(0. 55- 0. 89) (95% CI) 0. 0042 * p- value
(0.55-0.89) 0.0042
Sopravivenza madjana (xhur)
(95% CI) **p-value
(0. 56- 0. 93) (95% CI) 0. 0128 ** p- value
(95% CI) ***p-value Best overall response to study treatment
(95% CI) *** p- value L- aħjar rizultat sħiħ bit- trattament studjat [kimoterapija + / - radjuterapija] (%) (95% CI)
(60.4-74.6)
(60. 4- 74. 6) 72. 3 (65. 1- 78. 8)
(46.0-61.0)
(46. 0- 61. 0) 58. 6 (51. 0- 65. 8)
[chemotherapy +/ - radiotherapy] (%) (95% CI) ***p-value
*** p- value It- tul medjan taż- żmien għar- rispons tal -
72.3 (65.1-78.8)
n = 128
58.6 (51.0-65.8)
n = 106
n = 128 15.7 (13.4-24.6)
11. 7 (10. 2- 17. 4)
Clinical benefit parameters The performance status scale, for head and neck (PSS-HN) subscales designed to measure understandability of speech, ability to eat in public, and normalcy of diet, was significantly in favor of TPF as compared to PF.
32 Il- parametri tal- benefiċċju kliniku L- iskaletti ta ’ l- iskala ta ’ l- istatus ta ’ kapaċità, għar- ras u l- għonq (PSS- HN), maħduma biex jitkejlu l - ftehim fid- diskors, il- kapaċità biex wieħed jiekol fil- publiku, u jsegwi dieta normali, kienu b’ mod sinifikattiv favur TPF meta mqabbel ma ’ PF.
32 • Induction chemotherapy followed by chemoradiotherapy (TAX324) The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III, trial (TAX324).
• Kimoterapija Induttiva segwita bi kimoradjuterapija (TAX324) Is- sigurtà u l- effikaċja ta ’ docetaxel fit- trattament induttiv ta ’ pazjenti li kellhom kanċer tat- tip squamous cell tar- ras u l- għonq (SCCHN) lokalment avvanzat kienu evalwati fil fażi III ta ’ studju, open- label magħmul minn ċentri multipli, u fejn il- pazjenti tqassmu mingħajr għażla (TAX324).
33 Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
33 L- Effikaċja ta ’ docetaxel fit- trattament induttiv ta ’ pazjenti b’ SCCHN inoperabbli u lokalment avvanzat (Analiżi bl- Iskop li Titratta)
(95% CI) *p-value
(0. 54- 0. 90) (95% CI) 0. 0058 * p- value
(95% CI) **p-value
(0. 56- 0. 90) (95% CI) 0. 004 ** p- value
34 modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
It- tneħħija ta ’ docetaxel ma kienx immodifikat f’ pazjenti bi grad ħafif sa wieħed moderat taż - żamm ta ’ fluwidu, u m’ hemmx data fuq pazjenti bi grad sever taż- żamm ta ’ fluwidu.
Concentrate vial: polysorbate 80.
Kunjett ta ’ konċentrat: polysorbate 80.
Solvent vial: ethanol 95% water for injections.
Kunjett bis- solvent: ethanol 95% Ilma għall- injezzjonijiet
35 6.3 Shelf-life
35 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Do not store above 25 °C or below 2 °C.
Tahżinx f’ temperatura ’ l fuq minn 25 °Ċ jew taħt 2 °Ċ.
TAXOTERE 20 mg concentrate for solution for infusion vial
Kunjett ta ’ TAXOTERE 20 mg konċentrat għalsoluzzjoni għall- infużjoni:
This fill volume has been established during the development of TAXOTERE to compensate for liquid loss during preparation of the premix due to foaming, adhesion to the walls of the vial and "dead-volume".
Dan il- volum attwali, stabbilit waqt l- iżvilupp ta ’ TAXOTERE, qiegħed hemm biex ipatti għat- telf ta ’ likwidu waqt il- preparazzjoni ta ’ soluzzjoni inizjali, dovut għall - formazzjoni ta’ ragħwa, għal dak li jibqa ’ f’ kuntatt mal- ħġieġ tal- kunjett u għall- ammont ċkejken li jibqa ’ fil- flixkun u li ma jkunx jista ’ jitella ’ bil- labra tas- siringa.
This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE vial, there is a minimal extractable premix volume of 2 ml containing 10 mg/ ml docetaxel which corresponds to the labelled amount of 20 mg per vial.
Dan jikkorrispondi għal ammont ta ’ 20 mg imsemmi fuq it- tabella tal- kunjett.
Solvent vial contains 1.5 ml of a 13% w/ w solution of ethanol 95% in water for injections (fill volume:
Il- kunjett tas- solvent għandu volum ta ’ 1. 5 ml ta ’ 13% (w/ w) ta ’ soluzzjoni ta ’ ethanol 95% fl- ilma għall- injezzjonijiet.
The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 20 mg concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ ml docetaxel.
Meta jiżdied is- solvent kollu fil- kunjett ta ’ TAXOTERE 20 mg konċentrat għal soluzzjoni għall- infużjoni, is- soluzzjoni inizjali li tirriżulta tkun ta ’ 10 mg/ ml docetaxel.
TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing TAXOTERE solutions.
TAXOTERE hija sustanza kimika għall- użu kontra t- tumuri u, bħal kull sustanza potenzjalment tossika, trid tkun eżerċitata l- kawtela fl- immaniġġar u fil- preparazzjoni tat- taħlitiet ta ’ TAXOTERE.
If TAXOTERE concentrate, premix solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Jekk TAXOTERE konċentrat, jew is- soluzzjoni ta ’ qabel l- infużjoni, jew l- infużjoni nnifisha tiġi f’ kuntatt mal- ġilda, aħsel immedjatament u sew bis- sapun u l- ilma.
If TAXOTERE concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Jekk TAXOTERE konċentrat, jew is- soluzzjoni ta ’ qabel l- infużjoni, jew l- infużjoni innifisha tiġi f’ kuntatt mal- mukoża, aħsel immedjatament u sew bl- ilma.
36 Preparation for the intravenous administration
36 Il- preparazzjoni tal- prodott għall- għoti ġol- vini
a) Preparation of the TAXOTERE premix solution (10 mg docetaxel/ ml)
a) Preparazzjoni ta ’ TAXOTERE, soluzzjoni inizjali (10 mg docetaxel/ ml)
If the vials are stored under refrigeration, allow the required number of TAXOTERE boxes to stand at room temperature (below 25 °C) for 5 minutes.
Jekk il- kunjetti kienu maħżuna fil- friġġ, ħalli n- numru ta ’ kaxex ta ’ TAXOTERE li għandek bżonn f’ temperatura ambjentali (taħt 25 °Ċ) għal 5 minuti.
Using a syringe fitted with a needle, aseptically withdraw the entire contents of the solvent for TAXOTERE vial by partially inverting the vial.
Uża siringa b’ labra mwaħħla magħha u tella ’ il- kontenut sħiħ tal- kunjett tas- solvent ta ’ TAXOTERE, b’ mod asettiku, billi taqleb il- kunjett tas- solvent parzjalment rasu ’ l isfel.
Inject the entire contents of the syringe into the corresponding TAXOTERE vial.
Injetta il- kontenut sħiħ tas- siringa fil- kunjett korrispondenti ta ’ TAXOTERE.
However the chemical and physical stability of the premix solution has been demonstrated for 8 hours when stored either between 2 °C and 8 °C or at room temperature (below 25 °C).
Madankollu, l- istabbiltà kimika u fiżika tas- soluzzjoni inizjali ntweriet li ddum għal 8 sigħat meta tkun maħzuna bejn 2 °Ċ u 8 °Ċ jew f’ temperatura ambjentali (taħt 25 °Ċ).
b) Preparation of the infusion solution
b) Preparazzjoni ta’ soluzzjoni għal- infużjoni
The TAXOTERE infusion solution should be used within 4 hours and should be aseptically administered as a 1-hour infusion under room temperature (below 25 °C) and normal lighting conditions.
Is- soluzzjoni għall- infużjoni ta ’ TAXOTERE għandha tintuża fi żmien 4 sigħat u għandha tingħata b’ mod asettiku bħala infużjoni fuq tul ta ’ siegħa f’ temperatura ambjentali (taħt 25 °Ċ) u f’ dawl normali.
As with all parenteral products, TAXOTERE premix solution and infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.
Bħall- prodotti kollha parenterali, is- soluzzjoni mħallta lesta ta ’ TAXOTERE u s- soluzzjoni għall - infużjoni likwida għall- użu għandhom ikunu eżaminati viżwalment qabel l- użu; is- soluzzjonijiet li juru xi partikoli jew frak żgħir m’ għandhomx jintużaw.
27 November 1995 Date of latest renewal:
27 ta ’ Novembru 1995 Data ta ’ l- aħħar tiġdid:
27 November 2005
27 ta ’ Novembru 2005
TAXOTERE 80 mg concentrate and solvent for solution for infusion
TAXOTERE 80 mg konċentrat u solvent għal soluzzjoni għall- infużjoni
Each single-dose vial of TAXOTERE 80 mg concentrate contains docetaxel which is a trihydrate corresponding to 80 mg of docetaxel (anhydrous).
Kull kunjett b’ doża waħda ta ’ TAXOTERE 80 mg, konċentrat, li fih docetaxel li huwa tri- idrat, korrispondenti għal 80 mg ta ’ docetaxel (anidru).
TAXOTERE in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
TAXOTEREflimkien ma ’ doxorubicin huwa indikat għat- trattament ta ’ pazjenti b’ kanċer tas- sider lokalment avvanzat jew dak metastatiku, li ma kienux ħadu qabel terapija ċitotossika għal din il- marda.
TAXOTERE in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.
TAXOTERE flimkien ma ’ cisplatin huwa indikat għat- trattament ta ’ pazjenti b’ kanċer tal- pulmun lokalment avvanzat jew dak metastatiku li mhux ta ’ ċelluli żgħar u li ma jistax jitneħħa f’ pazjenti li ma kinux ħadu qabel terapija ċitotossika għal din il- marda.
39 Prostate cancer
39 Kanċer tal- prostata
For treatment
40 Kanċer tal- pulmun fejn iċ ċelluli m’ humiex żgħar F’ pazjenti li qatt ma ħadu l- kimoterapija qabel u li qed jiġu ikkurati għall- kanċer tal- pulmun li mhux ta ’ ċelluli żgħar, is- sistema tad- dożaġġi irrakkomandata hija docetaxel 75 mg/ m2 segwit immedjatament b’ cisplatin 75 mg/ m2 fuq perjodu ta ’ bejn 30 u 60 minuta.
40 after failure of prior platinum-based chemotherapy, the recommended dose is 75 mg/ m² as a single agent.
Għall- kura fejn il - kimoterapija preċedenti ibbażata fuq il- platinum falliet, id- doża irrakkomandata hija ta ’ 75 mg/ m2 bħala sustanza waħda.
• Induction chemotherapy followed by radiotherapy (TAX 323) For the induction treatment of inoperable locally advanced squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/ m2 as a 1 hour infusion followed by cisplatin 75 mg/ m2 over 1 hour, on day one, followed by 5-fluorouracil as a continuous infusion at 750 mg/ m2 per day for five days.
Fit- trattament induttiv ta ’ kanċer inoperabbli tat- tip squamous cell tal- ġilda, li huwa lokalment avvanzat, fir- ras u fl- għonq (SCCHN), id- doża irrakkomandata ta ’ docetaxel hija 75 mg/ m2 bħala infużjoni tul ta ’ siegħa, segwita minn cisplatin 75 mg/ m2 f’ tul ta ’ siegħa, fl- ewwel jum, segwit minn 5 - fluorouracil bħala infużjoni mingħajr waqfien ta ’ 750 mg/ m2 kuljum għal ħamest ijiem.
• Induction chemotherapy followed by chemoradiotherapy (TAX 324) For the induction treatment of patients with locally advanced (technically unresectable, low probability of surgical cure, and aiming at organ preservation) squamous cell carcinoma of the head and neck (SCCHN), the recommended dose of docetaxel is 75 mg/ m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/ m2 administered as a 30-minute to 3 hour infusion, followed by 5-fluorouracil 1000 mg/ m2/ day as a continuous infusion from day 1 to day 4.
Kimoterapija Induttiva segwita bi kimoradjuterapija (TAX324) It- trattament induttiv ta ’ pazjenti li kellhom kanċer tat- tip squamous cell tar- ras u l- għonq (SCCHN) lokalment avvanzat (li teknikalment ma jistax jitneħħa, bi probabilita baxxa ta ’ kura kirurġika u bi skop ta ’ preservazzjoni ta ’ l- organi), id- doża rrakkomandata ta ’ docetaxel hija 75 mg/ m2 bħala infużjoni tul ta ’ siegħa, segwita minn cisplatin 100 mg/ m2 f’ tul ta ’ 30- minuta sa 3 sigħat, segwit minn 5- fluorouracil bħala infużjoni mingħajr waqfien ta ’ 1000 mg/ m2 kuljum minn jum 1 sa jum 4.
This regimen is administered every 3 weeks for 3 cycles.
Dan ir - reġim jingħata kull 3 ġimgħat għal 3 ċikli.
Following chemotherapy, patients should receive chemoradiotherapy.
Wara l- kimoterapija il- pazjenti għandhom jirċievu l - kimoradjuterapija.
Adjuvant therapy for breast cancer In the pivotal trial in patients who received adjuvant therapy for breast cancer and who experienced complicated neutropenia (including prolonged neutropenia, febrile neutropenia, or infection), it was recommended to use G-CSF to provide prophylactic coverage (eg, day 4 to 11) in all subsequent cycles.
Terapija miżjuda għal kanċer tas- sider Fil- prova tal- pern f’ pazjenti li ħadu terapija miżjuda għall- kanċer tas- sider u li kellhom newtropenija b’ komplikazzjonijiet (inklużi n- newtropenija fit- tul u n- newtrpenija akkompanjata bid- deni, jew l -
41 However, in clinical practice neutropenia could occur earlier.
Madankollu, fil- prattika klinika, in- newtropenija tista ’ tiġri qabel.
In combination with capecitabine • For capecitabine dose modifications, see capecitabine summary of product characteristics. • For patients developing the first appearance of a Grade 2 toxicity, which persists at the time of the next docetaxel/ capecitabine treatment, delay treatment until resolved to Grade 0-1, and resume at 100% of the original dose. • For patients developing the second appearance of a Grade 2 toxicity, or the first appearance of a Grade 3 toxicity, at any time during the treatment cycle, delay treatment until resolved to Grade 0-1, then resume treatment with docetaxel 55 mg/ m². • For any subsequent appearances of toxicities, or any Grade 4 toxicities, discontinue the docetaxel dose.
Meta jintuża flimkien ma ’ capecitabine: • Għat- tibdil fid- doża ta ’ capecitabine, ara sommarju tal- karatteristiċi tal- prodott ta ’ capecitabine. • Għal dawk il- pazjenti li titfaċċalhom l- ewwel darba t- tossiċità ta ’ Grad 2, li tippersisti saż- żmien meta jerġa ’ jkun imiss it- trattament b ’ docetaxel/ capecitabine, ittardja l- kura sakemm it- tossiċità tinżel għal Grad 0 sa 1, u mbagħad, erġa ’ ibda b’ 100% tad- doża oriġinali. • Għal dawk il- pazjenti li titfaċċalhom għat- tieni darba t- tossiċità ta ’ Grad 2, jew it- tossiċità ta ’ Grad 3 għall- ewwel darba, f’ kwalunkwe ħin waqt iċ- ċiklu tat- trattament, ittardja it- trattament sakemm it- tossiċità tinżel għal Grad 0 sa 1, u mbagħad kompli t- trattament b’ docetaxel 55 mg/ m2. • Għal kull grad ta ’ tossiċità li titfaċċa sussegwentement, jew għal- kwalunkwe tossiċità ta ’ Grad 4, waqqaf id- doża ta ’ docetaxel.
Toxicity
42
Second episode: then reduce docetaxel dose by 20%.
It- tieni episodju: imbagħad naqqas id- doża ta ’ docetaxel b’ 20%.
Third episode: reduce docetaxel dose by 20%.
It- tieni episodju: waqqaf 5- FU biss, fil- korsijiet kollha sussegwenti It- tielet episodju: naqqas id- doża ta ’ docetaxel b’ 20%.
42 Special populations:
Pazjenti speċjali:
Docetaxel must not be used in pregnant or breast-feeding women.
43 Docetaxel ma jistax jintuża fit- tqala jew f’ nisa li qegħdin ireddgħu.
43 In patients treated with docetaxel in combination with cisplatin and 5-fluorouracil (TCF), febrile neutropenia and neutropenic infection occurred at lower rates when patients received prophylactic G-CSF.
F’ pazjenti ittrattati b’ docetaxel flimkien ma ’ cisplatin u 5- fluorouracil (TCF), in- newtropenija bid- deni jew in- newtropenija assoċjata ma ’ infezzjoni ġraw f’ rati aktar baxxi f’ pazjenti li ngħataw il- profilassi bil- G- CSF.
Fluid retention
44 Iż- żamm ta ’ fluwidu
Therefore, the recommended dose of docetaxel in those patients with elevated liver function test (LFTs) is 75 mg/ m2 and LFTs should be measured at baseline and before each cycle (see section 4.2).
Għalhekk, id- doża irrakkomandata ta ’ docetaxel f’ dawk il- pazjenti li għandhom livelli għolja fit- testijiet tal- funzjoni tal- fwied (LFTs) huwa 75 mg/ m2 u l- LFTs irid jiġi meqjus fil- bidu u qabel kull ċiklu ta ’ trattament (ara sezzjoni 4. 2).
For patients with serum bilirubin levels > ULN and/ or ALT and AST > 3.5 times the ULN concurrent with serum alkaline phosphatase levels > 6 times the ULN, no dose-reduction can be recommended and docetaxel should not be used unless strictly indicated.
Għal dawk il- pazjenti li għandhom livelli ta ’ bilirubin fis- serum > ULN u/ jew l- ALT u l - AST > 3. 5 drabi mill- ULN, flimkien ma ’ livelli ta ’ alkaline phosphotase fis- serum tad- demm huwa > 6 drabi l- ULN, ebda tnaqqis fid- doża ma jista ’ jkun irrakkomandat, u docetaxel m’ għandux jintuża sakemm mhux strettament indikat.
44 Cardiac toxicity
Tossiċità kardijaka
Additional cautions for use in adjuvant treatment of breast cancer Complicated neutropenia For patients who experience complicated neutropenia (prolonged neutropenia, febrile neutropenia or infection), G-CSF and dose reduction should be considered (see section 4.2).
45 Miżuri oħra ta ’ kawtela fl- użu tat- trattament miżjud tal- kanċer tas- sider Newtropenija Komplikata Ghal dawk il- pazjenti li jiżviluppaw newtropenija komplikata (newtropenija fit- tul, newtropenija bid - deni jew b’ infezzjoni), għandhom jitqiesu l- użu ta ’ G- CSF u t- tnaqqis fid- doża (ara sezzjoni 4. 2).
45 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Limited data from a single uncontrolled study were suggestive of an interaction between docetaxel and carboplatin.
Data limitat minn studju wieħed mhux ikkontrollat, issuġġerixxa xi
46 • 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).
1312 u 121 pazjent li ħadu 100 mg/ m2 u 75 mg/ m2 ta ’ docetaxel bħala sustanza waħedha, • rispettivament. • 258 pazjent li ħadu docetaxel flimkien ma ’ doxorubicin. • 406 pazjent li ħadu docetaxel flimkien ma ’ cisplatin. • 92 pazjent ittrattati b ’ docetaxel flimkien ma ’ trastuzumab. • 255 pazjent li ħadu docetaxel flimkien ma ’ capecitabine. • 332 pazjent li ħadu docetaxel flimkien ma ’ prednisone jew prednisolone (effetti avversi klinikament importanti relatati mat- trattament huma irrapportati). • 744 pazjent li ħadu docetaxel flimkien ma ’ doxorubicin u cyclophosphamide (effetti avversi klinikament importanti relatati mat- trattament huma irrapportati). • 300 pazjent b’ adenokarċinoma ta ’ l- istonku (221 pazjent fil- fażi III ta ’ l- istudju u 79 pazjent fil - fażi II), li ħadu docetaxel flimkien ma ’ cisplatin u 5- fluorouracil (effetti avversi klinikament importanti relatati mat- trattament huma irrapportati). • 174 u 251 pazjent b’ kanċer tar- ras u ta ’ l- għonq li ħadu docetaxel flimkien ma’ cisplatin u 5 - fluorouracil (effetti avversi klinikament importanti relatati mat- trattament huma irrapportati).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
47 F’ kull sezzjoni ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetata ’ tagħhom.
The following adverse reactions are frequently observed with docetaxel:
Ir- reazzjonijiet avversi li jmissu huma ikkaġunati spiss b ’ docetaxel
47 extremities and may become generalised with a weight gain of 3 kg or more.
In- nefħa periferika x’ aktarx tibda fl- estremitajiet t’ isfel u tista ’ issir ġeneraliżżata b’ żieda fil- piż ta ’ 3 kg jew aktar.
TAXOTERE 100 mg/ m² single agent
48 TAXOTERE 100 mg/ m2 bħala sustanza użata waħedha:
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%)
Reazzjonijiet Avversi
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Reazzjonijiet Avversi mhux komuni ≥ 0. 1
0.7%)
0. 7%) Tromboċitopenija (G4:
Thrombocytopenia (G4:
sistema limfatika
Nervous system disorders
Disturbi fis- sistema nervuża Newropatija periferika tas- sensazzjoni (G3:
Peripheral sensory neuropathy (G3:
4. 1%); Newropatija periferika tal - movimenti (G3/ 4:
4.1%); Peripheral motor neuropathy (G3/ 4:
0. 07%) Disturbi respiratorji, toraċiċi u medjastinali
4%); Dysgeusia (severe:
Dispneja (sever:
0.07%)
2. 7%)
Dyspnoea (severe:
Stitikezza (severa:
2.7%)
0. 2%);
Oesophagitis (severe:
Uġigħ ta ’ żaqq (sever:
Musculoskeletal and connective tissue disorders
Disturbi muskolu- skeletrali Majalġja (severa 1. 4%) u tal- connective tissue Disturbi fil- metaboliżmu u Anoreksja n- nutrizzjoni Infezzjonijiet u Infezzjonijiet (G3/ 4: infestazzjonijiet 5. 7%; li jinkludu sepsis u pulmonite, fatali f’ 1. 7%)
5.7%; Infection associated including sepsis and with G4 neutropenia pneumonia, fatal in (G3/ 4:
Artralġja Infezzjoni assoċjata ma ’ G4 newtropenija (G3/ 4:
General disorders and administration site conditions
Disturbi vaskulari Disturbi ġenerali u Żamm tal- fluwidu kondizzjonijiet ta ’ mnejn (sever:
Fluid retention (severe:
6. 5%); jingħata Astenja (severa:
(severe:
11. 2%); Uġigħ Disturbi fis- sistema immuni Sensittività eċċessiva (G3/ 4:
0.4%) 11.2%); Pain
5. 3%)
Immune system disorders
Pressjoni baxxa; Pressjoni għolja; Emoraġija Reazzjoni fis- sit ta ’ l - infuzjoni; Uġigħ fis- sider, mhux dak tal- qalb (sever:
Hypersensitivity (G3/ 4:
0. 4%)
49 TAXOTERE 75 mg/ m² single agent
TAXOTERE 75 mg/ m² bħala sustanza użata waħedha:
MedDRA System Organ classes
Sistema tal- Klassifika tal -- Organi
Very common adverse reactions ≥ 10% of patients
Reazzjonijiet Avversi komuni ≥ 1 sa < 10% tal- pazjenti
Common adverse reactions ≥ 1 to < 10% of patients
ħafna ≥ 10% tal- pazjenti
Nail disorders (severe:
Mard tad- dwiefer (sever 0. 8%)
0.8%); Pain
0. 8%); Uġigħ
50 TAXOTERE 75 mg/ m² in combination with doxorubicin
50 TAXOTERE 75 mg/ m² użat flimkien ma ’ doxorubicin:
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients
Reazzjonijiet Avversi komuni ħafna ≥ 10% tal- pazjenti
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Reazzjonijiet Avversi mhux komuni ≥ 0. 1 to < 1% tal- pazjenti G3/ 4 Żieda fl- AST (< 1%);
G3/ 4 Blood bilirubin increased (< 2.5%); G3/ 4 Blood alkaline phosphatase increased (< 2.5%)
G3/ 4 Żieda fil- bilirubin fid- demm (< 2. 5%); G3/ 4 Żieda fl- alkaline phosphatase fid- demm (< 2. 5%)
G3/ 4 AST increased (< 1%); G3/ 4 ALT increased (< 1%)
G3/ 4 Żieda fl- ALT (< 1%)
Nervous system disorders
Disturbi fis- sistema nervuża Newropatija periferika Newropatija periferika Disturbi gastro- intestinali
Peripheral sensory Peripheral motor neuropathy (G3:
tas- sensazzjoni (G3:
Nausea (G3/ 4:
0. 4%) Tqalligħ (G3/ 4:
7.8%); Diarrhoea (G3/ 4:
tal- movimenti (G3/ 4:
Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit - tessuti ta ’ taħt il- ġilda Disturbi muskolu- skeletrali u tal- connective tissue u ta ’ l- għadam
Vascular disorders General disorders and administration site conditions
Disturbi vaskulari Disturbi ġenerali u
51 TAXOTERE 75 mg/ m² in combination with cisplatin
51 TAXOTERE 75 mg/ m² użat flimkien ma ’ cisplatin:
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Effetti mhux miztieqa mhux komuni ≥ 0. 1 to < 1% tal- pazjenti G3/ 4 Żieda fl- AST (0. 5%);
G3/ 4 AST increased (0.5%); G3/ 4 Blood alkaline phosphatase increased (0.3%)
G3/ 4 Żieda fl- alkaline phosphatase fid- demm (0. 3%)
9.6%); Vomiting (G3/ 4:
Rimettar (G3/ 4:
General disorders and administration site
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Fluid retention (severe:
9. 9%); Żamm tal- fluwidu (sever:
52 TAXOTERE 100 mg/ m² in combination with trastuzumab
52 TAXOTERE 100 mg/ m² użat flimkien ma ’ trastuzumab:
MedDRA System Organ classes
Sistema tal- Klassifika tal - Organi fid- Database
Very common adverse reactions ≥ 10% of patients
Reazzjonijiet Avversi Komuni ≥ 1 sa < 10% tal- pazjenti
Investigations Cardiac disorders Blood and lymphatic system disorders
Investigazzjonijiet Disturbi fil- qalb Disturbi tad- demm u tas -
Nervous system disorders
sistema limfatika
Paresthesia; Headache; Dysgeusia; Hypoaesthesia
Disturbi fis- sistema nervuża Parasteżija; Ugigħ ta ’ ras; Disgewżja; Ipoestesija Disturbi fl- għajnejn
Respiratory, thoracic and mediastinal disorders
Disturbi respiratorji, toraċiċi Fġir l- imnieħer; Uġigħ fil - u medjastinali
Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea; Cough; Rhinorrhoea
farinġi u l- larinġi; Farinġite tal - parti nażali; Qtugħ ta ’ nifs; Sogħla; Tnixxija mill- imnieħer
Alopecia; Erythema; Rash; Nail disorders Myalgia; Arthralgia; Pain in extremity; Bone pain; Back pain Anorexia
Disturbi muskolu- skeletrali u Majalġja; Artralġja; Uġigħ fl - estremitajiet; Uġigħ fl- għadam; tal- connective tissue u ta ’ l - Uġigħ tad- dahar għadam Disturbi fil- metaboliżmu u n - Anoreksja nutrizzjoni Disturbi vaskulari
Vascular disorders
Edima limfatika
Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Astenja; Edima periferika; Deni; Għejja; Infjammazzjoni tal- mukoża; Uġigħ; Mard bħall - influwenza; Uġigħ fis- sider; Riħ bid- deni
Symptomatic cardiac failure was reported in 2.2% of the patients who received docetaxel plus trastuzumab compared to 0% of patients given docetaxel alone.
Insuffiċjenza tal- qalb sintomatika kienet irrapportata f’ 2. 2% tal- pazjenti li ħadu TAXOTERE flimkien ma ’ trastuzumab meta mqabbel ma ’ 0% tal- pazjenti li ngħataw TAXOTERE waħdu.
In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Fil- qasam ta ’ l - istudji fejn TAXOTERE intuża flimkien ma ’ trastuzumab, 64% kienu ħadu qabel anthracycline bħala terapija miżjuda, meta mqabbel ma ’ 55% tal- fergħa ta ’ docetaxel biss.
53 TAXOTERE 75 mg/ m² in combination with capecitabine
53 TAXOTERE 75 mg/ m² użat flimkien ma ’ capecitabine:
Common adverse reactions ≥ 1 to < 10% of patients
Reazzjonijiet Avversi komuni ≥ 1 to < 10% tal- pazjenti
Dizziness; Headache (G3/ 4: < 1%); Neuropathy peripheral
Uġigħ ta ’ ras (G3/ 4: < 1%); Newropatija periferika
18%); Diarrhoea (G3/ 4:
14%);
14%); Nausea (G3/ 4:
Tqalligħ (G3/ 4:
24%); Alopecia (G3/ 4:
24%); Alopeċja (G3/ 4:
1%) Anorexia (G3/ 4:
Uġigħ fl- estremitajiet (G3/ 4: < 1%); Uġigħ tad- dahar (G3/ 4:
Pain in extremity (G3/ 4: < 1%); Back pain (G3/ 4:
Disturbi fil- metaboliżmu u n - nutrizzjoni
1%) Dehydration (G3/ 4:
Anoreksja( G3/ 4:
54 TAXOTERE 75 mg/ m² in combination with prednisone or prednisolone
TAXOTERE 75 mg/ m² użat flimkien ma ’ prednisone jew prednisolone:
Very common adverse reactions ≥ 10% of patients
Reazzjonijiet Avversi ≥ 1 to < 10% tal- pazjenti
1.2%); Dysgeusia (G3/ 4:
1. 2%); Disgewżja (G3/ 4:
Peripheral motor neuropathy (G3/ 4:
movimenti (G3/ 4:
Gastrointestinal disorders
Sistema tal- Klassifika tal -
Skin and subcutaneous tissue disorders Musculoskeletal and connective bone disorders Metabolism and nutrition disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda Disturbi muskolu- skeletrali u tal - connective tissue
0.3%) Arthralgia (G3/ 4:
0. 3%) Artralġja (G3/ 4:
Infections and infestations General disorders and administration site conditions Immune system disorders
Infezzjonijiet u infestazzjonijiet Mard ġenerali u kondizzjonijiet ta ’ mnejn jingħata Disturbi fis- sistema immuni
55 TAXOTERE 75 mg/ m² in combination with doxorubicin and cyclophosphamide
TAXOTERE 75 mg/ m² użat flimkien ma ’ doxorubicin u cyclophosphamide:
MedDRA System Organ classes Investigations
Sistema tal- Klassifika tal- Organi fid - Database MedDRA
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients Weight increased or decreased (G3/ 4:
≥ 10% tal- pazjenti Żieda jew tnaqqis fil - piż (G3/ 4:
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
pazjenti
0%)
0%); Newrokortikali( G3/ 4:
Eye disorders
0. 1%) 0%) Disturbi fl- għajnejn
Nausea (G3/ 4:
Ugigħ addominali (G3/ 4:
5.1%); Abdominal pain (G3/ 4:
Tqalligħ (G3/ 4:
Stomatitis (G3/ 4:
5. 1%); Stomatite (G3/ 4:
0.5%) 7.1%); Vomiting (G3/ 4:
7. 1%); Rimettar (G3/ 4:
4.3%); Diarrhoea (G3/ 4:
4. 3%); Dijarea (G3/ 4:
Colitis/ enteritis/ large intestine perforation
Reazzjonijiet Avversi mhux komuni ≥ 0. 1 to < 1% tal -
0.4%)
pazjenti
Anorexia (G3/ 4:
Disturbi fil- metaboliżmu Anoreksja (G3/ 4: u n- nutrizzjoni Infezzjonijiet u infestazzjonijiet
2.2%)
2. 2%) Infezzjoni (G3/ 4:
Infections and infestations
Disturbi vaskulari Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Infection (G3/ 4:
Vasodilatazzjoni (G3/ 4:
3.2%); Neutropenic infection.
0. 9%) Astenja (G3/ 4:
There were no septic deaths.
11%); Deni (G3/ 4:
Vascular disorders
1. 2%); Edima periferika (G3/ 4:
Vasodilatation (G3/ 4:
0. 4%)
57 TAXOTERE 75 mg/ m² in combination with cisplatin and 5-fluorouracil for gastric adenocarcinoma cancer
56 TAXOTERE 75 mg/ m² użat flimkien ma ’ cisplatin u 5- fluorouracil għal kanċer tat- tip adenokarċinoma ta ’ l- istonku:
MedDRA System Organ classes
Sistema tal- Klassifika tal- Organi
1.0%)
1. 0%)
58 TAXOTERE 75 mg/ m² in combination with cisplatin and 5-fluorouracil for Head and Neck cancer
57 TAXOTERE 75 mg/ m² użat flimkien ma ’ cisplatin and 5- fluorouracil (għal kanċer tar- ras u ta ’ l - għonq):
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Reazzjonijiet Avversi komuni ≥ 1 to < 10% tal- pazjenti
Cardiac disorders Blood and lymphatic system disorders
Reazzjonijiet Avversi mhux komuni ≥ 0. 1 to < 1% tal - pazjenti
Myocardial ischemia (G3/ 4:1.7%) Neutropenia (G3/ 4:
Investigazzjonijiet
Febrile neutropenia 76.3%); Anemia (G3/ 4:
Disturbi fil- qalb
5.2%)
Mard iskemiku tal - mijokardju (G3/ 4: 1. 7%) Newtropenija bid- deni
Nervous system disorders
Disturbi tad- demm u tas - sistema limfatika
Dysgeusia/ Parosmia; Dizziness Peripheral sensory neuropathy (G3/ 4:
9. 2%); Tromboċitopenija (G3/ 4:
Eye disorders
Sturdament Disturbi fis- sistema nervuża Disgewżja / Parosmja; Newropatija periferika tas- sensazzjoni (G3/ 4: 0. 6%) Disturbi fl- għajnejn
Hearing impaired
Nuqqas ta ’ smigħ Stitikezza;
0.6%); Constipation; Stomatitis (G3/ 4:
Tqalligħ (G3/ 4: 0. 6%); Stomatite (G3/ 4: 4. 0%); Dijarea (G3/ 4: 2. 9%); Rimettar (G3/ 4: 0. 6%)
0.6%)
Esofaġite/ disfaġja / odinofaġja (G3/ 4: 0. 6%); Uġigħ addominali; Dispepsja; Emoraġija gastrointestinali (G3/ 4: 0. 6%)
Alopecia (G3/ 4:
Alopeċja (G3/ 4: 10. 9%)
Anorexia (G3/ 4:
Disturbi fil- metaboliżmu u Anoreksja (G3/ 4:
0.6%)
0. 6%) n- nutrizzjoni Infezzjonijiet u infestazzjonijiet Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
Infections and infestations Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infezzjoni (G3/ 4: 6. 3%); Infezzjoni bin - newtropenija
Infection (G3/ 4:
Uġigħ tal- kanċer (G3/ 4:
0.6%)
Letarġija (G3/ 4: 3. 4%); Deni (G3/ 4:
General disorders and administration site conditions
0. 6%); Żamm tal- fluwidu; Edima
Lethargy (G3/ 4:
Mard tal- vini (G3/ 4:
3.4%); Pyrexia (G3/ 4:
0. 6%)
• Induction chemotherapy followed by chemoradiotherapy (TAX 324)
58 • Kimoterapija Induttiva segwita bi kimoradjuterapija (TAX324)
12.4%); Thrombocytopenia (G3/ 4:
Sturdament (G3/ 4:
4.0%); Febrile neutropenia
Disgewżja / Parosmja
0.4%); Peripheral sensory neuropathy (G3/ 4:
0. 4%); Newropatija periferika tas- sensazzjoni (G3/ 4:
Dizziness (G3/ 4:
Newropatija periferika tal- movimenti (G3/ 4:
13.9%); Stomatitis (G3/ 4:
Dispepsja (G3/ 4:
12.0%); Constipation (G3/ 4:
12. 0%); Stitikezza (G3/ 4:
Dyspepsia (G3/ 4:
Ugigħ gastro- intestinali (G3/ 4:
Vascular disorders General disorders and administration site conditions
59 Sistema tal- Klassifika tal- Organi fid - Database MedDRA Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Post-marketing experience
L- esperjenza wara Li tpoġġa
60
fis- suq:
In some cases concomitant factors may have contributed to the development of these effects. Sclerodermal-like changes usually proceded by peripheral lymphedema have been reported with docetaxel.
F’ xi każijiet, fatturi konkomittanti setgħu taw kontribut għall- iżvilupp ta ’ dawn l- effetti.
61 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.
Clinical data
61 Tagħrif kliniku
Docetaxel was administered as a 1-hour infusion, all other medicinal products were given as intravenous bolus on day one.
Iż- żewġ gruppi kienu ngħataw il- kura darba kull 3 ġimgħat għal 6. ċikli docetaxel kien ingħata bħala infużjoni tul siegħa, waqt li l- prodotti mediċinali l- oħra kienu ngħataw bħala bolus fil- vini fl - ewwel jum.
62 An interim analysis was performed with a median follow up of 55 months.
Sadattant, analiżi nħaddmet fuq perijodu medjan ta ’ 55 xahar.
In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/ m² every 3 weeks).
62 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).
More grade 3/ 4 adverse events were observed for docetaxel monotherapy (55.4%) compared to paclitaxel (23.0%).
Aktar ġrajjiet avversi kienu innotati b ’ docetaxel bħala monoterapija (55. 4%) meta mqabbel ma ’ paclitaxel (23%).
63 TAXOTERE in combination with doxorubicin
TAXOTERE użat flimkien ma ’ doxorubicin
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:
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% kontra 1. 1%).
TAXOTERE in combination with trastuzumab
63 TAXOTERE 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.
TAXOTERE in combination with capecitabine
TAXOTERE użat flimkien ma ’ capecitabine
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.
64 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.
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.
65 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.
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.
Adenokarċinoma ta ’ l- istonku Studju f’ ċentri multipli fejn kemm l- investigatur kif ukoll il- pazjent kienu jafu x’ mediċini kienu qed jintużaw, u li il- pazjenti tqassmu f’ gruppi mingħajr għażla, sar biex ikunu evalwati s- sigurtà u l - effikaċja ta ’ docetaxel, għat- trattament ta ’ pazjenti li kellhom adenokarċinoma metastatika ta ’ l - istonku, inklużi dawk li kellhom adenokarċinoma fil- parti fejn l- istonku jagħqad ma ’ l- esofagu, u li ma kienux ħadu qabel kimoterapija għall- mard metastatiku.
Time to progression (TTP) was the primary endpoint.
66 żmien li ħa t- tumur biex avvanza (TTP) kien l- aħħar stadju primarju tal- proċess.
• 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).
Kimoterapija Induttiva segwita bi radjuterapija (TAX323) Is- sigurtà u l- effikaċja ta ’ docetaxel fit- trattament induttiv ta ’ pazjenti li kellhom kanċer tat- tip squamous cell tar- ras u l- għonq (SCCHN), kienu evalwati fil fażi III ta ’ studju magħmul minn ċentri multipli, fejn kemm l- investigatur kif ukoll il- pazjent kienu jafu x’ mediċini qed jintużaw, u fejn il - pazjenti tqassmu mingħajr għażla (TAX323).
Patients on the docetaxel arm received docetaxel (T) 75 mg/ m2 followed by cisplatin (P) 75 mg/ m2 followed by 67 5-fluorouracil (F) 750 mg/ m2 per day as a continuous infusion for 5 days.
Pazjenti tal- fergħa ta ’ docetaxel ingħataw docetaxel (T) 75 mg/ m2, segwit minn cisplatin (P) 75 mg/ m2, segwit minn 5- fluorouracil (F) 750 mg/ m2 kuljum bħala infużjoni kontinwa għal 5 ijiem.
Patients on the comparator arm received cisplatin (P) 100 mg/ m2 followed by 5-fluorouracil (F) 1000 mg/ m2 per day for 5 days.
Din is -
This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
67 sistema ta ’ kura ingħatat kull tliet ġimgħat għal 4 ċikli fil- każ li, ta ’ l- anqas, rispons ċkejken kien ikun osservat wara żewġ ċikli (≥ 25% tnaqqis fid- daqs tat- tumur permezz ta ’ kejl f’ żewġ dimensjonijiet).
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 (PF/ RT).
Fit- tmiem tal- kimoterapija, b’ intervall minimu ta ’ 4 ġimgħat u intervall massimu ta ’ 7 ġimgħat, il - pazjenti fejn it- tumur m’ avvanzax, ingħataw ir- radjuterapija (RT), skond il- gwidi stabbiliti, ghal 7 ġimgħat (PF/ RT).
Cis + 5-FU
Docetaxel + Cis + 5- FU
Median progression free survival (months) (95% CI) Adjusted Hazard ratio
Tul medjan ta ’ sopravivenza mingħajr it- tumur
11.4 (10.1-14.0)
javvanza (xhur) (95% CI) Il- proporzjon aġġustat tar- riskju
0.70
(10. 1- 14. 0) 0. 70
8.3 (7.4-9.1)
(7. 4- 9. 1)
A Hazard ratio of less than 1 favors docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumor site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
Proporzjon ta ’ riskju ta ’ anqas minn 1 huwa favur docetaxel + cisplatin +5- FU * Cox model (aġġustament għas- sit tat- tumur Primarju, T and N stadji kliniċi u PSWHO) ** Logrank test *** Chi- square test
68 Quality of life parameters Patients treated with TPF experienced significantly less deterioration of their Global health score compared to those treated with PF (p = 0.01, using the EORTC QLQ-C30 scale).
Il- parametri tal- kwalità tal- ħajja Il- pazjenti ittrattati b’ TPF kellhom b’ mod sinifikattiv anqas ta ’ deterjorazzjoni fil- kejl tas- saħħa Globali, meta mqabbla ma ’ dawk ittrattati bi PF (p = 0. 01, meta tintuża l- iskala EORTC QLQ- C30).
Clinical benefit parameters The performance status scale, for head and neck (PSS-HN) subscales designed to measure understandability of speech, ability to eat in public, and normalcy of diet, was significantly in favor of TPF as compared to PF.
68 Il- parametri tal- benefiċċju kliniku L- iskaletti ta ’ l- iskala ta ’ l- istatus ta ’ kapaċità, għar- ras u l- għonq (PSS- HN), maħduma biex jitkejlu l - ftehim fid- diskors, il- kapaċità biex wieħed jiekol fil- publiku, u jsegwi dieta normali, kienu b’ mod sinifikattiv favur TPF meta mqabbel ma ’ PF.
69 Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
69 L- Effikaċja ta ’ docetaxel fit- trattament induttiv ta ’ pazjenti b’ SCCHN inoperabbli u lokalment avvanzat (Analiżi bl- Iskop li Titratta)
70 modified in patients with mild to moderate fluid retention and there are no data available in patients with severe fluid retention.
It- tneħħija ta ’ docetaxel ma kienx immodifikat f’ pazjenti bi grad ħafif sa wieħed moderat taż - żamm ta ’ fluwidu, u m’ hemmx data fuq pazjenti bi grad sever taż- żamm ta ’ fluwidu.
71 6.3 Shelf life
71 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
• 3 years. • Premix solution:
• Sentejn • Soluzzjoni mħallta għal- lest -:
Each blister pack contains: • one single-dose vial of concentrate and, • one single-dose vial of solvent.
Kull pakkett bil- fojl fih: • kunjett b’ doża waħda - ta ’ konċentrat u, • kunjett b’ doża waħda ta ’ solvent.
TAXOTERE 80 mg concentrate for solution for infusion vial
Kunjett ta ’ TAXOTERE 80 mg konċentrat għal soluzzjoni għall- infużjoni:
This overfill ensures that after dilution with the entire contents of the accompanying solvent for TAXOTERE vial, there is a minimal extractable premix volume of 8 ml containing 10 mg/ ml docetaxel which corresponds to the labelled amount of 80 mg per vial.
Dan jikkorrispondi għal ammont ta ’ 20 mg imsemmi fuq it- tabella tal- kunjett.
The addition of the entire contents of the solvent vial to the contents of the TAXOTERE 80 mg concentrate for solution for infusion vial ensures a premix concentration of 10 mg/ ml docetaxel.
Meta jiżdied is- solvent kollu fil- kunjett ta ’ TAXOTERE 80 mg konċentrat għal soluzzjoni għall- infużjoni, is- soluzzjoni inizjali li tirriżulta tkun ta ’ 10 mg/ ml docetaxel.
72 Preparation for the intravenous administration
72 Il- preparazzjoni tal- prodott għall- għoti ġol- vini
a) Preparation of the TAXOTERE premix solution (10 mg docetaxel/ ml)
a) Preparazzjoni ta’ TAXOTERE, soluzzjoni inizjali (10 mg docetaxel/ ml)
73 8.
73 8.
EU/ 1/ 95/ 002/ 002
EU/ 1/ 95/ 002/ 001
74 ANNEX II
74 ANNESS II
• CONDITIONS OF RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
76 ANNEX III
76 ANNESS III
78 PARTICULARS TO APPEAR ON OUTER PACKAGING AND THE IMMEDIATE PACKAGING CARTON/ TAXOTERE 20 mg
78 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U IL- PAKKETT LI JMISS MAL- PRODOTT KAXXA TAL- KARTUN/ TAXOTERE 20 mg
TAXOTERE 20 mg concentrate and solvent for solution for infusion
TAXOTERE 20 mg konċentrat u solvent għal soluzzjoni għall- infużjoni docetaxel
1 vial of TAXOTERE 20 mg concentrate for solution for infusion 20 mg docetaxel in 0.5 ml polysorbate 80 (40 mg/ ml) Fill:
Kunjett wieħed ta ’ TAXOTERE 20 mg konċentrat għal soluzzjoni għall- infużjoni 20 mg docetaxel f’ 0. 5 ml polysorbate 80 (40 mg/ ml) Volum attwali:
24.4 mg/ 0.61 ml 1 vial of solvent for TAXOTERE 13% (w/ w) ethanol 95% in water for injections Fill:
24. 4 mg/ 0. 61 ml Kunjett wieħed ta ’ solvent għal TAXOTERE 13% (w/ w) t’ ethanol 95% fl- ilma għall- injezzjonijiet Volum attwali: