qanastek/EMEA-V3 huggingface dataset:
On 14 November 2008, Sanofi-Aventis Pharma S. A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Taxotere/ Docetaxel Winthrop, to add the treatment of patients with operable breast cancer whose tumours overexpress HER2 in combination with trastuzumab, with or without carboplatin.
Fl- 14 ta ’ Novembru 2008, Sanofi- Aventis Pharma S. A. uffiċjalment innotifikat lill- Kumitat għall - Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) li tixtieq tirtira l- applikazzjoni tagħha għal indikazzjoni ġdida għal Taxotere/ Docetaxel Winthrop, bħala addizzjoni għat- trattament ta ’ pazjenti b’ kanċer tas- sider operabbli b’ iperesprezzjoni tat- tumuri tagħhom ta ’ HER2 f’ kombinazzjoni ma ’ trastuzumab, bi jew mingħajr carboplatin.
What is Taxotere/ Docetaxel Winthrop?
X’ inhu Taxotere/ Docetaxel Winthrop?
Taxotere/ Docetaxel Winthrop is a concentrate and solvent, which are made up into a solution for infusion (drip into a vein).
Taxotere/ Docetaxel Winthrop huwa konċentrat u solvent, li jitħalltu f’ soluzzjoni għall- infużjoni (dripp ġol- vina).
Taxotere/ Docetaxel Winthrop is an anticancer medicine.
Taxotere/ Docetaxel Winthrop huwa mediċina ta ’ kontra l- kanċer.
It is used in breast cancer that is advanced or ‘ metastatic’ (has spread to other parts of the body), and in breast cancer that can be treated with surgery.
Jintuża f’ kanċer tas- sider fi stadju avvanzat jew ‘ metastatiku ’ (li jkun infirex għal partijiet oħra tal- ġisem), u f’ kanċer tas- sider li jista ’ jkun ittrattat kirurġikament.
In these patients, Taxotere/ Docetaxel Winthrop is used in addition to surgery to remove the tumour, together with doxorubicin and cyclophosphamide (other anticancer medicines).
F’ dawn il- pazjenti, Taxotere/ Docetaxel Winthrop jintuża bħala addizzjoni għall- intervent kirurġiku biex jitneħħa t- tumur, flimkien ma ’ doxorubicin u ċiklofosfamide (cyclophosphamide, mediċini kontra l- kanċer oħrajn).
Taxotere/ Docetaxel Winthrop is also used in advanced or metastatic non-small cell lung cancer, in prostate cancer, in metastatic gastric adenocarcinoma (a type of stomach cancer) and in advanced head and neck cancer.
Taxotere/ Docetaxel Winthrop jintuża wkoll f’ kanċer tal- pulmun b’ ċelloli mhux żgħar fi stadju avvanzat jew metastatiku, f’ kanċer tal- prostata, f’ adenokarċinoma gastrika metastatika (tip ta ’ kanċer tal- istonku) u f’ kanċer avvanzat tar- ras u tal- għonq.
What was Taxotere/ Docetaxel Winthrop expected to be used for?
Għal xiex kien mistenni li jintuża Taxotere/ Docetaxel Winthrop?
Taxotere/ Docetaxel Winthrop was also expected to be used to treat breast cancer that can be treated with surgery when the cancer has been shown to be ‘ expressing’ large amounts of HER2: this is a type of cancer that produces (expresses) a specific protein called HER2 in large quantities on the surface of the tumour cells.
Taxotere/ Docetaxel Winthrop kien mistenni li jintuża wkoll f’ kanċer tas- sider li jista ’ jkun ittrattat kirurġikament meta l- kanċer ikun intwera li qed ‘ jesprimi ’ ammonti kbar ta ’ HER2: dan huwa tip ta ’ kanċer li jipproduċi (jesprimi) proteina speċifika msejħa HER2 fi kwantitajiet kbar fil- wiċċ ta ’ ċelloli tat- tumur.
Taxotere/ Docetaxel Winthrop was expected to be used in addition to surgery to remove the tumour in the following treatment combinations: • together with trastuzumab (another anticancer medicine), following treatment with doxorubicin and cyclophosphamide; • together with trastuzumab and carboplatin (another anticancer medicine).
Taxotere/ Docetaxel Winthrop kien mistenni li jintuża bħala addizzjoni għall- intervent kirurġiku biex ineħħi t- tumur fil- kombinazzjonijiet ta ’ trattament li ġejjin: • flimkien ma ’ trastuzumab (mediċina oħra kontra l- kanċer), wara kura b’ doxorubicin u ċiklofosfamide; • flimkien ma ’ trastuzumab u carboplatin (mediċina oħra kontra l- kanċer).
In both cases, all medicines were to be started at the same time.
Fiż- żewġ każijiet, il- mediċini kollha kellhom jinbdew fl- istess ħin.
How is Taxotere/ Docetaxel Winthrop expected to work?
Kif huwa mistenni li jaħdem Taxotere/ Docetaxel Winthrop?
The active substance in Taxotere/ Docetaxel Winthrop, docetaxel, belongs to the group of anticancer medicines known as the ‘ taxanes’.
Is- sustanza attiva f’ Taxotere/ Docetaxel Winthrop, docetaxel, tappartjeni għall- grupp ta ’ mediċini kontra l- kanċer magħruf bħala ‘ tassani ’.
Docetaxel blocks the ability of cells to destroy the internal ‘ skeleton ’ that allows them to divide and multiply.
Docetaxel jimblokka l- kapaċità taċ- ċelloli li jeqirdu l - ‘ iskeletru ’ intern li jħallihom jinqasmu u jimmultiplikaw.
With the skeleton still in place, the cells cannot divide and they eventually die.
Bl- iskeletru għadu f’ postu, iċ- ċelloli ma jistgħux jinqasmu u eventwalment imutu.
Docetaxel affects not only cancer cells, but also non-cancer cells such as blood cells, which can cause side effects.
Docetaxel jolqot mhux biss iċ- ċelloli tal- kanċer, iżda wkoll ċelloli mhux tal- kanċer bħalma huma ċelloli tad- demm, li jistgħu jikkaġunaw effetti sekondarji.
Reproduction is authorised provided the source is acknowledged. • the combination of doxorubicin and cyclophosphamide for 12 weeks, followed by Taxotere/ Docetaxel Winthrop for 12 weeks, either alone or in combination with trastuzumab; • the combination of Taxotere/ Docetaxel Winthrop, trastuzumab and carboplatin for 18 weeks.
Taxotere/ Docetaxel Winthrop ġie studjat fi studju ewlieni li jinvolvi aktar minn 3, 000 mara b’ kanċer tas- sider b’ espressjoni ta ’ HER2 li jista ’ jkun ittrattat kirurġikament.
In both groups, trastuzumab treatment was continued for a year.
Fiż- żewġ gruppi, it- trattament b’ trastuzumab tkompliet għal sena.
The main measure of effectiveness was how long the patients survived until their cancer came back.
Il- kejl ewlieni tal- effikaċja kien il - perjodu ta ’ sopravivenza tal- pazjenti sakemm il- kanċer tagħhom reġa ’ tfaċċa.
How far into the evaluation was the application when it was withdrawn?
Fejn kienet waslet l- evalwazzjoni tal- applikazzjoni qabel din ġiet irtirata?
The evaluation had finished and the CHMP had given a negative opinion.
L- evalwazzjoni kienet spiċċat u s- CHMP kien ta opinjoni negattiva.
The company had initiated an appeal process, but this had not yet finished when the company withdrew.
Il- kumpanija kienet bdiet proċess ta ’ appell, iżda dan kien għadu ma spiċċax meta l- kumpanija rtirat.
Based on the review of the data and the company’ s response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Taxotere/ Docetaxel Winthrop in the treatment of patients with operable breast cancer whose tumours overexpress HER2 in combination with trastuzumab, with or without carboplatin.
Abbażi tal- analiżi tad- dejta u t- tweġiba mogħtija mill- kumpanija għal- lista ta 'mistoqsijiet tas- CHMP fi żmien l- irtar, il- CHMP kien ta opinjoni negattiva u ma rrakkomandax li tingħata l- awtorizzazzjoni għat- tqegħid fis- suq għal Taxotere/ Docetaxel Winthrop fit- trattament ta ’ pazjenti b’ kanċer tas- sider operabbli b’ iperesprezzjoni tat- tumuri tagħhom ta ’ HER2 f’ kombinazzjoni ma ’ trastuzumab, bi jew mingħajr carboplatin.
What were the main concerns of the CHMP?
X’ kien it- tħassib ewlieni tas- CHMP?
The CHMP was concerned that it was not possible to establish the benefits of the treatment combinations including Taxotere/ Docetaxel Winthrop when used in addition to surgery, because of the way the single main study was designed.
Is- CHMP kien imħasseb dwar il- fatt li ma kienx possibbli li jistabbilixxi l- benefiċċji tal - kombinazzjonijiet tat- trattament inkluż Taxotere/ Docetaxel Winthrop meta użat f’ addizzjoni mal - intervent kirurġiku, minħabba l- mod ta ’ kif kien imfassal l- uniku istudju prinċipali.
The CHMP was also concerned that the company did not provide sufficient clinical evidence to justify the use of the combination of Taxotere/ Docetaxel Winthrop, carboplatin and trastuzumab.
Is- CHMP kien imħasseb ukoll li l- kumpanija ma pprovdietx prova klinika suffiċjenti biex tiġġustifika l- użu tal - kombinazzjoni ta ’ Taxotere/ Docetaxel Winthrop, carboplatin u trastuzumab.
Therefore, at the time of the withdrawal, the CHMP’ s view was that a benefit of Taxotere/ Docetaxel Winthrop had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Għalhekk, fi żmien l- irtirar, l- opinjoni tas- CHMP kienet li l- benefiċċju ta 'Taxotere/ Docetaxel Winthrop ma kienx intwera biżżejjed u li kwalunkwe benefiċċju li seta ’ kellu ma kienx jegħleb ir - riskji identifikati.
The letters from the company notifying the EMEA of the withdrawal of the application are available here and here.
L- ittri mill- kumpanija li jgħarrfu lill- EMEA bl- irtirar tal- applikazzjoni jinsabu hawn u hawn.
What are the consequences of the withdrawal for patients undergoing clinical trials with Taxotere/ Docetaxel Winthrop?
X’ inhuma l- konsegwenzi tal- irtirar għal dawk il- pazjenti li jkunu involuti fi provi kliniċi b ’ Taxotere/ Docetaxel Winthrop?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Taxotere/ Docetaxel Winthrop.
Il- kumpanija għarrfet lis- CHMP li ma kienx hemm konsegwenzi għall- pazjenti li jkunu għaddejjin minn provi kliniċi b’ Taxotere/ Docetaxel Winthrop.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Jekk inti qed tieħu sehem fi studju kliniku u trid iżjed tagħrif dwar it- trattament tiegħek, ikkuntattja lit - tabib li jkun qed jagħtik dan it- trattament.
What is happening for Taxotere/ Docetaxel Winthrop for the treatment of other types of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma and head and neck cancer?
X’ jiġri b’ Taxotere/ Docetaxel Winthrop għat- trattament ta ’ tipi oħrajn ta ’ kanċer tas- sider, kanċer tal- pulmun b’ ċelloli mhux żgħar, kanċer tal- prostata, adenokarċinoma gastrika u kanċer tar- ras u tal- għonq?
There are no consequences on the use of Taxotere/ Docetaxel Winthrop in its authorised indications, for which the balance of benefits and risks remains unchanged.
Ma hemm l- ebda konsegwenza fuq l- użu ta ’ Taxotere/ Docetaxel Winthrop fl- indikazzjonijiet awtorizzati, fejn il- bilanċ bejn il- benefiċċju u r- riskju jibqa ’ invarjat.
TAXOTERE 20 mg concentrate and solvent for solution for infusion
TAXOTERE 20 mg konċentrat u solvent għal soluzzjoni għall- infużjoni
Each single-dose vial of TAXOTERE 20 mg concentrate contains docetaxel which is a trihydrate corresponding to 20 mg of docetaxel (anhydrous).
Kull kunjett b’ doża waħda ta ’ TAXOTERE 20 mg, konċentrat, li fih docetaxel li huwa tri- idrat, korrispondenti għal 20 mg ta ’ docetaxel (anidru).
TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node- positive breast cancer.
TAXOTERE flimkien ma ’ doxorubicin u cyclophosphamide huwa indikat għat- trattament miżjud f’ pazjenti li għandhom kanċer operabbli, u li nfirex fil- glandoli limfatiċi, tas- sider.
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.
TAXOTERE flimkien 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 monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
TAXOTERE meta jingħata waħdu huwa indikat għat- trattament ta ’ pazjenti b’ kanċer tas- sider, lokalment avvanzat jew dak metastatiku, wara l- falliment ta ’ terapija ċitotossika.
TAXOTERE in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who previously have not received chemotherapy for metastatic disease.
TAXOTERE flimkien ma ’ trastuzumab huwa indikat għat- trattament ta’ pazjenti b’ kanċer metastatiku tas- sider, liema tumuri jesprimu bil- qawwa HER2, u li preċedentement ma kienux ħadu kimoterapija għall- mard metastatiku.
TAXOTERE in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
TAXOTERE flimkien ma ’ capecitabine huwa indikat għat- trattament ta ’ pazjenti b’ kanċer tas- sider lokalment avvanzat jew dak metastatiku, wara l- falliment tal- kimoterapija ċitotossika.
TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.
TAXOTERE huwa indikat għat- trattament ta ’ pazjenti b’ kanċer tal- pulmun lokalment avvanzat jew dak metastatiku li mhux ta ’ ċelluli żgħar wara falliment ta ’ kimoterapija ċitotossika li ngħatat qabel.
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.
TAXOTEREflimkien 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.
2 Prostate cancer
2 Kanċer tal- prostata
TAXOTERE in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostate cancer.
TAXOTERE flimkien ma ’ prednisone jew prednisolone huwa indikat għat- trattament tal- kanċer metastatiku tal- prostata, li ma jirrispondix għall- kura bl- ormoni.
TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease.
TAXOTERE flimkien ma ’ cisplatin u 5- fluorouracil huwa indikat fit- trattament ta ’ pazjenti li għandhom adenokarċinoma metastatika ta ’ l- istonku, inkluż l- adenokarċinoma tal- parti fejn l- istonku jingħaqad ma ’ l- esofagu, u li ma kienux ħadu l- kimoterapija qabel, għal mard metastatiku.
TAXOTERE in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.
TAXOTERE flimkien ma ’ cisplatin u 5- fluorouracil huwa indikat għat- trattament induttiv f’ pazjenti b’ kanċer tat- tip squamous tal- ġilda, lokalment avvanzat, tar- ras u l- għonq.
In combination with capecitabine, the recommended dose of docetaxel is 75 mg/ m2 every three weeks, combined with capecitabine at 1250 mg/ m2 twice daily (within 30 minutes after a meal) for 2 weeks followed by 1-week rest period.
Flimkien ma ’ capecitabine, id- doża irrakkomandata ta ’ docetaxel hija 75 mg/ m2 kull tliet ġimgħat, flimkien ma ’ capecitabine 1250 mg/ m2 darbtejn kuljum (fi żmien ta ’ 30 minuta wara l- ikel) għal ġimgħatejn, segwit b’ perijodu ta ’ waqfien għal ġimgħa.
For treatment
3 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- dożi irrakkomandata hija docetaxel 75 mg/ m2 segwit immedjatament b’ cisplatin 75 mg/ m2 fuq perjodu ta ’ bejn 30 u 60 minuta.
All patients on the docetaxel-containing arm of the TAX 323 and TAX 324 studies, received prophylactic antibiotics.
Il- pazjenti kollha tal- fergħa ta ’ docetaxel ta ’ l- istudji TAX 323 u TAX 324 irċevew profilassi bl- antibijotiċi
• 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.
• Kimoterapija Induttiva segwita bi radjuterapija (TAX 323) 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 (TAX 324) 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 irrakkomandata 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.
Following chemotherapy, patients should receive chemoradiotherapy.
Wara l- kimoterapija il- pazjenti għandhom jirċievu l- kimoradjuterapija.
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
Diarrhea grade 4
Dijarrea ta ’ grad 4 Stomatite/ mukożite ta ’ grad 3
5 Special populations:
Pazjenti speċjali:
Patients with hepatic impairment Based on pharmacokinetic data with docetaxel at 100 mg/ m² as single agent, patients who have both elevations of transaminase (ALT and/ or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/ m2 (see sections 4.4 and 5.2).
Ibbażat fuq tagħrif farmakokinetiku bid- docetaxel f’ doża ta ’ 100 mg/ m2 meta mogħti waħdu, il - pazjenti li għandhom livelli għoljin ta ’ l- enżimi trasaminażi (ALT u/ jew AST) aktar minn 1. 5 drabi ta ’ l- ogħla livell tal- firxa normali (ULN) u l- livell tal- enzima alkaline phosphatase aktar minn 2. 5 drabi ta ’ l- ULN, id- doża irrakkomandata ta ’ docetaxel hija 75 mg/ m2 (ara - sezzjonijiet 4. 4 u 5. 2).
For those patients with serum bilirubin > ULN and/ or ALT and AST > 3.5 times the ULN associated with alkaline phosphatase > 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 tal- bilirubin fid- demm > ULN u/ jew l- ALT u l- AST > 3. 5 drabi ta ’ l - ULN, assoċjati ma ’ livelli ta ’ alkaline phosphatase ta ’ > 6 darbiet l- ULN, ma jistax jkun irrakkomandat it- tnaqqis fid- doża, u d- docetaxel m’ għandux jintuża sakemm huwa strettament indikat.
4.3 Contraindications
6 4. 3 Kontra- indikazzjonijiet
For breast and non-small cell lung cancers, premedication consisting of an oral corticosteroid, such as dexamethasone 16 mg per day (e. g.
Għal kanċer tas- sider u dak tal- pulmun li mhux ta ’ l- għamla ta ’ ċelluli żgħar, trid tingħata l - premedikazzjoni li tikkonsisti f’ corticsteroid orali, bħal dexamethasone 16 mg kuljum (e. g.
Cutaneous reactions
7 Reazzjonijiet fil- ġilda
Others
8 Oħrajn
Leukemia In the docetaxel, doxorubicin and cyclophosphamide (TAC) treated patients, the risk of delayed myelodysplasia or myeloid leukemia requires haematological follow-up.
Lewkimja Fil- pazjenti ittrattati b ’ docetaxel, doxorubicin u cyclophosphamide (TAC), ir- riskju li jiżviluppaw myelodysplasia jew lewkimija tat- tip myeloid, fit- tard, jirrikjedi l- immoniterjar ematoloġiku wara t - trattament.
Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Minn 333 pazjent ittrattati b ’ docetaxel kull tliet ġimgħat fi studju fiq il- kanċer tal- prostata, 209 pazjent kellhom 65 sena jew aktar u 68 pazjent kienu akbar minn 75 sena.
Among the 300 (221 patients in the phase III part of the study and 79 patients in the phase II part) patients treated with docetaxel in combination with cisplatin and 5-fluorouracil in the gastric cancer study, 74 were 65 years of age or older and 4 patients were 75 years of age or older.
Fost 300 pazjent (li 221 minnhom kienu fil fażi III ta ’ l- istudju u 79 pazjent fil- fażi II) ittrattati b ’ docetaxel flimkien ma ’ cisplatin u 5- fluorouracil fl- istudju fuq il- kanċer ta ’ l- istonku, 74 pazjenti kellhom 65 sena jew aktar u 4 pazjenti kellhom 75 sena jew aktar.
Although the possible in vivo interaction of docetaxel with concomitantly administered medication has not been investigated formally, in vitro interactions with tightly protein-bound agents such as erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole and sodium valproate did not affect protein binding of docetaxel.
Għalkemm il- possibbiltà t’ interazzjoni in vivo ta ’ docetaxel ma ’ mediċini oħra li ngħatat konkomittantement ma kienux investigati formalment, l- interazzjonijiet in- vitro b’ sustanzi li huma marbuta sew mal- proteina bħal erythromycin, diphenhydramine, propranolol, propafenone, phenytoin, salicylate, sulfamethoxazole, u sodium valproate, m’ effetwawx ir- rabta ta ’ docetaxel mal- proteina; hekk ukoll dexamethasone m’ effetwawx l -
In addition, dexamethasone did not affect protein binding of docetaxel.
9 effetti fuq ir- rabta ta ’ Docetaxel mal- proteina.
9 • 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).
These reactions were described using the NCI Common Toxicity Criteria (grade 3 = G3; grade 3-4 = G3/ 4; grade 4 = G4) and the COSTART terms.
10 Dawn ir- reazzjonijiet kienu deskritti bl- użu ta ’ NCI Kriterji ta ’ Tossiċità Komuni (grad 3 = G3; grad 3- 4 = G3/ 4; grad 4 = G4) u t- terminoloġija COSTART.
The following adverse reactions are frequently observed with docetaxel:
Ir- reazzjonijiet avversi li jmissu huma ikkaġunati spiss b ’ docetaxel:
TAXOTERE 100 mg/ m² single agent
11 TAXOTERE 100 mg/ m2 bħala sustanza użata waħedha:
MedDRA System Organ classes Investigations
Sistema tal- Klassifika tal -
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 avveris mhux komuni ≥ 0. 1
0.7%)
0. 7%) Tromboċitopenija
Blood and lymphatic system disorders
Disturbi tad- demm u tas -
Thrombocytopenia (G4:
0. 2%)
Peripheral sensory neuropathy (G3:
Disturbi fis- sistema nervuża Newropatija periferika tas- sensazzjoni (G3:
Respiratory, thoracic and mediastinal disorders
0. 07%) Disturbi respiratorji, toraċiċi u medjastinali
5.3%); 0.2%); Diarrhoea (G3/ 4:
5. 3%); Dijarea (G3/ 4:
4%); Abdominal pain Nausea (G3/ 4:
4%); Tqalligħ (G3/ 4:
Oesophagitis (severe:
(severa: 0. 2%); Uġigħ ta ’ żaqq (sever:
1.4%) Arthralgia
1. 4%) Artralġja
Metabolism and
Disturbi fil- metaboliżmu u n- nutrizzjoni
Anorexia
Anoreksja Infezzjoni assoċjata
11
4. 6%)
MedDRA System Organ classes nutrition disorders
12 Sistema tal- Klassifika tal -
Very common adverse reactions ≥ 10% of patients
Reazzjonijiet avversi Reazzjonijiet avveris mhux komuni ≥ 0. 1
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
sa < 1% tal- pazjenti pazjenti
Infections and infestations
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn
Infections (G3/ 4:
Żamm tal- fluwidu (sever:
4.6%) 1.7%)
6. 5%);
Vascular disorders
Reazzjoni fis- sit ta ’ l - infuzjoni;
General disorders and administration site conditions
jingħata
(severe:
Uġigħ fis- sider, mhux dak tal- qalb (sever:
Nervous system disorders Reversibility data are available among 35.3% of patients who developed neurotoxicity following docetaxel treatment at 100 mg/ m² as single agent.
Data ta ’ riversibbiltà hija disponibbli f’ 35. 3% tal- pazjenti li żviluppaw newrotossiċità wara t - trattament b ’ docetaxel waħdu f’ doża ta ’ 100 mg/ m².
12 TAXOTERE 75 mg/ m² single agent
TAXOTERE 75 mg/ m² bħala sustanza użata waħedha:
MedDRA System Organ classes
Sistema tal- Klassifika tal -
Very common adverse reactions ≥ 10% of patients
Reazzjonijiet avversi komuni ≥ 1 sa < 10% tal- pazjenti
Common adverse reactions ≥ 1 to < 10% of patients
komuni ħafna ≥ 10% tal- pazjenti
Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders
Disturbi fil- ġilda u fit - tessuti ta ’ taħt il- ġilda
Metabolism and nutrition disorders
13 Sistema tal- Klassifika tal -
Infections and infestations Vascular disorders General disorders and administration site conditions
Disturbi vaskulari Infezzjonijiet u infestazzjonijiet Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
5%) Asthenia (severe:
5%) Astenja (severa:
13 TAXOTERE 75 mg/ m² in combination with doxorubicin
TAXOTERE 75 mg/ m² użat flimkien ma ’ doxorubicin:
MedDRA System Organ classes
Sistema tal- Klassifika tal- Organi fid- Database
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients
Reazzjonijiet avversi komuni ħafna
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Reazzjonijiet avversi komuni ≥ 1 to < 10% tal -
Investigations
≥ 10% tal- pazjenti
Cardiac disorders
G3/ 4 Żieda fl- alkaline G3/ 4 Żieda fl- ALT phosphatase fid- demm (< 1%) (< 2. 5%) Disturbi fil- qalb
Nervous system disorders
Newropatija periferika Disturbi fis- sistema
Peripheral sensory Peripheral motor neuropathy (G3:
Newropatija periferika
0.4%) neuropathy (G3/ 4:
tal- movimenti (G3/ 4:
0.4%)
nervuża
Gastrointestinal disorders
tas- sensazzjoni (G3:
Nausea (G3/ 4:
0. 4%)
5%); Stomatitis (G3/ 4:
0. 4%)
7.8%); Diarrhoea (G3/ 4:
5%); Stomatite (G3/ 4:
6.2%); Vomiting (G3/ 4:
6. 2%); Rimettar (G3/ 4:
5%); Constipation
5%); Stitikezza
Infections and infestations
Reazzjonijiet avversi mhux
Infusion site reaction 8.1%); Fluid retention (severe:
8. 1%); Żamm tal- fluwidu (sever: 1. 2%); Uġigħ
1.2%); Pain
Reazzjoni fis- sit ta ’ l - infuzjoni
14 TAXOTERE 75 mg/ m² in combination with cisplatin
TAXOTERE 75 mg/ m² użat flimkien ma ’ cisplatin:
Very common adverse reactions ≥ 10% of patients
Reazzjonijiet Avversi komuni ≥ 1 to < 10% tal -
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
komuni ≥ 0. 1 to < 1% tal - pazjenti
Metabolism and nutrition disorders
Disturbi fil- metaboliżmu u Anoreksja n- nutrizzjoni Infezzjonijiet u infestazzjonijiet
Vascular disorders
komuni ≥ 0. 1 to < 1% tal - pazjenti
15 TAXOTERE 100 mg/ m² in combination with trastuzumab
TAXOTERE 100 mg/ m² użat flimkien ma ’ trastuzumab:
Common adverse reactions ≥ 1 to < 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 - sistema limfatika
32%); Febrile neutropenia (includes neutropenia associated with fever and antibiotic use) or neutropenic sepsis
32%); Newtropenija bid- deni (tinkludi n -
Paresthesia; Headache; Dysgeusia; Hypoaesthesia
newtropenija assoċjata mad- deni u l - użu ta ’ l- antibijotiċi) jew newtropenija bis- sepsis Disturbi fis- sistema nervuża Parasteżija; Ugigħ ta ’ ras; Disgewżja; Ipoestesija Disturbi fl- għajnejn Disturbi repiratorji, toraċiċi u medjastinali
Epistaxis; Pharyngolaryngeal pain; Nasopharyngitis; Dyspnoea; Cough; Rhinorrhoea
Tidmigħ miżjud; Konġuntivite Fġir l- imnieħer; Uġigh fil farinġi u l - larinġi; Farinġite tal- parti nażali; Qtugħ ta ’ nifs; Sogħla; Tnixxija mill - imnieħer
Vascular disorders
Disturbi muskolu- skeletrali u Majalġja; Artralġja; Uġigħ fl - tal- connective tissue
Lymphoedema
estremitajiet; Uġigħ fl- għadam; Uġigħ tad- dahar
General disorders and administration site conditions
Disturbi fil- metaboliżmu u n - Anoreksja nutrizzjoni Disturbi vaskulari Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Edima limfatika 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 docetaxel flimkien ma ’ trastuzumab meta mqabbel ma ’ 0% tal- pazjenti li ngħataw docetaxel 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 docetaxel intuża flimkien ma ’ trastuzumab, 64% kienu ħadu qabel anthracycline bħala terapija miżjuda, meta mqabbel ma ’ 55% tal- fergħa ta ’ docetaxel biss.
Blood and lymphatic system disorders Very common:
16 Disturbi tad- demm u tas- sistema limfatika:
16 TAXOTERE 75 mg/ m² in combination with capecitabine
TAXOTERE 75 mg/ m² użat flimkien ma ’ capecitabine:
Very common adverse reactions ≥ 10% of patients
Reazzjonijiet Avversi komuni ≥ 1 to < 10% tal- pazjenti
3%)
3%) Sturdament;
Dysgeusia (G3/ 4: < 1%); Paraesthesia (G3/ 4: < 1%)
Disturbi fis- sistema nervuża Disgewżja (G3/ 4: < 1%); Uġigħ ta ’ ras (G3/ 4: < 1%); Parasteżija (G3/ 4: < 1%) Newropatija periferika Disturbi fl- għajnejn
1%); Cough (G3/ 4: < 1%); Epistaxis (G3/ 4: < 1%)
1%); Sogħla (G3/ 4: < 1%); Fġir l- imnieħer (G3/ 4: < 1%) Uġigh fil- parti ta ’ fuq taż- żaqq;
Skin and subcutaneous tissue disorders
tessuti ta ’ taħt il- ġilda
Musculoskeletal and connective tissue disorders Metabolism and nutrition disorders Infections and infestations
Disturbi muskolu- skeletral u tal- connective tissue
Pain in extremity (G3/ 4: < 1%); Back pain (G3/ 4:
Uġigħ fl- estremitajiet (G3/ 4: < 1%); Uġigħ tad- dahar (G3/ 4:
1%) Dehydration (G3/ 4:
1%);
General disorders and administration site conditions
Disturbi fil- metaboliżmu u n- nutrizzjoni Infezzjonijiet u infestazzjonijiet Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Asthenia (G3/ 4:
Anoreksja( G3/ 4:
3%); Pyrexia (G3/ 4:
3%); Deni (G3/ 4:
Lethargy; Pain
2%); Candidiasis orali( G3/ 4: < 1%) Letarġija; Uġigħ
17 TAXOTERE 75 mg/ m² in combination with prednisone or prednisolone
17 TAXOTERE 75 mg/ m² użat flimkien ma ’ prednisone jew prednisolone:
0.6%); Febrile neutropenia
0. 6%); Newtropenija bid- deni Newropatija periferika tal -
Peripheral sensory neuropathy (G3/ 4:
Disturbi fis- sistema nervuża Newropatija periferika tas - movimenti (G3/ 4:
0%)
0%) sensazzjoni (G3/ 4:
Peripheral motor neuropathy (G3/ 4:
1. 2%); Disgewzja (G3/ 4:
0%)
0%) Disturbi fl- għajnejn Disturbi respiratorji, toraċiċi u medjastinali
0.9%); Vomiting (G3/ 4:
Raxx esfoljattiv (G3/ 4:
1.2%)
0. 3%)
Skin and subcutaneous tissue disorders Musculoskeletal and connective bone disorders Metabolism and nutrition disorders
Disturbi fil- ġilda u fitt - tessuti ta ’ taħt il- ġilda
Alopecia; Nail disorders (no severe) Anorexia (G3/ 4:
Alopeċja; Mard tad- dwiefer (mhux sever)
0.6%)
Disturbi muskolu- skeletrali u tal- connective tissue Disturbi fil- metaboliżmu u n- nutrizzjoni
Exfoliative rash (G3/ 4:
0. 6%)
Infections and infestations General disorders and administration site conditions Immune system disorders
Infezzjonijiet u infestazzjonijiet Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
18 TAXOTERE 75 mg/ m² in combination with doxorubicin and cyclophosphamide
TAXOTERE 75 mg/ m² użat flimkien ma ’ doxorubicin u cyclophosphamide:
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Reazzjonijiet Avversi komuni ≥ 1 to < 10% tal - pazjenti
Nervous system disorders
Sistema tal- Klassifika tal- Organi fid - Database MedDRA
Dysgeusia (G3/ 4:
Reazzjonijiet Avversi komuni ħafna ≥ 10% tal- pazjenti
Peripheral motor 0.7%); neuropathy (G3/ 4:
Reazzjonijiet Avversi komuni ≥ 1 to < 10% tal - pazjenti Newropatija periferika
0%); Peripheral sensory Neurocortical (G3/ 4: neuropathy (G3/ 4:
Reazzjonijiet Avversi mhux komuni ≥ 0. 1 to < 1% tal- pazjenti Sinkope (G3/ 4:
Gastrointestinal disorders
toraċiċi u medjastinali Disturbi gastro - intestinali
Stomatitis (G3/ 4:
4. 3%); Dijarrea (G3/ 4:
Alopecia; Skin toxicity (G3/ 4:
0. 7%); Mard tad- dwiefer (G3/ 4:
0.7%); Nail disorders (G3/ 4:
0. 4%)
2.2%)
2. 2%)
3.2%); Neutropenic infection.
3. 2%); Infezzjoni assoċjata man- newtropenija.
Vascular disorders
Disturbi vaskulari Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Cardiac disorders
19 Disturbi fil- qalb:
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.
Disturbi fis- sistema riproduttiva u fis- sider:
20 TAXOTERE 75 mg/ m² in combination with cisplatin and 5-fluorouracil for gastric adenocarcinoma cancer
TAXOTERE 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
21 TAXOTERE 75 mg/ m² in combination with cisplatin and 5-fluorouracil for Head and Neck cancer
TAXOTERE 75 mg/ m² użat flimkien ma ’ cisplatin and 5- fluorouracil (għal kanċer tar- ras u ta ’ l - għonq):
MedDRA System Organ classes Investigations
Sistema tal- Klassifika tal - Organi fid- Database MedDRA Investigazzjonijiet
Very common adverse Common adverse reactions reactions ≥ 10% of patients ≥ 1 to < 10% of patients Weight increased
Reazzjonijiet Avversi komuni ħafna ≥ 10% tal- pazjenti
Uncommon adverse reactions ≥ 0.1 to < 1% of patients
Reazzjonijiet Avversi komuni ≥ 1 to < 10% tal - pazjenti Żieda fil- piż
Cardiac disorders Blood and lymphatic system disorders
Disturbi fil- qalb
Myocardial ischemia (G3/ 4:1.7%) Neutropenia (G3/ 4:
Mard iskemiku tal - mijokardju (G3/ 4: 1. 7%); Arritmija Newtropenija bid- deni
Febrile neutropenia 76.3%); Anemia (G3/ 4:
Newtropenija (G3/ 4:
9.2%); Thrombocytopenia (G3/ 4:
76. 3%); Anemija (G3/ 4:
Arrhythmia (G3/ 4:
9. 2%); Tromboċitopenija (G3/ 4:
0.6%)
5. 2%)
Nervous system disorders
Disgewżja / Parosmja; Sturdament Disturbi fis- sistema nervuża
Dysgeusia/ Parosmia; Dizziness Peripheral sensory neuropathy (G3/ 4:
Newropatija periferika tas- sensazzjoni (G3/ 4:
Lacrimation increased; Conjunctivitis
Tidmigħ miżjud; Konġuntivite
0.6%); Constipation; Stomatitis (G3/ 4:
21 Sistema tal- Klassifika tal - Reazzjonijiet Avversi Reazzjonijiet Avversi Organi fid- Database komuni ħafna komuni MedDRA ≥ 10% tal- pazjenti ≥ 1 to < 10% tal - pazjenti Stitikezza; Disturbi gastro- intestinali Tqalligħ (G3/ 4:
Esophagitis/ dysphagia/ 4.0%); odynophagia (G3/ 4:
Esofaġite/ disfaġja / 0. 6%); odinofaġja (G3/ 4:
Diarrhea (G3/ 4:
Stomatite (G3/ 4:
2.9%); 0.6%); Vomiting (G3/ 4:
0. 6%); 4. 0%); Dijarrea (G3/ 4:
0.6%)
2. 9%); Uġigħ addominali; Rimettar (G3/ 4:
Alopecia (G3/ 4:
0. 6%) Dispepsja; Emoraġija gastrointestinali (G3/ 4:
0.6%)
0. 6%) Disturbi fil- ġilda u fit - Alopeċja (G3/ 4:
Musculoskeletal and connective tissue disorders
Raxx bil- ħakk; tessuti ta ’ taħt il- ġilda 10. 9%) Ġilda xotta; Ġilda esfoljattiva (G3/ 4:
0.6%)
0. 6%) Disturbi muskolu- skeletrali Majalġja (G3/ 4:
0.6%)
0. 6%) u tal- connective tissue Disturbi fil- metaboliżmu u Anoreksja (G3/ 4: n- nutrizzjoni 0. 6%) Infezzjonijiet u Infezzjoni (G3/ 4: infestazzjonijiet 6. 3%); Infezzjoni bin - newtropenija Uġigh tal- kanċer (G3/ 4:
0.6%)
Neoplażmi beninni, 0. 6%) malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Disturbi vaskulari Disturbi fil- vini (G3/ 4:
Lethargy (G3/ 4:
0. 6%) Letarġija (G3/ 4:
3.4%); Pyrexia (G3/ 4:
Disturbi ġenerali u 3. 4%); kondizzjonijiet ta ’ mnejn Deni (G3/ 4:
0.6%); Fluid retention; Oedema
0. 6%); jingħata Żamm tal- fluwidu; Edima Disturbi fis- sistema Sensittività eċċessiva immuni (mhux severa)
Hypersensitivity (no severe)
Reazzjonijiet Avversi mhux komuni ≥ 0. 1 to < 1% tal- pazjenti
22
22 • Kimoterapija Induttiva segwita bi kimoradjuterapija (TAX324)
MedDRA System Organ classes
Sistema tal- Klassifika tal- Organi fid - Database MedDRA Investigazzjonijiet Disturbi fil- qalb
Very common adverse reactions ≥ 10% of patients
Reazzjonijiet Avversi komuni ħafna ≥ 10% tal- pazjenti Tnaqqis fil- piż
Arrhythmia (G3/ 4:
Reazzjonijiet Avversi komuni ≥ 1 to < 10% tal - pazjenti Arritmija (G3/ 4:
Weight increased Ischemia myocardial
Reazzjonijiet Avversi mhux komuni ≥ 0. 1 to < 1% tal - pazjenti Żieda fil- piż Mard iskemiku tal - mijokardju
12.4%); Thrombocytopenia (G3/ 4:
2. 0%)
4.0%); Febrile neutropenia
Newropatija periferika
0.4%); Peripheral sensory neuropathy (G3/ 4:
0. 4%); Newropatija periferika tas - sensazzjoni (G3/ 4:
Dizziness (G3/ 4:
tal- movimenti (G3/ 4:
Eye disorders Ear and labyrinth disorders
Disturbi fl- għajnejn Disturbi fil- widnejn u fis- sistema labirintika
Lacrimation increased
Tidmigħ miżjud Dispepsja (G3/ 4:
0.8%); Gastrointestinal pain (G3/ 4:
0. 4%)
1.2%); Gastrointestinal haemorrhage (G3/ 4:
Alopeċja (G3/ 4:
0.4%)
4. 0%); Raxx bil- ħakk
Skin and subcutaneous tissue disorders Musculoskeletal, connective tissue bone disorders
Disturbi muskolu - skeletrali u tal - connective tissue Disturbi fil - metaboliżmu u n - nutrizzjoni
Alopecia (G3/ 4:
Anoreksja (G3/ 4:
4.0%); Rash pruritic
12. 0%)
0.4%)
Majalġja (G3/ 4:
Anorexia (G3/ 4:
0. 4%)
Infections and infestations
Infezzjonijiet u infestazzjonijiet Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi)
3.6%)
3. 6%)
Cancer pain (G3/ 4:
Infezzjoni bin - newtropenija Uġigh tal- kanċer (G3/ 4:
Vascular disorders General disorders and administration site conditions
23 Sistema tal- Klassifika tal- Organi fid - Database MedDRA Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata
Lethargy (G3/ 4:
Reazzjonijiet Avversi komuni ħafna ≥ 10% tal- pazjenti Letarġija (G3/ 4:
Venous disorder
Reazzjonijiet Avversi komuni ≥ 1 to < 10% tal - pazjenti
Post-marketing experience
L- esperjenza wara li tpoġġa
23
fis- suq:
Nervous system disorders Rare cases of convulsion or transient loss of consciousness have been observed with docetaxel administration.
Disturbi fis- sistema nervuża:
These reactions sometimes appear during the infusion of the medicinal product.
Każijiet rari ta ’ aċċessjonijiet jew telf temporanju mis- sensi kien innotat fl- ingħatar ta ’ docetaxel.
Clinical data
25 Tagħrif kliniku
TAXOTERE in combination with doxorubicin and cyclophosphamide: adjuvant therapy
TAXOTERE 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.
0.59-0.88
0. 59- 0. 88
0.70 0.53-0.91
0. 70
0.46-0.82 0.63-1.08
0. 46- 0. 82 0. 63- 1. 08
0.0009 0.17
0. 0009 0. 17
0.29-0.70 0.66-1.33
0. 29- 0. 70 0. 66- 1. 33
0.0002 0.72
0. 0002 0. 72
TAXOTERE as single agent
TAXOTERE meta jintuża waħdu
In alkylating-failure patients, docetaxel was compared to doxorubicin (75 mg/ m² every 3 weeks).
26 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 ta ’ grad 3/ 4 kienu innotati b ’ docetaxel bħala monoterapija (55. 4%) meta mqabbel ma ’ paclitaxel (23%).
26 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:
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.
TAXOTERE in combination with trastuzumab
27 TAXOTERE użat flimkien ma ’ trastuzumab
Parameter
Docetaxel 1
(months)
(25- 45) 5. 1
11.4
10. 6
5.1
5. 7
(95% CI) Median TTP (months) (95% CI) Median Survival (months)
(95% CI) Medjan ta ’ Sopravivenza
(9.2-15.0) 10.6 (7.6-12.9) 30.52
(7. 6- 12. 9) 30. 52
(4.4-6.2) 5.7 (5.0-6.5) 22.12
(5. 0- 6. 5) 22. 12
27 TAXOTERE in combination with capecitabine
TAXOTERE 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 cancer after failure of cytotoxic chemotherapy, including an anthracycline.
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.
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.
28 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.
TAXOTERE in combination with platinum agents in chemotherapy-naïve patients
TAXOTERE 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 id- 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.
28 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:
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 total of 1006 patients with KPS ≥ 60 were randomized to the following treatment groups: • Docetaxel 75 mg/ m2 every 3 weeks for 10 cycles. • Docetaxel 30 mg/ m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles. • Mitoxantrone 12 mg/ m2 every 3 weeks for 10 cycles.
Docetaxel75 mg/ m2 kull 3 ġimgħat għal 10 ċikli. •
29
95% CI