natgillin/translations-raw huggingface dataset:
Neutropaenia, thrombocytopaenia, and anaemia were the most frequently reported hematologic events reported with both combination therapy of Caelyx plus bortezomib and bortezomib monotherapy.
Nevtropenija, trombocitopenija in anemija so bili najpogosteje prijavljeni hematološki učinki tako pri kombinirani terapiji z zdravilom Caelyx in bortezomibom kot pri monoterapiji z bortezomibom.
5%).
Incidenca nevtropenije 3. in 4. stopnje je bila višja v skupini za prejemanje kombinirane terapije kot v skupini za monoterapijo (28% v primerjavi s 14%) in tudi incidenca trombocitopenije 3. in 4. stopnje je bila višja v skupini za kombinirano terapijo kot v skupini za monoterapijo (22% v primerjavi s 14%), medtem ko je bila incidenca anemije podobna v obeh terapevtskih skupinah (7% v primerjavi s 5%).
Stomatitis was reported more frequently in the combination therapy group (16%) than in the monotherapy group (3%), and most cases were grade 2 or less in severity.
O stomatitisu so poročali pogosteje v skupini za kombinirano zdravljenje (16%) kot v skupini za monoterapijo (3%), in večina primerov je bila po jakosti 2. stopnje ali manj.
No grade 4 stomatitis was reported.
Stomatitis 3. stopnje so prijavili pri 2% bolnikov v skupini za kombinirano zdravljenje, primerov stomatitisa 4. stopnje pa ni bilo.
Treatment discontinuation of one or both agents due to adverse events was seen in 38% of patients.
Do ukinitve zdravljenja enega ali obeh zdravil zaradi pojava neželenih učinkov je prišlo pri 38% bolnikov.
Common adverse events which led to treatment discontinuation of bortezomib and Caelyx included PPE, neuralgia, peripheral neuropathy, peripheral sensory neuropathy, thrombocytopaenia, decreased ejection fraction, and fatigue.
PPE, nevralgija, periferna nevropatija, periferna senzorična nevropatija, trombocitopenija, zmanjšana iztisna frakcija srca in utrujenost.
Treatment Related Undesirable Effects Reported in Multiple Myeloma Clinical Trial (Caelyx 30 mg/ m2 in combination with bortezomib every 3 weeks) by Severity, MedDRA System Organ Class and Preferred Term Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100) CIOMS III AE by body system
Z zdravljenjem povezani neželeni učinki, ki so jih prijavili v kliničnem preskušanju pri bolnikih z multiplim mielomom (zdravljenih z zdravilom Caelyx 30 mg/ m2 v kombinaciji z bortezomibom na vsake 3 tedne), razvrščeni po jakosti ter po organskih sistemih v skladu z MedDRA- o in navedeni po najprimernejšem izrazu iz MedDRA- e Zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100, < 1/ 10), občasni (≥ 1/ 1. 000, < 1/ 100) CIOMS III Neželeni učinki,
All Severities n=318
3. ali 4. stopnje **
Grades III/ IV** n=318
razvrščeni po
15 Infections and infestations Common Blood and lymphatic system disorders
Pogosti Bolezni krvi in limfatičnega sistema
Neutropaenia, thrombocytopaenia
nevtropenija, trombocitopenija
Common Metabolism and Nutrition disorders
Pogosti Presnovne in prehranske motnje
Leukopaenia
levkopenija
Anorexia
neješčnost
Dehydration, hypokalaemia, hyperkalaemia, hypomagnesaemia, hyponatraemia, hypocalcaemia
dehidracija, hipokaliemija, hiperkaliemija, hipomagneziemija, hiponatremija, hipokalcemija
Uncommon Psychiatric disorders
Občasni
Common Nervous system disorders
14 Psihiatrične motnje Pogosti Bolezni živčevja
Neuralgia, peripheral neuropathy, neuropathy
nevralgija, periferna nevropatija, nevropatija
Uncommon Eye disorders
Občasni
16 Respiratory, thoracic, and mediastinal disorders Common
Pogosti
Uncommon Gastrointestinal disorders
Občasni Bolezni prebavil
Nausea, diarrhoea, vomiting, constipation, stomatitis
slabost, driska, bruhanje, zaprtje, stomatitis
Abdominal pain, dyspepsia
trebušne bolečine, dispepsija
Nausea, diarrhoea, vomiting, stomatitis
slabost, driska, bruhanje, stomatitis
Uncommon Skin and subcutaneous tissue disorders
Občasni Bolezni kože in podkožja
PPE*, rash
PPE *, izpuščaj
Uncommon Musculoskeletal and connective tissue disorders
Občasni
Common Reproductive system and breast disorders
15 Bolezni mišično - skeletnega sistema in vezivnega tkiva Pogosti Motnje reprodukcije in dojk
17 Investigations Common
Pogosti
* Palmar-plantar erythrodysesthesia (Hand-foot syndrome). ** Grade 3/ 4 adverse events are based on the adverse event terms of all severities with an overall incidence ≥ 5% (see adverse events listed in first column).
* Palmarno- plantarna eritrodisestezija (sindrom rok in stopal). ** Navedeni neželeni učinki 3. ali 4. stopnje so navedeni s termini pogostnosti za neželene učinke vseh jakosti s splošno incidenco ≥ 5% (glejte neželene učinke, naštete v prvem stolpcu).
AIDS-KS program:
Raziskave pri bolnikih, ki imajo z aidsom povezan Kaposijev sarkom:
Clinical studies on AIDS-KS patients treated at 20 mg/ m2 with Caelyx show that myelosuppression was the most frequent undesirable effect considered related to Caelyx occurring very commonly (in approximately one-half of the patients).
Klinične raziskave pri teh bolnikih z zdravilom Caelyx v odmerku 20 mg/ m2 kažejo, da je najpogostnejši neželeni učinek, povezan z zdravilom, mielosupresija in se pojavlja zelo pogosto (pojavila se je pri približno polovici bolnikov).
Temporarily suspend Caelyx treatment in patients when the ANC count is < 1,000/ mm3 and/ or the platelet count is < 50,000/ mm3.
Zdravljenje z zdravilom Caelyx začasno prekinite pri bolnikih, ki imajo absolutno število nevtrofilcev < 1. 000/ mm3 in/ ali število trombocitov < 50. 000/ mm3.
G-CSF (or GM-CSF) may be given as concomitant therapy to support the blood count when the ANC count is < 1,000/ mm3 in subsequent cycles.
Kot sočasno zdravljenje za izboljšanje krvne slike lahko v primeru zmanjšanja absolutnega števila nevtrofilcev na < 1. 000/ mm3 med naslednjimi ciklusi uporabite G- CSF (ali GM- CSF).
Opportunistic infections (OI’ s) are observed in KS patients after administration with Caelyx, and are frequently observed in patients with HIV-induced immunodeficiency.
Pri bolnikih s Kaposijevim sarkomom se po prejemanju zdravila Caelyx pojavljajo oportunistične okužbe in so pogoste pri bolnikih z imunsko pomanjkljivostjo zaradi HIV.
The most frequently observed OI’ s in clinical studies were candidiasis, cytomegalovirus, herpes simplex, Pneumocystis carinii pneumonia, and mycobacterium avium complex.
V kliničnih raziskavah so najpogostnejše oportunistične okužbe kandidiaza, okužba s citomegalovirusom, herpes simpleks, pljučnica zaradi okužbe s Pneumocystis carinii in kompleks Mycobacterium avium.
Undesirable effects observed in patients with AIDS-KS according to CIOMS III frequency categories (Very common (> 1/ 10); Common (> 1/ 100 ,< 1/10); Uncommon (> 1/1 ,000, < 1/100)) were as follows:
KS, razporejeni po kategorijah pogostnosti v skladu s CIOMS III (zelo pogosti (> 1/ 10); pogosti (> 1/ 100, < 1/ 10); občasni (> 1/ 1. 000, < 1/ 100)), so bili naslednji:
Common: oral moniliasis
Pogosti: moniliaza ust
Very common: neutropaenia, anaemia, leukopaenia Common: thrombocytopaenia
Zelo pogosti: nevtropenija, anemija, levkopenija Pogosti: trombocitopenija Presnovne in prehranske motnje:
Uncommon: confusion
Občasni: zmedenost
Common: dizziness Uncommon: paresthesia
Pogosti: omotica Občasni: parestezije
Common: retinitis
Pogosti: retinitis
18 Common: vasodilatation
Pogosti: vazodilatacija
Common: dyspnoea
Pogosti: dispneja
Very common: nausea Common: diarrhoea, stomatitis, vomiting, mouth ulceration, abdominal pain, glossitis, constipation, nausea and vomiting
Zelo pogosti: slabost Pogosti: driska, stomatitis, bruhanje, razjede v ustih, trebušne bolečine, glositis, zaprtje, slabost in bruhanje
Common: alopecia, rash Uncommon: palmar-plantar erythrodysesthesia (PPE)
Pogosti: alopecija, izpuščaj Občasni: palmarno- plantarna eritrodisestezija (PPE)
Common: asthenia, fever, infusion-associated acute reactions
Pogosti: astenija, zvišana telesna temperatura, akutne reakcije povezane z infuzijami
Common: weight loss.
Pogosti: hujšanje
Clinically significant laboratory abnormalities frequently (≥ 5%) occurred including increases in alkaline phosphatase; AST and bilirubin which were believed to be related to the underlying disease and not Caelyx.
V kliničnih raziskavah zdravila Caelyx so bili pogosti (≥ 5%) klinično pomembni nenormalni laboratorijski izvidi, vključno z zvišanjem alkalne fosfataze ter zvišanjem AST in bilirubina, za katera pa menijo, da sta bila posledici osnovne bolezni in ne zdravila Caelyx.
Reduction in haemoglobin and platelets were less frequently (< 5%) reported.
Redkeje (< 5%) so poročali o zmanjšanju vrednosti hemoglobina in števila trombocitov.
All patients:
17 Vsi bolniki:
100 out of 929 patients (10.8%) with solid tumours were described as having an infusion-associated reaction during treatment with Caelyx as defined by the following Costart terms: allergic reaction, anaphylactoid reaction, asthma, face oedema, hypotension, vasodilatation, urticaria, back pain, chest pain, chills, fever, hypertension, tachycardia, dyspepsia, nausea, dizziness, dyspnoea, pharyngitis, rash, pruritus, sweating, injection site reaction and medicinal product interaction.
100 od 929 bolnikov (10, 8%) s solidnimi tumorji je imelo med zdravljenjem z zdravilom Caelyx infuzijsko reakcijo, kot jo opredeljujejo naslednji izrazi Costart: alergijska reakcija, anafilaktoidna reakcija, astma, edem obraza, hipotenzija, vazodilatacija, urtikarija, bolečine v hrbtu, bolečine v prsih, mrzlica, zvišana telesna temperatura, hipertenzija, tahikardija, dispepsija, slabost, omotica, dispneja, faringitis, izpuščaj, srbenje, znojenje, reakcija na mestu injekcije in medsebojno delovanje zdravil.
Permanent treatment discontinuation was infrequently reported at 2%.
O dokončni prekinitvi zdravljenja so poročali redko, t. j. le pri 2% bolnikov.
A similar incidence of infusion reactions (12.4%) and treatment discontinuation (1.5%) was observed in the breast cancer program.
Pri bolnicah z rakom dojk so poročali o podobni incidenci infuzijskih reakcij (12, 4%) in prekinitve zdravljenja (1, 5%).
In patients with multiple myeloma receiving Caelyx plus bortezomib, infusion-associated reactions have been reported at a rate of 3%.
Pri bolnikih z multiplim mielomom, ki so prejemali zdravilo Caelyx z bortezomibom, so infuzijske reakcije prijavljali s 3% pogostnostjo.
In patients with AIDS-KS, infusion-associated reactions, were characterised by flushing, shortness of breath, facial oedema, headache, chills, back pain, tightness in the chest and throat and/ or hypotension and can be expected at the rate of 5% to 10%.
Pri bolnikih s Kaposijevim sarkomom, povezanim z aidsom, so bili za infuzijske reakcije značilni rdečica, težko dihanje, edem obraza, glavobol, mrzlica, bolečine v hrbtu, tiščanje v prsih in žrelu in/ ali hipotenzija in te lahko pričakujete v 5 do 10% primerov.
In all patients, infusion associated reactions occurred primarily during the first infusion.
Pri vseh bolnikih so se infuzijske reakcije pojavilepredvsem med prvo infuzijo.
Infusion reactions rarely recur after the first treatment cycle with Caelyx (see section 4.2).
Infuzijske reakcije se po prvem ciklusu zdravljenja z zdravilom Caelyx ponovijo le redko (glejte poglavje 4. 2).
Myelosuppression associated with anaemia, thrombocytopaenia, leukopaenia, and rarely febrile neutropaenia, has been reported in Caelyx -treated patients.
Pri bolnikih, zdravljenih z zdravilom Caelyx, so poročali o mielosupresiji, povezani z anemijo, trombocitopeniji, levkopeniji in redko febrilni nevtropeniji.
It did not interfere with patients completing therapy and no dosage adjustments are generally required, unless stomatitis is affecting a patient’ s ability to eat.
Zaradi stomatitisa pa ni bilo treba predčasno prekiniti zdravljenja in praviloma ni potrebna prilagoditev odmerka zdravila, razen če stomatitis negativno vpliva na zmožnost bolnika za uživanje hrane.
In this case, the dose interval may be extended by 1 - 2 weeks or the dose reduced (see section 4.2).
V tem primeru lahko razmik med odmerki podaljšate za 1 do 2 tedna ali pa zmanjšate odmerek zdravila (glejte poglavje 4. 2).
19 An increased incidence of congestive heart failure is associated with doxorubicin therapy at cumulative lifetime doses > 450 mg/ m2 or at lower doses for patients with cardiac risk factors.
Zdravljenje z doksorubicinom v kumulativnem življenjskem odmerku > 450 mg/ m2 ali v manjšem odmerku pri bolnikih s kardialnimi dejavniki tveganja je povezano s povečano incidenco kongestivnega srčnega popuščanja.
Endomyocardial biopsies on nine of ten AIDS-KS patients receiving cumulative doses of Caelyx greater than 460 mg/ m2 indicate no evidence of anthracycline-induced cardiomyopathy.
Pri devetih od desetih bolnikov, ki so imeli z aidsom povezan Kaposijev sarkom in so prejeli kumulativni odmerek zdravila Caelyx nad 460 mg/ m2, endomiokardna biopsija ni pokazala nobenih znakov antraciklinske kardiomiopatije.
The recommended dose of Caelyx for AIDS-KS patients is 20 mg/ m2 every two-to-three weeks.
Priporočeni odmerek zdravila Caelyx za bolnike, ki imajo z aidsom povezan Kaposijev sarkom, je 20 mg/ m2 na vsaka dva do tri tedne.
The cumulative dose at which cardiotoxicity would become a concern for these AIDS-KS patients (> 400 mg/ m2) would require more than 20 courses of Caelyx therapy over 40 to 60 weeks.
Za kumulativni odmerek, pri katerem bi kardiotoksičnost postala problem pri teh bolnikih (> 400 mg/ m2), bi bilo potrebnih več kot 20 ciklusov zdravljenja zdravilom Caelyx v času 40 do 60 tednov.
In addition, endomyocardial biopsies were performed in 8 solid tumour patients with cumulative anthracycline doses of 509 mg/ m2 – 1,680 mg/ m2.
Poleg tega so endomiokardno biopsijo opravili tudi pri 8 bolnikih s solidnimi tumorji s kumulativnimi odmerki antraciklinov od 509 do 1. 680 mg/ m2.
These grading scores are consistent with no or mild cardiac toxicity.
Razpon stopnje kardiotoksičnosti po Billinghamu je bil od 0 do 1, 5, kar pomeni odsotnost kardiotoksičnosti ali le blago kardiotoksičnost.
In the pivotal phase III trial versus doxorubicin, 58/ 509 (11.4%) randomized subjects (10 treated with Caelyx at a dose of 50 mg/ m2/ every 4 weeks versus 48 treated with doxorubicin at a dose of 60 mg/ m2/ every 3 weeks) met the protocol-defined criteria for cardiac toxicity during treatment and/ or follow-up.
V osrednji raziskavi 3. faze, v kateri so zdravilo Caelyx primerjali s standardnim doksorubicinom, je 58 od 509 (11, 4%) randomiziranih preiskovancev (od tega jih je bilo 10 zdravljenih z zdravilom Caelyx v odmerku 50 mg/ m2 na vsake 4 tedne in 48 s standardnim doksorubicinom v odmerku 60 mg/ m2 na vsake 3 tedne) izpolnjevalo kriterije kardiotoksičnosti po protokolu, med zdravljenjem in/ ali med spremljanjem po zdravljenju.
None of the 10 Caelyx subjects who had cardiac toxicity by LVEF criteria developed signs and symptoms of CHF.
Noben od 10 bolnikov na Caelyxu, ki je imel kardiotoksičnost po merilih iztisnega deleža, ni dobil znakov ali simptomov kongestivnega srčnega popuščanja.
In contrast, 10 of 48 doxorubicin subjects who had cardiac toxicity by LVEF criteria also developed signs and symptoms of CHF.
V nasprotju s tem pa je 10 od 48 bolnikov na standardnem doksorubicinu, ki so imeli kardiotoksičnost po merilih iztisnega deleža, dobilo tudi znake in simptome kongestivnega srčnega popuščanja.
In patients with solid tumours, including a subset of patients with breast and ovarian cancers, treated at a dose of 50 mg/ m2/ cycle with lifetime cumulative anthracycline doses up to 1,532 mg/ m2, the incidence of clinically significant cardiac dysfunction was low.
Pri bolnikih s solidnimi tumorji, vključno s podskupino bolnic z rakom dojk ali rakom jajčnikov, zdravljenih z odmerkom 50 mg/ m2 na ciklus z življenjskimi kumulativnimi odmerki antraciklinov do
Of the 418 patients treated with Caelyx 50 mg/ m2/ cycle, and having a baseline measurement of left ventricular ejection fraction (LVEF) and at least one follow-up measurement assessed by MUGA scan, 88 patients had a cumulative anthracycline dose of > 400 mg/ m2, an exposure level associated with an increased risk of cardiovascular toxicity with conventional doxorubicin.
Pri 418 bolnikih, zdravljenih z zdravilom Caelyx v odmerku 50 mg/ m2 na ciklus, pri katerih so opravili meritev vrednosti iztisnega deleža levega prekata na začetku raziskave in vsaj eno kontrolno meritev s slikanjem MUGA, jih je 88 prejelo kumulativni odmerek antraciklina > 400 mg/ m2 - to je količina, ki je bila pri standardnih pripravkih doksorubicina povezana z večjim tveganjem za pojav kardiovaskularne toksičnosti.
Furthermore, only 1 patient (cumulative anthracycline dose of 944 mg/ m2), discontinued study treatment because of clinical symptoms of congestive heart failure.
Poleg tega je le 1 bolnik (ki je dobil kumulativni odmerek antraciklina 944 mg/ m2) prekinil zdravljenje v raziskavi zaradi kliničnih simptomov kongestivnega srčnega popuščanja.
Although local necrosis following extravasation has been reported very rarely, Caelyx is considered to be an irritant.
Čeprav so o lokalni nekrozi po ekstravazaciji poročali zelo redko, Caelyx velja za dražečo snov.
If any signs or symptoms of extravasation occur (e. g., stinging, erythema) terminate the infusion immediately and restart in another vein.
Če se pojavijo kakršnikoli znaki ali simptomi ekstravazacije (npr. občutek zbadanja, eritem), je treba infundiranje nemudoma prekiniti in infuzijo nastaviti na drugi veni.
The application of ice over the site of extravasation for approximately 30 minutes may be helpful in alleviating the local reaction.
Približno 30- minutno polaganje ledu na mesto ekstravazacije lahko pomaga ublažiti lokalno reakcijo.
Recall of skin reaction due to prior radiotherapy has rarely occurred with Caelyx administration.
Med uporabo zdravila Caelyx se je v redkih primerih pojavila spominska kožna reakcija na predhodno obsevani koži.
Following the marketing of Caelyx, serious skin conditions including erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis have been reported very rarely.
V okviru postmarketinških izkušenj z zdravilom Caelyx so zelo redko poročali o resnih kožnih boleznih, vključno z multiformnim eritemom, Stevens- Johnsonovim sindromom in toksično epidermalno nekrolizo.
In patients treated with Caelyx, cases of venous thromboembolism, including thrombophlebitis, venous thrombosis and pulmonary embolism have been seen uncommonly.
Pri bolnikih, zdravljenih z zdravilom Caelyx, so občasno opažali primere venskih tromboembolizmov, vključno s tromboflebitisom, vensko trombozo in pljučno embolijo.
However, because patients with cancer are at increased risk for thromboembolic disease, a causal relationship cannot be determined.
Ker pa imajo bolniki z rakom že sicer povečano tveganje za tromboembolično bolezen, ni mogoče ugotoviti vzročne povezanosti z zdravilom.
20 Acute overdosing with doxorubicin hydrochloride worsens the toxic effects of mucositis, leukopaenia and thrombocytopaenia.
Akutno preveliko odmerjanje doksorubicinijevega klorida poslabša toksične učinke: mukozitis, levkopenijo in trombopenijo.
Cytotoxic agents (anthracyclines and related substances), ATC code:
Farmakoterapevtska skupina: citotoksična zdravila (antraciklinski antibiotiki in sorodne učinkovine), oznaka ATC:
A phase III randomized study of Caelyx versus doxorubicin in patients with metastatic breast cancer was completed in 509 patients.
19 Randomizirano raziskavo 3. faze, v kateri so zdravilo Caelyx primerjali s standardnim doksorubicinom pri bolnikih z metastatskim rakom dojk, je zaključilo 509 bolnikov.
The protocol-specified objective of demonstrating non-inferiority between Caelyx and doxorubicin was met, the hazard ratio (HR) for progression-free survival (PFS) was 1.00 (95% CI for HR=0.82 - 1.22).
Razmerje med tveganji (HR) za preživetje brez napredovanja bolezni (PFS) je bilo 1, 00 (95% interval zaupanja za HR= 0, 82 do 1, 22).
The treatment HR for PFS when adjusted for prognostic variables was consistent with PFS for the ITT population.
Terapevtski HR za PFS, korigiran z upoštevanjem prognostičnih spremenljivk, je bil v skladu z vrednostjo PFS za populacijo, ki naj bi jo zdravili ("intent- to- treat").
The primary analysis of cardiac toxicity showed the risk of developing a cardiac event as a function of cumulative anthracycline dose was significantly lower with Caelyx than with doxorubicin (HR=3.16, p < 0.001).
Primarna analiza kardiotoksičnosti je pokazala, da je tveganje za kardialne sopojave kot funkcija kumulativnega odmerka antraciklina bistveno manjše pri zdravilu Caelyx kot pri standardnem doksorubicinu (HR = 3, 16, p < 0, 001).
At cumulative doses greater than 450 mg/ m2 there were no cardiac events with Caelyx.
Pri kumulativnih odmerkih, večjih od 450 mg/ m2, ni bilo pri zdravilu Caelyx nobenih kardialnih sopojavov.
A phase III comparative study of Caelyx versus topotecan in patients with epithelial ovarian cancer following the failure of first-line, platinum based chemotherapy was completed in 474 patients.
Pri 474 bolnicah z epitelijskim rakom jajčnikov, pri katerih prvo zdravljenje s platinsko kemoterapijo ni bilo uspešno, so opravili primerjalno študijo tretje faze, v kateri so primerjali zdravilo Caelyx in topotekan.
There was a benefit in overall survival (OS) for Caelyx-treated patients over topotecan-treated patients as indicated by a hazard ratio (HR) of 1.216 (95% CI; 1.000, 1.478), p=0.050.
Ugotovili so ugoden učinek zdravila v smislu daljšega skupnega preživetja pri bolnicah, zdravljenih z zdravilom Caelyx, od tistega pri bolnicah, zdravljenih s topotekanom, kot je pokazala vrednost razmerja med tveganji (HR) 1, 216 (95% IZ; 1, 000, 1, 478), p=0, 050.
The survival rates at 1, 2 and 3 years were 56.3%, 34.7% and 20.2% respectively on Caelyx, compared to 54.0%, 23.6% and 13.2% on topotecan.
Stopnje preživetja za Caelyx po 1 letu so bile 56, 3%, po 2 letih 34, 7% in po 3 letih 20, 2%, v primerjavi z ustreznimi stopnjami za topotekan, ki so bile 54, 0%, 23, 6% in 13, 2%.
HR of 1.432 (95% CI; 1.066, 1.923), p=0.017.
V podskupini bolnic z rakom, ki se je odzival na platinsko kemoterapijo, pa je bila ta razlika večja: razmerje med tveganji (HR) je bilo 1, 432 (95% IZ; 1, 066, 1, 923), p=0, 017.
The survival rates at 1, 2 and 3 years were 74.1%, 51.2% and 28.4% respectively on Caelyx, compared to 66.2%, 31.0% and 17.5% on topotecan.
Stopnje preživetja za Caelyx so bile po 1 letu 74, 1%, po 2 letih 51, 2% in po 3 letih 28, 4%, v primerjavi z ustreznimi stopnjami za topotekan, ki so bile 66, 2%, 31, 0% in 17, 5%.
HR of 1.069 (95% CI; 0.823, 1.387), p=0.618.
Terapija je bila podobna v podskupini bolnic z rakom, ki se ni odzival na platinsko kemoterapijo: razmerje med tveganji (HR) je bilo 1, 069 (95% IZ; 0, 823, 1, 387), p=0, 618.
The survival rates at 1, 2 and 3 years were 41.5%, 21.1% and 13.8% respectively on Caelyx, compared to 43.2%, 17.2% and 9.5% on topotecan.
Stopnje preživetja za Caelyx so bile po 1 letu 41, 5%, po 2 letih 21, 1% in po 3 letih 13, 8%, v primerjavi z ustreznimi stopnjami za topotekan, ki so bile 43, 2%, 17, 2% in 9, 5%.
A phase III randomized, parallel-group, open-label, multicentre study comparing the safety and efficacy of Caelyx plus bortezomib combination therapy with bortezomib monotherapy in patients with multiple myeloma who have received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy, was conducted in 646 patients.
Pri 646 bolnikih je bila opravljena randomizirana, odprta, multicentrična študija III. faze pri vzporednih skupinah za primerjavo varnosti in učinkovitosti kombinirane terapije z zdravilom Caelyx in bortezomibom in monoterapije z bortezomibom pri bolnikih z multiplim mielomom, ki so prejeli najmanj eno predhodno terapijo in pri katerih bolezen ni napredovala med prejemanjem antraciklinske terapije.