FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant submitted data from one bioequivalence study of diclofenac epolamine tablets vs. Flector granules for oral solution in healthy volunteers under fasted conditions.
Croatian: Podnositelj zahtjeva dostavio je podatke iz jednog ispitivanja bioekvivalencije tableta diklofenak epolamina s granulama Flector za oralnu otopinu u zdravih dobrovoljaca u stanju gladovanja.
English: This was a single-dose openlabel randomised 2x2 crossover study of acceptable design.
Croatian: To je bilo jednodozno otvoreno randomizirano unakrsno ispitivanje s prihvatljivim planom izvedbe.
English: One study demonstrating the bioequivalence of diclofenac epolamine tablets vs. Flector (diclofenac epolamine) granules for oral solution in healthy volunteers in the fasted state was submitted by the applicant in support of this MAA.
Croatian: U prilog zahtjevu za odobrenje za stavljanje u promet lijeka podnositelj zahtjeva podnio je jedno ispitivanje koje pokazuje bioekvivalenciju tableta diklofenak epolamin s granulama Flector (diklofenak epolamin) za oralnu otopinu u zdravih dobrovoljaca u stanju gladovanja.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Croatian: Put primjene Unutarnje pakovanje Veličina pakovanja
English: Benefit-risk assessment and discussion
Croatian: Procjena koristi i rizika i rasprava
English: The heterogeneity could also play a role in the two studies.
Croatian: Heterogenost bi također mogla imati važnu ulogu u tim dvama ispitivanjima.
English: The therapeutic indication of Lartruvo is:
Croatian: Terapijska indikacija za lijek Lartruvo glasi:
English: The EC requested the CHMP to give its opinion on whether the marketing authorisation for this product should be maintained, varied, suspended or revoked.
Croatian: Europska komisija zatražila je od CHMP-a da iznese svoje mišljenje o tome treba li odobrenje za stavljanje u promet ovog lijeka zadržati, izmijeniti, obustaviti ili opozvati.
English: Unfavourable effects
Croatian: Nepovoljni učinci
English: Even the post-discontinuation therapy is balanced.
Croatian: Čak je i terapija nakon prekida liječenja uravnotežena.
English: All anaphylactic reactions occurred during the first olaratumab infusion.
Croatian: Sve anafilaktičke reakcije dogodile su se tijekom prve infuzije olaratumaba.
English: However, this remains higher in the investigational arm.
Croatian: Međutim, stopa je i dalje viša u ispitivanoj skupini.
English: Safety analysis by age category (<65 vs >=65 years) showed higher toxicity in older subjects, although this occurred equally in both arms.
Croatian: Analiza sigurnosti prema dobnim kategorijama (<65 naspram >= 65 godina) pokazala je višu razinu toksičnosti u starijih ispitanika, iako je ona podjednako zabilježena u objema skupinama.
English: The results of the ANNOUNCE study confirmed the safety profile seen in the previous phase II study.
Croatian: Rezultati ispitivanja ANNOUNCE potvrdili su sigurnosni profil utvrđen u prethodnom ispitivanju faze II.
English: It is plausible that a different rate of several histologies between the two studies could have had an impact in the dissimilar efficacy observed.
Croatian: Moguće je i da je različita stopa nekoliko histoloških nalaza između dvaju ispitivanja imala učinak na primijećenu različitu djelotvornost.
English: Baseline patient and disease characteristics appeared overall well balanced.
Croatian: Osnovne karakteristike bolesnika i bolesti općenito su djelovale kao dobro uravnotežene.
English: In January 2019, the marketing authorisation holder communicated to the European Medicines Agency high level preliminary results of the JGDJ study.
Croatian: U siječnju 2019. nositelj odobrenja za stavljanje u promet obavijestio je Europsku agenciju za lijekove o preliminarnim rezultatima na visokoj razini ispitivanja JGDJ.
English: In addition, the rate of (consolidated) musculoskeletal pain was similar between the 2 treatment arms.
Croatian: Osim toga, stopa (konsolidirane) mišićno-koštane boli bila je slična u dvjema liječenim skupinama.
English: The study gave rise to concerns about lack of efficacy, because it did not meet the primary objective to prolong survival in the overall population or in the leiomyosarcoma sub-population.
Croatian: Ispitivanje je izazvalo zabrinutost zbog nedovoljne djelotvornosti jer nije ispunjen primarni cilj produženja preživljenja u ukupnoj populaciji ili u subpopulaciji s lejomiosarkomom.
English: Neither the exploratory analysis of PDGFR-α expression nor the immunogenicity appear to explain the absence of benefit.
Croatian: Čini se da ni istraživačka analiza ekspresije PDGFR-α ni imunogenost ne pružaju objašnjenje za nepostojanje koristi.
English: Therefore, pursuant to Article 116 of Directive 2001/83/EC, the Committee recommends the revocation of the marketing authorisation for Lartruvo.
Croatian: Direktive 2001/83/EZ, Odbor preporučuje ukidanje odobrenja za stavljanje u promet lijeka Lartruvo.
English: Favourable effects
Croatian: Povoljni učinci
English: However, the median duration of doxorubicin treatment was 18 weeks and 23 weeks for the investigational and control groups, respectively.
Croatian: Međutim, medijan trajanja liječenja doksorubicinom jest 18 tjedana za ispitivanu i 23 tjedna za kontrolnu skupinu.
English: • The Committee considered the procedure under Article 20 of Regulation (EC) No 726/2004 for Lartruvo.
Croatian: • Odbor je razmotrio postupak upućivanja u skladu s člankom 20. Uredbe (EZ) br. 726/2004 za lijek Lartruvo;
English: The subgroup analyses do not reveal any subgroup of interest where there could be some benefit.
Croatian: Analizom podskupina nije utvrđeno da bi određena interesna podskupina mogla imati neke koristi.
English: ANNOUNCE as the confirmatory trial was specifically designed to show differences in OS.
Croatian: Ispitivanje ANNOUNCE kao potvrdno ispitivanje posebno je osmišljeno kako bi pokazalo razlike u OS-u.
English: The sample size, conduct of the study, endpoints, statistical methods or randomisation do not seem to explain the discrepancy between ANNOUNCE and the phase II JGDG.
Croatian: Veličina uzorka, provedba ispitivanja, krajnje točke, statističke metode ili randomizacija ne pružaju objašnjenje za razlike u rezultatima ispitivanjâ ANNOUNCE i ispitivanja JGDG faze II.
English: According to the protocol, doxorubicin 75 mg/m2 was to be administered (after olaratumab or placebo) on day 1 of cycles 1 to 8 (of 3 weeks each).
Croatian: Prema protokolu, doksorubicin (75 mg/m2) trebalo je davati (nakon olaratumaba ili placeba) 1. dana ciklusâ 1 do 8 (svaki ciklus u trajanju od tri tjedna).
English: Deaths due to adverse events were overall similar in both arms (7[2.7%] vs 6 [2.4%]).
Croatian: Smrtni slučajevi uslijed štetnih događaja općenito su bili slični u objema skupinama (7[2,7 %] naspram 6 [2.4 %]).
English: When excluding the event of oedema not associated with an AE suggestive of cardiac dysfunction or a significant decrease in left ventricular function, the true incidence of cardiac dysfunction was 9.3% in the investigational arm and 6.8% in the control arm.
Croatian: Ako se isključi pojava edema koji nije povezan sa štetnim događajem koji upućuje na srčanu disfunkciju ili znatno smanjenje funkcije lijeve klijetke, stvarna pojava srčane disfunkcije iznosila je 9,3 % u ispitivanoj skupini i 6,8 % u kontrolnoj skupini.
English: Infusion related reactions, cardiac arrhythmia and cardiac dysfunction are considered events of special interest for olaratumab.
Croatian: Reakcije povezane s davanjem infuzije, srčana aritmija i srčana disfunkcija smatraju se nuspojavama od posebnog interesa za olaratumab.
English: On 25 January 2019 the European Commission (EC) triggered a procedure under Article 20 of Regulation (EC) No 726/2004, and requested the CHMP to assess the above concerns and their impact on the benefit-risk balance of Lartruvo.
Croatian: Europska komisija pokrenula je 25. siječnja 2019. postupak u skladu s člankom 20. Uredbe (EZ) br. 726/2004 te je od CHMP-a zatražila da ocijeni prethodno navedene zabrinutosti i njihov mogući učinak na omjer koristi i rizika lijeka Lartruvo.
English: Nausea, neutropenia and fatigue were the most frequently reported TEAEs.
Croatian: Mučnina, neutropenija i umor najčešće su prijavljivani TEAE-ovi.
English: No new safety concerns arose from the ANNOUNCE study.
Croatian: Iz ispitivanja ANNOUNCE nisu proizašla nova sigurnosna pitanja.
English: Furthermore, there was no clinical benefit in key secondary efficacy endpoints.
Croatian: Nadalje, u ključnim sekundarnim krajnjim točkama djelotvornosti nije utvrđena klinička korist.
English: It was designed to confirm the OS benefit previously shown in the smaller phase 1b/2 study JGDG.
Croatian: Cilj ispitivanja bio je potvrditi korist za OS koja je prethodno utvrđena u manjem ispitivanju (JGDG) faze 1b/2.
English: No difference was observed in any of the other secondary endpoints analysed in the ITT population.
Croatian: Nije zamijećena razlika ni u jednoj od drugih sekundarnih krajnjih točaka koje su analizirane kod populacije koju se namjeravalo liječiti.
English: These data seem to suggest a different tolerability to doxorubicin depending on the group, which appears to be different from that observed in the previous phase II trial, where the exposure to doxorubicin was higher for patients in the investigational group as compared to the control group (7 vs 4).
Croatian: Ti podatci ukazuju na razlike u pogledu podnošljivosti doksorubicina ovisno o skupini, što se razlikuje od zamijećene podnošljivosti u prethodnom ispitivanju faze II., kad je izloženost doksorubicinu bila viša u bolesnika u ispitivanoj skupini u usporedbi s kontrolnom skupinom (7 naspram 4).
English: • The Committee, as a consequence, concluded that Lartruvo lacks therapeutic efficacy and that the benefit-risk of Lartruvo is not favourable.
Croatian: • Odbor je posljedično zaključio da lijek Lartruvo nije terapijski djelotvoran te da omjer rizika i koristi od lijeka Lartruvo nije pozitivan.
English: It seems no single reason can explain the discrepancy in results between phase II JGDG and phase III ANNOUNCE studies.
Croatian: Čini se da nema niti jednog razloga kojim bi se mogla objasniti tolika razlika između ispitivanja faze II. (JGDG) i ispitivanja faze III. (ANNOUNCE).
English: Overall, the results of the ANNOUNCE study are mature and robust to draw the conclusion that the study showed lack of therapeutic efficacy associated with olaratumab treatment in the authorised indication.
Croatian: Općenito, rezultati ispitivanja ANNOUNCE dovoljno su pouzdani i čvrsti kako bi se moglo zaključiti da je ispitivanje ukazalo na nedostatak terapijske djelotvornosti povezane s liječenjem olaratumabom u odobrenoj indikaciji.
English: Even though the primary endpoint of that study (PFS) did not reveal a clear delay in the tumour progression for the experimental arm, the longer survival associated with the olaratumab combination treatment supported the granting of a conditional marketing authorisation.
Croatian: Iako primarna krajnja točka tog ispitivanja (PFS) nije ukazivala na jasnu odgodu progresije tumora za eksperimentalnu skupinu, dulje preživljenje povezano s liječenjem kombinacijom olaratumaba bilo je potkrepljujući razlog za dodjeljivanje uvjetnog odobrenja za stavljanje lijeka u promet.
English: All the sensitivity analyses carried out in the ANNOUNCE study, both in the ITT population an in the LMS group, point in the same direction (no favourable effect of olaratumab).
Croatian: Sve analize osjetljivosti provedene u okviru ispitivanja ANNOUNCE u populaciji koju se namjeravalo liječiti i u skupini koja ima LMS dovode do istoga zaključka (nema pozitivnog učinka od olaratumaba).
English: • The Committee reviewed the results of the ANNOUNCE (JGDJ) study, which was conducted to fulfil the specific obligation with a view to confirming a favourable benefit-risk balance for the conditional marketing authorisation for Lartruvo, pursuant to Article 14-a of Regulation (EC) No
Croatian: • Odbor je pregledao rezultate ispitivanja ANNOUNCE (JGDJ) koje je provedeno radi ispunjavanja posebne obveze u svrhu potvrde pozitivnog omjera koristi i rizika za uvjetno odobrenje za stavljanje lijeka Lartruvo u promet, u skladu s člankom 14.a Uredbe (EZ) br. 726/2004.;
English: ‘in combination with doxorubicin, for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin'.
Croatian: „u kombinaciji s doksorubicinom za liječenje odraslih bolesnika s uznapredovalim sarkomom mekog tkiva koji nisu pogodni za kurativno kirurško ili radioterapijsko liječenje i koji prethodno nisu bili liječeni doksorubicinom”.
English: The ANNOUNCE (JGDJ) study was then requested as a specific obligation to confirm the efficacy and safety of olaratumab in same population for whom Lartruvo is currently indicated.
Croatian: Tada je, kao posebna obveza, zatraženo ispitivanje ANNOUNCE (JGDJ) kako bi se potvrdila djelotvornost i sigurnost olaratumaba u istoj populaciji za koju je trenutačno indiciran lijek Lartruvo.
English: There are also no data regarding the toxicity observed in subjects in the investigational arm when treated with olaratumab maintenance.
Croatian: Također nema podataka u pogledu zamijećene toksičnosti u ispitanika iz ispitivane skupine kada su primali terapiju održavanja olaratumabom.
English: Frequency of patients with TEAE leading to treatment discontinuation was similar in both arms (4.3% vs 4.4%).
Croatian: Učestalost bolesnika s TEAE-ima koji su doveli do prekida liječenja slična je u objema skupinama (4,3 % naspram 4,4 %).
English: The patient disposition of the ANNOUNCE trial does not indicate major differences between arms in reasons for treatment discontinuation.
Croatian: Raspoloživost bolesnika u ispitivanju ANNOUNCE ne ukazuje na velike razlike između skupina kad je riječ o razlozima za prekid liječenja.
English: The median of the number of cycles received were higher in the control arm (6 vs 7) and the median of cumulative dose per body surface area (mg/m2) was also higher for the control group (409 vs 483).
Croatian: Medijan broja primljenih ciklusa liječenja bio je viši u kontrolnoj skupini (6 i 7), kao i medijan kumulativne doze po tjelesnoj površini (mg/m2) (409 naspram 483).
English: The different exposure to doxorubicin between investigational arm and the control group was noted.
Croatian: Zamijećena je razlika u izloženosti doksorubicinu između ispitivane i kontrolne skupine.
English: In the LMS population, ORR was in favour of the control arm (no statistical significance) and DCR was statistically significant in favour of the control arm.
Croatian: U populaciji s LMS-om, kontrolna skupina imala je pozitivan ORR (bez statističkog značaja), dok je DCR bio statistički značajno pozitivan za kontrolnu skupinu.
English: CHMP opinion
Croatian: Mišljenje CHMP-a Budući da:
English: The analyses of ANNOUNCE study showed that PDGFR-α status did not have any predictive role of the response to olaratumab in terms of OS or PFS, and that PDGFR-α was a poor prognostic factor, consistently with literature data.
Croatian: Analize iz ispitivanja ANNOUNCE pokazale su da status PDGFR-α nema nikakvu ulogu u predviđanju odgovora na olaratumab s obzirom na OS ili PFS te da je PDGFR-α loš prognostički čimbenik, što je u skladu s podatcima iz literature.
English: Consequently, as the ANNOUNCE study was imposed as a specific obligation to confirm the efficacy and safety of olaratumab in the authorised indication, the conditional marketing authorisation for Lartruvo should be revoked.
Croatian: Stoga je, s obzirom na to da je ispitivanje ANNOUNCE nametnuto kao posebna obveza radi potvrde djelotvornosti i sigurnosti olaratumaba u odobrenoj indikaciji, potrebno opozvati uvjetno odobrenje za stavljanje lijeka Lartruvo u promet.
English: The baseline characteristics appear to be evenly balanced, both in histology and disease at randomization.
Croatian: Osnovne karakteristike randomizacije ravnomjerne su u pogledu histologije i bolesti.
English: The rate of haematological toxicities (neutropenia, thrombocytopenia, anaemia and febrile neutropenia) and gastrointestinal toxicities (nausea, vomiting and diarrhoea) was balanced between the treatment arms.
Croatian: Stopa hematološke toksičnosti (neutropenija, trombocitopenija, anemija i neutropenija praćena vrućicom) i gastrointestinalne toksičnosti (mučnina, povraćanje i proljev) podjednako su bile zastupljene u liječenim skupinama.
English: No difference was seen in OS in the LMS population either.
Croatian: Također nije zamijećena razlika u OS-u za populaciju s LMS-om.
English: STS is a disease which encompasses a wide range of different tumour histologies, some of them with different prognosis and specific treatments.
Croatian: Sarkom mekoga tkiva bolest je koja obuhvaća širok raspon različitih histologija tumora, pri čemu postoje različite prognoze i posebna liječenja.
English: The rate of potential immediate (i.e. occurring on the day of infusion) hypersensitivity reactions was higher in the investigational arm for all grade events (11.7% vs. 7.2%) and Grade ≥3 events (2.3% vs 0.8%) but no fatal events were reported.
Croatian: Stopa potencijalnih trenutnih (odnosno na dan dobivanja infuzije) reakcija preosjetljivosti bila je viša u ispitivanoj skupini za nuspojave svih stupnjeva (11,7 % naspram 7,2 %) i nuspojave 3. i višeg stupnja (2,3 % naspram 0,8 %), ali nije bilo prijavljenih smrtonosnih nuspojava.
English: Lartruvo was granted a conditional marketing authorisation under Article 14(7) of Regulation (EC) No. 726/2004, valid throughout the European Union, on 9 November 2016.
Croatian: Dana 9. studenoga 2016. za lijek Lartruvo izdano je uvjetno odobrenje za stavljanje u promet u skladu s člankom 14. stavkom 7. Uredbe (EZ) br. 726/2004 koje vrijedi na prostoru Europske unije.
English: A total of 170 (66.1%) vs 158 (63.5%) of patients died in the investigational vs control arm, respectively, mostly attributed to study disease (63.4% vs 61%).
Croatian: U ispitivanoj skupini preminulo je ukupno 170 bolesnika (66,1 %) naspram 158 bolesnika (63,5 %) u kontrolnoj skupini, i to većinom od ispitivane bolesti (63,4 % naspram 61 %).
English: The primary endpoint for this study was OS in the ITT population and in the LMS population.
Croatian: Primarna krajnja točka za to ispitivanje bio je OS u populaciji koju se namjerava liječiti i u populaciji s LMS-om.
English: The median PFS was 5.42 months in the investigational arm and 6.77 months in the control arm (HR=1.231 [95% CI: 1.009, 1.502]; p=0.042).
Croatian: Medijan PFS-a bio je 5,42 mjeseci u ispitivanoj skupini i 6,77 mjeseci u kontrolnoj skupini (HR = 1,231 [95 % CI: 1,009, 1,502]; p=0,042).
English: Of those, 2 TEAE leading to deaths were considered related to study treatment in the investigational arm (pneumonia and aspiration) vs none in the control arm.
Croatian: Od prethodno navedenih TEAE-ova, za dva od njih koji su doveli do smrtnih slučajeva smatra se da su povezani s liječenjem u okviru ispitivanja u ispitivanoj skupini (upala pluća i aspiracija) naspram nijednoga u kontrolnoj skupini.
English: No significant difference in PFS between the treatment arms in the LMS population was found.
Croatian: Nije utvrđena značajna razlika u PFS-u između liječenih skupina u populaciji s LMS-om.
English: • The Committee noted that no benefit was observed from adding Lartruvo to doxorubicin in the treatment of patients with advanced soft tissue sarcoma, when compared to doxorubicin alone.
Croatian: • Odbor je primijetio da nije uočena korist od dodavanja lijeka Lartruvo doksorubicinu u liječenju bolesnika s uznapredovalim sarkomom mekog tkiva u usporedbi s terapijom u kojoj se primjenjuje samo doksorubicin.
English: Compared to the currently recommended posology of olaratumab (15 mg/kg on days 1 and 8 of each 3 week cycle), a loading cycle of 20 mg/kg on day 1 and day 8 of cycle 1 was used, to minimize the number of patients exposed to sub-therapeutic olaratumab serum levels without an increased risk of toxicity, based on PK and matched case-control analysis by exposure quartiles results.
Croatian: U usporedbi s trenutačno predloženim doziranjem olaratumaba (15 mg/kg 1. i 8. dana svakoga ciklusa od tri tjedna), ciklus opterećenja s 20 mg/kg 1. i 8. dana prvog ciklusa primjenjivao se radi smanjenja broja bolesnika izloženih subterapijskim razinama olaratumaba u serumu bez povećanog rizika od toksičnosti, na temelju farmakokinetike i odgovarajuće kontrolne studije slučaja prema rezultatima izloženosti u kvartilima.
English: Even though no new safety concerns arose from the ANNOUNCE study, any safety concerns associated with olaratumab render the benefit-risk balance of Lartruvo negative in view of the lack of therapeutic efficacy observed in the study.
Croatian: Iako iz ispitivanja ANNOUNCE nisu proizašle nove zabrinutosti u pogledu sigurnosti, zbog svih razloga za zabrinutost u pogledu sigurnosti povezanih s olaratumabom omjer rizika i koristi lijeka Lartruvo ocjenjuje se negativnim s obzirom na terapijsku nedjelotvornost koja je uočena u ispitivanju.
English: Immediate non-anaphylactic reactions were reported in 9.3% patients and were grade 1/2 in severity.
Croatian: Trenutne neanafilaktičke reakcije, stupnja 1/2, zabilježene su u 9,3 % bolesnika
English: The Kaplan-Meier curves for OS are overlapping.
Croatian: Krivulje Kaplan-Meier za OS se preklapaju.
English: There was a significant difference in PFS in the ITT population based on investigator assessment, but in favour of the control arm.
Croatian: Postojala je značajna razlika u PFS-u kod populacije koju se namjeravalo liječiti na temelju ocjene ispitivača, ali u korist kontrolne skupine.
English: The incidence for all grades of events in the cardiac dysfunction AESI category was 18.3% in the investigational arm and 13.7% in the control arm, the majority being events of peripheral oedema (13.2 vs 9.2%) and oedema (1.2% vs 0%).
Croatian: Učestalost svih stupnjeva srčane disfunkcije u kategoriji nuspojava od posebnog interesa u ispitivanoj skupini bila je 18,3 %, a u kontrolnoj skupini 13,7 %, pri čemu se u većini slučajeva radilo o perifernom edemu (13,2 % naspram 9,2 %) i edemu (1,2 % naspram 0 %).
English: Doxorubicin was administered for a maximum of 8 cycles every 3 weeks, along with olaratumab/placebo which was continued after 8 cycles until PD, unacceptable toxicity, death, or other withdrawal criteria.
Croatian: Doksorubicin se davao bolesnicima u najviše osam ciklusa svaka tri tjedna, a nakon osam ciklusa nastavljalo se s kombinacijom olaratumaba i placeba sve do pojave progresije bolesti, neprihvatljive toksičnosti, smrti, ili drugih kriterija za prekid liječenja.
English: In order to confirm the efficacy and safety of olaratumab, the marketing authorisation holder was required to submit as specific obligation, by January 2020, the clinical study report of a phase III randomised double-blind confirmatory study comparing doxorubicin plus olaratumab versus doxorubicin in patients with advanced or metastatic soft tissue sarcoma (Study I5B-MCJGDJ [JGDJ]; ANNOUNCE), including exploratory biomarker data.
Croatian: Kako bi se potvrdila djelotvornost i sigurnost olaratumaba, nositelju odobrenja za stavljanje u promet nametnuta je posebna obveza da do siječnja 2020. dostavi izvješće o kliničkom ispitivanju o randomiziranom dvostruko slijepom potvrdnom ispitivanju faze III. u kojemu se uspoređuje kombinacija doksorubicina i olaratumaba s doksorubicinom u bolesnika s uznapredovalim metastatskim sarkomom mekog tkiva (ispitivanje I5B-MCJGDJ [JGDJ]; ANNOUNCE), uključujući istraživačke podatke o biomarkerima.
English: The latter showed an unexpected survival gain in patients with advanced/metastatic STS recruited in the United States.
Croatian: U tom ispitivanju došlo je do neočekivanog porasta preživljenja u bolesnika iz Sjedinjenih Američkih Država s uznapredovalim/metastatskim sarkomom mekog tkiva.