natgillin/translations-raw huggingface dataset:
Patienterne blev randomiseret i forholdet 2:1 til at få en intravenøs infusion af Cyramza 8 mg/kg (n= 238) eller placebo (n= 117) hver anden uge.
Patients were randomised in a 2:1 ratio to receive an intravenous infusion of Cyramza 8 mg/kg (n= 238) or placebo (n= 117) every 2 weeks.
Ved klargøring som anvist indeholder infusionsopløsninger af Cyramza ingen antimikrobielle konserveringsmidler.
After dilution When prepared as directed, infusion solutions of Cyramza contain no antimicrobial preservatives.
Eventuelt ubrugt ramucirumab, som er tilbage i et hætteglas, skal bortskaffes, da produktet ikke indeholder antimikrobielle konserveringsmidler.
Discard any unused portion of ramucirumab left in a vial, as the product contains no antimicrobial preservatives.
Den eneste subgruppe med HR > 1 var patienter med sygdomsprogression < 3 måneder efter påbegyndelse af førstelinjebehandling med bevacizumab (HR 1,02 [95 % KI: 0,68-1,55]).
The one sub-group with HR > 1 was for patients with disease progression from start of first-line bevacizumab treatment of <3 months (HR 1.02 [95% CI: 0.68 to 1.55]).
Den anbefalede dosis af Cyramza til behandling af mavekræft, til behandling af fremskreden kræft i tyktarmen eller endetarmen og til behandling af leverkræft er 8 mg pr. kilogram legemsvægt én gang hver anden uge.
The recommended dose of Cyramza for the treatment of gastric cancer, for the treatment of advanced cancer of the colon or rectum and for the treatment of liver cancer is 8 mg per kilogram of your body weight once every 2 weeks.
Hvis du oplever en infusionsrelateret reaktion under behandlingen med Cyramza, vil du få medicin inden alle efterfølgende infusioner.
If you experience an infusion-related reaction during Cyramza therapy, you will be given premedication for all future infusions.
Tabel 12: Resumé af effektdata i REACH-2 - Intent to treat (ITT) population Cyramza N=197
Table 12: Summary of efficacy data in REACH-2 - Intent to treat (ITT) population Cyramza N=197
Baseret på PopPK var eksponeringen for ramucirumab den samme hos patienter med let nedsat nyrefunktion (kreatininclearance [CrCl] ≥ 60 til < 90 ml/min), moderat nedsat nyrefunktion (CrCl ≥ 30 til <60 ml/min) og svært nedsat nyrefunktion (CrCl < 15-29 ml/min) som hos patienter med normal nyrefunktion (CrCl ≥ 90 ml/min).
Based on PopPK, ramucirumab exposure was similar in patients with mild renal impairment (creatinine clearance [CrCl] ≥60 to <90 ml/min), moderate renal impairment (CrCl ≥30 to <60 ml/min) or severe renal impairment (CrCl 15 to 29 ml/min) as compared to patients with normal renal function (CrCl ≥90 ml/min).
Tabel 7: Bivirkninger rapporteret hos patienter behandlet med ramucirumab i kombination med kemoterapi i kliniske fase 3-studier (RAINBOW, REVEL og RAISE)
Table 7: ADRs reported in patients treated with ramucirumab in combination with chemotherapy in phase 3 clinical trials (RAINBOW, REVEL and RAISE)
Febril neutropenid
Febrile neutropeniad
Før kemoterapien skal der foretages komplet blodtælling.
Prior to chemotherapy, patients should have a complete blood count.
- alvorlig blødning i tarmen: symptomerne kan omfatte ekstrem træthed, svaghed, svimmelhed eller ændring i farven af afføringen.
- severe bleeding in your gut: symptoms may include extreme tiredness, weakness, dizziness or changes in the colour of your stools.
Patienter med planocellulær histologi har en højere risiko for at udvikle alvorlig pulmonal blødning, dog blev der ikke observeret en øget hyppighed af grad 5 pulmonal blødning hos ramucirumabbehandlede patienter med planocellulær histologi i REVEL-studiet.
Patients with squamous histology are at higher risk of developing serious pulmonary bleeding, however, no excess of Grade 5 pulmonary haemorrhage was observed in ramucirumab treated patients with squamous histology in REVEL.
Når urinproteinniveauet er faldet til <2 g/24 timer, skal behandlingen genoptages ved et reduceret dosisniveau (se tabel 3).
Once the urine protein level returns to <2 g/24 hours, treatment should be resumed at a reduced dose level (see Table 3).
Tabel 6: Bivirkninger rapporteret hos patienter behandlet med ramucirumab som monoterapi i kliniske fase 3-studier (REGARD, REACH-2 og REACH patienter med alfaføtoprotein ≥400 ng/ml)
Table 6: ADRs reported in patients treated with ramucirumab as monotherapy in phase 3 clinical trials (REGARD, REACH-2 and REACH patients with alpha fetoprotein ≥ 400 ng/ml)
EU/1/14/957/002 - 2 hætteglas med 10 ml 13.
EU/1/14/957/002 - 2 vials of 10 ml.
Symptomer på dette kan omfatte en brændende følelse i munden, sår, blister eller hævelse.
Symptoms may include a burning sensation in the mouth, ulceration, blisters or swelling.
e Dette omfatter: abdominale smerter, nedre abdominale smerter, øvre abdominale smerter og leversmerter.
e Includes: abdominal pain, abdominal pain lower, abdominal pain upper, and hepatic pain.
Baseret på PopPK var eksponeringen for ramucirumab den samme hos patienter med let nedsat leverfunktion (total-bilirubin > 1,0-1,5 gange øvre normalgrænse (ULN) og enhver ASAT eller total-bilirubin ≤ 1,0 ULN og ASAT > ULN) og moderat nedsat leverfunktion (total bilirubin > 1,5-3,0 ULN og enhver AST) som hos patienter med normal leverfunktion (total-bilirubin og ASAT ≤ ULN).
Based on PopPK, ramucirumab exposure in patients with mild hepatic impairment (total bilirubin >1.0-1.5 upper limit of normal (ULN) and any AST or total bilirubin ≤1.0 ULN and AST >ULN) or moderate hepatic impairment (total bilirubin > 1.5-3.0 ULN and any AST) was similar to patients with normal hepatic function (total bilirubin and AST ≤ ULN).
Tabel 6 og 7 viser bivirkninger fra kliniske placebokontrollerede fase 3-studier relateret til ramucirumab anvendt enten som monoterapi ved gastrisk cancer og HCC eller i kombination med forskellige kemoterapiregimer ved behandling af gastrisk cancer, mCRC og NSCLC.
Tables 6 and 7 below list the adverse drug reactions (ADRs) from placebo controlled phase III clinical trials associated with ramucirumab used either as a monotherapy treatment for gastric cancer and HCC or in combination with different chemotherapy regimens for the treatment of gastric cancer, mCRC and NSCLC.
Brug af anden medicin sammen med Cyramza
Other medicines and Cyramza
Behandlingen med Cyramza vil blive stoppet permanent, hvis du oplever en alvorlig infusionsrelateret reaktion.
Cyramza will be permanently stopped if you experience a severe infusion-related reaction.
Sådan får du Cyramza
How you are given Cyramza
Tilsæt en tilstrækkelig mængde 9 mg/ml (0,9 %) natriumchloridinjektionsvæske til beholderen, så den samlede mængde bliver 250 ml.
Add a sufficient quantity of sodium chloride 9 mg/ml (0.9%) solution for injection to the container to make the total volume 250 ml.
Behandling med ramucirumab skal seponeres midlertidigt, hvis der er sårhelingskomplikationer, indtil såret er komplet helet (se pkt 4.4).
Ramucirumab therapy should be temporarily discontinued if there are wound healing complications, until the wound is fully healed (see section 4.4).
Patienter, som fik en eller anden form for terapeutisk antikoagulationsbehandling og/eller kronisk behandling med nonsteroide anti-inflammatoriske lægemidler eller trombocytfunktionshæmmere, blev ekskluderet fra det kliniske NSCLC-studie REVEL.
Patients receiving any kind of therapeutic anticoagulation and/or chronic therapy with non-steroidal anti-inflammatory drugs or anti-platelet agents were excluded from the REVEL NSCLC clinical trial.
For at blive inkluderet i studiet skulle patienterne have total bilirubin på ≤ 1,5 mg/dl og AST og ALT ≤ 3 gange
To be included in the study, patients were required to have total bilirubin of ≤1.5 mg/dl and AST and ALT ≤3 times ULN, or ≤5 times ULN if liver metastases were present.
- Betændelse i munden (stomatitis): Når Cyramza gives i kombination med kemoterapi, kan det øge risikoen for, at du får betændelse i munden.
- Inflammation of the mouth (‘stomatitis'): Cyramza, when given in combination with chemotherapy may increase the risk of developing inflammation of the mouth.
Cyramza kan øge risikoen for problemer med sårheling.
Cyramza may increase the risk of problems with wound healing.
For EORTC QLQ-C30 rapporterede patienter i ramucirumab plus FOLFIRI-armen om et forbigående fald i QoL på de fleste af skalaerne sammenlignet med patienter i placebo plus FOLFIRI-armen.
EORTC QLQ-C30, patients in the ramucirumab plus FOLFIRI treatment arm reported a transient decrease in QoL compared to the patients in the placebo plus FOLFIRI treatment arm in most of the scales.
Gastrointestinal blødninga,f Gastrointestinal perforationa
Gastrointestinal haemorrhage eventsa,f Gastrointestinal perforationa
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Cyramza i alle undergrupper af den pædiatriske population med gastrisk cancer, adenokarcinom i kolon og rektum, lungecancer og levercancer (se pkt.
The European Medicines Agency has waived the obligation to submit the results of studies with Cyramza in all subsets of the paediatric population in gastric adenocarcinoma, in adenocarcinoma of the colon and rectum, in lung carcinoma, and liver cancer (see section 4.2 for information on paediatric use).
- har lungekræft og for nyligt har haft blødning i lungerne (ophostning af lyst rødt blød), eller hvis du regelmæssigt tager visse typer gigtmedicin eller smertestillende medicin (nonsteroid anti-inflammatorisk medicin) eller medicin, som påvirker blodets størkningsevne.
- have lung cancer and have had recent bleeding in the lung (coughing up bright red blood) or you are regularly taking non-steroidal anti-inflammatory medicines, or medicines which affect blood clotting ability.
Tabel 5: Dosisjustering af FOLFIRI-komponenter på grund af specifikke bivirkninger BIVIRKNING NCI
Table 5: Dose modification of FOLFIRI components due to specific ADRs
Hvis der forekommer medicinsk signifikant hypertension, som ikke kan kontrolleres forsvarligt med antihypertensiv behandling, skal behandling med ramucirumab seponeres permanent (se pkt.
If there is medically significant hypertension that cannot be controlled safely with antihypertensive therapy, ramucirumab therapy should be permanently discontinued (see section 4.4).
I alt 1.072 patienter blev randomiseret (1:1) til enten Cyramza (n=536) 8 mg/kg eller placebo (n=536) i kombination med FOLFIRI.
A total of 1072 patients were randomised (1:1) to receive either Cyramza (n=536) at 8 mg/kg or placebo (n=536), in combination with FOLFIRI.
Cyramza 8 mg/kg eller placebo blev administreret ved intravenøs infusion hver anden uge (på dag 1 og 15) i en 28-dages serie.
Cyramza at 8 mg/kg or placebo was administered by intravenous infusion every 2 weeks (on days 1 and 15) of a 28-day cycle.
Dosisjusteringer Din læge eller sygeplejerske vil holde øje med bivirkninger under hver infusion.
During each infusion, your doctor or nurse will check for side effects.
Derfor bør du ikke amme dit barn under behandlingen med Cyramza og i mindst 3 måneder efter sidste dosis.
you should not breast-feed your baby during treatment with Cyramza and for at least 3 months after you receive the last dose.
Palmoplantar erytrodysæstesi syndromg
Palmar-plantar erthyrodysaesthesia syndromeg
Cyramza bruges til behandling af leverkræft, der er fremskreden eller ikke kan fjernes ved operation, hos voksne, som tidligere har været behandlet med et andet lægemiddel mod kræft (sorafenib) og som har forhøjet niveau af et bestemt protein i blodet (alfaføtoprotein).
Cyramza is used to treat liver cancer that is advanced or cannot be taken out by surgery, in adults who have been previously treated with another anticancer medicine (sorafenib) and who have an elevated level of a particular protein in the blood (alpha fetoprotein).
Patienterne skulle have ECOG- performancestatus (PS) 0 eller 1 og sygdomsprogression indenfor 6 måneder efter den sidste dosis af førstelinjebehandlingen.
Patients were required to have ECOG PS 0 or 1 and to have disease progression within 6 months of the last dose of first-line therapy.
På centre i den østlige del af Asien blev der administreret en reduceret docetaxeldosis på 60 mg/m2 hver 21. dag.
Sites in East Asia administered a reduced dose of docetaxel at 60 mg/m2 every 21 days.
Hos mCRC-patienter, som blev behandlet med ramucirumab plus FOLFIRI i RAISE-studiet, var proteinuri (1,5 %) den hyppigste bivirkning (≥1 %), som medførte seponering af ramucirumab.
In the RAISE study, in mCRC patients treated with ramucirumab plus FOLFIRI, the most frequent (≥1%) ADR that led to the discontinuation of ramucirumab was proteinuria (1.5%).
Ved anvendelse af fyldt intravenøs infusionsbeholder Ud fra den beregnede mængde ramucirumab fjernes den tilsvarende mængde 9 mg/ml (0,9 %) natriumchloridinjektionsvæske fra den fyldte 250 ml intravenøse beholder.
In case of pre-filled intravenous infusion container usage Based on the calculated volume of ramucirumab, remove the corresponding volume of sodium chloride 9 mg/ml (0.9%) solution for injection from the pre-filled 250 ml intravenous container.
Dyremodeller knytter imidlertid angiogenese, VEGF og VEGF-receptor 2 til kritiske elementer i den kvindelige reproduktion, den embryoføtale udvikling og den postnatale udvikling.
Reproductive toxicity studies with ramucirumab have not been performed, however, animal models link angiogenesis, VEGF and VEGF Receptor 2 to critical aspects of female reproduction, embryo-foetal development, and postnatal development.
Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du fortælle det til din læge inden påbegyndelse af behandlingen.
Before starting treatment you must tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or you are planning to have a baby.
Patienter med nylig alvorlig pulmonal, gastrointestinal eller postoperativ blødning, tegn på CNS-blødning, tumor involverende de større luftveje eller blodårer, intratumorkavitation og tidligere signifikant blødning eller ukontrollerede trombotiske sygdomme blev ekskluderet.
Patients with recent serious pulmonary, gastrointestinal, or postoperative bleeding, evidence of CNS haemorrhage, tumour involvement of major airway or blood vessel, intra-tumour cavitation, and history of significant bleeding or uncontrolled thrombotic disorders were excluded.
Cyramza administreres efter fortynding som en intravenøs infusion over ca. 60 minutter.
After dilution, Cyramza is administered as an intravenous infusion over approximately 60 minutes.
Patienterne skulle have oplevet sygdomsprogression inden for 4 måneder efter sidste dosis af førstelinjebehandlingen for metastatisk sygdom, eller under adjuverende behandling eller inden for 6 måneder efter sidste dosis af den adjuverende behandling, og have ECOG PS på 0-1.
Patients were required to have experienced disease progression during, or within 4 months after the last dose of, first-line therapy for metastatic disease, or during adjuvant treatment or within 6 months after the last dose of adjuvant therapy, and had ECOG PS 0-1.
Justering af docetaxeldosis
Docetaxel dose adjustments
Effektresultaterne er vist i tabel 8.
Efficacy results are shown in Table 8.
Symptomerne kan være: ekstrem træthed, svaghed, svimmelhed eller ændring i farven af afføringen.
Symptoms may include: extreme tiredness, weakness, dizziness or changes in the colour of your stools.
Median-alderen var 62 år, og 40 % af patienterne var ≥ 65 år, 57 % af patienterne var mænd, 76 % var kaukasiere og 20 % asiater, 49 % havde ECOG-PS 0, 49 % af patienterne havde KRAS-muterende tumorer, og 24 % af patienterne havde TTP < 6 måneder efter påbegyndelse af førstelinjebehandling.
Median age was 62 years and 40% of patients were ≥65 years; 57% of patients were male; 76% were White and 20% Asian; 49% had ECOG PS 0; 49% of patients had KRAS mutant tumours; and 24% of patients had TTP <6 months after commencing first-line treatment.
For østasiatiske patienter skal en reduceret startdosis af docetaxel på 60 mg/m2 på dag 1 i en serie på 21 dage overvejes.
For East Asian patients, a reduced docetaxel starting dose of 60 mg/m2 on day 1 of a 21 day cycle should be considered.
Den anbefalede dosis af docetaxel er 75 mg for hver kvadratmeter (m²) kropsoverflade én gang hver 3. uge.
The recommended dose of docetaxel is 75 mg for every square metre (m²) of your body's surface area once every 3 weeks.
Der blev givet systemisk anti-cancerbehandling efter afslutning af studiet til 54 % af de patienter, der fik Cyramza plus FOLFIRI, og til 56 % af de patienter, der fik placebo plus FOLFIRI.
Post discontinuation systemic anticancer therapy was given to 54% of patients receiving Cyramza plus FOLFIRI and 56% of patients receiving placebo plus FOLFIRI.
Hvis der observeres partikler eller misfarvning, skal hætteglasset bortskaffes.
If particulate matter or discolouration is identified, discard the vial.
Hvis en patient udvikler sårhelingskomplikationer under behandlingen, skal ramucirumab seponeres, indtil såret er komplet helet (se pkt.
If a patient develops wound healing complications during therapy, ramucirumab should be discontinued until the wound is fully healed (see section 4.2).
Klinisk relevante reaktioner (herunder grad ≥ 3) forbundet med antiangiogen behanding observeret hos patienter behandlet med ramucirumab i kliniske studier omfattede: gastrointestinale perforationer, infusionsrelaterede reaktioner og proteinuri (se pkt.
Clinically relevant reactions (including Grade ≥3) associated with antiangiogenic therapy observed in ramucirumab-treated patients across clinical studies were: gastrointestinal perforations, infusionrelated reactions and proteinuria (see sections 4.2 and 4.4).
Hvis dette sker for øst-asiatiske patienter ved en startdosis på 60 mg/m², skal docetaxel seponeres (se Dosering).
In this case, East Asian patients with a starting dose of 60 mg/m² should have docetaxel treatment discontinued (see Posology).
Hvis du har leverkræft, vil din læge overvåge dig for tegn og symptomer på forvirring og/eller desorientering forbundet med kroniske leverproblemer.
If you have liver cancer your doctor will monitor you for signs and symptoms of confusion and/or disorientation associated with chronic liver problems and will stop treatment with Cyramza if you develop these signs and symptoms.
Det gives sammen med en medicinkombination kaldet ”FOLFIRI-kemoterapi”, som indeholder fluoruracil, folinsyre og irinotecan.
It is given with other medicines called ‘FOLFIRI chemotherapy', including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Se produktresumeet for docetaxel for specifik doseringsvejledning.
See docetaxel prescribing information for specific dosing advice.
Det er ikke relevant at anvende ramucirumab hos den pædiatriske population til indikationerne fremskreden gastrisk cancer, adenokarcinom i den gastroøsofagale overgang, adenokarcinom i kolon og rektum, lungecancer eller hepatocellulært karcinom.
There is no relevant use of ramucirumab in the paediatric population for the indications of advanced gastric cancer or gastro-oesophageal adenocarcinoma, adenocarcinoma of the colon and rectum, lung carcinoma, and hepatocellular carcinoma.
Cyramza indeholder natrium
Cyramza contains sodium
Hepatisk encefalopatic
Hepatic encephalopathyc
Effektresultaterne er vist i tabel 9.
Efficacy results are shown in Table 9.
Behandlingen med Cyramza vil blive stoppet midlertidigt, hvis du: - udvikler forhøjet blodtryk, indtil det er bragt under kontrol med blodtrykssænkende medicin - udvikler problemer med sårheling, indtil såret er helet, eller inden en planlagt operation - skal have en planlagt operation, 4 uger før operationen
- develop high blood pressure, until it is controlled with anti-hypertensive medicine - develop wound healing problems, until the wound is healed - will undergo planned surgery, four weeks prior to surgery
Patienterne blev randomiseret i forholdet 1:1 til at få Cyramza plus paclitaxel (n=330) eller placebo plus paclitaxel (n=335).
Patients were randomised in a 1:1 ratio to receive Cyramza plus paclitaxel (n=330) or placebo plus paclitaxel (n=335).
Patienterne blev randomiseret i forholdet 1:1 til Cyramza plus docetaxel (n=628) eller placebo plus docetaxel (n=625).
Patients were randomised in a 1:1 ratio to receive Cyramza plus docetaxel (n=628) or placebo plus docetaxel (n=625).
Farmakokinetikken for paclitaxel blev ikke påvirket ved samtidig administration af ramucirumab, og farmakokinetikken for ramucirumab blev ikke påvirket ved samtidig administration af paclitaxel.
The pharmacokinetics of paclitaxel were not affected when co-administered with ramucirumab and the pharmacokinetics of ramucirumab were not affected when co-administered with paclitaxel.
Hypoalbuminæmia Hyponatriæmia
Hypoalbuminaemiaa Hyponatraemiaa
Ramucirumab skal seponeres permanent, hvis medicinsk signifikant hypertension ikke kan kontrolleres med antihypertensiv behandling (se pkt.
Ramucirumab should be permanently discontinued if medically significant hypertension cannot be controlled with antihypertensive therapy (see section 4.2).
Ramucirumab i kombination med FOLFIRI
Ramucirumab in combination with FOLFIRI
ORR i Cyramza plus paclitaxel-gruppen var 27,9 % og 16,1 % i placebo plus paclitaxel-gruppen.
Cyramza plus paclitaxel arm was 27.9% and in the placebo plus paclitaxel arm was 16.1%.
Farmakoinetikken for docetaxel blev ikke påvirket ved samtidig administration af ramucirumab.
The pharmacokinetics of docetaxel were not affected when co-administered with ramucirumab.
Proteinuri Patienterne skal monitoreres for udvikling eller forværring af proteinuri under behandlingen med ramucirumab.
Patients should be monitored for the development or worsening of proteinuria during ramucirumab therapy.
Hætteglas indeholder enten 100 mg eller 500 mg som en 10 mg/ml opløsning ramucirumab.
Vials contain either 100 mg or 500 mg as a 10 mg/ml solution of ramucirumab.
I REACH-2-studiet blev der for HCC observeret en relevant sammenhæng mellem eksponering og effekt for ramucirumab, hvilket viste, at kun patienter med en eksponering over medianen oplevede en forbedring i OS sammenlignet med placebo.
In the REACH-2 study for HCC, a relevant exposure-efficacy association was observed for ramucirumab which showed that only patients with above-median exposure experienced an improvement in OS, compared to placebo, and these exposure-efficacy relationships remained after attempts to adjust for other prognostic factors.
Subgrupperesultater for OS inkluderede følgende: ikke-planocellulær histologi (HR 0,83; 95 % KI: 0;71-0,97; median OS [mOS]: 11,1 vs 9,7 måneder) og planocellulær histologi (HR 0,88; 95 % KI: 0,69-1,13; mOS: 9,5 vs 8,2 måneder); patienter med tidligere vedligeholdelsesbehandling (HR 0,69; 95 % KI: 0,51-0,93; mOS: 14,4 vs 10,4 måneder); tid siden start af tidligere behandling < 9 måneder (HR 0,75; 95 % KI: 0,64-0,88; mOS: 9,3 vs 7,0 måneder; patienter < 65 år (HR 0,74, 95 % KI: 0,62-0,87; mOS: 11,3 vs 8,9 måneder).
A consistent improvement (ramucirumab plus docetaxel vs placebo plus docetaxel) was observed in important subgroups for PFS and OS. OS subgroup results included the following: non-squamous histology (HR 0.83; 95% CI: 0.71 to 0.97; median OS [mOS]: 11.1 vs 9.7 months) and squamous histology (HR 0.88; 95% CI: 0.69 to 1.13; mOS: 9.5 vs 8.2 months); patients with prior maintenance (HR 0.69; 95% CI: 0.51 to 0.93; mOS: 14.4 vs 10.4 months); time since start of prior therapy <9 months (HR 0.75; 95% CI: 0.64 to 0.88; mOS: 9.3 vs 7.0 months); patients <65 years old (HR 0.74, 95% CI: 0.62, 0.87; mOS: 11.3 vs 8.9 months).
Patienterne skulle have oplevet sygdomsprogression under førstelinjebehandling eller inden for 4 måneder efter sidste dosis af førstelinjebehandlingen og have en ECOG PS på 0-1.
Patients were required to have experienced disease progression during, or within 4 months after the last dose of first-line therapy and with ECOG PS 0-1.