Iskalni niz je ali predolg ali pa vsebuje preveč besed.
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NPO
1 Prevajalska redakcija
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EMEA
Samo NPO
BSC Alone
2 Prevajalska redakcija
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EMEA
Vectibix+NPO
Vectibix+BSC
3 Prevajalska redakcija
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EMEA
CCR so obsegali samo NPO (n = 105), nizek odmerek citarabina in NPO (n = 49) ali standardno indukcijsko kemoterapijo in NPO (n = 25).
CCR consisted of BSC alone (n = 105), low-dose cytarabine plus BSC (n = 49) or standard induction chemotherapy plus BSC (n = 25).
4 Prevajalska redakcija
RS
EMEA
11, 1, 18, 6) med bolniki, deležnimi samo NPO.
11.1, 18.6 ] for patients receiving BSC alone.
5 Prevajalska redakcija
RS
EMEA
Nekorigirano razmerje tveganja za skupino s peroralnim topotekanom in NPO glede na skupino s samo NPO je bilo 0, 64 (95 % IZ:
The unadjusted hazard ratio for oral topotecan plus BSC group relative to BSC alone group was 0.64 (95 % CI:
6 Prevajalska redakcija
RS
EMEA
84 dni za peroralni topotekan in NPO, 90 dni za NPO), pri katerih ponovno zdravljenje z intravensko kemoterapijo ni bilo primerno.
84 days for oral topotecan + BSC, 90 days for BSC ] and for whom retreatment with intravenous chemotherapy was not considered appropriate.
7 Prevajalska redakcija
RS
EMEA
Izboljšanje preživetja z zdravilom Vidaza je bilo dosledno, ne glede na izbrano skupino CCR (samo NPO, nizek odmerek citarabina in NPO ali standardna indukcijska kemoterapija in NPO) v kontrolni skupini.
The survival benefits of Vidaza were consistent regardless of the CCR treatment option (BSC alone, low-dose cytarabine plus BSC or standard induction chemotherapy plus BSC) utilised in the control arm.
8 Prevajalska redakcija
RS
EMEA
6, 1, 14, 1 ] bolnikov, ki so dobivali Vectibix in NPO, in pri 0 % [ 95 % IZ:
6.1, 14.1 ] Vectibix plus BSC patients, and 0 % [ 95 % CI:
9 Prevajalska redakcija
RS
EMEA
Deleža preživetja brez napredovanja na prvem pričakovanem obisku (8. teden) sta bila 45, 5 % z Vectibixom in NPO in 24, 6 % samo z NPO, kar je razlika 20, 9 % [ 95 % IZ:
The progression-free survival rates at the first scheduled visit (week 8) were 45.5 % on Vectibix plus BSC and 24.6 % on BSC alone, a difference of 20.9 % [ 95 % CI:
10 Prevajalska redakcija
RS
EMEA
84 dni za zdravljenje s peroralnim topotekanom v kombinaciji z NPO; 90 dni za zdravljenje z NPO samo ] in pri katerih zdravljenje z intravensko obliko kemoterapije ni bilo primerno.
84 days for oral topotecan + BSC, 90 days for BSC ] and for whom retreatment with i. v chemotherapy was not considered appropriate.
11 Prevajalska redakcija
RS
EMEA
Mediano preživetje bolnikov, zdravljenih s topotekanom in NPO, je bilo 25, 9 tedna [ 95 % IZ:
The median survival for patients treated with topotecan + BSC was 25.9 weeks [ 95 % C. I.
12 Prevajalska redakcija
RS
EMEA
Celotno preživetje v skupini, ki je dobivala peroralni topotekan in NPO, je bilo statistično značilno boljše kot v skupni, ki je bila deležna le NPO (vrednost p za log- rang = 0, 0104).
Oral topotecan plus BSC group had a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p=0.0104).
13 Prevajalska redakcija
RS
EMEA
To gre morda na račun bolnikov, randomiziranimi na NPO, ki so po napredovanju dobivali panitumumab.
This may be due to patients receiving panitumumab after progression among those randomized to BSC.
14 Prevajalska redakcija
RS
EMEA
Deleža preživetja brez napredovanja na prvem načrtovanem pregledu (8. teden) v skupini z divjim tipom KRAS sta bila 59, 7 % z Vectibixom in NPO in 21, 0 % samo z NPO, kar je razlika 38, 7 % [ 95 % IZ:
The progression-free survival rates at the first scheduled visit (week 8) in the KRAS wild-type group were 59.7 % on Vectibix plus BSC and 21.0 % on BSC alone, a difference of 38.7 % [ 95 % CI:
15 Prevajalska redakcija
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EMEA
Bolniki so bili v razmerju 1: 1 randomizirani bodisi na zdravljenje z Vectibixom v odmerku 6 mg/ kg enkrat na dva tedna in najboljšo podporno oskrbo (NPO) (kar ni vključevalo kemoterapije) bodisi na samo NPO.
Patients were randomised 1:1 to receive Vectibix at a dose of 6 mg/ kg given once every two weeks plus best supportive care (not including chemotherapy) (BSC) or BSC alone.
16 Prevajalska redakcija
RS
EMEA
Deleža preživetja brez napredovanja na prvem načrtovanem pregledu (8. teden) v skupini z mutantnim KRAS sta bila 21, 4 % z Vectibixom in NPO in 28, 0 % samo z NPO, kar je razlika - 6, 6 % [ 95 % IZ: - 19, 0, 5, 9 ].
The progression-free survival rates at the first scheduled visit (week 8) in the KRAS mutant group were 21.4 % on Vectibix plus BSC and 28.0 % on BSC alone, a difference of -6.6 % [ 95 % CI: -19.0, 5.9 ].
17 Prevajalska redakcija
RS
EMEA
Azacitidin z najboljšo podporno oskrbo (NPO) (n = 179) je bil primerjan z običajnimi režimi oskrbe (CCR - conventional care regimens).
Azacitidine plus best supportive care (BSC) (n = 179) was compared to conventional care regimens (CCR).
18 Prevajalska redakcija
RS
EMEA
Srednji čas preživetja bolnikov, ki so bili zdravljeni s peroralnim topotekanom v kombinaciji z NPO je bil 25, 9 tednov [ 95 % interval zaupanja 18, 3; 31, 6 ] pri bolnikih, ki so bili zdravljeni z NPO samo pa 13, 9 tednov [ 95 % interval zaupanja 11, 1; 18, 6 ] [ p=0. 0104 ].
The median survival for patients treated with topotecan + BSC was 25.9 weeks [ 95 % C. I. 18.3, 31.6 ] compared to 13.9 weeks [ 95 % C. I. 11.1, 18.6 ] for patients receiving BSC alone [ p=0.0104 ].
19 Prevajalska redakcija
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EMEA
Delež odziva (raziskovalčeva ocena) pri bolnikih, ki so po napredovanju ob uporabi NPO prešli v skupino s panitumumabom, je bil 22 % (95 % IZ:
Response rate (investigator assessment) in patients that crossed over to panitumumab after progression on BSC alone was 22 % (95 % CI:
20 Prevajalska redakcija
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EMEA
Relaps drobnoceličnega pljučnega raka V preskušanju III. faze (študija 478) so primerjali peroralni topotekan v kombinaciji z najboljšo podporno oskrbo [ NPO ] (n = 71) in NPO samo (n = 70) pri bolnikih z relapsom po terapiji prve izbire (mediani čas do napredovanja od terapije prve izbire:
Relapsed SCLC A phase III trial (study 478) compared oral topotecan plus Best Supportive Care [ BSC ] [ n=71 ] with BSC alone [ n=70 ] in patients who had relapsed following first line therapy [ median time to progression [ TTP ] from first-line therapy:
21 Prevajalska redakcija
RS
EMEA
Med 176 bolniki, ki so dobili Vectibix po napredovanju med zdravljenjem s samo NPO, je bil delež odziva (po raziskovalčevi oceni) 11, 4 % (95 % IZ:
Among the 176 patients who received Vectibix after progression on BSC alone, the response rate (investigator assessment) was 11.4 % (95 % CI:
22 Prevajalska redakcija
RS
EMEA
Po napredovanju bolezni so bolniki, ki so prejemali samo NPO, lahko prešli v spremljajočo študijo in dobivali Vectibix v odmerku 6 mg/ kg enkrat na dva tedna.
Upon disease progression BSC alone patients were eligible to crossover to a companion study and receive Vectibix at a dose of 6 mg/ kg given once every two weeks.
23 Prevajalska redakcija
RS
EMEA
41 Neslepljeno ocenjene navedbe bolnikov samih o simptomih so pokazale dosleden trend k boljšemu simptomatskemu stanju v skupini, zdravljeni s peroralnim topotekanom in NPO.
Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan + BSC.
24 Prevajalska redakcija
RS
EMEA
V analizi, ki je uporabila korekcijo možne pristranosti zaradi nenačrtovanih ocenjevanj, je bil delež napredovanja bolezni ali smrti pri bolnikih, ki so dobivali Vectibix, za 40 % manjši od tistega pri bolnikih, ki so dobivali NPO [ razmerje ogroženosti = 0, 60, (95 % IZ: 0, 49, 0, 74), stratificirani log- rang test: p < 0, 0001 ].
In an analysis adjusting for potential bias from unscheduled assessments, the rate of disease progression or death in patients who received Vectibix was reduced by 40 % relative to patients that received BSC [ Hazard Ratio = 0.60, (95 % CI 0.49, 0.74), stratified log-rank p < 0.0001 ].
25 Prevajalska redakcija
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EMEA
• CA225025: v tej randomizirani študiji so pri bolnikih z metastatskim kolorektalnim rakom, ki so predhodno prejemali zdravljenje na osnovi oksaliplatina, iritonekana in fluoropirimidina, primerjali dodajanje cetuksimaba kot samostojnega zdravila k najboljši podporni oskrbi (NPO) (287 bolnikov) z najboljšo podporno oskrbo (285 bolnikov).
• CA225025: This randomised study in patients with metastatic colorectal cancer who had received prior oxaliplatin-, irinotecan- and fluoropyrimidine-based treatment for metastatic disease compared the addition of cetuximab as a single agent to best supportive care (BSC) (287 patients) with best supportive care (285 patients).
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NPO