natgillin/translations-raw huggingface dataset:
There is evidence that the metabolism of 5-FU in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid, thereby interfering with the synthesis of deoxyribonucleic acid (DNA).
16 Obstajajo dokazi, da presnova 5- FU v anabolični poti zavira reakcijo metiliranja deoksiuridinske kisline v timidinsko kislino, s čimer ovira sintezo deoksiribonukleinske kisline (DNA).
The incorporation of 5-FU also leads to inhibition of RNA and protein synthesis.
Vgraditev 5 - FU zavira tudi sintezo RNA in proteinov.
Since DNA and RNA are essential for cell division and growth, the effect of 5-FU may be to create a thymidine deficiency that provokes unbalanced growth and death of a cell.
Ker sta RNA in DNA bistveni za rast in delitev celice, povzroči 5- FU pomanjkanje timidina, kar izzove neuravnoteženo rast in smrt celice.
The effects of DNA and RNA deprivation are most marked on those cells which proliferate more rapidly and which metabolise 5-FU at a more rapid rate.
Učinki pomanjkanja DNA in RNA so najopaznejši v celicah, ki se hitreje delijo in hitreje presnavljajo 5- FU.
15 Colon and colorectal cancer:
Rak kolona in kolorektalni rak:
Adjuvant Therapy with Xeloda in colon cancer Data from one multicentre, randomised, controlled phase III clinical trial in patients with stage III (Dukes’ C) colon cancer supports the use of Xeloda for the adjuvant treatment of patients with colon cancer (XACT Study; M66001).
Adjuvantno zdravljenje z zdravilom Xeloda pri raku kolona Podatki iz multicentričnega, randomiziranega, kontroliranega kliničnega preskušanja faze III pri bolnikih s stadijem III raka kolona (Dukes C) podpirajo uporabo zdravila Xeloda za adjuvantno zdravljenje bolnikov z rakom kolona (študija X- ACT, M66001).
In this trial, 1987 patients were randomised to treatment with Xeloda (1250 mg/ m2 twice daily for 2 weeks followed by a 1-week rest period and given as 3-week cycles for 24 weeks) or 5-FU and leucovorin (Mayo Clinic regimen:
V tem preskušanju so randomizirali 1987 bolnikov v zdravljenje z zdravilom Xeloda (1250 mg/ m2 dvakrat na dan 2 tedna, sledil je enotedenski premor, dobili so 3- tedenske cikluse v 24 tednih) ali s 5- FU in levkovorinom (shema Mayo:
20 mg/ m2 leucovorin IV followed by 425 mg/ m2 IV bolus 5-FU, on days 1 to 5, every 28 days for 24 weeks).
20 mg/ m2 levkovorina intravensko, sledilo je 425 mg/ m2 5- FU v obliki intravenskega bolusa vsakih 28 dni – na prvi do peti dan 24 tednov).
Xeloda was at least equivalent to IV 5-FU/ LV in disease-free survival in per protocol population (hazard ratio 0.92; 95% CI 0.80- 1.06).
Glede na preživetje brez bolezni v populaciji po protokolu je bilo zdravilo Xeloda vsaj ekvivalentno intravenskemu 5- FU/ LV (razmerje ogroženosti 0, 92; 95 -% interval zaupanja 0, 80−1, 06).
In the all-randomised population, tests for difference of Xeloda vs 5-FU/ LV in disease-free and overall survival showed hazard ratios of 0.88 (95% CI 0.77 – 1.01; p = 0.068) and 0.86 (95% CI 0.74 – 1.01; p = 0.060), respectively.
V celotni randomizirani populaciji so analize zdravljenja z zdravilom Xeloda v primerjavi s 5- FU/ LV v preživetju brez bolezni pokazale razmerje ogroženosti 0, 88 (95 -% interval zaupanja 0, 77−1, 01; p = 0, 068), v celokupnem preživetju pa 0, 86 (95 -% interval zaupanja 0, 74−1, 01; p = 0, 060).
The median follow up at the time of the analysis was 6.9 years.
Mediana spremljanja v času analize je bila 6, 9 leta.
In a preplanned multivariate Cox analysis, superiority of Xeloda compared with bolus 5-FU/ LV was demonstrated.
V vnaprej načrtovani multivariantni Coxovi analizi so dokazali superiornost zdravila Xeloda v primerjavi s 5 - FU/ LV v bolusu.
In the all-randomised population, Xeloda was shown to be superior to 5FU/ LV for disease-free survival (hazard ratio 0.849; 95% CI 0.739 - 0.976; p = 0.0212), as well as for overall survival (hazard ratio 0.828; 95% CI 0.705 - 0.971; p = 0.0203).
V celotni randomizirani populaciji je bilo zdravilo Xeloda superiorno v primerjavi s 5- FU/ LV v preživetju brez bolezni (razmerje ogroženosti 0, 849; 95 -% interval zaupanja 0, 739−0, 976; p = 0, 0212), kot tudi v celokupnem preživetju (razmerje ogroženosti 0, 828; 95 -% interval zaupanja 0, 705−0, 971; p = 0, 0203).
Currently, data on the use of Xeloda in combination with other chemotherapeutic agents in adjuvant therapy of colon cancer is not available.
Trenutno ni na voljo podatkov o uporabi zdravila Xeloda v kombinaciji z drugimi kemoterapijami pri adjuvantnem zdravljenju raka kolona.
Monotherapy with Xeloda in metastatic colorectal cancer Data from two identically-designed, multicentre, randomised, controlled phase III clinical trials (SO14695; SO14796) support the use of Xeloda for first line treatment of metastatic colorectal cancer.
Samostojno zdravljenje z zdravilom Xeloda pri metastatskem kolorektalnem raku Podatki dveh enako zasnovanih multicentričnih, randomiziranih, kontroliranih preskušanj faze III (SO14695, SO14796) podpirajo uporabo zdravila Xeloda v prvi liniji zdravljenja metastatskega kolorektalnega raka.
604 patients were randomised to treatment with 5-FU and leucovorin (Mayo regimen:
V teh študijah so 603 randomizirane bolnike zdravili z zdravilom Xeloda v tritedenskem ciklu jemanja 1250 mg/ m2/ dvakrat na dan 14 dni, čemur je sledil enotedenski premor, 604 randomizirane bolnike pa s 5- FU in levkovorinom (shema Mayo:
20 mg/ m2 leucovorin IV followed by 425 mg/ m2 IV bolus 5-FU, on days 1 to 5, every 28 days).
20 mg/ m2 levkovorina intravensko, sledilo je 425 mg/ m2 5- FU v obliki intravenskega bolusa vsakih 28 dni – na prvi do peti dan).
16.7% (Mayo regimen); p < 0.0002.
Celokupen odgovor v randomiziranih skupinah (raziskovalčeva ocena) je bil 25, 7% (Xeloda) v primerjavi s 16, 7% (shema Mayo); p < 0, 0002.
144 days (Mayo regimen).
Mediana časa do napredovanja bolezni je bila 140 dni (Xeloda) v primerjavi s 144 dnevi (shema Mayo).
391 days (Mayo regimen).
Mediana preživetja je bila 392 dni (Xeloda) v primerjavi s 391 dnevi (shema Mayo).
Currently, no comparative data are available on Xeloda monotherapy in colorectal cancer in comparison with first line combination regimens.
Trenutno še nimamo podatkov o primerjavi samostojnega zdravljenja z zdravilom Xeloda s kombiniranim zdravljenjem v okviru prvega zdravljenja.
16 Combination therapy in first-line treatment of metastatic colorectal cancer Data from a multicentre, randomised, controlled phase III clinical study (NO16966) support the use of Xeloda in combination with oxaliplatin or in combination with oxaliplatin and bevacizumab for the first-line treatment of metastatic colorectal cancer.
Kombinirano zdravljenje v prvi liniji metastatskega kolorektalnega raka Podatki iz multicentrične, randomizirane, kontrolirane klinične študije faze III (NO16966) podpirajo uporabo zdravila Xeloda v kombinaciji z oksaliplatinom ali v kombinaciji z oksaliplatinom in bevacizumabom v prvi liniji zdravljenja metastatskega kolorektalnega raka.
The study contained two parts: an initial 2-arm part in which 634 patients were randomised to two different treatment groups, including XELOX or FOLFOX-4, and a subsequent 2x2 factorial part in which 1401 patients were randomised to four different treatment groups, including XELOX plus placebo, FOLFOX-4 plus placebo, XELOX plus bevacizumab, and FOLFOX-4 plus bevacizumab.
Študija je bila sestavljena iz dveh delov: začetnega dela iz dveh skupin, v katerem so 634 bolnikov randomizirali v dve različni skupini zdravljenja, po shemi XELOX ali shemi FOLFOX- 4, in poznejšega dela s faktorskim načrtom 2x2 v katerem so 1401 bolnika randomizirali v štiri različne skupine zdravljenja, XELOX in placebo, FOLFOX- 4 in placebo, XELOX in bevacizumab ter FOLFOX- 4 in bevacizumab.
Table 6
17 Preglednica 6.
Treatment Regimens in Study NO16966 (mCRC) Treatment Starting Dose
Sheme zdravljenja Zdravljenje
Schedule
Začetni odmerek Shema zdravljenja 2
FOLFOX-4 or
FOLFOX- 4 ali
Oxaliplatin on Day 1, every 2 weeks Leucovorin on Days 1 and 2, every 2
oksaliplatin 1. dan, vsake 2 tedna levkovorin 1. in 2. dan, vsake 2 tedna
5-Fluorouracil
5- fluorouracil
400 mg/ m2 IV bolus,
400 mg/ m2 i. v. bolus,
5-fluorouracil IV bolus/ infusion,
5- fluorouracil i. v. bolus/ infuzija,
followed by 600 mg/ m2 IV 22 hr
22 h
each on Days 1 and 2, every 2 weeks
oboje 1. in 2. dan, vsake 2 tedna
Day 1, prior to FOLFOX-4, every 2 weeks
1. dan, pred FOLFOX- 4, vsake 2 tedna
130 mg/ m2 IV 2 hr 2 1000 mg/ m oral
1000 mg/ m2 peroralno
Oxaliplatin on Day 1, every 3 weeks Capecitabine oral twice daily for 2
oksaliplatin 1. dan, vsake 3 tedne kapecitabin peroralno dvakrat na dan 2 tedna (sledi 1- tedenski premor)
XELOX+ Bevacizumab
XELOX + bevacizumab
twice daily
dvakrat na dan
7.5 mg/ kg IV 30-90 mins
30– 90 min
IV bolus injection immediately after leucovorin
i. v. injekcija v bolusu neposredno po levkovorinu
Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival in the eligible patient population and the intent-to-treat population (see Table 7).
Ne- inferiornost zdravljenja, ki vsebuje XELOX v primerjavi z zdravljenjem, ki vsebuje FOLFOX- 4 v celokupni primerjavi, je bila dokazana glede na preživetje brez napredovanja bolezni v primerni populaciji bolnikov in populaciji bolnikov, ki so jo nameravali zdraviti (glejte preglednico 7).
The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see Table 7).
Glede na rezultate za celokupno preživetje je zdravljenje po shemi XELOX enakovredno zdravljenju po shemi FOLFOX- 4 (glejte preglednico 7).
A comparison of XELOX plus bevacizumab versus FOLFOX-4 plus bevacizumab was a pre-specified exploratory analysis.
Primerjava zdravljenja po shemi XELOX v kombinaciji z bevacizumabom in zdravljenja po shemi FOLFOX- 4 v kombinaciji z bevacizumabom je bila vnaprej določena eksploratorna analiza.
In this treatment subgroup comparison, XELOX plus bevacizumab was similar compared to FOLFOX-4 plus bevacizumab in terms of progression-free survival (hazard ratio 1.01; 97.5% CI 0.84 - 1.22).
V tej primerjavi podskupin je bilo preživetje brez napredovanja bolezni v skupini, ki se je zdravila po shemi XELOX v kombinaciji z bevacizumabom, podobno kot v skupini, ki se je zdravila po shemi FOLFOX- 4 v kombinaciji z bevacizumabom (razmerje ogroženosti 1, 01; 97, 5 -% interval zaupanja 0, 84−1, 22).
The median follow up at the time of the primary analyses in the intent-to-treat population was 1.5 years; data from analyses following an additional 1 year of follow up are also included in Table 7.
Mediana spremljanja v času primarne analize v populaciji, ki so jo nameravali zdraviti, je bila 1, 5 leta; podatki iz analize po dodatnem enoletnem spremljanju so prav tako vključeni v preglednico 7.
However, the on-treatment PFS analysis did not confirm the results of the general PFS and OS analysis: the hazard ratio of XELOX versus FOLFOX-4 was 1.24 with 97.5% CI 1.07 - 1.44.
Analiza preživetja brez napredovanja bolezni ob zdravljenju (on - treatment progression- free survival) ni potrdila rezultata celotne analize preživetja brez napredovanja bolezni in celokupnega preživetja: razmerje ogroženosti za zdravljenje po shemi XELOX v primerjavi s FOLFOX- 4 je bilo 1, 24 (97, 5 -% interval zaupanja 1, 07−1, 44).
Although sensitivity analyses show that differences in regimen schedules and timing of tumor assessments impact the on- treatment PFS analysis, a full explanation for this result has not been found.
Čeprav je analiza občutljivosti pokazala, da na preživetje brez napredovanja bolezni ob zdravljenju vplivajo razlike med odmerjanji v shemah zdravljenja in čas ocene tumorja, popolne razlage tega rezultata niso našli.
Key efficacy results for
18 Preglednica 7.
the non-inferiority analysis of Study NO16966 P R I M A R Y A N A L Y S IS
Glavni rezultati o učinkovitosti za analizo ne- inferiornosti v študiji NO16966.
XELOX/ XELOX+P/ XELOX+BV
OSNOVNA ANALIZA XELOX/ XELOX + P / FOLFOX- 4/ FOLFOX- 4 + P / XELOX + BEVACIZUMAB FOLFOX- 4 + BEVACIZUMAB
N= 1017)
(EPP *: n = 967; ITT **: n = 1017) (EPP *: n = 937; ITT **: n = 1017) Razmerje ogroženosti
(97.5% CI)
(97, 5 -% CI)
Progression-free Survival
Preživetje brez napredovanja bolezni 241
577 581 ADDITIONAL 1 YEAR OF FOLLOW UP
577 581 DODATNO ENOLETNO SPREMLJANJE
0.97 (0.84; 1.14) 0.96 (0.83; 1.12) HR
0, 97 (0, 84; 1, 14) 0, 96 (0, 83; 1, 12) Razmerje ogroženosti
Progression-free Survival
Preživetje brez napredovanja bolezni 242
*EPP=eligible patient population; **ITT=intent-to-treat population
* EPP = primerna populacija bolnikov (eligible patient population); ** ITT = populacija bolnikov, ki so jih nameravali zdraviti (intent- to- treat population); CI = interval zaupanja (confidence interval); P = placebo
Data from a randomised, controlled phase III study (CAIRO) support the use of Xeloda at a starting dose of 1000 mg/ m2 for 2 weeks every 3 weeks in combination with irinotecan for the first-line treatment of patients with metastatic colorectal cancer.
Podatki iz randomizirane, kontrolirane študije faze III (CAIRO) podpirajo uporabo zdravila Xeloda v začetnem odmerku 1000 mg/ m2 2 tedna vsake 3 tedne v kombinaciji z irinotekanom v prvi liniji zdravljenja bolnikov z metastatskim kolorektalnim rakom.
820 Patients were randomized to receive either sequential treatment (n=410) or combination treatment (n=410).
V skupino, ki je prejela zaporedno zdravljenje (n = 410) in skupino, ki je prejela kombinacijo zdravil (n = 410), so randomizirali 820 bolnikov.
Sequential treatment consisted of first-line treatment with Xeloda (1250 mg/ m2 twice daily for 14 days), second-line irinotecan (350 mg/ m2 on day 1), and third-line combination of capecitabine (1000 mg/ m2 twice daily for 14 days) with oxaliplatin (130 mg/ m2 on day 1).
Zaporedno zdravljenje je vključevalo zdravljenje z zdravilom Xeloda (1250 mg/ m2 dvakrat na dan 14 dni) v prvi liniji, z irinotekanom (350 mg/ m2 1. dan) v drugi liniji in s kombinacijo kapecitabina (1000 mg/ m2 dvakrat na dan 14 dni) in oksaliplatina (130 mg/ m2 1. dan) v tretji liniji.
Combination treatment consisted of first-line treatment of Xeloda (1000 mg/ m2 twice daily for 14 days) combined with irinotecan (250 mg / m2 on day 1) (XELIRI) and second-line capecitabine (1000 mg/ m2 twice daily for 14 days) plus oxaliplatin (130 mg/ m2 on day 1).
Zdravljenje s kombinacijo zdravil je vključevalo zdravljenje z zdravilom Xeloda (1000 mg/ m2 dvakrat na dan 14 dni) in irinotekanom (250 mg/ m2 1. dan) (XELIRI) v prvi liniji ter kapecitabinom (1000 mg/ m2 dvakrat na dan 14 dni) in oksaliplatinom (130 mg/ m2 1. dan) v drugi liniji.
In first-line treatment the median progression-free survival in the intent-to-treat population was 5.8 months (95%CI 5.1 - 6.2 months) for Xeloda monotherapy and 7.8 months (95%CI 7.0 - 8.3 months; p=0.0002) for XELIRI.
V prvi liniji zdravljenja je bila mediana preživetja brez napredovanja bolezni v populaciji, ki so jo nameravali zdraviti, 5, 8 meseca (95 -% interval zaupanja 5, 1−6, 2 meseca) za samostojno zdravljenje z zdravilom Xeloda in 7, 8 meseca (95 -% interval zaupanja 7, 0−8, 3 meseca; p = 0, 0002) za zdravljenje s shemo XELIRI.
Data from an interim analysis of a multicentre, randomised, controlled phase II study (AIO KRK 0604) support the use of Xeloda at a starting dose of 800 mg/ m2 for 2 weeks every 3 weeks in combination with irinotecan and bevacizumab for the first-line treatment of patients with metastatic colorectal cancer.
Podatki iz vmesne analize multicentrične, randomizirane, kontrolirane študije faze II (AIO KRK 0604) podpirajo uporabo zdravila Xeloda v začetnem odmerku 800 mg/ m2 2 tedna vsake 3 tedne v kombinaciji z irinotekanom in bevacizumabom v prvi liniji zdravljenja bolnikov z metastatskim kolorektalnim rakom.
Xeloda (800 mg/ m2 twice daily for two weeks followed by a 7-day rest period), irinotecan (200 mg/ m2 as a 30 minute infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/ kg as a 30 to 90 minute infusion on day 1 every 3 weeks); a total of 118 patients were randomised to treatment with Xeloda combined with oxaliplatin plus bevacizumab:
Randomizirali so 115 bolnikov v zdravljenje z zdravilom Xeloda v kombinaciji z irinotekanom (XELIRI) in bevacizumabom: zdravilo Xeloda (800 mg/ m2 dvakrat na dan dva tedna, čemur je sledil 7- dnevni premor), irinotekan (200 mg/ m2 v 30- minutni infuziji 1. dan vsake 3 tedne) in bevacizumab (7, 5 mg/ kg v 30 do 90- minutni infuziji 1. dan vsake 3 tedne).
Xeloda (1000 mg/ m2 twice daily for two weeks followed by a 7-day rest period), oxaliplatin (130 mg/ m2 as a 2 hour infusion on day 1 every 3 weeks), and bevacizumab (7.5 mg/ kg as a 30 to 90 minute infusion on day 1 every 3 weeks).
V zdravljenje z zdravilom Xeloda v kombinaciji z oksaliplatinom in bevacizumabom pa je bilo skupaj randomiziranih 118 bolnikov: zdravilo Xeloda (1000 mg/ m2 dvakrat na dan dva tedna, čemur je sledil 7- dnevni premor), oksaliplatin (130 mg/ m2 v 2- urni infuziji 1. dan vsake 3 tedne) in bevacizumab (7, 5 mg/ kg v 30 do 90 - minutni infuziji 1. dan vsake 3 tedne).
Progression-free survival at 6 months in the intent-to-treat population was 80% (XELIRI plus bevacizumab) versus 74% (XELOX plus bevacizumab).
Preživetje brez napredovanja bolezni po 6 mesecih v populaciji, ki so jo nameravali zdraviti, je bilo 80% (XELIRI in bevacizumab) v primerjavi s 74% (XELOX in bevacizumab).
Overall response rate (complete response plus partial response) was 45% (XELOX plus bevacizumab) versus 47% (XELIRI plus bevacizumab).
Celokupen odgovor (skupek popolnega in delnega) je bil 45% (XELOX in bevacizumab) v primerjavi s 47% (XELIRI in bevacizumab).
Combination therapy in second-line treatment of metastatic colorectal cancer Data from a multicentre, randomised, controlled phase III clinical study (NO16967) support the use of Xeloda in combination with oxaliplatin for the second-line treatment of metastastic colorectal cancer.
19 Kombinirano zdravljenje v drugi liniji metastatskega kolorektalnega raka Podatki iz multicentrične, randomizirane, kontrolirane klinične študije faze III (NO16967) podpirajo uporabo zdravila Xeloda v kombinaciji z oksaliplatinom v drugi liniji zdravljenja metastatskega kolorektalnega raka.
In this trial, 627 patients with metastatic colorectal carcinoma who have received prior treatment with irinotecan in combination with a fluoropyrimidine regimen as first line therapy were randomised to treatment with XELOX or FOLFOX-4.
V tem preskušanju je bilo 627 bolnikov z metastatskim kolorektalnim rakom, ki so prej prejeli zdravljenje z irinotekanom v kombinaciji s fluoropirimidini v prvi liniji zdravljenja, randomiziranih v zdravljenje po shemi XELOX ali FOLFOX- 4.
XELOX was demonstrated to be non-inferior to
Odmerjanje zdravljenja po shemah XELOX in FOLFOX- 4 (brez dodatka placeba ali bevacizumaba) je opisano v preglednici 6.
18 FOLFOX-4 in terms of progression-free survival in the per-protocol population and intent-to-treat population (see Table 8).
Zdravljenje po shemi XELOX je bilo ne- inferiorno zdravljenju po shemi FOLFOX- 4 glede na preživetje brez napredovanja bolezni v populaciji po protokolu in populaciji, ki so jo nameravali zdraviti (glejte preglednico 8).
The results indicate that XELOX is equivalent to FOLFOX-4 in terms of overall survival (see Table 8).
Glede na rezultate za celokupno preživetje je zdravljenje po shemi XELOX enakovredno zdravljenju po shemi FOLFOX- 4 (glejte preglednico 8).
The median follow up at the time of the primary analyses in the intent- to-treat population was 2.1 years; data from analyses following an additional 6 months of follow up are also included in Table 8.
Mediana spremljanja v času primarne analize v populaciji, ki so jo nameravali zdraviti, je bila 2, 1 leta; podatki iz analize po dodatnih 6 mesecih spremljanja so prav tako vključeni v preglednico 8.
the non-inferiority analysis of Study NO16967 PRIMARY ANALYSIS
Glavni rezultati o učinkovitosti za analizo ne- inferiornosti v študiji NO16967.
XELOX
OSNOVNA ANALIZA XELOX FOLFOX- 4
N= 314) HR
(PPP *: n = 251; ITT **: n = 313) (PPP *: n = 252; ITT **: n = 314) Razmerje ogroženosti
(95% CI)
(95 -% CI)
Progression-free Survival
Preživetje brez napredovanja bolezni 154
ADDITIONAL 6 MONTHS OF FOLLOW UP HR
DODATNO ŠESTMESEČNO SPREMLJANJE Razmerje ogroženosti
*PPP=per-protocol population; **ITT=intent-to-treat population
* PPP = populacija po protokolu (per- protocol population); ** ITT = populacija, ki so jo nameravali zdraviti (intent- to- treat population), CI = interval zaupanja (confidence interval)
Data from a multicentre, randomised, controlled phase III clinical trial in patients with advanced gastric cancer supports the use of Xeloda for the first-line treatment of advanced gastric cancer (ML17032).
Podatki iz multicentričnega, randomiziranega, kontroliranega kliničnega preskušanja faze III pri bolnikih z napredovalim rakom želodca podpirajo uporabo zdravila Xeloda v prvi liniji zdravljenja napredovalega raka želodca (ML17032).
In this trial, 160 patients were randomised to treatment with Xeloda (1000 mg/ m2 twice daily for 2 weeks followed by a 7-day rest period) and cisplatin (80 mg/ m2 as a 2-hour infusion every 3 weeks).
V tem preskušanju so 160 bolnikov randomizirali v zdravljenje z zdravilom Xeloda (1000 mg/ m2 dvakrat na dan 2 tedna, sledil je 7- dnevni premor) in cisplatinom (80 mg/ m2, v 2- urni infuziji vsake 3 tedne).
A total of 156 patients were randomised to treatment with 5-FU (800 mg/ m2 per day, continuous infusion on days 1 to 5 every 3 weeks) and cisplatin (80 mg/ m2 as a 2-hour infusion on day 1, every 3 weeks).
V zdravljenje s 5- FU (800 mg/ m2 na dan, v kontinuirani infuziji od 1. do 5. dne vsake 3 tedne) in cisplatinom (80 mg/ m2, v 2- urni infuziji 1. dan, vsake 3 tedne) pa so skupno randomizirali 156 bolnikov.
Xeloda in combination with cisplatin was non-inferior to 5-FU in combination with cisplatin in terms of progression-free survival in the per protocol analysis (hazard ratio 0.81; 95% CI 0.63 - 1.04).
Zdravilo Xeloda je bilo v kombinaciji s cisplatinom neinferiorno kombinaciji 5- FU in cisplatina glede na preživetje brez napredovanja bolezni v analizi po protokolu (razmerje ogroženosti 0, 81; 95 -% interval zaupanja 0, 63– 1, 04).
The median progression-free survival was 5.6 months (Xeloda + cisplatin) versus 5.0 months (5-FU + cisplatin).
Mediana preživetja brez napredovanja bolezni je bila 5, 6 meseca (Xeloda + cisplatin) v primerjavi s 5, 0 meseca (5- FU + cisplatin).
The hazard ratio for duration of survival (overall survival) was similar to the hazard ratio for progression-free survival (hazard ratio 0.85; 95% CI 0.64 - 1.13).
Razmerje ogroženosti za trajanje preživetja (celokupnega) je bilo podobno razmerju ogroženosti za preživetje brez napredovanja bolezni (razmerje ogroženosti 0, 85; 95 -% interval zaupanja 0, 64– 1, 13).
The median duration of survival was 10.5 months (Xeloda + cisplatin) versus 9.3 months (5-FU + cisplatin).
Mediana trajanja preživetja je bila 10, 5 meseca (Xeloda + cisplatin) v primerjavi z 9, 3 meseca (5- FU + cisplatin).
Data from a randomised multicentre, phase III study comparing capecitabine to 5-FU and oxaliplatin to cisplatin in patients with advanced gastric cancer supports the use of Xeloda for the first-line treatment of advanced gastric cancer (REAL-2).
20 Podatki iz randomizirane, multicentrične študije faze III, ki je primerjala kapecitabin s 5- FU in oksaliplatin s cisplatinom pri bolnikih z napredovalim rakom želodca, podpirajo uporabo zdravila Xeloda v prvi liniji zdravljenja napredovalega raka želodca (REAL- 2).
In this trial, 1002 patients were randomised in a 2x2 factorial design to one of the following 4 arms:
V tem preskušanju sta bila 1002 bolnika randomizirana v eno od naslednjih štirih skupin po 2x2 faktorskem načrtu:
- ECF: epirubicin (50 mg/ m2 as a bolus on day 1 every 3 weeks), cisplatin (60 mg/ m2 as a two
ECF: epirubicin (50 mg/ m2 kot bolus 1. dan vsake 3 tedne), cisplatin (60 mg/ m2 v 2- urni infuziji
hour infusion on day 1 every 3 weeks) and 5-FU (200 mg/ m2 daily given by continuous infusion via a central line).
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