natgillin/translations-raw huggingface dataset:
In this trial, 87% of patients had disease that was IHC 3+, and 95% of patients entered had disease that was IHC 3+ and/ or FISH positive.
V tem preskušanju je imelo 87% bolnic bolezen, ki je bila IHK 3+, 95% vključenih bolnic pa je imelo bolezen, ki je bila IHK 3+ in/ ali FISH- pozitivna.
Parameter
parameter
Docetaxel
Docetaksel in trastuzumab1
Response rate (95% CI) Median Duration of response
delež odziva (95% IZ) mediano trajanje odziva
61% (50-71)
61% (50– 71)
34% (25-45)
34% (25– 45)
(95% CI) Median TTP (months) (95% CI) Median Survival (months)
(95% IZ) mediani ČDN (meseci) (95% IZ) mediano preživetje (meseci)
(9.2-15.0) 10.6 (7.6-12.9) 30.52
(9, 2– 15, 0) 10, 6 (7, 6– 12, 9) 30, 52
(4.4-6.2) 5.7 (5.0-6.5) 22.12
(4, 4– 6, 2) 5, 7 (5, 0– 6, 5) 22, 12
(26.8-ne)
(26, 8– no)
(17.6-28.9)
(17, 6– 28, 9)
TTP = time to progression; “ ne” indicates that it could not be estimated or it was not yet reached.
ČDN = čas do napredovanja; “ no ” pomeni, ni bilo mogoče oceniti ali še ni doseženo.
1 Full analysis set (intent-to-treat) 2 Estimated median survival
1 celotna množica za analizo (z- namenom- zdravljenja) 2 ocenjeno mediano preživetje
27 cancer after failure of cytotoxic chemotherapy, including an anthracycline.
27 Docetaxel Winthrop v kombinaciji s kapecitabinom
In this trial, 255 patients were randomised to treatment with docetaxel (75 mg/ m2 as a 1 hour intravenous infusion every 3 weeks) and capecitabine (1250 mg/ m2 twice daily for 2 weeks followed by 1-week rest period).
V tem preskušanju so 255 bolnic randomizirali na zdravljenje z docetakselom (75 mg/ m2 v 1- urni intravenski infuziji na 3 tedne) in kapecitabinom (1. 250 mg/ m2 dvakrat na dan 2 tedna s sledečim 1- tedenskim premorom).
256 patients were randomised to treatment with docetaxel alone (100 mg/ m2 as a 1 hour intravenous infusion every 3 weeks).
256 bolnic so randomizirali na zdravljenje z docetakselom samim (100 mg/ m2 v 1- urni intravenski infuziji na 3 tedne).
Survival was superior in the docetaxel + capecitabine combination arm (p = 0.0126).
Preživetje je bilo boljše v kraku s kombinacijo docetaksel + kapecitabin (p = 0, 0126).
352 days (docetaxel alone).
Mediana preživetja je bila 442 dni (docetaksel + kapecitabin) v prim. s 352 dnevi (samo docetaksel).
29.7% (docetaxel alone); p = 0.0058.
Celotna objektivna deleža odziva v vsej randomizirani populaciji (ocena raziskovalca) sta bila 41, 6% (docetaksel + kapecitabin) in 29, 7% (samo docetaksel), p = 0, 0058.
Time to progressive disease was superior in the docetaxel + capecitabine combination arm (p < 0.0001).
Čas do napredovanja bolezni je bil v kraku s kombinacijo docetaksel + kapecitabin boljši (p < 0, 0001).
128 days (docetaxel alone).
Mediana časa do napredovanja je bila 186 dni (docetaksel + kapecitabin) v prim. s 128 dnevi (samo docetaksel).
In a phase III study, in previously treated patients, time to progression (12.3 weeks versus 7 weeks) and overall survival were significantly longer for docetaxel at 75 mg/ m² compared to Best Supportive Care.
V študiji III. faze pri predhodno zdravljenih bolnikih sta bila čas do napredovanja (12, 3 tedna v prim. s 7 tedni) in celotno preživetje z docetakselom v odmerku 75 mg/ m2 značilno daljša kot z najboljšo podporno oskrbo.
The 1-year survival rate was also significantly longer in docetaxel (40%) versus BSC (16%).
Tudi enoletni delež preživetja je bil z docetakselom značilno daljši (40%) kot z najboljšo podporno oskrbo (16%).
There was less use of morphinic analgesic (p < 0.01), non-morphinic analgesics (p < 0.01), other disease-related medications (p = 0.06) and radiotherapy (p < 0.01) in patients treated with docetaxel at 75 mg/ m² compared to those with BSC.
Bolniki, zdravljeni z docetakselom v odmerku 75 mg/ m2, so rabili manj morfinskih analgetikov (p < 0, 01), nemorfinskih analgetikov (p < 0, 01), drugih z boleznijo povezanih zdravil (p = 0, 06) in radioterapije (p < 0, 01) kot tisti, ki so bili deležni najboljše podporne oskrbe.
The overall response rate was 6.8% in the evaluable patients, and the median duration of response was 26.1 weeks.
Pri ocenljivih bolnikih je bil celotni delež odziva 6, 8%, mediana trajanja odziva pa 26, 1 tednov.
Docetaxel Winthrop in combination with platinum agents in chemotherapy-naïve patients
Docetaxel Winthrop v kombinaciji s platinskimi zdravili pri bolnikih, ki še niso bili zdravljeni s kemoterapijo
In a phase III trial, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either docetaxel (T) 75 mg/ m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/ m2 over 30-60 minutes every 3 weeks, docetaxel 75 mg/ m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ ml. min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/ m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/ m2 administered on day 1 of cycles repeated every 4 weeks.
Druga je na 3 tedne dobivala docetaksel 75 mg/ m2 v 1- urni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ ml. min) v 30– 60 minutah, tretja pa na 4 tedne vinorelbin (V) 25 mg/ m2 v 6– 10 minutah 1., 8., 15. in 22. dan, ki mu je 1. dan ciklusov sledil cisplatin 100 mg/ m2.
Statistical Analysis
statistična analiza
Overall Survival (Primary end-point):
celotno preživetje (primarna končna točka)
n
n = 408
= 408
n =
Median Survival (months)
mediana preživetja (meseci)
Hazard Ratio:
razmerje tveganj:
[97.2% CI:
[97, 2% IZ:
0.937; 1.342]*
0, 937, 1, 342] *
1-year Survival (%)
1- letno preživetje (%)
Treatment difference:
razlika zdravljenj:
5.4% [95% CI: -1.1; 12.0]
5, 4% [95% IZ: - 1, 1, 12, 0]
2-year Survival (%)
2- letno preživetje (%)
6.2% [95% CI:
6, 2% [95% IZ:
Median Time
mediana časa do napredovanja
(weeks):
(tedni):
1.032
razmerje tveganj:
[95% CI:
1, 032 [95% IZ:
0.876; 1.216]
0, 876, 1, 216]
Overall Response Rate (%):
celotni delež odziva (%)
7.1% [95% CI:
7, 1% [95% IZ:
Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
Korigirano za multiple primerjave in prilagojeno za stratifikacijske faktorje (stadij bolezni in predel zdravljenja) na podlagi ocenljive populacije bolnikov.
28 Secondary end-points included change of pain, global rating of quality of life by EuroQoL-5D, Lung Cancer Symptom Scale, and changes in Karnosfky performance status.
Sekundarne končne točke so vključevale spremembe bolečin, celotno oceno kakovosti življenja z EuroQoL- 5D, Lung Cancer Symptom Scale in spremembe zmogljivostnega stanja po Karnofskem.
For docetaxel/ carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Za kombinacijo docetaksel/ karboplatin v primerjavi z referenčno terapevtsko kombinacijo VCis ni bilo mogoče dokazati niti enakovredne niti neinferiorne učinkovitosti.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter phase III trial.
Varnost in učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom pri bolnikih z metastatskim hormonsko neodzivnim rakom prostate je bila ocenjena v randominizirani multicentrični študiji faze III.
A total of 1006 patients with KPS ≥ 60 were randomized to the following treatment groups: • Docetaxel 75 mg/ m2 every 3 weeks for 10 cycles. • Docetaxel 30 mg/ m2 administered weekly for the first 5 weeks in a 6 week cycle for 5 cycles. • Mitoxantrone 12 mg/ m2 every 3 weeks for 10 cycles.
V spodnje skupine zdravljenja je bilo randomiziranih skupno 1006 bolnikov z zmogljivostjo po Karnofskem ≥ 60: • Docetaksel 75 mg/ m2 vsake 3 tedne, 10 ciklov. • Docetaxel 30 mg/ m2 aplicirano tedensko prvih 5 tednov 6 tedenskega cikla, ki se ponovi v 5- ih ciklih. • Mitoksantron 12 mg/ m2 vsake 3 tedne, 10 ciklov.
Endpoint
Končna točka
Docetaxel every Docetaxel every 3 weeks week
3 tedne
Mitoxantrone every 3 weeks
vsake 3 tedne 337
Number of patients Median survival (months) 95% CI Hazard ratio 95% CI p-value† * Number of patients PSA** response rate (%) 95% CI p-value* Number of patients Pain response rate (%) 95% CI p-value* Number of patients Tumor response rate (%) 95% CI p-value* † Stratified log rank test
17, 4
335 334 18.9 17.4 (17.0-21.2) (15.7-19.0) 0.761 0.912 (0.619-0.936) (0.747-1.113) 0.0094 0.3624 291 282 45.4 47.9 (39.5-51.3) (41.9-53.9) 0.0005 < 0.0001 153 154 34.6 31.2 (27.1-42.7) (24.0-39.1) 0.0107 0.0798 141 134 12.1 8.2 (7.2-18.6) (4.2-14.2) 0.1112 0.5853
16, 5
337 16.5 (14.4-18.6) -- -- -- 300 31.7 (26.4-37.3) -- 157 21.7 (15.5-28.9) -- 137 6.6 (3.0-12.1) --
mediana preživetja (meseci)
*Threshold for statistical significance = 0.0175 **PSA:
95% IZ
Prostate-Specific Antigen
(0, 619- 0, 936) 0, 0094
Given the fact that docetaxel every week presented a slightly better safety profile than docetaxel every 3 weeks, it is possible that certain patients may benefit from docetaxel every week.
95% IZ p- vrednost * število bolnikov odzivnost na bolečino (%) 95% IZ p - vrednost *
No statistical differences were observed between treatment groups for Global Quality of Life.
število bolnikov odzivnost tumorja (%) 95% IZ p - vrednost *
Gastric adenocarcinoma
134 8, 2 (4, 2- 14, 2) 0, 5853
A multicenter, open-label, randomized trial, was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including
Glede na to, da je docetaksel tedensko pokazal nekoliko boljši profil varnosti kot docetaksel vsake tri tedne, je možno, da bi določenim bolnikom koristil docetaksel tedensko.
29 adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Opravljeno je bilo multicentrično, odprto, randomizirano preskušanje za oceno varnosti in učinkovitosti docetaksela pri zdravljenju bolnikov z metastatskim adenokarcinomom želodca, vključno z adenokarcinomom na gastroezofagealnem prehodu, ki za metastatsko bolezen še niso prejemali kemoterapije.
A total of 445 patients with KPS > 70 were treated with either docetaxel (T) (75 mg/ m2 on day 1) in combination with cisplatin (C) (75 mg/ m2 on day 1) and 5-fluorouracil (F) (750 mg/ m2 per day for 5 days) or cisplatin (100 mg/ m2 on day 1) and 5-fluorouracil (1000 mg/ m2 per day for 5 days).
Skupaj je bilo zdravljenih 445 bolnikov z oceno zmogljivosti po Karnofskem > 70; prejemali so bodisi docetaksel (T) (75 mg/ m2 1. dan) v kombinaciji s cisplatinom (C) (75 mg/ m2 1. dan) in 5- fluorouracilom (F) (750 mg/ m2 na dan, 5 dni), bodisi cisplatin (100 mg/ m2 1. dan) in 5- fluorouracil (1000 mg/ m2 na dan, 5 dni).
The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favor of the TCF arm.
V kraku s TCF se je tveganje za napredovanje zmanjšalo za 32, 1%, ČDN pa je bil ob tem značilno daljši (p = 0, 0004).
Overall survival was also significantly longer (p = 0.0201) in favor of the TCF arm with a risk reduction of mortality of 22.7%.
V kraku s TCF je bilo značilno daljše (p = 0, 0201) tudi celotno preživetje, tveganje umrljivosti pa se je zmanjšalo za 22, 7%.
Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
30 Učinkovitost docetaksela pri zdravljenju bolnikov z adenokarcinomom želodca
(4.86-5.91)
(4, 86– 5, 91)
(3.45-4.47)
(3, 45– 4, 47)
(95% CI) *p-value
(95% IZ) * vrednost p
(1.189-1.825) 0.0004
(1, 189– 1, 825) 0, 0004
(95% CI) 2-year estimate (%) Hazard ratio
(95% IZ) 2- letna ocena (%) razmerje tveganja
(8.38-10.58) 18.4
(8, 38– 10, 58) 18, 4
(7.16-9.46) 8.8
(7, 16– 9, 46) 8, 8
(1.041-1.606) 0.0201
(1, 041– 1, 606) 0, 0201
Overall Response Rate (CR+PR) (%) p-value Progressive Disease as Best Overall
celotni delež odziva (popolni odziv +delni odziv) (%)
Response (%) *Unstratified logrank test
odziv (%) * nestratificirani log- rang test
A survival update analysis conducted with a median follow-up time of 41.6 months no longer showed a statistically significant difference although always in favour of the TCF regimen and showed that the benefit of TCF over CF is clearly observed between 18 and 30 months of follow up.
Ponovna analiza preživetja, narejena pri medianem času spremljanja 41, 6 mesecev, ni več pokazala statistično značilne razlike, čeprav je bila shema s TCF še vedno ugodnejša; pokazala pa je, da so koristi TCF v primerjavi s CF jasno opazne med 18. in 30. mesecem spremljanja.
Patients treated with TCF had a longer time to 5% definitive deterioration of global health status on the QLQ-C30 questionnaire (p = 0.0121) and a longer time to definitive worsening of Karnofsky performance status (p = 0.0088) compared to patients treated with CF.
Pri bolnikih, zdravljenih s TCF, je bil v primerjavi s tistimi, ki so jih zdravili s CF, daljši tako čas do 5% trajnega poslabšanja splošnega zdravstvenega stanja po vprašalniku QLQ -- C30 (p = 0, 0121) kot čas do trajnega poslabšanja stanja zmogljivosti po Karnofskem (p = 0, 0088).
• Induction chemotherapy followed by radiotherapy (TAX323) The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized trial (TAX323).
• Indukcijska kemoterapija in nato radioterapija (TAX323) Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov s skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenjevali v multicentričnem odprtem randomiziranemu preskušanju faze III (TAX323).
Patients on the docetaxel arm received docetaxel (T) 75 mg/ m2 followed by cisplatin (P) 75 mg/ m2 followed by 5-fluorouracil (F) 750 mg/ m2 per day as a continuous infusion for 5 days.
Bolniki v kraku z docetakselom so prejelidocetaksel (T) 75 mg/ m2, ki mu je sledil cisplatin (P) 75 mg/ m2, temu pa 5- fluorouracil (F) 750 mg/ m2 na dan v obliki neprekinjene infuzije 5 dni.
This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
To shemo so uporabljali 4 cikluse vsake 3 tedne, če so po 2 ciklusih opazili vsaj majhen odziv (≥ 25% zmanjšanje dvodimenzionalno merjene velikosti tumorja).
30 progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (TPF/ RT).
Na koncu kemoterapije (z najkrajšim presledkom 4 tedne in najdaljšim presledkom 7 tednov) so bolniki, ki jim bolezen ni napredovala, 7 tednov dobivali radioterapijo (RT) v skladu s smernicami ustanove (TPF/ RT).
Patients on the comparator arm received cisplatin (P) 100 mg/ m2 followed by 5-fluorouracil (F) 1000 mg/ m2 per day for 5 days.
Bolniki v primerjalnem kraku so dobili cisplatin (P) 100 mg/ m2, ki mu je sledil 5- fluorouracil (F) 1000 mg/ m2 na dan 5 dni.
This regimen was administered every three weeks for 4 cycles in case at least a minor response (≥ 25% reduction in bidimensionally measured tumour size) was observed after 2 cycles.
To terapevtsko shemo so uporabljali vsake tri tedne za 4 cikle, če so po 2 ciklih opazili vsaj manjši odziv (≥ 25% zmanjšanje dvodimenzionalno merjene velikosti tumorja).
At the end of chemotherapy, with a minimal interval of 4 weeks and a maximal interval of 7 weeks, patients whose disease did not progress received radiotherapy (RT) according to institutional guidelines for 7 weeks (PF/ RT).
Na koncu kemoterapije, z minimalnim intervalom 4 tednov in maksimalnim intervalom 7 tednov, so bolniki, katerih bolezen ni napredovala, 7 tednov prejemali radioterapijo (RT) v skladu s smernicami ustanove (PF/ RT).
Locoregional therapy with radiation was delivered either with a conventional fraction (1.8 Gy - 2.0 Gy once a day, 5 days per week for a total dose of 66 to 70 Gy), or accelerated/ hyperfractionated regimens of radiation therapy (twice a day, with a minimum interfraction interval of 6 hours, 5 days per week).
Lokoregionalno terapijo z obsevanjem so aplicirali bodisi s konvecionalno frakcijo (1, 8 Gy – 2, 0 Gy enkrat na dan, 5 dni na teden v celotnem odmerku 66 do 70 Gy), ali s pospešenimi / hiperfrakcioniranimi shemami obsevalnega zdravljenja (dvakrat na dan, z minimalnim intervalom med frakcijama 6 ur, 5 dni na teden).
Patients on the TPF arm received antibiotic prophylaxis with ciprofloxacin 500 mg orally twice daily for 10 days starting on day 5 of each cycle, or equivalent.
Bolniki na kraku TPF so prejemali antibiotično profilakso s ciprofloksacinom 31 v odmerku 500 mg peroralno dvakrat na dan 10 dni z začetkom 5. dne vsakega cikla, ali enakovredno profilakso.
11.4 vs.
Primarni končni cilji v tej študiji, preživetje brez napredovanja bolezni (PFS), je bilo signifikantno daljše na kraku TPF kot na kraku PF, p = 0, 0042 (mediano PFS:
8.3 months respectively) with an overall median follow up time of 33.7 months.
11, 4 proti 8, 3 meseca), celotni mediani čas spremljanja pa je bil 33, 7 meseca.
18.6 vs.
Tudi mediano celotno preživetje (OS) je bilo signifikantno daljše na kraku TPF kot na kraku PF (mediano OS:
14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
18, 6 proti 14, 5 mesecev) z 28% zmanjšanjem tveganja smrti, p = 0, 0128.
Docetaxel + Cis + 5-FU
docetaksel + Cis + 5- FU
(95% CI) Adjusted Hazard ratio
Mediano preživetje brez napredovanja bolezni (meseci) (95% interval zaupanja) Popravljeno razmerje tveganja (95% interval zaupanja) * p- vrednost
(10.1-14.0)
11, 4 (10, 1- 14, 0) 0, 70 (0, 55- 0, 89) 0, 0042
Median survival (months)
Mediano preživetje (meseci)
(95% CI) Hazard ratio
(95% interval zaupanja) Razmerje tveganja
(95% CI) **p-value
(95% interval zaupanja) ** p- vrednost
Best overall response to chemotherapy (%)
Najboljši celotni odziv na kemoterapijo (%)
(95% CI) ***p-value Best overall response to study treatment
(95% interval zaupanja) *** p- vrednost Najboljši celotni odziv na proučevano
[chemotherapy +/ - radiotherapy] (%) (95% CI) ***p-value
zdravljenje [kemoterapija + / - radioterapija] (%) (95% interval zaupanja) *** p- vrednost
Median duration of response to chemotherapy ± radiotherapy (months) (95% CI) Hazard ratio
(95% interval zaupanja) Razmerje tveganja
(0.52-0.99) 0.0457
(10, 2- 17, 4)
A Hazard ratio of less than 1 favors docetaxel + cisplatin + 5-FU *Cox model (adjustment for Primary tumor site, T and N clinical stages and PSWHO) **Logrank test *** Chi-square test
(0, 52- 0, 99) (95% interval zaupanja) 0, 0457 ** p- vrednost Razmerje tveganj manj kot 1 je v prid kombinaciji docetaksel + cisplatin + 5- FU * Model po Cox- u (prilagoditev glede na mesto primarnega tumorja, klinični stadij T in N in stanje zmogljivosti po WHO) ** Logrank test *** Hi - kvadrat test
Quality of life parameters Patients treated with TPF experienced significantly less deterioration of their Global health score compared to those treated with PF (p = 0.01, using the EORTC QLQ-C30 scale).
Parametri kvalitete življenja Pri bolnikih, zdravljenih s TPF, se je lestvica globalnega zdravja signifikantno manj poslabšala kot pri tistih, ki so bili zdravljeni s PF (p = 0, 01, uporabljena je bila lestvica EORTC QLQ- C30).
31 Clinical benefit parameters The performance status scale, for head and neck (PSS-HN) subscales designed to measure understandability of speech, ability to eat in public, and normalcy of diet, was significantly in favor of TPF as compared to PF.
Parametri klinične koristnosti Lestvica stanja zmogljivosti s podlestvicama za glavo in vrat (PSS- HN), namenjenima merjenju razumljivosti govora, sposobnosti uživanja hrane na javnem mestu in normalnosti hrane, je signifikantno govorila v korist TPF v primerjavi s PF.
• Induction chemotherapy followed by chemoradiotherapy (TAX324) The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III, trial (TAX324).
32 • Indukcijska kemoterapija in nato kemoradioterapija (TAX324) Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v randomiziranem multicentričnem odprtem preskušanju III. faze (TAX324).
Patients on the docetaxel arm received docetaxel (T) 75 mg/ m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/ m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/ m²/ day from day 1 to day 4.
Bolniki v kraku z docetakselom so dobili docetaksel (T) 75 mg/ m2 v intravenski infuziji 1. dan, ki mu je sledil cisplatin (P) 100 mg/ m2 v 30- minutni do 3- urni intravenski infuziji in nato stalna intravenska infuzija 5- fluorouracila (F) 1000 mg/ m2/ dan od 1. do 4. dneva.
All patients who did not have progressive disease were to receive chemoradiotherapy (CRT) as per protocol (TPF/ CRT).
Vsi bolniki, ki niso imeli napredujoče bolezni, so dobili kemotradioterapijo (KRT) po protokolu (TPF/ KRT).
Patients on the comparator arm received cisplatin (P) 100 mg/ m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1000 mg/ m²/ day from day 1 to day 5.
Bolniki v primerjalnem kraku so dobivali cisplatin (P) 100 mg/ m2 v 30- minutni do 3- urni intravenski infuziji 1. dan in nato stalno intravensko infuzijo 5- fluorouracila (F) 1000 mg/ m2/ dan od 1. do 5. dneva.
All patients who did not have progressive disease were to receive CRT as per protocol (PF/ CRT).
Vsi bolniki, ki niso imeli napredujoče bolezni, so dobili KRT po protokolu (PF/ KRT).
During radiotherapy, carboplatin (AUC 1.5) was given weekly as a one-hour intravenous infusion for a maximum of 7 doses.
Med radioterapijo so vsak teden dobili karboplatin (AUC 1, 5) v enourni intravenski infuziji do največ 7 odmerkov.
Radiation was delivered with megavoltage equipment using once daily fractionation (2 Gy per day, 5 days per week for 7 weeks, for a total dose of 70-72 Gy).
Bolnike so obsevali z megavoltažno opremo s frakcioniranjem enkrat na dan (2 Gy na dan, 5 dni na teden 7 tednov, tako da je bil celotni odmerek 70– 72 Gy).
Surgery on the primary site of disease and/ or neck could be considered at anytime following completion of CRT.
Operacija na primarnem mestu bolezni in/ ali vratu je prišla v poštev kadarkoli po koncu kemoradioterapije.
The primary efficacy endpoint in this study, overall survival (OS) was significantly longer (log-rank test, p = 0.0058) with the docetaxel-containing regimen compared to PF (median OS:
CP je bilo značilno daljše (log- rang test, p = 0, 0058) pri shemi z docetakselom kot s PF (mediano CP: shema z docetakselom 70, 6, PF 30, 1 meseca).
70.6 versus 30.1 months respectively), with a 30% risk reduction in mortality compared to PF (hazard ratio (HR) = 0.70, 95% confidence interval (CI) = 0.54-0.90) with an overall median follow up time of 41.9 months.
Ob tem so pri shemi z docetakselom ugotovili tudi 30% zmanjšanje tveganja umrljivosti v primerjavi s PF (razmerje ogroženosti (OR) = 0, 70, 95% interval zaupanja (IZ) = 0, 54– 0, 90); celotni mediani čas spremljanja je bil 41, 9 meseca.
The secondary endpoint, PFS, demonstrated a 29% risk reduction of progression or death and a 22 month improvement in median PFS (35.5 months for TPF and 13.1 for PF).
Sekundarna končna točka, preživetje brez napredovanja (PBN), je pokazala 29% zmanjšanje tveganja za napredovanje ali smrt ter 22- mesečno izboljšanje medianega PBN (35, 5 mesecev pri TPF in 13, 1 pri PF).
This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
RO 0, 71, 95% IZ 0, 56- 0, 90, log- rang test p = 0, 004.
Efficacy results are presented in the table below:
Rezultate učinkovitosti prikazuje spodnja tabela:
32 Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
33 Učinkovitost docetaksela v indukcijskem zdravljenju bolnikov z lokalno napredovalim SCCHN (analiza z namenom zdravljenja)
Endpoint
Docetaksel + Cis + Končna točka
Docetaxel + Cis + 5-FU n = 255
Cis + 5- FU
Cis + 5-FU n = 246
= 246 30, 1