natgillin/translations-raw huggingface dataset:
Den samlede overlevelsesrate var 6, 8% i de evaluerbare patienter, og median- varigheden for respons var 26, 1 uge.
The overall response rate was 6.8% in the evaluable patients, and the median duration of response was 26.1 weeks.
1218 patienter med inoperabel ikke- småcellet lungekræft stadium IIIB eller IV med KPS på 70% eller mere og som ikke tidligere havde fået kemoterapi mod denne tilstand, blev i et fase III- studie randomiseret til enten docetaxel (T) 75 mg/ m2 administreret som 1- times infusion umiddelbart efterfulgt af cisplatin (Cis) 75 mg/ m2 administreret i løbet af 30- 60 minutter hver 3. uge, docetaxel 75 mg/ m2 som en 1- times infusion i kombination med carboplatin (AUC 6 mg/ ml per min) administreret i løbet af 30- 60 minutter hver 3. uge, vinorelbin (V) 25 mg / m2 administreret i løbet af 6 til 10 minutter på dag 1, 8, 15, 22 efterfulgt af cisplatin 100 mg/ m2 administreret på dag 1 af cyklusser gentaget hver 4. uge.
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.
Overlevelsesdata, median progressionstid og responsrater for forsøgets to arme arme er illustreret i nedenstående tabel:
Survival data, median time to progression and response rates for two arms of the study are illustrated in the following table:
Total overlevelse (Primær endepunkt)
Overall Survival (Primary end-point):
Median overlevelsestid (måneder)
Median Survival (months)
Harzard ratio:
Hazard Ratio:
1, 122
1.122
(97, 2% CI: 0. 937; 1, 342) *
0.937; 1.342]*
1- års overlevelse (%)
1-year Survival (%)
Behandlingsforskel 5, 4% (95% CI: - 1, 1; 12, 0)
5.4% [95% CI: -1.1; 12.0]
2- års overlevelse (%)
2-year Survival (%)
Behandlingsforskel 6, 2% (95% CI: 0, 2; 12, 3)
0.2; 12.3]
Gennemsnitlig tid til progression
Median Time
Hazard ratio:
Hazard Ratio:
1, 032
1.032
(95% CI: 0, 876; 1, 216)
0.876; 1.216]
Total response rate (%)
Overall Response Rate (%):
Behandlingsforskel (95% CI: 0, 7; 13, 5)
7.1% [95% CI:
*: rettet for multible sammenligninger og justeret for stratification faktorer (stadie af sygdommen og behandlingsregion), baseret på beregnelig patientpopulation.
Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
Sekundære endepunkter inkluderede forandring i smerter, global rating af livskvalitet med EuroQoL - 5D, lungekræft- symptom skala, og forandringer i karnosfkys performance status.
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.
Resultater på disse endepunkter understøttede de primære endepunkter- resultater.
Results on these end-points were supportive of the primary end-points results.
For docetaxel / Carboplatin- kombinationen kunne der hverken bevises ekvivalent eller non- inferior effekt sammenlignet med referencebehandlingen kombination VCis.
For docetaxel/ carboplatin combination, neither equivalent nor non-inferior efficacy could be proven compared to the reference treatment combination VCis.
Prostata- kræft
Prostate cancer
Sikkerheden og effekten af docetaxel i kombination med prednison eller prednisolon hos patienter med hormonrefraktær prostatakræft blev undersøgt i et randomiseret multicenter fase III- forsøg.
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.
I alt 1006 patienter med KPS ≥ 60 blev randomiseret i følgende behandlingsgrupper: • Docetaxel 75 mg/ m2 hver 3. uge i 10 behandlingsrunder. • Docetaxel 30 mg/ m2 administreret ugentlig i de første 5 uger i en 6 ugers behandlingsrunde i 5 behandlingsrunder. • Mitoxantrone 12 mg/ m2 hver 3. uge i 10 behandlingsrunder.
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.
Stigningen i overlevelse set i armen med ugentlig docetaxel var ikke statistisk signifikant sammenlignet med mitxantron kontrol- armen.
The increase in survival seen in the docetaxel weekly arm was not statistically significant compared to the mitoxantrone control arm.
Effekt- endepunkterendepunkt for docetaxel - armene versus kontrol- armen er vist i den følgende tabel:
Efficacy endpoints for the docetaxel arms versus the control arm are summarized in the following table:
Docetaxel hver Docetaxel hver 3. uge uge
Docetaxel every Docetaxel every 3 weeks week
Mitoxantrone Hver 3. uge
Mitoxantrone every 3 weeks
Antal patienter Median overlevelsestid (måneder) 95% CI Hazard ratio 95% CI p- værdi † * Antal patienter PSA ** - response rate (%) 95% CI p- værdi * Antal patienter Smerte- response rate (%) 95% CI p- værdi * Antal patienter Tumor- response rate (%) 95% CI p- værdi *
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
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
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
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) --
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) --
* Tærskel for statististiskl signifikans =0, 0175 ** PSA:
*Threshold for statistical significance = 0.0175 **PSA:
Prostata- Specific Antigen
Prostate-Specific Antigen
Gastrisk adenocarcinom
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.
En multicenter, åben, randomiseret undersøgelse har evalueret sikkerhed og effekt af docetaxel til behandling af patienter med metastatisk gastrisk adenocarcinom, inklusive adenocarcinom af den gastrooesophagele forbindelse.
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
Patienterne havde ikke tidligere modtaget kemoterapi for metastatisk sygdom.
29 adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
445 patienter med KPS > 70 blev behandlet med enten docetaxel (T) (75 mg/ m2 på dag 1) i kombination med cisplatin (C) (75 mg/ m2 på dag 1) og 5- fluorouracil (F) (750 mg/ m2 pr. dag i 5 dage) eller cisplatin (100 mg/ m2 på dag 1) og 5- fluorouracil (1000 mg/ m2 pr. dag i 5 dage).
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).
Behandlings - cyklus var på 3 uger for TCF- armen og 4 uger for CF- armen.
The length of a treatment cycle was 3 weeks for the TCF arm and 4 weeks for the CF arm.
Median- antallet af cyklusser administreret pr. patient var 6 (med en range på 1- 16) for TCF- armen sammenlignet med 4 (med en range på 1- 12) for CF- armen.
The median number of cycles administered per patient was 6 (with a range of 1-16) for the TCF arm compared to 4 (with a range of 1-12) for the CF arm.
Nedsættelsen af risikoen for progression var 32, 1% og blev associeret med en signifikant længere TTP (p = 0, 0004) til fordel for TCF- armen. Overlevelse i alt var også signifikant længere (p = 0, 0201) til fordel for TCF - armen med en nedsættelse af risikoen for død på 22, 7%.
Overall survival was also significantly longer (p = 0.0201) in favor of the TCF arm with a risk reduction of mortality of 22.7%.
30 Effekten af docetaxel ved behandling af patienter med gastrisk adenocarcinom
Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
(95% CI) * p- værdi
(95% CI) *p-value
(95% CI) 2- års estimat (%) Hazard ratio
(95% CI) 2-year estimate (%) Hazard ratio
Respons rate ialt (CR+PR) (%) p- værdi Progressiv sygdom som bedste
Overall Response Rate (CR+PR) (%) p-value Progressive Disease as Best Overall
overlevelse respons (%) * Ustratificerede logrank test
Response (%) *Unstratified logrank test
Undergruppe- analyser på tværs af alder, køn og race favoriserede samstemmende TCF- armen sammenlignet med CF- armen.
Subgroup analyses across age, gender and race consistently favored the TCF arm compared to the CF arm.
Fordelen ved TCF- regimet kontra CF- regimet var helt tydelig mellem 18 og 30 måneders follow- up.
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.
Som helhed viste livskvalitet (LK) og kliniske fordele resultater i overensstemmelse med fremgang til fordel for TCF- armen.
Overall, quality of life (QoL) and clinical benefit results consistently indicated improvement in favor of the TCF arm.
De patienter, der blev behandlet i TCF- armen, havde længere tid til 5% definitiv forværring af den globale sundhedsstatus på QLQ- C30- spørgeskemaet (p = 0, 0121) og en længere tid til definitiv forværring af Karnofsky performance status (p = 0, 0088) sammenlignet med patienterne, som fik behandling med CF.
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.
• Induktions kemoterapi efterfulgt af strålebehandling (TAX 323) Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med pladecellecarcinom i hovedet og halsen (SCCHN) blev evalueret i en fase III, multicenter, åben, randomiseret undersøgelse (TAX323).
• 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).
Patienter i docetaxel- armen modtog docetaxel (T) 75 mg/ m2 efterfulgt af cisplatin (P) 75 mg/ m2 efterfulgt af 5 - fluorouracil 750 mg/ m2 daglig som en kontinuerlig infusion i 5 dage.
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.
Ved slutningen af kemoterapi fik patienter, hvis sygdomstilstand ikke var forværret, strålebehandling i 7 uger med et interval på mindst 4 uger og maksimalt 7 uger, udført efter fastlagte retningslinier (TPF/ RT) I komparator- armen af studiet fik patienterne cisplatin (P) 100 mg/ m2 efterfulgt af 5- fluorouracil (F) 1000 mg/ m2 (PF) daglig i 5 dage.
Patients on the comparator arm received cisplatin (P) 100 mg/ m2 followed by 5-fluorouracil (F) 1000 mg/ m2 per day for 5 days.
Dette regime blev administreret hver 3. uge i 4 cyklusser hos patienter, hvor der som mindstemål efter 2 cyklusser blev observeret en mindre respons (≥ 25% reduktion i den bidimensionalt målte tumor størrelse).
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.
Efter endt kemoterapi, med et minimum interval på 4 uger og et maksimum interval på 7 uger, blev de patienter, hvis sygdom ikke forværredes, strålebehandlet (RT) i 7 uger i henhold til de fastlagte retningslinier (PF/ RT).
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).
Lokoregional behandling med stråling blev givet enten med en konventionel fraktion (1, 8 Gy- 2, 0 Gy en gang daglig, 5 dage om ugen til en total dosis på 66 til 70 Gy), eller accelererede/ hyperfraktionerede regimer af strålebehandling (to gange daglig, med et minimum interfraktion- interval på 6 timer, 5 dage pr. uge).
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).
31 kemoterapi, før eller efter strålebehandling.
Surgical resection was allowed following chemotherapy, before or after radiotherapy.
Behandlingen begyndte på dag 5 i hver cyklus, eller tilsvarende.
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.
Det primære endepunkt i denne undersøgelse, progression- fri overlevelse (PFS), var signifikant længere i TPF- armen sammenlignet med PF- armen, p = 0, 0042 (median PFS:
The primary endpoint in this study, progression-free survival (PFS), was significantly longer in the TPF arm compared to the PF arm, p = 0.0042 (median PFS:
8, 3 måneder respektivt) med en samlet median- opfølgningstid på 33, 7 måneder.
8.3 months respectively) with an overall median follow up time of 33.7 months.
Median overlevelse ialt var også signifikant længere til fordel for TPF- armen sammenlignet med PF - armen (median OS:
Median overall survival was also significantly longer in favor of the TPF arm compared to the PF arm (median OS:
14, 5 måneder respektivt) med en 28% reduktion af risikoen for død, p = 0, 0128.
14.5 months respectively) with a 28% risk reduction of mortality, p = 0.0128.
Effekt af docetaxel i indledende behandling til patienter med inoperable, lokale fremskredne SCCHN (Hensigt at behandle- analyse)
Efficacy of docetaxel in the induction treatment of patients with inoperable locally advanced SCCHN (Intent-to-Treat Analysis)
Docetaxel+ Cis+5- FU
Docetaxel + Cis + 5-FU
Cis+5- FU
+ 5-FU
Median progression fri overlevelse (måneder) (95% CI) Tilpasset hazard ratio
(95% CI) Adjusted Hazard ratio
11, 4 (10, 1- 14, 0)
(10.1-14.0)
8, 3 (7, 4- 9, 1)
(7.4-9.1)
(95% CI) Hazard ratio
(95% CI) Hazard ratio
(95% CI) ** p- værdi
(95% CI) **p-value
Bedste respons ialt til kemoterapi (%)
Best overall response to chemotherapy (%)
(95% CI) *** p- værdi Bedste respons ialt til undersøgelsesbehandling
(95% CI) ***p-value Best overall response to study treatment
[kemoterapi + / - strålebehandling] (%) (95% CI) *** p- værdi
[chemotherapy +/ - radiotherapy] (%) (95% CI) ***p-value
Median varighed af respons til kemoterapi ± strålebehandling (måneder) (95% CI) Hazard ratio
Median duration of response to chemotherapy ± radiotherapy (months) (95% CI) Hazard ratio
Med en hazard ratio < 1 kan docetaxel + cisplatin+5- FU anvendes med fordel * Cox model (tilpasning til primær tumor, T og N kliniske stadier og PSWHO) ** Logrank test *** Chi- square- test
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
Livskvalitetsparametre De patienter, der fik behandling med TPF udviklede signifikant mindre tilbagegang af deres globale sundhedsscore i forhold til patienter i behandling med PF (p = 0, 01, under anvendelse af EORTC QLQ- C30- skalaen).
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).
Skalaen var signifikant til fordel for TPF i forhold til PF.
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.
Median tid til første tilbagegang af WHO performance status var signifikant længere i TPF- armen end med PF.
Median time to first deterioration of WHO performance status was significantly longer in the TPF arm compared to PF.
Smerteintensitet- scoren forbedredes under behandlingen i begge grupper, hvilket indikerer en god smertekontrol.
Pain intensity score improved during treatment in both groups indicating adequate pain management.
32 • Induktions kemoterapi efterfulgt af kemostråleterapi (TAX 324) Sikkerheden og effekten af docetaxel i den indledende behandling af patienter med lokalt fremskredent pladecellecarcinom i hoved og hals (SCCHN) blev evalueret i et randomiseret, multicenter, open- label fase III studie (TAX 324).
• 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).
Succesrig organbevarelse indgik ikke formelt som succeskriterium.
The efficacy and safety evaluation solely addressed survival endpoints and the success of organ preservation was not formally addressed.
Patienter i docetaxel- armen modtog docetaxel (T) 75 mg/ m2 ved intravenøs infusion på dag 1, efterfulgt af cisplatin (P) 100 mg/ m2 administreret som en 30 minutter til 3 timers intravenøs infusion, efterfulgt af kontinuerlig intravenøs infusion af 5- fluorouracil( F) 1000 mg/ m2/ dag fra dag 1 til dag 4.
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.
Patienter uden forværret sygdom skulle ifølge protokollen modtage CRT (PF/ CRT).
All patients who did not have progressive disease were to receive chemoradiotherapy (CRT) as per protocol (TPF/ CRT).
Patienter i komparator- armen modtog cisplatin (P) 100 mg/ m2 administreret som en 30 minutter til 3 timers intravenøs infusion på dag 1, efterfulgt af kontinuerlig intravenøs infusion af 5- fluorouracil( F) 1000 mg/ m2/ dag fra dag 1 til dag 5.
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.
Alle patienter uden forværret sygdom skulle ifølge protokollen modtage CRT (PF/ CRT).
All patients who did not have progressive disease were to receive CRT as per protocol (PF/ CRT).
Efter induktions- kemoterapi skulle patienter i begge behandlingsarme modtage 7 ugers CRT med et minimumsinterval på 3 uger, og ikke senere end 8 uger efter påbegyndelse af sidste cyklus (dag 22 til dag 56 af sidste cyklus).
Patients in both treatment arms were to receive 7 weeks of CRT following induction chemotherapy with a minimum interval of 3 weeks and no later than 8 weeks after start of the last cycle (day 22 to day 56 of last cycle).
Under strålebehandlingsforløbet blev der givet carboplatin (AUC 1, 5) ugentligt som en 1- times intravenøs infusion med et maksimum på 7 doser.
During radiotherapy, carboplatin (AUC 1.5) was given weekly as a one-hour intravenous infusion for a maximum of 7 doses.
Stråling blev udført med megavolt udstyr, med en daglig fraktionering (2 Gy pr. dag, 5 dage om ugen i 7 uger, dosis i alt 70- 72 Gy).
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).
Kirurgisk indgreb på det primære sygdomssted og/ eller hals kunne overvejes når som helst efter endt CRT.
Surgery on the primary site of disease and/ or neck could be considered at anytime following completion of CRT.
Alle patienter i studiets docetaxel- arm modtog profylaktisk antibiotika.
All patients on the docetaxel-containing arm of the study received prophylactic antibiotics.
Det primære endepunkt for effektivitet i dette studie, overlevelse i alt (OS), var signifikant længere (log- rank test, p=0, 0058) i det regime, der indeholdt docetaxel sammenlignet med PF (median OS:
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:
70, 6 mod 30, 1 måneder, respektivt), med en 30% nedsat risiko i mortalitet sammenlignet med PF (hazard ratio (HR) = 0, 70; 95% konfidensinterval (CI) = 0, 54- 0, 90) med en samlet median opfølgningstid på 41, 9 måneder.
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.
Det sekundære endepunkt, progressionsfri overlevelse, (PFS) viste 29% nedsat risiko for forværring eller død og en 22 måneder forbedring i median PFS (35, 5 måned for TPF og 13, 1 måned for PF).
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).
Dette var også statistisk signifikant med en HR på 0, 71; 95% CI 0, 56- 0, 90; log- rank test p = 0, 004.
This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
33 Effekt af docetaxel i indledende behandling til patienter med lokale fremskredne SCCHN (Hensigt at behandle- analyse)
32 Efficacy of docetaxel in the induction treatment of patients with locally advanced SCCHN (Intent-to-Treat Analysis)
ENDEPUNKT Median overlevelse i alt (måneder)
Endpoint
Docetaxel + Cis + 5- FU n = 255 70, 6
Docetaxel + Cis + 5-FU n = 255
Cis n
Cis + 5-FU n = 246
(95% CI) Hazard ratio:
Median overall survival (months) (95% CI) Hazard ratio:
(20, 9- 51, 5)
30.1 (20.9-51.5)
Median progressionsfri overlevelse (måneder)
Median PFS (months)
(95% CI) Hazard ratio
(95% CI) Hazard ratio:
(10, 6- 20, 2)
(10.6 - 20.2)
(0, 56- 0, 90) 0, 004
(0.56 - 0.90) 0.004
Bedste respons ialt på kemoterapi (%)
Best overall response (CR + PR) to
(95% CI) *** p- værdi
chemotherapy (%) (95% CI)
(57, 9- 70, 2
(57.9-70.2)
76, 5
***p-value
[kemoterapi + / - strålebehandling] (%) (95% CI)
Best overall response (CR + PR) to study treatment [chemotherapy +/ - chemoradiotherapy] (%) (95%CI)
*** p- værdi
***p-value
Not Applicable
A Hazard ratio of less than 1 favors docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Fase I- studier har undersøgt docetaxels farmakokinetiske egenskaber hos kræftpatienter efter indgift af 20 - 115 mg/ m2.
The pharmacokinetics of docetaxel have been evaluated in cancer patients after administration of 20-115 mg/ m2 in phase I studies.