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Overall Survival Analysis From a Randomized Phase II Study of Axitinib With or Without Dose Titration in First-Line Metastatic Renal Cell Carcinoma
BI. Rini, Y. Tomita, B. Melichar, T. Ueda, V. Grünwald, MN. Fishman, H. Uemura, M. Oya, AH. Bair, GI. Andrews, B. Rosbrook, E. Jonasch,
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, fáze II, časopisecké články, randomizované kontrolované studie, práce podpořená grantem, Research Support, N.I.H., Extramural
- MeSH
- analýza přežití MeSH
- dospělí MeSH
- dvojitá vazba (komunikace) MeSH
- imidazoly aplikace a dávkování terapeutické užití MeSH
- indazoly aplikace a dávkování terapeutické užití MeSH
- inhibitory angiogeneze aplikace a dávkování terapeutické užití MeSH
- karcinom z renálních buněk farmakoterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- metastázy nádorů MeSH
- nádory ledvin farmakoterapie MeSH
- přežití bez známek nemoci MeSH
- rozvrh dávkování léků MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Research Support, N.I.H., Extramural MeSH
BACKGROUND: In a randomized phase II trial in metastatic renal cell carcinoma (mRCC), objective response rate was significantly higher with axitinib versus placebo titration (54% vs. 34%; 1-sided P = .019). PATIENTS AND METHODS: Treatment-naive patients with mRCC (n = 213) received axitinib 5 mg twice per day (b.i.d.) for 4 weeks. Patients meeting dose titration criteria were randomized to receive axitinib 5 mg b.i.d. with axitinib or placebo titration (n = 56 each); 91 patients ineligible for randomization continued axitinib 5 mg b.i.d.; 10 discontinued before randomization. RESULTS: Median overall survival (95% confidence interval [CI]) was 42.7 months (24.7-not estimable) with axitinib titration versus 30.4 months (23.7-45.0) with placebo titration (stratified hazard ratio, 0.785; 95% CI, 0.485-1.272; 1-sided P = .162), and 41.6 months (95% CI, 33.0-not estimable) in nonrandomized patients. Safety data were consistent with previous reports. CONCLUSION: Median overall survival was numerically longer in patients with first-line mRCC who received axitinib versus placebo titration. No new safety signal was observed after long-term axitinib treatment in first-line mRCC.
Department of Hematology and Oncology Cleveland Clinic Taussig Cancer Institute Cleveland OH
Department of Urology Keio University School of Medicine Tokyo Japan
Department of Urology Kinki University Faculty of Medicine Osaka Japan
H Lee Moffitt Cancer Center Tampa FL
Palacky University Medical School and Teaching Hospital Olomouc Czech Republic
Prostate Center and Division of Urology Chiba Cancer Center Chiba Japan
The University of Texas M D Anderson Cancer Center Houston TX
Citace poskytuje Crossref.org
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- $a BACKGROUND: In a randomized phase II trial in metastatic renal cell carcinoma (mRCC), objective response rate was significantly higher with axitinib versus placebo titration (54% vs. 34%; 1-sided P = .019). PATIENTS AND METHODS: Treatment-naive patients with mRCC (n = 213) received axitinib 5 mg twice per day (b.i.d.) for 4 weeks. Patients meeting dose titration criteria were randomized to receive axitinib 5 mg b.i.d. with axitinib or placebo titration (n = 56 each); 91 patients ineligible for randomization continued axitinib 5 mg b.i.d.; 10 discontinued before randomization. RESULTS: Median overall survival (95% confidence interval [CI]) was 42.7 months (24.7-not estimable) with axitinib titration versus 30.4 months (23.7-45.0) with placebo titration (stratified hazard ratio, 0.785; 95% CI, 0.485-1.272; 1-sided P = .162), and 41.6 months (95% CI, 33.0-not estimable) in nonrandomized patients. Safety data were consistent with previous reports. CONCLUSION: Median overall survival was numerically longer in patients with first-line mRCC who received axitinib versus placebo titration. No new safety signal was observed after long-term axitinib treatment in first-line mRCC.
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