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Efficacy and safety of dostarlimab in combination with chemotherapy in patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in a phase 3, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY)
MA. Powell, D. Cibula, DM. O'Malley, I. Boere, MS. Shahin, A. Savarese, DM. Chase, L. Gilbert, D. Black, J. Herrstedt, S. Sharma, S. Kommoss, MA. Gold, AM. Thijs, K. Ring, MF. Bolling, J. Buscema, SE. Gill, P. Nowicki, N. Nevadunsky, M. Callahan,...
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, randomizované kontrolované studie, klinické zkoušky, fáze III, multicentrická studie
- MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- humanizované monoklonální protilátky aplikace a dávkování škodlivé účinky MeSH
- karboplatina * aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- lokální recidiva nádoru * farmakoterapie MeSH
- mikrosatelitní nestabilita MeSH
- nádory endometria * farmakoterapie patologie MeSH
- oprava chybného párování bází DNA MeSH
- paclitaxel * aplikace a dávkování škodlivé účinky MeSH
- protokoly protinádorové kombinované chemoterapie * terapeutické užití škodlivé účinky aplikace a dávkování MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
OBJECTIVES: Part 1 of the RUBY trial (NCT03981796) demonstrated improved survival in patients with primary advanced or recurrent endometrial cancer (EC) treated with dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel. Here, we examine additional efficacy and safety data from patients with mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) EC in the RUBY trial. METHODS: Patients were randomized 1:1 to dostarlimab 500 mg or placebo plus carboplatin-paclitaxel every 3 weeks for 6 cycles followed by dostarlimab or placebo every 6 weeks for up to 3 years. In the dMMR/MSI-H population of RUBY Part 1, analysis of progression-free survival by investigator assessment compared with blinded independent central review, sensitivity analyses of the source-verified population compared with the randomized population, and analysis of safety in this population were completed. RESULTS: In total, 118 patients with dMMR/MSI-H were enrolled in the RUBY trial (53, dostarlimab arm; 65, placebo arm). At the first interim analysis, a 72% reduction in the risk of progression or death (P < 0.0001) was seen with dostarlimab plus carboplatin-paclitaxel by investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which was consistent with blinded independent central review per RECIST v1.1. Likewise, sensitivity analyses of the source-verified dMMR/MSI-H population compared with the randomized dMMR/MSI-H population were consistent for progression-free survival and overall survival. Safety results seen in the dMMR/MSI-H population were similar to those previously reported for the overall population. CONCLUSIONS: All primary and secondary efficacy assessments demonstrate the consistent benefit of dostarlimab plus carboplatin-paclitaxel. The improvements seen in survival and the manageable safety profile support the favorable benefit-risk profile for dostarlimab plus carboplatin-paclitaxel in patients with dMMR/MSI-H primary advanced or recurrent EC.
Arizona Center for Cancer Care Phoenix AZ USA
Baptist MD Anderson Cancer Center Jacksonville FL USA
David Geffen School of Medicine at UCLA Los Angeles CA USA
Department of Gynecologic Oncology University of Cincinnati Medical Center Cincinnati OH USA
Department of Medical Oncology Catharina Hospital Eindhoven the Netherlands
Department of Obstetrics Gynecology AMITA Health Adventist Medical Center Hinsdale IL USA
Division of Gynecologic Oncology St Vincent Indianapolis Hospital Indianapolis IN USA
Georgia Cancer Center Augusta University Augusta GA USA
Gynecologic Oncology Arizona Oncology Tucson AZ USA
Karolinska University Hospital Solna Sweden
Medical Oncology IRCCS Regina Elena National Cancer Institute Rome Italy
Oklahoma Cancer Specialists and Research Institute Tulsa OK USA
St Joseph's Candler Gynecologic Oncology and Surgical Specialists Candler Hospital Savannah GA USA
The Ohio State University and The James Comprehensive Cancer Center Columbus OH USA
University of Virginia Health System Charlottesville VA USA
Washington University School of Medicine Washington University in St Louis St Louis MO USA
Citace poskytuje Crossref.org
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- $a Powell, Matthew A $u National Cancer Institute-sponsored NRG Oncology, Washington University School of Medicine, St Louis, MO, USA. Electronic address: mpowell@wustl.edu
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- $a Efficacy and safety of dostarlimab in combination with chemotherapy in patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer in a phase 3, randomized, placebo-controlled trial (ENGOT-EN6-NSGO/GOG-3031/RUBY) / $c MA. Powell, D. Cibula, DM. O'Malley, I. Boere, MS. Shahin, A. Savarese, DM. Chase, L. Gilbert, D. Black, J. Herrstedt, S. Sharma, S. Kommoss, MA. Gold, AM. Thijs, K. Ring, MF. Bolling, J. Buscema, SE. Gill, P. Nowicki, N. Nevadunsky, M. Callahan, L. Willmott, C. McCourt, C. Billingsley, SA. Ghamande, Z. He, MM. Balas, S. Stevens, E. Fleming, MR. Mirza
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- $a OBJECTIVES: Part 1 of the RUBY trial (NCT03981796) demonstrated improved survival in patients with primary advanced or recurrent endometrial cancer (EC) treated with dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel. Here, we examine additional efficacy and safety data from patients with mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) EC in the RUBY trial. METHODS: Patients were randomized 1:1 to dostarlimab 500 mg or placebo plus carboplatin-paclitaxel every 3 weeks for 6 cycles followed by dostarlimab or placebo every 6 weeks for up to 3 years. In the dMMR/MSI-H population of RUBY Part 1, analysis of progression-free survival by investigator assessment compared with blinded independent central review, sensitivity analyses of the source-verified population compared with the randomized population, and analysis of safety in this population were completed. RESULTS: In total, 118 patients with dMMR/MSI-H were enrolled in the RUBY trial (53, dostarlimab arm; 65, placebo arm). At the first interim analysis, a 72% reduction in the risk of progression or death (P < 0.0001) was seen with dostarlimab plus carboplatin-paclitaxel by investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), which was consistent with blinded independent central review per RECIST v1.1. Likewise, sensitivity analyses of the source-verified dMMR/MSI-H population compared with the randomized dMMR/MSI-H population were consistent for progression-free survival and overall survival. Safety results seen in the dMMR/MSI-H population were similar to those previously reported for the overall population. CONCLUSIONS: All primary and secondary efficacy assessments demonstrate the consistent benefit of dostarlimab plus carboplatin-paclitaxel. The improvements seen in survival and the manageable safety profile support the favorable benefit-risk profile for dostarlimab plus carboplatin-paclitaxel in patients with dMMR/MSI-H primary advanced or recurrent EC.
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