{
    "abstract": "In the ENGOT-EN6-NSGO/GOG3031/RUBY trial, dostarlimab+carboplatin-paclitaxel demonstrated significant improvement in progression free survival and a positive trend in overall survival compared with placebo+carboplatin-paclitaxel, with manageable toxicity, in patients with primary advanced or recurrent endometrial cancer. Here we report on patient-reported outcomes in the mismatch repair-deficient/microsatellite instability-high population, a secondary endpoint in the trial.\nPatients were randomized 1:1 to dostarlimab+carboplatin-paclitaxel or placebo+carboplatin-paclitaxel every 3 weeks for 6 cycles followed by dostarlimab or placebo monotherapy every 6 weeks for \u22643 years or until disease progression. Patient-reported outcomes, assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Endometrial Cancer Module, were prespecified secondary endpoints. A mixed model for repeated measures analysis, a prespecified exploratory analysis, was conducted to generate least-squares means to compare between-treatment differences while adjusting for correlations across multiple time points within a patient and controlling for the baseline value. Results are provided with 2-sided, nominal p values.\nOf 494 patients enrolled, 118 were mismatch repair-deficient/microsatellite instability-high. In this population, mean change from baseline to end of treatment showed visual improvements in global quality of life (QoL), emotional and social function, pain, and back/pelvis pain for dostarlimab+carboplatin-paclitaxel. Meaningful differences (least-squares mean [standard error]) favoring the dostarlimab arm were reported for change from baseline to end of treatment for QoL (14.7 [5.45]; p=0.01), role function (12.7 [5.92]); p=0.03), emotional function (14.3 [4.92]; p<0.01), social function (13.5 [5.43]; p=0.01), and fatigue (-13.3 [5.84]; p=0.03).\nPatients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer receiving dostarlimab+carboplatin-paclitaxel demonstrated improvements in several QoL domains over patients receiving placebo+carboplatin-paclitaxel. The observed improvements in progression free survival and overall survival while improving or maintaining QoL further supports dostarlimab+carboplatin-paclitaxel as a standard of care in this setting.\nClinicalTrials.gov NCT03981796.",
    "authors": [
        {
            "affiliation": "Department of Oncology, Ordine Mauriziano Torino, University of Torino, Torino, Italy giorgio.valabrega@unito.it.",
            "firstname": "Giorgio",
            "initials": "G",
            "lastname": "Valabrega"
        },
        {
            "affiliation": "Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Washington University School of Medicine, St Louis, Missouri, USA.",
            "firstname": "Matthew A",
            "initials": "MA",
            "lastname": "Powell"
        },
        {
            "affiliation": "Department of Obstetrics and Gynecology, Turku University Hospital, Turku, Finland.",
            "firstname": "Sakari",
            "initials": "S",
            "lastname": "Hietanen"
        },
        {
            "affiliation": "Division of Gynecologic Oncology, Western Pennsylvania Hospital, Allegheny Health Network, Pittsburgh, Pennsylvania, USA.",
            "firstname": "Eirwen M",
            "initials": "EM",
            "lastname": "Miller"
        },
        {
            "affiliation": "Department of Gynecology, Hungarian National Institute of Oncology, Budapest, Hungary.",
            "firstname": "Zoltan",
            "initials": "Z",
            "lastname": "Novak"
        },
        {
            "affiliation": "AdventHealth Cancer Institute, Orlando, Florida, USA.",
            "firstname": "Robert",
            "initials": "R",
            "lastname": "Holloway"
        },
        {
            "affiliation": "Department of Obstetrics and Gynecology, Breast and Gynecologic Oncology Cancer Center, Hochtaunus-Kliniken Bad Homburg, Bad Homburg, Germany.",
            "firstname": "Dominik",
            "initials": "D",
            "lastname": "Denschlag"
        },
        {
            "affiliation": "Baystate Gynecologic Oncology, Springfield, Massachusetts, USA.",
            "firstname": "Tashanna",
            "initials": "T",
            "lastname": "Myers"
        },
        {
            "affiliation": "Department of Gynecologic Oncology, Catharina Een Santeon Ziekenhuis, Eindhoven, Netherlands.",
            "firstname": "Anna M",
            "initials": "AM",
            "lastname": "Thijs"
        },
        {
            "affiliation": "University of Washington School of Medicine, Seattle, Washington, USA.",
            "firstname": "Kathryn P",
            "initials": "KP",
            "lastname": "Pennington"
        },
        {
            "affiliation": "Division of Gynecologic Oncology, McGill University Health Centre, Montreal, Quebec, Canada.\nThe Gerald Bronfman Department of Oncology, McGill University, Montreal, Quebec, Canada.",
            "firstname": "Lucy",
            "initials": "L",
            "lastname": "Gilbert"
        },
        {
            "affiliation": "Division of Gynecologic Oncology, Billings Clinic, Billings, Montana, USA.",
            "firstname": "Evelyn",
            "initials": "E",
            "lastname": "Fleming"
        },
        {
            "affiliation": "Ilan Bruchim Hillel Yaffe Medical Center, Hadera, Israel.",
            "firstname": "Oleksandr",
            "initials": "O",
            "lastname": "Zub"
        },
        {
            "affiliation": "Division of Gynecology Oncology, Indiana University Health and Simon Cancer Center, Indianapolis, Indiana, USA.",
            "firstname": "Lisa M",
            "initials": "LM",
            "lastname": "Landrum"
        },
        {
            "affiliation": "AGO Study Group, Wiesbaden, Germany.\nEvangelische Kliniken Essen-Mitte, Essen, Germany.\nMedical School and University Medical Center OWL, Klinikum Lippe, Department of Gynecology, Gynecologic Oncology and Obstetrics, Bielefeld University, Detmold, Germany.",
            "firstname": "Beyhan",
            "initials": "B",
            "lastname": "Ataseven"
        },
        {
            "affiliation": "Department of Gynecologic Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, Michigan, USA.",
            "firstname": "Radhika",
            "initials": "R",
            "lastname": "Gogoi"
        },
        {
            "affiliation": "Department of Gynecologic Oncology, Parkview Health, Fort Wayne, Indiana, USA.",
            "firstname": "Iwona",
            "initials": "I",
            "lastname": "Podzielinski"
        },
        {
            "affiliation": "Texas Oncology, Fort Worth, Texas, USA.",
            "firstname": "Noelle",
            "initials": "N",
            "lastname": "Cloven"
        },
        {
            "affiliation": "GOG Foundation and the Division of Gynecologic Oncology, Florida Cancer Specialists and Research Institute, West Palm Beach, Florida, USA.",
            "firstname": "Bradley J",
            "initials": "BJ",
            "lastname": "Monk"
        },
        {
            "affiliation": "Sharma Gynecology Oncology, Hinsdale, Illinois, USA.",
            "firstname": "Sudarshan",
            "initials": "S",
            "lastname": "Sharma"
        },
        {
            "affiliation": "Department of Obstetrics and Gynecology, University of Cincinnati Cancer Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.",
            "firstname": "Thomas J",
            "initials": "TJ",
            "lastname": "Herzog"
        },
        {
            "affiliation": "Department of Gynecologic Oncology, Women and Infants Hospital of Rhode Island, Providence, Rhode Island, USA.",
            "firstname": "Ashley",
            "initials": "A",
            "lastname": "Stuckey"
        },
        {
            "affiliation": "GOG Foundation and the Departments of Obstetrics/Gynecology and Medicine and Division of Gynecologic Oncology, Laura and Isaac Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA.",
            "firstname": "Bhavana",
            "initials": "B",
            "lastname": "Pothuri"
        },
        {
            "affiliation": "Gynecologic Oncology Program, Duke Cancer Institute, Durham, North Carolina, USA.",
            "firstname": "Angeles Alvarez",
            "initials": "AA",
            "lastname": "Secord"
        },
        {
            "affiliation": "Department of Obstetrics and Gynecology, David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, California, USA.",
            "firstname": "Dana",
            "initials": "D",
            "lastname": "Chase"
        },
        {
            "affiliation": "GSK, Bengaluru, India.",
            "firstname": "Veena",
            "initials": "V",
            "lastname": "Vincent"
        },
        {
            "affiliation": "GSK, Collegeville, Pennsylvania, USA.",
            "firstname": "Oren",
            "initials": "O",
            "lastname": "Meyers"
        },
        {
            "affiliation": "GSK, London, UK.",
            "firstname": "Jamie",
            "initials": "J",
            "lastname": "Garside"
        },
        {
            "affiliation": "Department of Oncology, Rigshospitalet, Copenhagen University Hospital, and the Nordic Society of Gynecological Oncology Clinical Trial Unit, Copenhagen, Denmark.",
            "firstname": "Mansoor Raza",
            "initials": "MR",
            "lastname": "Mirza"
        },
        {
            "affiliation": "Willis-Knighton Cancer Center, Willis-Knighton Health System, Gynecologic Oncology Associates, Shreveport, Louisiana, USA.",
            "firstname": "Destin",
            "initials": "D",
            "lastname": "Black"
        }
    ],
    "conclusions": null,
    "copyrights": "\u00a9 IGCS and ESGO 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.",
    "doi": "10.1136/ijgc-2024-005484",
    "journal": "International journal of gynecological cancer : official journal of the International Gynecological Cancer Society",
    "keywords": [
        "Uterine Cancer",
        "Uterus"
    ],
    "methods": null,
    "publication_date": "2024-09-26",
    "pubmed_id": "39322611",
    "results": "Of 494 patients enrolled, 118 were mismatch repair-deficient/microsatellite instability-high. In this population, mean change from baseline to end of treatment showed visual improvements in global quality of life (QoL), emotional and social function, pain, and back/pelvis pain for dostarlimab+carboplatin-paclitaxel. Meaningful differences (least-squares mean [standard error]) favoring the dostarlimab arm were reported for change from baseline to end of treatment for QoL (14.7 [5.45]; p=0.01), role function (12.7 [5.92]); p=0.03), emotional function (14.3 [4.92]; p<0.01), social function (13.5 [5.43]; p=0.01), and fatigue (-13.3 [5.84]; p=0.03).",
    "title": "Patient-reported outcomes in the subpopulation of patients with mismatch repair-deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer treated with dostarlimab plus chemotherapy compared with chemotherapy alone in the ENGOT-EN6-NSGO/GOG3031/RUBY trial.",
    "xml": "<Element 'PubmedArticle' at 0x7885039b5990>"
}