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Pembrolizumab plus Chemotherapy in Advanced Endometrial Cancer.
Eskander, Ramez N; Sill, Michael W; Beffa, Lindsey; Moore, Richard G; Hope, Joanie M; Musa, Fernanda B; Mannel, Robert; Shahin, Mark S; Cantuaria, Guilherme H; Girda, Eugenia; Mathews, Cara; Kavecansky, Juraj; Leath, Charles A; Gien, Lilian T; Hinchcliff, Emily M; Lele, Shashikant B; Landrum, Lisa M; Backes, Floor; O'Cearbhaill, Roisin E; Al Baghdadi, Tareq; Hill, Emily K; Thaker, Premal H; John, Veena S; Welch, Stephen; Fader, Amanda N; Powell, Matthew A; Aghajanian, Carol.
Affiliation
  • Eskander RN; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Sill MW; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Beffa L; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Moore RG; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Hope JM; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Musa FB; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Mannel R; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Shahin MS; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Cantuaria GH; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Girda E; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Mathews C; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Kavecansky J; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Leath CA; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Gien LT; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Hinchcliff EM; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Lele SB; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Landrum LM; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Backes F; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • O'Cearbhaill RE; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Al Baghdadi T; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Hill EK; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Thaker PH; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • John VS; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Welch S; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Fader AN; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Powell MA; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
  • Aghajanian C; From the Division of Gynecologic Oncology, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Diego, Rebecca and John Moores Cancer Center, La Jolla (R.N.E.), and the Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP),
N Engl J Med ; 388(23): 2159-2170, 2023 Jun 08.
Article de En | MEDLINE | ID: mdl-36972022
ABSTRACT

BACKGROUND:

Standard first-line chemotherapy for endometrial cancer is paclitaxel plus carboplatin. The benefit of adding pembrolizumab to chemotherapy remains unclear.

METHODS:

In this double-blind, placebo-controlled, randomized, phase 3 trial, we assigned 816 patients with measurable disease (stage III or IVA) or stage IVB or recurrent endometrial cancer in a 11 ratio to receive pembrolizumab or placebo along with combination therapy with paclitaxel plus carboplatin. The administration of pembrolizumab or placebo was planned in 6 cycles every 3 weeks, followed by up to 14 maintenance cycles every 6 weeks. The patients were stratified into two cohorts according to whether they had mismatch repair-deficient (dMMR) or mismatch repair-proficient (pMMR) disease. Previous adjuvant chemotherapy was permitted if the treatment-free interval was at least 12 months. The primary outcome was progression-free survival in the two cohorts. Interim analyses were scheduled to be triggered after the occurrence of at least 84 events of death or progression in the dMMR cohort and at least 196 events in the pMMR cohort.

RESULTS:

In the 12-month analysis, Kaplan-Meier estimates of progression-free survival in the dMMR cohort were 74% in the pembrolizumab group and 38% in the placebo group (hazard ratio for progression or death, 0.30; 95% confidence interval [CI], 0.19 to 0.48; P<0.001), a 70% difference in relative risk. In the pMMR cohort, median progression-free survival was 13.1 months with pembrolizumab and 8.7 months with placebo (hazard ratio, 0.54; 95% CI, 0.41 to 0.71; P<0.001). Adverse events were as expected for pembrolizumab and combination chemotherapy.

CONCLUSIONS:

In patients with advanced or recurrent endometrial cancer, the addition of pembrolizumab to standard chemotherapy resulted in significantly longer progression-free survival than with chemotherapy alone. (Funded by the National Cancer Institute and others; NRG-GY018 ClinicalTrials.gov number, NCT03914612.).
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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Protocoles de polychimiothérapie antinéoplasique / Tumeurs de l&apos;endomètre Type d'étude: Clinical_trials / Etiology_studies Limites: Female / Humans Langue: En Journal: N Engl J Med Année: 2023 Type de document: Article
Texte intégral
Ajouter à My VHL
Imprimer
XML
PubMed Links
Recherche sur Google

Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Protocoles de polychimiothérapie antinéoplasique / Tumeurs de l&apos;endomètre Type d'étude: Clinical_trials / Etiology_studies Limites: Female / Humans Langue: En Journal: N Engl J Med Année: 2023 Type de document: Article