Category Ranking
98%
Total Visits
921
Avg Visit Duration
2 minutes
Citations
20
Article Abstract
Purpose: Lenvatinib plus pembrolizumab (len + pembro) significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in previously treated advanced or recurrent endometrial cancer (aEC) in the phase III Study 309/KEYNOTE-775. We report results from the phase III, randomized, open-label European Network of Gynaecological Oncological Trial-en9/LEAP-001 study (ClinicalTrials.gov identifier: NCT03884101) that evaluated len + pembro versus chemotherapy in first-line aEC.
Methods: Patients with stage III to IV or recurrent, radiographically apparent EC and no previous chemotherapy or disease progression ≥6 months after neo/adjuvant platinum-based chemotherapy were randomly assigned 1:1 to lenvatinib 20 mg once daily plus pembrolizumab 200 mg once every 3 weeks or paclitaxel 175 mg/m plus carboplatin AUC 6 mg/mL/min once every 3 weeks. Primary end points were PFS and OS, evaluated in the mismatch repair-proficient (pMMR) and all-comers populations. Noninferiority was assessed for OS at final analysis (FA) for len + pembro versus chemotherapy (multiplicity-adjusted, one-sided nominal alpha, .0159; null hypothesis-tested hazard ratio [HR], 1.1).
Results: Eight hundred forty-two patients were randomly assigned (len + pembro, n = 420 [pMMR population, n = 320]; chemotherapy, n = 422 [pMMR population, n = 322]). At FA (data cutoff, October 2, 2023), median PFS (95% CI) in the pMMR population was 9.6 (8.2 to 11.9) versus 10.2 (8.4 to 10.5) months with len + pembro versus chemotherapy (hazard ratio [HR], 0.99 [95% CI, 0.82 to 1.21]) and among all-comers was 12.5 (10.3 to 15.1) versus 10.2 (8.4 to 10.4) months (HR, 0.91 [95% CI, 0.76 to 1.09]; descriptive analyses). Median OS (95% CI) in the pMMR population was 30.9 (25.4 to 37.7) versus 29.4 (26.2 to 35.4) months with len + pembro versus chemotherapy (HR, 1.02 [95% CI, 0.83 to 1.26]; noninferiority = .246, not statistically significant per multiplicity control strategy) and among all-comers was 37.7 (32.2 to 43.6) versus 32.1 (27.2 to 35.7) months (HR, 0.93 [95% CI, 0.77 to 1.12]). Grade ≥3 treatment-related adverse events occurred in 331/420 (79%) versus 274/411 (67%) treated patients.
Conclusion: First-line len + pembro did not meet prespecified statistical criteria for PFS or OS versus chemotherapy in pMMR aEC.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11936476 | PMC |
| http://dx.doi.org/10.1200/JCO-24-01326 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
PASS-01: Randomized Phase II Trial of Modified FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel and Molecular Correlatives for Previously Untreated Metastatic Pancreatic Cancer.
J Clin Oncol
September 2025
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins University School of Medicine, Baltimore, MD.
Purpose: To assess modified folinic acid/leucovorin, fluorouracil, irinotecan, oxaliplatin (FOLFIRINOX; mFFX) versus gemcitabine/nab-paclitaxel (GnP) in de novo metastatic pancreatic ductal adenocarcinoma (PDAC) and explore predictive biomarkers.
Patients And Methods: Patients were randomly assigned 1:1 to mFFX or GnP with exclusion of germline pathogenic variants in or . The primary end point was progression-free survival (PFS) between arms with 0.
Investigating the know-do gap in antibiotics prescribing: Experimental evidence from India.
Sci Adv
September 2025
Sol Price School of Public Policy, University of Southern California, Los Angeles, CA, USA.
Antimicrobial resistance is largely driven by overuse of antibiotics, which is particularly common in low- and middle-income countries. We combine provider knowledge assessments and over 2000 anonymous standardized patient visits to providers in India to examine why they overprescribe antibiotics for pediatric diarrhea and figure out how to reduce overprescribing. Seventy percent of providers prescribed antibiotics without indication of bacterial infection.
View Article and Find Full Text PDFEvaluating the impact of relative dose intensity on efficacy of trastuzumab deruxtecan for metastatic breast cancer in the real-world clinical setting.
Ann Acad Med Singap
August 2025
Division of Medical Oncology, National Cancer Centre Singapore, Singapore.
Introduction: Trastuzumab deruxtecan (T-DXd) has revolutionised treatment for metastatic breast cancer (MBC). While effective, its high cost and toxicities, such as fatigue and nausea, pose challenges.
Method: Medical records from the Joint Breast Cancer Registry in Singapore were used to study MBC patients treated with T-DXd (February 2021-June 2024).
Is there a chance for curative treatment for metastatic pancreatic adenocarcinoma? A systematic review with meta-analysis.
Langenbecks Arch Surg
September 2025
Department of Surgery HBP Unit, Simone Veil Hospital, University of Reims Champagne-Ardenne, Troyes, France.
Introduction: Pancreatic adenocarcinomas (PDAC) have a poor prognosis, with a 5-year relative Survival rate of 11.5%. Only 20% of patients are initially eligible for resection, and 50% of patients presented with metastatic disease, currently only candidates' palliative treatment.
View Article and Find Full Text PDFTrends in Patient-Reported Outcomes After Breast-Conserving Surgery and Partial-Breast Versus Whole-Breast Irradiation.
Ann Surg Oncol
September 2025
Breast Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Background: Although several trials have demonstrated the oncologic safety of partial-breast irradiation (PBI) compared with whole-breast irradiation (WBI), data on patient-reported outcomes are mixed. Here we compare breast satisfaction and chest well-being using the BREAST-Q questionnaire among patients undergoing PBI versus WBI.
Patients And Methods: We identified patients undergoing lumpectomy and radiation, and analyzed their BREAST-Q scores preoperatively and postoperatively at 6 months, 1 year, 2 years, and 3 years.