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- Vicky Makker
- Memorial Sloan Kettering Cancer Center, New York, NY
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- Matthew H. Taylor
- Oregon Health & Science University, Portland, OR
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- Carol Aghajanian
- Memorial Sloan Kettering Cancer Center, New York, NY
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- Ana Oaknin
- Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
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- James Mier
- Beth Israel Deaconess Medical Center, Boston, MA
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- Allen L. Cohn
- Rocky Mountain Cancer Center, Denver, CO
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- Margarita Romeo
- Catalan Institute of Oncology, B-ARGO, Badalona, Spain
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- Raquel Bratos
- MD Anderson Cancer Center España, Madrid, Spain
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- Marcia S. Brose
- Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA
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- Christopher DiSimone
- Arizona Oncology Associates, Tucson, AZ
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- Mark Messing
- Texas Oncology, Bedford, TX
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- Daniel E. Stepan
- Formerly of Eisai Inc., Woodcliff Lake, NJ
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- Corina E. Dutcus
- Eisai, Woodcliff Lake, NJ
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- Jane Wu
- Eisai, Woodcliff Lake, NJ
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- Emmett V. Schmidt
- Merck & Co. Inc., Kenilworth, NJ
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- Robert Orlowski
- Merck & Co. Inc., Kenilworth, NJ
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- Pallavi Sachdev
- Eisai, Woodcliff Lake, NJ
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- Robert Shumaker
- Formerly of Eisai Inc., Woodcliff Lake, NJ
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- Antonio Casado Herraez
- San Carlos University Teaching Hospital, Madrid, Spain
抄録
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> Patients with advanced endometrial carcinoma have limited treatment options. We report final primary efficacy analysis results for a patient cohort with advanced endometrial carcinoma receiving lenvatinib plus pembrolizumab in an ongoing phase Ib/II study of selected solid tumors. </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> Patients took lenvatinib 20 mg once daily orally plus pembrolizumab 200 mg intravenously once every 3 weeks, in 3-week cycles. The primary end point was objective response rate (ORR) at 24 weeks (ORR<jats:sub>Wk24</jats:sub>); secondary efficacy end points included duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Tumor assessments were evaluated by investigators per immune-related RECIST. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> At data cutoff, 108 patients with previously treated endometrial carcinoma were enrolled, with a median follow-up of 18.7 months. The ORR<jats:sub>Wk24</jats:sub> was 38.0% (95% CI, 28.8% to 47.8%). Among subgroups, the ORR<jats:sub>Wk24</jats:sub> (95% CI) was 63.6% (30.8% to 89.1%) in patients with microsatellite instability (MSI)–high tumors (n = 11) and 36.2% (26.5% to 46.7%) in patients with microsatellite-stable tumors (n = 94). For previously treated patients, regardless of tumor MSI status, the median DOR was 21.2 months (95% CI, 7.6 months to not estimable), median PFS was 7.4 months (95% CI, 5.3 to 8.7 months), and median OS was 16.7 months (15.0 months to not estimable). Grade 3 or 4 treatment-related adverse events occurred in 83/124 (66.9%) patients. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> Lenvatinib plus pembrolizumab showed promising antitumor activity in patients with advanced endometrial carcinoma who have experienced disease progression after prior systemic therapy, regardless of tumor MSI status. The combination therapy had a manageable toxicity profile. </jats:p></jats:sec>
収録刊行物
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 38 (26), 2981-2992, 2020-09-10
American Society of Clinical Oncology (ASCO)