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Pembrolizumab plus Lenvatinib in patients with metastatic Renal Cell Carcinoma: real-world evidences from the international ARON- 1 study
C. Porta, F. Massari, T. Taha, E. Grande, MT. Bourlon, R. Kanesvaran, U. Basso, J. Molina-Cerrillo, T. Alonso-Gordoa, ZW. Myint, G. Fornarini, T. Buttner, SH. Park, Y. Ürün, U. De Giorgi, R. Pichler, P. Rescigno, T. Buchler, H. Studentova, B....
Language English Country Germany
Document type Journal Article
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- MeSH
- Quinolines * therapeutic use administration & dosage pharmacology MeSH
- Adult MeSH
- Phenylurea Compounds * therapeutic use administration & dosage pharmacology MeSH
- Antibodies, Monoclonal, Humanized * therapeutic use administration & dosage pharmacology MeSH
- Carcinoma, Renal Cell * drug therapy mortality pathology MeSH
- Middle Aged MeSH
- Humans MeSH
- Neoplasm Metastasis MeSH
- Kidney Neoplasms * drug therapy pathology mortality MeSH
- Antineoplastic Combined Chemotherapy Protocols * therapeutic use MeSH
- Retrospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
BACKGROUND: Pembrolizumab plus lenvatinib is a treatment option for metastatic Renal Cell Carcinoma (mRCC). In the ARON-1 study we investigated we the real-world experiences gained from the use of this combination for mRCC. METHODS: We retrospectively investigated real-world clinical outcomes of mRCC patients receiving pembrolizumab plus lenvatinib within the ARON-1 study. Overall survival (OS) was calculated from the start of pembrolizumab plus lenvatinib to death for any cause. Progression-Free Survival (PFS) was defined as the time from the start of pembrolizumab to progression or death from any cause. Duration of response (DoR) was defined as the time from the start of pembrolizumab to disease progression or death, whichever occurred first, in patients who achieved complete remission (CR) or partial response (PR). Overall Response Rate (ORR) was defined as the proportion of patients who achieve a CR or PR per RECIST criteria. Adverse events were retrospectively collected from electronic and paper charts and categorized by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. RESULTS: Overall, we included 202 mRCC patients treated with pembrolizumab plus lenvatinib. The median follow-up time was 15.1 months. The median OS was not reached (NR), with a median PFS of 25.6 months and an Overall Response Rate (ORR) of 59%. The median Duration of Response (DoR) was 26.2 months. G3-G4 adverse events (AEs) were observed in 92 patients (46%), with hypertension being the most common AE (13%). CONCLUSIONS: Pembrolizumab plus lenvatinib is an effective and tolerable treatment for mRCC also in the real-world setting.
Clinical Oncology Sociedad de Oncología y Hematología del Cesar Valledupar Colombia
Department of Medical and Surgical Sciences University of Bologna Bologna Italy
Department of Medical Oncology Faculty of Medicine Ankara University Ankara Turkey
Department of Medical Oncology Hospital Ramón y Cajal Madrid Spain
Department of Medical Oncology MD Anderson Cancer Center Madrid Madrid Spain
Department of Medicine and Surgery University of Parma Parma Italy
Department of Oncology Faculty of Medicine and Dentistry Palacký University Olomouc Czech Republic
Department of Urology Medical University of Innsbruck Innsbruck Austria
Department of Urology University Hospital Bonn Bonn Germany
Division of Medical Oncology Markey Cancer Center University of Kentucky Lexington KY USA
Division of Medical Oncology National Cancer Centre Singapore Singapore Singapore
Interdisciplinary Department of Medicine University of Bari A Moro Bari Italy
IRCCS Istituto Tumori Giovanni Paolo 2 70124 Bari Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
Latin American Cooperative Oncology Group LACOG Porto Alegre Brazil
Medical Oncology IRCCS Azienda Ospedaliero Universitaria di Bologna Bologna Italy
Medical Oncology Tawam Hospital Al Ain UAE
Medical Oncology Unit Macerata Hospital Macerata Italy
Medical Oncology Unit University Hospital of Parma Parma Italy
Oncology 1 Unit Department of Oncology Istituto Oncologico Veneto IOV IRCCS Padua Italy
Oncology and Hematology Department Hospital Sírio Libanês Brasília Brazil
Oncology Unit Hospital Israelita Albert Einstein São Paulo SP Brazil
References provided by Crossref.org
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