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International multicenter real-world REGistry for patients with metastatic renAL cell carcinoma - Meet-URO 33 study (REGAL study).
Rebuzzi, Sara Elena; Fornarini, Giuseppe; Signori, Alessio; Buti, Sebastiano; Procopio, Giuseppe; De Giorgi, Ugo; Pignata, Sandro; Naglieri, Emanuele; Maruzzo, Marco; Banna, Giuseppe Luigi; Rescigno, Pasquale; Messina, Carlo; Mattana, Alvise; Basso, Umberto; Bimbatti, Davide.
Afiliación
  • Rebuzzi SE; Medical Oncology Unit, Ospedale San Paolo, Savona, Italy.
  • Fornarini G; Department of Internal Medicine and Medical Specialties (Di.M.I.), University of Genova, Genova, Italy.
  • Signori A; Medical Oncology Unit 1, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
  • Buti S; Department of Health Sciences (DISSAL), Section of Biostatistics, University of Genova, Genova, Italy.
  • Procopio G; Medical Oncology Unit, University Hospital of Parma, Parma, Italy. sebabuti@libero.it.
  • De Giorgi U; Department of Medicine and Surgery, University of Parma, Parma, Italy. sebabuti@libero.it.
  • Pignata S; Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano, Italy.
  • Naglieri E; Medical Oncology Department, IRCCS Istituto Romagnolo per lo studio dei tumori (IRST) "Dino Amadori", Meldola, Italy.
  • Maruzzo M; Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy.
  • Banna GL; U.O. Oncologia, IRCCS Istituto Tumori Giovanni Paolo II, Bari, Italy.
  • Rescigno P; IOV - IRCCS, Oncologia 1, Istituto Oncologico Veneto, Padova, Italy.
  • Messina C; Portsmouth Hospitals University NHS Trust, Portsmouth, PO6 3LY, UK.
  • Mattana A; Faculty of Science and Health, School of Pharmacy and Biomedical Sciences, University of Portsmouth, Portsmouth, PO1 2UP, UK.
  • Basso U; Translational and Clinical Research Institute, Centre for Cancer, Newcastle University, Newcastle Upon Tyne, UK.
  • Bimbatti D; Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy.
BMC Cancer ; 24(1): 757, 2024 Jun 24.
Article en En | MEDLINE | ID: mdl-38914928
ABSTRACT

BACKGROUND:

Nowadays, different therapeutic options are available for the first-line treatment of metastatic renal cell carcinoma (mRCC). Immuno-combinations are the standard first-line therapy in all mRCC patients regardless of the International Metastatic RCC Database Consortium (IMDC) risk category, even though TKI monotherapy is still a therapeutic option in selected patients. However, comparisons between the different first-line treatment strategies are lacking and few real-world data are available in this setting. For this reason, the regimen choice represents an important issue in clinical practice and the optimal treatment sequence remains unclear.

METHODS:

The REGAL study is a multicentric prospective observational study enrolling mRCC patients treated with first-line systemic therapy according to clinical practice in a real-world setting. A retrospective cohort of mRCC patients who received first-line systemic therapy from the 1st of January 2021 will also be included. The primary objective is to identify potential prognostic and predictive factors that could help guide the treatment choice; secondary objectives included the assessment of the prognostic performance of the novel prognostic Meet-URO score (IMDC score + neutrophil-to-lymphocyte ratio + bone metastases) compared with the IMDC score and the comparison between treatment strategies according to response and survival outcomes and toxicity profile.

DISCUSSION:

Considering the high number of therapeutic first-line strategies available for mRCC, the identification of clinical prognostic and predictive factors to candidate patients to a preferable systemic therapy is still an unmet clinical need. The Meet-URO 33 study aims to provide a large-scale real-world database on mRCC patients, to identify the clinical predictive and prognostic factors and the different performances between the ICI-based combinations according to response, survival and toxicity. TRIAL REGISTRATION CESC IOV 2023-78.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Células Renales / Sistema de Registros / Neoplasias Renales Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Carcinoma de Células Renales / Sistema de Registros / Neoplasias Renales Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article País de afiliación: Italia Pais de publicación: Reino Unido