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.
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.
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.
CESC IOV 2023-78.
BMC cancer. 2024 Jun 24*** epublish ***
Sara Elena Rebuzzi, Giuseppe Fornarini, Alessio Signori, Sebastiano Buti, Giuseppe Procopio, Ugo De Giorgi, Sandro Pignata, Emanuele Naglieri, Marco Maruzzo, Giuseppe Luigi Banna, Pasquale Rescigno, Carlo Messina, Alvise Mattana, Umberto Basso, Davide Bimbatti
Medical Oncology Unit, Ospedale San Paolo, Savona, Italy., Medical Oncology Unit 1, IRCCS Ospedale Policlinico San Martino, Genova, Italy., Department of Health Sciences (DISSAL), Section of Biostatistics, University of Genova, Genova, Italy., Medical Oncology Unit, University Hospital of Parma, Parma, Italy. ., Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, Milano, Italy., Medical Oncology Department, IRCCS Istituto Romagnolo per lo studio dei tumori (IRST) "Dino Amadori", Meldola, Italy., Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy., U.O. Oncologia, IRCCS Istituto Tumori Giovanni Paolo II, Bari, Italy., IOV - IRCCS, Oncologia 1, Istituto Oncologico Veneto, Padova, Italy., Portsmouth Hospitals University NHS Trust, Portsmouth, PO6 3LY, UK., Translational and Clinical Research Institute, Centre for Cancer, Newcastle University, Newcastle Upon Tyne, UK., Oncology Unit, ARNAS Civico, Palermo, Italy.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/38914928