International multicenter real-world REGistry for patients with metastatic renAL cell carcinoma - Meet-URO 33 study (REGAL study)

• Published in: BMC cancer Vol. 24; no. 1; pp. 757 - 5
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 24.06.2024; BioMed Central; BMC
• Subjects: Aged; Antimitotic agents; Antineoplastic agents; Carcinoma, Renal cell; Carcinoma, Renal Cell - drug therapy; Carcinoma, Renal Cell - mortality; Carcinoma, Renal Cell - pathology; Care and treatment; Clinical medicine; Clinical practice; Consent; Data collection; Decision making; Development and progression; Diagnosis; Disease control; Dosage and administration; Drug therapy; Female; Health aspects; Histology; Humans; IMDC score; Immune checkpoint inhibitor; Immunotherapy; Kidney cancer; Kidney Neoplasms - drug therapy; Kidney Neoplasms - mortality; Kidney Neoplasms - pathology; Leukocytes (neutrophilic); Lymphocytes; Male; Medical prognosis; Medical research; Medicine, Experimental; Metastases; Metastasis; Metastatic renal cell carcinoma; Middle Aged; Observational studies; Patients; Prognosis; Prospective Studies; Real-world; Registries; Regulatory approval; Renal cell carcinoma; Retrospective Studies; Study Protocol; Toxicity; Italy; Metastatic renal cell carcinoma; Prospective; IMDC score; Immune checkpoint inhibitor; Meet-URO score; Immunotherapy; Real-world; Clinical practice; Retrospective
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-024-12319-1

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.