Long-term responders to nivolumab in previously treated advanced renal cell carcinoma: a sub-analysis of meet-URO15 study.

Although nivolumab prolongs overall survival (OS) in pretreated patients with metastatic renal cell carcinoma (mRCC), underlining clinical and biological features of long-term responses are still to be determined.

This study aims to investigate clinical and pathological characteristics of mRCC patients who achieved long-term responses during nivolumab treatment.

A retrospective analysis was performed on mRCC patients receiving nivolumab as second or further therapy line between May 2016 and January 2019 in 34 Italian Oncology Centres. Outcome assessments and logistic regression were performed to evaluate factors influencing long-term responses.

A total of 571 patients with a median age of 61 years (range 17-85) were included in the analysis. With a median follow-up of 22.1 (1.0-89.0) months, 23.1% of patients were 2-year progression-free on treatment with nivolumab, hence they were categorized as long-term responders. Baseline characteristics, including age, gender, and histology, were similar between long- and short-term responders. Karnofsky Performance Status ≥ 80% was significantly associated with long-term response (p = 0.02), while bone metastases (p = 0.03), International mRCC Database Consortium intermediate-poor risk (p < 0.01) and Neutrophil-to-Lymphocyte Ratio ≥ 3.2 (p = 0.02) were associate with short-term responses. Long-term responders exhibited a median progression-free survival of 55.0 months versus 4.0 months of the short-term responders. The median OS was not reached in long-term responders while it was 17.0 months for short*term responders.

This retrospective analysis sheds light on factors associated with long-term response to nivolumab in mRCC. Understanding these clinical features will be essential for selecting patients who may mostly benefit from immunotherapy.

Cancer immunology, immunotherapy : CII. 2024 Jul 02*** epublish ***

Carlo Messina, Martina Catalano, Giandomenico Roviello, Annalice Gandini, Marco Maruzzo, Ugo De Giorgi, Paolo Pedrazzoli, Andrea Sbrana, Paolo Andrea Zucal, Cristina Masini, Emanuele Naglieri, Giuseppe Procopio, Michele Milella, Fabio Catalano, Lucia Fratino, Stefania Pipitone, Riccardo Ricotta, Stefano Panni, Veronica Mollica, Mariella Soraru, Veronica Prati, Francesco Atzori, Marilena Di Napoli, Marco Messina, Franco Morelli, Giuseppe Prati, Franco Nole, Andrea Malgeri, Marianna Tudini, Francesca Vignani, Alessia Cavo, Alessio Signori, Giuseppe Luigi Banna, Pasquale Rescigno, Sebastiano Buti, Sara Elena Rebuzzi, Giuseppe Fornarini

Oncology Unit, A.R.N.A.S. Civico Palermo, Palermo, Italy., Department of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, Viale Pieraccini 6, 50139, Florence, Italy., Department of Health Sciences, Section of Clinical Pharmacology and Oncology, University of Florence, Viale Pieraccini 6, 50139, Florence, Italy. ., Medical Oncology Unit 1, IRCCS Ospedale Policlinico San Martino of Genova, Genova, Italy., Oncology 1 Unit, Department of Oncology, Istituto Oncologico Veneto IOV - IRCCS, Padova, Italy., Department of Medical Oncology, IRCCS Istituto Romagnolo Per Lo Studio Dei Tumori (IRST) "Dino Amadori", Meldola, Italy., Dipartimento di Medicina Interna e Terapia Medica, Università Degli Studi di Pavia, Pavia, Italy., Oncology Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy., Department of Biomedical Sciences, Humanitas University, Milano, Pieve Emanuele, Italy., Medical Oncology Unit, AUSL-IRCCS of Reggio Emilia, Reggio Emilia, Italy., Division of Medical Oncology, IRCCS Istituto Tumori "Giovanni Paolo II", Bari, Italy., SS Oncologia Medica Genitourinaria, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milano, Italy., Section of Innovation Biomedicine - Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona and Verona University and Hospital Trust (AOUI Verona), Verona, Italy., Medical Oncology, Centro di Riferimento Oncologico di Aviano, National Cancer Institute, Aviano, Italy., Azienda Ospedaliero Universitaria di Modena, Modena, Italy., Medical Oncology Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) MultiMedica, Milan, Italy., Medical Oncology Unit, ASST - Istituti Ospitalieri Cremona Hospital, Cremona, Italy., Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., U. O. Oncologia, Ospedale Di Camposampiero, Camposampiero, Italy., Medical Oncology Unit, ASL CN 2, Alba-Bra, Italy., Medical Oncology Department, University Hospital, University of Cagliari, Cagliari, Italy., Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy., UOC Oncologia Medica, Istituto Fondazione G. Giglio, Cefalù, Italy., Medical Oncology Department, Casa Sollievo Della Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy., Department of Oncology, Advanced Technologies AUSL - IRCCS Reggio Emilia, Reggio Emilia, Italy., Medical OncologyDivision of Urogenital & Head & Neck Tumors, IEO, European Institute of Oncology IRCCS, Milano, Italy., Department of Medical Oncology, Fondazione Policlinico Campus Bio-Medico, Roma, Italy., Medical Oncology, St. Salvatore Hospital, L'Aquila, Italy., Division of Medical Oncology, Ordine Mauriziano Hospital, Torino, Italy., Oncology Unit, Villa Scassi Hospital, Genova, Italy., Department of Health Sciences, Section of Biostatistics, University of Genova, Genoa, Italy., Portsmouth Hospitals University NHS Trust, Portsmouth, P06 3LY, UK., Translational and Clinical Research Institute, Centre for Cancer, Newcastle University, Newcastle Upon Tyne, UK., Oncology Unit, University Hospital of Parma, Parma, Italy., Medical Oncology Unit, Ospedale San Paolo, Savona, Italy.

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