Maria Giuseppa Vitale1, Stefania Pipitone2, Marta Venturelli2, Cinzia Baldessari2, Camillo Porta3, Federica Iannuzzi3, Umberto Basso4, Sarah Scagliarini5, Paolo Andrea Zucali6, Luca Galli7, Sabrina Rossetti8, Claudia Caserta9, Sergio Bracarda9, Roberto Iacovelli10, Cristina Masini11, Alessio Cortellini12, Stefania Di Girolamo13, Sebastiano Buti14, Giuseppe Fornarini15, Francesco Carrozza16, Matteo Santoni17, Francesco Caputo2, Stefania Giaquinta2, Sara Balduzzi2, Roberto D'Amico2, Giovanna Vitale18, Pasquale Mighali2, Roberto Sabbatini2. 1. Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy. Electronic address: vitalemariag@gmail.com. 2. Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy. 3. Department of Internal Medicine, University of Pavia and Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia, Italy. 4. Department of Medical Oncology, Istituto Oncologico Veneto IOV IRCCS, Padua, Italy. 5. Department of Medical Oncology, AO "Antonio Cardarelli", Naples, Italy. 6. Humanitas Clinical and Research Cancer, Humanitas Cancer Center, IRCCS, Rozzano, Milan, Italy. 7. Medical Oncology Unit, Department of Translational Research and New Technologies in Medicine, University of Pisa, Pisa, Italy. 8. Departmental Unit of Experimental Uro-Andrologic Clinical Oncology, Istituto Nazionale Tumori Fondazione G. Pascale- IRCCS, Naples, Italy. 9. Department of Medical Oncology, Department of Oncology, Azienda Ospedaliera Santa Maria, Terni, Italy. 10. Medical Oncology Unit, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy. 11. Medical Oncology Unit, AO Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia, Italy. 12. Medical Oncology Unit, St Salvatore Hospital, University of L'Aquila, L'Aquila, Italy. 13. Medical Oncology Unit, AUSL di Imola, Imola, Italy. 14. Medical Oncology Unit, University Hospital of Parma, Parma, Italy. 15. Department of Medical Oncology, Ospedale Policlinico "San Martino", Genoa, Italy. 16. Medical Oncology Unit, City Hospital, Faenza, Italy. 17. Oncology Unit, Macerata Hospital, Macerata, Italy. 18. Faculty of Medicine and Surgery, Università Degli Studi Della Campania "Luigi Vanvitelli", Caserta, Italy.
Abstract
BACKGROUND: Immunotherapy has brought clinical benefits to patients with metastatic renal cell cancer (mRCC). Most patients tolerate immunotherapy but serious immune-related adverse events (irAEs) have been reported. Some studies indicate a correlation between irAEs and clinical response in other cancer types (eg, lung cancer and melanoma). For patients with mRCC, the impact of irAE on clinical outcome is unknown. PATIENTS AND METHODS: A retrospective review of 167 patients with mRCC treated with nivolumab as standard of care between March 2017 and January 2018 in 16 Italian centers was performed. irAEs were assessed using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. RESULTS: Any grade and grade 3/4 irAEs occurred in 46% and 8.9% of patients, respectively. The median time to appearance of irAEs was 10 weeks; 38.8% of patients required steroid treatment. The most common irAEs were cutaneous (33.7%) and gastrointestinal (23.3%). The median overall survival and progression-free survival were 20.13 and 7.86 months, respectively. Patients with irAEs showed a greater overall survival (hazard ratio, 0.38; 95% confidence interval [CI], 0.23-0.63) and progression-free survival (hazard ratio, 0.44; 95% CI, 0.29-0.66) benefit as well as better overall response rate (27.3% vs. 13.7%; odds ratio, 2.36; 95% CI, 1.03-5.44) and disease control rate (68.8% vs. 48%; odds ratio, 2.4; 95% CI, 1.23-4.67) if compared with those without irAEs. No correlation was found between steroid use and clinical outcomes. CONCLUSIONS: Our analysis revealed that the appearance of irAEs was associated with better outcomes in patients treated with nivolumab. This data may be limited by sample size and the retrospective nature of the study.
BACKGROUND: Immunotherapy has brought clinical benefits to patients with metastatic renal cell cancer (mRCC). Most patients tolerate immunotherapy but serious immune-related adverse events (irAEs) have been reported. Some studies indicate a correlation between irAEs and clinical response in other cancer types (eg, lung cancer and melanoma). For patients with mRCC, the impact of irAE on clinical outcome is unknown. PATIENTS AND METHODS: A retrospective review of 167 patients with mRCC treated with nivolumab as standard of care between March 2017 and January 2018 in 16 Italian centers was performed. irAEs were assessed using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. RESULTS: Any grade and grade 3/4 irAEs occurred in 46% and 8.9% of patients, respectively. The median time to appearance of irAEs was 10 weeks; 38.8% of patients required steroid treatment. The most common irAEs were cutaneous (33.7%) and gastrointestinal (23.3%). The median overall survival and progression-free survival were 20.13 and 7.86 months, respectively. Patients with irAEs showed a greater overall survival (hazard ratio, 0.38; 95% confidence interval [CI], 0.23-0.63) and progression-free survival (hazard ratio, 0.44; 95% CI, 0.29-0.66) benefit as well as better overall response rate (27.3% vs. 13.7%; odds ratio, 2.36; 95% CI, 1.03-5.44) and disease control rate (68.8% vs. 48%; odds ratio, 2.4; 95% CI, 1.23-4.67) if compared with those without irAEs. No correlation was found between steroid use and clinical outcomes. CONCLUSIONS: Our analysis revealed that the appearance of irAEs was associated with better outcomes in patients treated with nivolumab. This data may be limited by sample size and the retrospective nature of the study.
Authors: Christopher Hino; Kevin Nishino; Bryan Pham; Won Jin Jeon; Michael Nguyen; Huynh Cao Journal: Front Immunol Date: 2022-08-16 Impact factor: 8.786
Authors: Karen Kelly; Juliane Manitz; Manish R Patel; Sandra P D'Angelo; Andrea B Apolo; Arun Rajan; Vijay Kasturi; Isabell Speit; Marcis Bajars; John Warth; James L Gulley Journal: J Immunother Cancer Date: 2020-11 Impact factor: 13.751