Editta Baldini1, Alice Lunghi1, Enrico Cortesi2, Daniele Turci3, Diego Signorelli4, Valeria Stati5, Barbara Melotti6, Biagio Ricciuti7, Antonio Frassoldati8, Giampiero Romano9, Giovanni Luca Ceresoli10, Alfonso Illiano11, Francesco Verderame12, Gianpiero Fasola13, Enrico Ricevuto14, Paolo Marchetti15, Carmine Pinto16, Giacomo Cartenì17, Vieri Scotti18, Carmelo Tibaldi19, Luisa Fioretto20, Diana Giannarelli21. 1. Department of Medical Oncology, San Luca Hospital, Lucca, Italy. 2. Department of Medical Oncology, University of Rome La Sapienza, Rome, Italy. 3. Unit of Medical Oncology, S. Maria Delle Croci Hospital, Ravenna, Italy. 4. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy. 5. Thoracic Oncology Division, European Institute of Oncology, Milan, Italy. 6. Unit of Medical Oncology, Policlinico S.Orsola-Malpighi, University of Bologna, Bologna, Italy. 7. Department of Medical Oncology, Santa Maria Della Misericordia Hospital, Perugia, Italy. 8. Department of Morphology, Surgery and Experimental Medicine, S Anna University Hospital, Ferrara, Italy. 9. Department of Oncology, Vito Fazzi Hospital, Lecce, Italy. 10. Department of Oncology, Cliniche Humanitas Gavazzeni, Bergamo, Italy. 11. Department of Public Health, University of Naples Federico II, Naples, Italy. 12. Department of Hematology and Oncology, Hospital Vincenzo Cervello, Palermo, Italy. 13. Department of Oncology, University and General Hospital, Udine, Italy. 14. Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy. 15. Department of Medical Oncology, Sapienza, University of Rome, and IDI-IRCCS, Rome, Italy. 16. Department of Medical Oncology, S. Maria Hospital-IRCCS, Reggio Emilia, Italy. 17. Department of Medical Oncology, Azienda Ospedaliero-Universitaria A. Cardarelli, Napoli, Italy. 18. Department of Oncology, Radiation Oncology Unit, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy. 19. Department of Medical Oncology, San Luca Hospital, Lucca, Italy. Electronic address: carmelo.tibaldi@uslnordovest.toscana.it. 20. Department of Oncology, SM Annunziata Hospital, Florence, Italy. 21. Biostatistical Unit, Regina Elena National Cancer Institute, IRCCS, Rome, Italy.
Abstract
OBJECTIVES: The incidence of any and of severe-grade immune-related adverse events (irAEs) with second-line nivolumab monotherapy is 31-65 % and 2-5 % respectively. While potentially serious and even fatal, in the absence of an appropriate therapy, such events might be indicators of the activation of the immune system and, potentially, of efficacy. MATERIALS AND METHODS: We collected the records of 1959 non-small-cell lung cancer (NSCLC) patients treated with nivolumab in the Italian expanded access program, and we registered the appearance of any and of severe grade irAEs. We retrospectively searched for correlations between toxicity and efficacy parameters by using Cox's regression analysis. RESULTS: Overall, 342 (17.8%) patients developed an irAE of any grade. We observed that patients developing irAE of any grade achieved a significantly higher response rate (RR 27.2% vs 15.2%; p < 0.0001), disease control rate (DCR 60.5% vs 40.2%; p < 0.0001), median progression-free survival (mPFS 6.0 months [95% CI 4.9-7.1] vs 3.0 [95% CI: 2.8-3.2], p < 0.0001) and median overall survival (mOS 16.7 months [95% CI: 13.5-19.9] vs 9.4 [95% CI: 8.4-10.4], p < 0.00001) compared to patients who did not. At multivariate analysis the development of an irAE remained an independent indicator of nivolumab efficacy (HR 1.44 [95% CI: 1.22-1.71] p < 0.0001). CONCLUSIONS: This report, performed in Caucasian NSCLC patients, showed that the appearance of irAEs correlated with outcome.
OBJECTIVES: The incidence of any and of severe-grade immune-related adverse events (irAEs) with second-line nivolumab monotherapy is 31-65 % and 2-5 % respectively. While potentially serious and even fatal, in the absence of an appropriate therapy, such events might be indicators of the activation of the immune system and, potentially, of efficacy. MATERIALS AND METHODS: We collected the records of 1959 non-small-cell lung cancer (NSCLC) patients treated with nivolumab in the Italian expanded access program, and we registered the appearance of any and of severe grade irAEs. We retrospectively searched for correlations between toxicity and efficacy parameters by using Cox's regression analysis. RESULTS: Overall, 342 (17.8%) patients developed an irAE of any grade. We observed that patients developing irAE of any grade achieved a significantly higher response rate (RR 27.2% vs 15.2%; p < 0.0001), disease control rate (DCR 60.5% vs 40.2%; p < 0.0001), median progression-free survival (mPFS 6.0 months [95% CI 4.9-7.1] vs 3.0 [95% CI: 2.8-3.2], p < 0.0001) and median overall survival (mOS 16.7 months [95% CI: 13.5-19.9] vs 9.4 [95% CI: 8.4-10.4], p < 0.00001) compared to patients who did not. At multivariate analysis the development of an irAE remained an independent indicator of nivolumab efficacy (HR 1.44 [95% CI: 1.22-1.71] p < 0.0001). CONCLUSIONS: This report, performed in Caucasian NSCLCpatients, showed that the appearance of irAEs correlated with outcome.
Authors: Benjamin C Park; Seungyeon Jung; Steven T Chen; Anna K Dewan; Douglas B Johnson Journal: Am J Clin Dermatol Date: 2022-06-16 Impact factor: 6.233
Authors: Michael Zhang; Adrian J Rodrigues; Erqi L Pollom; Iris C Gibbs; Scott G Soltys; Steven L Hancock; Joel W Neal; Sukhmani K Padda; Kavitha J Ramchandran; Heather A Wakelee; Steven D Chang; Michael Lim; Melanie Hayden Gephart; Gordon Li Journal: J Neurooncol Date: 2021-01-07 Impact factor: 4.130