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.
| Original language | English |
|---|---|
| Pages (from-to) | 59-64 |
| Number of pages | 6 |
| Journal | Lung Cancer |
| Volume | 140 |
| DOIs | |
| Publication status | Published - Feb 2020 |
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Keywords
- Immuno-Related adverse events
- Nivolumab
- Outcomes
ASJC Scopus subject areas
- Oncology
- Pulmonary and Respiratory Medicine
- Cancer Research
Cite this
Immune-related adverse events correlate with clinical outcomes in NSCLC patients treated with nivolumab : The Italian NSCLC expanded access program. / Baldini, Editta; Lunghi, Alice; Cortesi, Enrico; Turci, Daniele; Signorelli, Diego; Stati, Valeria; Melotti, Barbara; Ricciuti, Biagio; Frassoldati, Antonio; Romano, Giampiero; Ceresoli, Giovanni Luca; Illiano, Alfonso; Verderame, Francesco; Fasola, Gianpiero; Ricevuto, Enrico; Marchetti, Paolo; Pinto, Carmine; Cartenì, Giacomo; Scotti, Vieri; Tibaldi, Carmelo; Fioretto, Luisa; Giannarelli, Diana.
In: Lung Cancer, Vol. 140, 02.2020, p. 59-64.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Immune-related adverse events correlate with clinical outcomes in NSCLC patients treated with nivolumab
T2 - The Italian NSCLC expanded access program
AU - Baldini, Editta
AU - Lunghi, Alice
AU - Cortesi, Enrico
AU - Turci, Daniele
AU - Signorelli, Diego
AU - Stati, Valeria
AU - Melotti, Barbara
AU - Ricciuti, Biagio
AU - Frassoldati, Antonio
AU - Romano, Giampiero
AU - Ceresoli, Giovanni Luca
AU - Illiano, Alfonso
AU - Verderame, Francesco
AU - Fasola, Gianpiero
AU - Ricevuto, Enrico
AU - Marchetti, Paolo
AU - Pinto, Carmine
AU - Cartenì, Giacomo
AU - Scotti, Vieri
AU - Tibaldi, Carmelo
AU - Fioretto, Luisa
AU - Giannarelli, Diana
PY - 2020/2
Y1 - 2020/2
N2 - 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.
AB - 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.
KW - Immuno-Related adverse events
KW - Nivolumab
KW - Outcomes
UR - http://www.scopus.com/inward/record.url?scp=85076673885&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85076673885&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2019.12.014
DO - 10.1016/j.lungcan.2019.12.014
M3 - Article
AN - SCOPUS:85076673885
VL - 140
SP - 59
EP - 64
JO - Lung Cancer
JF - Lung Cancer
SN - 0169-5002
ER -