Published 2020
| Version v1
Publication
Late immune-related adverse events in long-term responders to PD-1/PD-L1 checkpoint inhibitors: A multicentre study
Creators
- Nigro O.
- Pinotti G.
- De Galitiis F.
- Di Pietro F. R.
- Giusti R.
- Filetti M.
- Bersanelli M.
- Lazzarin A.
- Bordi P.
- Catino A.
- Pizzutilo P.
- Galetta D.
- Marchetti P.
- Botticelli A.
- Scagnoli S.
- Russano M.
- Santini D.
- Torniai M.
- Berardi R.
- Ricciuti B.
- De Giglio A.
- Chiari R.
- Russo A.
- Adamo V.
- Tudini M.
- Silva R. R.
- Bolzacchini E.
- Giordano M.
- Di Marino P.
- De Tursi M.
- Rijavec E.
- Ghidini M.
- Vallini I.
- Stucci L. S.
- Tucci M.
- Pala L.
- Conforti F.
- Queirolo P.
- Tanda E.
- Spagnolo F.
- Cecchi F.
- Bracarda S.
- Macrini S.
- Santoni M.
- Battelli N.
- Fargnoli M. C.
- Porzio G.
- Tuzi A.
- Suter M. B.
- Ficorella C.
- Cortellini A.
Contributors
Others:
- Nigro, O.
- Pinotti, G.
- De Galitiis, F.
- Di Pietro, F. R.
- Giusti, R.
- Filetti, M.
- Bersanelli, M.
- Lazzarin, A.
- Bordi, P.
- Catino, A.
- Pizzutilo, P.
- Galetta, D.
- Marchetti, P.
- Botticelli, A.
- Scagnoli, S.
- Russano, M.
- Santini, D.
- Torniai, M.
- Berardi, R.
- Ricciuti, B.
- De Giglio, A.
- Chiari, R.
- Russo, A.
- Adamo, V.
- Tudini, M.
- Silva, R. R.
- Bolzacchini, E.
- Giordano, M.
- Di Marino, P.
- De Tursi, M.
- Rijavec, E.
- Ghidini, M.
- Vallini, I.
- Stucci, L. S.
- Tucci, M.
- Pala, L.
- Conforti, F.
- Queirolo, P.
- Tanda, E.
- Spagnolo, F.
- Cecchi, F.
- Bracarda, S.
- Macrini, S.
- Santoni, M.
- Battelli, N.
- Fargnoli, M. C.
- Porzio, G.
- Tuzi, A.
- Suter, M. B.
- Ficorella, C.
- Cortellini, A.
Description
Background: Data on spectrum and grade of immune-related adverse events (irAEs) in long-term responders to immune checkpoint inhibitors (ICIs) are lacking. Methods: We performed a retrospective multicenter study to characterized irAEs occurring after a 12-months minimum treatment period with PD-(L)1 ICIs in patients with advanced cancer. IrAEs were categorized into 'early' (≤12 months) and 'late' (>12 months). Results: From September 2013 to October 2019, 436 consecutive patients were evaluated. Two hundred twenty-three experienced any grade early-irAEs (51.1%), whereas 132 experienced any grade late-irAEs (30.3%) (p < 0.0001). Among the latter, 29 (22%) experienced a recurrence of an early-irAEs, whereas 103 (78%) experienced de novo late-irAEs involving different system/organ. Among patients with late-irAEs, 21 experienced GIII/GIV irAEs (4.8%). Median time to onset of early-irAEs was 3.4 months (95% confidence interval [CI]: 2.8–4.2), whereas the median time to onset of late-irAEs was 16.6 months (95% CI: 15.8–17.6). Cumulative time-adjusted risk of disease progression according to both the early-irAEs (hazard ratio [HR] = 0.63 [95% CI: 0.30–1.29], p = 0.204) and late-irAEs occurrence revealed no statistically significant differences (HR = 0.75 [95% CI: 0.37–1.56], p = 0.452). In addition, the time-adjusted cumulative risk of death in accordance with both early-irAEs (HR = 0.79 [95% CI: 0.34–1.86], p = 0.598) and late-irAEs (HR = 0.92 [95% CI: 0.49–1.74], p = 0.811) did not show statistically significant differences. Conclusion: Although less frequent than early-irAEs, late-irAEs are quite common in long responders to PD-(L)1 ICIs and are different in terms of spectrum and grade. Time-adjusted analysis revealed that the cumulative risk of disease progression and death were not significantly reduced in patients who experienced late-irAEs.
Additional details
Identifiers
- URL
- https://hdl.handle.net/11567/1183495
- URN
- urn:oai:iris.unige.it:11567/1183495
Origin repository
- Origin repository
- UNIGE