LBPO.CL04 · 临床研究 · Late-Breaking
Extracorporeal photopheresis vs. systemic immunosuppression for treatment of immune-related adverse events: Final analysis of the prospective two-arm PRIA study
作者与单位
摘要 Abstract
Purpose : Checkpoint inhibitor-induced immune-related adverse events (irAEs) can be steroid-refractory (sr) or steroid-dependent (sd), necessitating second-line therapy. This study compared extracorporeal photopheresis (ECP) with immunosuppressants (IS) in managing sr/sd-irAEs, balancing irAE mitigation with anti-tumor efficacy.
Patients : This prospective, two-arm study analyzed 46 patients (23 ECP, 23 IS) with 12 distinct sr/sd-irAEs and five different tumor entities. Toxicities affected the gastrointestinal tract, skin, lung, musculoskeletal system, and serosal membranes, with up to seven prior treatment lines for irAEs. Patients underwent 12 weeks of either six cycles of ECP or investigator's choice IS, with longitudinal assessment of irAE outcome, quality of life (QoL), tumor response, and blood analyses.
Results : At week 12, the ECP group exhibited a higher clinical irAE response rate (94% vs. 81%; p = 0.22), improved QoL scores (p = 0.01) and required significantly less steroids than the IS cohort with 437 mg vs. 1405 mg cumulative prednisolone equivalent, respectively (p = 0.02). ECP patients with advanced cutaneous melanoma showed superior overall survival (15 vs. 10 months; p = 0.02), longer progression-free survival (9 vs. 3 months; p = 0.01), and lower cancer progression rates (33% vs. 67%; p = 0.12) compared to the IS group. ECP was more frequently utilized in multi-toxicity cases (44% vs. 9%; p = 0.016) and in patients with prior second-line treatment refractoriness (39% vs. 17%; p = 0.19). No significant safety concerns were observed with ECP; one fatality in the IS group was linked to infection under immunosuppression.
Conclusion : ECP demonstrates clinical superiority over IS in managing sr/sd-irAEs, with a favorable safety profile, and preserved anti-tumor response. A multicenter trial is planned for further investigation.
利益披露 Disclosure
L. Wein, None.
C. Ertl,
BMS Independent Contractor.
GSK Independent Contractor.
Immunocore Independent Contractor.
Kyowa Kirin Independent Contractor.
MSD Independent Contractor.
T. Ruf, None..
M. Morak, None..
Y. Wang, None..
C. Schmitt, None..
X. Garza Vazquez, None..
V. Glatzel, None..
R. David-Rus, None..
M. Mitwalli, None.
J. Srour,
Derma2Go Independent Contractor.
Abbvie Independent Contractor.
Almirall Independent Contractor.
Novartis Independent Contractor.
La Roche Posay Independent Contractor.
BMS Independent Contractor.
Leo Independent Contractor.
UCB Independent Contractor.
Beiersdorf Independent Contractor.
Boehringer Ingelheim Independent Contractor.
P. Schöpf, None.
D. Tomsitz,
BMS Independent Contractor.
Roche Independent Contractor.
Novartis Independent Contractor.
Sanofi Independent Contractor.
Recordati Independent Contractor.
Kyowa Kirin Independent Contractor.
Sun Pharma Independent Contractor.
Pierre Fabre Independent Contractor.
L. E. French,
Janssen Independent Contractor.
Leo Pharma Independent Contractor.
Eli Lilly Independent Contractor.
Almirall Independent Contractor.
Union Therapeutics Independent Contractor.
Regeneron Independent Contractor.
Novartis Independent Contractor.
Amgen Independent Contractor.
Abbvie Independent Contractor.
UCB Independent Contractor.
Biotest Independent Contractor.
Boehringer Ingelheim Independent Contractor.
InflaRx Independent Contractor.
Alys Pharmaceuticals Independent Contractor.
L. Heinzerling,
BiomeDx Independent Contractor.
BMS Independent Contractor, ).
Kyowa Kirin Independent Contractor.
Merck Independent Contractor, ).
MSD Independent Contractor.
Myoncare Independent Contractor.
Novartis Independent Contractor, ).
Pierre-Fabre Independent Contractor, ).
Roche Independent Contractor.
Sanofi Independent Contractor.
SUN Independent Contractor.
Therakos Independent Contractor.
Agenus ).
AstraZeneca Inc. ).
Hoffmann-La Roche AG ).
Huya Bioscience ).
Immunocore ).
IO Biotech ).
Merck Sharp & Dome GmbH ).
Miltenyi Biomedicine GmbH ), Other, Additional Company Researcher/Grabt/Contract: Pfizer, Regeneron, Replimune, and Sanofi Aventis.