Diego A. Díaz García, Medical Oncologist, CEO and Founder at CánCare – Advanced Specialty in Oncology, shared a post on LinkedIn:
“Immunotherapy Discontinuation at 2 Years in Advanced NSCLC.
The I-STOP study evaluated real-world outcomes in patients with advanced NSCLC treated with single-agent PD-1/PD-L1 inhibitors for 24 months or more across 12 Italian centers. Patients with CR, PR, or SD at 24 months were analyzed according to treatment discontinuation versus continuation using a 24-month landmark approach.
Among 173 patients (median follow-up 55.4 months), 16.2% discontinued immunotherapy at 2 years.
Overall survival:
Median OS not reached in either group
HR 1.22 (95% CI 0.50–2.95), p=0.66
Progression-free survival:
Median PFS 35.6 months in the discontinuation group vs not reached with continuation
HR 2.16 (95% CI 1.04–4.48), p=0.035
Higher risk of progression after discontinuation was observed in patients with:
- PD-L1 ≤50%
- Brain metastases
- ECOG PS ≥1
- KRAS mutations
Rechallenge response rate: 62.5%
Late grade 3–4 immune-related AEs: 3.5%
Discontinuation at 24 months appears feasible and does not compromise OS in selected patients with durable disease control. However, PFS differences and high-risk subgroups suggest that a uniform 2-year stop strategy may not fit all.
Can we refine duration using clinical and molecular risk stratification? Prospective validation is needed.”
Title: Real-world outcomes of immunotherapy discontinuation at two years in advanced non-small cell lung cancer: Final results of the I-STOP study
Authors: Maria Gemelli, Luca Sala, Alessandro Morabito, Vincenzo Sforza, Alessio Cortellini, Giulia La Cava, Federica Bertolini, Giorgia Guaitoli, Simona Carnio, Silvia Novello, Alessandro Leonetti, Marcello Tisei, Francesca Mazzoni, Federica Cosso, Marianna Macerelli, Alexandro Membrino, Giulio Metro, Rita Chiari, Carlo Genova, Rossana Berardi, Elena Tassistro, Laura Antolini, Diego Luigi Cortinovis
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