SNF-CLIMEDIN: A HECOG prospective randomized trial of digital support and intervention in patients with advanced non-small cell lung cancer (NSCLC)—Final results.

Abstract

1515 Background: This trial aims to investigate the feasibility and effectiveness of online digital intervention to NSCLC patients in terms of adverse events (AEs), quality of life (QoL), cost, and the interrelation with clinical and molecular characteristics. Methods: This prospective randomized trial recruited 200 advanced NSCLC patients (3/22-10/23). Final analysis was undertaken in 12/24. All had NGS tissue analysis for 161 genes, and received standard treatment (predominantly immuno-chemotherapy). Through the CareAcross online platform, they received information about their disease and treatment, and periodically reported any of the 22 preplanned AEs. Patients were randomized 1:1 in the Intervention (A) and Control (B) arm; patients in arm A received digitally, additionally, evidence-based guidance for the reported AEs. The study was designed to assess AE improvement (measured per patient as reduction of AEs reported at last contact, compared to those previously reported) and QoL. EQ5D-5L scores were collected. Patient-case level hospitalization data were collected and costs were estimated based on reimbursed cost as defined by the Ministry of Health. Results were correlated with patients’ clinical and molecular characteristics. Results: Clinical and molecular characteristics will be presented during ASCO Congress. Comparing arms A vs B: ORR: 42.1% vs 41.7%; Median PFS: 11m (8.0-15) vs 10m (7.0-13), 1-year PFS: 43% (31%-54%) vs 42% (31%-53%) (p = 0.4). Median OS: 15m (12-20) vs 16m (12-21), 1-year OS: 59% (48%-68%) for both arms (p = 0.9). PFS and OS were improved for those with best responses (p < 0.001). Patients with EGFR mutations had better OS (p = 0.05). The most common AEs reported in both arms were fatigue, cough, anorexia, nausea. More AEs were reported online vs to clinicians (89% vs 68% of patients; p < 0.01). Baseline EQ5D-5L was similar for both arms; when compared with data at best response, Anxiety/Depression showed the biggest difference in improvement for arm A vs B. Among the 22 ΑEs, 17 improved more in arm A, 1 improved equally, and 4 improved more in Arm B. The comparative improvements of rash and stomatitis in arm A vs B were statistically significant (p = 0.0073 & p = 0.0447). The mean hospitalization cost (arm A vs B, in Euros) was 455.4 (95%CI: 91.9-941.5) vs 779.5 (346.6-1328.5) (p < 0.001); the mean diagnostics cost was 20.3 (0.5-50.8) vs 73.3 (1.3-186.1) (p < 0.001). Conclusions: Digital oncology is feasible, cost-effective by reducing hospitalizations and tends to improve QoL (especially anxiety and depression) and most AEs of NSCLC patients regardless of clinical and molecular status. Patients report, digitally, more informative AEs for clinical and research analysis. Through the digital transformation of healthcare, digital oncology can be a complementary tool to the Oncology team and warrants further exploration. Clinical trial information: NCT05372081 .