Secondary outcome results
toxicity
DISEASE PROGRESSION, SECONDARY, ADVERSE EVENT
The secondary endpoints were duration of response, PFS, OS, clinical benefit rate and safety. In 93 patients with a confirmed or unconfirmed objective response, the median duration of response was 9.7 months (95% CI 6.8–13) in cohort 1, 7.6 months (95% CI 4.2–9.2) in cohort 2 and 6.8 months (95% CI 2.8–not reached) in cohort 3. After a median follow-up of 15.6 months (95% CI 12.6–16.7), the median PFS was 11.1 months (95% CI 8.5–14.4) in cohort 1, 6.7 months (95% CI 4.4–8.3) in cohort 2 and 4.2 months (95% CI 2.0–5.7) in cohort 3. In the multivariable analysis adjusted for clinical characteristics, cohort 1 was associated with longer PFS (adjusted HR: 0.53, 95% CI 0.34–0.84, In total, 145 patients (81%) permanently discontinued treatment: 49 (72.1%) in cohort 1, 61 (83.6%) in cohort 2 and 35 (92.1%) in cohort 3. The reason for discontinuation was disease progression in 125 (86.2%) patients and toxicity in 13 (9%) patients. Adverse events were consistent with previous data