7 research outputs found
DNA damage response and repair (DDR) gene mutations as an alternative mechanism to generate high TMB in never smoker NSCLC patients
Trustworthy artificial intelligence models using real-world and circulating genomics data for the prediction of immunotherapy efficacy in non-small cell lung cancer patients
Baseline circulating immature neutrophils anticipate hyperprogressive disease (HPD) upon 1st-line PD-1/PD-L1 inhibitors (ICI) in non-small cell lung cancer (NSCLC) patients (pts) and are reduced by platinum-based chemotherapy (PCT) and ICI combinations
Efficacy of immune checkpoint inhibitors in non-small cell lung cancer with novel actionable oncogenic driver alterations
KRAS and LKB1 mutation conferring prognostic and predictive role on liquid biopsy in advanced NSCLC
Impact of hyponatremia in a tertiary cancer center: a one-year-survey at National Cancer Institute of Milan
STYLE (NCT03449173): A Phase 2 Trial of Sunitinib in Patients With Type B3 Thymoma or Thymic Carcinoma in Second and Further Lines.
Thymic malignancies are rare tumors with few therapeutic options. The STYLE trial was aimed to evaluate activity and safety of sunitinib in advanced or recurrent type B3 thymoma (T) and thymic carcinoma (TC).
In this multicenter, Simon 2 stages, phase 2 trial, patients with pretreated T or TC were enrolled in two cohorts and assessed separately. Sunitinib was administered 50 mg daily for 4 weeks, followed by a 2-week rest period (schedule 4/2), until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR). Progression-free survival, overall survival, disease control rate and safety were secondary endpoints.
From March 2017 to January 2022, 12 patients with T and 32 patients with TC were enrolled. At stage 1, ORR was 0% (90% confidence interval [CI]: 0.0-22.1) in T and 16.7% (90% CI: 3.1-43.8) in TC, so the T cohort was closed. At stage 2, the primary endpoint was met for TC with ORR of 21.7% (90% CI: 9.0%-40.4%). In the intention-to-treat analysis, disease control rate was 91.7% (95% CI: 61.5%-99.8%) in Ts and 89.3% (95% CI: 71.8%-97.7%) in TCs. Median progression-free survival was 7.7 months (95% CI: 2.4-45.5) in Ts and 8.8 months (95% CI: 5.3-11.1) in TCs; median overall survival was 47.9 months (95% CI: 4.5-not reached) in Ts and 27.8 months (95% CI: 13.2-53.2) in TCs. Adverse events occurred in 91.7% Ts and 93.5% TCs. Grade 3 or greater treatment-related adverse events were reported in 25.0% Ts and 51.6% TCs.
This trial confirms the activity of sunitinib in patients with TC, supporting its use as a second-line treatment, albeit with potential toxicity that requires dose adjustment