Publications

Computed tomography angiography (CTA) has played a significant role in evaluation of coronary artery disease in the last decade and has demonstrated high sensitivity and negative predictive values. However, the positive predictive value as compared with invasive fractional flow reserve (FFR) is limited. CT-FFR has emerged as a disruptive noninvasive technology with higher specificity and diagnostic accuracy for detection of hemodynamically significant coronary lesions as compared with invasive FFR than conventional coronary CTA. CT-FFR has been shown to be cost-effective as a gate-keeper to invasive coronary angiography and has the potential to limit unnecessary invasive angiography studies.

BACKGROUND

Second-line treatment options for advanced head and neck squamous cell carcinoma (HNSCC) are limited. The phase Ib KEYNOTE-012 study evaluated the safety and the efficacy of pembrolizumab for the treatment of HNSCC after long-term follow-up.

METHODS

Multi-centre, non-randomised trial included two HNSCC cohorts (initial and expansion) in which 192 patients were eligible. Patients received pembrolizumab 10 mg/kg every 2 weeks (initial cohort; N = 60) or 200 mg every 3 weeks (expansion cohort; N = 132). Co-primary endpoints were safety and overall response rate (ORR; RECIST v1.1; central imaging vendor review).

RESULTS

Median follow-up was 9 months (range, 0.2-32). Treatment-related adverse events (AEs) of any grade and grade 3/4 occurred in 123 (64%) and 24 (13%) patients, respectively. No deaths were attributed to treatment-related AEs. ORR was 18% (34/192; 95% CI, 13-24%). Median response duration was not reached (range, 2+ to 30+ months); 85% of responses lasted ≥6 months. Overall survival at 12 months was 38%.

CONCLUSIONS

Some patients received 2 years of treatment and the responses were ongoing for more than 30 months; the durable anti-tumour activity and tolerable safety profile, observed with long-term follow-up, support the use of pembrolizumab as a treatment for recurrent/metastatic HNSCC.