Publications

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.

The prevalence of HIV is exceptionally high among Jamaican men who have sex with men (JMSM) compared to similar populations within the Caribbean. A noticeable gap in the literature is the impact of childhood sexual abuse (CSA) and sexual assault on the state of the epidemic among this population. This study focused on JMSM's experiences with CSA and sexual assault and how these domains relate to HIV prevention. We analyzed qualitative data from 20 semi-structured in-depth interviews and focus group discussions with 10 men. Common themes emerged that highlight the patterns and nature of the abuse, the characteristics of the perpetrators, and the ways in which participants engage agency and resiliency as a basis to reclaim personal power. These findings serve as a catalyst for understanding how experiences with CSA and sexual assault affect the lives of young JMSM; how those experiences may impact attitudes and behaviors regarding HIV testing, engagement in care; and have implications for shaping legal policy, clinical, and mental health services for JMSM survivors.