Xevinapant or placebo plus chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck: TrilynX phase III study design.

Xevinapant is a first-in-class antagonist of inhibitor of apoptosis proteins, which enhances cancer cell sensitivity to chemotherapy and radiotherapy. In a phase II randomized study in patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN), xevinapant plus standard-of-care cisplatin-based chemoradiotherapy (CRT) showed superior efficacy versus placebo plus CRT. Here, we describe the design of TrilynX (NCT04459715), a randomized, double-blind, phase III study. In total, 700 patients with unresected LA SCCHN will be randomized 1:1 to receive xevinapant or placebo plus standard-of-care CRT followed by xevinapant monotherapy or placebo. The primary end point is event-free survival by blinded independent review committee. Secondary end points include progression-free survival, locoregional control, overall survival and safety.

Xevinapant is being developed as a new type of cancer treatment. Xevinapant works by enhancing the effects of chemotherapy and radiotherapy (chemoradiotherapy), which are standard anticancer treatments. Researchers are studying whether adding xevinapant to these treatments could be helpful for people with head and neck cancers that have not spread to other parts of the body and cannot be removed by surgery. In a study of 96 people with this disease, those treated with chemoradiotherapy plus xevinapant on average lived longer than people treated with chemoradiotherapy plus placebo (liquid that looked the same but did not contain any medicine). To confirm the results, researchers have started a larger study, called TrilynX, that will compare the same treatments in around 700 people worldwide. This study will show if adding xevinapant to chemoradiotherapy can help to keep the cancer from progressing, control symptoms better and help people live longer. Clinical trial registration: NCT04459715 (ClinicalTrials.gov).

Public attitude and justification to purchase antibiotics in the Eastern region Al Ahsa of Saudi Arabia.

Use of non-prescription antibiotics can portend danger and predispose the populace to changes in bacterial resistance pattern. The aims of this study were to (a) evaluate the knowledge and attitudes of residents of Al-Ahsa community, Saudi Arabia on the use of non-prescribed antibiotics. (b) To identify possible predictors (if any) for self-medication within the community. A cross-sectional survey study, using self-administered questionnaire was conducted in two sections; demographics and self-medication attitude (in form of self-antibiotic use). Questions contained the following outcomes; for demographics; gender, age, education level and common disease within the community. Whereas the second part evaluated sources of information, knowledge of antibiotics, frequency/duration of use, underlined illness in which drug use was employed, names of antibiotics used and awareness of adverse effects of antibiotics. Results revealed that the adult population in the 18-40 year age range constituted about 82.5% of the respondents. Also 18-29 age group made of 60.5% of the respondents and that 56.8% the respondents are university graduates. Cold (18.8%) and sore throat (13.0%) were the diseases commonly found among the community that drove them to using non-prescribed antibiotics. About 337 (72.8%) of the respondent mention the use of antibiotics to treat the illness, and 21 (4.5%) were aiming to prevent the illness. While, 19.4% of the respondents admitted to taking non-prescribed antibiotics for both prevention and treatment of illness. 43.6% of the respondents disclosed that they are not aware of the dangers of using non-prescribed antibiotics. In conclusion the use of non-prescribed antibiotics in this community is evident, as a significant number use them from previous experience for prevention and treatment of illness. Therefore introduction of rational use of drugs will help in limiting the attendant development of bacterial resistance.