Society for Immunotherapy of Cancer (SITC) recommendations on intratumoral immunotherapy clinical trials (IICT): from premalignant to metastatic disease.

BACKGROUND: Intratumorally delivered immunotherapies have the potential to favorably alter the local tumor microenvironment and may stimulate systemic host immunity, offering an alternative or adjunct to other local and systemic treatments. Despite their potential, these therapies have had limited success in late-phase trials for advanced cancer resulting in few formal approvals. The Society for Immunotherapy of Cancer (SITC) convened a panel of experts to determine how to design clinical trials with the greatest chance of demonstrating the benefits of intratumoral immunotherapy for patients with cancers across all stages of pathogenesis. METHODS: An Intratumoral Immunotherapy Clinical Trials Expert Panel composed of international key stakeholders from academia and industry was assembled. A multiple choice/free response survey was distributed to the panel, and the results of this survey were discussed during a half-day consensus meeting. Key discussion points are summarized in the following manuscript. RESULTS: The panel determined unique clinical trial designs tailored to different stages of cancer development-from premalignant to unresectable/metastatic-that can maximize the chance of capturing the effect of intratumoral immunotherapies. Design elements discussed included study type, patient stratification and exclusion criteria, indications of randomization, study arm determination, endpoints, biological sample collection, and response assessment with biomarkers and imaging. Populations to prioritize for the study of intratumoral immunotherapy, including stage, type of cancer and line of treatment, were also discussed along with common barriers to the development of these local treatments. CONCLUSIONS: The SITC Intratumoral Immunotherapy Clinical Trials Expert Panel has identified key considerations for the design and implementation of studies that have the greatest potential to capture the effect of intratumorally delivered immunotherapies. With more effective and standardized trial designs, the potential of intratumoral immunotherapy can be realized and lead to regulatory approvals that will extend the benefit of these local treatments to the patients who need them the most.

[Ophthalmic agents during pregnancy]. / Ophthalmika in der Schwangerschaft.

The use of ophthalmic agents during pregnancy and breastfeeding always represents an off-label use. Therefore, the use of drugs must be particularly carefully assessed with respect to the risk-benefit assessment. In this overview the literature databank of the PubMed library, pharmaceutical lists (Red List, Swiss pharmaceutical compendium), guidelines of the specialist societies the German Society of Ophthalmology (DOG), the Swiss Society of Ophthalmology (SOG), the European Glaucoma Society (EGS), the American Academy of Ophthalmology (AAO) and internet portals (embryotox, reprotox) were inspected and recommendations for the use of ophthalmic agents during pregnancy and breastfeeding were derived. More attention should be dedicated to this topic in the specialist societies.

Conversion Rate of Abstracts Presented at Plastic Surgery The Meeting From 2010 to 2019: A 10-Year Analysis of Factors for Success.

BACKGROUND: Presentations are an important means of knowledge generation. Publication of these studies is important for dissemination of findings beyond meeting attendees. We analyzed a 10-year sample of presented abstracts at Plastic Surgery The Meeting and describe factors that improve rate and speed of conversion to peer-reviewed publication. METHODS: Abstracts presented between 2010 and 2019 at Plastic Surgery The Meeting were sourced from the American Society of Plastic Surgery Abstract Archive. A random sample of 100 abstracts from each year was evaluated. Abstract information and demographics were recorded. The title or author and keywords of each abstract were searched using a standardized workflow to find a corresponding published paper on PubMed, Google Scholar, and Google. Data were analyzed for trends and factors affecting conversion rate. RESULTS: A total of 983 presented abstracts were included. The conversion rate was 54.1%. Residents and fellows constituted the largest proportion of presenters (38.4%). There was a significant increase in medical student and research fellow presenters during the study period (P < 0.001). Conversion rate was not affected by the research rank of a presenter's affiliated institution (ß = 1.001, P = 0.89), geographic location (P = 0.60), or subspecialty tract (P = 0.73). US academics had a higher conversion rate (61.8%) than US nonacademics (32.7%) or international presenters (47.1%) (P < 0.001). Medical students had the highest conversion rate (65.6%); attendings had the lowest (45.0%). Research fellows had the lowest average time to publication (11.6 months, P = 0.007). CONCLUSIONS: Lower levels of training, factors associated with increased institution-level support, and research quality affect rate and time to publication. These findings highlight the success of current models featuring medical student and research fellow-led projects with strong resident and faculty mentorship.