Accelerating the Future of Oncology Drug Development: The Role of Consortia in the Delivery of Precision Oncology Early Phase Clinical Trials.

Purpose: Over the past 15 years, the landscape of early phase clinical trials (EPCTs) has undergone a remarkable expansion in both quantity and intricacy. The proliferation of sites, trials, sponsors, and contract research organizations has surged exponentially, marking a significant shift in research conduct. However, EPCT operations suffer from numerous inefficiencies, such as cumbersome start-up processes, which are particularly critical when drug safety and the recommended phase II dose need to be established in a timely manner.

Changes in Breast Cancer Risk Associated with Benign Breast Disease from 1967 to 2013.

Background: Benign breast disease (BBD) increases breast cancer (BC) risk progressively for women diagnosed with non-proliferative (NP) change, proliferative disease without atypia (PDWA), and atypical hyperplasia (AH). Leveraging data from 18,704 women in the Mayo BBD Cohort (1967-2013), we evaluated temporal trends in BBD diagnoses and how they have influenced associated BC risk over four decades.

Methods: BC risk trends associated with BBD were evaluated using standardized incidence ratios (SIRs) and age-period-cohort modeling across four eras-pre-mammogram (1967-1981), pre-core needle biopsy (CNB) (1982-1992), transition to CNB (1993-2001), and CNB era (2002-2013).

Near-infrared spectroscopy-enabled electromechanical systems for fast mapping of biomechanics and subcutaneous diagnosis.

Fast and accurate assessment of skin mechanics holds great promise in diagnosing various epidermal diseases, yet substantial challenges remain in developing simple and wearable strategies for continuous monitoring. Here, we present a design concept, named active near-infrared spectroscopy patch (ANIRP) for continuously mapping skin mechanics. ANIRP addresses these challenges by integrating near-infrared (NIR) sensing with mechanical actuators, enabling rapid measurement (<1 s) of Young's modulus, high spatial sensing density (~1 cm), and high spatial sensitivity (<1 mm).

Randomized Phase II Study of Durvalumab with or without Tremelimumab in Patients with Metastatic Castration-Resistant Prostate Cancer.

Purpose: PD-L1 is overexpressed by dendritic cells in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing on androgen receptor pathway inhibitors. We tested whether checkpoint blockade could enhance antitumor activity in mCRPC.

Patients And Methods: In a multicenter open-label noncomparative randomized phase II study, patients with mCRPC treated with ≤1 prior cytotoxic chemotherapy, with measurable disease and progression on abiraterone and/or enzalutamide, were randomized to durvalumab 1,500 mg intravenously every 4 weeks ±4 doses of tremelimumab 75 mg intravenously.