Development of at-home sample collection logistics for large-scale seroprevalence studies.

BACKGROUND: Serological studies rely on the recruitment of representative cohorts; however, such efforts are specially complicated by the conditions surrounding the COVID19 pandemic. METHODS: We aimed to design and implement a fully remote methodology for conducting safe serological surveys that also allow for the engagement of representative study populations. RESULTS: This design was well-received and effective. 2,066 participants ≥18 years old were enrolled, reflecting the ethnic and racial composition of Massachusetts. >70% of them reported being satisfied/extremely satisfied with the online enrollment and at-home self-collection of blood samples. While 18.6% reported some discomfort experienced with the collection process, 72.2% stated that they would be willing to test weekly if enrolled in a long-term study. CONCLUSIONS: High engagement and positive feedback from participants, as well as the quality of self-collected specimens, point to the usefulness of this fully remote, self-collection-based study design for future safer and efficient population-level serological surveys.

Parallel phase Ib studies of two schedules of buparlisib (BKM120) plus carboplatin and paclitaxel (q21 days or q28 days) for patients with advanced solid tumors.

PURPOSE: Phosphatidylinositol-3-kinase I (PI3K) inhibition sensitizes a wide range of cancer cell lines to platinum/taxane-based chemotherapy. This phase I study combines buparlisib, a pan-class 1A PI3K inhibitor, with two schedules of carboplatin and paclitaxel for patients with advanced solid tumors (ClinicalTrials.gov, NCT01297452). METHODS: There were two regimens: Group 1 received carboplatin AUC 5 and paclitaxel 175 mg/m(2), on day 1 of a 21-day cycle with pegfilgrastim support; Group 2 received carboplatin AUC 5 (day 1) and paclitaxel 80 mg/m(2) (days 1, 8, and 15) on a 28-day cycle without growth factor support. In both groups, three dose levels of buparlisib were explored: 50, 80, and 100 mg/day. Primary endpoint was to identify recommended phase II doses of buparlisib in both groups. RESULTS: Thirty subjects enrolled, 16 in Group 1 and 14 in Group 2. The DLTs were elevated alkaline phosphatase (n = 1) and uncomplicated neutropenia (n = 2). The median numbers of cycles were 5 (Group 1) and 6 (Group 2). The MTDs for buparlisib were 100 mg/day in Group 1 and 80 mg/day in Group 2. Among 25 patients with measurable disease, the confirmed objective response rate was 20% (one complete response, four partial responses). Among three patients with known loss of PTEN expression, all derived clinical benefit from treatment. CONCLUSION: The addition of buparlisib to carboplatin + paclitaxel was well tolerated, and preliminary activity was notable against tumors with loss of PTEN expression.