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Phase II study of 2 dosing regimens of cemiplimab, a human monoclonal anti-PD-1, in metastatic cutaneous squamous cell carcinoma (mCSCC) [Meeting Abstract]

Rischin, D; Lim, A M; Schmults, C D; Khushalani, N I; Hughes, B G; Schadendorf, D; Dunn, L A; Chang, A L S; Hauschild, A; Ulrich, C; Eigentler, T; Migden, M R; Pavlick, A C; Geiger, J; Stankevich, E; Li, S; Lowy, I; Fury, M G; Guminski, A
Background: Cemiplimab-rwlc is the only US FDA-approved treatment for patients (pts) with advanced CSCC. The primary analysis of a weight-based regimen of cemiplimab 3 mg/kg IV dosed every 2 weeks (Q2W) in mCSCC has been published; follow-up data are reported here. The primary analysis for the approved fixed-dosing regimen of cemiplimab 350 mg IV dosed every 3 weeks (Q3W) in mCSCC, which displays comparable pharmacokinetics to weight-based dosing, is also reported.
Method(s): In a phase II study (NCT02760498), pts with mCSCC received IV cemiplimab as a weight-based regimen for up to 96 weeks (Group [Gp] 1, n=59) or a fixed regimen for up to 54 weeks (Gp 3, n=56). The primary objective was objective response rate (ORR) per independent central review (ICR; RECIST 1.1 for scans, modifiedWHOcriteria for photos).
Result(s): Baseline characteristics were similar in both gps (Table). Median (range) duration of follow-up was 16.5 (1.1-26.6) months (mos) for the Gp 1 update and 8.1 (0.6-14.1) mos for the Gp 3 primary analysis. ORR (95% confidence interval [CI]) by ICR was 49.2% (35.9-62.5%) in Gp 1, 39.3% (26.5-53.2%) in Gp 3, and 44.3% (35.1-53.9%) for both gps combined. ORR by investigator assessment was 49.2% (35.9-62.5%) in Gp 1, 51.8% (38.0-65.3%) in Gp 3, and 50.4% (41.0-59.9%) combined. Median duration of response (DOR) per ICR has not been reached (range: Gp 1, 2.8-21.6 mos; Gp 3, 2.1-11.1 mos). Estimated 12-month DOR (95% CI) per ICR was 88.9% (69.3-96.3%) in Gp 1 and not evaluable in Gp 3. Similar proportions of pts in both gps experienced an adverse event (AE), most commonly diarrhea, fatigue, and nausea (Table). Grade >=3 AEs were reported in 45.2% (52/115) of pts in both gps combined, most commonly anemia (6.1%, 7/115).
Conclusion(s): The primary analysis of Gp 3 confirms that the approved dose of cemiplimab 350 mg IV Q3W confers comparable efficacy and safety to the weight-based regimen (Gp 1) in mCSCC. Responses in both mCSCC cohorts were durable
ISSN: 1569-8041
CID: 4286022

The Role of Empathy in Burnout, Compassion Satisfaction, and Secondary Traumatic Stress among Social Workers

Wagaman, M Alex; Geiger, Jennifer M; Shockley, Clara; Segal, Elizabeth A
Social workers are at risk for experiencing burnout and secondary traumatic stress (STS) as a result of the nature of their work and the contexts within which they work. Little attention has been paid to the factors within a social worker's control that may prevent burnout and STS and increase compassion satisfaction. Empathy, which is a combination of physiological and cognitive processes, may be a tool to help address burnout and STS. This article reports on the findings of a study of social workers (N = 173) that explored the relationship between the components of empathy, burnout, STS, and compassion satisfaction using the Empathy Assessment Index and the Professional Quality of Life instruments. It was hypothesized that higher levels of empathy would be associated with lower levels of burnout and STS, and higher levels of compassion satisfaction. Findings suggest that components of empathy may prevent or reduce burnout and STS while increasing compassion satisfaction, and that empathy should be incorporated into training and education throughout the course of a social worker's career.
PMID: 26173361
ISSN: 0037-8046
CID: 1675212

Using undergraduate researchers to build vector and West Nile virus surveillance capacity

Hokit, Grant; Alvey, Sam; Geiger, Jennifer M O; Johnson, Gregory D; Rolston, Marni G; Kinsey, Daniel T; Tall Bear, Neva
Vector surveillance for infectious diseases is labor intensive and constantly threatened by budget decisions. We report on outcomes of an undergraduate research experience designed to build surveillance capacity for West Nile Virus (WNV) in Montana (USA). Students maintained weekly trapping stations for mosquitoes and implemented assays to test for WNV in pools of Culex tarsalis. Test results were verified in a partnership with the state health laboratory and disseminated to the ArboNET Surveillance System. Combined with prior surveillance data, Cx. tarsalis accounted for 12% of mosquitoes with a mean capture rate of 74 (+/-SD = 118) Cx. tarsalis females per trap and a minimum infection rate of 0.3 infected mosquitoes per 1000 individuals. However, capture and infection rates varied greatly across years and locations. Infection rate, but not capture rate, was positively associated with the number of WNV human cases (Spearman's rho = 0.94, p < 0.001). In most years, detection of the first positive mosquito pool occurred at least a week prior to the first reported human case. We suggest that undergraduate research can increase vector surveillance capacity while providing effective learning opportunities for students.
PMID: 23912200
ISSN: 1660-4601
CID: 1439722

Origin of the endemic fern genus Diellia coincides with the renewal of Hawaiian terrestrial life in the Miocene

Schneider, Harald; Ranker, Tom A; Russell, Stephen J; Cranfill, Raymond; Geiger, Jennifer M O; Aguraiuja, Ruth; Wood, Ken R; Grundmann, Michael; Kloberdanz, Keelie; Vogel, Johannes C
The enigmatic fern genus Diellia, endemic to the Hawaiian archipelago, consists of five extant and one recently extinct species. Diellia is morphologically highly variable, and a unique combination of characters has led to several contrasting hypotheses regarding the relationship of Diellia to other ferns. A phylogenetic analysis of four chloroplast loci places Diellia within 'black-stemmed' rock spleenworts of the species-rich genus Asplenium, as previously suggested by W. H. Wagner. Using an external calibration point, we estimate the divergence of the Diellia lineage from its nearest relatives to have occurred at ca. 24.3 Myr ago matching an independent estimate for the renewal of Hawaiian terrestrial life (ca. 23 Myr ago). We therefore suggest that the ancestor of the Diellia lineage may have been among the first successful colonists of the newly emerging islands in the archipelago. Disparity between morphological and nucleotide sequence variation within Diellia is consistent with a recent rapid radiation. Our estimated time of the Diellia radiation (ca. 2 Myr ago) is younger than the oldest island of Kaua'i (ca. 5.1 Myr ago) but older than the younger major islands of Maui (ca. 1.3 Myr ago), Lana'i (ca. 1.3 Myr ago) and Hawaii (ca. 0.43 Myr ago).
PMID: 15734701
ISSN: 0962-8452
CID: 1439632