Sandra Munro, PhD, CMPP
Writing Samples:
The global burden of typhoid and paratyphoid fevers: a systematic analysis for the Global Burden of Disease Study
The assignment was to submit a 300-word abstract for a manuscript. Since it was specified that the abstract should be formatted for The Lancet, I used British English. (Note: I wrote this Abstract in December 2018; the study was published in February 2019.)
Background
Quantification of the global burden of typhoid and paratyphoid is key to understanding the magnitude of enteric disease and implementing effective vaccine policy. We estimated the incidence and mortality of typhoid and paratyphoid, separately and collectively, from the Global Burden of Disease (GBD) 2016 Study using improved methods.
Methods
We modelled the combined incidence and individual proportions of typhoid and paratyphoid, and then characterized the total cases proportionally by location, age, sex, and year. We then modelled case fatality by age and income, and calculated separate estimates of case fatality. Mortality was estimated as the product of incidence and fatality for typhoid and paratyphoid, respectively. Estimates of burden were quantified by years of life lost to premature mortality (YLLs), years lived with disability (YLDs), and disability-adjusted life years (DALYs).
Findings
We estimated 15.5 (95% confidence interval: 13.6–17.8) million combined cases (11.8 and 3.8 million typhoid and paratyphoid, respectively) and 153.4 (85.9–253.4) thousand combined deaths (128.2 and 25.2 thousand typhoid and paratyphoid, respectively) occurred globally in 2016. The highest incidence and mortality rates were among children and older adults and among those living in lower-income countries. The majority of cases were attributable to Salmonella Typhi. There were 113.5 (74.9–158.7) and 10.4 (6.9–15.1) thousand YLDs, 8.7 (4.8–14.4) and 1.6 (0.8–3.1) million YLLs, and 8.8 (4.9–14.5) and 1.6 (0.8–3.1) million DALYs attributable to typhoid and paratyphoid in 2016, respectively.
Interpretation
We present the relative contributions of typhoid and paratyphoid, empirical estimates of incidence and case fatality by age and income, and critical information on trends in incidence and mortality. Despite the decline in incidence and mortality of typhoid and paratyphoid over the past two decades, they remain a major cause of death and disability globally.
(Word count: 292)
Pembrolizumab in Patients with Metastatic Breast Cancer with High Tumor Mutational Burden: Results from the Targeted Agent and Profiling Utilization Registry Study
The assignment was to develop an abstract from information presented in a poster. It was to be no more than 2600 characters (no spaces), including title, background, methods, results, and conclusion.
Background
The Targeted Agent and Profiling Utilization Registry (TAPUR) study is a phase II basket trial aimed at evaluating the antitumor activity of US Food and Drug Administration-approved agents in patients with advanced cancer and targetable genomic alterations. The results of treatment with pembrolizumab, an immune checkpoint inhibitor, in a cohort of patients with metastatic breast cancer (MBC) with high tumor mutational burden (HTMB) are presented.
Methods
Patients with advanced MBC with no remaining standard treatment options, Eastern Cooperative Oncology Group (ECOG) performance status 0–1, adequate organ function, and measurable disease were eligible for enrollment. All patients had tumors with HTMB ranging from 9–37 mutations/megabase (Muts/Mb). Patients received pembrolizumab at 2 mg/kg over 30 minutes (n=8) or 200 mg (n=20) every 3 weeks (wks) until disease progression. Tumor evaluations were performed at 8 and 16 wks after treatment initiation. A Simon’s optimal two-stage design was used to test the null hypothesis of 15% disease control (DC) rate versus the alternative of 35%. In stage 1, 10 patients are enrolled; if ≥ 2 patients experience DC, consisting of objective response (OR) or stable disease (SD) at 16+ wks, the cohort is expanded to stage 2 with 28 patients enrolled. If ≥ 7 of 28 patients have DC, the drug is considered worthy of further study.
Results
A total of 28 female MBC patients with a median age of 63 were enrolled between October 2016 to July 2018. The DC rate was 37% (90% CI, 24% to 46%), and the OR rate was 21% (95% CI, 8% to 41%). Results for secondary endpoints included median progression-free survival (mPFS) at 10.6 wks (95% CI, 7.7 to 21.1 weeks), and median overall survival (mOS) at 31.6 weeks (95% CI, 11.9 to infinity). There was no correlation observed between PFS and Muts/Mb. Four patients experienced adverse events (AE) or serious AEs (SAEs) potentially related to pembrolizumab including grade 3 AEs (weight loss, hypoalbuminemia, and hyponatremia), grade 2 SAE (urinary tract infection), and grade 3 SAEs (colonic obstruction and hepatic failure).
Conclusion
Pembrolizumab demonstrated anti-tumor activity in MBC patients with HTMB and no remaining standard treatment options. Further study of pembrolizumab is warranted in this population to confirm efficacy.
(2124 characters, no spaces, including Title)
Sample Abstracts:
I wrote the abstracts below as proficiency tests. Although they were based on real studies, they are not the actual abstracts that were ultimately published.