Incidence and prognostic impact of amenorrhea during adjuvant therapy in high-risk premenopausal breast cancer: analysis of a National Cancer Institute of Canada Clinical Trials Group Study--NCIC CTG MA.5.

PURPOSE: To investigate the therapeutic impact of chemotherapy-induced amenorrhea in premenopausal patients with breast cancer. PATIENTS AND METHODS: We conducted a retrospective cohort study of a National Cancer Institute of Canada Clinical Trials Group phase III trial involving premenopausal patients randomized to receive cyclophosphamide, methotrexate, and fluorouracil (CMF), versus intensive cyclophosphamide, epirubicin, and fluorouracil (CEF). The objectives of our study were to describe the incidence of amenorrhea at 6 and 12 months post-random assignment and to determine the association of amenorrhea with relapse-free and overall survival. RESULTS: Data on 442 patients were used in our analyses. Despite the higher cumulative dose of cyclophosphamide in the CMF treatment arm, at 6 months post-random assignment, the rate of amenorrhea was higher in the CEF group (relative risk, 1.2; 95% CI, 1.0 to 1.3), with no difference at 12 months. In the receptor-positive subgroup, 6-month amenorrhea rates were not associated with prognosis. In contrast, amenorrhea at 12 months was significantly associated with relapse-free survival (hazard ratio, 0.51; 95% CI, 0.32 to 0.82; P = .005) and overall survival (hazard ratio, 0.40; 95% CI, 0.22 to 0.72; P = .002). CONCLUSION: Late chemotherapy-induced amenorrhea seems to be associated with improved outcome in patients with premenopausal, receptor-positive breast cancer.     

“Food Is Our Love Language”: Using Talanoa to Conceptualize Food Security for the Māori and Pasifika Diaspora in South-East Queensland,Australia

Queensland is home to the largest diaspora of Māori and Pasifika peoples in Australia. They form an understudied population concerning experiences and challenges of food insecurity. This community co-designed research aims to explore the conceptualization of household food security by Māori and Pasifika peoples living in south-east Queensland. Participatory action research and talanoa were used to collect and analyse forty interviews with leaders representing 22 Māori and Pasifika cultural identities in south-east Queensland. Eight key themes emerged that conceptualise food security as an integral part of the culture and holistic health. These themes included: spirituality, identity, hospitality and reciprocity, stigma and shame, expectations and obligations, physical and mental health and barriers and solutions. Addressing food insecurity for collectivist cultures such as Māori and Pasifika peoples requires embracing food sovereignty approaches for improved food security through the co-design of practical solutions that impact social determinants and strengthen existing networks to produce and distribute affordable and nutritious food.     

The effects of early pregnancy loss on health outcomes and health care utilization and costs

ObjectiveTo evaluate the effects of early pregnancy loss on subsequent health care use and costs.Data SourcesLinked administrative health databases from Manitoba, Canada.Study DesignThis was a population‐based cohort study. The exposure of interest was first recorded ectopic pregnancy or miscarriage (EPM). Outcomes included visits to all ambulatory care providers, family physicians (FPs), specialists, and hospitals, as well as the costs associated with these visits. We also assessed the impact of EPM on a global measure of health service utilization and the incidence and costs of psychotropic medications.Data Collection/Extraction MethodsWe identified women who experienced their first recorded loss (EPM) from 2003–2012 and created a propensity score model to match these women to women who experienced a live birth, with outcome measures available through 31 December 2014. We used a difference in differences approach with multivariable negative binomial models and generalized estimating equations (GEE) to assess the impact of EPM on the aforementioned health care utilization indicators.Principal FindingsEPM was associated with a short‐term increase in visits to, and costs associated with, certain ambulatory care providers. These findings were driven in large part by increased visits/costs to FPs (rate difference [RD]: $19.92 [95% CI: $16.33, $23.51]) and obstetrician‐gynecologists (OB‐GYNs) (RD $9.41 [95% CI: $8.42, $10.40]) in the year immediately following the loss, excluding care associated with the loss itself. We also detected an increase in hospital stays and costs and a decrease in the use of psychotropic medications relative to matched controls.ConclusionPregnancy loss may lead to subsequent increases in certain types of health care utilization. While the absolute costs associated with post‐EPM care are relatively small, the observed patterns of service utilization are informative for providers and policy makers seeking to support women following a loss.     

Treatment sequence network meta-analysis in Crohn’s disease: a methodological case study

Objective: Several biologic therapies are available for the treatment of mild-to-moderate Crohn’s disease (CD). This network meta-analysis (NMA) aimed to assess the comparative efficacy of ustekinumab, adalimumab, vedolizumab and infliximab in the maintenance of clinical response and remission after 1?year of treatment.

Methods: A systematic literature search was performed to identify relevant randomized controlled trials (RCTs). Key outcomes of interest were clinical response (CD activity index [CDAI] reduction of 100 points; CDAI-100) and remission (CDAI score under 150 points; CDAI < 150). A treatment sequence Bayesian NMA was conducted to account for the re-randomization of patients based on different clinical definitions, the lack of similarity of the common comparator for each trial and the full treatment pathway from the induction phase onwards.

Results: Thirteen RCTs were identified. Ustekinumab 90?mg q8w was associated with statistically significant improvement in clinical response relative to placebo and vedolizumab 300?mg. For clinical remission, ustekinumab 90?mg q8w was associated with statistically significant improvement relative to placebo and vedolizumab 300?mg q8w. Findings from sub-population analyses had similar results but were not statistically significant.

Conclusions: The NMA suggest that ustekinumab is associated with the highest likelihood of reaching response or remission at 1?year compared with placebo, adalimumab and vedolizumab. Results should be interpreted with caution because this is a novel methodology; however, the treatment sequence analysis may be the most methodologically sound analysis to derive estimates of comparative efficacy in CD in the absence of head-to-head evidence.     

Relative Accuracy of Fine-Needle Aspiration and Frozen Section in the Diagnosis of Well-Differentiated Thyroid Cancer

The need for and extent of thyroid surgery for a thyroid nodule is usually primarily based on fine-needle aspiration (FNA) and frozen section diagnosis. The relative role of these modalities in 66 patients who had undergone FNA and subsequent thyroidectomy with frozen section was investigated. Cases that demonstrated discordance between FNA and frozen section (n = 22; 33%) were identified, and all slides were re-reviewed by a cytopathologist using current established cytologic criteria. A change in diagnosis was made in 13 cases with an increase in accuracy of FNA from 71% to 88%. The accuracy of frozen section (92%) did not change appreciably with re-review (94%). The accuracy of FNA and frozen section combined was found to be 98%. The rate of discordance decreased from 33% to 13% with re-review. When strict histologic and cytologic criteria are applied, FNA and frozen section are accurate and complementary methods that help in determining the operative management of thyroid masses. However, when FNA yields a diagnosis of “follicular neoplasm,” frozen section is unlikely to change this diagnosis.