Assessing the discordance rate between local and central HER2 testing in women with locally determined HER2-negative breast cancer.

BackgroundThe importance of human epidermal growth factor receptor 2 (HER2) as a prognostic and predictive marker in invasive breast cancer is well established. Accurate assessment of HER2 status is essential to determine optimal treatment options.MethodsBreast cancer tumor tissue samples from the VIRGO observational cohort tissue substudy that were locally HER2-negative were retested centrally with both US Food and Drug Administration (FDA)-approved immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) assays, using FDA-approved assay cutoffs; results were compared.ResultsOf the 552 unique patient samples centrally retested with local HER2-negative results recorded, tumor samples from 22 (4.0%) patients were determined to be HER2-positive (95% confidence interval [CI] = 2.5%-5.7%). Of these, 18 had been tested locally by only one testing methodology; 15 of 18 were HER2-positive after the central retesting, based on the testing methodology not performed locally. Compared with the 530 patients with centrally confirmed HER2-negative tumors, the 22 patients with centrally determined HER2-positive tumors were younger (median age 56.5 versus 60.0 years) and more likely to have ER/PR-negative tumors (27.3% versus 22.3%). These patients also had shorter median progression-free survival (6.4 months [95% CI = 3.8-15.9 months] versus 9.1 months [95% CI = 8.3-10.3 months]) and overall survival (25.9 months [95% CI = 13.8-not estimable] versus 27.9 months [95% CI = 25.0-32.9 months]).ConclusionsThis study highlights the limitations of employing just one HER2 testing methodology in current clinical practice. It identifies a cohort of patients who did not receive potentially efficacious therapy because their tumor HER2-positivity was not determined by the test initially used. Because of inherent limitations in testing methodologies, it is inadvisable to rely on a single test to rule out potential benefit from HER2-targeted therapy

Cancer research across Africa: a comparative bibliometric analysis

Introduction Research is a critical pillar in national cancer control planning. However, there is a dearth of evidence for countries to implement affordable strategies. The WHO and various Commissions have recommended developing stakeholder-based needs assessments based on objective data to generate evidence to inform national and regional prioritisation of cancer research needs and goals. Methodology Bibliometric algorithms (macros) were developed and validated to assess cancer research outputs of all 54 African countries over a 12-year period (2009–2020). Subanalysis included collaboration patterns, site and domain-specific focus of research and understanding authorship dynamics by both position and sex. Detailed subanalysis was performed to understand multiple impact metrics and context relative outputs in comparison with the disease burden as well as the application of a funding thesaurus to determine funding resources. Results African countries in total published 23 679 cancer research papers over the 12-year period (2009–2020) with the fractional African contribution totalling 16 201 papers and the remaining 7478 from authors from out with the continent. The total number of papers increased rapidly with time, with an annual growth rate of 15%. The 49 sub-Saharan African (SSA) countries together published just 5281 papers, of which South Africa’s contribution was 2206 (42% of the SSA total, 14% of all Africa) and Nigeria’s contribution was 997 (19% of the SSA total, 4% of all Africa). Cancer research accounted for 7.9% of all African biomedical research outputs (African research in infectious diseases was 5.1 times than that of cancer research). Research outputs that are proportionally low relative to their burden across Africa are paediatric, cervical, oesophageal and prostate cancer. African research mirrored that of Western countries in terms of its focus on discovery science and pharmaceutical research. The percentages of female researchers in Africa were comparable with those elsewhere, but only in North African and some Anglophone countries. Conclusions There is an imbalance in relevant local research generation on the continent and cancer control efforts. The recommendations articulated in our five-point plan arising from these data are broadly focused on structural changes, for example, overt inclusion of research into national cancer control planning and financial, for example, for countries to spend 10% of a notional 1% gross domestic expenditure on research and development on cancer

Effect of Pretreatment Renal Function on Treatment and Clinical Outcomes in the Adjuvant Treatment of Older Women With Breast Cancer: Alliance A171201, an Ancillary Study of CALGB/CTSU 49907

CALGB 49907 showed the superiority of standard therapy, which included either cyclophosphamide/doxorubicin (AC) or cyclophosphamide/methotrexate/fluorouracil over single-agent capecitabine in the treatment of patients age ≥ 65 with early-stage breast cancer. The treatment allowed dosing adjustments of methotrexate and capecitabine for pretreatment renal function. The purpose of the current analysis was to assess the relationship between pretreatment renal function and five end points: toxicity, dose modification, therapy completion, relapse-free survival, and overall survival

Quality indicators for systemic anticancer therapy services: a systematic review of metrics used to compare quality across healthcare facilities.

PURPOSE: The number of systemic anticancer therapy (SACT) regimens has expanded rapidly over the last decade. There is a need to ensure quality of SACT delivery across cancer services and systems in different resource settings to reduce morbidity, mortality, and detrimental economic impact at individual and systems level. Existing literature on SACT focuses on treatment efficacy with few studies on quality or how SACT is delivered within routine care in comparison to radiation and surgical oncology. METHODS: Systematic review was conducted following PRISMA guidelines. EMBASE and MEDLINE were searched and handsearching was undertaken to identify literature on existing quality indicators (QIs) that detect meaningful variations in the quality of SACT delivery across different healthcare facilities, regions, or countries. Data extraction was undertaken by two independent reviewers. RESULTS: This review identified 63 distinct QIs from 15 papers. The majority were process QIs (n = 55, 87.3%) relating to appropriateness of treatment and guideline adherence (n = 28, 44.4%). There were few outcome QIs (n = 7, 11.1%) and only one structural QI (n = 1, 1.6%). Included studies solely focused on breast, colorectal, lung, and skin cancer. All but one studies were conducted in high-income countries. CONCLUSIONS: The results of this review highlight a significant lack of research on SACT QIs particularly those appropriate for resource-constrained settings in low- and middle-income countries. This review should form the basis for future work in transforming performance measurement of SACT provision, through context-specific QI SACT development, validation, and implementation

Phase II Trial of Simple Oral Therapy with Capecitabine and Cyclophosphamide in Patients with Metastatic Breast Cancer: SWOG S0430

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/139899/1/onco0179.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/139899/2/onco0179-sup-0001.pd

Overall Survival with Fulvestrant plus Anastrozole in Metastatic Breast Cancer

BACKGROUND We previously reported prolonged progression-free survival and marginally prolonged overall survival among postmenopausal patients with hormone receptor-positive metastatic breast cancer who had been randomly assigned to receive the aromatase inhibitor anastrozole plus the selective estrogen-receptor down-regulator fulvestrant, as compared with anastrozole alone, as first-line therapy. We now report final survival outcomes. METHODS We randomly assigned patients to receive either anastrozole or fulvestrant plus anastrozole. Randomization was stratified according to adjuvant tamoxifen use. Analysis of survival was performed by means of two-sided stratified log-rank tests and Cox regression. Efficacy and safety were compared between the two groups, both overall and in subgroups. RESULTS Of 707 patients who had undergone randomization, 694 had data available for analysis. The combination-therapy group had 247 deaths among 349 women (71%) and a median overall survival of 49.8 months, as compared with 261 deaths among 345 women (76%) and a median overall survival of 42.0 months in the anastrozole-alone group, a significant difference (hazard ratio for death, 0.82; 95% confidence interval (CIS, 0.69 to 0.98; P=0.03 by the log-rank test). In a subgroup analysis of the two strata, overall survival among women who had not received tamoxifen previously was longer with the combination therapy than with anastrozole alone (median, 52.2 months and 40.3 months, respectively; hazard ratio, 0.73; 95% CI, 0.58 to 0.92); among women who had received tamoxifen previously, overall survival was similar in the two groups (median, 48.2 months and 43.5 months, respectively; hazard ratio, 0.97; 95% CI, 0.74 to 1.27) (P=0.09 for interaction). The incidence of long-term toxic effects of grade 3 to 5 was similar in the two groups. Approximately 45% of the patients in the anastrozole-alone group crossed over to receive fulvestrant. CONCLUSIONS The addition of fulvestrant to anastrozole was associated with increased long-term survival as compared with anastrozole alone, despite substantial crossover to fulvestrant after progression during therapy with anastrozole alone. The results suggest that the benefit was particularly notable in patients without previous exposure to adjuvant endocrine therapy.National Cancer Institute; AstraZeneca6 month embargo; published 28 March 2019.This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at [email protected]

Social support and its implications in older, early-stage breast cancer patients in CALGB 49907 (Alliance A171301): Social support in older breast cancer patients

Most studies point to a direct association between social support and better cancer outcomes. This study examined whether baseline social support is associated with better survival and fewer chemotherapy-related adverse events in older, early-stage breast cancer patients

The challenge of measuring intra-individual change in fatigue during cancer treatment

Evaluate how well three different patient-reported outcomes (PROs) measure individual change

Consensus Statement: Expedition Inspiration Fund for Breast Cancer Research Meeting 2002

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/44212/1/10549_2004_Article_5094133.pd