Comparative Effectiveness and Safety of Trastuzumab Biosimilars to Herceptin for Adjuvant Treatment of HER2+ Breast Cancer.

Background: Ontario publicly funds reference trastuzumab (Herceptin) and four biosimilar trastuzumab products for adjuvant treatment of HER2+ breast cancer. We assessed the real-world safety and effectiveness of biosimilar trastuzumab compared to Herceptin for adjuvant treatment of patients with HER2+ breast cancer. Methods: This was a population-based, retrospective study comparing the safety and effectiveness of biosimilar trastuzumab and Herceptin for neoadjuvant/adjuvant treatment of HER2+ breast cancer from 2016 to 2021. Treatment patients started biosimilar trastuzumab from November 2019 to June 2021; historical comparator patients started Herceptin from June 2016 to October 2019. Safety outcomes death within 30 days of last dose of trastuzumab, direct hospitalization, emergency department visit leading to hospitalization, early treatment discontinuation, and in-patient admission for congestive heart failure were measured using logistic/negative binomial regression. Overall survival (OS) was measured using Kaplan-Meier methods and Cox proportional hazards regression. Propensity score matching was applied. Results: From June 2016 to 2021, 5071 patients with breast cancer were treated with neoadjuvant/adjuvant trastuzumab. The rate of direct hospitalization (RR: 0.85, 95% CI: 0.74-0.98, p-value: 0.032) was significantly lower in biosimilar compared to Herceptin patients. OS (log-rank test p = 0.98) and risk of mortality (HR: 1.29, 95% CI: 0.72-2.30, p-value = 0.39) did not significantly differ between treatment groups. Conclusions: Biosimilar trastuzumab demonstrated similar safety and effectiveness to Herceptin. The findings can help improve confidence in and use of biosimilars and demonstrate the value of real-world evidence generation for supporting biosimilar implementations and reassessments.

Delivery of Cancer Care in Ontario, Canada, During the First Year of the COVID-19 Pandemic.

Importance: The COVID-19 pandemic has impacted cancer systems worldwide. Quantifying the changes is critical to informing the delivery of care while the pandemic continues, as well as for system recovery and future pandemic planning. Objective: To quantify change in the delivery of cancer services across the continuum of care during the COVID-19 pandemic. Design, Setting, and Participants: This population-based cohort study assessed cancer screening, imaging, diagnostic, treatment, and psychosocial oncological care services delivered in pediatric and adult populations in Ontario, Canada (population 14.7 million), from April 1, 2019, to March 1, 2021. Data were analyzed from May 1 to July 31, 2021. Exposures: COVID-19 pandemic. Main Outcomes and Measures: Cancer service volumes from the first year of the COVID-19 pandemic, defined as April 1, 2020, to March 31, 2021, were compared with volumes during a prepandemic period of April 1, 2019, to March 31, 2020. Results: During the first year of the pandemic, there were a total of 4 476 693 cancer care services, compared with 5 644 105 services in the year prior, a difference of 20.7% fewer services of cancer care, representing a potential backlog of 1 167 412 cancer services. While there were less pronounced changes in systemic treatments, emergency and urgent imaging examinations (eg, 1.9% more parenteral systemic treatments) and surgical procedures (eg, 65% more urgent surgical procedures), major reductions were observed for most services beginning in March 2020. Compared with the year prior, during the first pandemic year, cancer screenings were reduced by 42.4% (-1 016 181 screening tests), cancer treatment surgical procedures by 14.1% (-8020 procedures), and radiation treatment visits by 21.0% (-141 629 visits). Biopsies to confirm cancer decreased by up to 41.2% and surgical cancer resections by up to 27.8% during the first pandemic wave. New consultation volumes also decreased, such as for systemic treatment (-8.2%) and radiation treatment (-9.3%). The use of virtual cancer care increased for systemic treatment and radiation treatment and psychosocial oncological care visits, increasing from 0% to 20% of total new or follow-up visits prior to the pandemic up to 78% of total visits in the first pandemic year. Conclusions and Relevance: In this population-based cohort study in Ontario, Canada, large reductions in cancer service volumes were observed. While most services recovered to prepandemic levels at the end of the first pandemic year, a substantial care deficit likely accrued. The anticipated downstream morbidity and mortality associated with this deficit underscore the urgent need to address the backlog and recover cancer care and warrant further study.

Diabetes, kidney disease and cardiovascular disease patients. Assessing care of complex patients using outpatient testing and visits: additional metrics by which to evaluate health care system functioning.

BACKGROUND: The triad of cardiovascular disease (CVD), chronic kidney disease (CKD) and diabetes mellitus (DM) share many fundamental disease pathways. Patients with these conditions contribute excessively to health care costs. Opportunities for system redesign require metrics by which to evaluate the impact. METHODS: Using a provincial comprehensive set of administrative billing databases (outpatient visits, laboratory tests, pharmacy and hospital inpatient services), we itemized the prevalence of each and combination of conditions, resource utilization associated with each condition and combinations, using ICD 9-10 billing codes and standard definitions. Three consecutive years (2003-2005) were used to establish stability of findings. RESULTS: CKD, CVD and DM diagnoses are found in 422 124 persons within a province of 4.3 million individuals (10%); 1.7% had all three conditions. The median age of each cohort varied significantly between those with multiple conditions (67-79 years) versus those with single condition (56-72 years). The median number of physician visits was 26 per patient year. Duplicate testing accounted for expenditures of $3 million/annum; 7.55% of patients accounted for 34.4% of duplicate tests. Those with DM or CKD had similar use of medications, physician visits and hospital days. Those with all conditions (CVD-CKD-DM) had a median of 6 in-hospital days/year. A significant proportion were not on ACE/ARB or statin medications (30 and 45%, respectively). CONCLUSION: Patients with chronic, complex conditions consume a large number of outpatient and inpatient resources. Documenting these allows identification of a set of metrics by which to design and measure health care system redesign initiatives. Potential targets to benchmark in designing more effective systems have been identified.

The sex factor: epidemiology and management of chronic obstructive pulmonary disease in British Columbia.

BACKGROUND: The prevalence and mortality of chronic obstructive pulmonary disease (COPD) in women have been predicted to overtake that of men within the next decade. These predictions are based in part on data from surveys using self-reports of a COPD diagnosis. Whether these predictions have been realized is unknown. METHODS: The prevalence and mortality of men and women in British Columbia were compared from fiscal years 1992/1993 to 2003/2004 using administrative health services data. Case definitions for COPD were developed using International Classification of Diseases ninth and 10th revision (ICD-9/10) codes applied to medical and hospital data. Individuals 45 years and older, who had at least two physician visits or one hospitalization for specified COPD ICD-9/10 codes within a 365-day window, were considered to be cases. Cases were ascertained from 1992 to 2004. RESULTS: In 2003/2004, men had a greater prevalence (4.7% versus 4.0% in women) and a higher all-cause mortality rate (5.4% versus 4.1% in women) than women. Both men and women with COPD had low COPD medication use (45%) and low referral for lung function testing (55%). Including the ICD-9 code for 'bronchitis, not specified as acute or chronic' (ICD-9 490) in the case definition resulted in a greater prevalence of COPD in women than in men overall, and in the 45 to 64 year age group. CONCLUSION: Prevalence and mortality measured with administrative health data do not show evidence of relative increase in the prevalence of COPD for women in British Columbia. However, further analysis of ICD-9 490 may identify an early 'at-risk' group, specifically in women.

Cancer incidence and mortality in Ontario First Nations, 1968-1991 (Canada).

OBJECTIVE: To determine cancer incidence and mortality rates in Ontario First Nations (FN) people (native Indians) during 1968-1991 and to compare these with rates in the Ontario population. METHODS: A cohort of 141,290 Ontario FN was created from registration files maintained by the Canadian government. Cancers and deaths were ascertained by linkage to the provincial cancer registry and mortality file, which also provided general population comparison data. RESULTS: Cancer incidence was significantly lower in FN compared to the general population for all cancer (rate ratio (RR) = 0.72 for females; 0.62 for males), breast cancer (RR = 0.54), lung cancer in men (RR = 0.68), prostate cancer (RR = 0.57) and colorectal cancer (RR = 0.58 and 0.57 in men and women, respectively). Rates were significantly higher in FN for cervical cancer (RR = 1.73) and gallbladder cancer (2.05 and 2.20 in men and women, respectively). Incidence rates increased significantly in FN people between 1968-1975 and 1984-1991 for all cancer and for the major cancers (breast, lung, prostate and colorectal). Colorectal cancer rate ratios were significantly higher in 1984-1991 than in 1968-1975, indicating converging incidence rates. Patterns of cancer mortality were similar. CONCLUSIONS: These trends are compatible with a population in epidemiologic transition to the Euro-American disease pattern which is dominated by chronic diseases.

In search of a healing place: Aboriginal women in Vancouver's Downtown Eastside.

Research on general health service delivery in urban areas of Canada shows that Aboriginal people face formidable barriers in accessing culturally appropriate and timely care. Over the past decade, Urban Aboriginal Health Centres (UAHCs) have emerged to address the unmet health concerns of Aboriginal people living in metropolitan areas of the country. The purpose of this research was to address the gap in social science literature on how the health care concerns of Aboriginal women are being met by UAHCs. The research aimed to give voice to Aboriginal women by asking them whether the appropriate professional services and educational programs they need to address their health care needs were being provided in the inner city. A case-study approach was used whereby three separate focus groups were conducted with Aboriginal women who were clients of the Vancouver Native Health Society (VNHS), its sister organization, Sheway, or residents of Vancouver's Downtown Eastside (DTES). In addition, twenty-five semi-structured interviews were conducted with VNHS staff, health providers, government representatives, and community leaders in health care (total n=61). The findings indicate that despite efforts from various quarters to articulate the health and social concerns of the country's marginalized populations, such has not been the case for Aboriginal women living in one of Canada's most prosperous cities. Many Aboriginal women expressed a strong desire for a Healing Place, based on a model of care where their health concerns are addressed in an integrated manner, where they are respected and given the opportunity to shape and influence decision-making about services that impact their own healing.