Comparison of Use of Neoadjuvant Systemic Treatment for Breast Cancer and Short-term Outcomes Before vs During the COVID-19 Era in Ontario, Canada.

Importance: In response to an increase in COVID-19 infection rates in Ontario, several systemic treatment (ST) regimens delivered in the adjuvant setting for breast cancer were temporarily permitted for neoadjuvant-intent to defer nonurgent breast cancer surgical procedures.

Objective: To examine the use and compare short-term outcomes of neoadjuvant-intent vs adjuvant ST in the COVID-19 era compared with the pre-COVID-19 era.

Design, Setting, And Participants: This was a retrospective population-based cohort study in Ontario, Canada.

Tools for the Economic Evaluation of Precision Medicine: A Scoping Review of Frameworks for Valuing Heterogeneity-Informed Decisions.

Background And Objective: Precision medicine highlights the importance of exploring heterogeneity in the effectiveness and costs of interventions. Our objective was to identify and compare frameworks for valuing heterogeneity-informed decisions, and consider their strengths and weaknesses for application to precision medicine.

Methods: We conducted a scoping review to identify papers that proposed an analytical framework to place a value, in terms of costs and health benefits, on using heterogeneity to inform treatment selection.

Validating Restricted Mean Survival Time Estimates From Reconstructed Kaplan-Meier Data Against Original Trial Individual Patient Data From Trials Conducted by the Canadian Cancer Trials Group.

Objectives: The development of novel cancer therapies, including immuno-oncology agents, has increased interest in reconstructed individual patient data (IPD) based restricted mean survival time (RMST) analyses. Additionally, reconstructed IPD-based RMST is recommended in cost-effectiveness analyses when original trial IPD are not available. Nevertheless, recently concerns regarding potential bias of reconstructed-IPD RMST have been presented, because reconstructed-IPD RMSTs have not been validated and previous validation endpoints may not capture the entire Kaplan-Meier (KM) curve, especially the "tail.

Real-World Cost-Effectiveness of First-Line Gemcitabine Plus Nab-Paclitaxel vs FOLFIRINOX in Patients With Advanced Pancreatic Cancer.

Background: There are no randomized control trials (RCTs) comparing gemcitabine and nab-paclitaxel (Gem-Nab) and fluorouracil, folinic acid, irinotecan, oxaliplatin (FOLFIRINOX) for advanced pancreatic cancer (APC). Although it is well known that RCT-based efficacy often does not translate to real-world effectiveness, there is limited literature investigating comparative cost-effectiveness of Gem-Nab vs FOLFIRINOX for APC. We aimed to examine the real-world cost-effectiveness of Gem-Nab vs FOLFIRINOX for APC in Ontario, Canada.

Cancer Patients' Experiences with Telehealth before and during the COVID-19 Pandemic in British Columbia.

Background: Patients have had their cancer care either postponed or changed to telehealth visits to reduce exposure to COVID-19. However, it is unclear how these changes may have affected their experiences. We aim to identify patient characteristics that affect telehealth experiences and evaluate their preferences for using telehealth in the future.

Whole-genome and transcriptome analysis enhances precision cancer treatment options.

Background: Recent advances are enabling delivery of precision genomic medicine to cancer clinics. While the majority of approaches profile panels of selected genes or hotspot regions, comprehensive data provided by whole-genome and transcriptome sequencing and analysis (WGTA) present an opportunity to align a much larger proportion of patients to therapies.

Patients And Methods: Samples from 570 patients with advanced or metastatic cancer of diverse types enrolled in the Personalized OncoGenomics (POG) program underwent WGTA.

Are patients with cancer at higher risk of COVID-19-related death? A systematic review and critical appraisal of the early evidence.

Background: Early reports suggested that COVID-19 patients with cancer were at higher risk of COVID-19-related death. We conducted a systematic review with risk of bias assessment and synthesis of the early evidence on the risk of COVID-19-related death for COVID-19 patients with and without cancer.

Methods And Findings: We searched Medline/Embase/BioRxiv/MedRxiv/SSRN databases to 1 July 2020.

The risk of contracting SARS-CoV-2 or developing COVID-19 for people with cancer: A systematic review of the early evidence.

Background: The early COVID-19 literature suggested that people with cancer may be more likely to be infected with SARS-CoV-2 or develop COVID-19 than people without cancer, due to increased health services contact and/or immunocompromise. While some studies were criticised due to small patient numbers and methodological limitations, they created or reinforced concerns of clinicians and people with cancer. These risks are also important in COVID-19 vaccine prioritisation decisions.

Challenges with sex-specific subgroup analyses in oncology clinical trials for drug approvals between 2015-2020.

Introduction: Women continue to be underrepresented in oncology clinical trials, leading to poor, underpowered subgroup analyses that cannot be generalized to cancer patients in practice. In 2014, the US Food and Drug Administration (FDA) released an Action Plan, which included actions to improve the quality and reporting of demographic subgroup data. We sought to evaluate the five-year progress since the release of this report by assessing the credibility of sex-specific subgroup analyses in oncology clinical trials.

Health-related quality of life data collected in chimeric antigen receptor T-cell (CAR-T) therapy clinical trials.

Introduction: Chimeric antigen receptor T-cell (CAR-T) therapy represents a novel approach to cancer treatment, particularly advanced cancer. Much of the current evidence for the effectiveness of these therapies is associated with considerable uncertainty. This uncertainty poses a challenge for decision-makers and health systems responsible for granting patients access to these therapies.

Parametric Survival Extrapolation of Early Survival Data in Economic Analyses: A Comparison of Projected Versus Observed Updated Survival.

Objectives: To establish the value of cancer drugs by cost-effectiveness analysis, lifetime parametric survival extrapolations are often fitted to early data. Recent literature suggests that the benefit of cancer agents in primary publications is often different compared with updated data. This study aimed to examine the projected survival based on parametric extrapolations compared with observed survival based on updated data.

Pembrolizumab alone or with chemotherapy for metastatic non-small-cell lung cancer: A systematic review and network meta-analysis.

Pembrolizumab monotherapy has replaced chemotherapy as first-line treatment for patients with metastatic non-small-cell lung cancer with tumor programmed death-ligand 1 expression ≥ 50%. The benefit of chemotherapy combined with pembrolizumab, as compared to pembrolizumab monotherapy, remains uncertain. This systematic review and network meta-analysis aimed to compare these therapies through a network of randomized controlled trials.

Mapping Canadian Data Assets to Generate Real-World Evidence: Lessons Learned from Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration's RWE Data Working Group.

Canadian provinces routinely collect patient-level data for administrative purposes. These real-world data (RWD) can be used to generate real-world evidence (RWE) to inform clinical care and healthcare policy. The CanREValue Collaboration is developing a framework for the use of RWE in cancer drug funding decisions.

Cancer treatment-related financial toxicity experienced by patients in low- and middle-income countries: a scoping review.

Purpose: In the past decade, literature has called attention to financial toxicities experienced by cancer patients. Though studies have addressed research questions in high-income countries, there remains a paucity of in-depth reviews regarding low- and middle-income countries (LMICs). Our scoping review provides an overview of treatment-related financial toxicities experienced by cancer patients in LMICs.

The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada.

Regulatory and reimbursement decisions for drugs and vaccines are increasingly based on limited safety and efficacy evidence. In this environment, life-cycle approaches to evaluation are needed. A life-cycle approach grants market approval and/or positive reimbursement decisions based on an undertaking to conduct post-market clinical trials that address evidentiary uncertainties, relying on the collection and analysis of post-market data.

Impact of cancer surgery slowdowns on patient survival during the COVID-19 pandemic: a microsimulation modelling study.

Background: With the declaration of the global pandemic, surgical slowdowns were instituted to conserve health care resources for anticipated surges in patients with COVID-19. The long-term implications on survival of these slowdowns for patients with cancer in Canada is unknown.

Methods: We constructed a microsimulation model based on real-world population data on cancer care from Ontario, Canada, from 2019 and 2020.

Comparative Effectiveness and Safety of Pertuzumab and Trastuzumab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy for Treatment of Metastatic Breast Cancer.

Importance: To date, limited studies have examined the comparative outcomes of pertuzumab treatment in the real-world setting. End-of-study analyses of the CLEOPATRA trial found median overall survival (OS) of 57.1 months in patients receiving pertuzumab compared with 40.

Defining a Core Data Set for the Economic Evaluation of Precision Oncology.

Objectives: Precision oncology is generating vast amounts of multiomic data to improve human health and accelerate research. Existing clinical study designs and attendant data are unable to provide comparative evidence for economic evaluations. This lack of evidence can cause inconsistent and inappropriate reimbursement.

Cost-effectiveness Analysis of Pertuzumab With Trastuzumab in Patients With Metastatic Breast Cancer.

Importance: The initial assessment of pertuzumab use for treatment of metastatic breast cancer by health technology assessment agencies suggested that pertuzumab was not cost-effective. In Ontario, Canada, pertuzumab became funded in November 2013 based on the substantial clinical benefit. To date, there is a paucity of analysis of pertuzumab using real-world data for cost-effectiveness.

Feasibility, Acceptability, and Clinical Significance of a Dyadic, Web-Based, Psychosocial and Physical Activity Self-Management Program () Tailored to the Needs of Men with Prostate Cancer and Their Caregivers: A Multi-Center Randomized Pilot Trial.

Background: Prostate cancer is the most common cancer diagnosis among men. Family caregivers (often female spouses) play a key role in ensuring patients' needs are met, frequently assuming their role with no formal training, which can contribute to a high burden. The purpose of this study was to pilot -the first dyadic, Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram for men with prostate cancer and their caregivers.

Economic Evaluation of a Geriatric Oncology Clinic.

Geriatric assessment (GA) is supported by recent trials and guidelines yet rarely implemented due to a lack of resources. We performed an economic evaluation of a geriatric oncology clinic. Pre-GA proposed treatments and post-GA actual treatments were obtained from a detailed chart review of patients seen at a single academic centre.

Vaccine nationalism will persist: global public goods need effective engagement of global citizens.

Covid-19 presents a unique opportunity to transform democratic engagement in the governance of global public goods. In this paper, I describe a global public goods framework and how it relates to Covid-19 vaccines, and summarize some of the global responses to Covid-19. I discuss some of the global threats to health and prosperity posed by the inequitable distribution of vaccines, and propose transformative thinking to democratically engage citizens in the governance of global public goods.