Publications by authors named "Richard L Schilsky"

202 Publications

What can heart failure trialists learn from oncology trialists?

Eur Heart J 2021 06;42(24):2373-2383

Department of Medicine, University of Mississippi Medical Center, 2500 North State St, Jackson, MS, 39216, USA.

Globally, there has been little change in mortality rates from cardiovascular (CV) diseases or cancers over the past two decades (1997-2018). This is especially true for heart failure (HF) where 5-year mortality rates remain as high as 45-55%. In the same timeframe, the proportion of drug revenue, and regulatory drug approvals for cancer drugs, far out paces those for CV drugs. In 2018, while cancer drugs made 27% of Food and Drug Administration drug approvals, only 1% of drug approvals was for a CV drug, and over this entire 20 year span, only four drugs were approved for HF in the USA. Cardiovascular trialists need to reassess the design, execution, and purpose of CV clinical trials. In the area of oncology research, trials are much smaller, follow-up is shorter, and targeted therapies are common. Cardiovascular diseases and cancer are the two most common causes of death globally, and although they differ substantially, this review evaluates whether some elements of oncology research may be applicable in the CV arena. As one of the most underserved CV diseases, the review focuses on aspects of cancer research that may be applicable to HF research with the aim of streamlining the clinical trial process and decreasing the time and cost required to bring safe, effective, treatments to patients who need them. The paper is based on discussions among clinical trialists, industry representatives, regulatory authorities, and patients, which took place at the Cardiovascular Clinical Trialists Workshop in Washington, DC, on 8 December 2019 (https://www.globalcvctforum.com/2019 (14 September 2020)).
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http://dx.doi.org/10.1093/eurheartj/ehab236DOI Listing
June 2021

'Strategic' development of precision cancer medicine in the United States.

Mol Oncol 2021 Jul 24;15(7):1747-1749. Epub 2021 Jun 24.

University of Chicago, Chicago, IL, USA.

The availability of advanced omics technologies has largely driven development of precision cancer medicine in the United States, but integration in routine cancer care has been challenging. Here, we consider some parameters that would enable a more coordinated, integrated, efficient, and equitable implementation of precision cancer medicine.
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http://dx.doi.org/10.1002/1878-0261.13023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8253098PMC
July 2021

Digital Display Precision Predictor: the prototype of a global biomarker model to guide treatments with targeted therapy and predict progression-free survival.

NPJ Precis Oncol 2021 Apr 28;5(1):33. Epub 2021 Apr 28.

American Society of Clinical Oncology (ASCO), Alexandria, VA, USA.

The expanding targeted therapy landscape requires combinatorial biomarkers for patient stratification and treatment selection. This requires simultaneous exploration of multiple genes of relevant networks to account for the complexity of mechanisms that govern drug sensitivity and predict clinical outcomes. We present the algorithm, Digital Display Precision Predictor (DDPP), aiming to identify transcriptomic predictors of treatment outcome. For example, 17 and 13 key genes were derived from the literature by their association with MTOR and angiogenesis pathways, respectively, and their expression in tumor versus normal tissues was associated with the progression-free survival (PFS) of patients treated with everolimus or axitinib (respectively) using DDPP. A specific eight-gene set best correlated with PFS in six patients treated with everolimus: AKT2, TSC1, FKB-12, TSC2, RPTOR, RHEB, PIK3CA, and PIK3CB (r = 0.99, p = 5.67E-05). A two-gene set best correlated with PFS in five patients treated with axitinib: KIT and KITLG (r = 0.99, p = 4.68E-04). Leave-one-out experiments demonstrated significant concordance between observed and DDPP-predicted PFS (r = 0.9, p = 0.015) for patients treated with everolimus. Notwithstanding the small cohort and pending further prospective validation, the prototype of DDPP offers the potential to transform patients' treatment selection with a tumor- and treatment-agnostic predictor of outcomes (duration of PFS).
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http://dx.doi.org/10.1038/s41698-021-00171-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8080819PMC
April 2021

Pembrolizumab in Patients With Metastatic Breast Cancer With High Tumor Mutational Burden: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

J Clin Oncol 2021 Aug 12;39(22):2443-2451. Epub 2021 Apr 12.

American Society of Clinical Oncology, Alexandria, VA.

Purpose: The TAPUR Study is a phase II basket trial that aims to identify signals of antitumor activity of commercially available targeted agents in patients with advanced cancers harboring genomic alterations known to be drug targets. Results in a cohort of patients with metastatic breast cancer (mBC) with high tumor mutational burden (HTMB) treated with pembrolizumab are reported.

Methods: Patients with advanced mBC received standard doses of either 2 mg/kg or 200 mg infusions of pembrolizumab every 3 weeks. Simon's two-stage design was used with a primary study end point of disease control (DC) defined as objective response or stable disease of at least 16 weeks duration. If two or more patients in stage I achieved DC, the cohort would enroll 18 additional patients in stage II. Secondary end points include progression-free survival (PFS), overall survival, and safety.

Results: Twenty-eight patients were enrolled from October 2016 to July 2018. All patients' tumors had HTMB ranging from 9 to 37 mutations/megabase. DC and objective response were noted in 37% (95% CI, 21 to 50) and 21% of patients (95% CI, 8 to 41), respectively. Median PFS was 10.6 weeks (95% CI, 7.7 to 21.1); median overall survival was 30.6 weeks (95% CI, 18.3 to 103.3). No relationship was observed between PFS and tumor mutational burden. Five patients experienced ≥ 1 serious adverse event or grade 3 adverse event at least possibly related to pembrolizumab consistent with the product label.

Conclusion: Pembrolizumab monotherapy has antitumor activity in heavily pretreated patients with mBC characterized by HTMB. Our findings support the recent US Food and Drug Administration approval of pembrolizumab for treatment of patients with unresectable or metastatic solid tumors with HTMB without alternative treatment options.
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http://dx.doi.org/10.1200/JCO.20.02923DOI Listing
August 2021

Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Prior Therapies Work Group.

Clin Cancer Res 2021 May 9;27(9):2408-2415. Epub 2021 Feb 9.

Cancer Care Specialists of Central Illinois, Decatur, Illinois.

Purpose: Restrictive eligibility criteria induce differences between clinical trial and "real-world" treatment populations. Restrictions based on prior therapies are common; minimizing them when appropriate may increase patient participation in clinical trials.

Experimental Design: A multi-stakeholder working group developed a conceptual framework to guide evaluation of prevailing practices with respect to using prior treatment as selection criteria for clinical trials. The working group made recommendations to minimize restrictions based on prior therapies within the boundaries of scientific validity, patient centeredness, distributive justice, and beneficence.

Recommendations: (i) Patients are eligible for clinical trials regardless of the number or type of prior therapies and without requiring a specific therapy prior to enrollment unless a scientific or clinically based rationale is provided as justification. (ii) Prior therapy (either limits on number and type of prior therapies or requirements for specific therapies before enrollment) could be used to determine eligibility in the following cases: a) the agents being studied target a specific mechanism or pathway that could potentially interact with a prior therapy; b) the study design requires that all patients begin protocol-specified treatment at the same point in the disease trajectory; and c) in randomized clinical studies, if the therapy in the control arm is not appropriate for the patient due to previous therapies received. (iii) Trial designers should consider conducting evaluation separately from the primary endpoint analysis for participants who have received prior therapies.

Conclusions: Clinical trial sponsors and regulators should thoughtfully reexamine the use of prior therapy exposure as selection criteria to maximize clinical trial participation..
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http://dx.doi.org/10.1158/1078-0432.CCR-20-3854DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8170959PMC
May 2021

Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non-Small Cell Lung Cancer: Real-World Analysis of Select ASCO- Recommendations.

Clin Cancer Res 2021 May 9;27(9):2430-2434. Epub 2021 Feb 9.

Levine Cancer Institute, Atrium Health, Charlotte, North Carolina.

Purpose: Cancer clinical trials often accrue slowly or miss enrollment targets. Strict eligibility criteria are a major reason. Restrictive criteria also limit opportunities for patient participation while compromising external validity of trial results. We examined the impact of broadening select eligibility criteria on characteristics and number of patients eligible for trials, using recommendations of the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research.

Experimental Design: A retrospective, observational analysis used electronic health record data from ASCO's CancerLinQ Discovery database. Study cohort included patients with advanced non-small cell lung cancer treated from 2011 to 2018. Patients were grouped by traditional criteria [no brain metastases, no other malignancies, and creatinine clearance (CrCl) ≥ 60 mL/minute] and broadened criteria (including brain metastases, other malignancies, and CrCl ≥ 30 mL/minute).

Results: The analysis cohort included 10,500 patients. Median age was 68 years, and 73% of patients were White. Most patients had stage IV disease (65%). A total of 5,005 patients (48%) would be excluded from trial participation using the traditional criteria. The broadened criteria, however, would allow 98% of patients (10,346) to be potential participants. Examination of patients included by traditional criteria (5,495) versus those added (4,851) by broadened criteria showed that the number of women, patients aged 75+ years, and those with stage IV cancer was significantly greater using broadened criteria.

Conclusions: This analysis of real-world data demonstrated that broadening three common eligibility criteria has the potential to double the eligible patient population and include trial participants who are more representative of those encountered in practice..
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http://dx.doi.org/10.1158/1078-0432.CCR-20-3857DOI Listing
May 2021

Continuing to Broaden Eligibility Criteria to Make Clinical Trials More Representative and Inclusive: ASCO-Friends of Cancer Research Joint Research Statement.

Clin Cancer Res 2021 May 9;27(9):2394-2399. Epub 2021 Feb 9.

American Society of Clinical Oncology, Alexandria, Virginia.

Purpose: Restrictive clinical trial eligibility criteria (EC) limit the number of patients who can enroll and potentially benefit from protocol-driven, investigational treatment plans and reduce the generalizability of trial results to the broader population. Following publication of expert stakeholder recommendations for broadening EC in 2017, the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research () convened working groups to produce additional recommendations and analyze the potential impact on clinical trials using real-world data.

Experimental Design: Multistakeholder working groups were appointed by an ASCO- leadership group to propose recommendations for more inclusive EC related to: washout periods, concomitant medications, prior therapies, laboratory reference ranges and test intervals, and performance status.

Results: The four working groups, ASCO Board of Directors, and leadership support the recommendations included in this statement to modernize EC related to washout periods, concomitant medications, prior therapies, laboratory references ranges and test intervals, and performance status to make trial populations more inclusive and representative of cancer patient populations.

Conclusions: Implementation of the recommendations is intended to result in greater ease of determining patient eligibility. Increased opportunities for patient participation in research will help address longstanding underrepresentation of certain groups in clinical trials and produce evidence that is more informative for a broader patient population. More patients eligible will also likely speed clinical trial accrual..
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http://dx.doi.org/10.1158/1078-0432.CCR-20-3852DOI Listing
May 2021

Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement.

JCO Oncol Pract 2021 01 6;17(1):41-51. Epub 2021 Jan 6.

Levine Cancer Institute, Atrium Health, Charlotte, NC.

Purpose: Feasibility assessments (FAs) are important to establish site capabilities to conduct clinical trials and their suitability for specific trials. However, current FA methods used by biotechnology and pharmaceutical (biotech-pharma) trial sponsors and contract research organizations (CROs) are costly, inefficient, unnecessarily burdensome, and resource intensive. These methods delay trial start-up, act as a barrier to site participation, and ultimately reduce timely patient access to clinical trials and novel treatments.

Methods: An ASCO Task Force was convened to assess the specific burdens and challenges with FAs and to develop recommendations to improve their efficiencies and effectiveness. Stakeholders (including trial sites, biotech-pharma sponsors, and CROs) provided insights into challenges and offered solutions through two surveys and an in-person meeting. The Task Force used the feedback to formulate consensus recommendations to improve FAs for oncology clinical trials.

Results: Three key recommendations were identified for application across all biotech-pharma sponsored trials: (1) implement a streamlined and uniform FA process across trials and sponsors; (2) minimize and standardize questions; and (3) leverage technology to centralize FAs, facilitate communications, and reduce redundancies.

Conclusion: There is an urgency to improve the current FA process, which is costly, inconsistent, inefficient, labor intensive, and of uncertain effectiveness. All stakeholders stand to benefit from implementing these recommendations, which aim to minimize burdens and ensure that more trial sites and patients have timely access to oncology clinical trials. To have meaningful impact, adoption and consistent execution of these recommendations across all trials, sponsors, CROs, and sites are essential.
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http://dx.doi.org/10.1200/OP.20.00821DOI Listing
January 2021

American Society of Clinical Oncology Road to Recovery Report: Learning From the COVID-19 Experience to Improve Clinical Research and Cancer Care.

J Clin Oncol 2021 01 8;39(2):155-169. Epub 2020 Dec 8.

The Center for Cancer and Blood Disorders, Fort Worth, TX.

This report presents the American Society of Clinical Oncology's (ASCO's) evaluation of the adaptations in care delivery, research operations, and regulatory oversight made in response to the coronavirus pandemic and presents recommendations for moving forward as the pandemic recedes. ASCO organized its recommendations for clinical research around five goals to ensure lessons learned from the COVID-19 experience are used to craft a more equitable, accessible, and efficient clinical research system that protects patient safety, ensures scientific integrity, and maintains data quality. The specific goals are: (1) ensure that clinical research is accessible, affordable, and equitable; (2) design more pragmatic and efficient clinical trials; (3) minimize administrative and regulatory burdens on research sites; (4) recruit, retain, and support a well-trained clinical research workforce; and (5) promote appropriate oversight and review of clinical trial conduct and results. Similarly, ASCO also organized its recommendations regarding cancer care delivery around five goals: (1) promote and protect equitable access to high-quality cancer care; (2) support safe delivery of high-quality cancer care; (3) advance policies to ensure oncology providers have sufficient resources to provide high-quality patient care; (4) recognize and address threats to clinician, provider, and patient well-being; and (5) improve patient access to high-quality cancer care via telemedicine. ASCO will work at all levels to advance the recommendations made in this report.
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http://dx.doi.org/10.1200/JCO.20.02953DOI Listing
January 2021

Governance of a Learning Health Care System for Oncology: Patient Recommendations.

JCO Oncol Pract 2021 04 23;17(4):e479-e489. Epub 2020 Oct 23.

University of Michigan, Ann Arbor, MI.

Purpose: The learning health care system (LHS) was designed to enable real-time learning and research by harnessing data generated during patients' clinical encounters. This novel approach begets ethical questions regarding the oversight of users and uses of patient data. Understanding patients' perspectives is vitally important.

Materials And Methods: We conducted democratic deliberation sessions focused on CancerLinQ, a real-world LHS. Experts presented educational content, and then small group discussions were held to elicit viewpoints. The deliberations centered around whether policies should permit or deny certain users and uses of secondary data. De-identified transcripts of the discussions were examined by using thematic analysis.

Results: Analysis identified two thematic clusters: expectations and concerns, which seemed to inform LHS governance recommendations. Participants expected to benefit from the LHS through the advancement of medical knowledge, which they hoped would improve treatments and the quality of their care. They were concerned that profit-driven users might manipulate the data in ways that could burden or exploit patients, hinder medical decisions, or compromise patient-provider communication. It was recommended that restricted access, user fees, and penalties should be imposed to prevent users, especially for-profit entities, from misusing data. Another suggestion was that patients should be notified of potential ethical issues and included on diverse, unbiased governing boards.

Conclusion: If patients are to trust and support LHS endeavors, their concerns about for-profit users must be addressed. The ethical implementation of such systems should consist of patient representation on governing boards, transparency, and strict oversight of for-profit users.
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http://dx.doi.org/10.1200/OP.20.00454DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8257992PMC
April 2021

Cetuximab in Patients with Breast Cancer, Non-Small Cell Lung Cancer, and Ovarian Cancer Without KRAS, NRAS, or BRAF Mutations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Target Oncol 2020 12;15(6):733-741

American Society of Clinical Oncology, 2318 Mill Road, Alexandria, VA, 22314, USA.

Background: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study, a phase II basket study, evaluates anti-tumor activity of commercially available targeted agents in patients with advanced cancers harboring genomic alterations known as drug targets.

Objective: With no known genomic targets predictive of sensitivity to cetuximab, cetuximab was evaluated in patients with breast cancer (BC), non-small cell lung cancer (NSCLC), and ovarian cancer (OC), without KRAS, NRAS, or BRAF mutations.

Patients And Methods: Eligible patients with advanced BC, NSCLC, and OC received a cetuximab loading dose, then weekly infusions (250 mg/m over 60 min). A Simon two-stage design, requiring ten patients in stage I, was employed per each disease-specific cohort. The primary endpoint was disease control (objective response or stable disease for at least 16 weeks). If two or more patients in stage I achieved disease control, the cohort would enroll 18 more patients in stage II. Power and alpha of the design are 85% and 10%, respectively. Secondary endpoints included progression-free survival, overall survival, and safety.

Results: Patients with BC (n = 10), NSCLC (n = 10), and OC (n = 29) were enrolled between June 2016 and September 2018. No objective responses or stable disease for at least 16 weeks were observed in the BC and NSCLC cohorts. No objective responses and four patients with stable disease for at least 16 weeks were observed in the OC cohort. Six of 49 patients reported grade 3 or higher adverse events or serious adverse events at least possibly related to cetuximab.

Conclusions: Cetuximab does not have clinical activity in patients with advanced BC, NSCLC, and OC without KRAS, NRAS, or BRAF mutations.

Clinical Trial Registration: NCT02693535 (26 February, 2016).
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http://dx.doi.org/10.1007/s11523-020-00753-7DOI Listing
December 2020

Sunitinib in Patients with Metastatic Colorectal Cancer (mCRC) with FLT-3 Amplification: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Target Oncol 2020 12;15(6):743-750

American Society of Clinical Oncology, 2318 Mill Road, Alexandria, VA, 22314, USA.

Background: TAPUR is a pragmatic, phase II basket study evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancers harboring genomic alterations known to be drug targets. Sunitinib is an oral multikinase inhibitor of FMS-like tyrosine kinase-3 (FLT-3), among other targets. Results from a cohort of patients with metastatic colorectal cancer (mCRC) with FLT-3 amplification treated with sunitinib are reported.

Objective: This study aimed to investigate whether patients with mCRC with FLT-3 amplification would be responsive to sunitinib, an oral multikinase inhibitor.

Methods: Eligible patients received a standard sunitinib dose of 50 mg orally for 4 weeks followed by 2 weeks off. Simon's two-stage design was used with the primary study endpoint of objective response (OR) or stable disease (SD) at 16 weeks based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary endpoints were progression-free survival, overall survival, and safety.

Results: Ten patients were enrolled from November 2016 to April 2018. All patients had mCRC with FLT-3 amplification. No ORs were observed. Although two patients had SD at 16 weeks, one died because of disease progression shortly thereafter and the cohort was closed. A single grade 3 adverse event of diarrhea was reported as possibly related to sunitinib.

Conclusions: Monotherapy with sunitinib does not have clinical activity in patients with mCRC with FLT-3 amplification and should not be prescribed for off-label use. Other treatments should be considered for these patients, including treatments offered in clinical trials.

Clinical Trial Registration: NCT02693535 (26 February 2016).
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http://dx.doi.org/10.1007/s11523-020-00752-8DOI Listing
December 2020

Development and Validation of a Natural Language Processing Tool to Generate the CONSORT Reporting Checklist for Randomized Clinical Trials.

JAMA Netw Open 2020 10 1;3(10):e2014661. Epub 2020 Oct 1.

School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.

Importance: Adherence to the Consolidated Standards of Reporting Trials (CONSORT) for randomized clinical trials is associated with improvingquality because inadequate reporting in randomized clinical trials may complicate the interpretation and the application of findings to clinical care.

Objective: To evaluate an automated reporting checklist generation tool that uses natural language processing (NLP), called CONSORT-NLP.

Design, Setting, And Participants: This study used published journal articles as training, testing, and validation sets to develop, refine, and evaluate the CONSORT-NLP tool. Articles reporting randomized clinical trials were selected from 25 high-impact-factor journals under the following categories: (1) general and internal medicine, (2) oncology, and (3) cardiac and cardiovascular systems.

Main Outcomes And Measures: For an evaluation of the performance of this tool, an accuracy metric defined as the number of correct assessments divided by all assessments was calculated.

Results: The CONSORT-NLP tool uses the widely used Portable Document Format as an input file. Of the 37 CONSORT reporting items, 34 (92%) were included in the tool. Of these 34 reporting items, 30 were fully implemented; 28 (93%) of the fully implemented CONSORT reporting items had an accuracy of more than 90% for the validation set. The remaining 2 (7%) had an accuracy between 80% and 90% for the validation set. Two to 5 articles were selected from each of these journals for a total of 158 articles to establish a training set of 111 articles to train CONSORT-NLP for CONSORT reporting items, a testing set of 25 articles to refine CONSORT-NLP, and a validation set of 22 articles to assess the performance of CONSORT-NLP. The CONSORT-NLP tool used the Portable Document Format of the articles as input files. A CONSORT-NLP graphical user interface was built using Java in 2019. The time required to complete the CONSORT checklist manually vs using the CONSORT-NLP tool was compared for 30 articles. Two case studies for randomized clinical trials are provided as an illustration for the CONSORT-NLP tool. For the 30 articles investigated, CONSORT-NLP required a mean (SD) 23.0 (4.1) seconds, whereas the manual reviewer required a mean (SD) 11.9 (2.2), 22.6 (4.6), and 57.6 (7.1) minutes, for 3 reviewers, respectively.

Conclusions And Relevance: The CONSORT-NLP tool is designed to assist in the reporting of randomized clinical trials. Potential users of CONSORT-NLP include clinicians, researchers, and scientists who plan to publish a randomized trial study in a peer-reviewed journal. The use of CONSORT-NLP may help them save substantial time when generating the CONSORT checklist. This tool may also be useful for manuscript reviewers and journal editors who review these articles.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.14661DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7545295PMC
October 2020

Delivering Cancer Care During the COVID-19 Pandemic: Recommendations and Lessons Learned From ASCO Global Webinars.

JCO Glob Oncol 2020 Sep;6:1461-1471

Department of Surgical Oncology, Gifu University, Graduate School of Medicine, Gifu, Japan.

Purpose: In response to the COVID-19 pandemic, the ASCO launched a Global Webinar Series to address various aspects of cancer care during the pandemic. Here we present the lessons learned and recommendations that have emerged from these webinars.

Methods: Fifteen international health care experts from different global regions and oncology disciplines participated in one of the six 1-hour webinars to discuss the latest data, share their experiences, and provide recommendations to manage cancer care during the COVID-19 pandemic. These sessions include didactic presentations followed by a moderated discussion and questions from the audience. All recommendations have been transcribed, categorized, and reviewed by the experts, who have also approved the consensus recommendations.

Results: The summary recommendations are divided into different categories, including risk minimization; care prioritization of patients; health care team management; virtual care; management of patients with cancer undergoing surgical, radiation, and systemic therapy; clinical research; and recovery plans. The recommendations emphasize the protection of patients and health care teams from infections, delivery of timely and appropriate care, reduction of harm from the interruption of care, and preparation to handle a surge of new COVID-19 cases, complications, or comorbidities thereof.

Conclusion: The recommendations from the ASCO Global Webinar Series may guide practicing oncologists to manage their patients during the ongoing pandemic and help organizations recover from the crisis. Implementation of these recommendations may improve understanding of how COVID-19 has affected cancer care and increase readiness to manage the current and any future outbreaks effectively.
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http://dx.doi.org/10.1200/GO.20.00423DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7529523PMC
September 2020

The National Clinical Trials Network and the cooperative groups: The road not taken.

Cancer 2020 12 24;126(23):5008-5013. Epub 2020 Sep 24.

American Society of Clinical Oncology, Alexandria, Virginia.

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http://dx.doi.org/10.1002/cncr.33210DOI Listing
December 2020

Progress in Cancer Research, Prevention, and Care.

N Engl J Med 2020 Sep;383(10):897-900

From the American Society of Clinical Oncology, Alexandria, VA (R.L.S.); the Health and Medicine Division, National Academies of Science, Engineering, and Medicine, Washington, DC (S.N.); the University of Chicago Comprehensive Cancer Center, Chicago (M.M.L.B.); and the Dana-Farber Cancer Institute, Harvard Medical School, Brigham and Women's Hospital, and Boston Children's Hospital - all in Boston (E.J.B.).

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http://dx.doi.org/10.1056/NEJMp2007839DOI Listing
September 2020

The International Collaboration for Cancer Classification and Research.

Int J Cancer 2021 02 9;148(3):560-571. Epub 2020 Oct 9.

American Society of Clinical Oncology, Alexandria, Virginia, USA.

Gaps in the translation of research findings to clinical management have been recognized for decades. They exist for the diagnosis as well as the management of cancer. The international standards for cancer diagnosis are contained within the World Health Organization (WHO) Classification of Tumours, published by the International Agency for Research on Cancer (IARC) and known worldwide as the WHO Blue Books. In addition to their relevance to individual patients, these volumes provide a valuable contribution to cancer research and surveillance, fulfilling an important role in scientific evidence synthesis and international standard setting. However, the multidimensional nature of cancer classification, the way in which the WHO Classification of Tumours is constructed, and the scientific information overload in the field pose important challenges for the translation of research findings to tumour classification and hence cancer diagnosis. To help address these challenges, we have established the International Collaboration for Cancer Classification and Research (IC R) to provide a forum for the coordination of efforts in evidence generation, standard setting and best practice recommendations in the field of tumour classification. The first IC R meeting, held in Lyon, France, in February 2019, gathered representatives of major institutions involved in tumour classification and related fields to identify and discuss translational challenges in data comparability, standard setting, quality management, evidence evaluation and copyright, as well as to develop a collaborative plan for addressing these challenges.
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http://dx.doi.org/10.1002/ijc.33260DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756795PMC
February 2021

Closing the Rural Cancer Care Gap: Three Institutional Approaches.

JCO Oncol Pract 2020 07 23;16(7):422-430. Epub 2020 Jun 23.

American Society of Clinical Oncology, Alexandria, VA.

Patients in rural areas face limited access to medical and oncology providers, long travel times, and low recruitment to clinical trials, all of which affect quality of care and health outcomes. Rural counties also have high rates of cancer-related mortality and other negative treatment outcomes. On April 10, 2019, ASCO hosted Closing the Rural Cancer Care Gap, the second event in its State of Cancer Care in America series. The event focused on two aspects of rural cancer care: a review of the major issues and concerns in delivering rural cancer care and a discussion of creative solutions to address rural-nonrural disparities. This article draws from the event and supporting literature to summarize the challenges to delivering high-quality care in rural communities, update ASCO's workforce data on the geographic distribution of oncologists, and highlight 3 institutional approaches to addressing these challenges in diverse rural settings. The experience of the 3 institutions featured in the article suggests that increasing rural patients' access to care requires expanding services and decreasing travel distances, mitigating financial burdens when insurance coverage is limited, opening avenues to clinical trial participation, and creating partnerships between providers and community leaders to address local gaps in care. Because the characteristics of rural communities, health care resources, and patient populations are not homogeneous, rural health disparities require local solutions that are based on community needs, available resources, and trusting and collaborative partnerships.
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http://dx.doi.org/10.1200/OP.20.00174DOI Listing
July 2020

Early Impact of COVID-19 on the Conduct of Oncology Clinical Trials and Long-Term Opportunities for Transformation: Findings From an American Society of Clinical Oncology Survey.

JCO Oncol Pract 2020 Jul 12;16(7):417-421. Epub 2020 May 12.

American Society of Clinical Oncology, Alexandria, VA.

The coronavirus disease 2019 (COVID-19) pandemic has disrupted all aspects of clinical care, including cancer clinical trials. In March 2020, ASCO launched a survey of clinical programs represented on its Cancer Research Committee and Research Community Forum Steering Group and taskforces to learn about the types of changes and challenges that clinical trial programs were experiencing early in the pandemic. There were 32 survey respondents; 14 represented academic programs, and 18 represented community-based programs. Respondents indicated that COVID-19 is leading programs to halt or prioritize screening and/or enrollment for certain clinical trials and cease research-only visits. Most reported conducting remote patient care where possible and remote visits and monitoring with sponsors and/or contract research organizations (CROs); respondents viewed this shift positively. Numerous challenges with conducting clinical trials were reported, including enrollment and protocol adherence difficulties with decreased patient visits, staffing constraints, and limited availability of ancillary services. Interactions with sponsors and CROs about modifying trial procedures were also challenging. The changes in clinical trial procedures identified by the survey could serve as strategies for other programs attempting to maintain their clinical trial portfolios during the COVID-19 pandemic. Additionally, many of the adaptations to trials made during the pandemic provide a long-term opportunity to improve and transform the clinical trial system. Specific improvements could be expanded use of more pragmatic or streamlined trial designs, fewer clinical trial-related patient visits, and minimized sponsor and CRO visits to trial programs.
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http://dx.doi.org/10.1200/OP.20.00275DOI Listing
July 2020

Patient Preferences Regarding Informed Consent Models for Participation in a Learning Health Care System for Oncology.

JCO Oncol Pract 2020 09 30;16(9):e977-e990. Epub 2020 Apr 30.

University of Michigan, Ann Arbor, MI.

Purpose: The expansion of learning health care systems (LHSs) promises to bolster research and quality improvement endeavors. Stewards of patient data have a duty to respect the preferences of the patients from whom, and for whom, these data are being collected and consolidated.

Methods: We conducted democratic deliberations with a diverse sample of 217 patients treated at 4 sites to assess views about LHSs, using the example of CancerLinQ, a real-world LHS, to stimulate discussion. In small group discussions, participants deliberated about different policies for how to provide information and to seek consent regarding the inclusion of patient data. These discussions were recorded, transcribed, and de-identified for thematic analysis.

Results: Of participants, 67% were female, 61% were non-Hispanic Whites, and the mean age was 60 years. Patients' opinions about sharing their data illuminated 2 spectra: trust/distrust and individualism/collectivism. Positions on these spectra influenced the weight placed on 3 priorities: promoting societal altruism, ensuring respect for persons, and protecting themselves. In turn, consideration of these priorities seemed to inform preferences regarding patient choices and system transparency. Most advocated for a policy whereby patients would receive notification and have the opportunity to opt out of including their medical records in the LHS. Participants reasoned that such a policy would balance personal protections and societal welfare.

Conclusion: System transparency and patient choice are vital if patients are to feel respected and to trust LHS endeavors. Those responsible for LHS implementation should ensure that all patients receive an explanation of their options, together with standardized, understandable, comprehensive materials.
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http://dx.doi.org/10.1200/JOP.19.00300DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7846056PMC
September 2020

Reply to M. Hutton-Potts and A.M. Joshua.

JCO Oncol Pract 2020 05 2;16(5):285-286. Epub 2020 Apr 2.

Clifford A. Hudis, MD and Richard L. Schilsky, MD, American Society of Clinical Oncology, Alexandria, VA.

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http://dx.doi.org/10.1200/OP.20.00100DOI Listing
May 2020

Status Update on Data Required to Build a Learning Health System.

J Clin Oncol 2020 05 25;38(14):1602-1607. Epub 2020 Mar 25.

US Food and Drug Administration, Silver Spring, MD.

Wide adoption of electronic health records (EHRs) has raised the expectation that data obtained during routine clinical care, termed "real-world" data, will be accumulated across health care systems and analyzed on a large scale to produce improvements in patient outcomes and the use of health care resources. To facilitate a learning health system, EHRs must contain clinically meaningful structured data elements that can be readily exchanged, and the data must be of adequate quality to draw valid inferences. At the present time, the majority of EHR content is unstructured and locked into proprietary systems that pose significant challenges to conducting accurate analyses of many clinical outcomes. This article details the current state of data obtained at the point of care and describes the changes necessary to use the EHR to build a learning health system.
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http://dx.doi.org/10.1200/JCO.19.03094DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7213586PMC
May 2020

Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.

Oncologist 2020 03 8;25(3):e405-e411. Epub 2019 Dec 8.

Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts, USA.

A number of important drugs used to treat cancer-many of which serve as the backbone of modern chemotherapy regimens-have outdated prescribing information in their drug labeling. The Food and Drug Administration is undertaking a pilot project to develop a process and criteria for updating prescribing information for longstanding oncology drugs, based on the breadth of knowledge the cancer community has accumulated with the use of these drugs over time. This article highlights a number of considerations for labeling updates, including selecting priorities for updating; data sources and evidentiary criteria; as well as the risks, challenges, and opportunities for iterative review to ensure prescribing information for oncology drugs remains relevant to current clinical practice.
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http://dx.doi.org/10.1634/theoncologist.2019-0698DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7066705PMC
March 2020

Clinical Cancer Advances 2020: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology.

J Clin Oncol 2020 04 4;38(10):1081. Epub 2020 Feb 4.

University of Texas MD Anderson Cancer Center, Houston, TX.

A Message From Asco’s President: Shortly before I was elected President of ASCO, I attended the 65th birthday party of a current patient. She had been diagnosed 10 years earlier with metastatic breast cancer and hadn't been sure she wanted to move forward with further treatment. With encouragement, she elected to participate in a clinical trial of an investigational drug that is now widely used to treat breast cancer. Happily, here we were, celebrating with her now-married daughters, their husbands, and three beautiful grandchildren, ages 2, 4, and 8. Such is the importance of clinical trials and promising new therapies.Clinical research is about saving and improving the lives of individuals with cancer. It's a continuing story that builds on the efforts of untold numbers of researchers, clinicians, caregivers, and patients. ASCO's report tells part of this story, sharing the most transformative research of the past year. The report also includes our latest thinking on the most urgent research priorities in oncology.ASCO's 2020 Advance of the Year-Refinement of Surgical Treatment of Cancer-highlights how progress drives more progress. Surgery has played a fundamental role in cancer treatment. It was the only treatment available for many cancers until the advent of radiation and chemotherapy. The explosion in systemic therapies since then has resulted in significant changes to when and how surgery is performed to treat cancer. In this report, we explore how treatment successes have led to less invasive approaches for advanced melanoma, reduced the need for surgery in renal cell carcinoma, and increased the number of patients with pancreatic cancer who can undergo surgery.Many research advances are made possible by federal funding. With the number of new US cancer cases set to rise by roughly a third over the next decade, continued investment in research at the national level is crucial to continuing critical progress in the prevention, screening, diagnosis, and treatment of cancer.While clinical research has translated to longer survival and better quality of life for many patients with cancer, we can't rest on our laurels. With ASCO's Research Priorities to Accelerate Progress Against Cancer, introduced last year and updated this year, we've identified the critical gaps in cancer prevention and care that we believe to be most pressing. These priorities are intended to guide the direction of research and speed progress.Of course, the effectiveness or number of new treatments is meaningless if patients don't have access to them. High-quality cancer care, including clinical trials, is out of reach for too many patients. Creating an infrastructure to support patients is a critical part of the equation, as is creating connections between clinical practices and research programs. We have much work to do before everyone with cancer has equal access to the best treatments and the opportunity to participate in research. I know that ASCO and the cancer community are up for this challenge.Sincerely,Howard A. "Skip" Burris III, MD, FACP, FASCOASCO President, 2019-2020.
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http://dx.doi.org/10.1200/JCO.19.03141DOI Listing
April 2020

Discrepancies in Financial Self-Disclosures and Open Payments Reporting Among Authors of Clinical Oncology Research Studies.

J Clin Oncol 2020 02 9;38(5):480-487. Epub 2019 Dec 9.

American Society of Clinical Oncology, Alexandria, VA.

Purpose: Company-reported payments from the Open Payments database (OP) have been compared with self-disclosed financial relationships made by physician authors. Discrepancies have been viewed as under-reporting of financial relationships. Our goal was to perform a systematic comparison to determine sources of discordance between company-reported and self-reported financial relationships.

Methods: Financial disclosures reported by 163 authors and presenters who published in or who presented an abstract at the ASCO 2018 Annual Meeting were obtained and matched to payment data in OP. Categories included ownership, research, consulting/services, honoraria, expenses, royalty/patent/intellectual property, and other disclosures. Measures of concordance and discordance were calculated on the basis of matches on both company and category of disclosure and matches on company. Results are reported overall and within certain categories of disclosures.

Results: Overall concordance between disclosures to ASCO and payments in OP was 16% for company and category matching and 24% for matching on the basis of company only. Authors tended to report more disclosures for research and consulting to ASCO than appear in OP. Expense disclosures were more frequently reported in OP than to ASCO. No payments were categorized as ownership in OP, but 35 authors/presenters disclosed ownership (including stock) to ASCO.

Conclusion: Our results reveal substantial discordance between self-reported and company-reported financial relationships for authors who report clinical oncology research. These findings support the calls for development of standardized disclosure policies across medicine.
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http://dx.doi.org/10.1200/JCO.19.02467DOI Listing
February 2020

Talking the Talk About Tumor Genomic Testing.

J Natl Cancer Inst 2020 05;112(5):436-437

American Society of Clinical Oncology, Alexandria, VA.

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http://dx.doi.org/10.1093/jnci/djz175DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7225677PMC
May 2020

Effect of Public Deliberation on Patient Attitudes Regarding Consent and Data Use in a Learning Health Care System for Oncology.

J Clin Oncol 2019 12 2;37(34):3203-3211. Epub 2019 Oct 2.

University of Pennsylvania, Philadelphia, PA.

Purpose: We sought to generate informed and considered opinions regarding acceptable secondary uses of deidentified health information and consent models for oncology learning health care systems.

Methods: Day-long democratic deliberation sessions included 217 patients with cancer at four geographically and sociodemographically diverse sites. Patients completed three surveys (at baseline, immediately after deliberation, and 1-month follow-up).

Results: Participants were 67.3% female, 21.7% black, and 6.0% Hispanic. The most notable changes in perceptions after deliberation related to use of deidentified medical-record data by insurance companies. After discussion, 72.3% of participants felt comfortable if the purpose was to make sure patients receive recommended care ( 79.5% at baseline; = .03); 24.9% felt comfortable if the purpose was to determine eligibility for coverage or reimbursement ( 50.9% at baseline; < .001). The most notable change about secondary research use related to believing it was important that doctors ask patients at least once whether researchers can use deidentified medical-records data for future research. The proportion endorsing high importance decreased from baseline (82.2%) to 68.7% immediately after discussion ( < .001), and remained decreased at 73.1% ( = .01) at follow-up. At follow-up, non-Hispanic whites were more likely to consider it highly important to be able to conduct medical research with deidentified electronic health records (96.8% 87.7%; = .01) and less likely to consider it highly important for doctors to get a patient's permission each time deidentified medical record information is used for research (23.2% 51.6%; < .001).

Conclusion: This research confirms that most patients wish to be asked before deidentified medical records are used for research. Policies designed to realize the potential benefits of learning health care systems can, and should be, grounded in informed and considered public opinion.
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http://dx.doi.org/10.1200/JCO.19.01693DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6881101PMC
December 2019

Determining If a Somatic Tumor Mutation Is Targetable and Options for Accessing Targeted Therapies.

J Oncol Pract 2019 11 6;15(11):575-583. Epub 2019 Aug 6.

American Society of Clinical Oncology.

Targeted cancer therapies are drugs and biologics designed to affect cancer cell growth by blocking or interfering with specific molecular pathways in the cancer cell. Use of targeted agents usually requires verification through molecular testing that the patient's tumor harbors the molecular biomarker that is the target of the drug or is predictive of treatment benefit. Genomic mutations may be clinically actionable if they are associated with response or resistance to a potential therapy. If a genomic test reveals an actionable alteration, there are several options for accessing the targeted therapy. This article is intended to help clinicians determine if a tumor mutation is potentially treatable with a marketed or investigational drug or biologic product and to offer guidance on how to access the product of interest.
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http://dx.doi.org/10.1200/JOP.19.00262DOI Listing
November 2019

Improving Cancer Diagnosis and Care: Patient Access to High-Quality Oncologic Pathology.

Oncologist 2019 10 31;24(10):1287-1290. Epub 2019 Jul 31.

Department of Pathology and Laboratory Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.

Drawing on discussions at a workshop hosted by the National Cancer Policy Forum, current challenges in pathology are reviewed and practical steps to facilitate high‐quality cancer diagnosis and care through improved patient access to expertise in oncologic pathology are highlighted.
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http://dx.doi.org/10.1634/theoncologist.2019-0261DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6795152PMC
October 2019
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