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For individuals living in rural areas, access to cancer care can be difficult. Barriers to access cross international boundaries and have a negative impact on treatment outcomes. Current models to increase rural access in the United States are reviewed, as is a system-wide approach to this problem in Australia. Ongoing efforts to increase access to clinical trials for patients in rural areas are also discussed.

Purpose: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. Results of a cohort of patients with various solid tumors with germline or somatic BRCA1/2 mutations treated with talazoparib are reported., Methods: Eligible patients had advanced solid tumors, measurable disease (RECIST), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and no standard treatment options. Patients with germline BRCA -mutated human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer were not eligible for this study. Primary end point was disease control (DC) determined by investigator assessment of objective response (OR) or stable disease (SD) of at least 16 weeks duration (SD16+). The results were evaluated on the basis of a one-sided exact binomial test with a null DC rate of 15% versus 35% (power = 0.82; α = .10). Secondary end points were OR, progression-free survival, overall survival, duration of response, duration of SD, and safety., Results: Twenty-eight patients (20 cancer types) with BRCA1/2 mutations were enrolled from December 2019 to September 2021 and collapsed into a single histology pooled cohort for analysis. All patients were evaluable for efficacy. One complete response, nine partial response, and six SD16+ were observed for DC and OR rates of 57% (one-sided 90% CI, 43 to 100) and 36% (95% CI, 19 to 56), respectively. The null hypothesis of a 15% DC rate was rejected ( P < .001). Patients with OR had the following tumor types: breast (2), nonmelanoma skin, mesothelioma, stomach, uterus, non-small cell lung cancer, ovary, hepatocellular carcinoma, and pancreas. Thirteen patients had at least one grade 3-5 adverse event (AE) or serious AE at least possibly related to talazoparib. All were consistent with the drug label except bilirubin increase and hyponatremia (both grade 3 AEs)., Conclusion: Talazoparib demonstrated antitumor activity in patients with advanced solid tumors and BRCA1/2 mutations, including cancer types for which poly ADP-ribose polymerase inhibitors are not yet US Food and Drug Administration-approved.

Anticancer agents can impair ovarian function, resulting in premature menopause and associated long-term health effects. Ovarian toxicity is not usually adequately assessed in trials of anticancer agents, leaving an important information gap for patients facing therapy choices. This American Society of Clinical Oncology (ASCO) statement provides information about the incorporation of ovarian toxicity measures in trial design. ASCO recommends: (1) measurement of ovarian toxicity in relevant clinical trials of anticancer agents that enrol post-pubertal, pre-menopausal patients; (2) collection of ovarian function measures at baseline and at 12-24 months after anticancer agent cessation, as a minimum, and later in line with the trial schedule; and (3) assessment of both clinical measures and biomarkers of ovarian function. ASCO recognises that routine measurement of ovarian toxicity and function in cancer clinical trials will add additional complexity and burden to trial resources but asserts that this issue is of such importance to patients that it cannot continue to be overlooked., Competing Interests: Declaration of interests WC reports honoraria from AstraZeneca, Pfizer, Merck Serono, and Eisai. RAA reports grants or contracts (research funding) and consulting fees from Roche Diagnostics. ND reports employment by AstraZeneca; grants or contracts (research funding) from Amgen, Novartis, Genentech, Lilly, Pfizer, Daiichi Sankyo, and Immunomedics; and travel, accommodations, expenses, and stock options from AstraZeneca. DS reports grants or contracts (research funding) from Janssen; consulting fees (advisory role) from Janssen Oncology, AstraZeneca, Boston Scientific, Bayer, Blue Earth, Varian Medical Systems, Pfizer, and Myovant Sciences; and honoraria from Varian Medical Systems. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Despite efforts to enhance enrollment and the merger of national cooperative groups, < 5% of patients with cancer will enroll into a clinical trial. Additionally, clinical trials are affected by a lack of diversity inclusive of minority patients, rural residents, or low-income individuals. COVID-19 further exacerbated known barriers of reduced physician-patient interaction, physician availability, trial activation and enrollment, financial resources, and capacity for conducting research. Based on the cumulative insight of academic and community clinical researchers, we have created a white paper identifying existing challenges in clinical trial conduct and have provided specific recommendations of sustainable modifications to improve efficiency in the activation and conduct of clinical trials with an overarching goal of providing improved access and care to our patients with cancer., Competing Interests: Cathy EngConsulting or Advisory Role: Bayer Schering Pharma, Foundation Medicine, Array BioPharma, Natera Emerson Y. ChenOther Relationship: Horizon CME, Taiho Pharmaceutical Mark LewisConsulting or Advisory Role: Boehringer IngelheimOther Relationship: Medscape Jonathan StrosbergConsulting or Advisory Role: NovartisSpeakers' Bureau: Ipsen, LexiconResearch Funding: Novartis Ramya ThotaConsulting or Advisory Role: Array BioPharmaResearch Funding: Abbvie, Bristol-Myers Squibb Paul ObersteinConsulting or Advisory Role: Merck, BTG, Tyme, IpsenResearch Funding: Merck, Roche/GenentechTravel, Accommodations, Expenses: Merck Gary BuchschacherResearch Funding: Roche/Genentech, AstraZeneca, MerckTravel, Accommodations, Expenses: Roche/Genentech, AstraZeneca Sandip PatelConsulting or Advisory Role: Bristol-Myers Squibb, AstraZeneca/MedImmune, Nektar, Compugen, IlluminaSpeakers' Bureau: Merck, Boehringer IngelheimResearch Funding: Bristol-Myers Squibb, Pfizer, Roche/Genentech, Amgen, AstraZeneca/MedImmune, Fate Therapeutics, Merck Davendra SohalConsulting or Advisory Role: Perthera, Ability PharmaSpeakers' Bureau: IncyteResearch Funding: Celgene, Genentech, Bristol-Myers Squibb, Rafael Pharmaceuticals, Apexigen, Amgen Philip PhilipHonoraria: Celgene, Bayer, Ipsen, Merck, AstraZeneca, TriSalus Life Sciences, Blueprint Medicines, Syncore, Array BioPharmaConsulting or Advisory Role: Celgene, Ipsen, Merck, TriSalus Life Sciences, Daiichi Sankyo, Syncore, Taiho PharmaceuticalSpeakers' Bureau: Celgene, Bayer, Ipsen, Novartis, IncyteResearch Funding: Bayer, Incyte, Karyopharm Therapeutics, Merck, Taiho Pharmaceutical, Momenta Pharmaceuticals, Novartis, Plexxikon, Immunomedics, Regeneron, Genentech, Tyme, Caris Life Sciences, ASLAN Pharmaceuticals, QED Therapeutics, Halozyme, Boston Biomedical, Advanced Accelerator Applications, Lilly, Merus, QED Therapeutics, Incyte, Caris Life SciencesTravel, Accommodations, Expenses: Rafael Pharmaceuticals, Celgene, AbbVie Arvind DasariConsulting or Advisory Role: Ipsen, Novartis, Voluntis, LexiconResearch Funding: Novartis, Eisai, Hutchison MediPharma, Merck, Guardant Health, Ipsen Hagan KenneckeHonoraria: IpsenResearch Funding: Taiho Pharmaceutical Stacey SteinConsulting or Advisory Role: Genentech/Roche, Eisai, QED Therapeutics, ExelixisNo other potential conflicts of interest were reported.

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.

Patients with cancer are presumed to be at increased risk from COVID-19 infection-related fatality due to underlying malignancy, treatment-related immunosuppression, or increased comorbidities. A total of 218 COVID-19-positive patients from March 18, 2020, to April 8, 2020, with a malignant diagnosis were identified. A total of 61 (28%) patients with cancer died from COVID-19 with a case fatality rate (CFR) of 37% (20/54) for hematologic malignancies and 25% (41/164) for solid malignancies. Six of 11 (55%) patients with lung cancer died from COVID-19 disease. Increased mortality was significantly associated with older age, multiple comorbidities, need for ICU support, and elevated levels of D-dimer, lactate dehydrogenase, and lactate in multivariate analysis. Age-adjusted CFRs in patients with cancer compared with noncancer patients at our institution and New York City reported a significant increase in case fatality for patients with cancer. These data suggest the need for proactive strategies to reduce likelihood of infection and improve early identification in this vulnerable patient population. SIGNIFICANCE: COVID-19 in patients with cancer is associated with a significantly increased risk of case fatality, suggesting the need for proactive strategies to reduce likelihood of infection and improve early identification in this vulnerable patient population. This article is highlighted in the In This Issue feature, p. 890 ., (©2020 American Association for Cancer Research.)

Background: Precision oncology increasingly utilizes molecular profiling of tumors to determine treatment decisions with targeted therapeutics. The molecular profiling data is valuable in the treatment of individual patients as well as for multiple secondary uses., Objective: To automatically parse, categorize, and aggregate clinical molecular profile data generated during cancer care as well as use this data to address multiple secondary use cases., Methods: A system to parse, categorize and aggregate molecular profile data was created. A naÿve Bayesian classifier categorized results according to clinical groups. The accuracy of these systems were validated against a published expertly-curated subset of molecular profiling data., Results: Following one year of operation, 819 samples have been accurately parsed and categorized to generate a data repository of 10,620 genetic variants. The database has been used for operational, clinical trial, and discovery science research., Conclusions: A real-time database of molecular profiling data is a pragmatic solution to several knowledge management problems in the practice and science of precision oncology., (© The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Background: Cancer care near the end of life (EOL) has become more aggressive over the years. Palliative care services (PCS) may decrease this aggressive cancer care in terminally ill cancer patients. Our objective was to observe the aggressiveness of cancer care near the EOL among Veterans Affairs cancer patients before and after the institution of a PCS team. We also assessed the time taken prior to death to initiate a PCS consultation and its effect on the aggressiveness of cancer care near the EOL., Methods: This is a retrospective chart review analysis performed at the local Veterans Affairs hospital looking at the last 100 patients in each of the years, 2002 and 2008, who died with active cancer. Only patients in 2008 had access to a PCS team., Results: In the last 30 days of life, compared to 2002, patients in 2008 had a higher incidence of: chemotherapy administration, more than one hospital admission, more than 14 days of hospital stay, intensive care unit admissions, and in-hospital deaths. Patients with timely PCS consults in 2008 appeared to have a lower incidence of: chemotherapy administration, more than one emergency department visit, more than one hospital admission, more than 14-day hospital stays, intensive care unit admissions, and deaths in the hospital. Timely PCS consults were associated with earlier and more frequent hospice referral., Conclusions: Cancer care near the EOL has become more aggressive with time at one of the hospitals in the Veterans Affairs healthcare system (VAHS). Institution of a PCS service was unable to completely decrease this trend of increasing aggressiveness of cancer care near the EOL. However, timely PCS consults may help attenuate this aggressiveness.