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Counterpoint: Implementing Population Genetic Screening for Lynch Syndrome Among Newly Diagnosed Colorectal Cancer Patients—Will the Ends Justify the Means?

Michael J. Hall

Inherited mutations in 1 of 4 known mismatch repair genes (MLH1, MSH2, MSH6, PMS2) are associated with various cancer risks collectively referred to as Lynch syndrome. Roughly 3 of every 100 new colorectal cancers (CRCs) have an underlying Lynch mutation. Tumor-based screening for Lynch among all patients with newly diagnosed CRC could theoretically improve the ability to identify Lynch and prevent cancer among at-risk family members, but the patient-level and social implications of this approach must be carefully considered before adopting this strategy. Poorly addressed issues include the role/timing of informed consent for testing, access and cost barriers associated with genetic counseling and DNA testing, psychosocial burdens to the thousands of middle-aged and elderly patients with CRC coping with surgical and chemotherapy treatments and poor prognosis, the need for providers to warn third-party relatives of risk for Lynch syndrome, limited effectiveness of screening, and the cost burden to society when poor DNA testing uptake, test limitations, and modest screening compliance are considered. Diverse barriers to the success of a population-based Lynch screening program in the United States remain (e.g., clinical resource needs, financial limitations, clinical expertise gaps, educational deficits). Data supporting clinical efficacy (feasibility) and effectiveness (real-life performance) are critical before important policy changes are adopted, especially where issues of hereditary cancer risk and genetic privacy are involved.

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Interpretation of Genetic Testing for Lynch Syndrome in Patients With Putative Familial Colorectal Cancer

Christina Rybak and Michael J. Hall

Colorectal cancer (CRC) risk assessment involves the evaluation of an individual's personal and family history for characteristics of an inherited susceptibility to develop CRC. Lynch syndrome (LS), or hereditary nonpolyposis colorectal cancer, is the most common cause of hereditary CRC, underlying 2% to 3% of patients with newly diagnosed (incident) CRC. Risk assessment for LS is complex, and the interpretation of the many available tests can be challenging even for the genetics specialist. A move toward universal (reflex) LS screening for mismatch repair in all patients with incident CRC supports the importance of improving the awareness and understanding of LS testing, teaching rational testing approaches, and honing interpretive skills among cancer care providers. This article reviews important clinical features of LS genetic evaluation using 3 pedigree-based case examples from the Fox Chase Cancer Center Gastrointestinal Risk Assessment Clinic.

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The Relevance of Hereditary Cancer Risks to Precision Oncology: What Should Providers Consider When Conducting Tumor Genomic Profiling?

Rishi Jain, Michelle J. Savage, Andrea D. Forman, Reetu Mukherji, and Michael J. Hall

Through tumor genomic profiling (TGP), existing and novel treatments can be selected to better target the specific dysregulated molecular pathways that drive growth and spread of a patient's tumor. Although the primary purpose of TGP is to detect targetable somatic mutations for treatment, TGP may also uncover germline mutations with important implications for patients and family members. Oncology care providers should be aware of the hereditary cancer risks associated with genes commonly tested by TGP. Further, patients should be informed about the possible discovery of hereditary cancer risk information and the relevance of this information to their health and that of family members, and should have their preferences toward further evaluation of hereditary risk information that could be revealed by TGP documented in the medical record and followed.

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Gene Panel Testing for Inherited Cancer Risk

Michael J. Hall, Andrea D. Forman, Robert Pilarski, Georgia Wiesner, and Veda N. Giri

Next-generation sequencing technologies have ushered in the capability to assess multiple genes in parallel for genetic alterations that may contribute to inherited risk for cancers in families. Thus, gene panel testing is now an option in the setting of genetic counseling and testing for cancer risk. This article describes the many gene panel testing options clinically available to assess inherited cancer susceptibility, the potential advantages and challenges associated with various types of panels, clinical scenarios in which gene panels may be particularly useful in cancer risk assessment, and testing and counseling considerations. Given the potential issues for patients and their families, gene panel testing for inherited cancer risk is recommended to be offered in conjunction or consultation with an experienced cancer genetic specialist, such as a certified genetic counselor or geneticist, as an integral part of the testing process.

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NCCN Policy Summit: Reducing the Cancer Burden Through Prevention and Early Detection

Lindsey Bandini, Alyssa Schatz, Victoria Hood, Nikia Clark, Michael J. Hall, and Robert W. Carlson

Cancer prevention, screening, and early detection play an integral role in cancer incidence and outcomes. It is estimated that 30% to 50% of cancers worldwide are preventable, and it is well established that early detection of many cancers is associated with improved treatment outcomes. A recent NCCN Policy Summit: Reducing the Cancer Burden Through Prevention and Early Detection brought together healthcare providers, payers, policymakers, patient advocates, industry representatives, and technology representatives to explore challenges, triumphs, and outstanding questions surrounding current practices. Keynotes were delivered by Dr. Lisa Richardson, Director of the Division of Cancer Prevention and Control within the CDC, and Dr. Danielle Carnival, White House Cancer Moonshot Coordinator. Dr. Richardson focused on the field of public health, translating its utility in preventing and diagnosing cancer in the United States, while Dr. Carnival discussed ambitious goals by the Cancer Moonshot in reducing the cancer burden. Panelists highlighted characteristics of high-impact prevention and early detection programs, including how genetic testing has impacted this space. Existing programs are often challenged due to limitations in data, as well as financial, structural, and social barriers to motivating individuals to act on recommendations. Despite these barriers, we can learn from highly successful programs and should apply proven attributes, such as community engagement, more broadly.

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HSR20-087: Prevalence and Correlates of Psychological Distress in Patients Enrolling on Phase I Clinical Trials Using the NCCN Distress Thermometer and Problem List

Alexandra Hunt, Elizabeth Handorf, Vipin Khare, Matthew Blau, Yana Chertock, Carolyn Fang, Michael J. Hall, and Rishi Jain

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Distress and Financial Distress in Adults With Cancer: An Age-Based Analysis

Caitlin R. Meeker, Yu-Ning Wong, Brian L. Egleston, Michael J. Hall, Elizabeth R. Plimack, Lainie P. Martin, Margaret von Mehren, Bianca R. Lewis, and Daniel M. Geynisman

Background: Although financial distress is commonly recognized in patients with cancer, it may be more prevalent in younger adults. This study sought to evaluate disparities in overall and financial distress in patients with cancer as a function of age. Methods: This was a single-center cross-sectional study of patients with solid malignancies requiring cancer therapy. The patient questionnaire included demographics, financial concerns, and measures of overall and financial distress. Data analyses compared patients in 3 age groups: young (<50 years), middle-aged (50–64 years), and elderly (≥65 years). Results: The cohort included 119 patients (median age, 62 years; 52% female; 84% white; 100% insured; 36% income ≥$75,000). Significant financial concerns included paying rent/mortgage (P=.003) and buying food (P=.032). Impact of Event Scale (IES) results revealed significant distress in 73% young, 64% middle-aged, and 44% elderly patients. The mean Distress Thermometer (DT) score was 6.1 (standard deviation [SD], 2.9) for young patients, 5.4 (SD, 2.6) for middle-aged, and 4.4 (SD, 3.3) for elderly patients. Young patients were more likely than elderly patients to have a higher IES distress score (P=.016) and DT score (P=.048). The mean InCharge score was lowest (indicating greatest financial distress) in the young group and progressed with age: 5.0 (SD, 1.9), 5.7 (SD, 2.7), and 7.4 (SD, 1.9), respectively (P<.001). Multivariable analyses revealed that the relationship between financial distress and overall distress was strongest in the middle-age group; as the DT increased by 1 point, the InCharge scores decreased by 0.52 (P<.001). Conclusions: Overall and financial distress are more common in young and middle-aged patients with cancer. There are several factors, including employment, insurance, access to paid sick leave, children, and education, that affect younger and middle-aged adults and are less of a potential stressor for elderly individuals.

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HSR19-088: Severe Obesity Does Not Worsen Transplantation Outcome in Multiple Myeloma

Zhubin J. Gahvari, Michael Lasarev, Jens C. Eickhoff, Aric C. Hall, Peiman Hematti, Mark B. Juckett, Vaishalee P. Kenkre, and Natalie S. Callander

Background: Obesity, and in particular severe obesity, is increasingly prevalent in the United States. Epidemiological studies have shown an association in multiple myeloma (MM) between obesity and mortality (Teras et al, Br J Haematol 2014). Autologous peripheral blood stem cell transplantation (autoPBSCT) remains a crucial aspect of treating MM, and the NCCN Guidelines recommend all eligible patients be evaluated for transplant. There is limited data analyzing the relationship between severe obesity and transplant outcomes in MM patients in the era of modern therapy, routine post-transplant maintenance, and genetic-based risk stratification. Methods: We retrospectively reviewed consecutive patients undergoing autoPBSCT for MM at our institution from 2010–2017. Patients were categorized by body mass index (BMI) and Revised International Staging System (R-ISS) score. Patients were followed from time of first transplant until death. Surviving patients and those lost to follow-up were censored at last point of contact. Cox proportional hazard regression models and associated log-rank tests were used to assess whether age, BMI, lag time between diagnosis and transplant, and R-ISS score were associated with risk of death. Post-transplant hospital length of stay (LOS) was evaluated using generalized linear models with response following a gamma distribution. Results: 314 patients (59.2% male) were included. BMI was categorized as nonobese ([16, 30) kg/m2; n=178, 56.7%), obese ([30, 35) kg/m2; n=72, 22.9%) or severely obese ([35, 55) kg/m2; n=64, 20.4%) and was not found to be associated with risk of death following transplant, either independently (P=.17) or when adjusting for age, sex, lag, and R-ISS (P=.26). As expected, R-ISS score was associated (P=.006) with risk of death after transplant. No association was found between mean LOS and BMI (P=.875). Kaplan-Meier mortality estimates are shown in . Conclusions: Obesity and severe obesity were not associated with an increased risk of mortality for MM patients receiving autoPBSCT. Although severe obesity is a health hazard, this should not be used to exclude patients from transplant.

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NCCN Guidelines Insights: Genetic/Familial High-Risk Assessment: Colorectal, Version 3.2017

Samir Gupta, Dawn Provenzale, Scott E. Regenbogen, Heather Hampel, Thomas P. Slavin Jr, Michael J. Hall, Xavier Llor, Daniel C. Chung, Dennis J. Ahnen, Travis Bray, Gregory Cooper, Dayna S. Early, James M. Ford, Francis M. Giardiello, William Grady, Amy L. Halverson, Stanley R. Hamilton, Jason B. Klapman, David W. Larson, Audrey J. Lazenby, Patrick M. Lynch, Arnold J. Markowitz, Robert J. Mayer, Reid M. Ness, Niloy Jewel Samadder, Moshe Shike, Shajanpeter Sugandha, Jennifer M. Weiss, Mary A. Dwyer, and Ndiya Ogba

The NCCN Guidelines for Genetic/Familial High-Risk Assessment: Colorectal provide recommendations for the management of patients with high-risk syndromes associated with an increased risk of colorectal cancer (CRC). The NCCN Panel for Genetic/Familial High-Risk Assessment: Colorectal meets at least annually to assess comments from reviewers within their institutions, examine relevant data, and reevaluate and update their recommendations. These NCCN Guidelines Insights focus on genes newly associated with CRC risk on multigene panels, the associated evidence, and currently recommended management strategies.

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NCCN Guidelines Insights: Colorectal Cancer Screening, Version 1.2018

Dawn Provenzale, Samir Gupta, Dennis J. Ahnen, Arnold J. Markowitz, Daniel C. Chung, Robert J. Mayer, Scott E. Regenbogen, Amie M. Blanco, Travis Bray, Gregory Cooper, Dayna S. Early, James M. Ford, Francis M. Giardiello, William Grady, Michael J. Hall, Amy L. Halverson, Stanley R. Hamilton, Heather Hampel, Jason B. Klapman, David W. Larson, Audrey J. Lazenby, Xavier Llor, Patrick M. Lynch, June Mikkelson, Reid M. Ness, Thomas P. Slavin Jr, Shajanpeter Sugandha, Jennifer M. Weiss, Mary A. Dwyer, and Ndiya Ogba

The NCCN Guidelines for Colorectal Cancer (CRC) Screening outline various screening modalities as well as recommended screening strategies for individuals at average or increased-risk of developing sporadic CRC. The NCCN panel meets at least annually to review comments from reviewers within their institutions, examine relevant data, and reevaluate and update their recommendations. These NCCN Guidelines Insights summarize 2018 updates to the NCCN Guidelines, with a primary focus on modalities used to screen individuals at average-risk for CRC.