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David M. Dunning and Thomas A. Paivanas

The Resource-Based Relative Value Scale (RBRVS) system instituted by Centers for Medicare and Medicaid Services has lead to the implementation of a new financial analysis paradigm based on relative value units (RVUs). RVU-based financial tools have great potential to allow in-depth analysis of all components of the cancer care delivery system. Because all medical oncology practices must become conversant in RVU terminology and methodology, RVU-based financial tools will allow standardization and benchmarking for intra- and interpractice comparisons. Understanding this approach is essential for sound business management. The emotional and financial pressures facing the medical oncologist in private practice are enormous, with no real relief in sight. The complexity of managing the business of private practice oncology rivals that of managing the complexity of cancer care. With anticipated reductions in total net revenue per clinical treatment protocol per course of care, funds available for providers and their practices will be severely reduced. Only those practices with superlative RVU-based cost and revenue accounting systems will be able to prospectively and efficiently manage their businesses. Clearly, management of the Oncology Practice Econometric Model (OPEM) expense RVU or similar RVU-based data will be required for survival. The purpose of this article is to explore an RVU-based model to analyze the professional, infusion, and therapeutic components of contemporary cancer care.

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David M. Thomas and Andrew J. Wagner

Connective tissue tumors comprise a rich array of subtypes, many of which possess strong pathognomonic phenotypes and genotypes of therapeutic significance. This article describes recent applications of targeted and nontargeted therapeutic agents in connective tissue tumors that illustrate important themes in drug development. Targeted therapy has exploited the paradigms of oncogene and lineage addiction. In other cases, potential targets are more difficult to classify, such as the role of the insulin-like growth factor 1 pathway in Ewing's sarcoma. Understanding why these pathways seem critical in some cancers, and in some individuals but not others, is important in identifying novel therapeutic opportunities in an age of personalized medicine.

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Michael A. Cilento, Nicola K. Poplawski, Sellvakumaram Paramasivam, David M. Thomas, and Ganessan Kichenadasse

PARP inhibitors are orally administered antineoplastic agents that affect the homologous recombination (HR) repair pathway, and are approved by the FDA for the treatment of ovarian, breast, pancreatic, and prostate cancers. This report presents a case of recurrent endometrial carcinoma occurring in a woman with a germline pathogenic PALB2 whole-exon deletion. This uncommon finding in a patient with endometrial carcinoma provided the opportunity to use a management strategy of PARP inhibition with olaparib, resulting in a prolonged response to treatment; however, disease progression eventually occurred. Further studies are required to elucidate the mechanisms underlying resistance to PARP inhibition, and the potential future treatment options in this setting. Current recommendations for risk management of female carriers of PALB2 variants focus on breast and ovarian cancer risk. This case raises the additional question of a potential role for risk-reducing hysterectomy in female carriers of PALB2 variants.

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David E. Gerber, Thomas Y. Sheffield, M. Shaalan Beg, Erin L. Williams, Valerie L. Clark, Yang Xie, M.E. Blair Holbein, Celette Sugg Skinner, and Simon J. Craddock Lee

Background: During the COVID-19 public health emergency, the FDA and NIH altered clinical trial requirements to protect participants and manage study conduct. Given their detailed knowledge of research protocols and regular contact with patients, clinicians, and sponsors, clinical research professionals offer important perspectives on these changes. Methods: We developed and distributed an anonymous survey assessing COVID-19–related clinical trial adjustment experiences, perceptions, and recommendations to Clinical Research Office personnel at the Harold C. Simmons Comprehensive Cancer Center. Responses were compared using the Fisher exact test. Results: A total of 94 of 109 contacted research personnel (87%) responded. Among these individuals, 58% had >5 years’ professional experience in clinical research, and 56% had personal experience with a COVID-19–related change. Respondents perceived that these changes had a positive impact on patient safety; treatment efficacy; patient and staff experience; and communication with patients, investigators, and sponsors. More than 90% felt that positive changes should be continued after COVID-19. For remote consent, telehealth, therapy shipment, off-site diagnostics, and remote monitoring, individuals with personal experience with the specific change and individuals with >5 years’ professional experience were numerically more likely to recommend continuing the adjustment, and these differences were significant for telehealth (P=.04) and therapy shipment (P=.02). Conclusions: Clinical research professionals perceive that COVID-19–related clinical trial adjustments positively impact multiple aspects of study conduct. Those with greatest experience—both specific to COVID-19–related changes and more generally—are more likely to recommend that these adjustments continue in the future.

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Michael H. Levy, Michael D. Adolph, Anthony Back, Susan Block, Shirley N. Codada, Shalini Dalal, Teresa L. Deshields, Elisabeth Dexter, Sydney M. Dy, Sara J. Knight, Sumathi Misra, Christine S. Ritchie, Todd M. Sauer, Thomas Smith, David Spiegel, Linda Sutton, Robert M. Taylor, Jennifer Temel, Jay Thomas, Roma Tickoo, Susan G. Urba, Jamie H. Von Roenn, Joseph L. Weems, Sharon M. Weinstein, Deborah A. Freedman-Cass, and Mary Anne Bergman

These guidelines were developed and updated by an interdisciplinary group of experts based on clinical experience and available scientific evidence. The goal of these guidelines is to help patients with cancer experience the best quality of life possible throughout the illness trajectory by providing guidance for the primary oncology team for symptom screening, assessment, palliative care interventions, reassessment, and afterdeath care. Palliative care should be initiated by the primary oncology team and augmented by collaboration with an interdisciplinary team of palliative care experts.

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Kavea Panneerselvam, Rajan N. Amin, Dongguang Wei, Dongfeng Tan, Phillip J. Lum, Hao Chi Zhang, David M. Richards, Mehmet Altan, Petros Grivas, John A. Thompson, Anusha S. Thomas, and Yinghong Wang

Background: Although immune checkpoint inhibitors (ICIs) have provided practice-changing outcomes in treating many cancers, ICI-related gastrointestinal toxicity can limit their use. Upper gastrointestinal toxicity is not common nor as well described as lower gastrointestinal toxicity. We aimed to characterize the clinical presentation, endoscopic and histologic features, treatment response, and outcomes of ICI-related esophagitis. Methods: We retrospectively studied patients at The University of Texas MD Anderson Cancer Center in whom esophagitis developed after receiving ICIs from June 2011 through January 2020. We included patients with endoscopic evidence of esophagitis and excluded those with other obvious causes of esophagitis. A chi-square test was used to assess associations between categorical variables. The Mann-Whitney U test was used to compare differences between continuous variables. Results: Of 657 consecutive patients who underwent esophagogastroduodenoscopy (EGD) during or within 6 months of completing ICI-based therapy, 21 (3%) had esophagitis deemed to be from ICIs. Of these patients, 1 (5%) received an inhibitor of CTLA-4 alone, 15 (71%) received anti–PD-1 or PD-L1 monotherapy, and 5 (24%) received a combination of these. Median time from ICI initiation to onset of esophagitis was 4 months. Upon evaluation with EGD, only 3 patients (14%) had isolated esophageal involvement; 18 (86%) had concurrent involvement of the stomach, duodenum, or both. Most patients (67%) were treated with proton pump inhibitors, and 4 (19%) received steroids (prednisone or budesonide). The mortality rate was 38% (median follow-up, 15 months). Conclusions: Esophagitis associated with ICI use is rare. The diagnosis is one of exclusion because its clinical presentation appears similar to that of inflammation resulting from other causes. It often occurs in conjunction with other upper gastrointestinal toxicity. Symptoms are mild and respond well to nonimmunosuppressive treatment, with few severe complications.

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Carrie Zornosa, Jonathan L. Vandergrift, Gregory P. Kalemkerian, David S. Ettinger, Michael S. Rabin, Mary Reid, Gregory A. Otterson, Marianna Koczywas, Thomas A. D'Amico, Joyce C. Niland, Rizvan Mamet, and Katherine M. Pisters

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) allow many systemic therapy options for patients with metastatic non–small cell lung cancer (NSCLC). This analysis uses the NCCN NSCLC Outcomes Database to report on first-line therapy practice patterns and concordance with NCCN Guidelines. The analysis was limited to patients diagnosed with metastatic NSCLC between September 2006 and November 2009 at 1 of 8 participating NCCN Member Institutions. Patient characteristics, regimens used, and guidelines concordance were analyzed. Institutional variation and changes in practice over time were also measured. A total of 1717 patients were included in the analysis. Of these, 1375 (80%) were treated with systemic therapy, most often in the form of a carboplatin-based doublet (51%) or carboplatin-based doublet with targeted therapy (17%). Overall, 76% of patients received care that was concordant with NCCN Guidelines. Among patients with good performance status (n = 167), the most common reasons for not receiving first-line therapy were that therapy was not recommended (39%) or death occurred before treatment (33%). The most common reason for receiving nonconcordant drug therapy was the administration of pemetrexed or erlotinib before its incorporation into the NCCN Guidelines for first-line therapy (53%). Most patients in this cohort received care that was concordant with NCCN Guidelines. The NSCLC Outcomes Database is a valuable resource for evaluating practice patterns and concordance with NCCN Guidelines among patients with NSCLC.

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Ann M. Berger, Amy Pickar Abernethy, Ashley Atkinson, Andrea M. Barsevick, William S. Breitbart, David Cella, Bernadine Cimprich, Charles Cleeland, Mario A. Eisenberger, Carmen P. Escalante, Paul B. Jacobsen, Phyllis Kaldor, Jennifer A. Ligibel, Barbara A. Murphy, Tracey O'Connor, William F. Pirl, Eve Rodler, Hope S. Rugo, Jay Thomas, and Lynne I. Wagner

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Robert J. Motzer, Neeraj Agarwal, Clair Beard, Sam Bhayani, Graeme B. Bolger, Michael A. Carducci, Sam S. Chang, Toni K. Choueiri, Steven L. Hancock, Gary R. Hudes, Eric Jonasch, David Josephson, Timothy M. Kuzel, Ellis G. Levine, Daniel W. Lin, Kim A. Margolin, M. Dror Michaelson, Thomas Olencki, Roberto Pili, Thomas W. Ratliff, Bruce G. Redman, Cary N. Robertson, Charles J. Ryan, Joel Sheinfeld, Philippe E. Spiess, Jue Wang, and Richard B. Wilder

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Michael Levy, Thomas Smith, Amy Alvarez-Perez, Anthony Back, Justin N. Baker, Anna C. Beck, Susan Block, Shalini Dalal, Maria Dans, Thomas R. Fitch, Jennifer Kapo, Jean S. Kutner, Elizabeth Kvale, Sumathi Misra, William Mitchell, Diane G. Portman, Todd M. Sauer, David Spiegel, Linda Sutton, Eytan Szmuilowicz, Robert M. Taylor, Jennifer Temel, Roma Tickoo, Susan G. Urba, Elizabeth Weinstein, Finly Zachariah, Mary Anne Bergman, and Jillian L. Scavone

The NCCN Guidelines for Palliative Care provide interdisciplinary recommendations on palliative care for patients with cancer. The NCCN Guidelines are intended to provide guidance to the primary oncology team on the integration of palliative care into oncology. The NCCN Palliative Care Panel's recommendations seek to ensure that each patient experiences the best quality of life possible throughout the illness trajectory. Accordingly, the NCCN Guidelines outline best practices for screening, assessment, palliative care interventions, reassessment, and after-death care.