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Roy Beveridge, John Fox, Susan A. Higgins, Martin Kohn, John J. Mahoney, Lee N. Newcomer, Andrew von Eschenbach and Clifford Goodman

Complex challenges face all players in the oncology landscape, from health care policy leaders and third-party payers, to practicing physicians and nurses, to patients and their families. In these unsteady economic times, possible answers proposed by some may represent part of the problem to others. A distinguished panel assembled at the NCCN 18th Annual Conference: Advancing the Standard of Cancer Care to explore the changing oncology landscape. This article is the synopsis of that discussion, with panelists shedding light on such issues as the astronomic cost of medical care, the need for clinicians to think outside the formulary, and the therapeutic decision-making process in the new world of “big data.”

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Ganessan Kichenadasse, John O. Miners, Arduino A. Mangoni, Andrew Rowland, Ashley M. Hopkins and Michael J. Sorich

Background: Immune-related adverse events (irAEs) are known to occur in patients with cancer who are treated with immune checkpoint inhibitors. However, limited literature exists on the incidence, time of onset, and risk factors for irAEs, particularly those affecting multiple organs, associated with anti–PD-L1 inhibitors. Methods: A post hoc pooled analysis was conducted using individual patient data from atezolizumab monotherapy arms of 4 non–small cell lung cancer clinical trials. Incidence, clinical patterns, outcomes, and risk factors were investigated of selected organ-specific and multiorgan irAEs during treatment using the anti–PD-L1 inhibitor atezolizumab. Results: From a total of 1,548 patients, 730 irAE episodes were reported in 424 patients (27%). Skin irAEs were the most common (42%), followed by laboratory abnormalities (27%) and endocrine (11.6%), neurologic (7.6%), and pulmonary (6.2%) irAEs. A total of 84 patients (5.4%) had multiorgan irAEs, 70 had 2, 13 had 3, and 1 had 4 different organs affected. “Skin plus” or “laboratory plus” were the most common irAE multiorgan clusters. Patients with multiorgan irAEs were more likely to be white and have a good performance status, a lower baseline neutrophil-lymphocyte ratio, and a good or intermediate lung immune prognostic index score. Multiorgan irAEs were also associated with improved overall survival (hazard ratio, 0.47; 95% CI, 0.28–0.78; P<.0001) but not with progression-free survival (hazard ratio, 0.92; 95% CI, 0.62–1.35; P=.74) compared with the cohort with no irAEs. Conclusions: Multiorgan irAEs occurred in 5.4% of patients treated with atezolizumab in non–small cell lung cancer trials. Future trials should consider routine reporting of data on multiorgan toxicities in addition to organ-specific toxicities.

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Lydia T. Madsen, Deborah A. Kuban, Seungtaek Choi, John W. Davis, Jeri Kim, Andrew K. Lee, Delora Domain, Larry Levy, Louis L. Pisters, Curtis A. Pettaway, John F. Ward, Christopher Logothetis and Karen E. Hoffman

Clinical oncology trials are hampered by low accrual rates, with fewer than 5% of adult patients with cancer treated on study. Clinical trial enrollment was evaluated at The University of Texas MD Anderson Cancer Center's Multidisciplinary Prostate Cancer Clinic (MPCC) to assess whether a clinical trial initiative, introduced in 2006, impacted enrollment. The trial initiative included posting trial-specific information in clinic, educating patients about appropriate clinical trial options during the treatment recommendation discussion, and providing patients with trial-specific educational information. The investigators evaluated the frequency of clinical trial enrollment for men with newly diagnosed prostate cancer seen in the MPCC from 2004 to 2008. Logistic regression evaluated the impact of patient characteristics and the clinical trial initiative on trial enrollment. The median age of the 1370 men was 64 years; 32% had low-risk, 49% had intermediate-risk, and 19% had high-risk disease. Overall, 74% enrolled in at least one trial and 29% enrolled in more than one trial. Trial enrollment increased from 39% before the initiative (127/326) to 84% (880/1044) after the trial initiative. Patient enrollment increased in laboratory studies (from 25% to 80%), quality-of-life studies (from 10% to 26%), and studies evaluating investigational treatments and systemic agents (from 6% to 15%) after the trial initiative. In multivariate analysis, younger men (P<.001) and men seen after implementation of the clinical trial initiative (P<.001) were more likely to enroll in trials. Clinical trial enrollment in the MPCC was substantially higher than that seen nationally in adult patients with cancer, and enrollment rates increased after the introduction of a clinical trial initiative.

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Donald A. Podoloff, Ranjana H. Advani, Craig Allred, Al B. Benson III, Elizabeth Brown, Harold J. Burstein, Robert W. Carlson, R. Edward Coleman, Myron S. Czuczman, Dominique Delbeke, Stephen B. Edge, David S. Ettinger, Frederic W. Grannis Jr., Bruce E. Hillner, John M. Hoffman, Krystyna Kiel, Ritsuko Komaki, Steven M. Larson, David A. Mankoff, Kenneth E. Rosenzweig, John M. Skibber, Joachim Yahalom, JQ Michael Yu and Andrew D. Zelenetz

The use of positron emission tomography (PET) is increasing rapidly in the United States, with the most common use of PET scanning related to oncology. It is especially useful in the staging and management of lymphoma, lung cancer, and colorectal cancer, according to a panel of expert radiologists, surgeons, radiation oncologists, nuclear medicine physicians, medical oncologists, and general internists convened in November 2006 by the National Comprehensive Cancer Network. The Task Force was charged with reviewing existing data and developing clinical recommendations for the use of PET scans in the evaluation and management of breast cancer, colon cancer, non-small cell lung cancer, and lymphoma. This report summarizes the proceedings of this meeting, including discussions of the background of PET, possible future developments, and the role of PET in oncology. (JNCCN 2007;5(Suppl 1):S1–S22)

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Min Huang, Joyce O’Shaughnessy, Jing Zhao, Amin Haiderali, Javier Cortes, Scott Ramsey, Andrew Briggs, Vassiliki Karantza, Gursel Aktan, Cynthia Z. Qi, Chenyang Gu, Jipan Xie, Muhan Yuan, John Cook, Michael Untch, Peter Schmid and Peter A. Fasching

Background: Pathologic complete response (pCR) is a common efficacy endpoint in neoadjuvant therapy trials for triple-negative breast cancer (TNBC). Previous studies have shown that pCR is strongly associated with improved long-term survival outcomes, including event-free survival (EFS) and overall survival (OS). However, the trial-level associations between treatment effect on pCR and long-term survival outcomes are not well established. This study sought to evaluate these associations by incorporating more recent clinical trials in TNBC. Methods: A literature review identified published randomized controlled trials (RCTs) of neoadjuvant therapy for TNBC that reported results for both pCR and EFS/OS. Meta-regression models were performed to evaluate the association of treatment effect on pCR and EFS/OS. Sensitivity analyses were conducted to assess the impact of divergent study designs. Results: Ten comparisons from 8 RCTs (N=2,478 patients) were identified from the literature review. The log (odds ratio) of pCR was a significant predictor of the log (hazard ratio) of EFS (P=.003), with a coefficient of determination of 0.68 (95% CI, 0.41–0.95). There was a weaker association between pCR and OS (P=.18), with a coefficient of determination of 0.24 (95% CI, 0.01–0.77). Consistent results were found in the exploratory analysis and sensitivity analyses. Conclusions: This is the first study that has shown a trial-level association between pCR and survival outcomes in TNBC. By incorporating the most up-to-date RCTs, this study showed a significant trial-level association between pCR and EFS. A positive association between pCR and OS was also recorded.

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Margaret A. Tempero, Mokenge P. Malafa, Stephen W. Behrman, Al B. Benson III, Ephraim S. Casper, E. Gabriela Chiorean, Vincent Chung, Steven J. Cohen, Brian Czito, Anitra Engebretson, Mary Feng, William G. Hawkins, Joseph Herman, John P. Hoffman, Andrew Ko, Srinadh Komanduri, Albert Koong, Andrew M. Lowy, Wen Wee Ma, Nipun B. Merchant, Sean J. Mulvihill, Peter Muscarella II, Eric K. Nakakura, Jorge Obando, Martha B. Pitman, Sushanth Reddy, Aaron R. Sasson, Sarah P. Thayer, Colin D. Weekes, Robert A. Wolff, Brian M. Wolpin, Jennifer L. Burns and Deborah A. Freedman-Cass

The NCCN Guidelines for Pancreatic Adenocarcinoma discuss the diagnosis and management of adenocarcinomas of the exocrine pancreas and are intended to assist with clinical decision-making. These NCCN Guidelines Insights summarize major discussion points from the 2014 NCCN Pancreatic Adenocarcinoma Panel meeting. The panel discussion focused mainly on the management of borderline resectable and locally advanced disease. In particular, the panel discussed the definition of borderline resectable disease, role of neoadjuvant therapy in borderline disease, role of chemoradiation in locally advanced disease, and potential role of newer, more active chemotherapy regimens in both settings.

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Al B. Benson III, Thomas A. Abrams, Edgar Ben-Josef, P. Mark Bloomston, Jean F. Botha, Bryan M. Clary, Anne Covey, Steven A. Curley, Michael I. D'Angelica, Rene Davila, William D. Ensminger, John F. Gibbs, Daniel Laheru, Mokenge P. Malafa, Jorge Marrero, Steven G. Meranze, Sean J. Mulvihill, James O. Park, James A. Posey, Jasgit Sachdev, Riad Salem, Elin R. Sigurdson, Constantinos Sofocleous, Jean-Nicolas Vauthey, Alan P. Venook, Laura Williams Goff, Yun Yen and Andrew X. Zhu

Hepatobiliary Cancers Clinical Practice Guidelines in Oncology NCCN Categories of Evidence and Consensus Category 1: The recommendation is based on high-level evidence (e.g., randomized controlled trials) and there is uniform NCCN consensus. Category 2A: The recommendation is based on lower-level evidence and there is uniform NCCN consensus. Category 2B: The recommendation is based on lower-level evidence and there is nonuniform NCCN consensus (but no major disagreement). Category 3: The recommendation is based on any level of evidence but reflects major disagreement. All recommendations are category 2A unless otherwise noted. Clinical trials: The NCCN believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. Overview Hepatobiliary cancers are highly lethal. In 2008, approximately 21,370 persons in the United States were estimated to be diagnosed with liver or intrahepatic bile duct cancer and 9520 with gallbladder cancer or other biliary tract cancer. Furthermore, approximately 18,410 deaths from liver or intrahepatic bile duct cancer and 3340 deaths from gallbladder cancer or other biliary tract cancer were estimated to occur.1 The types of hepatobiliary cancers covered in these guidelines include hepatocellular carcinoma (HCC), gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma. By definition, these guidelines cannot incorporate all possible clinical variations and are not intended to replace good clinical judgment or individualization of treatments. Although not explicitly stated at every decision point of the guidelines, patient participation in prospective clinical trials is the preferred option for treatment of hepatobiliary cancers. HCC Risk Factors and...
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William G. Wierda, John C. Byrd, Jeremy S. Abramson, Seema Bhat, Greg Bociek, Danielle Brander, Jennifer Brown, Asher Chanan-Khan, Steve E. Coutre, Randall S. Davis, Christopher D. Fletcher, Brian Hill, Brad S. Kahl, Manali Kamdar, Lawrence D. Kaplan, Nadia Khan, Thomas J. Kipps, Jeffrey Lancet, Shuo Ma, Sami Malek, Claudio Mosse, Mazyar Shadman, Tanya Siddiqi, Deborah Stephens, Nina Wagner, Andrew D. Zelenetz, Mary A. Dwyer and Hema Sundar

Hairy cell leukemia (HCL) is a rare type of indolent B-cell leukemia, characterized by symptoms of fatigue and weakness, organomegaly, pancytopenia, and recurrent opportunistic infections. Classic HCL should be considered a distinct clinical entity separate from HCLvariant (HCLv), which is associated with a more aggressive disease course and may not respond to standard HCL therapies. Somatic hypermutation in the IGHV gene is present in most patients with HCL. The BRAF V600E mutation has been reported in most patients with classic HCL but not in those with other B-cell leukemias or lymphomas. Therefore, it is necessary to distinguish HCLv from classic HCL. This manuscript discusses the recommendations outlined in the NCCN Guidelines for the diagnosis and management of classic HCL.

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NCCN Guidelines Insights: Kidney Cancer, Version 2.2020

Featured Updates to the NCCN Guidelines

Robert J. Motzer, Eric Jonasch, M. Dror Michaelson, Lakshminarayanan Nandagopal, John L. Gore, Saby George, Ajjai Alva, Naomi Haas, Michael R. Harrison, Elizabeth R. Plimack, Jeffrey Sosman, Neeraj Agarwal, Sam Bhayani, Toni K. Choueiri, Brian A. Costello, Ithaar H. Derweesh, Thomas H. Gallagher, Steven L. Hancock, Christos Kyriakopoulos, Chad LaGrange, Elaine T. Lam, Clayton Lau, Bryan Lewis, Brandon Manley, Brittany McCreery, Andrew McDonald, Amir Mortazavi, Phillip M. Pierorazio, Lee Ponsky, Bruce G. Redman, Bradley Somer, Geoffrey Wile, Mary A. Dwyer, CGC, Lydia J. Hammond and Griselda Zuccarino-Catania

The NCCN Guidelines for Kidney Cancer provide multidisciplinary recommendations for the clinical management of patients with clear cell and non–clear cell renal cell carcinoma, and are intended to assist with clinical decision-making. These NCCN Guidelines Insights summarize the NCCN Kidney Cancer Panel discussions for the 2020 update to the guidelines regarding initial management and first-line systemic therapy options for patients with advanced clear cell renal cell carcinoma.

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Peter R. Carroll, J. Kellogg Parsons, Gerald Andriole, Robert R. Bahnson, Erik P. Castle, William J. Catalona, Douglas M. Dahl, John W. Davis, Jonathan I. Epstein, Ruth B. Etzioni, Thomas Farrington, George P. Hemstreet III, Mark H. Kawachi, Simon Kim, Paul H. Lange, Kevin R. Loughlin, William Lowrance, Paul Maroni, James Mohler, Todd M. Morgan, Kelvin A. Moses, Robert B. Nadler, Michael Poch, Chuck Scales, Terrence M. Shaneyfelt, Marc C. Smaldone, Geoffrey Sonn, Preston Sprenkle, Andrew J. Vickers, Robert Wake, Dorothy A. Shead and Deborah A. Freedman-Cass

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Prostate Cancer Early Detection provide recommendations for prostate cancer screening in healthy men who have elected to participate in an early detection program. The NCCN Guidelines focus on minimizing unnecessary procedures and limiting the detection of indolent disease. These NCCN Guidelines Insights summarize the NCCN Prostate Cancer Early Detection Panel's most significant discussions for the 2016 guideline update, which included issues surrounding screening in high-risk populations (ie, African Americans, BRCA1/2 mutation carriers), approaches to refine patient selection for initial and repeat biopsies, and approaches to improve biopsy specificity.