This article discusses state-of-the-art techniques for predicting risk of death after acute pulmonary embolism (PE), with special attention to how underlying malignancy adversely affects survival after an episode. Current methods of risk stratification generally categorize patients with PE as low-, moderate-, and high-risk for in-hospital adverse outcomes of respiratory failure, circulatory shock, and death. Published risk stratification studies find that patients with PE and an underlying malignancy have a worse prognosis, but no validated risk stratification criteria have been published specifically for these patients. Standard treatment is full-dose heparin followed by oral anticoagulation. The term escalated treatment refers to the use of systemic or intrapulmonary fibrinolytic agents, catheter-based treatment, or surgical embolectomy. Most patients with low-risk PE (normal vital signs and normal serum troponin, brain natriuretic peptide, and normal echocardiography) are treated successfully with standard anticoagulation, and many can be treated as outpatients. In contrast, patients with high-risk PE (systolic blood pressure < 90 mm Hg and no contraindications) often benefit from escalated treatment. Treatment decisions for patients with moderate-risk PE (normotension with evidence of right ventricular damage or dysfunction) are most controversial. Most patients in this category of risk recover with standard therapy, but some benefit from escalated treatment. Patients with cancer with an incidentally discovered PE should be risk stratified the same as those who have clinically suspected PE.
Risk Stratification for Acute Pulmonary Embolism
Jeffrey A. Kline and David W. Miller
Chemo- and Radiotherapy in Adjuvant Management of Optimally Debulked Endometrial Cancer
David Scott Miller, Gini Fleming, and Marcus E. Randall
The role of chemotherapy and radiotherapy in adjuvant management of optimally debulked endometrial cancer with extrauterine involvement is evolving. Recent studies have suggested an expanded role for chemotherapy and questioned the benefit of radiation therapy. Ongoing and planned clinical trials should provide clarification.
Quality Indicators in the Management of Bladder Cancer
Jeffrey S. Montgomery, David C. Miller, and Alon Z. Weizer
Bladder cancer is predominantly seen in elderly patients. With the aging United States population, the incidence and prevalence of bladder cancer are on the rise, heightening the relevance of this disease as a public health issue. Despite having one of the greatest average cancer treatment costs per patient, improvements in disease-specific survival have been subtle. Clinical guidelines based predominantly on expert opinion and randomized controlled studies offer some guidance, but adherence to these guidelines is lacking. Building awareness of quality indicators to optimize patient care represents an opportunity to improve bladder cancer outcomes. Although quality indicators exist for other disease states, widely accepted quality indicators for the management of bladder cancer have not yet been established. This article proposes an initial set of quality indicators for both non–muscle-invasive and muscle-invasive bladder cancer based on established clinical guidelines and the available literature.
CLO21-022: Efficacy and Safety Outcomes With Therapies for Stage I-III Merkel Cell Carcinoma (MCC): A Systematic Literature Review
David Miller, Roberto Palencia, Ting Yu, Amrita Sandhu, Sarah Webb, Tom Blaikie, and Murtuza Bharmal
Pediatric Aggressive Mature B-Cell Lymphomas, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology
Matthew Barth, Ana C. Xavier, Saro Armenian, Anthony N. Audino, Lindsay Blazin, David Bloom, Jong Chung, Kimberly Davies, Hilda Ding, James B. Ford, Paul J. Galardy, Rabi Hanna, Robert Hayashi, Cathy Lee-Miller, Andrea Judit Machnitz, Kelly W. Maloney, Lianna Marks, Paul L. Martin, David McCall, Martha Pacheco, Anne F. Reilly, Mikhail Roshal, Sophie Song, Joanna Weinstein, Sara Zarnegar-Lumley, Nicole McMillian, Ryan Schonfeld, and Hema Sundar
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Pediatric Aggressive Mature B-Cell Lymphomas include recommendations for the diagnosis and management of pediatric patients with primary mediastinal large B-cell lymphoma (PMBL) and sporadic variants of Burkitt lymphoma and diffuse large B-cell lymphoma. PMBL is now considered as a distinct entity arising from mature thymic B-cells accounting for 2% of mature B-cell lymphomas in children and adolescents. This discussion section includes the recommendations outlined in the NCCN Guidelines for the diagnosis and management of pediatric patients with PMBL.
Ovarian Cancer, Version 2.2020, NCCN Clinical Practice Guidelines in Oncology
Deborah K. Armstrong, Ronald D. Alvarez, Jamie N. Bakkum-Gamez, Lisa Barroilhet, Kian Behbakht, Andrew Berchuck, Lee-may Chen, Mihaela Cristea, Maria DeRosa, Eric L. Eisenhauer, David M. Gershenson, Heidi J. Gray, Rachel Grisham, Ardeshir Hakam, Angela Jain, Amer Karam, Gottfried E. Konecny, Charles A. Leath III, Joyce Liu, Haider Mahdi, Lainie Martin, Daniela Matei, Michael McHale, Karen McLean, David S. Miller, David M. O’Malley, Sanja Percac-Lima, Elena Ratner, Steven W. Remmenga, Roberto Vargas, Theresa L. Werner, Emese Zsiros, Jennifer L. Burns, and Anita M. Engh
Epithelial ovarian cancer is the leading cause of death from gynecologic cancer in the United States and is the country’s fifth most common cause of cancer mortality in women. A major challenge in treating ovarian cancer is that most patients have advanced disease at initial diagnosis. These NCCN Guidelines discuss cancers originating in the ovary, fallopian tube, or peritoneum, as these are all managed in a similar manner. Most of the recommendations are based on data from patients with the most common subtypes─high-grade serous and grade 2/3 endometrioid. The NCCN Guidelines also include recommendations specifically for patients with less common ovarian cancers, which in the guidelines include the following: carcinosarcoma, clear cell carcinoma, mucinous carcinoma, low-grade serous, grade 1 endometrioid, borderline epithelial, malignant sex cord-stromal, and malignant germ cell tumors. This manuscript focuses on certain aspects of primary treatment, including primary surgery, adjuvant therapy, and maintenance therapy options (including PARP inhibitors) after completion of first-line chemotherapy.
NCCN Guidelines® Insights: Ovarian Cancer, Version 3.2022
Featured Updates to the NCCN Guidelines
Deborah K. Armstrong, Ronald D. Alvarez, Floor J. Backes, Jamie N. Bakkum-Gamez, Lisa Barroilhet, Kian Behbakht, Andrew Berchuck, Lee-may Chen, Viola C. Chitiyo, Mihaela Cristea, Maria DeRosa, Eric L. Eisenhauer, David M. Gershenson, Heidi J. Gray, Rachel Grisham, Ardeshir Hakam, Angela Jain, Amer Karam, Gottfried E. Konecny, Charles A. Leath III, Gary Leiserowitz, Joyce Liu, Lainie Martin, Daniela Matei, Michael McHale, Karen McLean, David S. Miller, Sanja Percac-Lima, Steven W. Remmenga, John Schorge, Daphne Stewart, Premal H. Thaker, Roberto Vargas, Andrea Wahner Hendrickson, Theresa L. Werner, Emese Zsiros, Mary A. Dwyer, and Lisa Hang
Epithelial ovarian cancer is the leading cause of death from gynecologic cancer in the United States, with less than half of patients living >5 years following diagnosis. The NCCN Guidelines for Ovarian Cancer provide recommendations for the diagnosis, evaluation, treatment, and follow-up for patients with ovarian, fallopian tube, and primary peritoneal cancers. These NCCN Guidelines Insights summarize the panel discussion behind recent important updates to the guidelines, including revised guidance on alternative chemotherapy regimens for patients with advanced age and/or comorbidities, a new algorithm for recurrent low-grade serous carcinoma based on developing research and novel therapeutic agents, and updated language regarding tumor molecular analysis applications in ovarian cancer.
Prostate Cancer, Version 2.2014
James L. Mohler, Philip W. Kantoff, Andrew J. Armstrong, Robert R. Bahnson, Michael Cohen, Anthony Victor D’Amico, James A. Eastham, Charles A. Enke, Thomas A. Farrington, Celestia S. Higano, Eric Mark Horwitz, Christopher J. Kane, Mark H. Kawachi, Michael Kuettel, Timothy M. Kuzel, Richard J. Lee, Arnold W. Malcolm, David Miller, Elizabeth R. Plimack, Julio M. Pow-Sang, David Raben, Sylvia Richey, Mack Roach III, Eric Rohren, Stan Rosenfeld, Edward Schaeffer, Eric J. Small, Guru Sonpavde, Sandy Srinivas, Cy Stein, Seth A. Strope, Jonathan Tward, Dorothy A. Shead, and Maria Ho
Prostate cancer has surpassed lung cancer as the most common cancer in men in the United States. The NCCN Guidelines for Prostate Cancer provide multidisciplinary recommendations on the clinical management of patients with prostate cancer based on clinical evidence and expert consensus. NCCN Panel guidance on treatment decisions for patients with localized disease is represented in this version. Significant updates for early disease include distinction between active surveillance and observation, a new section on principles of imaging, and revisions to radiation recommendations. The full version of these guidelines, including treatment of patients with advanced disease, can be found online at the NCCN website.
NCCN Guidelines Insights: Palliative Care, Version 2.2017
Maria Dans, Thomas Smith, Anthony Back, Justin N. Baker, Jessica R. Bauman, Anna C. Beck, Susan Block, Toby Campbell, Amy A. Case, Shalini Dalal, Howard Edwards, Thomas R. Fitch, Jennifer Kapo, Jean S. Kutner, Elizabeth Kvale, Charles Miller, Sumathi Misra, William Mitchell, Diane G. Portman, David Spiegel, Linda Sutton, Eytan Szmuilowicz, 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. These NCCN Guidelines Insights summarize and provide context for the updated guidelines recommendations regarding hospice and end-of-life (EOL) care. Updates for 2017 include revisions to and restructuring of the algorithms that address important EOL concerns. These recommendations were revised to provide clearer guidance for oncologists as they care for patients with cancer who are approaching the transition to EOL care. Recommendations for interventions and reassessment based on estimated life expectancy were streamlined and reprioritized to promote hospice referrals and improved EOL care.
Performance Status Restriction in Phase III Cancer Clinical Trials
Joseph Abi Jaoude, Ramez Kouzy, Walker Mainwaring, Timothy A. Lin, Austin B. Miller, Amit Jethanandani, Andres F. Espinoza, Dario Pasalic, Vivek Verma, Noam A. VanderWalde, Benjamin D. Smith, Grace L. Smith, C. David Fuller, Prajnan Das, Bruce D. Minsky, Claus Rödel, Emmanouil Fokas, Reshma Jagsi, Charles R. Thomas Jr, Ishwaria M. Subbiah, Cullen M. Taniguchi, and Ethan B. Ludmir
Background: Patients with good performance status (PS) tend to be favored in randomized clinical trials (RCTs), possibly limiting the generalizability of trial findings. We aimed to characterize trial-related factors associated with the use of PS eligibility criteria and analyze patient accrual breakdown by PS. Methods: Adult, therapeutic, multiarm phase III cancer-specific RCTs were identified through ClinicalTrials.gov. PS data were extracted from articles. Trials with a PS restriction ECOG score ≤1 were identified. Factors associated with PS restriction were determined, and the use of PS restrictions was analyzed over time. Results: In total, 600 trials were included and 238,213 patients had PS data. Of those trials, 527 studies (87.8%) specified a PS restriction cutoff, with 237 (39.5%) having a strict inclusion criterion (ECOG PS ≤1). Enrollment criteria restrictions based on PS (ECOG PS ≤1) were more common among industry-supported trials (P<.001) and lung cancer trials (P<.001). Nearly half of trials that led to FDA approval included strict PS restrictions. Most patients enrolled across all trials had an ECOG PS of 0 to 1 (96.3%). Even among trials that allowed patients with ECOG PS ≥2, only 8.1% of those enrolled had a poor PS. Trials of lung, breast, gastrointestinal, and genitourinary cancers all included <5% of patients with poor PS. Finally, only 4.7% of patients enrolled in trials that led to subsequent FDA approval had poor PS. Conclusions: Use of PS restrictions in oncologic RCTs is pervasive, and exceedingly few patients with poor PS are enrolled. The selective accrual of healthier patients has the potential to severely limit and bias trial results. Future trials should consider a wider cancer population with close toxicity monitoring to ensure the generalizability of results while maintaining patient safety.