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Martin S. Tallman, Eunice S. Wang, Jessica K. Altman, Frederick R. Appelbaum, Vijaya Raj Bhatt, Dale Bixby, Steven E. Coutre, Marcos De Lima, Amir T. Fathi, Melanie Fiorella, James M. Foran, Aric C. Hall, Meagan Jacoby, Jeffrey Lancet, Thomas W. LeBlanc, Gabriel Mannis, Guido Marcucci, Michael G. Martin, Alice Mims, Margaret R. O’Donnell, Rebecca Olin, Deniz Peker, Alexander Perl, Daniel A. Pollyea, Keith Pratz, Thomas Prebet, Farhad Ravandi, Paul J. Shami, Richard M. Stone, Stephen A. Strickland, Matthew Wieduwilt, Kristina M. Gregory, OCN, Lydia Hammond and Ndiya Ogba
Acute myeloid leukemia (AML) is the most common form of acute leukemia among adults and accounts for the largest number of annual deaths due to leukemias in the United States. Recent advances have resulted in an expansion of treatment options for AML, especially concerning targeted therapies and low-intensity regimens. This portion of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for AML focuses on the management of AML and provides recommendations on the workup, diagnostic evaluation and treatment options for younger (age <60 years) and older (age ≥60 years) adult patients.
Brian Jenssen, Frank Leone, Sarah Evers-Casey, Rinad Beidas and Robert Schnoll
Enrique Soto-Perez-de-Celis, Pedro N. Aguiar Jr, Mónica L. Cordón, Yanin Chavarri-Guerra and Gilberto de Lima Lopes Jr
Background: Treatment options are limited for patients with advanced hepatocellular carcinoma (HCC) that progresses after treatment with sorafenib. Cabozantinib, an oral small molecule inhibitor of multiple tyrosine kinase receptors, recently showed improved overall survival (OS) compared with placebo in sorafenib-pretreated patients with advanced HCC in the CELESTIAL trial. This study assessed the cost-effectiveness of cabozantinib for second-line treatment of patients with advanced HCC from a US healthcare system perspective. Patients and Methods: Cost and utility data were extracted from the CELESTIAL trial and used to determine the cost-effectiveness of cabozantinib compared with placebo plus best supportive care. The main outcome of this study was the incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life year (QALY) gained by using cabozantinib compared with placebo plus best supportive care in sorafenib-pretreated HCC. Results: In the base-case analysis using data from the CELESTIAL trial, the incremental QALY and ICER were 0.067 and $1,040,675 for cabozantinib compared with placebo and best supportive care. OS reported in the CELESTIAL trial (hazard ratio, 0.76; 95% CI, 0.63–0.92) had the strongest association with the ICER. In one-way sensitivity analyses, there were no scenarios in which cabozantinib was cost-effective. In a cost-threshold analysis, cabozantinib would have to be priced at least $50 per pill to be cost-effective considering a willingness to pay of $100,000 per QALY. Although the CELESTIAL trial demonstrated that cabozantinib improves OS compared with placebo in patients with HCC that progresses after treatment with sorafenib, our analysis shows that cabozantinib is not a cost-effective therapy in this scenario. Conclusions: At current costs, cabozantinib is not cost-effective for second-line therapy of HCC in the United States.
Armin Shahrokni, Bella Marie Vishnevsky, Brian Jang, Saman Sarraf, Koshy Alexander, Soo Jung Kim, Robert Downey, Anoushka Afonso and Beatriz Korc-Grodzicki
Background: The American Society of Anesthesiologists physical status (ASA PS) classification system is the most common method of assessing preoperative functional status. Comprehensive geriatric assessment (CGA) has been proposed as a supplementary tool for preoperative assessment of older adults. The goal of this study was to assess the correlation between ASA classification and CGA deficits among oncogeriatric patients and to determine the association of each with 6-month survival. Patients and Methods: Oncogeriatric patients (aged ≥75 years) who underwent preoperative CGA in an outpatient geriatric clinic at a single tertiary comprehensive cancer center were identified. All patients underwent surgery, with a hospital length of stay (LOS) ≥1 day and at least 6 months of follow-up. ASA classifications were obtained from preoperative anesthesiology notes. Preoperative CGA scores ranged from 0 to 13. Six-month survival was assessed using the Social Security Death Index. Results: In total, 81 of the 980 patients (8.3%) included in the study cohort died within 6 months of surgery. Most patients were classified as ASA PS III (85.4%). The mean number of CGA deficits for patients with PS II was 4.03, PS III was 5.15, and PS IV was 6.95 (P<.001). ASA classification was significantly associated with age, preoperative albumin level, hospital LOS, and 30-day intensive care unit (ICU) admissions. On multivariable analysis, 6-month mortality was associated with number of CGA deficits (odds ratio [OR], 1.14 per each unit increase in CGA score; P=.01), 30-day ICU admissions (OR, 2.77; P=.003), hospital LOS (OR, 1.03; P=.02), and preoperative albumin level (OR, 0.36; P=.004). ASA classification was not associated with 6-month mortality. Conclusions: Number of CGA deficits was strongly associated with 6-month mortality; ASA classification was not. Preoperative CGA elicits critical information that can be used to enhance the prediction of postoperative outcomes among older patients with cancer.
Amy A. Kirkham, Kelcey A. Bland, Holly Wollmann, Alis Bonsignore, Don C. McKenzie, Cheri Van Patten, Karen A. Gelmon and Kristin Campbell
Background: Overwhelming randomized controlled trial evidence demonstrates that exercise has positive health impacts during and after treatment for breast cancer. Yet, evidence generated by studies in which exercise programs are delivered outside a tightly controlled randomized trial setting is limited. The purpose of this study was to assess the effectiveness of an evidence-based exercise program with real-world implementation on physical fitness and quality of life (QoL). Patients and Methods: Oncologists referred women with early-stage breast cancer who were scheduled to receive adjuvant chemotherapy. The program consisted of supervised aerobic and resistance exercise of moderate to vigorous intensity 3 times per week until the end of treatment (chemotherapy ± radiotherapy), then twice per week for 10 weeks, followed by once per week for 10 weeks. Health-related physical fitness and QoL were assessed at baseline, end of treatment, end of program, and 1-year follow-up. Results: A total of 73 women were enrolled. Estimated peak VO2 (VO2peak), QoL, and body weight were maintained between baseline and end of treatment, whereas muscular strength improved (P<.01). By the end of the program, VO2peak, heart rate recovery, waist circumference, and some aspects of QoL were improved (all P<.01) relative to baseline. One year later, VO2peak, QoL, and waist circumference were maintained relative to end of program, whereas the improvements in strength and heart rate recovery had dissipated (all P<.01). Conclusions: Evidence-based exercise programming delivered with real-world implementation maintained VO2peak, strength, and QoL during adjuvant treatment and improved these measures after treatment completion among women with breast cancer. Continued guidance and support may be required for long-term maintenance of strength improvements in this population.
Jarushka Naidoo, Jiajia Zhang, Evan J. Lipson, Patrick M. Forde, Karthik Suresh, Kendall F. Moseley, Seema Mehta, Shawn G. Kwatra, Alyssa M. Parian, Amy K. Kim, John C. Probasco, Rosanne Rouf, Jennifer E. Thorne, Satish Shanbhag, Joanne Riemer, Ami A. Shah, Drew M. Pardoll, Clifton O. Bingham III, Julie R. Brahmer and Laura C. Cappelli
Background: Immune checkpoint inhibitors (ICIs) may cause immune-related adverse events (irAEs). Methods to obtain real-time multidisciplinary input for irAEs that require subspecialist care are unknown. This study aimed to determine whether a virtual multidisciplinary immune-related toxicity (IR-tox) team of oncology and medicine subspecialists would be feasible to implement, be used by oncology providers, and identify patients for whom multidisciplinary input is sought. Patients and Methods: Patients treated with ICIs and referred to the IR-tox team in August 2017 through March 2018 were identified. Feasibility was defined as receipt of electronic referrals and provision of recommendations within 24 hours of referral. Use was defined as the proportion of referring providers who used the team’s recommendations, which was determined through a postpilot survey. Demographics and tumor, treatment, and referral data were collected. Patient features and irAE associations were analyzed. Results: The IR-tox team was found to be feasible and used: 117 referrals from 102 patients were received in 8 months, all providers received recommendations within 24 hours, 100% of surveyed providers used the recommendations, and 74% changed patient management based on IR-tox team recommendations. Referrals were for suspected irAEs (n=106; 91%) and suitability to treat with ICIs (n=11; 10%). In referred patients, median age was 64 years, 54% were men, 13% had prior autoimmunity, and 46% received ICI combinations versus monotherapy (54%). The most commonly referred toxicities were pneumonitis (23%), arthritis (16%), and dermatitis (15%); 15% of patients had multisystem toxicities. Multiple referrals were more common in those treated with combination ICIs (odds ratio [OR], 6.0; P=.035) or with multisystem toxicities (OR, 8.1; P=.005). The IR-tox team provided a new multidisciplinary forum to assist providers in diagnosing and managing complex irAEs. This model identifies educational and service needs, and patients with irAEs for whom multidisciplinary care is most sought. Conclusions: A virtual multidisciplinary toxicity team for irAEs was a feasible and used service, and facilitated toxicity identification and management.
Featured Updates to the NCCN Guidelines
Andrew D. Zelenetz, Leo I. Gordon, Jeremy S. Abramson, Ranjana H. Advani, Nancy L. Bartlett, Paolo F. Caimi, Julie E. Chang, Julio C. Chavez, Beth Christian, Luis E. Fayad, Martha J. Glenn, Thomas M. Habermann, Nancy Lee Harris, Francisco Hernandez-Ilizaliturri, Mark S. Kaminski, Christopher R. Kelsey, Nadia Khan, Susan Krivacic, Ann S. LaCasce, Amitkumar Mehta, Auayporn Nademanee, Rachel Rabinovitch, Nishitha Reddy, Erin Reid, Kenneth B. Roberts, Stephen D. Smith, Erin D. Snyder, Lode J. Swinnen, Julie M. Vose, Mary A. Dwyer and Hema Sundar
Diffuse large B-cell lymphomas (DLBCLs) and follicular lymphoma (FL) are the most common subtypes of B-cell non-Hodgkin’s lymphomas in adults. Histologic transformation of FL to DLBCL (TFL) occurs in approximately 15% of patients and is generally associated with a poor clinical outcome. Phosphatidylinositol 3-kinase (PI3K) inhibitors have shown promising results in the treatment of relapsed/refractory FL. CAR T-cell therapy (axicabtagene ciloleucel and tisagenlecleucel) has emerged as a novel treatment option for relapsed/refractory DLBCL and TFL. These NCCN Guidelines Insights highlight important updates to the NCCN Guidelines for B-Cell Lymphomas regarding the treatment of TFL and relapsed/refractory FL and DLBCL.