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Prostate Cancer, Version 3.2024

Featured Updates to the NCCN Guidelines

Edward M. Schaeffer, Sandy Srinivas, Nabil Adra, Yi An, Rhonda Bitting, Brian Chapin, Heather H. Cheng, Anthony Victor D’Amico, Neil Desai, Tanya Dorff, James A. Eastham, Thomas A. Farrington, Xin Gao, Shilpa Gupta, Thomas Guzzo, Joseph E. Ippolito, R. Jeffrey Karnes, Michael R. Kuettel, Joshua M. Lang, Tamara Lotan, Rana R. McKay, Todd Morgan, Julio M. Pow-Sang, Robert Reiter, Mack Roach III, Tyler Robin, Stan Rosenfeld, Ahmad Shabsigh, Daniel Spratt, Russell Szmulewitz, Benjamin A. Teply, Jonathan Tward, Richard Valicenti, Jessica Karen Wong, Jenna Snedeker, and Deborah A. Freedman-Cass

The NCCN Guidelines for Prostate Cancer include recommendations for staging and risk assessment after a prostate cancer diagnosis and for the care of patients with localized, regional, recurrent, and metastatic disease. These NCCN Guidelines Insights summarize the panel's discussions for the 2024 update to the guidelines with regard to initial risk stratification, initial management of very-low-risk disease, and the treatment of nonmetastatic recurrence.

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Gastroesophageal Adenocarcinomas With Defective Mismatch Repair: Current Knowledge and Clinical Management

Matthew R. Strickland, Eric M. Lander, Michael K. Gibson, David H. Ilson, Jaffer A. Ajani, and Samuel J. Klempner

Esophageal, gastroesophageal junction, and gastric adenocarcinomas, referred to collectively as gastroesophageal adenocarcinomas (GEAs), are a major cause of global cancer-related mortality. Our increasing molecular understanding has led to the addition of biomarker-directed approaches to defined subgroups and has improved survival in selected patients, such as those with HER2 and Claudin18.2 overexpression. Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of cancer, including GEA, but biomarkers beyond PD-L1 expression are lacking. Mismatch repair deficiency and/or high microsatellite instability (dMMR/MSI-H) is observed in 8% to 22% of nonmetastatic GEA, and 3% to 5% of patients with metastatic disease. dMMR/MSI-H tumors are associated with more favorable prognosis and significant benefit from ICIs, although some heterogeneity exists. The activity of ICIs in advanced dMMR/MSI-H cancer is seen across lines of therapy and should be recommended in the frontline setting. In patients with nonmetastatic dMMR/MSI-H cancer, increasing evidence suggests that perioperative and adjuvant chemotherapy may not provide benefit to the dMMR/MSI-H subgroup. The activity of perioperative chemotherapy-free immune checkpoint regimens in patients with nonmetastatic dMMR/MSI-H cancer is highly promising and underscores the need to identify this unique subgroup. We recommend MMR/MSI testing for all patients with GEA at diagnosis, and review the key rationale and clinical management implications for patient with dMMR/MSI-H tumors across disease stages.

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Key Performance Indicators and Metrics for the Implementation of an Oral Chemotherapy Adherence Program

Benyam Muluneh, James B. Collins IV, Brian Lam, Emily Mackler, and Jennifer Elston Lafata

Background: Oral anticancer agents (OAAs) transformed cancer care for patients, extending survival and delaying progression in certain cases. There are multiple pharmacy-driven models to improve patient knowledge and adherence to OAAs. However, a lack of measurable key performance indicators (KPIs) has limited the adoption, implementation, and maintenance of these models. The objective of this study was to identify a set of KPIs, their metrics, and the target values that indicated improved patient care through an OAA adherence program. Methods: A literature review was conducted to identify an initial list of defined KPIs, metrics of the KPIs, and targets for success. We assembled an advisory panel of clinicians (n=9), administrators (n=7), and patients (n=2) from across an academic and affiliated community cancer center to gauge agreement on identified KPIs for use within a structured adherence intervention. We used a Qualtrics survey consisting of questions measured using a 5-point Likert scale response that ranged from 1 (strongly disagree) to 5 (strongly agree) and a subsequent consensus-building discussion with the advisory panel to identify agreeability with the definitions, metrics, and targets of identified KPIs. Results: Eleven KPIs were identified: (1) time to intended OAA initiation; (2) adherence rate during active treatment; (3) adverse events; (4) medication-related financial toxicity; (5) patient satisfaction; (6) treatment-related emergency department visits; (7) treatment-related hospital admissions; (8) proportion of patients with adherence, toxicity, and financial barriers assessed; (9) proportion of patients referred to social work; (10) time spent by patient in each phase of care as defined by the intervention’s standard operating procedure; and (11) revenue generated by billing for service. Conclusions: This study identified 11 KPIs that can be used in evaluating the success of an OAA adherence program. Use of these KPIs will be piloted after formal implementation of the program in both academic and community cancer centers.

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Treatment Patterns and Survival Outcomes in Patients With Breast Cancer on Medicaid, Pre- and Post-Expansion

Siran M. Koroukian, Weichuan Dong, Jeffrey M. Albert, Uriel Kim, Kirsten Eom, Johnie Rose, Cynthia Owusu, Kristine M. Zanotti, Gregory Cooper, and Jennifer Tsui

Background: The objective of this study was to evaluate the impact of Medicaid expansion on breast cancer treatment and survival among Medicaid-insured women in Ohio, accounting for the timing of enrollment in Medicaid relative to their cancer diagnosis and post-expansion heterogeneous Medicaid eligibility criteria, thus addressing important limitations in previous studies. Methods: Using 2011–2017 Ohio Cancer Incidence Surveillance System data linked with Medicaid claims data, we identified women aged 18 to 64 years diagnosed with local-stage or regional-stage breast cancer (n=876 and n=1,957 pre-expansion and post-expansion, respectively). We accounted for women’s timing of enrollment in Medicaid relative to their cancer diagnosis, and flagged women post-expansion as Affordable Care Act (ACA) versus non-ACA, based on their income eligibility threshold. Study outcomes included standard treatment based on cancer stage and receipt of lumpectomy, mastectomy, chemotherapy, radiation, hormonal treatment, and/or treatment for HER2-positive tumors; time to treatment initiation (TTI); and overall survival. We conducted multivariable robust Poisson and Cox proportional hazards regression analysis to evaluate the independent associations between Medicaid expansion and our outcomes of interest, adjusting for patient-level and area-level characteristics. Results: Receipt of standard treatment increased from 52.6% pre-expansion to 61.0% post-expansion (63.0% and 59.9% post-expansion in the ACA and non-ACA groups, respectively). Adjusting for potential confounders, including timing of enrollment in Medicaid, being diagnosed in the post-expansion period was associated with a higher probability of receiving standard treatment (adjusted risk ratio, 1.14 [95% CI, 1.06–1.22]) and shorter TTI (adjusted hazard ratio, 1.14 [95% CI, 1.04–1.24]), but not with survival benefits (adjusted hazard ratio, 1.00 [0.80–1.26]). Conclusions: Medicaid expansion in Ohio was associated with improvements in receipt of standard treatment of breast cancer and shorter TTI but not with improved survival outcomes. Future studies should elucidate the mechanisms at play.

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Long-Term Outcomes of dMMR/MSI-H Rectal Cancer Treated With Anti–PD-1–Based Immunotherapy as Curative-Intent Treatment

Jie-Hai Yu, Le-En Liao, Bin-Yi Xiao, Xuan Zhang, Ai-Wen Wu, Yong Cheng, Jing-Hua Tang, Wu Jiang, Ling-Heng Kong, Kai Han, Wei-Jian Mei, Zhi-Gang Hong, Wan-Jun Yang, Dan-Dan Li, Zhi-Zhong Pan, Yun-Feng Li, Xiao-Shi Zhang, and Pei-Rong Ding

Background: Neoadjuvant anti–PD-1 therapy has shown encouraging efficacy in patients with deficient DNA mismatch repair (dMMR)/microsatellite instability-high (MSI-H) locally advanced rectal cancer (LARC), which suggests its potential as a curative-intent therapy and a promising treatment option for organ preservation. We aimed to investigate the long-term outcomes of patients with dMMR/MSI-H LARC who experienced clinical complete response (cCR) after anti–PD-1 therapy. Methods: We retrospectively analyzed patients with dMMR/MSI-H LARC who achieved cCR and received nonoperative management following neoadjuvant anti–PD-1–based treatment from 4 Chinese medical centers. Patients were followed up for at least 1 year after they achieved cCR, their clinical data were collected, and survival outcomes were analyzed using the Kaplan-Meier method. Results: A total of 24 patients who achieved cCR and received nonoperative management from March 2018 to May 2022 were included, with a median age of 51.0 years (range, 19.0–77.0 years). The median treatment course to reach cCR was 6.0 (range, 1.0–12.0). Fifteen patients (62.5%) continued their treatments after experiencing cCR, and the median treatment course was 17.0 (range, 3.0–36.0). No local regrowth or distant metastasis was observed in a median follow-up time of 29.1 months (range, 12.6–48.5 months) after cCR. The 3-year disease-free and overall survivals were both 100%. Conclusions: Patients with dMMR/MSI-H locally advanced or low-lying rectal cancer who achieved cCR following anti–PD-1–based therapy had promising long-term outcomes. A prospective clinical trial with a larger sample size is required to further validate these findings.

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Compliance With NCCN Guidelines for Evaluation and Treatment of Anemia Among Patients With Solid Tumors

Demetra Hypatia Hufnagel, Lia Manfredi Bos, Alaina Johnson Brown, and Lauren Shore Prescott

Background: NCCN Guidelines for Hematopoietic Growth Factors recommend evaluation and treatment of anemia in patients with cancer. However, a paucity of data exists regarding compliance with these recommendations. Methods: A retrospective cohort study was performed of patients diagnosed with any solid tumor at Vanderbilt University Medical Center from 2008 to 2017. Tumor registry–confirmed cancer cases were identified by ICD-O codes using the Synthetic Derivative database. Anemia was defined as hemoglobin (Hgb) level ≤11 g/dL and graded according to CTCAE version 5.0. Absolute, functional, and possible functional iron deficiency were defined based on NCCN Guidelines. Results: A total of 25,018 patients met inclusion criteria. Median age was 60 years. The most common malignancies were respiratory tract, prostate, and nonprostate urologic (11% each). Among 8,695 patients with Hgb levels available prior to diagnosis, 1,484 (17%) were noted to be anemic proximal to diagnosis. Of the 25,018 patients, 11,019 (44%) were anemic within 6 months of diagnosis. Of these patients, 4,686 (43%) had grade 2 (moderate) anemia and 9,623 (87%) had normocytic anemia. Patients with retroperitoneal/peritoneal cancers had the highest prevalence of anemia (83/110; 75%). A total of 4,125 (37%) underwent any evaluation of their anemia, of whom 1,742 (16%) had iron studies performed and 1,528 (14%) had vitamin B12 or folate studies performed. Fewer than half of patients with anemia received treatment (n=4,318; 39%), including blood transfusion (n=3,528; 32%), oral iron supplementation (n=1,279; 12%), or intravenous iron supplementation (n=97; 1%). Anemia treatment was significantly more frequent as the grade of anemia increased (any treatment among grade 1/mild: 12%; grade 2/moderate: 31%; grade 3/severe: 77%; χ2 [2, n=11,019]=3,020.6; P<.001). Patients with penile and testicular cancers had the highest prevalence of anemia evaluation (n=57; 79%). Conclusions: Anemia is common in patients with solid tumors; yet, compliance with NCCN Guidelines for evaluation and treatment of anemia remains low. There are opportunities to improve compliance with guidelines across the spectrum of cancer care.

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Effect of Patient Navigation on Completion of Lung Cancer Screening in Vulnerable Populations

Sheena Bhalla, Vijaya Natchimuthu, Jessica L. Lee, Urooj Wahid, Hong Zhu, Noel O. Santini, Travis Browning, Heidi A. Hamann, David H. Johnson, Hsienchang Chiu, Simon J. Craddock Lee, and David E. Gerber

Background: Although low-dose, CT–based lung cancer screening (LCS) can decrease lung cancer mortality in high-risk individuals, the process may be complex and pose challenges to patients, particularly those from minority underinsured and uninsured populations. We conducted a randomized controlled trial of telephone-based navigation for LCS within an integrated, urban, safety-net health care system. Patients and Methods: Patients eligible for LCS were randomized (1:1) to usual care with or without navigation at Parkland Health in Dallas, Texas. The primary endpoint was completion of the first 3 consecutive steps in a patient’s LCS process. We explored differences in completion of LCS steps between navigation and usual care groups, controlling for patient characteristics using the chi-square test. Results: Patients (N=447) were randomized to either navigation (n=225) or usual care (n=222). Mean patient age was 62 years, 46% were female, and 69% were racial/ethnic minorities. There was no difference in completion of the first 3 steps of the LCS algorithm between arms (12% vs 9%, respectively; P=.30). For ordered LCS steps, completion rates were higher among patients who received navigation (86% vs 79%; P=.03). The primary reason for step noncompletion was lack of order placement. Conclusions: In this study, lack of order placement was a key reason for incomplete LCS steps. When orders were placed, patients who received navigation had higher rates of completion. Clinical team education and enhanced electronic health record processes to simplify order placement, coupled with patient navigation, may improve LCS in safety-net health care systems.

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Response to Dabrafenib Plus Trametinib in a Patient With an Uncommon Activating BRAF Mutation: A First in Non–Small Cell Lung Cancer

John A. Sharp, Daniel Jones, Julia K. Rotow, Panos M. Fidias, Erin Bertino, and Dwight H. Owen

Mutations in BRAF are present in 4% of non–small cell lung cancer (NSCLC), of which half are well-characterized activating variants affecting codon 600 (classified as class I). These mutations, most commonly BRAF V600E, have been associated with response to BRAF/MEK-directed small molecule kinase inhibitors. NSCLC with kinase-activating BRAF mutations occurring at other codons (class II variants) represent a substantial portion of BRAF-mutated NSCLC, but use of targeted therapy in these tumors is still under investigation. Class II mutations have been described in other tumor types and have been associated with response to BRAF/MEK-targeted agents, although optimal treatment strategies for these patients are lacking. This report presents a case of a woman with metastatic NSCLC harboring a class II BRAF p.N486_P490del variant who had a sustained clinical response to combination therapy with dabrafenib and trametinib. This first report of the use of BRAF/MEK-targeted therapy for this variant in NSCLC supports consideration of such treatment for tumors with class II BRAF variants.

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Impact of the Breast Cancer Index for Extended Endocrine Decision-Making: First Results of the Prospective BCI Registry Study

Tara B. Sanft, Jenna Wong, Brandon O’Neal, Natalia Siuliukina, Rachel C. Jankowitz, Mark D. Pegram, Jenny R. Fox, Yi Zhang, Kai Treuner, and Joyce A. O’Shaughnessy

Background: The Breast Cancer Index (BCI) test assay provides an individualized risk of late distant recurrence (5–10 years) and predicts the likelihood of benefitting from extended endocrine therapy (EET) in hormone receptor–positive early-stage breast cancer. This analysis aimed to assess the impact of BCI on EET decision-making in current clinical practice. Methods: The BCI Registry study evaluates long-term outcomes, decision impact, and medication adherence in patients receiving BCI testing as part of routine clinical care. Physicians and patients completed pre-BCI and post-BCI test questionnaires to assess a range of questions, including physician decision-making and confidence regarding EET; patient preferences and concerns about the cost, side effects, drug safety, and benefit of EET; and patient satisfaction regarding treatment recommendations. Pre-BCI and post-BCI test responses were compared using McNemar’s test and Wilcoxon signed rank test. Results: Pre-BCI and post-BCI questionnaires were completed for 843 physicians and 823 patients. The mean age at enrollment was 65 years, and 88.4% of patients were postmenopausal. Of the tumors, 74.7% were T1, 53.4% were grade 2, 76.0% were N0, and 13.8% were HER2-positive. Following BCI testing, physicians changed EET recommendations in 40.1% of patients (P<.0001), and 45.1% of patients changed their preferences for EET (P<.0001). In addition, 38.8% of physicians felt more confident in their recommendation (P<.0001), and 41.4% of patients felt more comfortable with their EET decision (P<.0001). Compared with baseline, significantly more patients were less concerned about the cost (20.9%; P<.0001), drug safety (25.4%; P=.0014), and benefit of EET (29.3%; P=.0002). Conclusions: This analysis in a large patient cohort of the BCI Registry confirms and extends previous findings on the significant decision-making impact of BCI on EET. Incorporating BCI into clinical practice resulted in changes in physician recommendations, increased physician confidence, improved patient satisfaction, and reduced patient concerns regarding the cost, drug safety, and benefit of EET.

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Volume 22 (2024): Issue 2 (Mar 2024)