National Comprehensive Cancer Network Recommends Research Articles

Abstract B141 Self-reported distress in multiple myeloma patients at first consultation at a transplant referral center

Abstract The National Comprehensive Cancer Network (NCCN) recommends screening all cancer patients for distress to facilitate psychosocial support and referrals. This distress is associated with treatment delays and other obstacles that may affect patient outcomes. The prevalence of distress in patients with multiple myeloma (MM) and its variation among underrepresented minorities and vulnerable groups is unknown. We hypothesized that patients with advanced disease, racial minorities, and vulnerable individuals would report higher distress levels. New patients with MM seen between 1/1/2015-12/31/2022 at a tertiary medical center were identified. All patients receive the NCCN Distress Thermometer (DT) survey for completion at initial consultation as standard of care. Baseline characteristics of patients who completed the survey were compared with those of patients who did not. Among those with survey data, DT score was categorized as <4 (low), 4–6 (moderate), and >6 (high). DT score was analyzed by sociodemographic and disease-related factors. The 2020 Social Vulnerability Index (SVI) at the county level was calculated using Zip codes and categorized as less vulnerable (score <50) or more vulnerable (>=50). Of 1,011 new MM patient consultations, 683 patients had an available DT survey at initial consultation. In patients without the survey (N=328), a higher proportion was older than 75 years (21% vs 16% P=0.04), non-Hispanic Black (NHB) [22% vs. 9%, P<0.01], and with more advanced disease (ISS III 20% vs 14%, P<0.01). There was lower autologous stem cell transplant utilization in the group with missing survey data (71% vs 79%, P<0.01). Among those with DT survey, younger age, female sex, advanced stage, and shorter time from diagnosis to consult was associated with higher distress. In patients with DT survey data and SVI (N=683), the mean SVI was 0.37 (std dev 0.31) and 166 (28%) had more vulnerability. Younger age and NHB race were associated with more vulnerability. The more vulnerable group also had a shorter time from diagnosis to consult (1.2 vs 1.8 months, P<0.01). In the more vulnerable group, high DT score was seen with younger age and NHB race. There was no difference in transplant utilization by SVI group. No significant differences were found in the proportion of patients reporting concerns for physical, practical, emotional, social concerns by vulnerability. In this tertiary referral center study, we observed the greatest disparity by the completion of the NCCN DT survey highlighting a missed opportunity to identify individuals who may benefit from additional services. Among those who completed the survey, patient-reported distress was influenced by age, sex, and MM stage. Younger age was associated with more vulnerability. This may be due to minority status as a theme in the SVI calculator and the known association of younger age at MM onset in NHB individuals. Next steps including an adjusted analysis will be shown in the final presentation. Citation Format: Noel Estrada-Merly, James F Wu, Anita D'Souza. Self-reported distress in multiple myeloma patients at first consultation at a transplant referral center [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B141.

How to Tackle Discordance in Adjuvant Chemotherapy Recommendations by Using Oncotype DX Results, in Early-Stage Breast Cancer.

The use of the Oncotype DX test reduces the rate of adjuvant chemotherapy recommendations. Few in-depth analyses have been performed on this decision-making process. We retrospectively analyzed patient data based on available Oncotype DX test results (RS) irrespective of nodal status at a single center. We collected recommendations from six oncologists, first without RS (pre-RS) and then with RS results (post-RS). We investigated changes in recommendations, agreement between oncologist decisions, and the effect of different National Comprehensive Cancer Network (NCCN) recommendation categories (for, against, and considering chemotherapy). Data from 201 patients were included in the analysis. Recommendation of chemotherapy decreased by an average of 39.5%. Agreement improved substantially with RS, with a kappa value pre-RS of 0.37 (fair agreement) and post-RS of 0.75 (substantial agreement). Discordance remained substantial in cases where the NCCN recommendations considered chemotherapy only (32%). Pre-RS consensus against chemotherapy predicted low RS results (50 out of 51 patients). Post-RS consensus was highest in the NCCN chemotherapy recommendation group. The Oncotype DX test substantially improves decision accuracy in recommending adjuvant chemotherapy. It may be further improved with a consensus decision. In the case of pre-RS consensus against chemotherapy, the test can be spared.

Clinical value of guideline recommended molecular targets and genome targeted cancer therapies: cross sectional study

ObjectiveTo assess the clinical benefit and actionability of molecular targets for genome targeted cancer drugs recommended for clinical practice by the National Comprehensive Cancer Network (NCCN).DesignCross sectional study.Participants/settingGenome targeted cancer...

Preoperative and Intraoperative Identification of Sentinel Lymph Nodes in Melanoma Surgery.

According to the American Joint Commission on Cancer (AJCC) 8th edition guidelines, SLN biopsy is recommended for primary melanomas with a Breslow thickness of at least 1 mm. Additionally, the National Comprehensive Cancer Network (NCCN) recommends that a SLN biopsy may be considered for melanoma patients with T1b lesions, which are 0.8-1 mm thick or less than 0.8 mm thick with ulceration. It can also be considered for T1a lesions that are less than 0.8 mm thick but have other adverse features, such as a high mitotic rate, lymphovascular invasion, or a positive deep margin. To reduce the false negative rate of melanoma SLN biopsy, we have introduced the intraoperative use of Sentinella, a gamma camera, to enhance the identification rate of SLNs beyond that of the traditional gamma hand-held probe. At the Center for Melanoma Research and Treatment at the California Pacific Medical Center, a multidisciplinary approach has been established to treat melanoma patients when the diagnosis of primary melanoma is made with a referral to our melanoma center. This comprehensive approach at the melanoma tumor board, including the efforts of pathologists, radiologists, dermatologists, surgical, medical and radiation oncologists, results in a consensus to deliver personalized and high-quality care for our melanoma patients. This multidisciplinary program for the management of melanoma can be duplicated for other types of cancer. This article consists of current knowledge to document the published methods of identification of sentinel lymph nodes. In addition, we have included new data as developed in our melanoma center as newly published materials in this article to demonstrate the utility of these methods in melanoma sentinel lymph node surgery. Informed consent has been waived by our IRB regarding the acquisition of clinical data as presented in this study.

AI-Generated Content in Cancer Symptom Management: A Comparative Analysis Between ChatGPT and NCCN

BackgroundArtificial intelligence-driven tools, like ChatGPT, are prevalent sources for online health information. Limited research has explored the congruity between AI-generated content and professional treatment guidelines. This study seeks to compare recommendations for cancer-related symptoms generated from ChatGPT with guidelines from the National Comprehensive Cancer Network (NCCN). InterventionWe extracted treatment recommendations for nine symptoms from NCCN, separated into four full Supportive Care sections and five subsections of the Palliative Care webpage. We entered "How can I reduce my cancer-related [symptom]" into ChatGPT- 3.5 for these same symptoms and extracted its recommendations. A comparative content analysis focused on recommendations for medications, consultations, and non-pharmacological strategies. We compared word count and Flesch-Kincaid Grade Level (FKGL) readability for each NCCN and ChatGPT section. OutcomesThe mean percent agreement between NCCN and ChatGPT recommendations was 37.3% (range 16.7%–81.8%). NCCN offered more specific medication recommendations. ChatGPT did recommend medications in the constipation and diarrhea sections that were not recommended by NCCN. Significant differences in word count (P=0.03) and FKGL (P<0.01) were found for NCCN Supportive Care webpages, with ChatGPT having lower word count and reading level. In the NCCN Palliative Care webpage subsections, there was no significant difference in word count (P=0.076), but FKGL was significantly lower with ChatGPT (P<0.01). Conclusions/Lessons LearnedWhile ChatGPT provides concise, accessible supportive care advice, discrepancies with guidelines raise concerns for patient-facing symptom management recommendations. Future research should consider how AI can be used in conjunction with evidence-based guidelines to support cancer patients’ supportive care needs.

Analysis of healthcare provider management of immune-related adverse events and concordance with NCCN Guidelines.

11136 Background: Immune checkpoint inhibitors (ICIs) are a mainstay of treatment for many cancers but can cause immune-related adverse events (irAEs) that require prompt recognition and management. In 2017, we developed an online interactive decision support tool [www.clinicaloptions.com/immuneAEtool] for healthcare providers (HCPs) with case-specific recommendations for managing irAEs from a medical oncology expert. In 2019 and 2023, we updated the tool to offer recommendations from the latest National Comprehensive Cancer Network (NCCN) Guidelines. Here, we report a comparison of self-reported irAE management from HCPs using the 2023 tool vs NCCN recommendations and a comparison of practice patterns between the 2023 and 2019 tools. Methods: To use the online tool, HCPs entered the affected organ system, symptom grade/severity, and their planned management strategy. The tool showed the NCCN management recommendation for that irAE and then asked if the recommendation changed their intended management approach. Results: From July to December 2023, 172 HCPs entered 241 case scenarios into the tool; 53% treated &lt;10 patients/month with ICIs, and 38% of HCPs practiced in the United States. The most common irAEs involved the gastrointestinal (GI)/hepatobiliary (hep)/pancreatic (29% of cases) or dermatologic/oral (19%) systems. Overall, the planned irAE management strategy of HCPs matched the NCCN recommendations in 55% of cases, an increase from the 49% concordance rate in our 2019 analysis. In the current analysis, the lowest concordance was observed for infusion-related reactions (20%), musculoskeletal irAEs (46%), and dermatologic/oral mucosa irAEs (46%; Table). Furthermore, US HCPs had a lower overall concordance rate (46%) than non-US HCPs (66%). Approximately one half (56%) of all HCPs indicated that the NCCN recommendations in the tool changed their management plan. Conclusions: These data suggest that many HCPs are challenged to optimally manage irAEs and are not managing their patients in concordance with NCCN guidelines. A detailed analysis of HCP irAE management vs NCCN recommendations, including by organ system and severity, along with a comparison of 2023 vs 2019 practice patterns, will be presented. [Table: see text]

Clinical applicability of guideline-recommended molecular targets and genome-targeted cancer therapies.

11049 Background: Genomic testing has expanded the possibilities of precision medicine, particularly for advanced, treatment-resistant cancer cases. However, the clinical relevance of most genetic alterations remains uncertain, which can lead physicians to overestimate the benefits of tailored therapies. The National Comprehensive Cancer Network (NCCN) guidelines are cancer-specific treatment recommendations that often determine insurance coverage. We assessed the evidence for clinical benefit and actionability of molecular targets for genome-targeted cancer drugs recommended by NCCN. Methods: We identified genome-targeted therapies for solid cancers from the most recent NCCN guidelines. Trial design characteristics were obtained from publications supporting the NCCN recommendations. Genome target actionability was assessed with the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of molecular Targets (ESCAT). This ranges from genome alternation-therapy combinations that lead to improved outcomes (Tier I) to treatments with potential clinical relevance (Tiers II or III) to those with undetermined relevance (Tiers IV to X). Clinical benefit was evaluated using the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS). Molecular targets at ESCAT Tier I in combination with a given treatment associated with studies demonstrating substantial clinical benefit by ESMO-MCBS (Grades 4-5) were designated as high-benefit, while those linked to studies achieving an ESMO-MCBS Grade of 3 were categorized as promising but unproven. Results: We extracted411 recommendations from NCCN supporting 74 genome-targeted drugs targeting 50 driver alterations. Most recommendations (346/411, 84%) referred to clinical trial data, while one-sixth (65/411, 16%) relied on case reports or preclinical studies. Clinical trials were mostly Phase I or Phase II (271/346, 78%), single arm (262/346, 76%), and evaluated overall response rate as the primary endpoint (271/346, 78%). Over half of target recommendations had Tier I target actionability (246/411, 60%), over one-third were Tier II or III (142/411, 35%), and the rest were undetermined (23/411, 6%). Among 267 scorable trials,12% (32/267) demonstrated substantial clinical benefit (ESMO-MCBS Grades 4-5) and 45% (121/267) were Grade 3. When combining both frameworks,12% (32/267) genomic-based cancer treatments were high-benefit and 33% (88/267) were promising-but-unproven. Conclusions: About one-eighth of genome-targeted cancer therapies recommended in NCCN guidelines received a high benefit rating, while one-third were identified as having a promising but unproven substantial benefit according to the ESCAT and ESMO-MCBS frameworks. Ensuring NCCN recommendations are aligned with well-documented clinical benefits is crucial for promoting informed, evidence-based genomic-guided treatment decisions.

Patient characteristics associated with primary prophylactic granulocyte colony-stimulating factor (G-CSF) use among women treated for early-stage breast cancer.

e12605 Background: The National Comprehensive Cancer Network (NCCN) recommends several chemotherapy regimens for early-stage breast cancer that have elevated risk of neutropenia (&gt;20%). In these regimens, primary prophylactic use of granulocyte colony-stimulating factor (G-CSF) is recommended. Little is known about how patient-level factors relate to receipt of prophylactic G-CSF among women receiving these regimens. Methods: In the Optimal Breast Cancer Chemotherapy Dosing (OBCD) Study, we examined use of G-CSF among women with stage I-IIIA breast cancer between 2005-2019 in Kaiser Permanente Northern California (KPNC) and Kaiser Permanente Washington (KPWA). We evaluated the patient-level factors associated with primary prophylactic G-CSF use (≤7 days before to ≤3 days after first day of chemotherapy) among women receiving chemotherapy regimens with high risk of neutropenia, for which the NCCN guidelines recommend prophylactic G-CSF use. Multivariable-adjusted prevalence ratios (PR) and their corresponding 95% Confidence Intervals (95% CI) were calculated using generalized linear models of the Poisson family with a log link-function and robust standard errors. Results: Overall, while all 3,083 women receiving these regimens ultimately received G-CSF, 2412 (79%) received primary prophylactic G-CSF within the period 7 days prior to 3 days post first cycle. Younger women had higher prevalence of prophylactic G-CSF receipt (82.7% in ages 18-39 years vs. 58.1% in 70+ years). Black women had higher prevalence of receipt compared to white women (82.7% in non-Hispanic Black women vs 76.1% in White women). Women with a higher body mass index (BMI) had lower prevalence of receipt compared to normal weight women (73.3% in 35+ kg/m2 group vs 81.5% in 18.5-&lt;25 kg/m2 group). In multivariable models, older women were less likely to receive prophylactic G-CSF (PR70+ vs 18-39: 0.69; 95% CI: 0.57-0.84; p-trend&lt;0.001), as were those with a higher BMI (PRBMI 35+ vs 18.5-&lt;25: 0.92; 95% CI: 0.85, 0.97; p-trend=0.006), and a later year of diagnosis (PR2016-19 vs 2005-07: 0.81; 95% CI: 0.77, 0.85; p-trend&lt;0.001). Although race/ethnicity was not significantly associated with receipt of prophylactic G-CSF use overall in multivariable models, we observed Non-Hispanic Black women to experience slightly higher likelihood of G-CSF receipt than Non-Hispanic White women (PR: 1.08; 95% CI: 1.02, 1.15). Conclusions: Women of older age and those with higher BMI were less likely to receive primary prophylactic G-CSF, as were women treated in later years. Further research looking at timing of G-CSF use is warranted, as are studies examining provider/facility-level factors in relation to patterns of G-CSF use, G-CSF’s impact on survival outcomes, and the real-world impact of decisions around G-CSF use across age, BMI, and racial/ethnic groups.

Exploring AI-generated content and professional guidelines in cancer symptom management: A comparative analysis between ChatGPT and NCCN guidelines.

e13610 Background: Artificial intelligence (AI)-driven tools, like ChatGPT, have become widely-available sources for online health information. Limited research has explored the congruity between AI-generated content and professional treatment guidelines. This study seeks to compare recommendations for cancer-related symptoms generated from ChatGPT with guidelines from National Comprehensive Cancer Network (NCCN), a provider focused source requiring users to log in or register to access its recommendations. Utilizing a provider-focused source like NCCN serves as a benchmark to assess whether ChatGPT recommendations align with the standards typically endorsed by clinicians. Methods: We extracted treatment recommendations from four NCCN Supportive Care webpages (Cancer Pain, Antiemesis, Cancer-Related Fatigue, and Distress Management) and five subsections of the NCCN Palliative Care webpage (dyspnea, constipation, diarrhea, sleep disturbances, and anorexia/cachexia). We then entered "How can I reduce my cancer-related [symptom]" into ChatGPT 3.5 and extracted its recommendations. We calculated and compared word count and Flesch-Kincaid Grade Level readability for each NCCN and ChatGPT section. We completed a comparative content analysis focusing on recommendations for medications, consultations, and non-pharmacological strategies. Results: Across the nine NCCN Supportive Care and Palliative Care webpages, the mean word count was 2393.8 (SD=2601.4) and the mean Flesch-Kincaid Grade Level was 17.3 (SD=1.4) vs 382.4 (SD=29.6) and 11.6 (SD=0.8) for ChatGPT. The mean percent agreement between NCCN and ChatGPT recommendations was 44.6% (range 14.3%-81.8%). ChatGPT and NCCN guidelines shared fewer than half of their symptom-related recommendations in all but one section, fatigue. NCCN offered specific medication recommendations across all sections. ChatGPT's recommendations lacked the specificity observed in NCCN's guidelines including often not suggesting any medications. ChatGPT recommended specific medications in the shortness of breath and diarrhea sections that were not recommended by NCCN. NCCN's guidelines often did not include recommendations related to spirituality or palliative care consults, areas that ChatGPT addressed. Conclusions: While ChatGPT provides concise, accessible supportive care advice including many non-medical support recommendations, discrepancies with guidelines raise concerns for patient-facing symptom management recommendations. Overall, AI-generated content like ChatGPT can assist in providing preliminary information but should be researched in conjunction with comprehensive, evidence-based guidance provided by healthcare professionals. Healthcare providers should work with AI developers to ensure data sources are high-quality and accurate.

Should All Patients With Stage IE Gastric Mucosa-Associated Lymphoid Tissue Lymphoma Receive Antibiotic Eradication Therapy for Helicobacter pylori?

H. pylori eradication therapy (HPE) can lead to tumor regression in H. pylori-positive (HPP) gastric mucosa-associated lymphoid tissue (MALT) lymphoma. However, some patients do not have detectable H. pylori (HP) infection (H. pylori-negative [HPN]) and the guidelines differ in their initial approach to HPN patients. The National Comprehensive Cancer Network (NCCN) recommends proceeding to radiation therapy, whereas European Society for Medical Oncology suggests HPE for every patient, even those who are HPN. To address this issue, we evaluated the effectiveness of HPE in limited-stage gastric MALT lymphoma. We retrospectively reviewed patients newly diagnosed with stage IE gastric MALT lymphoma between January 2002 and December 2022. The primary outcome was the complete remission (CR) rate defined as no macroscopic findings of lymphoma and negative gastric biopsy at the follow-up gastric endoscopy. Fifty-two patients were reviewed, and HP infection was detected in 19 (36.5%) patients-14 by immunostaining, three by serology, and one each by stool antigen and urea breath test. All 19 HPP and eight of the 33 HPN patients received HPE treatment. The CR rate was 63% (12/19) in HPP patients and 13% (1/8) in HPN patients (P = .033). After a median follow-up of 89.7 months, only two of the 12 HPP patients achieving CR have relapsed; the one HPN patient who received HPE remains in CR at 12+ months. For limited-stage HPP gastric MALT lymphoma, HPE is an effective and durable first-line treatment and should be used. For HPN patients, the CR rate with HPE is very low in our experience and is thus in support of the NCCN guideline.

Abstract PO5-10-08: Clinical Value of Molecular Targets and Genome-Targeted Cancer Therapies Recommended by the National Comprehensive Cancer Network for Advanced Breast Cancer

Abstract Background: Genomic testing has expanded the possibilities of precision cancer medicine, particularly for advanced, treatment-resistant breast cancer cases. However, the clinical significance of most genetic alterations remains uncertain, potentially overestimating tailored therapies. The National Comprehensive Cancer Network (NCCN) guidelines are evidence-based cancer-specific recommendations used in clinical practice and that are often determinative for insurance coverage. In this study, we assessed the validity of the targets and the clinical benefit of genome-targeted cancer drugs recommended in the NCCN guidelines for metastatic breast cancer. Methods: We identified genome-targeted oncology therapies supporting advanced breast cancer recommendations in the most recent NCCN breast cancer guideline (version 4.2023). Genome-targeted drugs were defined as involving use of a genomic test in which the drug targeted a genomic alteration. We analyzed data from trials supporting advanced genome-targeted breast cancer drugs recommendations. When multiple (or overlapping) articles for the same study were identified, the most recent publication was included. We extracted key details of each trial, including trial design, blinding, phase of clinical trial and primary efficacy end points. We cross-referenced the FDA-approved indications as of 30 June 2023 with the NCCN recommendations for each drug. Strength of evidence supporting molecular targetability was evaluated using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of molecular Targets (ESCAT). Clinical benefit for genome-targeted oncology therapies was assessed using the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS). We considered a substantial clinical benefit as a grade of 4 or 5. Molecular targets qualifying for ESCAT category level I-A and I-B associated with substantial clinical benefit by ESMO-MCBS were rated as high-benefit genomic-targeted breast cancer treatments. Results: We identified 47 recommendations supporting 17 genome-targeted drugs, which targeted 11 driver alterations. Out of these recommendations, 29 (62%) aligned with the FDA indications. We associated 47 trials with these recommendations, most randomized (24, 51%), phase 3 (23, 49%) and open-label (42, 89%). The most common primary endpoint (22, 47%) was overall response rate, followed by progression-free survival/time to progression (21, 45%). Twenty-four trials (51%) had a I-A ESCAT targetability, 7 (15%) had a I-B targetability, 6 (13%) had a I-C targetability score and 10 (21%) were categorized as II-B. ERBB2 amplification, germline BRCA1/2 mutations, PIK3CA mutations, and ESR1 mutation were mainly classified as tier I-A based on randomized trials demonstrating the effectiveness of approved targeted therapies in patients with these alterations. By contrast, RET fusions, NTRK fusions, high-tumor mutational burden and microsatellite instability were ranked as tier I-C and somatic BRCA mutations, germline PALB2 mutations and HER-2 mutations as II-B. Six trials (14%, 6/42) supporting drug approval demonstrated substantial ESMO-MCBS clinical benefit. Overall, 6 recommendations (14%) had high-benefit genomic-based cancer treatments. Conclusions: Fewer than one-fifth of molecular-targeted cancer therapies recommended in NCCN guidelines for metastatic breast cancer demonstrated substantial patient benefits. Value frameworks like ESCAT and ESMO-MCBS can help stakeholders identify therapies with the greatest potential. Citation Format: Ariadna Tibau, Thomas J. Hwang, Jerry Avorn, Aaron Kesselheim. Clinical Value of Molecular Targets and Genome-Targeted Cancer Therapies Recommended by the National Comprehensive Cancer Network for Advanced Breast Cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-10-08.

Inconsistent Associations Between Risk Factor Profiles and Adjuvant Radiation Therapy (ART) Treatment in Patients with Cutaneous Squamous Cell Carcinoma and Utility of the 40-Gene Expression Profile to Refine ART Guidance.

National Comprehensive Cancer Network (NCCN) recommendations for adjuvant radiation therapy (ART) use are similar for High Risk and Very High Risk cutaneous squamous cell carcinoma (cSCC) with negative post-surgical margins. Although studies report reductions in disease progression following ART treatment, ART use is likely inconsistent when guided by available risk factors. This study evaluated the association of ART with clinical risk factors in ART-treated and untreated patients and showed the clinical utility of the 40-gene expression profile (40-GEP) for guiding ART. A multicenter study of 954 patients was conducted with institutional review board (IRB) approval. The 40-GEP test was performed using primary tumor tissue from patients with either a minimum of 3years of follow-up or a documented regional or distant metastasis. Unsupervised hierarchical cluster analysis identified patterns of clinical risk factors for ART-treated patients, then identified untreated patients with matching risk factor profiles. Results were cross-referenced to 40-GEP test results to determine utility of the test to guide ART. Analysis demonstrated inconsistent implementation of ART for eligible patients. Cluster analysis identified four patient profiles based on clusters of risk factors and, notably, matching profiles in ART-treated and untreated patients. Further, the analysis identified patients who received but could have deferred ART on the basis of 40-GEP test result and biologically low risk of metastasis, and untreated patients who likely would have benefitted from ART on the basis of their 40-GEP test result. ART guidance is not determined by the presence of specific clinicopathologic factors, with treated and untreated patients sharing the same risk factor profiles. cSCC risk determination based on NCCN recommendations for clinical factor assessment results in inconsistent use of ART. Including tumor biology-based prognostic information from the 40-GEP refines risk and identifies patients who are most appropriate and likely to benefit from ART, and those that can consider deferring ART.

A Digital Intervention to Improve Skin Self-Examination Among Survivors of Melanoma: Protocol for a Type-1 Hybrid Effectiveness-Implementation Randomized Trial.

Although melanoma survival rates have improved in recent years, survivors remain at risk of recurrence, second primary cancers, and keratinocyte carcinomas. The National Comprehensive Cancer Network recommends skin examinations by a physician every 3 to 12 months. Regular thorough skin self-examinations (SSEs) are recommended for survivors of melanoma to promote the detection of earlier-stage, thinner melanomas, which are associated with improved survival and lower treatment costs. Despite their importance, less than a quarter of survivors of melanoma engage in SSEs. Previously, our team developed and evaluated a web-based, fully automated intervention called mySmartSkin (MSS) that successfully improved SSE among survivors of melanoma. Enhancements were proposed to improve engagement with and outcomes of MSS. The purpose of this paper is to describe the rationale and methodology for a type-1 hybrid effectiveness-implementation randomized trial evaluating the enhanced MSS versus control and exploring implementation outcomes and contextual factors. This study will recruit from state cancer registries and social media 300 individuals diagnosed with cutaneous malignant melanoma between 3 months and 5 years after surgery who are currently cancer free. Participants will be randomly assigned to either enhanced MSS or a noninteractive educational web page. Surveys will be collected from both arms at baseline and at 3, 6, 12, and 18 months to assess measures of intervention engagement, barriers, self-efficacy, habit, and SSE. The primary outcome is thorough SSE. The secondary outcomes are the diagnosis of new or recurrent melanomas and sun protection practices. Multilevel modeling will be used to examine whether there are significant differences in survivor outcomes between MSS and the noninteractive web page over time. Mixed methods will evaluate reach, adoption, implementation (including costs), and potential for maintenance of MSS, as well as contextual factors relevant to those outcomes and future scale-up. This trial has the potential to improve outcomes in survivors of melanoma. If MSS is effective, the results could guide its implementation in oncology care and nonprofit organizations focused on skin cancers. RR1-10.2196/52689.

Disparities and Underutilization of Surgery for Early Stage Small Cell Lung Cancer

BackgroundThe National Comprehensive Cancer Network recommends surgical resection for stage I small cell lung cancer (SCLC). Despite these recommendations and the curative potential of such surgery, many continue to underutilize surgery. Our aim is to investigate factors that contribute to underutilization of surgery for stage I SCLC. MethodsThe National Cancer Database was queried to identify patients with SCLC stage I-IV from 2004 to 2018. Staging was defined by the American Joint Committee on Cancer guidelines. Cochran-Armitage analysis was performed to analyze trends in surgical treatment for patients diagnosed with stage I SCLC. Multivariable logistic regression assessed relationships between patient factors and surgical treatment. ResultsA total of 296,583 patients were diagnosed with SCLC. Of the stage I patients (n = 13,003), only 29.4.% (n = 3823) underwent surgery. Trend analysis demonstrated increased frequency of surgical treatment for stage I SCLC over years 2004 to 2017, from 14.9% to 39.6% (P < .0001). Factors that were associated with underutilization of surgery for stage I SCLC include African American race, lower median income, nonprivate insurance or Medicare, community facility, and geographic regions other than the Northeast. ConclusionsSurgical treatment for stage I SCLC remains underutilized and our study identifies notable associated factors. The recognition of these factors may help patients overcome barriers to receiving recommended treatments, improve guideline adherence, and overall quality of care for stage I SCLC patients.

Efficacy of Sunitinib in Patients With Favorable and Intermediate Risk Metastatic Renal Cell Carcinoma - Lithuanian National Cancer Institute Experience.

According to the European Society for Medical Oncology (ESMO) and National Comprehensive Cancer Network (NCCN) recommendations, sunitinib is one of the recommended regimens for favorable and intermediate-risk metastatic renal cell carcinoma (mRCC) patients. The objective of this study was to evaluate sunitinib efficacy as a first-line treatment for mRCC patients with favorable/intermediate prognostic risk in a real-world setting. Patients diagnosed with mRCC and confirmed as appropriate candidates for the first-line systemic treatment were included in this retrospective study. The prognostic risk was evaluated according to the model of the International Metastatic RCC Database Consortium (IMDC). Patients received sunitinib as a first-line treatment. A total of 94 patients were enrolled from 2019 to the 2020and 67 of them were included in the detailed analysis. Median progression-free survival (PFS) was 23.4 (95%CI=17.3-29.5), and median overall survival (OS) was 66 months (95%CI=44.9-87.1). The age over 60 years was a significant negative predictor for PFS and OS. Regarding the IMDC model for disease risk prediction, the number of two risk factors in the intermediate risk group was a significant predictor for a shorter response to the first-line therapy. Sunitinib is an effective tyrosine kinase inhibitor, which can be used as a first-line treatment in favorable/intermediate-risk groups of patients with mRCC, especially in countries where novel systemic treatment modalities are not yet available.

Liquid Biopsy: A Highly Useful Tool to Decide Personalized Therapy in Veteran Patients with Metastatic Pancreaticobiliary Cancer

Abstract Introduction/Objective Pancreatic cancer is one of the leading causes of death in Veteran patients. Early detection and treatment of the pancreatic cancers are key to the successful management of pancreatic cancer with good patient outcome. The National Comprehensive Cancer Network (NCCN) recommends tumor molecular profiling in all patient cases of unresectable or metastatic pancreatic adenocarcinomas and biliary tract cancers who are candidates for chemotherapy. This testing can be performed using liquid biopsy to obtain this molecular profiling from circulating tumor cells (CTC) to obtain information that may impact treatment. However, the literature of metastatic pancreaticobiliary cancers targeted by liquid biopsies and the mutations found is sparse, particularly for the veteran population. Methods/Case Report A retrospective review was performed of all patients with a submitted liquid biopsy specimen at a Veteran Affairs Medical Center (VAMC) from April 2020 to March 3rd, 2023, to examine those patients with metastatic pancreaticobiliary cancers, specifically pancreatic adenocarcinoma, and cholangiocarcinoma. Information on mutations detected was collected. Results (if a Case Study enter NA) There were a total of 5 patient specimens with a history of metastatic pancreatic adenocarcinoma (4 cases/5) and cholangiocarcinoma (1 case/5). The first liquid biopsy from a patient with a history of metastatic pancreaticobiliary cancer was sent on April 14th, 2020, and the last was sent on November 12th, 2021. TP53 was detected on all the successfully tested pancreatic adenocarcinoma cases. Other mutations detected in the individual pancreatic adenocarcinoma cases were KRAS, TET2 BCOR, DNMT3A, FUBP1, RAD21, and STAG2. The mutations found on the single cholangiocarcinoma case included DNMT3A and TP53. 1 of the 4 cases sent on a patient with pancreatic adenocarcinoma resulted in a sample failure. Conclusion Liquid biopsies provided comprehensive molecular profiling in cases of metastatic pancreatic adenocarcinoma and biliary tract cancer in the veteran population treated at a local VAMC to help decide on personalized therapy, in compliance with the recommendations of the NCCN. The results of this pilot quality assurance study help highlight the potential of liquid biopsies to detect most commonly mutated genes such as KRAS and T53 in pancreatic cancer.

The impact of converting to telehealth for cancer genetic counseling and testing during the COVID-19 pandemic.

The COVID-19 outbreak in March 2020 resulted in a shift to telemedicine for cancer genetic counseling (GC). The objective of this study was to determine the effect of telehealth (TH) services on patient acceptance of recommended genetic testing, time to test completion, and follow-up test-disclosure GC appointment, as well as compliance with National Comprehensive Cancer Network (NCCN) recommendations for medical screenings when testing positive for a genetic variant. Data for this retrospective cohort study were collected at a tertiary-care academic health center using the electronic medical record and laboratory portal. Patients with traditional in-person visits (the 2019 control group) and date-matched TH visits (2020) were compared. In total, 206 new GC appointments occurred in the in-person group and 184 new appointments occurred in the TH group. The in-person group was more likely to consent to testing than the TH cohort (92.6% vs. 82.1%, p = 0.003) and had increased rates of sample submission (99.5% vs. 93.75%, p < 0.01), as well as a shorter turn-around time between their initial appointment and laboratory result reporting (34.24 vs. 20.32 days, p < 0.01). There was no increase in time from initial to follow-up GC appointments (67.87 days for control, 62.39 days for THs, p = 0.37). With >2.5 years of follow-up for all study participants, there were no statistically significant differences in pathogenic variant (PV) carrier compliance with screening recommendations. During the COVID-19 pandemic, use of TH allowed patients to access GC with no significant differences in time between initial consultation and follow-up. However, in-person visits were associated with increased patient willingness to consent to and complete genetic testing. This work offers a nuanced look at the success of TH GC during the pandemic and follow-up with screening recommendations, while offering future opportunities to address the acceptance of testing as GC is practiced in a virtual or hybrid model.

Cost-Effectiveness of Surveillance after Metastasectomy of Stage IV Colorectal Cancer.

Surveillance of stage IV colorectal cancer (CRC) after curative-intent metastasectomy can be effective for detecting asymptomatic recurrence. Guidelines for various forms of surveillance exist but are supported by limited evidence. We aimed to determine the most cost-effective strategy for surveillance following curative-intent metastasectomy of stage IV CRC. We performed a decision analysis to compare four active surveillance strategies involving clinic visits and investigations elicited from National Comprehensive Cancer Network (NCCN) recommendations. Markov model inputs included data from a population-based cohort and literature-derived costs, utilities, and probabilities. The primary outcomes were costs (2021 Canadian dollars) and quality-adjusted life years (QALYs) gained. Over a 10-year base-case time horizon, surveillance with follow-ups every 12 months for 5 years was most economically favourable at a willingness-to-pay threshold of CAD 50,000 per QALY. These patterns were generally robust in the sensitivity analysis. A more intensive surveillance strategy was only favourable with a much higher willingness-to-pay threshold of approximately CAD 425,000 per QALY, with follow-ups every 3 months for 2 years then every 12 months for 3 additional years. Our findings are consistent with NCCN guidelines and justify the need for additional research to determine the impact of surveillance on CRC outcomes.

Potential pathogenic germline variant reporting from tumor comprehensive genomic profiling complements classic approaches to germline testing

Existing guidance regarding clinically informed germline testing for patients with cancer is effective for evaluation of classic hereditary cancer syndromes and established gene/cancer type associations. However, current screening methods may miss patients with rare, reduced penetrance, or otherwise occult hereditary risk. Secondary finding of suspected germline variants that may confer inherited cancer risk via tumor comprehensive genomic profiling (CGP) has the potential to help address these limitations. However, reporting practices for secondary finding of germline variants are inconsistent, necessitating solutions for transparent and coherent communication of these potentially important findings. A workflow for improved confidence detection and clear reporting of potential pathogenic germline variants (PPGV) in select cancer susceptibility genes (CSG) was applied to a research dataset from real-world clinical tumor CGP of > 125,000 patients with advanced cancer. The presence and patterns of PPGVs identified across tumor types was assessed with a focus on scenarios in which traditional clinical germline evaluation may have been insufficient to capture genetic risk. PPGVs were identified in 9.7% of tumor CGP cases using tissue- and liquid-based assays across a broad range of cancer types, including in a number of “off-tumor” contexts. Overall, PPGVs were identified in a similar proportion of cancers with National Comprehensive Cancer Network (NCCN) recommendations for germline testing regardless of family history (11%) as in all other cancer types (9%). These findings suggest that tumor CGP can serve as a tool that is complementary to traditional germline genetic evaluation in helping to ascertain inherited susceptibility in patients with advanced cancer.

Impact of early mammography screening on time to diagnosis.

e18870 Background: Initial mammography screening age recommendations vary by organization, with the United States Preventive Services Taskforce recommendations beginning at 50 years and the American College of Obstetricians and Gynecologists and the National Comprehensive Cancer Network recommendations beginning at age 40 years. This study aimed to examine the impact of early age recommendation for initiating screening mammography (i.e., 40 years) on time to breast cancer diagnosis. Methods: This is a retrospective cohort study of adult women who received a screening mammogram between 1/1/2012 and 12/31/2022. The outcome of interest was a breast cancer diagnosis (ICD-9 code: 174.X; ICD-10 code: C50.X) any time after the initial screening. Members were stratified by age at the initial mammogram, with on-time mammograms defined as those occurring during the 50th year of life and early mammograms defined as those occurring in the 40th year. Survival analysis was conducted between the two groups. Incidence rate differences (IRD) and ratios were calculated between groups for 1-, 3-, 5-, and 10-year follow-up analysis; logistic regression modeling was also performed. All analyses were conducted in Python and R; p &lt; 0.05 was considered significant. Results: In total, 22,843 members were included in the study, with 11,730 (51.4%) having on-time mammograms. On-time screening members were more likely to have unknown socioeconomic status (SES) compared to early screening members (26.4% vs. 24.6%, p = 0.022) and to reside in rural zip codes (42.2% vs. 39.1%, p &lt; 0.001). After 10 years of follow-up, 285 of 2,647 remaining members developed breast cancer (incidence rate 10.77 cases per 1,000 person-years [PY] observed [95% confidence interval (CI) 9.55-12.1 cases per 1,000 PY]). Early mammograms were associated with significantly lower IRD at 3- (IRD: -1.85 cases per 1,000 PY [95% CI -2.76 to -0.93]; p = 0.0001), 5- (IRD: -1.92 cases per 1,000 PY [95% CI -2.86 to -0.97]; p = 0.0001), and 10- (IRD: -7.15 cases per 1,000 PY [95% CI -9.66 to -4.64], p &lt; 0.0001) year follow up periods. Early mammograms were associated with significantly longer time to diagnosis during survival analysis (97.5% diagnosis-free vs. 95.4%, p &lt; 0.0001). Controlling for SES, early mammograms were associated with significantly lower hazard for breast cancer diagnosis at any time (hazard ratio [HR]: 0.62 [95% CI 0.48-0.78], p &lt; 0.0001). Unknown SES was also associated with significantly lower hazard compared to those with medium SES (HR: 0.47 [95% CI 0.33-0.67], p &lt; 0.0001); however, no other SES categories demonstrated significant differences. Conclusions: The primary goal of breast cancer screening is to reduce breast cancer incidence and mortality. In this study, early mammography at age 40 years was associated with significantly lower incidence rates after 3-, 5, and 10-year follow-ups. Additional studies on the impact of early mammography and breast cancer mortality in this population are warranted.