bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect on patient empowerment through the EPEP program.
Authors: Diallo Aicha , Rode Tracy T. 
Published: July 2024

e21009 Background: There is a critical need to support oncology providers seeking to empower their patients and care partners by connecting them to trusted resources. To fill this gap, the Patient Empowerment Network (PEN) created the Empowering Providers to Empower Patients (EPEP) program to improve physician-patient communication and shared decision-making by creating a clear path to support providers in empowering their patients and care partners. Methods: The EPEP program, developed by an interdisciplinary team of experts for oncology health care professionals, launched in March 2023 with a focus on lung cancer resources. The program includes digital resources such as Roundtables (30-minute webinars + segments with leading experts, clinicians, and peers), an HCP Portal (a system that informs and collates vetted resources), a Resource Guide (resource guide for HCPs), and a Roundup Blog (article with key takeaways summarizing program). Following two roundtables in March 2023, we assessed initial provider engagement with EPEP using digital engagement metrics and a five-item questionnaire. Results: Since the launch, 212 oncology providers have access to the suite of digital resources. The content has been viewed and downloaded almost 13,595 times. Surveys conducted following the roundtables indicated that the program was well-received. Of 21 respondents, n=18 (86%) rated their experience as very positive; agreed or strongly agreed that the program gave them the confidence to better facilitate shared decision-making with their patients; and said they found relevant resources to share with their patients and their families. Sample feedback included, “I would say it gave me the confidence to raise the flag on timing. Sometimes we test and are not doing this in a timely way. Thanks for this program.” And “These conversations are so critical. Thank you for a great program.” And, “I thought the conversation was excellent; we need more of this. I thought the tips were spot-on and very helpful.” Providers wanted communication tools focused on the “timing of testing following the initial workup,” “pathology conversations” and “anxiety and fear after the cancer diagnosis, long-term side effects, screening and early detection of lung cancer.” Conclusions: The EPEP program serves as a trusted digital space for providers to objectively share and recommend resources to their oncology patients. The program now includes removing practice barriers that may be caused by a lack of awareness and outdated practices. The long-term goal is to improve physician-patient communication and shared decision-making while also empowering cancer patients and family members to ask informed questions based on where they are in their cancer journey.
Community oncology preparedness and perceptions of challenges in care with HER2/HER3 therapy for NSCLC.
Authors: Ackbarali Tariqa , Cohen-Solal Karine , Bazhenova Lyudmila , Janne Pasi A. 
Published: July 2024

e21010 Background: The rapid pace of advances in molecular testing and targeted treatment for non-small cell lung cancer (NSCLC) can make it difficult to stay up to date with new developments. Accelerating the integration of practice-changing data requires clarification of actionable vs non-actionable mutations, relevance for therapeutic decisions, and treatment options for patients. To address this need further an educational program was designed in 2023. Methods: A one-hour online, video-based program was designed for clinicians and their teams and hosted on OMedLive from February 2023. Knowledge and competence questions were administered pre-, and immediate post-activity. and the intersection of patient and clinician perspectives, including behavioral impact, and qualitative insights. Behavioral impact, perception, and practice pattern questions were also assessed immediately post-activity. Results: More than 1,700 participants have engaged in the educational program to date. Of the participants in the clinician program, 94% were physicians and 93% noted their specialty as oncology with 67% identifying as treaters seeing an average of 8 patients with NSCLC on a monthly basis. Low baseline (8% - 40%) knowledge and competence was observed for awareness of NGS-based approaches to detect ERBB2 mutations, trial eligibility criteria and outcomes, time to onset of drug-related toxicities, and ability to identify patients who would benefit from clinical trials with HER3 investigational therapies. Only 28% were confident in their ability to appropriately test for HER2 mutational status and 47% likely to incorporate testing for HER2 expression level or amplification prior to the selection of targeted therapy. The greatest challenges in managing patients with HER2-mutated NSCLC was identified as managing side effects (33%), affordability of therapy for patients (27%), and adherence to treatment schedules (17%). Conclusions: The outcomes of this educational program demonstrate a need for greater alignment and education among pathology and oncology team members on HER2 testing for patients with NSCLC. Additional education is needed relevant to investigational HER3 therapeutics, the appropriate patient to receive these therapies, and the potential application within the current treatment landscape. As these agents deepen their impact in the NSCLC landscape, it is important to prepare teams for timely management of adverse events.
Tracking the information-seeking patterns and preferences of US-based medical oncologists (MOs): A 2-year longitudinal assessment.
Authors: Love Neil , Paley Douglas , Dvorkin Jennifer , Cerenzia Wendy 
Published: July 2024

e21012 Background: The rapid pace of scientific advancement demands that community-based MOs continually access new information and effectively apply it in their clinical practices to improve long-term patient outcomes. A variety of dissemination vehicles are currently available to facilitate the transfer of knowledge, including continuing medical education (CME) activities. Despite the significant resources allocated for the development of these modalities, little definitive data is available documenting MOs’ preference for, utilization of and perspectives on the benefits and limitations of CME. This longitudinal assessment sought to establish a baseline understanding of MOs’ patterns of engagement with CME activities following the upheaval caused by COVID, and gauge if and/or how this has shifted as the pandemic has subsided further. Methods: In April 2022 a 56-question online survey was distributed to 4,623 US-based MOs from a proprietary database. A small honorarium was offered for participation. Responses were collected from 83 MOs. A 2-year follow up assessment is planned for April 2024 to track changes in preferences and participation. Results: 83% of MOs “agree” or “strongly agree” that the pace of oncology advancements is quicker now than it was in the past yet only 25% spend more time accessing CME. On average, MOs dedicate 6 hours a week to seeking oncology-related information, in which utilization of CME activities is included. MOs believe CME activities are useful for helping to stay up to date with advances in oncology (3.5 on a 1-5 scale) and 55% believe the application of new and emerging therapies within oncology would be slower if CME was no longer available. MOs are most interested in CME activities featuring practically oriented topics including recently presented clinical trial findings , molecular testing and analysis and treatment sequencing . Notably, the highest-ranking MO consideration for participation in a CME program was the topic, followed by faculty and then the length of the activity. In terms of length, MOs preferred 30-to-60-minute programs rather than shorter (15 minutes or less). All surveyed MOs utilize some form of CME with preferences varying for different virtual, live in-person and enduring formats. Despite its wide-scale proliferation, only 34% of MOs use social media for professional purposes including accessing oncology education. Conclusions: MOs value CME activities and utilize both in-person and virtual programs on a regular basis. As concerns over COVID have diminished, it is predicted that established interest in asynchronous forms of education will wane with an increased shift toward in-person meetings. The results of this longitudinal study are critical to ensure that oncology CME resources are designed to effectively convey needed information and in turn positively affect patient care.
Tucidinostat plus toripalimab in patients with unresectable or metastatic melanoma: An open-label, single-arm phase II study.
Authors: Mao Lili , Dai Jie , Bai Xue , Kong Yan , Sheng Xinan , Chi Zhihong , Cui Chuanliang , Lian Bin , Tang Bixia , Yan Xieqiao , Wang Xuan , Li Siming , Zhou Li , Wei Xiaoting , Li Juan , Li Caili , Duan Rong , Xu Huayan , Guo Jun , Si Lu 
Published: July 2024

e21527 Background: Acral and mucosal melanoma respond poorly to anti–PD-1 monotherapy. Tucidinostat, a benzamide class of histone deacetylase (HDAC) inhibitor, potentially augments immunotherapy with PD-1 blockade. We therefore conducted a phase II study to investigate the safety and efficacy of tucidinostat plus toripalimab in unresectable or metastatic melanoma. Methods: This was a single center, single arm phase II clinical trial. Patients with pathologically confirmed locally advanced unresectable or metastatic melanoma were enrolled and received 30 mg tucidinostat orally twice a week and 240 mg toripalimab every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint was the confirmed ORR per RECIST v1.1. Secondary endpoints included progression free survival (PFS), disease control rate (DCR), overall survival (OS), and safety. Results: Between October 2022 and May 2023, a total of 21 patients(pts) were enrolled. All pts were included in the safety analysis set and 18 pts were included in the full analysis set (FAS) for efficacy analysis. In the FAS, the median age was 56.0 years (range: 49 to 60), 6 pts (33.3%) were acral melanoma, 9 (50.0%) mucosal melanoma, 1 (5.6%) cutaneous melanoma and 2 (11.1%) unknown primary melanoma. 15 pts were treated as first-line, and 3 pts were as second-line. By Dec 2023, the median follow-up was 8.8 mo (95% CI:7.6-10.4) , Confirmed ORR was 27.8% (95% CI:9.7-53.5%). The DCR was 61.1% (95% CI:35.7-82.7%). Median progression-free survival was 4.1 months (95%CI: 1.4-NR) ,OS was not reached. Subgroup analysis showed that, in acral and mucosal melanoma pts, the confirmed ORR was 50.0%(95%CI:11.8-88.2%) and 22.2%(95%CI: 2.8-60.0%), respectively. The incidence of treatment-related adverse events (TRAEs) was 90.5% (19/21). The most common ≥3 grade TRAEs were neutrophil reduction (28.6%), white blood cell count reduction (9.5%), alanine aminotransferase increase (9.5%), platelet count reduction (9.5%), aspartate aminotransferase increase (9.5%), and γ-glutamyl transferase increase (9.5%). No treatment-related deaths occurred. Conclusions: The combination of tucidinostat and toripalimab showed acceptable safety and encouraging efficacy in patients with unresectable or metastatic melanoma. Further research is warranted. Clinical trial information: NCT05478473 .
PD-1 inhibitors versus conventional therapies for adjuvant treatment of resected acral melanoma: A systematic review and meta-analysis.
Authors: Xu Yu , Li Tong , Sun Wei , Yan Wangjun , Wang Chun-Meng , Hu Tu , Zhang Xiaowei , Luo Zhiguo , Liu Xin , Chen Yong 
Published: July 2024

e21555 Background: Acral melanoma (AM) is a rare and aggressive melanoma subtype with unique characteristics in western Caucasian population, but mostly prevalent in Asian population. FDA has approved pembrolizumab and nivolumab for the adjuvant treatment of melanoma. However, its role in AM is still unclear. In US and mainland of China, high-dose interferon alfa was once approved, while in other part of the world, there was no standard treatment for adjuvant therapy of AM. Thus, we performed a meta-analysis to summarize the efficacy of anti-PD-1 monotherapy in patients with AM in adjuvant setting and derive implications for early-stage AM management. Methods: A systematic review of electronic databases was conducted to identify studies that assessed relapse-free survival (RFS) and overall survival (OS) between adjuvant PD-1 and conventional therapy (interferon (IFN) / chemotherapy) or observation alone in patients with AM. RFS was the primary endpoint, OS was the secondary endpoint. We estimated RFS/OS using the fixed-effect model. Statistical analyses in our study were carried out using Stata 12.0 (Stata Corp LP, College Station, TX, USA). Results: Five retrospective studies that totally involving 516 patients with AM were recruited, including 3 China studies and 2 non-China studies. Among them, there were 260 PD-1, 74 IFN, 178 OBS and 4 chemotherapy, respectively. Adjuvant PD-1 inhibitor achieved better efficacy than conventional therapy, showing significant improvement both in RFS (HR 0.76, 95%Cl 0.61-0.95) and OS (HR 0.57 0.37-0.88). This trend of RFS/OS benefit was observed in all subgroups, includes control treatment (OBS/IFN) or study region (China/non-China). Conclusions: Our data supports that patients with resected AM are more likely to derive benefit from adjuvant PD-1 comparing to conventional treatment or observation alone. Perspective studies are warranted to explore the role of adjuvant PD-1 in AM. [Table: see text]
Sex as a predictor of progression-free survival in sentinel node-negative stage II melanoma.
Authors: Adigbli George , Issa Fadi , Cassell Oliver 
Published: July 2024

e21560 Background: Adjuvant immunotherapy can improve outcomes for resected stage IIB/C melanoma patients, but also poses challenges. Many patients are cured by surgery alone, making them susceptible to unnecessary treatment risks. Additionally, current staging may overlook some high-risk stage IIA patients who could benefit from immunotherapy. Accurate risk assessment is therefore critical to balance benefits and risks of early immunotherapy and optimise patient selection. This study sought to identify clinicopathologic predictors to refine risk stratification for sentinel lymph node-negative (SLN(-)) stage II melanoma patients, with a focus on the role of sex in prognostic accuracy and treatment personalisation. Methods: We retrospectively analysed 565 stage II melanoma patients with negative sentinel lymph node biopsies at four UK hospitals between 2004-2017. The primary outcome was progression-free survival (PFS). Analysed clinicopathologic factors included Breslow thickness, ulceration sex and tumour-infiltrating lymphocytes (TILs). Univariate and multivariate analyses were conducted. Results: Median follow-up was 9.5 years. Melanoma progression occurred in 24% of patients. Sex emerged as a significant PFS predictor. Specifically, stage IIA and IIB males had higher progression risks than females at the same stages. We also observed disparities across stages; for instance, PFS was significantly worse in stage IIA males than stage IIB females (PFS difference: χ2 = 5.629, p = 0.018), revealing gaps in the prognostic accuracy of current staging systems. Stage IIB females—identified as at risk by current standards—had 5-year PFS of 91%. This highlights potential overestimation of their treatment needs and subsequent risk of undue exposure to treatment toxicity. The sex-based discrepancies observed may be partially explained by differences in antitumor immune function, evidenced by the discovery that Non-brisk TILs-an independent predictor of high progression risk in SLN(-) stage II melanoma- were associated with a 20% reduction in PFS in males vs females (p < 0.001). Conclusions: Significant sex-based PFS disparities exist among sentinel lymph node-negative stage II melanoma patients, with implications for treatment decisions. Incorporating sex enables more refined risk assessment than current substaging alone. Specifically, stage IIA males may be under-recognised for progression risks, while many stage IIB females could face overtreatment. Our findings advocate for nuanced, sex-specific approaches to enhance prognostic accuracy and optimise patient care.
Gene signature to predict hypophysitis in patients with melanoma treated with anti-PD-1 in adjuvant setting.
Authors: Simeone Ester , Mallardo Domenico , Festino Lucia , Vanella Vito , Trojaniello Claudia , Vitale Maria Grazia , Ottaviano Margaret , Sparano Francesca , Facchini Bianca Arianna , Cioli Eleonora , Isaja Antonio , Caraco Corrado , Ascierto Paolo Antonio ,   melanoma pascale
Published: July 2024

e21562 Background: Adjuvant anti-PD-1 treatment has shown to improve recurrence free survival and distant metastases free survival in melanoma patients from stage II to IV. Until now ,we have no data about overall survival of these patients nor biomarkers to select them to the best therapy , avoiding in this way severe and some times durable toxicities.Hypophysitis is a rare immune-related adverse event (irAE) and in adjuvant setting may represent a chronic irAE that may affect quality of life , such as fertility in young people.There are no clinical factors able to predict hypophysitis due to adjuvant anti-PD-1 therapy. Methods: Gene profiling analysis was performed using NanoString IO360 panel from basal PBMCs of patients treated with anti-PD1 in adjuvant setting. Patient’s characteristics are reported in table1. ROC curves were used to determine the best cut off. Survival rates were evaluated and compared using the Kaplan–Meier method. Results: Eighty pts treated with adjuvant anti-PD-1were included in a retrospective analysis from December 2019 to September 2021. Among which 12 pts developed hyphosytis. Ten pts completed treatment regularly, while two were discontinued both at week 12 due to metastatic disease. A pts developed liver metastases, the other one liver, multiple lymph nodes and soft tissues metastases. Grade 2 hypophysitis was diagnosed as the only irAE in all pts (100%). Median time of onset was 3 months (9 pts ≤6 months and 7 pts ≤3 months). A specific gene signature for predicting the onset of hypophysitis has been identified and characterized with 4 genes: IFITM2,CTSS,DUSP1,HLA-B that are mainly involved in the activation of innate-like lymphocyte populations, such as natural killer (NK) cells and innate lymphoid cells (ILCs), and adaptive immune cells, such as T helper 1 (TH1) cells and CD8+ cytotoxic T lymphocytes (CTLs). High gene signature was mostly related to hypophysitis event than lower group (HR: 0.11 95%IC 0.03-0.39, p = 0,0007). Moreover, at data lock all pts who developed hypophysitis were censored with mean overall survival of 35.60 months, 95%CI 30,86-40, 41. Conclusions: A predictive gene signature of hypophysitis was found in melanoma patients treated with adjuvant anti-PD1.Moreover, hypophysitis seems to correlate to better outcome. [Table: see text]
Detection of molecular residual disease in stage II and III melanoma utilizing circulating tumor DNA.
Authors: Chen Emily , Brunsgaard Elise Kornreich , Kuzel Timothy , Tan Alan 
Published: July 2024

e21564 Background: Overall survival for patients with melanoma has significantly improved with advancements in immunotherapy, especially with immune checkpoint inhibitors and BRAF/MEK inhibitors becoming standard of care for advanced melanoma. However, the decision to proceed with adjuvant therapy should be considered against the risk of adverse side effects, particularly in early-stage melanoma patients. Accurate biomarkers are needed to risk stratify patients, determine who will most likely benefit from adjuvant therapy, and identify when the ideal time is to initiate treatment. This study evaluates the prognostic value of personalized, tumor-informed circulating tumor DNA (ctDNA) testing in patients with stage II and III melanoma. Methods: In this real-world study, plasma samples (n =429) were analyzed from 90 stage IIA-IIID cutaneous melanoma patients treated at Rush University Medical Center between 03/30/2021 and 01/30/2024. A clinically-validated, personalized, tumor-informed 16-plex PCR assay (SignateraTM, Natera, Inc.) was used for detection and quantification of ctDNA in plasma samples. Results: Personalized, tumor-informed ctDNA assays were created using tissue samples from either initial biopsy or surgical excision specimen. Assay design was successful for 100% (90/90) of patients with sufficient tissue; test requests for 4 patients could not proceed due to insufficient tissue. ctDNA was detectable in 28% (25/90) of patients at one or more time points. There was a higher ctDNA-positivity rate in stage III patients (20/50, 40%) compared to stage II patients (5/40, 13%). Of the 25 patients with identifiable ctDNA during surveillance, 13 tested positive on the initial test (2 stage II and 11 stage III). Eighteen of the 25 ctDNA-positive patients received immunotherapy; eight patients achieved sustained ctDNA clearance, 2 had transient clearance, 2 have remained positive on ctDNA testing, and 6 continue to receive adjuvant IO and follow-up ctDNA testing. Clinical or radiographic recurrence occurred in 11/90 patients, 10 of whom tested positive for ctDNA. Conclusions: Personalized, tumor-informed ctDNA offers an adjunct to conventional monitoring for melanoma patients to detect molecular residual disease and was found to be prognostic in our patient cohort. Prospective studies are needed to evaluate the role of ctDNA in clinical decision making for surveillance imaging intervals and appropriate initiation, intensification, or discontinuation of adjuvant therapy.