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Updates in the Treatment of Metastatic Urothelial Cancer

Presented by: Thomas W. Flaig

The past decade has seen a host of advancements in the management of metastatic urothelial carcinoma. Although efforts to identify novel systemic therapies are still ongoing, immune checkpoint inhibitors have become the preferred treatment option in this patient population. Recommendations for optimal treatment strategies—based on a patient’s eligibility for cisplatin—have been outlined in the NCCN Guidelines for Bladder Cancer in both the first-line and subsequent-line settings.

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Updates to the Management of Cutaneous Melanoma

Presented by: Douglas B. Johnson

The systemic therapeutic landscape for cutaneous melanoma continues to evolve, with numerous diverse options currently available. Several clinical trials have resulted in approvals from the FDA and subsequent revisions to the NCCN Guidelines, which reflect the most up-to-date, evidence-based data relating to the evaluation and management of these malignant neoplasms. Combination checkpoint blockades, anti–PD-1 and anti–CTLA-4 monotherapies, and mutation-directed therapies are among the NCCN-recommended approaches across the neoadjuvant, first-line, and later-line settings. Tumor-infiltrating lymphocyte therapy, a recent addition in the later-line setting, may mark a new era in the management of metastatic disease.

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Updates to the Management of Endometrial Cancer

Presented by: Nadeem R. Abu-Rustum

Endometrial cancer has moved from being a histologic diagnosis alone to one that also considers the molecular classification of the tumor. Molecular classification is not only feasible but highly recommended because it improves the diagnostic classification and provides prognostic information that may guide treatment. The NCCN Cervical/Uterine Cancers Guidelines recognize the novel approach proposed by FIGO, but has concerns about the 2023 FIGO staging system and therefore does not recommend its use by clinicians. Advances in systemic treatment, particularly the introduction of immunotherapy, has greatly improved outcomes in endometrial cancer, especially for patients with mismatch repair–deficient tumors.

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Updates to the Management of HR-Positive, HER2-Negative Breast Cancer

Presented by: William J. Gradishar

Metastatic hormone receptor–positive, HER2-negative breast cancer treatment is increasingly individualized as more of the tumor landscape is described and targeted therapies are developed. CDK4/6 inhibitors have demonstrated consistency in prolonging progression-free survival across several clinical trials in advanced disease. Research in endocrine therapy highlighted the noninferiority of fulvestrant compared with aromatase inhibitors after disease progression. Studies such as the PEARL and Young-PEARL trials challenged the superiority of chemotherapy over endocrine therapy in certain populations, including premenopausal women. Sequential CDK4/6 inhibitor therapy after disease progression showed potential benefits, though definitive data are lacking. Targeting the PI3 kinase pathway, particularly with capivasertib in patients with pathway alterations, showed significant improvements in progression-free survival. ESR mutations have been identified as a key factor in resistance to endocrine therapy, with elacestrant showing promise in overcoming this challenge. Finally, in early-stage cancer, the question of whether ovarian suppression along with endocrine therapy can show the same results as chemotherapy is being explored, but the answer remains to be seen.

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Updates to the Management of Multiple Myeloma

Presented by: Natalie S. Callander and Shaji K. Kumar

Patients with smoldering myeloma should undergo periodic risk assessment—if they are deemed at high risk for disease progression, clinical trials or lenalidomide with or without dexamethasone should be considered. The initial treatment of newly diagnosed myeloma should be based on the patient’s risk, fitness, and preferences. Induction with a quadruplet regimen, followed by autologous transplantation and maintenance therapy, remains the standard of care, especially for those with high-risk disease. For patients with standard-risk disease not undergoing immediate transplantation, triplet or quadruplet induction followed by maintenance is the standard. Appropriate treatment of relapsed disease depends on response to previous treatment, residual side effects, and comorbidities. T-cell–redirecting therapies and other novel agents have shown activity, even in heavily pretreated patients. Most patients will require multiple lines of therapy over the course of the disease.

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Updates to Treatment of Recurrent Metastatic Head and Neck Cancers

Presented by: Cristina P. Rodriguez

The introduction of immune checkpoint inhibitors (ICIs), such as pembrolizumab and nivolumab, has significantly improved overall survival in both the first- and second-line settings for patients with head and neck squamous cell carcinomas. In nasopharyngeal carcinomas, the combination of gemcitabine + cisplatin with PD-1 inhibitors has demonstrated impressive response rates and overall survival benefits. However, the unique immune-related adverse events associated with ICIs require patient counseling. Ongoing clinical trials are exploring novel combinations of ICIs with EGFR monoclonal antibodies, tyrosine kinase inhibitors, and therapeutic vaccines to further improve treatment outcomes. Biomarkers, such as circulating HPV-DNA and actionable molecular alterations (eg, HRAS mutations), may help guide treatment decisions and predict patient responses in the future.

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Decline in Smartphone-Assessed Physical Activity Level is Associated With Clinical Outcomes in Phase I/II Clinical Cancer Trials

Calvin G. Brouwer, Joeri A.J. Douma, Evelien J.M. Kuip, Sonja Zweegman, Niels W.C.J van de Donk, Maria T.E. Hopman, Myra E. van Linde, Henk M.W. Verheul, and Laurien M. Buffart

Background: A decline in physical function may be an early predictor for complications of cancer treatment. This study examined whether repeated objective smartphone measurements of physical activity and exercise capacity in patients with cancer are feasible during early-phase clinical trials (EPCTs) and whether a decline in physical function is associated with clinical outcomes. Methods: Physical activity (steps/day) and exercise capacity (6-minute walk test [6MWT]) were measured with a smartphone before EPCT start (T0) and after 4 weeks (T1) and 8 weeks (T2). Univariable logistic regression analyzed associations between a decline in step count (≥20%), 6MWT distance (≥10%), or deterioration of ECOG performance status (PS) and trial discontinuation at 8 weeks and 90 days. Cox proportional hazards models were used to examine associations with progression-free survival (PFS) and overall survival (OS), adjusting for trial phase (I vs II), cancer type (hematologic malignancy vs solid tumor), and PS (0 vs ≥1). Results: Among 117 included patients, valid step count and 6MWT measurements were available for 96.6% and 76.7% of patients at T0, 74.4% and 53.3% at T1, and 89.7% and 54.4% at T2, respectively. Patients experiencing step count decline between T0 and T1 had higher odds of trial discontinuation at 8 weeks (odds ratio, 8.67; 95% CI, 1.94–61.43), and decline between T1 and T2 was associated with discontinuation at 90 days (odds ratio, 5.20; 95% CI, 1.43–21.14). Step count decline was significantly associated with shorter PFS (hazard ratio, 3.54; 95% CI, 2.06–6.08) and OS (hazard ratio, 2.31; 95% CI, 1.26–4.23). Declines in 6MWT distance or deterioration in ECOG PS were not associated with trial discontinuation or survival. Conclusions: Repeated smartphone measurements of physical activity are feasible in patients participating in EPCTs. Additionally, physical activity decline is significantly associated with trial discontinuation, PFS, and OS. Hence, we envision that objective smartphone measurements of physical activity will contribute to optimal treatment development for patients with cancer.

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Enhancing Readability of Online Patient-Facing Content: The Role of AI Chatbots in Improving Cancer Information Accessibility

Andres A. Abreu, Gilbert Z. Murimwa, Emile Farah, James W. Stewart II, Lucia Zhang, Jonathan Rodriguez, John Sweetenham, Herbert J. Zeh III, Sam C. Wang, and Patricio M. Polanco

Background: Internet-based health education is increasingly vital in patient care. However, the readability of online information often exceeds the average reading level of the US population, limiting accessibility and comprehension. This study investigates the use of chatbot artificial intelligence to improve the readability of cancer-related patient-facing content. Methods: We used ChatGPT 4.0 to rewrite content about breast, colon, lung, prostate, and pancreas cancer across 34 websites associated with NCCN Member Institutions. Readability was analyzed using Fry Readability Score, Flesch-Kincaid Grade Level, Gunning Fog Index, and Simple Measure of Gobbledygook. The primary outcome was the mean readability score for the original and artificial intelligence (AI)–generated content. As secondary outcomes, we assessed the accuracy, similarity, and quality using F1 scores, cosine similarity scores, and section 2 of the DISCERN instrument, respectively. Results: The mean readability level across the 34 websites was equivalent to a university freshman level (grade 13±1.5). However, after ChatGPT’s intervention, the AI-generated outputs had a mean readability score equivalent to a high school freshman education level (grade 9±0.8). The overall F1 score for the rewritten content was 0.87, the precision score was 0.934, and the recall score was 0.814. Compared with their original counterparts, the AI-rewritten content had a cosine similarity score of 0.915 (95% CI, 0.908–0.922). The improved readability was attributed to simpler words and shorter sentences. The mean DISCERN score of the random sample of AI-generated content was equivalent to “good” (28.5±5), with no significant differences compared with their original counterparts. Conclusions: Our study demonstrates the potential of AI chatbots to improve the readability of patient-facing content while maintaining content quality. The decrease in requisite literacy after AI revision emphasizes the potential of this technology to reduce health care disparities caused by a mismatch between educational resources available to a patient and their health literacy.

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Efficacy and Toxicity Analysis of mFOLFIRINOX in High-Grade Gastroenteropancreatic Neuroendocrine Neoplasms

Michele Borghesani, Anna Reni, Eleonora Lauricella, Alice Rossi, Viola Moscarda, Elena Trevisani, Irene Torresan, Taymeyah Al-Toubah, Elisabetta Filoni, Claudio Luchini, Riccardo De Robertis, Luca Landoni, Aldo Scarpa, Camillo Porta, Michele Milella, Jonathan Strosberg, Mauro Cives, and Sara Cingarlini

Background: High-grade neuroendocrine neoplasms (NENs) comprise both well-differentiated grade 3 neuroendocrine tumors (G3 NETs) and poorly differentiated neuroendocrine carcinomas (NECs). Mixed neuroendocrine–non-neuroendocrine neoplasms (MiNENs) nearly always include poorly differentiated NEC as the neuroendocrine component. The efficacy and safety of frontline mFOLFIRINOX chemotherapy has never been investigated in patients with high-grade NENs. Patients and Methods: We conducted a multi-institutional retrospective analysis of patients with advanced high-grade NEN of the gastroenteropancreatic tract or of unknown origin seen between February 2016 and April 2023 who received treatment with frontline mFOLFIRINOX. Results: A total of 35 patients were included (G3 NETs: n=2; NECs: n=25; MiNENs: n=8; stage III: n=5; stage IV: n=30). The objective response rate was 77% (complete response: 3%; partial response: 74%). Median progression-free survival was 12 months (95% CI, 9.2–16.2 months) and median overall survival was 20.6 months (95% CI, 17.2–30.6 months). No significant differences in efficacy were seen according to primary site, histopathology, and Ki-67 proliferative index. All 5 patients with stage III disease who received mFOLFIRINOX obtained an objective response and underwent radical surgery or definitive radiotherapy with curative intent, with a recurrence rate of 40%. Grade 3 or 4 adverse events were observed in 43% of patients (mainly neutropenia and diarrhea). Females were at significantly increased risk of developing severe toxicities. Conclusions: mFOLFIRINOX shows antitumor activity against high-grade NENs. Well-designed, prospective clinical trials are needed to assess the efficacy of mFOLFIRINOX in both the neoadjuvant and metastatic settings.

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Outcomes in Nonmetastatic Hormone Receptor–Positive HER2-Negative Pure Mucinous Breast Cancer: A Multicenter Cohort Study

Ryan Ying Cong Tan, Whee Sze Ong, Kyung-Hun Lee, Seri Park, Jabed Iqbal, Yeon Hee Park, Jeong Eon Lee, Jong Han Yu, Ching-Hung Lin, Yen-Shen Lu, Makiko Ono, Takayuki Ueno, Yoichi Naito, Tatsuya Onishi, Geok-Hoon Lim, Su-Ming Tan, Han-Byoel Lee, Jiwon Koh, Wonshik Han, Seock-Ah Im, Veronique Kiak Mien Tan, Nitar Phyu, Fuh-Yong Wong, Puay Hoon Tan, and Yoon-Sim Yap

Background: Although considered a favorable subtype, pure mucinous breast cancer (PMBC) can recur, and evidence for adjuvant therapy is limited. We aimed to compare outcomes of nonmetastatic PMBC with invasive ductal carcinoma (IDC) and invasive lobular carcinoma (ILC) to address these uncertainties. Methods: Individual patient-level data from 6 centers on stage I–III hormone receptor–positive and HER2-negative PMBC, IDC, and ILC were used to analyze recurrence-free interval (RFI), recurrence-free survival (RFS), and overall survival (OS), and to identify prognostic factors for PMBC. Results: Data from 20,684 IDC cases, 1,475 ILC cases, and 943 PMBC cases were used. Median follow-up was 6.6 years. Five-year RFI, RFS, and OS for PMBC were 96.1%, 94.9%, and 98.1%, respectively. On multivariable Cox regression, PMBC demonstrated superior RFI (hazard ratio [HR], 0.59; 95% CI, 0.43–0.80), RFS (HR, 0.70; 95% CI, 0.56–0.89), and OS (HR, 0.71; 95% CI, 0.53–0.96) compared with IDC. ILC showed comparable outcomes to IDC. Fewer than half (48.7%) of recurrences in PMBC were distant, which was a lower rate than for IDC (67.3%) and ILC (80.6%). In contrast to RFI, RFS events were driven more by non–breast cancer deaths in older patients. Significant prognostic factors for RFI among PMBC included positive lymph node(s) (HR, 2.42; 95% CI, 1.08–5.40), radiotherapy (HR, 0.44; 95% CI, 0.23–0.85), and endocrine therapy (HR, 0.25; 95% CI, 0.09–0.70). No differential chemotherapy associations with outcomes were detected across PMBC subgroups by nodal stage, tumor size, and age. A separate SEER database analysis also did not find any association of improved survival with adjuvant chemotherapy in these subgroups. Conclusions: Compared with IDC, PMBC demonstrated superior RFI, RFS, and OS. Lymph node negativity, adjuvant radiotherapy, and endocrine therapy were associated with superior RFI. Adjuvant chemotherapy was not associated with better outcomes.