Licitra L, Tahara M, Harrington K
… +19 more, Olivera Hurtado de Mendoza M, Guo Y, Aksoy S, Fang M, Csőszi T, Klochikhin M, Bueno de Oliveira T, Takahashi S, Yang MH, Swiecicki PL, Even C, Fayette J, Dutcus C, Okpara CE, Shen J, Benjamin K, Gumuscu B, Haddad RI, LEAP-010 investigators
PURPOSE: The PD-1 inhibitor pembrolizumab is approved as first-line treatment for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). In LEAP-010 (ClinicalTrials.gov identifier: NCT04199104), the mult...PURPOSE: The PD-1 inhibitor pembrolizumab is approved as first-line treatment for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). In LEAP-010 (ClinicalTrials.gov identifier: NCT04199104), the multikinase inhibitor lenvatinib plus pembrolizumab was evaluated as first-line therapy in participants with PD-L1 combined positive score (CPS) ≥1 R/M HNSCC. METHODS: In this phase III, randomized, placebo-controlled, double-blind study, participants 18 years and older with PD-L1 CPS ≥1 R/M HNSCC deemed incurable by local therapy were randomly assigned 1:1 to lenvatinib 20 mg plus pembrolizumab 200 mg IV once every 3 weeks for ≤35 cycles or placebo orally once daily plus pembrolizumab 200 mg IV once every 3 weeks for ≤35 cycles. Primary end points were objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Per the prespecified analysis plan, ORR and PFS were reported from the first interim analysis (IA1; data cutoff: July 6, 2022), and OS from IA2 (data cutoff: May 30, 2023). RESULTS: Five hundred eleven participants were randomly assigned to lenvatinib plus pembrolizumab (n = 256) or placebo plus pembrolizumab (n = 255). The median time from random assignment to data cutoff was 11.5 months for IA1 and 21.3 months for IA2. At IA1, the median PFS was 6.2 months for lenvatinib plus pembrolizumab versus 2.8 months for placebo plus pembrolizumab (hazard ratio [HR], 0.64 [95% CI, 0.50 to 0.81]; = .0001040); the ORR was 46.1% versus 25.4%, respectively (difference = 20.2% [95% CI, 10.5 to 29.6]; = .0000251). At IA2, the median OS was 15.0 months for lenvatinib plus pembrolizumab versus 17.9 months for placebo plus pembrolizumab (HR,1.15 [95% CI, 0.91 to 1.45]; = .882). At IA2, 170 (66.9%) participants receiving lenvatinib plus pembrolizumab had grade 3-4 all-cause adverse events compared with 97 (38.3%) participants on placebo plus pembrolizumab. CONCLUSION: In participants with PD-L1 CPS ≥1 R/M HNSCC, first-line lenvatinib plus pembrolizumab significantly improved ORR and PFS, but not OS, compared with placebo plus pembrolizumab. The safety profile was consistent with published data.
PURPOSE: Patients with stage II/III human epidermal growth factor receptor 2 (HER2)-positive or triple-negative breast cancer (TNBC) frequently receive neoadjuvant therapy (NAT). Although pathologic complete response (pC...PURPOSE: Patients with stage II/III human epidermal growth factor receptor 2 (HER2)-positive or triple-negative breast cancer (TNBC) frequently receive neoadjuvant therapy (NAT). Although pathologic complete response (pCR) correlates with improved outcomes, many non-pCR patients have long-term survival. Circulating tumor-DNA (ctDNA) minimal residual disease (MRD) assessment may provide additional or superior risk stratification. METHODS: Pathologic Response Evaluation and Detection in Circulating Tumor-DNA is a prospective, multicenter study evaluating ctDNA as a biomarker of treatment response using a tumor-informed, ultrasensitive (<100 parts per million) assay. The primary objective was to determine whether the negative predictive value (NPV) of post-NAT ctDNA for pCR was ≥90%. A prespecified secondary objective for the TNBC cohort was to assess associations between ctDNA and 5-year invasive disease-free survival (IDFS). ctDNA was evaluated at baseline, after NAT before surgery, and after surgery. RESULTS: Of 227 enrolled patients, 220 were evaluable for pCR (48% HER2-positive; 52% TNBC) and 91 patients (41%) had pCR. The primary objective was not met. Although all patients with pCR were ctDNA-negative after NAT, 40% of non-pCR patients were also ctDNA-negative (NPV, 60% [95% CI, 0.50 to 0.69]). However, the prespecified secondary objective was met. Detectable ctDNA after NAT was prognostic for recurrence (hazard ratio [HR], 8.9 [95% CI, 2.4 to 33]; = .001), independent of pCR. Additionally, detectable ctDNA after surgery identified patients at extremely high recurrence risk (HR, 128 [95% CI, 15 to 1,083]; < .001), while ctDNA-negative patients after surgery had 94% 5-year IDFS. CONCLUSION: In HER2-positive breast cancer and TNBC, ctDNA after NAT does not discriminate pCR from non-pCR. However, ctDNA provides markedly superior prognostic stratification, identifying patients with exceptional outcomes and those at extreme risk. These findings support ctDNA-guided therapeutic de-escalation and escalation strategies.
UNLABELLED: . . PURPOSE: To provide guidance to oncology clinicians on using effective communication to optimize the patient-clinician relationship, patient and clinician well-being, and caregiver well-being. METHODS:...UNLABELLED: . . PURPOSE: To provide guidance to oncology clinicians on using effective communication to optimize the patient-clinician relationship, patient and clinician well-being, and caregiver well-being. METHODS: ASCO convened a multidisciplinary panel of medical oncologists, hematologists, nurses, hospice and palliative medicine clinicians, and communication skills and advocacy experts to develop recommendations. Guideline development involved a systematic review of the literature and a formal consensus process. The systematic review encompassed systematic reviews and randomized controlled trials (RCTs) published from October 1, 2016, through January 16, 2025. RESULTS: The systematic review identified 73 publications (54 systematic reviews and 19 RCTs). Included studies varied with respect to setting and the interventions and outcomes evaluated. Recommendations were developed using a formal consensus process. Draft recommendations underwent two rounds of consensus voting before being finalized. RECOMMENDATIONS: Recommendations address core communication skills and tasks that apply across the continuum of cancer care, as well as specific topics such as discussion of goals of care and prognosis, treatment selection, end-of-life care, facilitating involvement of the patient's support network, and clinician training in communication skills. In addition, new topics addressed by this update include telehealth, interprofessional communication, and boundary setting. Recommendations are accompanied by suggested strategies for implementation. Full implementation of communication best practices will require that health systems provide adequate time, training, and support for clinicians.Additional information is available at www.asco.org/supportive-care-guidelines.
Hurvitz SA, Layman RM, Curigliano G
… +24 more, André F, Cristofanilli M, Kim SB, Martínez Rodríguez JL, Nadal JC, Kim GM, Lo L, Remolina-Bonilla YA, Rosselli G, Emile G, Korbenfeld E, Puig JM, Wesolowski R, Martin M, Ring A, Han HS, Giordano A, Mutka SC, Moss K, Suzuki S, Sullivan B, Gorbatchevsky I, Pistilli B, VIKTORIA-1 Study Group
J Clin Oncol
· 2026 Apr · PMID 41802242
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PURPOSE: Gedatolisib potently targets all four class I PI3K isoforms and mTORC1 and mTORC2 to comprehensively block the PI3K/AKT/mTOR pathway and has shown compelling activity in early clinical trials with palbociclib an...PURPOSE: Gedatolisib potently targets all four class I PI3K isoforms and mTORC1 and mTORC2 to comprehensively block the PI3K/AKT/mTOR pathway and has shown compelling activity in early clinical trials with palbociclib and fulvestrant. METHODS: This phase III randomized trial (VIKTORIA-1; ClinicalTrials.gov identifier: NCT05501886) evaluated the efficacy of gedatolisib-based therapy, comparing gedatolisib, palbociclib, and fulvestrant (gedatolisib triplet) and gedatolisib plus fulvestrant (gedatolisib doublet) with fulvestrant monotherapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HER2-), wild-type (WT) advanced breast cancer. Eligible patients had disease progression during or after CDK4/6 inhibitor and aromatase inhibitor treatment. Comparison of progression-free survival as assessed by blinded independent central review for gedatolisib triplet versus fulvestrant and gedatolisib doublet versus fulvestrant was the primary objective. RESULTS: A total of 392 patients were randomly assigned 1:1:1. The median study follow-up was 10.1 months. The median progression-free survival was 9.3 months in the gedatolisib-triplet group, 2.0 months in the fulvestrant group (hazard ratio [HR] for progression or death, 0.24 [95% CI, 0.17 to 0.35]; < .001), and 7.4 months in the gedatolisib-doublet group (HR, 0.33 [95% CI, 0.24 to 0.48]; < .001 fulvestrant). Grade ≥3 treatment-related adverse events (TRAEs) reported in the gedatolisib-triplet and gedatolisib-doublet groups, respectively, included neutropenia (62.3%, 0.8%), stomatitis (19.2%, 12.3%), rash (4.6%, 5.4%), hyperglycemia (2.3%, 2.3%), and diarrhea (1.5%, 0.8%). Study treatment discontinuation because of TRAEs was reported in 2.3% (triplet) and 3.1% (doublet) of patients. CONCLUSION: The addition of gedatolisib to fulvestrant, with or without palbociclib, significantly reduced the risk of disease progression or death in patients with hormone receptor-positive/HER2-, WT advanced breast cancer.
Total neoadjuvant therapy (TNT) has become a cornerstone in the treatment of locally advanced rectal cancer, improving systemic control and increasing the potential for organ preservation. However, current trials and gui...Total neoadjuvant therapy (TNT) has become a cornerstone in the treatment of locally advanced rectal cancer, improving systemic control and increasing the potential for organ preservation. However, current trials and guidelines continue to treat rectal cancer as a homogeneous entity, overlooking the significant anatomic and therapeutic differences between mid- and low-rectal tumors. This uniform approach fails to reflect the impact of tumor location on both oncologic outcomes and functional consequences. Low-rectal cancers-defined as tumors located < 1 cm from the anal ring-pose distinct anatomic and functional challenges. These include more complex lymphatic drainage, higher risks of positive margins, and greater impact on continence. By contrast, mid-rectal tumors are generally more amenable to standard resection with preserved function and may benefit from treatment deintensification, particularly regarding radiotherapy. Drawing on data from over 80 studies and clinical trials, this review argues that mid- and low-rectal cancers should be considered distinct clinical entities requiring tailored treatment strategies. We examine evidence supporting radiotherapy de-escalation for mid-rectal tumors and intensified TNT for low-rectal tumors when organ and sphincter preservation is essential. Adopting a location-specific, patient-centered approach can better align treatment intensity with oncologic risk and individual functional priorities, ultimately improving both outcomes and quality of life.
Huang SW, Liang YL, Tao YL
… +19 more, Li WF, Zhou GQ, Mao YP, Guo R, Chen L, Xu S, Liu X, Zhang N, Liu F, Shen LF, Zhou YY, Yuan YW, Zou GR, Jin F, Tang LL, Sun Y, Li YQ, Ma J, Liu N
J Clin Oncol
· 2026 Apr · PMID 41791006
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PURPOSE: Personalized immunotherapy strategies are urgently needed for patients with locoregionally advanced nasopharyngeal carcinoma (NPC). We aim to identify biomarkers predictive of immunotherapy benefits, using data...PURPOSE: Personalized immunotherapy strategies are urgently needed for patients with locoregionally advanced nasopharyngeal carcinoma (NPC). We aim to identify biomarkers predictive of immunotherapy benefits, using data from the phase III CONTINUUM (ClinicalTrials.gov identifier: NCT03700476) and DIPPER (ClinicalTrials.gov identifier: NCT03427827) randomized clinical trials. PATIENTS AND METHODS: Tumor samples from 407 patients in the CONTINUUM (discovery cohort) and DIPPER (validation cohort) trials were subjected to RNA sequencing. In the discovery cohort, metabolic gene-based consensus clustering was performed to determine subtypes. A machine learning-based classifier was subsequently developed in the discovery cohort and then applied to the validation cohort to assign metabolic subtypes. Gene set enrichment analyses were used to characterize the biological features of each metabolic subtype. The clinical end point was event-free survival (EFS). RESULTS: In the discovery cohort, three metabolic subtypes were identified with distinct tumor-intrinsic and immune features as well as differential EFS benefits from adding anti-PD-1 to chemoradiotherapy (CRT). Specifically, the MS1 subtype exhibited a significant improvement in 3-year EFS in the anti-PD-1 plus CRT arm compared with the CRT-alone arm (3-year EFS, 90.2% 69.6%; hazard ratio, 0.27 [95% CI, 0.11 to 0.67]), whereas MS2 (3-year EFS, 94.1% 93.8%) and MS3 subtypes (3-year EFS, 75.0% 75.0%) derived no significant survival benefit. The subtype features were preserved in the validation cohort, with consistent prognostic and predictive value. A pooled analysis of both cohorts demonstrated the significant interaction between metabolic subtypes and the treatment effect ( = 0.0074). CONCLUSION: In this biomarker study, we defined metabolic subtypes of NPC that predicted the EFS benefit from immunotherapy. This novel molecular classification provides a promising predictive biomarker for personalized treatment decision for patients with locoregionally advanced NPC.
PURPOSE: This study investigates the relationship between prediagnosis financial hardship (FH) and cancer stage, and the mediating role of cancer screening in breast cancer. METHODS: This case-control study used linked,...PURPOSE: This study investigates the relationship between prediagnosis financial hardship (FH) and cancer stage, and the mediating role of cancer screening in breast cancer. METHODS: This case-control study used linked, deidentified records from adult cancer patients diagnosed with stage I to IV solid tumors (2014-2017) from the Western Washington SEER registry, along with credit report data from TransUnion and health care claims, encompassing various cancers. FH was defined as at least one record of collections, charge-offs, delinquent mortgage payments, tax liens, foreclosures, repossessions, or bankruptcies within 2 years before diagnosis. We used multivariable log-binomial regression to assess the association between FH and late-stage diagnosis (stages III and IV) overall and by cancer screening category, and mediation analysis to evaluate the role of screening mammography in breast cancer. RESULTS: Among 50,148 patients with cancer (mean age 64 years, 52% female, 85% non-Hispanic White), 30% experienced FH before diagnosis, which was associated with a 14% higher probability of late-stage diagnosis (adjusted risk ratio [aRR], 1.14 [95% CI, 1.11 to 1.17]). This association was stronger for cancers with organized screening (aRR, 1.25 [95% CI, 1.21 to 1.29]) and those detectable by physical examinations (aRR, 1.44 [95% CI, 1.31 to 1.59]), but not for cancers without these protocols (aRR, 1.00 [95% CI, 0.94 to 1.07]), with variations among individual sites. Among patients with breast cancer, 70% of the increased risk of late-stage diagnosis was attributable to the nonreceipt of screening. CONCLUSION: FH significantly affects cancer stage at diagnosis, especially for cancers with organized screening and physical examinations. In breast cancer, this association is largely attributed to lack of screening. These findings underscore FH as an important social determinant of health and the need for targeted interventions to improve screening access.
Zhou H, Zhao H, Hou X
… +13 more, Wang Y, He Z, Li Y, Ma Y, Zhao Y, Huang Y, Chen L, Xiao S, Zhu H, Zhu Y, Fang W, Zhang L, Yang Y
J Clin Oncol
· 2026 Apr · PMID 41779981
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PURPOSE: To evaluate the safety and efficacy of izalontamab brengitecan (iza-bren) in patients with non-small cell lung cancer (NSCLC) harboring actionable genomic alterations (GAs) outside of classical epidermal growth...PURPOSE: To evaluate the safety and efficacy of izalontamab brengitecan (iza-bren) in patients with non-small cell lung cancer (NSCLC) harboring actionable genomic alterations (GAs) outside of classical epidermal growth factor receptor () mutations. METHODS: Eligible patients had locally advanced or metastatic NSCLC with prespecific actionable GAs, had progressed after standard treatment and received no more than one previous line of chemotherapy. iza-bren was administered at the dose of 2.5 mg/kg once per day on days 1 and 8 of each 3-week cycle. The primary end point was safety. The secondary end points included objective response rate (ORR), disease control rate (DCR), and duration of response. The exploratory end points included progression-free survival (PFS) and overall survival (OS). RESULTS: A total of 83 patients with NSCLC were enrolled in four cohorts: exon20ins/nonclassical mutations (n = 14), human epidermal growth factor receptor 2 () mutation (n = 19), // mutation (n = 26), and /// fusion (n = 24). The most common grade ≥3 treatment-related adverse events (TRAEs) were thrombocytopenia (51.8%), anemia (44.6%), and neutropenia (43.4%). The most frequent nonhematologic TRAEs of all grades were nausea (49.4%), asthenia (45.8%), stomatitis (44.6%), and diarrhea (38.6%). One case of grade 2 interstitial lung disease was observed. The confirmed ORR was 39.7%, and the DCR was 85.9%. The median PFS was 7.0 months (95% CIs, 5.4 to 10.5), while OS data were immature. Patients with exon20ins or other nonclassical mutations achieved an ORR of 69.2% with a median PFS of 10.5 months (95% CI, 6.9 to not reached); the -mutant cohort had an ORR of 52.9% and a median PFS of 7.5 months (95% CI, 5.4 to not reached). CONCLUSION: iza-bren demonstrated encouraging antitumor activity and a manageable safety profile in pretreated NSCLC patients with diverse GAs outside of classical mutations, especially in exon20ins/nonclassical and mutations.
Liu T, Luo S, Yuan X
… +22 more, Liu D, Zhou Z, Wang X, Deng Y, Chen J, Liu M, Zhou H, Ren X, Qiu W, Cao Y, Cai S, Dong Y, Zhang Y, Wang W, Liang J, Xu P, Liu H, Zhao K, Fan Y, Dou N, Huang C, Li J
PURPOSE: Antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) could be a promising strategy for HER2-expressing gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) and c...PURPOSE: Antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 2 (HER2) could be a promising strategy for HER2-expressing gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) and colorectal cancer (CRC). We conducted a phase I trial to assess trastuzumab rezetecan, a novel HER2-targeted ADC, in HER2-expressing advanced GC/GEJ and CRC. METHODS: Patients with HER2-expressing advanced GC/GEJ and CRC whose disease progressed on and/or had no available/applicable standard treatment were enrolled. Patients were intravenously given trastuzumab rezetecan at 3.2, 4.8, 6.4, and 8.0 mg/kg (once every 3 weeks) in an i3+3 dose-escalation scheme, followed by pharmacokinetics expansion at selected doses and then clinical expansion. The primary end points were dose-limiting toxicity (DLT) and safety. RESULTS: Between March 30, 2021, and August 1, 2023, 100 patients were enrolled (57 with GC/GEJ and 43 with CRC). One DLT occurred in the 8.0 mg/kg dose cohort. Grade ≥3 treatment-related adverse events (TRAEs) were reported in 66 (66.0%) patients. Only 5 (5.0%) patients discontinued treatment because of TRAEs. In HER2-positive GC/GEJ (n = 40), trastuzumab rezetecan achieved an objective response rate (ORR) of 45.0%, a median progression-free survival (PFS) of 9.0 months (95% CI, 7.0 to 11.3), and a median overall survival (OS) of 16.3 months (95% CI, 12.4 to not reached [NR]). In GC/GEJ with HER2 immunohistochemical 2+ and in situ hybridization-negative (n = 12), trastuzumab rezetecan had an ORR of 25.0%, a median PFS of 12.2 months (95% CI, 2.8 to 14.0), and an immature median OS. In HER2-positive CRC (n = 37), trastuzumab rezetecan had an ORR of 40.5%, a median PFS of 9.5 months (95% CI, 7.3 to 11.2), and a median OS of 22.7 months (95% CI, 17.5 to NR). CONCLUSION: Trastuzumab rezetecan showed tolerable safety and preliminary efficacy in HER2-expressing advanced GC/GEJ and CRC.
PURPOSE: Brain metastases (BMs) of triple-negative breast cancer (TNBC) are lethal, often associated with a limited life span and lack of effective antitumor agents. Here we reported a triple combination therapy consisti...PURPOSE: Brain metastases (BMs) of triple-negative breast cancer (TNBC) are lethal, often associated with a limited life span and lack of effective antitumor agents. Here we reported a triple combination therapy consisting of adebrelimab, bevacizumab, and cisplatin/carboplatin in BMs of TNBC. METHODS: This phase II clinical trial involved patients with TNBC with active BMs. Participants were administered with adebrelimab, bevacizumab, and cisplatin/carboplatin until disease progression or unacceptable toxic effects. The primary end point was the objective response rate in CNS (CNS-ORR) according to the Response Assessment in Neuro-Oncology BMs criteria, and the secondary end points included the clinical benefit rate in CNS (CNS-CBR), progression-free survival (PFS), overall survival (OS), the first progression site, and safety. RESULTS: A total of 35 patients were enrolled and treated, and the median lines of previous treatment were 2 (range, 0-4). The confirmed CNS-ORR was 77.1% (27/35, 95% CI, 59.9 to 89.6), and the CNS-CBR was 80.0% (28/35, 95% CI, 63.1 to 91.6). The median overall PFS was 8.3 months (95% CI, 5.8 to 11.5), whereas the median CNS-PFS was 10.3 months (95% CI, 7.4 to 14.3) and the median OS was 21.1 months (95% CI, 13.2 to not reached). Among the 28 patients who progressed, progression was intracranial-only in 32.1% (9/28) patients, extracranial-only in 35.7% (10/28) patients, and both in 32.1% (9/28) patients. The incidence of grade ≥3 treatment-related adverse events was 65.7% (23/35). Treatment-related serious adverse events occurred in five patients (14.3%), and no treatment-related deaths were reported. CONCLUSION: The combination of adebrelimab, bevacizumab, and cisplatin/carboplatin was the first regimen to demonstrate promising intracranial antitumor activity and prolonged PFS and CNS-PFS, along with a manageable safety profile, warranting further investigation.
Walter TP, Mazieres J, Otto J
… +28 more, Lena H, Lepage C, Smith D, Madelaine J, Gérinière L, Egenod T, El Hajbi F, Ferru A, Clément-Duchene C, Madroszyk A, Brotelle T, Bouhier-Leporrier K, Desrame J, Ghiringhelli F, Paleiron N, Khalil A, Milot L, Chevallier O, Couvelard A, Lantuejoul S, Langlais A, Morin F, Duruisseaux M, Michel P, Louvet C, Westeel V, Girard N, IFCT-FFCD-GERCOR GCO
PURPOSE: There is no standard second-line therapy for gastroenteropancreatic (GEP) and lung large-cell neuroendocrine carcinoma (NEC) after the failure of platinum-based chemotherapy. This study aimed to investigate the...PURPOSE: There is no standard second-line therapy for gastroenteropancreatic (GEP) and lung large-cell neuroendocrine carcinoma (NEC) after the failure of platinum-based chemotherapy. This study aimed to investigate the efficacy of nivolumab ± ipilimumab. METHODS: The GCO-001-NIPINEC (ClinicalTrials.gov identifier: NCT03591731) trial was a noncomparative, open-label, phase II trial. The main inclusion criteria were age ≥18 years, performance status (PS) ≤2, advanced large- and small-cell GEP-NEC and large-cell lung NEC, and second- or third-line treatment for NECs refractory to platinum-based chemotherapy. Patients were randomly assigned (1:1) and stratified by age and PS to receive nivolumab (3 mg/kg/once every 2 weeks) ± ipilimumab (1 mg/kg/once every 6 weeks) for 2 years or until progression or unacceptable toxicity. The primary end point was objective response rate (ORR) at 8 weeks, assessed by investigators. RESULTS: A total of 185 patients (91 in the nivolumab arm and 94 in the nivolumab-ipilimumab arm) were enrolled between December 2018 and March 2021; 169 were analyzed (median age of 64.5 years, 71% male, 91% PS 0-1). The main primary tumor locations were lungs (50%), colorectal (15%), gastroesophageal (14%), and pancreatic (13%) regions. The ORR at 8 weeks was 7.2% (95% CI, 2.7 to 15.1]) in the nivolumab arm and 14.0% (95% CI, 7.4 to 23.1) in the nivolumab-ipilimumab arm. The best ORR was 9.6% and 20.9%, respectively, whereas the median progression-free and overall survival were approximately 2 months and 6 months in both arms. One treatment-related death occurred, in the nivolumab arm. The grade 3-4 adverse events (≥5%) were asthenia (13%), gamma-glutamyl transferase increase (10%), alkaline phosphatase increase (9%), dyspnea (7%), and anemia (6%) in the nivolumab-ipilimumab arm. CONCLUSION: Nivolumab-ipilimumab could be a second-/third-line treatment option for patients with NECs. However, given the limited magnitude of benefit, studies are warranted to evaluate its use earlier and/or associated with chemotherapy.
PURPOSE: This national study was undertaken to determine screening mammography rates among transgender and gender diverse (TGD) individuals. METHODS: TGD individuals and cisgender women who qualified to receive screening...PURPOSE: This national study was undertaken to determine screening mammography rates among transgender and gender diverse (TGD) individuals. METHODS: TGD individuals and cisgender women who qualified to receive screening mammography based on American College of Radiology guidelines were identified in the longitudinal OptumLabs Data Warehouse. The primary end point was the percentage of patients who had high rates of screening (>75% recommended screenings). Multivariable analyses were conducted in a matched population of transgender men to cisgender women to identify and adjust for factors associated with high adherence. Individuals were matched at a 1:4 ratio (transgender men: cisgender women) on age, race/ethnicity, year of enrollment in their health care plan, and duration of follow-up. RESULTS: This study focused on 10,478 TGD individuals (3,778 transgender men; 1,294 transgender women; 5,406 with gender dysphoria not meeting other TGD criteria, NMOT) and 6,218,369 cisgender women. For transgender men, transgender women, individuals with gender dysphoria NMOT, and cisgender women, high mammography rates were observed in 41.1% (95% CI, 39.5 to 42.6), 7.4% (95% CI, 6.0 to 8.8), 11.9% (95% CI, 11.0 to 12.7), and 38.3% (95% CI, 38.3 to 38.4), respectively ( < .0001). When transgender men were compared with 15,112 matched cisgender women, an age-based differential association was observed between sex and high mammography rates (interaction = .0003); compared with cisgender women, transgender men appeared more likely to manifest high rates of screening at age 40-49 years (odds ratios [ORs], 1.38 [95% CI, 1.28 to 1.50]; < .0001) and 50-59 years (OR, 1.57 [95% CI, 1.35 to 1.81]; < .0001) but not in the older age groups. CONCLUSION: The relatively high rates of screening mammography in cisgender women and transgender men suggest clinicians are offering mammography to individuals who are at average or high breast cancer risk, as compared with cisgender women, and not to transgender women at low risk.