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1278 citation(s) found for "Fu, Wayne".

Anomalous Aortic Origin of the Right Coronary Artery in Adults: Surgical Reimplantation With Intermediate-Term Results
Sabha, Dina, Alomari, Mohammad , Hyasat, Laith , Yamin, Saif , Alkirmeen, Rana, Hammoudeh, A, Hyasat, Bahi, Kirmeen, Rana Al, Garg, Pankaj

World Journal for Pediatric and Congenital Heart Surgery | June 11, 2026 | Volume: No volume available | Issue: No issue available | Pages: No page available

10.1177/21501351261450105 | PMID 42272401 Get It

Background Anomalous aortic origin of the right coronary artery (AAORCA) with an intramural course is a rare but potentially life-threatening anomaly due to its association with exertional ischemia and sudden cardiac death. Surgical correction aims to eliminate the ischemic mechanism. This study reports a single-center experience with adult patients who underwent right coronary artery (RCA) reimplantation for AAORCA. Methods A retrospective review was conducted of symptomatic adult patients with AAORCA who underwent RCA reimplantation between June 2017 and August 2024. Baseline clinical features, perioperative outcomes, and follow-up data were assessed. Results Forty patients (85% [34/40] male; median age 44 years) were included. The most common presenting symptom was exertional chest pain (82.5%, [33/40]), followed by dyspnea (45%, [18/40]) and syncope or presyncope (30%, [12/40]). Coronary computed tomography angiography (CCTA) was performed to diagnose the high-risk coronary features. All patients underwent RCA reimplantation into the right sinus of Valsalva. One patient also received a saphenous-vein graft to the distal-RCA. There was no in-hospital or follow-up mortality. At a mean follow-up of 30.3 ± 20.5 months, 8/40 patients (20%) reported recurrent symptoms, including chest pain (10%, [4/40]), dyspnea on exertion (5%, [2/40]), and palpitation (5%, [2/40]). Surveillance CCTA or invasive angiography performed in 14 patients, including 8 symptomatic patients, confirmed the widely patent RCA with no ostial stenosis or kinking. Post operative exercise testing in all these patients was negative. Conclusions In adults with AAORCA and an intramural or interarterial course; reimplantation of the RCA into the right-sinus of Valsalva achieves excellent early- to midterm outcomes, with low mortality, symptom resolution, and durable coronary patency.
An Open-label Study Evaluating the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Tanruprubart Single Dose in Participants From North America and Europe With Guillain-Barré Syndrome (P3-19.004)
Ladha, Shafeeq, Grover, Kavita, Morrison, Glenn, Lin, Ping, Kroon, Henk‐André, Allen, Jeffrey, Ladha, Shafeeq , Mustafa, Rafid , Grover, Kavita Mohindra , Lin, Ping , Allen, Jeffrey

Neurology | June 10, 2026 | Volume: 106 | Issue: 11_Supplement_1 | Pages: No page available

10.1212/wnl.0000000000216099 Get It

NRG-GI008: Colon adjuvant chemotherapy based on evaluation of residual disease (CIRCULATE-NORTH AMERICA).
Dasari, Arvind, Yu, Guan, Kopetz, Scott, Puhalla, Shannon L., Lucas, Peter C., Sahin, Ibrahim Halil, Deming, Dustin A. , Philip, Philip Agop, Hong, Theodore S., Rojas-Khalil, Yesenia, Loree, J M, George, Thomas J., Lieu, Christopher, Dasari, Arvind , Yu, Guan, Kopetz, Scott , Puhalla, Shannon L. , Sahin, Ibrahim Halil, Philip, Philip Agop, Rojas-Khalil, Yesenia, Loree, Jonathan M. , Wolmark, Norman , Yothers, Greg , George, Thomas J.

Journal of Clinical Oncology | May 28, 2026 | Volume: 44 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2026.44.16_suppl.tps3686 Get It

TPS3686 Background: Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer (CC) to determine need for adjuvant chemotherapy (AC). However, circulating tumor DNA (ctDNA) represents a highly specific and sensitive approach (especially with serial monitoring) for identifying minimal/molecular residual disease (MRD) post-surgery in CC patients (pts), and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. CC pts who do not have detectable ctDNA (ctDNA–) are at a much lower risk of recurrence and may be spared the toxicities associated with AC. Furthermore, for CC pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal AC regimen has not been established. We hypothesize that for pts whose CC has been resected, ctDNA status may be used to risk-stratify for making decisions about AC. Methods: In this prospective phase II/III trial, up to 1,912 pts with resected stage IIB, IIC, and III CC will be enrolled. Based on the post-operative ctDNA status using personalized and tumor-informed assay (Signatera, bespoke assay), those who are ctDNA– (Cohort A) will be randomized to immediate AC with fluoropyrimidine (FP)+oxaliplatin (Ox) for 3-6 mos per established guidelines v serial ctDNA monitoring. Patients who are ctDNA+ post-operatively, or with serial monitoring (Cohort B), will be randomized to FP+Ox v more intensive AC with addition of irinotecan (I) for 6 mos. One cycle of chemotherapy is allowed while awaiting ctDNA testing results for cohort assignment. The primary endpoints for Cohort A are time to ctDNA+ status (phase II) and disease-free survival (DFS) (phase III) in the immediate v delayed AC arms. The primary endpoint for Cohort B is DFS in the FP+Ox v FP+Ox+I arms for both phase II and phase III portions of the trial. Secondary endpoints include prevalence of detectable ctDNA post-operatively, time-to-event outcomes (overall survival and time to recurrence) by ctDNA status, and the assessment of compliance to adjuvant therapy. Biospecimens including archival tumor tissue, as well as post-operative plus serial matched/normal blood samples, will be collected for exploratory correlative research. Active enrollment across the NCTN started in June 2022 with CCTG sites joining in August 2023. Accrual is 1,123/1,912 (as of 1/20/2026). *Drs. Dasari and Lieu contributed equally to the development of this trial. Clinical trial information: NCT05174169 .
Artificial intelligence comparison of Google MedGemma and ChatGPT-5 in expert-reviewed gastrointestinal and genitourinary oncology cases.
Zidan, Ali , El-Sururi, Mousa, Belbase, Avi, Pelster, Meredith, Bouferraa, Youssef , Lin, Daniel , Cohen, Steven J., Eslinger, Cody , Garmezy, Benjamin, Maughan, Benjamin L., Odabashian, Roupen, Bashir, Babar , Pelster, Meredith S. , Khorana, Alok A. , Xie, Hao , Maughan, Benjamin L. , Odabashian, Roupen

Journal of Clinical Oncology | May 28, 2026 | Volume: 44 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2026.44.16_suppl.e15509 Get It

e15509 Background: Large language models (LLMs) are increasingly explored for oncology decision support, yet comparative evidence evaluating medical-specific versus general-purpose LLMs using expert-reviewed clinical cases is limited. We compared a medical-specific LLM (Google MedGemma 27B) with a general-purpose LLM (ChatGPT-5) using gastrointestinal (GI) and genitourinary (GU) oncology vignettes. Methods: This cross-sectional study evaluated 32 de-identified oncology vignettes (26 GI, 6 GU) created by a U.S. board-certified medical oncologist and informed by real-world cases. Vignettes included text-only information on the clinical context, description of pathology, tumor staging, biomarkers, and relevant comorbidities. Both LLMs were prompted to provide National Comprehensive Cancer Network(NCCN) guideline-based treatment recommendations, monitoring strategies, maintenance therapy considerations, and references, along with a self-reported confidence score (0–100). Board-certified U.S. medical oncologists independently reviewed outputs using a structured instrument; two disease specific expert oncologists evaluated each case. Outcomes included correctness and comprehensiveness (1–10 scales), hallucinations (factually fabricated or unsupported statements), NCCN traceability, potential patient harm, and clinician trust. Associations between accuracy and comprehensiveness were assessed using correlation coefficients. Inter-rater reliability was assessed using a two-way random-effects intraclass correlation coefficient (ICC). Results: ChatGPT-5 demonstrated higher mean correctness (8.65 vs 4.68) and comprehensiveness (8.68 vs 5.22) scores compared with MedGemma 27B. Accuracy and comprehensiveness were strongly correlated overall (Pearson r = 0.93, p < 0.001), with significant model-specific correlations (ChatGPT-5 r = 0.86, p < 0.001; MedGemma r = 0.77, p < 0.001). Hallucinations occurred less frequently with ChatGPT-5 (12.3% vs 65%), and NCCN-traceable recommendations were more common (75.4% vs 36.7%). Responses judged as potentially harmful occurred in 18.5% of ChatGPT-5 outputs versus 70% of MedGemma outputs. Clinician trust favored ChatGPT-5 (84.6% vs 15%). Inter-rater reliability improved with rater averaging (ICC(A,k): correctness 0.72; comprehensiveness 0.64). Conclusions: In expert-reviewed GI and GU oncology cases, ChatGPT-5 demonstrated higher clinical accuracy, comprehensiveness, and guideline alignment than a medical-specific LLM; however, a substantial rate of hallucinations and potentially harmful recommendations persisted across models. These findings underscore that, despite performance differences, current LLMs require rigorous clinician oversight and should not be used as standalone decision-support tools in oncology.
Patient correlates of patient-provider communication and financial toxicity in Black and White patients with cancer.
Hamel, Lauren M. , Dougherty, David W. , Heath, Elisabeth I. , Mabunda, Lorna, Austin, Teneisha , Assad, Hadeel , Mamdani, Hirva, Bacall, Helda, Bouyer, Adrienne, Cackowski, Frank C. , Gogoi, Radhika, Goldman, Erica, Beal, Eliza W., Jarbo, Nouran, Angers, Keri, Eggly, Susan, Eggly, Susan , Kim, Seongho , Mabunda, Lorna, Mamdani, Hirva Mansurali , Hallak, Mohammed Najeeb Al , Gogoi, Radhika P. , Winer, Ira Seth , Beal, Eliza Wright

Journal of Clinical Oncology | May 28, 2026 | Volume: 44 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2026.44.16_suppl.e13730 Get It

e13730 Background: Financial toxicity, the burden of treatment cost, affects up to half of people with cancer and can affect survival. Financial toxicity is a health equity issue, disproportionately affecting Black patients. This cross-sectional study used baseline data from the Discussions of Cost (DISCO) Trial, an RCT to improve patient-provider treatment cost discussions and, in turn, mitigate financial toxicity, to examine whether Black and White patients differed in patient-provider communication perceptions and financial toxicity correlates. Methods: Data were collected from 2021-2025 at an NCI-designated comprehensive cancer center. Participants were Black or White patients diagnosed with solid tumor cancers. At baseline, patients completed demographic measures; communication measures of self-efficacy in patient-provider interactions (e.g., “I am confident I know what questions to ask a provider”); self-efficacy in managing cancer treatment costs (e.g., “I am confident I can understand treatment costs”); and whether they have a provider- or patient-centered approach (e.g., “the provider should decide what gets talked about”); and financial measures including economic burden (e.g., “it’s difficult to live on my income”); treatment cost distress (e.g., “worries about paying for my cancer treatment keep me up at night”); and anticipated material hardship (e.g., “I worry about the financial problems I will have in the future as a result of my treatment”). Comparisons were conducted by patient race. Results: A total of 202 patients participated (116 Black patients, 86 White patients). White patients were more likely to have advanced degrees, a higher annual income, and less likely to have Medicaid compared to Black patients. Black patients reported higher self-efficacy for managing treatment costs ( p = .002) and a higher provider-focused orientation to the patient-provider relationship ( p = .001), than White patients. Black patients reported greater levels of financial burden ( p < .001), cost distress ( p = .005), and anticipated material hardship ( p = .003). There was no difference in self-efficacy for interacting with providers. Conclusions: These results suggest that a communication intervention for patients may help mitigate the experience of financial toxicity, especially for Black patients. Clinical trial information: NCT04766190 . Patient characteristics. Black Patients White Patients p -value Race 116 86 Education < High School High School/GED Some College 2 or 4-year College Degree Graduate/Professional College Trade/Technical/Vocational School 10352626712 0141631187 < .001 Annual Household Income 0 - $19,999 $20,000 - 39,999 $40,000 - 59,999 $60,000 - 79,999 $80,000 - 99,999 $100,000 - 149,999 $150,000 + 53201611431 51215991716 <.001 Insurance Type* Medicaid Medicare Medicare supplement Private None 604911330 113726393 <.001>.99<.001.20.15 *Patients could select more than one
DISCO app: Feasibility and acceptability of an intervention to reduce the financial burden of cancer in a diverse patient population.
Hamel, Lauren M. , Dougherty, David W. , Heath, Elisabeth I. , Mabunda, Lorna, Austin, Teneisha , Assad, Hadeel , Mamdani, Hirva, Bacall, Helda, Bouyer, Adrienne, Cackowski, Frank C. , Gogoi, Radhika, Goldman, Erica, Beal, Eliza W., Jarbo, Nouran, Angers, Keri, Eggly, Susan, Eggly, Susan , Kim, Seongho , Mabunda, Lorna, Mamdani, Hirva Mansurali , Hallak, Mohammed Najeeb Al , Gogoi, Radhika P. , Winer, Ira Seth , Beal, Eliza Wright

Journal of Clinical Oncology | May 28, 2026 | Volume: 44 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2026.44.16_suppl.e13729 Get It

e13729 Background: Financial toxicity, the burden of treatment cost, affects up to half of people with cancer and can affect survival. Financial toxicity is a health equity issue, disproportionately affecting Black patients. Patient education about cost and patient-provider cost discussions are recommended to mitigate financial toxicity but occur infrequently. The Discussions of Cost (DISCO) App, designed to mitigate financial toxicity through a tailorable education and communication intervention, was assessed for efficacy in an RCT with Black and White patients. Here we describe the DISCO App's feasibility and acceptability. Methods: Data were collected from 2021 to 2025 at an NCI-designated comprehensive cancer center. Participants were Black or White patients diagnosed with solid tumor cancers. While waiting to see their provider, patients randomized to the intervention arm used the DISCO App on a tablet. The DISCO App includes a video about treatment costs, ways to manage costs, and the importance of discussing costs with providers. Once patients enter their socio-demographic information (e.g., employment) and financial concerns, they receive a tailored list of cost questions to ask their provider. Patients responded to measures immediately after using the DISCO App. Feasibility was assessed by patient reports of how much time they needed to use the DISCO App and if they were able to use the DISCO App before the provider entered the exam room. Acceptability was measured by items assessing patient perceptions of the DISCO App (1 = strongly disagree; 5 = strongly agree). Descriptive statistics summarized results and mean comparisons were used to assess perceptions by patient self-identified race. Results: Of the 202 patients recruited, 124 were randomized to the intervention arm (67 Black patients; 57 White patients). All patients completed using the DISCO App prior to their provider entering the exam room and 80% of patients needed 15 minutes or less to use the DISCO App, with no difference by patient race. Black patients ( M = 4.4) reported finding the DISCO App more helpful than White patients ( M = 3.9; p = .02) and it brought up cost issues they had not considered (Black patients = 3.5; White patients = 3.0; p = .05). Patients reported the questions were easy to understand ( M = 4.4), helped them feel it was okay to talk with their provider about cost ( M = 4.0), that it prompted cost questions ( M = 3.3), that they learned what costs to consider (55%), and learned ways to manage cost (62%) with no differences by patient race. Conclusions: The DISCO App was feasible and acceptable to Black and White patients with cancer, with Black patients reporting more favorable perceptions than White patients. Next steps include assessing effectiveness in improving outcomes including prompting patient-provider treatment cost discussions and related financial toxicity outcomes (e.g., treatment adherence). Clinical trial information: NCT04766190 .
Gaps in access to chimeric antigen receptor T-cell (CAR-T) therapy post leukapheresis: Waiting time and post-leukapheresis treatment patterns in relapsed/refractory multiple myeloma (RRMM)—Real-world evidence from U.S. claims.
Ailawadhi, Sikander, Boytsov, Natalie, Multani, Jasjit, Zhou, Zifan , Niehoff, Nicole, Purser, Molly, Hartman, John, Palumbo, Teresa, Ailawadhi, Sikander , Boytsov, Natalie N. , Multani, Jasjit K. , Purser, Molly F. , Hartman, John, Chen, Chi‐Chang

Journal of Clinical Oncology | May 28, 2026 | Volume: 44 | Issue: 16_suppl | Pages: 7530-7530

10.1200/jco.2026.44.16_suppl.7530 Get It

7530 Background: B-cell maturation antigen (BCMA)-directed CAR-T therapy is a highly effective treatment with potential for long-term remission of RRMM with improved outcomes vs daratumumab-based regimens. CAR-T suitability may be limited by delays/manufacturing failure and changes in pt condition, financial situation, or access to specialized treatment centers. We characterized pts with RRMM who underwent leukapheresis to prepare for CAR-T and pt treatment waiting time, to understand the delays incurred prior to CAR-T infusion. Methods: A real-world study in the US using the PharMetrics Plus claims database (July 2020–September 2024) was performed. Eligible pts were aged ≥18 years with RRMM, had their first leukapheresis claim (index date) during the index period (March 2021–August 2024), were continuously enrolled in medical/pharmacy benefits for ≥180 days prior to and ≥30 days after index date, and were not clinical trial participants. Pt characteristics, rate of CAR-T receipt, and time to CAR-T receipt were assessed during the variable follow-up. Results: Overall, 337 pts who received leukapheresis were identified. Median (interquartile range) age was 62 (55–67) years, and 59.1% of pts were male. Mean National Cancer Institute (NCI) comorbidity index was 0.52. Most pts received care in the Midwest (31.8%) or Northeast (24.6%) regions. Most pts (95.9%) received leukapheresis in an outpatient setting. Median available follow-up time was 255 days (mean 337 days). During follow-up, 183 pts (54.3%) did not receive CAR-T after leukapheresis. Among pts who had ≥12 months of follow-up (n=143), the proportion of pts who did not receive CAR-T was similar at 53.1% (n=76). Among pts who received CAR-T during the follow-up (n=154; 45.7%), the median waiting time was 54.0 days (mean 56.7 days). The cohort of pts who did not receive CAR-T had a higher proportion of females (48.6%/31.8%), were more likely to have Medicaid (29.5%/7.8%), had higher NCI comorbidity index (scores 0.55/0.47), and most commonly received care in the Northeast (35.5%/11.7%) while pts who received CAR-T most commonly received care in the Midwest (23.0%/42.2%). The most common first classes of multiple myeloma medications after leukapheresis but prior to CAR-T infusion in pts who did/did not receive CAR-T were an alkylating agent (65.6%/36.1%), proteasome inhibitor (40.3%/30.6%), steroid (38.3%/39.3%), immunomodulatory drug (22.7%/27.3%), anti-CD38 (20.8%/20.8%), and stem cell transplant (0%/17.5%). Conclusions: Over half of pts receiving leukapheresis did not receive CAR-T infusion, highlighting a persistent gap between eligibility and treatment delivery. These data emphasize an urgent need for broadly accessible BCMA-targeted therapies that provide deep and durable responses.
A phase 2 trial of androgen deprivation therapy interruption in patients responding exceptionally to androgen receptor pathway inhibitor in metastatic hormone-sensitive prostate cancer (A-DREAM / Alliance A032101).
Choudhury, Atish D. , Ballman, Karla V., Reimers, Melissa A., Laccetti, Andrew Leonard , Ravi, Praful, Xiao, Han, Dooley, Katharine, Hillman, DW, Gartrell, Benjamin, Steen, Preston D. , Smith, Thomas J., Beltran, H, Chen, Ronald C., Berg, S., McKay, Rana R., Galsky, Matthew D., Rosenberg, Jonathan E., Morris, M J, Choudhury, Atish D , Ballman, K., Reimers, Melissa A. , Smieliauskas, Fabrice , Ravi, Praful , Xiao, Han , Dooley, Katharine , Hillman, David W. , Mazza, Gina L , Gartrell, Benjamin A. , Smith, Thomas J. , McKay, Rana R. , Galsky, Matthew D. , Rosenberg, Jonathan E , Morris, Michael J.

Journal of Clinical Oncology | May 27, 2026 | Volume: 44 | Issue: 16_suppl | Pages: 5004-5004

10.1200/jco.2026.44.16_suppl.5004 Get It

5004 Background: Patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) treated continuously with testosterone suppression (TS) plus an androgen receptor pathway inhibitor (ARPI) can experience cumulative toxicity. We conducted this single-arm phase 2 trial (NCT05241860) to test the hypothesis that pts who achieve favorable response to TS + ARPI can have prolonged treatment-free interval with testosterone recovery after treatment interruption (TI). Here we report on the primary endpoint. Methods: Eligible pts had mHSPC by conventional imaging with prostate-specific antigen (PSA) ≥ 5 ng/ml and testosterone ≥ 150 ng/dl prior to starting TS+ARPI, with PSA < 0.2 ng/ml and testosterone < 50 ng/dl at the time of enrollment after having received TS for 540-750 days and ARPI for ≥ 360 days. Prior local therapy, radiation to metastases and docetaxel were permitted. After enrollment, pts discontinued TS and ARPI and were followed with PSA and testosterone levels every 3 months (mo), CT/MRI and bone scan at least every 6 mo, and FACT-P questionnaire for patient-reported outcomes (PROs) every 6 mo. Treatment was resumed for PSA ≥ 5 ng/ml, radiographic change (progressive disease [PD] per RECIST 1.1 on CT/MRI or unconfirmed PD per PCWG3 on bone scan), or prostate cancer-related symptoms. The primary endpoint was proportion of men remaining treatment-free 18 mo after TI with eugonadal testosterone ( > 150 ng/dl). Target enrollment was 75 pts to differentiate 18-mo treatment-free rates of 0.30 (H 0 ) and 0.45 (H a ). Results: Of 79 pts enrolled between 07/2022 and 03/2024, 78 were eligible and underwent TI. Among these 78, median PSA prior to starting TS+ARPI was 19 (range 5-6759), 27 (35%) had high volume disease, 31 (40%) never received local therapy, and 55 (71%) did not receive radiation to metastases. By 18 mo after TI, 67% (52/78) recovered testosterone and 58% (45/78) remained treatment-free; 41% (32/78) remained treatment-free with testosterone recovery (80% CI 33.5-48.9%, one-sided p 0.0249). At median follow-up of 21.2 mo, 35% (27/78) resumed initial TS+ARPI after meeting re-initiation criteria (of whom 1 required treatment switch for PD 9 mo later); 5% (4/78) resumed prior to meeting criteria; 9% (7/78) pursued alternative therapy instead of resuming TS+ARPI per protocol; 5% (4/78) withdrew; 1 died of myocardial infarction prior to resuming treatment. 4 pts died, 1 of prostate cancer. Conclusions: The primary objective was achieved with 41% of favorable responders to TS+ARPI remaining treatment-free with testosterone recovery at 18 mo after TI. Analyses of biomarkers and PROs are in progress, and pts will be followed for long-term outcomes. Support: U10CA180821, U10CA180882, UG1CA189823, https://acknowledgments.alliancefound.org, Veracyte Inc. Clinical trial information: NCT05241860 .
Association of baseline quality of life (QOL) and early death in patients with metastatic renal cell carcinoma (mRCC) in the real-world prospective observational ODYSSEY study.
Ged, Yasser, Maughan, Benjamin L., Bhavsar, Nrupen Anjan, Costello, Brian A. , Kilari, Deepak , Gupta, Sorab , Bratton, Melyssa, Monk, Paul, Vaishampayan, Ulka N., Rose, Tracy L., Jabusch, Sarah, Ward, Kimberly T., Wu, Yuan, PAGE, COURTNEY, Zhang, Tian, George, Daniel J., Group, ODYSSEY Study, Vaishampayan, Ulka N. , Vaishampayan, Ulka , Harrison, Michael R. , Wulff, Elizabeth, Ged, Yasser , Maughan, Benjamin L. , Bhavsar, Nrupen Anjan , Appleman, Leonard J. , Zakharia, Yousef , Bratton, Melyssa R. , Monk, Paul , Rose, Tracy L. , Jabusch, Sarah , Ward, Kimberly T., Page, Courtney B , Zhang, T., George, Daniel J.

Journal of Clinical Oncology | May 27, 2026 | Volume: 44 | Issue: 16_suppl | Pages: 4559-4559

10.1200/jco.2026.44.16_suppl.4559 Get It

4559 Background: Baseline QOL has been linked to survival in mRCC therapy clinical trials (Cella, 2024); however, there is a paucity of prospectively collected real-world QOL data across front-line management strategies. We used data from ODYSSEY to examine the relationship between baseline QOL and early death. Methods: ODYSSEY is a multi-site, prospective observational study of 468 US pts with mRCC. Pts must have mRCC (any histology); have no prior systemic therapy (ST) or be within 3 months of starting ST; and follow up at a PCORnet study site. Exclusion criteria include treatment for cancer except mRCC. The primary objective is to determine patterns of change in QOL and symptom burden of pts with mRCC. Early death was defined as death within 12 months post-enrollment. All pts with non-missing FKSI-19 or FKSI-DRS at enrollment were included. Cumulative event probabilities as a function of time were stratified by either < or ≥ median QoL value and plotted as a step function vs time since enrollment to create cumulative event curves. To determine association between QoL at enrollment and early death, separate Cox proportional hazards models (unadjusted and adjusted) for time-to-first-event as a function of baseline QoL were fit. The adjusted model controlled for the following baseline covariates: IMDC risk (favorable vs intermediate or poor), histology (clear cell vs non). Results: As of 1/5/26, 468 pts were enrolled; 425 had non-missing FKSI-19 or FKSI-DRS at enrollment (329 immediate ST, 96 deferred ST [DST]). ST included 129 IO-IO, 108 IO-TKI, 92 Other. DST included 57 Active Surveillance, 22 Local Therapy Planned, 17 Other/Missing. 209 and 190 pts have < median FKSI-19 (score = 59) and FKSI-DRS (score = 29), respectively; 216 and 235 pts have ≥ median FKSI-19 and FKSI-DRS, respectively. Those below the median have lower rates of nephrectomy, worse IMDC risk and KPS, shorter time since RCC diagnosis, and higher rates of bone metastasis (all p<0.05). Cumulative event probabilities for death at 12 months are 21% and 7% in those < and ≥ median baseline FKSI-19, respectively; and 21% and 7% in those < and ≥ median baseline FKSI-DRS, respectively. For FKSI-19, the unadjusted hazard ratio (HR) for early death is 0.55 (95% CI: 0.43 – 0.70; p<0.001) and adjusted HR is 0.65 (0.49 – 0.85; p = 0.002) per 1 SD higher score. For FKSI-DRS, the unadjusted HR for early death is 0.57 (95% CI: 0.46 – 0.71; p<0.001) and adjusted HR is 0.66 (0.51 – 0.86; p =0.002) per 1 SD higher score (higher score indicates better QOL). Conclusions: Across management strategies in our ODYSSEY cohort of systemic therapy naïve mRCC patients, better baseline QOL was associated with better survival. This is to our knowledge the largest reported real world mRCC cohort with prospectively collected PROs. Future analyses will focus on association of outcomes with longitudinal PROs. Clinical trial information: NCT04919122 .
Staged Versus Immediate Complete Revascularization in Patients With STEMI and Multivessel Disease: An Updated Meta-analysis of Randomized Controlled Trials With Trial Sequential Analysis
Majeed, Mir W., Humayun, Zainab , Joshi, Dhruvi , Murtafa, Khubaib Mohammad , Consoli, Leo, Arif, Mohammad S., Khanday, Sadiya S., Srinivasan, Rohit V., Ruelas, Mariano G., Ratan, Piyush , Wani, Shariq A., Ali, Bismah Azam, Zehra, Saima, Mantoo, Mohsin R., Changal, Khalid H., Vallabhajosyula, Saraschandra, Baqal, Omar , Majeed, Mir Wajid , Consoli, Leo , Arif, Mohammad Sameem, Khanday, Sadiya Sajad, Srinivasan, Rohit Vondivillu , Ruelas, Mariano Gallo , Waleed, Muhammad, Wani, Shariq Ahmad , Baqal, Omar J , Mantoo, Mohsin Raj , Changal, Khalid Hamid, Vallabhajosyula, Saraschandra

Critical Pathways in Cardiology: A Journal of Evidence-Based Medicine | May 22, 2026 | Volume: 25 | Issue: 2 | Pages: e0422

10.1097/hpc.0000000000000422 | PMID 42171331 Get It

Complete revascularization improves outcomes in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD); however, the optimal timing of noninfarct-related artery intervention during the index procedure, immediate revascularization (IR) versus a staged approach (SR), remains uncertain. We conducted a systematic review and meta-analysis of randomized controlled trials comparing SR and IR in patients with STEMI and MVD. The primary outcome was major adverse cardiovascular events. Secondary outcomes included all-cause and cardiovascular mortality, recurrent myocardial infarction, unplanned ischemia-driven revascularization, stent thrombosis, stroke, major bleeding, acute kidney injury, and heart failure hospitalization. Random-effects models with Hartung–Knapp adjustment were used. Trial sequential analysis assessed evidence conclusiveness, and the certainty of evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation. Eight randomized trials, including 5077 patients (2556 SR; 2521 IR), were analyzed. No significant differences were observed between SR and IR for major adverse cardiovascular events [odds ratios (ORs), 1.07; 95% confidence intervals (CI), 0.76–1.49], recurrent myocardial infarction (OR, 1.30; 95% CI, 0.80–2.14), cardiovascular mortality (OR, 0.76; 95% CI, 0.51–1.13), or all-cause mortality (OR, 0.75; 95% CI, 0.54–1.06). Rates of stent thrombosis, stroke, unplanned ischemia-driven revascularization, major bleeding, acute kidney injury, and heart failure hospitalization were also comparable. Trial sequential analysis indicated insufficient information size to draw definitive conclusions, and the certainty of evidence ranged from very low to low. In patients with STEMI and MVD, staged and immediate complete revascularization provide comparable ischemic, safety, and mortality outcomes. Current evidence supports clinical equipoise, and revascularization timing should be individualized pending results from adequately powered trials.