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2816 citation(s) found for "Nuño, Laura".

Mucinous Appendiceal Neoplasms and Pseudomyxoma Peritonei: Imaging Features and Current Therapies
Jorgenson, Laura C. , Wang, Sherry S. , Navin, Patrick J. , Favazza, Christopher , Venkatesh, Sudhakar K. , Fidler, Jeff L. , Fletcher, Joel G. , Ehman, Eric C. , Sheedy, Shannon P. , Navin, Patrick , Venkatesh, Sudhakar K , Fidler, Jeff L. , Fletcher, Joel G , Grotz, Travis E. , Graham, Rondell P.

RadioGraphics | May 29, 2025 | Volume: 45 | Issue: 6 | Pages: No page available

10.1148/rg.240131 | PMID 40440192 Get It

Radiologists are integral members of the interdisciplinary team for patients with mucinous appendiceal neoplasms and can directly affect care by suggesting the diagnosis of pseudomyxoma peritonei, optimizing imaging protocols for evaluating peritoneal implants, and reporting the primary tumor and spilled tumor cells thoroughly.
Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO).
Levy, Benjamin , Marinis, Filippo de , Bonanno, Laura, Chu, Quincy S. , Baik, Christina S. , Riess, Jonathan W. , Leventakos, Konstantinos , Yang, James C. , Sequist, Lecia V. , Barrett, K., Igwegbe, I., Xu, Wanning , Ahn, Myung‐Ju , Bonanno, Laura, Sacher, Adrian Gerold , Bironzo, Paolo , Bazhenova, Lyudmila , Tiseo, Marcello , Proto, Claudia , Yang, Cheng‐Ta , Hartmaier, Ryan James

Journal of Clinical Oncology | May 28, 2025 | Volume: 43 | Issue: 16_suppl | Pages: 8513-8513

10.1200/jco.2025.43.16_suppl.8513 Get It

8513 Background: The MET pathway is a known mediator of EGFR-TKI resistance and represents a therapeutic vulnerability to select MET-TKIs. Savo is an oral, highly selective MET-TKI that, when combined with osi, has the potential to overcome MET-driven resistance after progressive disease (PD) on osi. The Phase 2 SAVANNAH study has demonstrated clinically meaningful activity with the combination of savo + osi in patients (pts) with EGFR-mutated (EGFRm) advanced NSCLC and MET overexpression/amplification (NCT03778229). Isolating the efficacy of savo in the use of savo + osi is a key question for this combination. Methods: A subset of SAVANNAH included eligible pts who had EGFRm advanced NSCLC with MET overexpression (IHC 3+ intensity in ≥90% of tumor cells [IHC3+/≥90%]) and/or amplification (≥10 MET gene copies by FISH [FISH10+]) after PD on first-line (1L) osi; asymptomatic stable brain metastases (treated/untreated) were allowed. Pts were randomized 2:1 (double-blind) to savo 300 mg BID + osi 80 mg QD, or savo 300 mg BID + PBO (stratified by investigator [INV] assessed baseline [BL] brain metastases [yes/no]), until INV-assessed PD per RECIST 1.1. Brain imaging occurred at BL and PD; pts with brain metastases were re-imaged at each tumor assessment to PD. Endpoints included objective response rate (ORR), duration of response (DoR), and progression-free survival (PFS) by BICR and INV; CNS PFS, and presence/absence of CNS lesions at PD by BICR. Results: Overall, 73 pts were randomized (savo + osi n=48; savo + PBO n=25). At BL, median age: 67 vs 65 years, female: 73% vs 64%, White: 73% vs 52% in the savo + osi and savo + PBO arms, respectively. Efficacy outcomes (ORR, DoR, and PFS) were higher with savo + osi than savo + PBO (Table). CNS PFS events by CNS BICR occurred in 5/14 (36% savo + osi) and 2/4 pts (50% savo + PBO). In pts without BL brain metastases, none of the 13 pts (savo + osi) with RECIST PD by BICR had a new CNS lesion; 6/11 pts in the savo + PBO arm developed a new CNS lesion. Conclusions: In EGFRm advanced NSCLC with MET IHC3+/≥90% and/or FISH10+ status after PD on 1L osi, efficacy of savo 300 mg BID + osi was numerically greater than savo + PBO and showed promising CNS activity. To date, this is one of the largest randomized data sets presented evaluating an oral MET-TKI in EGFRm NSCLC. Efficacy findings from SAVANNAH suggest that targeting both EGFR and MET is key and support further investigation of savo + osi and CNS activity in the Phase 3 SAFFRON study. Clinical trial information: NCT03778229 . Assessment Savo + osi (n=48) Savo + placebo (n=25) ORR, % (95% CI) BICR 58 (43, 72) 16 (5, 36) INV 54 (39, 69) 24 (9, 45) DoR, mo, median (95% CI) BICR 11.8 (6.0, NC) 4.5 (2.6, NC) INV 8.0 (4.9, 11.7) 4.2 (2.6, NC) PFS, mo, median (95% CI) BICR 8.3 (5.8, 15.1) 3.6 (1.4, 5.7) INV 7.6 (5.6, 11.0) 2.7 (1.4, 4.1) BICR, blinded independent central review; CI, confidence interval; mo, months; NC, not calculable.
Concordance between blinded independent central review committee and physician-assessed responses: Analyses based on a real-world external control arm in relapsed/refractory multiple myeloma using International Myeloma Working Group data.
Durie, Brian G.M. , Siddiqui, Muhaimen, Bonar, Nicolle , Spin, Paul , Green, Jeannette, Kroog, Glenn S. , Ma, Qiufei , Kumar, Shaji , Rosiñol, Laura , Weisel, Katja C , Jagannath, Sundar , Shokoohi, Mostafa , West, Michael, Hampp, Christian , Harnett, James , Humblet, Olivier , Breskin, Alexander

Journal of Clinical Oncology | May 28, 2025 | Volume: 43 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2025.43.16_suppl.e19521 Get It

e19521 Background: Blindedindependent central review (BICR) committees are often established for oncology trials to assessbestoverall response (BOR), while real-world (RW) studies typically rely on physician-assessed responses. To emulate clinical trial rigor, a BICR committee was implemented in the R5458-ONC-21101 RW data-derived external control arm study (NCT05673967) to evaluate BOR using International Myeloma Working Group (IMWG) criteria. A pre-specified concordance analysis compared BOR assessments between the BICR committee and treating site physicians. Methods: RW data were obtained from chart reviews at 15 participating International Myeloma Foundation IMWG sites. The BICR committee, comprised of three multiple myeloma experts, evaluated BOR through consensus voting. Per protocol, the committee reviewed case report forms consisting of data on serum and urine myeloma protein and free light chain levels; and, where available, bone marrow plasma cell percentage, presence of plasmacytomas, and bone lesion changes. Concordance between BICR- and physician-assessed BOR was evaluated for objective response rate defined as ≥partial response (PR), ≥very good partial response (VGPR), ≥complete response (CR), and stringent complete response (sCR), with non-evaluable responses excluded from the analysis. Cohen’s kappa (κ) was used to measure agreement, with values >0.6 indicating strong concordance. 1 Results: Of 279 evaluable lines of therapy from 203 patients (Table), the BOR of ≥PR was 45.2% by BICR assessment and 42.3% by treating physicians (κ=0.622). Concordance improved for BOR of ≥VGPR (22.2% by BICR vs 24.7% by treating physicians; κ=0.731) but was low for BOR of ≥CR (3.9% vs. 10.8%; κ=0.508) and sCR (1.1% vs. 4.7%; κ=0.364). Conclusions: BICR- and physician-assessed responses showed strong concordance for BOR of ≥PR and ≥VGPR. However, as expected, lower concordance for ≥CR and sCR was observed, as evaluation of CR per IMWG criteria requires a bone marrow biopsy, which is rarely performed in clinical practice. While the reliability of CR and sCR in RW data is less certain, these results suggest that BOR of ≥VGPR or ≥PR may be reliably ascertained in academic settings based on treating physician evaluations. 1. Landis JR, Koch GG. Biometrics 1977;33(1):159–74. Clinical trial information: NCT05673967 . Agreement of BICR- and physician-assessed responses. BICR assessed Physician assessed Observed agreement, % Cohen’s kappa* Number of evaluable lines of therapy 279 279 - - ≥PR, n (%) 126 (45.2) 118 (42.3) 81.4 0.622 ≥VGPR, n (%) 62 (22.2) 69 (24.7) 90.3 0.731 ≥CR, n (%) 11 (3.9) 30 (10.8) 93.2 0.508 sCR, n (%) 3 (1.1) 13 (4.7) 96.4 0.364 *A kappa value >0.6 indicates strong concordance. 1
Evaluation of eligibility criteria in randomized controlled trials for chronic lymphocytic leukemia over 15 years.
Budvytyte, Laura, Islam, Nadia, Hilal, Talal

Journal of Clinical Oncology | May 28, 2025 | Volume: 43 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2025.43.16_suppl.e23024 Get It

e23024 Background: Efforts to address disparities in clinical trial participation have increased over the past 30 years. Strict eligibility criteria in phase III interventional trials may exacerbate these disparities, limiting access and raising concerns about generalizability. Chronic lymphocytic leukemia (CLL), the most common chronic leukemia in adults, primarily affects older individuals and those with comorbidities, emphasizing the need for inclusive research. This study aimed to explore changes in eligibility criteria for phase III interventional CLL trials over 15 years. Methods: Clinical trial data were obtained from ClinicalTrials.gov, focusing on Phase 3 interventional studies related to CLL. The search used "chronic lymphocytic leukemia," filtered for adults aged 18–64 and older adults aged 65+. Trials enrolling patients between January 1, 2004, and December 1, 2019, were included. Trial designs, endpoints, and eligibility criteria were primarily extracted from published protocols when available and supplemented with information from ClinicalTrials.gov. Studies not specific to CLL, those evaluating supplements or vaccines, lacking a control arm, being single-center, or without investigational products were excluded from the data analysis. Data were grouped into three periods (2004–2008, 2009–2013, 2014–2019), and one-way ANOVA was used to assess differences in average eligibility criteria across these periods. Results: A total of 103 clinical trials were identified, with 47 included in the final analysis. Most were industry-funded (37 trials, 81%), while 10 (19%) were non-industry-funded. Regarding treatment settings, 60% targeted untreated patients, 32% focused on relapsed/refractory patients, and 9% included both. Interventions included chemoimmunotherapy (40%), targeted therapies (21%), combined approaches (36%), and other types (2%). The average number of eligibility criteria increased over time: 23.86 (IQR 14; range 12–39) in Period 1, 32.05 (IQR 19; range 18–59) in Period 2, and 46.25 (IQR 26.5; range 13–70) in Period 3. One-way ANOVA confirmed a significant difference across periods (F = 7.35, p < 0.001), showing a significant increase in the average number of criteria over time. Conclusions: Over 15 years, the number of eligibility criteria in phase III interventional CLL trials significantly increased, nearly doubling from 23.86 (2004–2008) to 46.25 (2014–2019). While this may improve internal validity, it risks excluding older patients and those with comorbidities, who are most affected by CLL. These findings highlight the need to balance scientific rigor with equitable access to ensure generalizability.
Comparative effectiveness of delivering early palliative care via video versus in-person on end-of-life outcomes in patients with advanced lung cancer.
Bauman, Jessica R. , El‐Jawahri, Areej , Rinaldi, Simone , Jackson, Vicki A. , Gallagher-Medeiros, Emily R., Rabideau, Dustin J. , Strand, Jacob J. , Zachariah, Finly , Shoemaker, Laura, Spoozak, Lori , Grey, Carl, Curseen, Kimberly , Szmuilowicz, Eytan , Rhodes, Ramona L. , Cullinan, Amelia , Horick, Nora , Bakitas, Marie , Jewett, Brianna, Temel, Jennifer S. , Greer, Joseph Andrew

Journal of Clinical Oncology | May 28, 2025 | Volume: 43 | Issue: 16_suppl | Pages: 1649-1649

10.1200/jco.2025.43.16_suppl.1649 Get It

1649 Background: Findings from our prior large-scale comparative effectiveness trial showed the equivalent effect of delivering early palliative care via video versus in-person on quality of life among patients with advanced non-small cell lung cancer (NSCLC). We now report on whether the two care delivery modalities were equivalent with respect to patient-reported communication with clinicians about their end-of-life (EOL) care preferences and hospice utilization. Methods: Between 6/14/2018 and 5/4/2023, we enrolled 1250 patients with newly diagnosed advanced NSCLC in a randomized trial of early palliative care across 22 US cancer centers. Patients were randomly assigned to meet with a palliative care clinician every 4 weeks from enrollment through the course of the disease, either via video or in the outpatient clinic. Participants completed self-report surveys at baseline and weeks 12, 24, 36, and 48, including an item asking if they had discussed with their clinicians the care they would want to receive if dying (yes/no); patients’ final assessments prior to death or last follow up were analyzed. We reviewed patients’ health records to collect data on hospice referral and length of stay. To test the equivalence in these outcomes, we used a binomial generalized linear model with the identity link function (pre-specified equivalence margin of ±8% for patient-reported communication about EOL care) and linear regression (pre-specified equivalence margin of ±6 days for mean length of stay in hospice). P-values were adjusted for multiplicity using a Bonferroni correction. Results: Of the 1250 enrolled participants, 888 (71.0%) completed at least one survey post baseline regarding whether they communicated with clinicians about EOL care preferences. Among those, 29.1% of the video group and 26.0% of the in-person group reported “yes,” indicating that they recalled such EOL care discussions (difference = 3.1%, 95% CI: -1.8%, 8.1%; p = 0.26 for equivalence). During the course of the trial, 733/1250 (58.6%) patients died, of whom 537/733 (73.3%) were referred to hospice. Mean lengths of hospice stay were 25.3 days for the video group versus 25.1 days for the in-person group (difference = 0.2, 95% CI: -7.0, 7.4; p = 0.46 for equivalence). When excluding outlying patients receiving hospice services > 180 days (n = 13), the mean lengths of hospice stay were 19.1 (video group) versus 19.7 (in-person group) days (difference = -0.6, 95% CI: -4.6, 3.3; p = 0.06 for equivalence). Conclusions: Although thresholds were not met to confirm equivalence statistically, the two modalities for delivering early palliative care demonstrate very similar outcomes with respect to patient-clinician communication about EOL care and hospice utilization. These findings provide further evidence of the utility of video visits for providing high quality palliative and EOL care. Clinical trial information: ClinicalTrials.gov Identifier ( NCT03375489 ) .
Serum estradiol (sE2) levels in premenopausal (PreM) women receiving neoadjuvant ovarian function suppression (OFS) with the oral SERD amcenestrant, alone, or in combination with letrozole or abemaciclib in the I-SPY2 Endocrine Optimization Pilot (EOP).
Chien, Jo, Norwood, Peter, Wei, Mei , Chen, Nan , Borowsky, Alexander D. , Melisko, Michelle , Mukhtar, Rita A. , Giridhar, Karthik V. , Goetz, Matthew P. , Vaklavas, Christos , Elias, Anthony , Rugo, Hope S. , Swigart, Lamorna Brown , Shatsky, Rebecca , Huppert, Laura Ann , Esserman, Laura J.

Journal of Clinical Oncology | May 28, 2025 | Volume: 43 | Issue: 16_suppl | Pages: 604-604

10.1200/jco.2025.43.16_suppl.604 Get It

604 Background: The addition of OFS to standard endocrine therapy (ET) improves iDFS for preM women with early-stage hormone receptor positive (HR+) breast cancer (BC). Incomplete OFS occurs in a subset of women, the long-term clinical significance of which is unclear. This study evaluates local sE2 levels in preM women receiving OFS with an oral SERD in the neoadjuvant (NA) setting. Methods: The EOP is a I-SPY2 sub-study investigating NA endocrine-based strategies in pts with HR+ HER2- Stage 2/3 BC predicted to have lower benefit from chemotherapy. Pts were randomized to oral amcenestrant 200 mg/d, alone or in combination with either letrozole 2.5 mg/d or abemaciclib 150 mg bid. Additional pts were randomized to a standard of care (SOC) arm consisting of an aromatase inhibitor. All PreM pts received OFS with monthly GnRHa up to 2 wks prior to C1D1 of study therapy. Pts were treated for 6 months prior to surgery. sE2 levels were collected locally prior to each GnRHa injection. Tumor Ki67 was assessed at 3 weeks and surgery, and associated with sE2 level. Statistical significance was determined using a two-sided Student’s t-test and a significance level 0.05. Results: Between 5/2021-8/2022, 74 pts were enrolled to an amcenestrant containing arm, 40 of whom were preM. 38/40 pts had at least one local sE2 level measured in follow up. Of these 38 pts (median age 45 years), 37 suppressed sE2 into the postmenopausal (postM) range at one or more follow-up timepoints. Of the 37 pts that completely suppressed into the postM range, 6 pts had sE2 levels rebound into the preM range (mean 319 pg/mL, range 20-848 pg/mL) with peak sE2 levels occurring at a median of 12 weeks from C1D1. One pt never suppressed to the postM range (peak sE2 1227 pg/mL) and was found to have an ovarian cyst after 3 months on amcenestrant, requiring surgery. One additional pt had multiple ovarian cysts (sE2 84 pg/mL). Median age of the 7 pts who had sE2 rebound was 43 years. There was no significant difference in Ki67 at 3 weeks and surgery between pts whose sE2 levels remained suppressed (median Ki67 2.0%) compared to those whose estradiol rebounded into the preM range or never suppressed (median Ki67 1.5%). In the 5 pts whose sE2 rebounded to > 200 pg/mL, all pts had tumor Ki67 < 10% at 3 weeks and surgery. Between 12/2022 and 8/2023, 20 pts were enrolled to AI +/- OFS and 11 pts were preM. Of the 11 preM pts, all pts suppressed sE2 to the postM range. No SOC patients had sE2 levels rebound into the preM range. Conclusions: In this study of neoadjuvant oral SERD with monthly OFS, 7/38 (18.4%) preM pts had sE2 levels remain or rebound into the preM range. sE2 levels did not appear to impact Ki67 suppression on NA ET. Work up for ovarian cysts should be considered in pts with symptoms, or significantly elevated or persistent sE2 levels. Clinical trial information: NCT01042379 .
I-SPY2 endocrine optimization pilot (EOP): Neoadjuvant lasofoxifene (Laso) in molecularly selected patients with hormone receptor positive (HR+)/HER2 negative (HER2-) stage 2/3 breast cancer (BC).
Wei, Mei , Veer, Laura van ‘t , Alkhafaji, Silver , Hirst, Gillian L. , Chen, Nan , Borowsky, Alexander D. , Chien, Jo, Hirst, Gillian L , Elias, Anthony , Giridhar, Karthik V. , Goetz, Matthew P. , Mukhtar, Rita A. , Vaklavas, Christos , Veer, Laura J. van’t , Rugo, Hope S. , Symmans, W. Fraser , Swigart, Lamorna Brown , Onishi, Natsuko , Yee, Douglas , Hylton, Nola M. , Esserman, Laura J.

Journal of Clinical Oncology | May 28, 2025 | Volume: 43 | Issue: 16_suppl | Pages: 612-612

10.1200/jco.2025.43.16_suppl.612 Get It

612 Background: EOP, an I-SPY2 sub-study, evaluates the tolerability and activity of novel endocrine strategies in stage 2/3 breast cancer (BC) patients (pts) predicted to have lower chemotherapy benefit. Laso, a selective estrogen receptor modulator (SERM), has shown favorable toxicity profile and activity in HR+/HER2- endocrine-resistant metastatic BC. Methods: Pts with Stage 2/3 HR+/HER2-, MammaPrint (MP) low risk BC were enrolled. Pts with MP High1 BC were included if clinically node-negative. Pts received oral laso 5 mg daily for six 28-day cycles. Laso was continued until the day prior to surgery. Premenopausal pts received ovarian function suppression (OFS) starting C2D1. The primary endpoint was feasibility (>75% of patients completing >75% study therapy). Baseline (T0), 3-wk (T1) biopsies, and the surgical specimen (T3) was assessed centrally for Ki-67. Breast MRI functional tumor volume (FTV) was performed at T0, T1, 12 weeks (T2), and pre-operatively (T3). Blood was collected for tumor informed ctDNA at T0, T1, T2, T3. Advance event (AE) was assessed using CTCAE V5. Results: From 3/2023 to 5/2024, 20 pts were enrolled. Median age 50.5 years, 50% premenopausal, and 1 male pt. 60% cN0, 80% MP low-risk signature. 18 (90%) pts completed >75% study therapy. Two pts discontinued treatment due to pt preference. Median Ki67 at T0 was 14.7%. At T1, 87.5% of pts remained or suppressed Ki67 to <10% and 37.5% suppressed to <2.7%. Ki67 at T1 was similar between pre-and postmenopausal pts despite OFS (Table). The median MRI FTV was 8.4 cc at T0, and 3.4 cc at T3. Median % FTV reduction from T0 to T3 was -47.5%. 2/20 pts (10%) achieved a modified PEPI score of 0. No patients achieved completed pathological response. Of the 16 pts with RCB results, 2 (12.5%) RCB-1, 6 (37.5%) RCB-2, 8 (50%) RCB-3 disease. 14 pts had ctDNA available at T0. 4/14 were ctDNA+ at T0, 2 of whom became ctDNA negative, and 2 remained ctDNA+. 10/14 pts were ctDNA negative at T0, 8 of whom remained negative, 2 became positive at T1 then cleared. All AEs were grade(G) 1 except 1 pt with G2 hot flashes. Most common AEs include hot flashes (85%), constipation (50%), fatigue (50%), and nausea (35%). One pt had G3 hypersensitivity and hypertension, both unrelated to therapy. Conclusions: Neoadjuvant laso demonstrates a favorable AE profile and promising anti-tumor activity in suppressing 3-wk Ki67 and MRI FTV change in pts with HR+ HER2-negative early BC. Ki67 suppression in premenopausal pts was seen in the absence of OFS. Clinical trial information: NCT01042379 . Ki67 expression at pre-treatment, and 3-wk time point. All Patients(n=20) Premenopausal (n=10) Postmenopausal (n=9) Median Ki67 expression Baseline 10.0% 12.5% 10.0% 3-wk 5.1% 3.0% 6.0% Number of pts with Ki67 expression <10% at 3-wk 87.5% 1 87.5% 85.7% Number of pts with Ki67 expression <2.7% at 3-wk 37.5% 50% 28.6% 1 Include the one male pt.
Early adverse symptoms to predict response to treatment among patients in the I-SPY trial.
Umashankar, Saumya , Roy, Ritu , Ruddy, Kathryn J. , Olshen, Adam B. , Michele, Angela De, Perlmutter, Jane , Hylton, Nola, Veer, Laura van ‘t , Melisko, Michelle , Advocates, I-SPY Trial Investigators and Patient, Basu, Amrita B , Wolf, Denise M. , Yau, Christina , Blaes, Anne , Yee, Douglas , Veer, Laura J. van’t , Shatsky, Rebecca , Isaacs, Claudine , Rugo, Hope S. , Esserman, Laura J. , Hershman, Dawn L. , Advocates, I-SPY Trial Investigators and Patient

Journal of Clinical Oncology | May 28, 2025 | Volume: 43 | Issue: 16_suppl | Pages: 610-610

10.1200/jco.2025.43.16_suppl.610 Get It

610 Background: The adverse event (AE) landscape in oncology is changing due to the introduction of immunotherapy and antibody drug conjugates. These AEs come with both short and long-term symptoms that significantly impact patient quality of life. Monitoring for early onset of symptoms could optimize therapy for a particular patient, maximizing potential efficacy while mitigating toxicity. It is also possible that some toxicities are directly associated with drug sensitivity. We sought to identify symptoms associated with pathologic complete response (pCR) using patient-reported outcomes (PROs) in early-stage high-risk breast cancer patients. Methods: Our study population included 288 stage II/III high-risk breast cancer patients enrolled on the I-SPY2 trial from 2021-2024, who received novel neoadjuvant therapies ± standard paclitaxel. pCR was assigned if tumor was absent in breast and nodes at surgery following neoadjuvant treatment. Patients (n = 288, pCR rate = 29%, 89% administered immunotherapy) were sent electronic PROs. 33 patient-reported AEs were measured using NCI's Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE). Each symptom was evaluated using severity, frequency, and interference on a Likert Scale. Presence of early PRO symptoms (cycles 1-3 of treatment) were binarized (at least one of moderate or greater), and odds ratios were computed with pCR as outcome. To assess whether higher grade AEs were enriched in patients that achieved a pCR, we also performed the Wilcoxan rank sum test using maximum (worst) symptom severity. Results: Of 288 patients included in our analysis (median age = 48 years, range = 20-78), 203 (70.5%) were White, 17 (5.9%) were Asian, 33 (11.5%) were Black or African American, and 35 (12.2%) were Hispanic. PRO analysis revealed that patients that had moderate to severe muscle pain (27% vs 10% OR = 3.15, p < 0.05), joint pain (22% vs 8% OR = 3.23, p < 0.05), headache (27% vs 12.5% OR = 2.59, p < 0.05), or mouth/throat sores (16% vs 5% OR = 3.56, p < 0.05) within weeks 1-3 had higher odds of achieving a pCR. When we looked at maximum severity between weeks 1-3, patients that achieved a PCR had higher grade muscle pain (p = 0.04), heart palpitations (p = 0.035), and significantly lower grade numbness and tingling (p = 0.002). Beyond 6 weeks, associations were weaker or insignificant. Conclusions: Our study utilizes an analysis framework that was able to determine sentinel symptoms such as muscle and joint pain, mouth/throat sores and palpitations as early as weeks 1-3 associated with increased efficacy. This may suggest an early immune reaction in patients that eventually respond favorably to treatment. Our work can help provide earlier proactive monitoring to mitigate toxicities, treatment redirection if needed, and a potential symptom-based early understanding to personalize treatment efficacy. A similar analysis is underway to predict immune related AEs. Clinical trial information: NCT01042379 .
ELEPHAS-01, ELEPHAS-02 and ELEPHAS-04: Multi-institutional observational prospective clinical trials to assess the accuracy of an ex vivo live tumor fragment platform for predicting immunotherapy response.
Hernan, Hilary, Wang, Valerie, Costa, Catarina , Derrick, Jackie, Tarlazzi, Rebecca, Léonard, A., Hrycyniak, Laura , Caenepeel, Sean , Toia, Giuseppe Vincenzo, Mukhopadhyay, Debabrata, Advani, Pooja , Gierman, Hinco J. , Derrick, Jackie, Leonard, Ann C., Korrer, Michael J. , Chandra, Tarun, Ziemlewicz, Timothy J. , Lubner, Sam Joseph , Kokabi, Nima , Toia, Giuseppe V.

Journal of Clinical Oncology | May 28, 2025 | Volume: 43 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2025.43.16_suppl.tps2689 Get It

TPS2689 Background: Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment. However, existing FDA approved companion diagnostic biomarkers like PD-L1, dMMR/MSI-H and TMB have low accuracy in predicting response. Ex vivo cytokine profiling of live tumor samples has shown promise as an improved means of predicting response to PD-1 blockade (Voabil, et al. Nat Med. 2021), but this approach has been limited to tumor resections given the need for large amounts of tissue. Here we present three clinical trials that leverage a novel approach using limited tissue from a single core needle biopsy (CNB) (20 gauge or larger). A sequential ex vivo treatment strategy is used, eliminating the need for a separate control arm and addressing challenges with tumor heterogeneity, particularly in CNBs where tissue is limiting. Using a specialized instrument, CNBs are cut into live tumor fragments (LTFs) which are viable in culture and retain the native tumor microenvironment, enabling cytokine profiling in response to ICI treatment ex vivo. Methods: ELEPHAS-01 (NCT05478538), ELEPHAS-02 (NCT05520099) and ELEPHAS-04 (NCT06349642) are observational prospective clinical trials initiated to characterize the accuracy of this approach for predicting ICI response. Over 750 patients that are being considered for standard of care (SOC) ICI therapy in the metastatic/relapse or neoadjuvant setting will be enrolled (Table). Fresh live CNBs are collected prior to treatment start and processed within 24 hrs enabling prediction of results within 72 hrs of receipt. LTFs are treated using a strategy where control (IgG) and SOC ICI treatments are performed sequentially on the same tissue in a single well. Changes in the cytokine secretion rates are then compared between ICI and control to characterize immunotherapy response. Additionally, tissue viability and tumor content measurements are used to assess tissue quality. Clinical response is measured using pathologic response in patients receiving neoadjuvant ICI therapy, while RECIST v1.1 is used in all other patients. The primary objective of these trials is to determine the platform’s ex vivo accuracy (e.g., sensitivity, specificity) for predicting clinical response to ICIs and comparing it to the accuracy of PD-L1, dMMR/MSI-H and TMB. Clinical trial information: NCT06349642 , NCT05478538 , NCT05520099 . ELEPHAS-01 (Lung) ELEPHAS-02 (Hoosier) ELEPHAS-04 (Mayo) Setting Metastatic & recurrent Metastatic & recurrent Metastatic, recurrent & neoadjuvant Tumor type Lung Bladder, kidney, colorectal, head and neck, lung, melanoma, endometrial Metastatic/recurrent: lung, skin, esophageal, cervical, endometrial, colon, liver, kidney, bladder Neoadjuvant: breast–TNBC, lung Enrollment as of 1/27/2025 26 44 20 Est. total enrollment 216 216 324 Clinical endpoints RECIST v1.1 RECIST v1.1 RECIST v1.1 & Pathologic response at surgery
Advancing the science of cancer in Latinos.
Jones, Rebecca , Banegas, Matthew P., Camargo, M. Constanza , Colón‐Otero, Gerardo , Despres, Cliff , Mendoza, Martín, Recio‐Boiles, Alejandro , Segarra-Vázquez, Barbara , Stanford, Sandi, Orozco, Nicolette M, Trapido, Edward , Ramirez, Amelie G , Fejerman, Laura , Lynce, Filipa , Moreno, Patricia I. , Stern, Mariana Carla , Tossas, Katherine Y.

Journal of Clinical Oncology | May 28, 2025 | Volume: 43 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2025.43.16_suppl.e13808 Get It

e13808 Background: Cancer is a leading cause of death for Latinos. They experience higher rates than their white peers of preventable, infectious-agent-causing-cancers, such as stomach & liver cancer. Latina women have experienced a 1% rise in cancer cases since 2011 & Latino children & adolescents experience higher rates of leukemia than any other racial/ethnic group. Latinos face disparities in access to healthcare, cancer screening & treatment, medical representation & experience lower rates of survival due to late-stage cancer diagnosis. Methods: To combat these inequities & identify equitable interventions for Latino health, the Institute of Health Promotion Research & the Mays Cancer Center established the Advancing the Science of Cancer in Latinos (ASCL) Conference. The fourth ASCL Conference convened in San Antonio, TX from February 21-23, 2024. The conference objectives were 1) Examine the intersection of health equity & biological underpinnings in cancer control, prevention, and treatment 2) Foster collaborative initiatives among attendees aimed at addressing cancer-related health disparities within the Latino community. The conference hosted 286 participants (speakers, researchers, physicians, healthcare professionals, patient advocates & students). It comprised of 23 sessions (3 keynotes, 6 plenaries, 6 breakouts, 3 general sessions, 1 special session, 1 lunch panel session) featuring insights from 51 speakers, a poster session highlighting 80 research abstracts & a rapid-fire session tailored for early-career investigators. Sessions focused on multiple topics relevant to Latino cancer research, clinical trials, survivorship, patient advocacy, climate change impacts on cancer, precision medicine, health policy & social determinants of health. Results: A post-conference survey from a cohort of 48 respondents underscored high levels of satisfaction, with 90% expressing contentment regarding the conference experience. Nearly all respondents (98%) rated the relevance of conference content to Latino cancer science as excellent, with 93% regarding the conference as an exceptional platform for information exchange. Impressions regarding session quality were positive, with 90% of respondents indicating a high level of satisfaction, & all survey respondents acknowledging the objectivity, balance & absence of commercial bias in the session content. Conclusions: Results showed that the resounding positivity in attendee feedback reflects the conference's success in fostering meaningful engagement among attendees. The ASCL conference facilitated an understanding of cultural nuances and barriers specific to the Latino community, stimulating collaborative efforts aimed at enhancing Latino health outcomes. Overall, this analysis affirms the conference's success in achieving its stipulated objectives and underscores the need of having consistently coordinated research endeavors to reduce Latino health disparities.