{"title":"Final Survival Outcomes With Ramucirumab Plus Erlotinib Versus Placebo Plus Erlotinib in Patients With Untreated EGFR-Mutated Metastatic NSCLC: RELAY Japanese Subset","authors":"Makoto Nishio MD, PhD , Takashi Seto MD, PhD , Martin Reck PhD , Edward B. Garon MD , Kazuto Nishio MD, PhD , Kazuo Kasahara MD, PhD , Kazumi Nishino MD, PhD , Miyako Satouchi MD, PhD , Kiyotaka Yoh MD , Hidetoshi Hayashi MD, PhD , Kazuko Sakai PhD , Sotaro Enatsu MD, PhD , Bente Frimodt-Møller MSc , Tomoko Matsui , Sunoj Chacko Varughese MSc , Michelle Carlsen MS , Carla Visseren-Grul MD , Kazuhiko Nakagawa MD, PhD","doi":"10.1016/j.jtocrr.2025.100819","DOIUrl":"10.1016/j.jtocrr.2025.100819","url":null,"abstract":"<div><h3>Introduction</h3><div>Significant improvement in progression-free survival (PFS; primary end point) was reported in the phase 3 RELAY study with ramucirumab (RAM) plus erlotinib (ERL) versus placebo (PL) in untreated <em>EGFR</em>-mutated NSCLC (hazard ratio [HR] = 0.59, 95% confidence interval [CI]: 0.46–0.76, <em>p</em> < 0.0001), including in the Japanese subset. We report updated PFS and final overall survival (OS) for the Japanese subset.</div></div><div><h3>Methods</h3><div>Patients (no central nervous system metastases) were randomized 1:1 (stratification included <em>EGFR</em> leucine to arginine substitution [L858R]/exon 19 deletion [ex19del]) to ERL (150 mg/d) with RAM (10 mg/kg; n = 106) or PL (n = 105) intravenously every 2 weeks. The study was not powered for OS.</div></div><div><h3>Results</h3><div>At final OS data cutoff (median follow-up = 48.2 mo), PFS benefit was sustained with RAM plus ERL versus PL plus ERL (median [m] PFS: 19.4 versus 11.2 mo; HR = 0.69, 95% CI: 0.51–0.93); the mOS was 54.3 and 46.0 months (HR = 0.91, 95% CI: 0.65–1.26), respectively. In L858R (n = 110) and ex19del (n = 100) subgroups, the mOS was 54.3 versus 43.2 months (HR = 0.63, 95% CI: 0.40–0.99) and 53.9 versus 62.1 months (HR = 1.40, 95% CI: 0.86–2.28), respectively. T790M rates post-progression were 52.0% versus 51.1%, respectively. Osimertinib as subsequent therapy was received by 61.0% versus 55.2% patients (L858R: 58.2% versus 48.1%; ex19del: 65.3% versus 62.7%); the median (range) osimertinib treatment duration was 16.8 (0.7–58.3) versus 20.1 (2.1–77.2) months. Safety was consistent with known RAM and ERL profiles, with no increased toxicity over time.</div></div><div><h3>Conclusions</h3><div>The Japanese subset reported that RAM plus ERL improved PFS, and a mOS greater than 50 months was achieved. OS differed by <em>EGFR</em> mutation type, with an indication of benefit for patients with L858R.</div></div><div><h3>Trial Registration</h3><div>NCT02411448</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 6","pages":"Article 100819"},"PeriodicalIF":3.0,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143905985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Phase 2 Trial of Combination Radiotherapy and Pembrolizumab Plus Chemotherapy in Patients With Previously Untreated Metastatic NSCLC: NJLCG 1902","authors":"Yoko Tsukita MD, PhD , Rei Umezawa MD, PhD , Taku Nakagawa MD, PhD , Akira Anbai MD, PhD , Tomonori Makiguchi MD, PhD , Hisashi Tanaka MD, PhD , Yosuke Horii MD, PhD , Aya Suzuki MD , Ryo Morita MD, PhD , Hitomi Nogawa MD , Hiroshi Yokouchi MD, PhD , Nozomu Kimura MD, PhD , Keiichi Jingu MD, PhD , Akira Inoue MD, PhD , Hisatoshi Sugiura MD, PhD , Eisaku Miyauchi MD, PhD","doi":"10.1016/j.jtocrr.2025.100817","DOIUrl":"10.1016/j.jtocrr.2025.100817","url":null,"abstract":"<div><h3>Introduction</h3><div>Treatment strategies that enhance the efficacy of immunotherapy are desired. Radiotherapy can enhance immunity, but the utility of adding radiotherapy to immunotherapy plus platinum-doubled chemotherapy in patients with metastatic NSCLC has not been explored.</div></div><div><h3>Methods</h3><div>This multicenter, single-arm phase 2 trial evaluated the efficacy and safety of combining radiotherapy with pembrolizumab plus chemotherapy in patients with previously untreated metastatic NSCLC. Patients begin receiving pembrolizumab plus platinum-doublet chemotherapy within 1 week of starting radiotherapy (30 Gy in 10 fractions). The primary end point was the 12-month progression-free survival (PFS) rate. The secondary end points included PFS, overall survival, and toxicity profiles.</div></div><div><h3>Results</h3><div>Forty patients were enrolled. In total, 37 and 38 patients were analyzed for efficacy and safety, respectively. The 12-month PFS rate was 44.3% (90% confidence interval [CI]: 30.3–57.3), which met the primary end point. The median PFS was 8.4 months (95% CI: 5.7–22.2), and the median overall survival was 30.1 months (95% CI: 22.3–not reached). Grade 3 or 4 adverse events occurred in 25 patients (65.8%), and one treatment-related death was reported. Pneumonitis was reported in 10 patients (26.3%), including two cases of grade 3 pneumonitis and one case of grade 5.</div></div><div><h3>Conclusions</h3><div>Adding radiotherapy to pembrolizumab plus platinum-doublet chemotherapy led to promising efficacy in patients with previously untreated metastatic NSCLC. Although caution should be exercised with regard to pneumonitis, adverse events were tolerable. Further research is needed to confirm the efficacy and safety of this strategy.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 5","pages":"Article 100817"},"PeriodicalIF":3.0,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143705769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Acknowledgment of Reviewers","authors":"","doi":"10.1016/S2666-3643(25)00026-8","DOIUrl":"10.1016/S2666-3643(25)00026-8","url":null,"abstract":"","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 3","pages":"Article 100810"},"PeriodicalIF":3.0,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143488857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Carina M. Behr PhD , Maarten J. IJzerman PhD , Michelle M.A. Kip PhD , Harry J.M. Groen MD, PhD , Marjolein A. Heuvelmans MD, PhD , Maarten van den Berge MD, PhD , Pim van der Harst MD, PhD , Marleen Vonder PhD , Rozemarijn Vliegenthart MD, PhD , Hendrik Koffijberg PhD
{"title":"Model-Based Cost-Utility Analysis of Combined Low-Dose Computed Tomography Screening for Lung Cancer, Chronic Obstructive Pulmonary Disease, and Cardiovascular Disease","authors":"Carina M. Behr PhD , Maarten J. IJzerman PhD , Michelle M.A. Kip PhD , Harry J.M. Groen MD, PhD , Marjolein A. Heuvelmans MD, PhD , Maarten van den Berge MD, PhD , Pim van der Harst MD, PhD , Marleen Vonder PhD , Rozemarijn Vliegenthart MD, PhD , Hendrik Koffijberg PhD","doi":"10.1016/j.jtocrr.2025.100813","DOIUrl":"10.1016/j.jtocrr.2025.100813","url":null,"abstract":"<div><h3>Introduction</h3><div>The conditional cost-effectiveness of low-dose computed tomography for lung cancer (LC) screening has been reported. Extending LC screening to chronic obstructive pulmonary disease (COPD) and cardiovascular disease (CVD), together with Big-3, could increase health benefits at marginal costs. This study aimed to estimate the cost-utility of Big-3 screening compared with no screening and LC screening in The Netherlands.</div></div><div><h3>Methods</h3><div>A microsimulation model was built to reflect the care pathway, using individual-level data from the National Lung Screening Trial individual-level data, and aggregated data from the literature. The model includes a simulation of the detection of the Big-3 diseases through screening and standard of care. The model also simulated tumor growth and the effects of smoking cessation and treatment. Hypothetical (former) smokers (aged 55–74 y) were simulated according to the National Lung Screening Trial criteria. Individuals with screening-detected diseases receiving (preventative) treatment experience a reduced risk of events and increased survival. A Dutch health system perspective and lifetime horizon were adopted.</div></div><div><h3>Results</h3><div>Simultaneous LC and CVD screening was the most cost-effective, with incremental costs and effects of €1937 and 0.22 quality-adjusted life-years (QALYs) versus no screening, and €595 and 0.08 QALYs versus LC screening, respectively. This yielded incremental cost-utility ratios of €8561 per QALY and €7154 per QALY versus no screening and LC screening, respectively. LC plus COPD screening was dominated by LC + CVD screening, which yielded lower health benefits and higher costs.</div></div><div><h3>Conclusions</h3><div>Simultaneous screening for LC + CVD in a high-risk population offers health benefits at low costs compared with no screening or LC screening alone. Adding COPD screening cannot yet be justified owing to the limited clinical evidence.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 5","pages":"Article 100813"},"PeriodicalIF":3.0,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143746252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gavin Yuan BA, Elena N. Petre MD, Etay Ziv MD, PhD, Brett Marinelli MD, Ken Zhao MD, Vlasios Sotirchos MD, Erica S. Alexander MD
{"title":"Yttrium-90 Radioembolization for Hepatic Metastases Secondary to Thymic Malignancies: A Case Report","authors":"Gavin Yuan BA, Elena N. Petre MD, Etay Ziv MD, PhD, Brett Marinelli MD, Ken Zhao MD, Vlasios Sotirchos MD, Erica S. Alexander MD","doi":"10.1016/j.jtocrr.2025.100812","DOIUrl":"10.1016/j.jtocrr.2025.100812","url":null,"abstract":"<div><div>The current guidelines for the treatment of extrathoracic metastases secondary to thymic neoplasms recommend chemotherapy. Thymic carcinomas are radiosensitive, and radiation therapy is recommended for intrathoracic masses and isolated metastases that are not amenable to resection. Liver-directed therapy, particularly yttrium-90 radioembolization, has been used for the treatment of oligometastatic diseases in the liver from various primaries. Here, we report three cases of radioembolization for the treatment of thymic carcinoma that metastasized to the liver.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 5","pages":"Article 100812"},"PeriodicalIF":3.0,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143768436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Primary Results from IMscin002: A Study to Evaluate Patient Preferences and Perceptions of Health Care Professionals for Atezolizumab Subcutaneous Versus Intravenous for the Treatment of NSCLC","authors":"Federico Cappuzzo MD , Zanete Zvirbule MD , Ernesto Korbenfeld MD , Jaroslaw Kolb-Sielecki MD , Dolores Isla MD, PhD , Aleksandra Szczesna MD, PhD , Amparo Yovanna Castro Sanchez PhD , Alberto Bustillos MD , Xiaoyan Liu PhD , Fiona Young MbChB , Nadia Tosti PhD , Marta Freitas Monteiro MSc, PhD , Margarita Majem MD, PhD","doi":"10.1016/j.jtocrr.2025.100815","DOIUrl":"10.1016/j.jtocrr.2025.100815","url":null,"abstract":"<div><h3>Introduction</h3><div>Subcutaneous (SC) atezolizumab, a co-formulation containing atezolizumab and recombinant human hyaluronidase PH20), has been approved for use in more than 50 countries for the same indications as intravenous (IV) atezolizumab. IMscin002 (NCT05171777), a phase 2, randomized, open-label, crossover trial, investigated patient preferences and health care professionals’ (HCPs’) perceptions of atezolizumab SC versus IV for the treatment of NSCLC; we report the primary results of IMscin002.</div></div><div><h3>Methods</h3><div>Patients with programmed death-ligand 1-positive resected NSCLC who had completed adjuvant chemotherapy without evidence of recurrence, and chemotherapy-naive patients with programmed death-ligand 1–high metastatic NSCLC were randomized 1:1 to arm A (atezolizumab SC then atezolizumab IV) or arm B (atezolizumab IV then atezolizumab SC). After cycle 3, patients switched administration routes. After cycle 6, the patients chose the route of administration for the continuation period. The primary end point was patient preference for SC or IV atezolizumab, and the secondary end points were patient- and HCP-reported outcomes and safety.</div></div><div><h3>Results</h3><div>A total of 179 patients were included in this study. Most patients (70.7%; n = 87 of 123) preferred SC atezolizumab over IV, with 79.4% (n = 85 of 107) choosing SC atezolizumab during the continuation period. Among the HCPs, 75.2% (n = 76 of 101) indicated that atezolizumab SC was more convenient than IV, and 77.8% (n = 77 of 99) strongly agreed or agreed that it would allow patients to spend less time in care units. No new or unexpected safety findings were identified, and switching between administration routes was well tolerated and managed.</div></div><div><h3>Conclusions</h3><div>Most patients preferred SC atezolizumab over IV. There were no new safety findings, and switching between the administration routes was well tolerated. These results support the preference for SC formulations to reduce the treatment burden.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 5","pages":"Article 100815"},"PeriodicalIF":3.0,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143800548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Combination of Lurbinectedin and Osimertinib for Treatment of EGFR-Mutated Transformed SCLC: A Brief Report","authors":"Aditi Singh MBBS, MPH , Arthi Sridhar MBBS , Aastha Poddar MBBS , Anastasios Dimou MD , Kaushal Parikh MBBS , Mohamed Shanshal MD , Anna Schwecke APRN, CNP, MS , Nicole Moffett APRN, CNP, MSN , Manish R. Patel DO , Aaron S. Mansfield MD , Konstantinos Leventakos MD, PhD","doi":"10.1016/j.jtocrr.2025.100807","DOIUrl":"10.1016/j.jtocrr.2025.100807","url":null,"abstract":"<div><div>Third-generation tyrosine kinase inhibitors are effective treatment of <em>EGFR</em>-mutated NSCLC. After an initial response, patients on this therapy ultimately develop resistance leading to disease progression. One of the resistance mechanisms is histological transformation to SCLC. There is no standard of care for the management of transformed SCLC. Given the rarity of transformed SCLC, it is important to study treatment options that are safe and effective for this disease. In this case series, three patients received treatment with lurbinectedin plus osimertinib after transformation to SCLC. In our limited experience, the combination was found to be safe.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 6","pages":"Article 100807"},"PeriodicalIF":3.0,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143855988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jonathan W. Riess MD, MS , Matthew S. Lara BS , Guillaume Luxardi PhD , Miguel Lopez de Rodas MD , Michiko Shimoda PhD , Karen Kelly MD , Primo N. Lara MD , Laurel Beckett PhD , Arta Monjazeb MD, PhD , Kurt A. Schalper MD, PhD , Emanual Maverakis MD , David R. Gandara MD
{"title":"A Phase 1/1B Trial of Pembrolizumab and Trametinib in Advanced NSCLC Enriched for KRAS Mutations","authors":"Jonathan W. Riess MD, MS , Matthew S. Lara BS , Guillaume Luxardi PhD , Miguel Lopez de Rodas MD , Michiko Shimoda PhD , Karen Kelly MD , Primo N. Lara MD , Laurel Beckett PhD , Arta Monjazeb MD, PhD , Kurt A. Schalper MD, PhD , Emanual Maverakis MD , David R. Gandara MD","doi":"10.1016/j.jtocrr.2025.100806","DOIUrl":"10.1016/j.jtocrr.2025.100806","url":null,"abstract":"<div><h3>Introduction</h3><div>MEK inhibition (MEKi) combined with programmed death ligand 1 inhibition (immune checkpoint inhibitor [ICI]) modulates the tumor immune microenvironment. This phase 1 study evaluated sequencing schemes of MEKi and ICI with trametinib and pembrolizumab in NSCLC.</div></div><div><h3>Methods</h3><div>In this 3+3 dose escalation study, patients with advanced NSCLC were treated with lead-in trametinib (arm A) or lead-in pembrolizumab (arm B) for cycle 1, followed by a 1.5 to 2 mg oral daily dose of trametinib (d 1–10) with pembrolizumab 200 mg intravenously every 21 days. Eligible patients with progressive disease on or after platinum-based chemotherapy were enrolled. Prior ICI was allowed. Tumor tissue was analyzed with quantitative immunofluorescence. High-parameter flow cytometry was performed on blood. Adverse events were graded using the Common Terminology Criteria for Adverse Events version 4 and efficacy was evaluated by Response Evaluation Criteria in Solid Tumors version 1.1.</div></div><div><h3>Results</h3><div>Fifteen patients enrolled (nine arm A and six arm B) with 13 (86%) harboring <em>KRAS</em> mutations and 10 (66%) receiving prior ICI. Five patients (33%) experienced at least one grade greater than or equal to 3 treatment-related adverse event including one dose-limiting toxicity (grade 3 esophagitis). Two patients had a partial response (ORR = 14%). Trametinib lead-in was associated with decreased T-regulatory cells and myeloid-derived suppressor cells (<em>p</em> = 0.002 and <em>p</em> = 0.05, respectively).</div></div><div><h3>Conclusions</h3><div>The activity of trametinib and pembrolizumab is modest in NSCLC with increased toxicity compared with programmed death ligand 1 blockade alone. The recommended phase 2 dose for the combination is 2 mg of oral trametinib (d 1–10) and 200 mg of intravenous pembrolizumab every 21 days, with lead-in trametinib. Adverse events were comparable with other MEKi and ICI combination studies. Though limited clinical activity was observed, lead-in MEKi may induce favorable immune cell alterations.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 6","pages":"Article 100806"},"PeriodicalIF":3.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144068073","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abhenil Mittal MD , Louis Everest MPH , Devalben Patel BSc, MLT , Luna J. Zhan MPH , M. Catherine Brown MSc , Fatemah Zaeimi BSc , Sabine Schmid MD , Khaleeq Khan HBSc , Kristen Dietrich MD , Karmugi Balaratnam MD , Miguel Garcia Pardo de Santayana MD , Lawson Eng MD, FRCPC , Adrian G. Sacher MD, MMSc , Frances A. Shepherd MD, FRCPC , Natasha B. Leighl MD, MMSc , John Cho MD, PhD , Marc De Perrot MD , Geoffrey Liu MD, MSc , Penelope Bradbury MD, FRACP
{"title":"Health Utility and Symptom Scores in Patients With Advanced Malignant Pleural Mesothelioma Treated in a Real-World Setting","authors":"Abhenil Mittal MD , Louis Everest MPH , Devalben Patel BSc, MLT , Luna J. Zhan MPH , M. Catherine Brown MSc , Fatemah Zaeimi BSc , Sabine Schmid MD , Khaleeq Khan HBSc , Kristen Dietrich MD , Karmugi Balaratnam MD , Miguel Garcia Pardo de Santayana MD , Lawson Eng MD, FRCPC , Adrian G. Sacher MD, MMSc , Frances A. Shepherd MD, FRCPC , Natasha B. Leighl MD, MMSc , John Cho MD, PhD , Marc De Perrot MD , Geoffrey Liu MD, MSc , Penelope Bradbury MD, FRACP","doi":"10.1016/j.jtocrr.2025.100802","DOIUrl":"10.1016/j.jtocrr.2025.100802","url":null,"abstract":"<div><h3>Introduction</h3><div>There is a paucity of real-world associations between EQ-5D-generated health utility scores (HUS), symptoms as measured by the Edmonton Symptom Assessment System (ESAS), and the patient-reported outcomes version of the common terminology criteria for adverse events (pro-CTCAE), and survival in patients with advanced Malignant Pleural Mesothelioma (aMPM).</div></div><div><h3>Methods</h3><div>Clinico-demographic variables and treatment information were captured retrospectively in patients diagnosed with aMPM between January 2004 and February 2021 at Princess Margaret Cancer Centre. Quality of life outcomes were measured using HUS, ESAS, and pro-CTCAE scales, by stable versus progressive disease and line-of-treatment states. Survival by mean ESAS scores were analyzed using the Kaplan-Meier method.</div></div><div><h3>Results</h3><div>Of the 262 patients, the median age was 69 years (interquartile range: 62–74), 77% were male individuals, 52% were ever-smokers, 67% were the epithelioid-subtype, and 62% received first-line systemic therapy for advanced disease. The mean baseline HUS at diagnosis was 0.68 (95% confidence interval: 0.62–0.74) with most symptoms consisting of pain, dyspnea, and fatigue. Pooled ESAS physical and psychological scores changed significantly with disease state: the mean scores were worst at baseline, improved with stable or responding disease (physical, <em>p</em> < 0.001; psychological, <em>p</em> < 0.001), and worsened at progressive disease (physical: <em>p</em> < 0.001; psychological, <em>p</em> < 0.001). Similar trends were seen in HUS and pro-CTCAE symptom severity/frequency. Patients with high baseline ESAS physical symptom burden had inferior overall survival (median = 8.9 [high] versus 12.6 months [low], <em>p</em> = 0.022). Weak-to-moderate correlations were observed between most ESAS domains and HU and between pro-CTCAE domains and HU. The strongest domain correlations were with well-being, shortness of breath, tiredness, and depression domains.</div></div><div><h3>Conclusions</h3><div>Baseline quality of life burden is high in patients with aMPM and is well captured by both EQ-5D and ESAS Individual ESAS and pro-CTCAE domains reported low/moderate correlations with HUS, reflecting the inability of one symptom to predict the entire disease state, thus paving the way for future mapping studies. The baseline physical symptom burden (ESAS) was prognostic of survival.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 6","pages":"Article 100802"},"PeriodicalIF":3.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alexander J. Didier BS , Mingjia Li MD , Jinesh Gheeya MD, PhD , Asrar Alahmadi MD , Jacob Kaufman MD, PhD , Regan Memmott MD, PhD , Kai He MD, PhD , Peter Shields MD , David P. Carbone MD, PhD , Carolyn Presley MD , Dwight Owen MD, MS , Logan Roof MD, MS
{"title":"Trends in Mesothelioma Mortality in the United States Between 1999 and 2020","authors":"Alexander J. Didier BS , Mingjia Li MD , Jinesh Gheeya MD, PhD , Asrar Alahmadi MD , Jacob Kaufman MD, PhD , Regan Memmott MD, PhD , Kai He MD, PhD , Peter Shields MD , David P. Carbone MD, PhD , Carolyn Presley MD , Dwight Owen MD, MS , Logan Roof MD, MS","doi":"10.1016/j.jtocrr.2025.100804","DOIUrl":"10.1016/j.jtocrr.2025.100804","url":null,"abstract":"<div><h3>Introduction</h3><div>Mesothelioma is a rare but aggressive cancer primarily caused by asbestos exposure. In March 2024, the Environmental Protection Agency banned asbestos in the United States, but its use will take years to phase out. Therefore, asbestos remains a threat, and incidence may remain stable or slowly decrease due to the long latency between exposure and diagnosis. This study investigates mesothelioma mortality trends in the United States from 1999 to 2020, focusing on demographic and geographic variations.</div></div><div><h3>Methods</h3><div>Data on mesothelioma-related deaths from 1999 to 2020 were extracted from the Centers for Disease Control and Prevention database. Variables including race/ethnicity, sex, geographic density, and mesothelioma subtype were assessed. Age-adjusted mortality rates were calculated per 1 million individuals and standardized to the 2000 United States population. Joinpoint regression identified statistically significant changes in mortality trends over time.</div></div><div><h3>Results</h3><div>From 1999 to 2020, there were 54,905 mesothelioma-related deaths in the United States (age-adjusted mortality rate = 7.5). Pleural mesothelioma accounted for 8.1% of deaths, peritoneal for 4.6%, pericardial for 0.01%, other sites for 10.9%, and unspecified sites for 76.3%. Most deaths (81.3%) occurred in individuals aged over 65 years. Overall mortality decreased from 8.5 in 1999 to 5.7 in 2020 at −1.9% annually. Non-Hispanic Whites had the highest mortality, and male individuals experienced higher mortality than female individuals. Suburban and rural populations had the highest mortality rates.</div></div><div><h3>Conclusions</h3><div>The study highlights significant declines in mesothelioma mortality in the United States from 1999 to 2020, with variations across demographic and geographic groups. Continued monitoring and targeted interventions are necessary to address disparities and further reduce mesothelioma mortality.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 5","pages":"Article 100804"},"PeriodicalIF":3.0,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143791226","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}