JTO Clinical and Research Reports最新文献

{"title":"Real-World Outcomes of Patients With Malignant Pleural Mesothelioma Receiving a Combination of Ipilimumab and Nivolumab as First- or Later-Line Treatment","authors":"Sabine Schmid MD ,&nbsp;Lisa Holer MSc ,&nbsp;Katrin Gysel MSc ,&nbsp;Kira-Lee Koster MD ,&nbsp;Sacha I. Rothschild MD ,&nbsp;Laura A. Boos MD ,&nbsp;Lorenz Frehner MD ,&nbsp;Sabine Cardoso Almeida MD ,&nbsp;Christian Britschgi MD, PhD ,&nbsp;Yannis Metaxas MD ,&nbsp;Michael Mark MD ,&nbsp;Patrizia Froesch MD ,&nbsp;Wolf-Dieter Janthur MD ,&nbsp;Anna Allemann MD ,&nbsp;Christine Waibel MD ,&nbsp;Catherine Von der Mühll-Schill MD ,&nbsp;Martin Früh MD ,&nbsp;Laetitia A. Mauti MD, PhD","doi":"10.1016/j.jtocrr.2024.100735","DOIUrl":"10.1016/j.jtocrr.2024.100735","url":null,"abstract":"<div><h3>Objectives</h3><div>On the basis of the positive results of CheckMate-743, first-line (1L) treatment of malignant pleural mesothelioma (MPM) with the combination of ipilimumab and nivolumab (ipi-nivo) has become a standard-of-care. Furthermore, patients who received 1L platinum/pemetrexed chemotherapy are often considered for second or further-line (2L+) ipi-nivo on the basis of MAPS2 results. Here we report on real-world survival and safety outcomes of ipi-nivo for patients with MPM in Switzerland.</div></div><div><h3>Methods</h3><div>Twelve cancer centers contributed data to this retrospective cohort. Baseline characteristics including age, sex, histology, programmed death-ligand 1 expression, Eastern Cooperative Oncology Group performance status (ECOG PS), and previous/subsequent therapies were collected. The efficacy and safety outcomes were assessed by local investigators.</div></div><div><h3>Results</h3><div>Of the 109 patients with MPM treated with ipi-nivo between November 2017 and March 2023 (median follow-up of 16.6 months) 75% had epithelioid, 9% biphasic, and 16% sarcomatoid histology. The median age was 72 years; 91% were males, and 83% had an ECOG PS of 0 to 1. Ipilimumab in combination with nivolumab was given as 1L in 43% and as 2L+ treatment in 57% of patients. The objective response rate was 21% in 1L and 15% in 2L+. Median progression-free survival was 6.5 and 2.8 months, respectively. Median overall survival (OS) from the start of ipi-nivo was 12.6 months for 1L and 6.9 months for 2L+. No differences in OS were observed depending on age and programmed death-ligand 1 expression. Nevertheless, the median OS was significantly worse in patients with an ECOG PS of 2 or higher than those with an ECOG PS of 0 to 1 (2.4 versus 11.9 months, <em>p</em> &lt; 0.001). Treatment-related adverse events (TRAEs) of any grade related to ipi-nivo treatment occurred in 65 patients (62%). The highest-grade TRAE was 1 to 2 in 58% of these patients and 3 or higher in 42% Treatment discontinuation due to a TRAE occurred in 22% of patients.</div></div><div><h3>Conclusion</h3><div>In this real-world cohort of patients with MPM treated with ipi-nivo survival outcomes were inferior to those reported in the CheckMate-743 and MAPS2 trials, whereas safety outcomes were similar.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"5 12","pages":"Article 100735"},"PeriodicalIF":3.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142653850","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":"CRYOVATE: A Pilot Study of Lung Cancer Cryoactivation in Combination With Immunotherapy in Advanced NSCLC","authors":"Antoine Desilets MD, MSc ,&nbsp;Gabryella Pinheiro PhD ,&nbsp;Wiam Belkaid PhD ,&nbsp;Olivier Salko MD ,&nbsp;Julie Malo ,&nbsp;Eleyine Zarour MD ,&nbsp;Adeline Jouquan MSc ,&nbsp;Anne-Julie Thibaudeau MSc ,&nbsp;Marc-Antoine Nolin MSc ,&nbsp;John Stagg PhD ,&nbsp;Marie Florescu MD ,&nbsp;Mustapha Tehfe MD ,&nbsp;Normand Blais MD, MSc ,&nbsp;Samer Tabchi MD ,&nbsp;Jean Chalaoui MD ,&nbsp;Philippe Stephenson MD ,&nbsp;Arielle Elkrief MD ,&nbsp;Vincent Quoc-Huy Trinh MD, MSc ,&nbsp;Bertrand Routy MD, PhD ,&nbsp;Moishe Liberman MD, PhD","doi":"10.1016/j.jtocrr.2024.100737","DOIUrl":"10.1016/j.jtocrr.2024.100737","url":null,"abstract":"<div><h3>Introduction</h3><div>NSCLC is the leading cause of cancer-related mortality. Although immune-checkpoint inhibitors (ICIs) have improved survival in patients with advanced NSCLC, treatment resistance remains a challenge. Cryoactivation, a technique inducing cell death by cycles of freezing and thawing, has the potential to augment tumor responses when combined with ICIs.</div></div><div><h3>Methods</h3><div>This single-arm phase 1 clinical trial enrolled patients with previously untreated advanced NSCLC and 50% or higher programmed cell death ligand-1 (PD-L1). Patients underwent cryoactivation followed by ICI monotherapy initiated 5 days later. The primary end point was the objective response rate. Co-secondary end points included the safety and feasibility of the procedure and overall survival. Immune cell infiltration by immunohistochemistry was performed on paired pre- and post-treatment samples, with patients dichotomized according to clinical benefit (CB) rate (CB versus no CB [NCB]).</div></div><div><h3>Results</h3><div>Eight patients were enrolled. Two patients achieved a partial response, yielding an objective response rate of 25%. Median progression-free survival and overall survival were 3.8 and 13.0 months, respectively. The cryoactivation procedure was well tolerated, without grade 3 to 4 adverse events. Post-hoc analysis reported a CB rate of 50%. Immunohistochemistry analysis reported a numerical difference in the cluster of differentiation 8–positive (CD8⁺) T cell infiltration in CB versus NCB in the pre- and post-treatment biopsies (<em>p</em> = 0.09) and an increase in CD8⁺ T cells in the post-treatment biopsies of CB versus NCB (<em>p</em> = 0.03).</div></div><div><h3>Conclusions</h3><div>Although cryoactivation combined with pembrolizumab was safe and well tolerated in patients with NSCLC, therapeutic benefits were not evident compared with historical cohorts of ICI monotherapy. Correlative analyses validated CD8⁺ T cell recruitment in patients deriving CB.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"5 12","pages":"Article 100737"},"PeriodicalIF":3.0,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142653785","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":"Radiotherapy Improves Survival in NSCLC After Oligoprogression on Immunotherapy: A Cohort Study","authors":"Lauren Julia Brown M.B.B.S., MClinTRes, FRACP ,&nbsp;Julie Ahn M.B.B.S. ,&nbsp;Bo Gao BMedSci M.B.B.S., FRACP, PhD ,&nbsp;Harriet Gee M.B.B.S., DPhil, FRANZCR ,&nbsp;Adnan Nagrial M.B.B.S., FRACP, PhD ,&nbsp;Inês Pires da Silva MD, FRACP, PhD ,&nbsp;Eric Hau BSc (Med), M.B.B.S., Grad Cert (Biostat), FRANZCR, PhD","doi":"10.1016/j.jtocrr.2024.100695","DOIUrl":"10.1016/j.jtocrr.2024.100695","url":null,"abstract":"<div><h3>Introduction</h3><div>The patterns of oligoprogression after first-line immune checkpoint inhibitors (ICIs) for metastatic NSCLC are yet to be well established. An increasing volume of data suggests that directed radiotherapy improves survival outcomes in patients with progression after ICIs.</div></div><div><h3>Methods</h3><div>A retrospective cohort study was performed on patients with metastatic NSCLC who had completed first-line programmed death-(ligand) 1 inhibitor therapy with or without chemotherapy at two high-volume cancer centers. We sought to characterize the frequency and location of oligoprogression and determine the overall survival (OS) after radiotherapy in this population.</div></div><div><h3>Results</h3><div>A total of 159 patients were included in the study. At first progression, 62 (39.0%) were classified as undergoing oligoprogression. Multivariate analysis confirmed the presence of brain metastases was associated with an increased likelihood of oligoprogression (OR = 2.44, <em>p</em> = 0.04) with most (63.2%) of these patients experiencing progression intracranially. The presence of liver metastases was associated with a decreased likelihood of oligoprogression (OR = 0.17, <em>p &lt;</em> 0.01). For patients with oligoprogression, those who received radiotherapy had a longer median progression-free survival-2 (PFS2) (17 versus 11.5 mo, HR = 0.51, <em>p</em> = 0.02) and a longer median OS (23 versus 13 mo, HR = 0.40, <em>p &lt;</em> 0.001) compared with those who did not receive radiotherapy. No difference in PFS2 or OS outcomes was observed between patients who received radiotherapy versus those who did not for systemic progression.</div></div><div><h3>Conclusions</h3><div>In patients with oligoprogressive metastatic NSCLC after treatment with first-line ICIs, radiotherapy significantly improves OS and PFS2 outcomes. Patients with baseline brain metastases are more likely to experience oligoprogression. Further prospective studies in directed, less heterogeneous populations of patients with metastatic NSCLC will be fundamental to optimize management.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"5 10","pages":"Article 100695"},"PeriodicalIF":3.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142424500","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":"Intracranial Response to Selpercatinib After Pralsetinib-Induced Disease Progression in Rearranged During Transfection Fusion-Positive Non-Small-Cell Lung Cancer: Case Report","authors":"Illaa Smesseim MD,&nbsp;Tijmen van der Wel MD,&nbsp;Sushil K. Badrising MD, PhD","doi":"10.1016/j.jtocrr.2024.100730","DOIUrl":"10.1016/j.jtocrr.2024.100730","url":null,"abstract":"<div><div>RET fusion-positive NSCLC accounts for 1% to 2% of lung carcinoma cases. Although two Food and Drug Administration–approved selective RET inhibitors, pralsetinib, and selpercatinib, have revealed efficacy in managing RET fusion-positive NSCLC, this case series is unique in its focus on the intracranial response to selpercatinib after disease progression during pralsetinib treatment. This report contributes to the literature by providing evidence of selpercatinib’s potential as a treatment option in such refractory cases. The patients described in both cases were diagnosed with metastatic RET fusion-positive NSCLC and developed intracranial metastases during pralsetinib treatment. After switching to selpercatinib, both exhibited significant intracranial responses. The first patient reported a reduction in brain metastasis size and maintained a response for over 1.5 years. The second patient also responded intracranially to selpercatinib but unfortunately passed away 8 months later owing to pulmonary hemorrhage, possibly linked to prior radiation treatment. These cases highlight the potential efficacy of selpercatinib in treating intracranial metastases in RET fusion-positive patients with NSCLC after pralsetinib-refractory progression. The key takeaway is that selpercatinib may offer a viable treatment option in such scenarios, although more extensive studies are needed to determine its role as a monotherapy or in combination with other treatments.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"5 12","pages":"Article 100730"},"PeriodicalIF":3.0,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142653722","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":"Developing a Conceptual Framework for a Person-Centered Approach to Improving Adherence and Outcomes in Lung Cancer Screening: The Engaged Approach to Lung Cancer Screening: A Brief Report","authors":"Margaret M. Byrne PhD ,&nbsp;Erin A. Hirsch PhD, MS ,&nbsp;Kaitlyn Hoover MS ,&nbsp;Jessica H. McCoy RN, BSN ,&nbsp;Courtney R. Blair MS ,&nbsp;Michelle Futrell RN ,&nbsp;Upal Basu Roy PhD, MPH ,&nbsp;Jamie L. Studts PhD","doi":"10.1016/j.jtocrr.2024.100728","DOIUrl":"10.1016/j.jtocrr.2024.100728","url":null,"abstract":"<div><h3>Introduction</h3><div>Translating outcomes from randomized trials of lung cancer screening into community practice settings has been challenging. We developed a framework—the Engaged Approach to Lung Cancer Screening (EA-LCS)—for improving adherence and individual and population health outcomes in LCS.</div></div><div><h3>Methods</h3><div>Employing community-engaged research, we conducted semistructured interviews with LCS program staff (N = 15) and participants (N = 7) and administered brief surveys to understand LCS adherence. We combined our knowledge of LCS implementation with data to formulate the EA-LCS framework<em>,</em> including principles and strategies instrumental for LCS adherence.</div></div><div><h3>Results</h3><div>Program staff identified four factors that facilitated adherence: (1) the use of specialized tracking software, (2) the importance of personal connection and a reliable touchpoint, (3) centralized program operations, and (4) standardization and streamlining of reports to participants and clinicians. Participant data identified four factors supporting adherence: (1) a single contact point and information availability, (2) tailored communications, (3) personalized results delivery, and (4) increased scan accessibility. Combined analyses identified three overarching themes in the EA-LCS framework: (1) respect, (2) trust, and (3) engagement.</div></div><div><h3>Conclusions</h3><div>The EA-LCS conceptual model integrates three foundational principles (person-centeredness, trustworthy relationships, and sustained communications) to enhance LCS adherence. Efforts are underway to translate the EA-LCS framework into materials to support adherence.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"5 12","pages":"Article 100728"},"PeriodicalIF":3.0,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142653719","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":"Analysis of Baseline Molecular Factors Associated With the Risk of Central Nervous System Progression Among Alectinib-Treated Patients With ALK–Positive NSCLC","authors":"Lianxi Song MD ,&nbsp;Huan Yan MD ,&nbsp;Qinqin Xu MD ,&nbsp;Chunhua Zhou MD ,&nbsp;Juan Liang MD ,&nbsp;Shaoding Lin MD ,&nbsp;Ruiguang Zhang MD ,&nbsp;Juan Yu MD ,&nbsp;Yang Xia MD ,&nbsp;Nong Yang MD ,&nbsp;Liang Zeng MD ,&nbsp;Yongchang Zhang MD","doi":"10.1016/j.jtocrr.2024.100729","DOIUrl":"10.1016/j.jtocrr.2024.100729","url":null,"abstract":"<div><h3>Introduction</h3><div>Despite receiving alectinib therapy, patients with ALK-positive NSCLC remain at risk of central nervous system (CNS) progression. Our retrospective study aimed to identify baseline clinical and molecular factors associated with the risk of CNS progression in this patient subset.</div></div><div><h3>Methods</h3><div>We analyzed the clinical, molecular, and imaging data of 318 patients with ALK-positive advanced NSCLC who received alectinib as first-line (1L-alectinib) or second-line (2L-alectinib) therapy at baseline (1L, n = 183; 2L, n = 135) and at disease progression (1L, n = 80; 2L, n = 76).</div></div><div><h3>Results</h3><div>The incidence rates of CNS progression were 23.7% after 1L-alectinib treatment and 31.6% after 2L-alectinib treatment. Compared with patients who received 1L-alectinib, CNS progression was similar in patients who received 2L-alectinib (<em>p</em> &gt; 0.05). Oligoprogression was detected in 55.0% (44 of 80) of patients who progressed after first-line alectinib, with the remaining 45.0% (36 of 80) having nonoligoprogression. Univariate and multivariate analyses and stepwise regression analyses consistently identified a higher likelihood of CNS progression among (1) patients who received 2L-alectinib than 1L-alectinib, (2) patients with non-3a/b variant <em>ALK</em> fusion than those with echinoderm microtubule-associated protein-like 4<em>–ALK</em> variant 3a/b, and (3) patients with programmed death ligand 1 (PD-L1) tumor proportion score (TPS) of 50% or higher than PD-L1 TPS of less than 50%.</div></div><div><h3>Conclusions</h3><div>Our study provided real-world evidence that patients who harbored PD-L1 TPS of 50% or higher were more likely to experience CNS progression during alectinib therapy. The association between CNS progression and breakpoint variants warrants further investigation. Our findings suggest that close monitoring and prompt intervention are crucial in prolonging the quality of life of this patient subset.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"5 12","pages":"Article 100729"},"PeriodicalIF":3.0,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142534273","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":"Regarding: “Olloni A, et al. Heart and Lung Dose as Predictors of Overall Survival in Patients With Locally Advanced Lung Cancer. A National Multicenter Study”","authors":"Arno C. Hessels MD, PhD,&nbsp;Mark L. Frederiks MSc,&nbsp;Christina T. Muijs MD, PhD,&nbsp;Peter van Luijk PhD","doi":"10.1016/j.jtocrr.2024.100718","DOIUrl":"10.1016/j.jtocrr.2024.100718","url":null,"abstract":"","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"5 11","pages":"Article 100718"},"PeriodicalIF":3.0,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142328173","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":"Simultaneous Occurrence of HER2 Mutations in EGFR Mutant NSCLC: Case Reports","authors":"Blerina Resuli MD ,&nbsp;Diego Kauffmann-Guerrero MD ,&nbsp;Jürgen Behr MD ,&nbsp;Amanda Tufman MD","doi":"10.1016/j.jtocrr.2024.100719","DOIUrl":"10.1016/j.jtocrr.2024.100719","url":null,"abstract":"<div><div><em>HER2</em> mutation and amplification have been identified as distinct molecular targets in lung cancer with different therapeutic and prognostic values. The coexistence of <em>HER2</em> and <em>EGFR</em> mutations is extremely rare, and therefore, no data exist on the best treatment in these cases.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"5 12","pages":"Article 100719"},"PeriodicalIF":3.0,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142552633","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":"Synchronous Oligometastasis and Oligoprogression as a Prognostic Marker in Patients With Extensive-Stage SCLC Treated With a Combination of Immune-Checkpoint Inhibitor and Chemotherapy (HOT2301)","authors":"Kana Hashimoto MD ,&nbsp;Daisuke Morinaga MD ,&nbsp;Hajime Asahina MD, PhD ,&nbsp;Mina Ishidoya MD ,&nbsp;Hajime Kikuchi MD, PhD ,&nbsp;Hiroshi Yokouchi MD, PhD ,&nbsp;Toshiyuki Harada MD, PhD ,&nbsp;Osamu Honjo MD ,&nbsp;Ryota Shigaki MD ,&nbsp;Taichi Takashina MD, PhD ,&nbsp;Yuka Fujita MD, PhD ,&nbsp;Mamoru Takahashi MD, PhD ,&nbsp;Yasutaka Kawai MD ,&nbsp;Ryotaro Kida MD ,&nbsp;Kenichiro Ito MD ,&nbsp;Noriaki Sukoh MD, PhD ,&nbsp;Ayumu Takahashi MD, PhD ,&nbsp;Fumihiro Hommura MD, PhD ,&nbsp;Yoshihito Ohhara MD, PhD ,&nbsp;Megumi Furuta MD, PhD ,&nbsp;Satoshi Oizumi MD, PhD","doi":"10.1016/j.jtocrr.2024.100715","DOIUrl":"10.1016/j.jtocrr.2024.100715","url":null,"abstract":"<div><h3>Introduction</h3><div>Oligometastasis and oligoprogression (OP) has not been adequately defined in extensive-stage SCLC (ES-SCLC) and may be a good indication for adding local treatment. Therefore, this multicenter study aimed to investigate the prognostic impact of oligometastasis and OP in ES-SCLC.</div></div><div><h3>Methods</h3><div>We enrolled patients who received chemoimmunotherapy between September 2019 and June 2022. Patients were classified into oligometastasis and non-oligometastasis groups by determining the number of original tumor lesions and distant metastases (worsening or newly appearing lesions) at the time of initial diagnosis and disease progression after first-line treatment.</div></div><div><h3>Results</h3><div>We retrospectively analyzed 265 consecutive patients with ES-SCLC. Synchronous oligometastasis (SOM) and OP was defined as less than or equal to five lesions in less than or equal to two organs, including lungs; 21.0% and 53.2% of patients had SOM and OP, respectively. Median progression-free survival was 5.8 months and 4.9 months in patients with and without SOM, respectively (hazard ratio [HR] = 0.72, 95% confidence interval [CI]: 0.51–1.02, <em>p</em> = 0.065). Median overall survival was 20.5 months and 15.0 months in patients with and without SOM (HR = 0.58, 95% CI: 0.37–0.95, <em>p</em> = 0.027) from the initiation of first-line treatment. The OP group revealed a better progression-free survival of 5.2 months (versus 3.2 mo, HR = 0.69, 95% CI: 0.50–0.96, <em>p</em> = 0.026) and overall survival of 15.1 months (versus 7.5 mo, HR = 0.44, 95% CI: 0.29–0.66, <em>p</em> = 0.027) from the initiation of second-line treatment compared with the non-OP group. The Lung Immune Prognostic Index score was significantly lower in the SOM and OP group.</div></div><div><h3>Conclusions</h3><div>ES-SCLC in patients with SOM and OP may be more indolent than that of the nonoligometastasis group, therefore, new treatment strategies, including the addition of local treatment, should be explored.</div></div><div><h3>Clinical trial registration</h3><div>This study was registered at UMIN-CTR (UMIN000053402).</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"5 11","pages":"Article 100715"},"PeriodicalIF":3.0,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358681","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":"The Whole Picture of First-Line Osimertinib for EGFR Mutation-Positive Advanced NSCLC: Real-World Efficacy, Safety, Progression Pattern, and Posttreatment Therapy (Reiwa Study)","authors":"Kageaki Watanabe MD ,&nbsp;Yukio Hosomi MD, PhD ,&nbsp;Katsuhiko Naoki MD, PhD ,&nbsp;Yoshiro Nakahara MD, PhD ,&nbsp;Yoko Tsukita MD, PhD ,&nbsp;Hirotaka Matsumoto MD, PhD ,&nbsp;Kiyotaka Yoh MD ,&nbsp;Yasuhito Fujisaka MD, PhD ,&nbsp;Satoshi Takahashi MD, PhD ,&nbsp;Saori Takata MD, PhD ,&nbsp;Kazuhiro Usui MD, PhD ,&nbsp;Kazuma Kishi MD, PhD ,&nbsp;Go Naka MD, PhD ,&nbsp;Shu Tamano MSS ,&nbsp;Kohei Uemura PhD ,&nbsp;Hideo Kunitoh MD, PhD","doi":"10.1016/j.jtocrr.2024.100720","DOIUrl":"10.1016/j.jtocrr.2024.100720","url":null,"abstract":"<div><h3>Introduction</h3><div>Osimertinib is used as the first-line treatment for EGFR mutation-positive NSCLC. Nevertheless, its efficacy and safety in clinical practice remain to be fully elucidated and the pattern of progression and the optimal subsequent treatment after osimertinib remains unclear.</div></div><div><h3>Methods</h3><div>This was a multicenter prospective observational study. EGFR mutation-positive patients with NSCLC who started first-line osimertinib from September 2018 to August 2020 were enrolled and followed up until August 2022.</div></div><div><h3>Results</h3><div>A total of 583 patients received osimertinib. The median progression-free and overall survival were 20.0 (95% confidence interval [CI]: 17.6–21.7) months and 41.0 (95% CI: 37.1–44.1) months, respectively. Grade 3 or worse adverse events were observed in 136 patients (23.3%). Progression patterns were categorized as central nervous system only, oligo-progression, and multiple organs on the basis of the Response Evaluation Criteria in Solid Tumors—progressive disease and occurred in 37 (10.8%), 156 (45.4%), and 151 patients (43.9%). The patient’s condition on progression was asymptomatic in 195 patients (56.7%). Osimertinib was continued in 163 patients (47.4%) after confirming progression. In clinically stable population with progressive disease (n = 247), survival after progression was 13.3 (95% CI: 10.9–16.4) months for those who continued osimertinib beyond progressive disease (n = 124), and 24.1 (95% CI: 17.7–34.0) months for those who discontinued osimertinib (n = 123) (hazard ratio = 2.01, 95% CI: 1.38–2.91, <em>p</em> = 0.0002). Platinum plus pemetrexed had the best overall survival benefits after osimertinib.</div></div><div><h3>Conclusions</h3><div>First-line osimertinib was found to have good effectiveness comparable to that reported in pivotal studies. Nevertheless, osimertinib should be discontinued among those who develop progression.</div></div><div><h3>Trial registration number</h3><div>UMIN000038683</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"5 11","pages":"Article 100720"},"PeriodicalIF":3.0,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142426750","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}