Journal of Thoracic Oncology最新文献

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Brief Report: Preventing Infusion-related Reactions With Intravenous Amivantamab: Results From SKIPPirr, a Phase 2 Study. 简要报告:静脉注射阿米万他单抗预防输液相关反应:2 期研究 SKIPPirr 的结果。
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-01-24 DOI: 10.1016/j.jtho.2025.01.018
Alexander I Spira, Luis Paz-Ares, Ji-Youn Han, Jin-Yuan Shih, Céline Mascaux, Upal Basu Roy, Jon Zugazagoitia, Yu Jung Kim, Chao-Hua Chiu, Sang-We Kim, Ernest Nadal, Ignacio Gil-Bazo, Sean P Murphy, Bailey G Anderson, Yichuan Xia, George Wang, Joshua M Bauml, Marc Chioda, Jairo Simoes, Parthiv J Mahadevia, Gilberto Lopes
{"title":"Brief Report: Preventing Infusion-related Reactions With Intravenous Amivantamab: Results From SKIPPirr, a Phase 2 Study.","authors":"Alexander I Spira, Luis Paz-Ares, Ji-Youn Han, Jin-Yuan Shih, Céline Mascaux, Upal Basu Roy, Jon Zugazagoitia, Yu Jung Kim, Chao-Hua Chiu, Sang-We Kim, Ernest Nadal, Ignacio Gil-Bazo, Sean P Murphy, Bailey G Anderson, Yichuan Xia, George Wang, Joshua M Bauml, Marc Chioda, Jairo Simoes, Parthiv J Mahadevia, Gilberto Lopes","doi":"10.1016/j.jtho.2025.01.018","DOIUrl":"https://doi.org/10.1016/j.jtho.2025.01.018","url":null,"abstract":"<p><strong>Introduction: </strong>Amivantamab, an EGFR-MET bispecific antibody, is approved for multiple indications in EGFR-mutated advanced non-small cell lung cancer (NSCLC) as monotherapy or combined with other agents. Intravenous amivantamab is associated with a 67% infusion-related reactions (IRR) rate.</p><p><strong>Methods: </strong>The phase 2 SKIPPirr study (NCT05663866) enrolled patients with EGFR-mutated (Ex19del/L858R) advanced NSCLC after progression on osimertinib and platinum-based chemotherapy who received intravenous amivantamab plus oral lazertinib (amivantamab-lazertinib), a third-generation tyrosine kinase inhibitor. Aiming to mitigate IRRs, 4 independent prophylactic approaches were evaluated using Simon's 2-stage design with an expansion stage if a cohort passed both stages: oral dexamethasone 4-mg twice daily (BID) given on cycle (C) 1 day (D) -1; oral dexamethasone 8-mg BID given on C1D-2, C1D-1, and morning of C1D1 (5 doses); oral montelukast 10-mg once daily given on C1D-4, C1D-3, C1D-2, C1D-1, and C1D1 (5 doses); subcutaneous methotrexate 25-mg (1 dose) given anytime between C1D-7 and C1D-3. Primary endpoint was C1D1 IRR incidence.</p><p><strong>Results: </strong>As of 24-June-2024, 68 patients were treated across all cohorts. The dexamethasone 8-mg cohort passed stages 1 and 2 proceeding to the expansion stage, with 24 additional patients treated. At C1D1, 9/40 patients (22.5%) experienced IRRs, resulting in an ∼3-fold decrease versus historical data (67.4%). By end of C3, 10/41 (24.4%) patients in the dexamethasone 8-mg cohort experienced IRRs (grades 1-2, except 1 grade 3 on C2D1). Amivantamab-lazertinib safety and efficacy were consistent with previous reports.</p><p><strong>Conclusion: </strong>Prophylaxis with 8-mg oral dexamethasone meaningfully reduced IRRs and can be readily implemented in clinical practice.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143047195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Lung cancer screening program quality indicators - review & recommendations - An International Association for the Study of Lung Cancer Delphi process study. 肺癌筛查计划质量指标--回顾与建议--国际肺癌研究协会德尔菲过程研究。
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-01-24 DOI: 10.1016/j.jtho.2025.01.019
Martin C Tammemägi, Andrea Borondy-Kitts, John K Field, Claudia I Henschke, Anant Mohan, Anna Kerpel-Fronius, Luigi Ventura, Dawei Yang, Long Jiang, Coenraad Fn Koegelenberg, Milena Cavic, Haval Balata, Lucia Viola, Javier J Zulueta, Ricardo Sales Dos Santos, Witold Rzyman, David F Yankelevitz, Annette McWilliams, Stephen Lam, Ella A Kazerooni, Rudolf M Huber
{"title":"Lung cancer screening program quality indicators - review & recommendations - An International Association for the Study of Lung Cancer Delphi process study.","authors":"Martin C Tammemägi, Andrea Borondy-Kitts, John K Field, Claudia I Henschke, Anant Mohan, Anna Kerpel-Fronius, Luigi Ventura, Dawei Yang, Long Jiang, Coenraad Fn Koegelenberg, Milena Cavic, Haval Balata, Lucia Viola, Javier J Zulueta, Ricardo Sales Dos Santos, Witold Rzyman, David F Yankelevitz, Annette McWilliams, Stephen Lam, Ella A Kazerooni, Rudolf M Huber","doi":"10.1016/j.jtho.2025.01.019","DOIUrl":"https://doi.org/10.1016/j.jtho.2025.01.019","url":null,"abstract":"<p><strong>Introduction: </strong>Lung cancer screening (LCS) using low-dose-computed tomography reduces lung cancer mortality in high-risk individuals. Evaluating and monitoring LCS programs are important to ensure and improve quality, efficiency and participant outcomes. There is no agreement on LCS quality indicators (QIs).</p><p><strong>Methods: </strong>Twenty multidisciplinary members of IASLC used a Delphi process to develop consensus Qis. They considered 50 Qis during information/discussion sessions and two anonymous voting rounds. ≥80% voting agree/strongly agree on a five-point Likert scale determined consensus.</p><p><strong>Results: </strong>Twenty essential and six desirable QIs were identified in 10 of 11 LCS pathway domain categories: ENTRY: Proportion eligible who got screened. SMOKING_CESSATION: Proportion current-smoking individuals offered cessation interventions.</p><p><strong>Imaging: </strong>Proportion screened requiring clinical diagnostic assessment, scans results distribution, proportion scans requiring early follow-up, proportion baseline/regular scans with actionable additional findings.</p><p><strong>Adherence to: </strong>Annual/regular scans, early interim scans, clinical diagnostic assessment.</p><p><strong>Diagnostic: </strong>Proportion suspicious-for-lung-cancer scans receiving clinical investigation, undergoing invasive diagnostic procedures.</p><p><strong>Outcomes: </strong>Cancer detection rate, stage distribution, interval cancer rate HARMS: Number/proportion of serious complications following invasive procedures, non-lung cancer diagnoses following invasive procedures, or following surgery, 30-day mortality following invasive procedure.</p><p><strong>Treatment: </strong>Proportion early-stage cancers receiving treatment with curative intent. WAIT_TIMES: Suspicious-for-lung-cancer scan to definitive diagnosis, curative-intent treatment for individuals with early-stage disease, scan completion to reporting results to PCP/participant.</p><p><strong>Equity: </strong>Race/sex/socioeconomic differences in adherence to regular screens, early-stage cancer treatment, offer of smoking cessation interventions, clinical investigation of suspicious-for-lung-cancer screens.</p><p><strong>Discussion: </strong>Review among panel members provide recommended LCS QIs that should be considered in development of LCS initiatives .</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143047205","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A single-arm, phase II study of sotorasib plus carboplatin/pemetrexed in advanced non-squamous non-small cell lung cancer patients with KRAS G12C mutation (WJOG14821L, SCARLET). sotorasib联合卡铂/培美曲塞治疗KRAS G12C突变(WJOG14821L, SCARLET)的晚期非鳞状非小细胞肺癌患者的单臂II期研究。
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-01-17 DOI: 10.1016/j.jtho.2025.01.006
Hiroaki Akamatsu, Shinya Sakata, Koichi Azuma, Hiroshige Yoshioka, Takehiro Uemura, Yuko Tsuchiya-Kawano, Seiya Esumi, Takashi Kurosaki, Yuki Sato, Tomohiro Sakamoto, Kiichiro Ninomiya, Ryo Toyozawa, Yasuto Yoneshima, Takehito Shukuya, Toshiyuki Kozuki, Kana Watanabe, Haruko Daga, Terufumi Kato, Toshiaki Takahashi, Mitsuo Osuga, Yasuhiro Koh, Satoshi Morita, Nobuyuki Yamamoto
{"title":"A single-arm, phase II study of sotorasib plus carboplatin/pemetrexed in advanced non-squamous non-small cell lung cancer patients with KRAS G12C mutation (WJOG14821L, SCARLET).","authors":"Hiroaki Akamatsu, Shinya Sakata, Koichi Azuma, Hiroshige Yoshioka, Takehiro Uemura, Yuko Tsuchiya-Kawano, Seiya Esumi, Takashi Kurosaki, Yuki Sato, Tomohiro Sakamoto, Kiichiro Ninomiya, Ryo Toyozawa, Yasuto Yoneshima, Takehito Shukuya, Toshiyuki Kozuki, Kana Watanabe, Haruko Daga, Terufumi Kato, Toshiaki Takahashi, Mitsuo Osuga, Yasuhiro Koh, Satoshi Morita, Nobuyuki Yamamoto","doi":"10.1016/j.jtho.2025.01.006","DOIUrl":"https://doi.org/10.1016/j.jtho.2025.01.006","url":null,"abstract":"<p><strong>Background: </strong>The efficacy and safety of sotorasib plus platinum-doublet chemotherapy in KRAS G12C-mutated non-squamous non-small cell lung cancer (non-Sq NSCLC) were previously reported with limited follow-up period.</p><p><strong>Method: </strong>SCARLET was a single-arm phase II study of chemotherapy-naïve patients with KRAS G12C-mutated non-Sq NSCLC. Participants received sotorasib 960 mg daily plus four cycles of carboplatin (area under the curve, 5)/pemetrexed 500 mg/m<sup>2</sup>, followed by sotorasib/pemetrexed until disease progression. The primary endpoint was the overall response rate (ORR); secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. Using plasma samples, next-generation sequencing was performed at baseline, 3 weeks, and disease progression (jRCT2051210086).</p><p><strong>Results: </strong>Thirty patients were enrolled between Oct 2021 and Jul 2022, with a median follow-up of 14.8 months. ORR was 88.9% (80% confidence interval [CI], 78.5-94.8%; 95% CI, 70.8-97.6%), median PFS was 6.6 months (95% CI, 5.3-16.7 months), and median OS was 20.6 months (95% CI, 8.1 months-not estimated). Among patients with programmed death ligand 1 expression levels ≥ 1% and < 1%, ORRs were 82.3 and 100% and median PFS was 7.6 and 9.7 months, respectively. Using plasma samples, patients without KRAS G12C at baseline, without KRAS-related pathway co-alterations, or who cleared KRAS G12C at 3 weeks had better median PFS (16.7, 13.9, 8.7 months, respectively). TP53 mutation and epidermal growth factor receptor (EGFR) and MET amplification were detected acquired resistances.</p><p><strong>Conclusion: </strong>In patients with KRAS G12C-mutated non-Sq NSCLC, sotorasib plus carboplatin/pemetrexed demonstrated favorable efficacy especially in PD-L1 <1%, with manageable toxicity.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143007770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of Comorbidities on the Mortality Benefits of Lung Cancer Screening: A Post-Hoc Analysis of the PLCO and NLST Trials. 合并症对肺癌筛查死亡率获益的影响:PLCO和NLST试验的事后分析
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-01-09 DOI: 10.1016/j.jtho.2025.01.003
Sebastien Gendarme, Ehsan Irajizad, James P Long, Johannes F Fahrmann, Jennifer B Dennison, Seyyed Mahmood Ghasemi, Rongzhang Dou, Robert J Volk, Rafael Meza, Iakovos Toumazis, Florence Canoui-Poitrine, Samir M Hanash, Edwin J Ostrin
{"title":"Impact of Comorbidities on the Mortality Benefits of Lung Cancer Screening: A Post-Hoc Analysis of the PLCO and NLST Trials.","authors":"Sebastien Gendarme, Ehsan Irajizad, James P Long, Johannes F Fahrmann, Jennifer B Dennison, Seyyed Mahmood Ghasemi, Rongzhang Dou, Robert J Volk, Rafael Meza, Iakovos Toumazis, Florence Canoui-Poitrine, Samir M Hanash, Edwin J Ostrin","doi":"10.1016/j.jtho.2025.01.003","DOIUrl":"10.1016/j.jtho.2025.01.003","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate how comorbidities affect mortality benefits of lung cancer screening (LCS) with low-dose computed tomography.</p><p><strong>Methods: </strong>We developed a comorbidity index (Prostate, Lung, Colorectal, and Ovarian comorbidity index [PLCO-ci]) using LCS-eligible participants' data from the Prostate, Lung, Colorectal, and Ovarian (PLCO) trial (training set) and the National Lung Screening Trial (NLST) (validation set). PLCO-ci predicts five-year non-lung cancer (LC) mortality using a regularized Cox model; with performance evaluated using the area under the receiver operating characteristics curve. In NLST, LC mortality (per original publication) was compared between low-dose computed tomography and chest radiograph arms across the PLCO-ci quintile (Q1-5) using a cause-specific hazard ratio (csHR) with 95% confidence intervals (CIs).</p><p><strong>Results: </strong>Analyses included 34,690 PLCO and 53,452 NLST participants (mean age: 62 y [±5 y] and 61 y [±5 y], 58% and 59% male individuals, and 39% and 41% active smokers, respectively). PLCO-ci predicted five-year non-LC mortality with an area under the receiver operating characteristics curve of 0.72 (95% CI: 0.71-0.74) in PLCO and 0.69 (95% CI: 0.67-0.70) in NLST. In NLST, at a median follow-up of 6.5 years, LC mortality was significantly reduced for participants with intermediate comorbidity (Q2, Q3, and Q4): csHR 0.62 (95% CI: 0.41-0.95), 0.68 (95% CI: 0.48-0.96), and 0.72 (95% CI: 0.54-0.96) respectively, with a nonstatistically significant reduction for Q1 (csHR = 0.72, 95% CI: 0.45-1.17) and no reduction for Q5 participants (csHR = 0.99, 95% CI: 0.79-1.23). Participants in Q2, Q3, and Q4 (60%) accounted for 89% of LC deaths averted among all NLST participants. Q1 participants had low LC incidence, whereas Q5 had higher localized LC lethality, more squamous cell carcinomas, and untreated LC.</p><p><strong>Conclusions: </strong>The PLCO-ci developed in this work shows that individuals with intermediate comorbidity benefited the most from LCS, highlighting the need of addressing comorbidities to achieve LC mortality benefits.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142971434","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Prospective Phase II Trial of First-Line Osimertinib for Patients With EGFR Mutation-Positive NSCLC and Poor Performance Status (OPEN/TORG2040). 一线奥西替尼治疗EGFR突变阳性非小细胞肺癌和不良状态患者的前瞻性II期试验(OPEN/TORG2040)。
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-01-02 DOI: 10.1016/j.jtho.2024.12.027
Tomoya Fukui, Nobuaki Mamesaya, Toshiaki Takahashi, Kazuma Kishi, Takahiro Yoshizawa, Takaaki Tokito, Koichi Azuma, Kei Morikawa, Satoshi Igawa, Yusuke Okuma, Yuta Yamanaka, Shinobu Hosokawa, Takashi Kasai, Ken Masubuchi, Shinji Nakamichi, Masaharu Aga, Jiichiro Sasaki, Akiko Kada, Akiko M Saito, Katsuhiko Naoki, Hiroaki Okamoto
{"title":"A Prospective Phase II Trial of First-Line Osimertinib for Patients With EGFR Mutation-Positive NSCLC and Poor Performance Status (OPEN/TORG2040).","authors":"Tomoya Fukui, Nobuaki Mamesaya, Toshiaki Takahashi, Kazuma Kishi, Takahiro Yoshizawa, Takaaki Tokito, Koichi Azuma, Kei Morikawa, Satoshi Igawa, Yusuke Okuma, Yuta Yamanaka, Shinobu Hosokawa, Takashi Kasai, Ken Masubuchi, Shinji Nakamichi, Masaharu Aga, Jiichiro Sasaki, Akiko Kada, Akiko M Saito, Katsuhiko Naoki, Hiroaki Okamoto","doi":"10.1016/j.jtho.2024.12.027","DOIUrl":"10.1016/j.jtho.2024.12.027","url":null,"abstract":"<p><strong>Introduction: </strong>Osimertinib is the first-line treatment for patients with NSCLC who have EGFR mutations and favorable performance status (PS). Despite the increasing clinical data on osimertinib, evidence for its use in patients with impaired PS remains limited. Therefore, a multicenter phase II trial (OPEN/TORG2040) was conducted to evaluate the efficacy and safety of first-line osimertinib treatment in patients with EGFR mutation-positive NSCLC and a poor PS.</p><p><strong>Methods: </strong>Patients with previously untreated advanced NSCLC harboring EGFR-sensitizing mutations and PS of 2 to 4 were enrolled. Osimertinib (80 mg once daily) was orally administered to eligible patients. The primary end point was objective response rate. The secondary end points were disease control rate, PS improvement rate, patient-reported outcomes, and safety.</p><p><strong>Results: </strong>Between February 2021 and February 2022, 30 patients with poor PS (22 with a PS of 2, six with a PS of 3, and two with a PS of 4) were enrolled. The median age was 75 (range, 41-92) years, and 18 patients had brain metastases. The objective response rate was 63.3% (90% confidence interval, 46.7%-77.9%; one-sided, p = 0.033). Disease control and PS improvement rates were 93.3% and 63.3%, respectively. Global health status/QoL also improved. Median progression-free and overall survival were 8.0 and 25.4 months, respectively. Eight patients (26.7%) experienced serious adverse events leading to discontinuation, and six (20.0%) experienced interstitial lung disease.</p><p><strong>Conclusions: </strong>This prospective study confirmed the efficacy of first-line osimertinib treatment in patients with EGFR mutation-positive NSCLC and poor PS, highlighting the need for interstitial lung disease risk management.</p><p><strong>Trial registration number: </strong>Japan Registry of Clinical Trials Identifier: jRCTs041200100.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142927273","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Amivantamab Plus Lazertinib in Patients With EGFR-Mutant NSCLC After Progression on Osimertinib and Platinum-Based Chemotherapy: Results From CHRYSALIS-2 Cohort A. Amivantamab + Lazertinib治疗egfr突变的非小细胞肺癌(NSCLC)患者在接受奥西替尼和铂基化疗进展后的疗效:来自CHRYSALIS-2队列A的结果
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-01-02 DOI: 10.1016/j.jtho.2024.12.029
Benjamin Besse, Koichi Goto, Yongsheng Wang, Se-Hoon Lee, Melina E Marmarelis, Yuichiro Ohe, Reyes Bernabe Caro, Dong-Wan Kim, Jong-Seok Lee, Sophie Cousin, Eiki Ichihara, Yongsheng Li, Luis Paz-Ares, Akira Ono, Rachel E Sanborn, Naohiro Watanabe, Maria Jose de Miguel, Carole Helissey, Catherine A Shu, Alexander I Spira, Pascale Tomasini, James Chih-Hsin Yang, Yiping Zhang, Enriqueta Felip, Frank Griesinger, Saiama N Waqar, Antonio Calles, Joel W Neal, Christina S Baik, Pasi A Jänne, S Martin Shreeve, Joshua C Curtin, Bharvin Patel, Michael Gormley, Xuesong Lyu, Jun Chen, Pei-Ling Chu, Janine Mahoney, Leonardo Trani, Joshua M Bauml, Meena Thayu, Roland E Knoblauch, Byoung Chul Cho
{"title":"Amivantamab Plus Lazertinib in Patients With EGFR-Mutant NSCLC After Progression on Osimertinib and Platinum-Based Chemotherapy: Results From CHRYSALIS-2 Cohort A.","authors":"Benjamin Besse, Koichi Goto, Yongsheng Wang, Se-Hoon Lee, Melina E Marmarelis, Yuichiro Ohe, Reyes Bernabe Caro, Dong-Wan Kim, Jong-Seok Lee, Sophie Cousin, Eiki Ichihara, Yongsheng Li, Luis Paz-Ares, Akira Ono, Rachel E Sanborn, Naohiro Watanabe, Maria Jose de Miguel, Carole Helissey, Catherine A Shu, Alexander I Spira, Pascale Tomasini, James Chih-Hsin Yang, Yiping Zhang, Enriqueta Felip, Frank Griesinger, Saiama N Waqar, Antonio Calles, Joel W Neal, Christina S Baik, Pasi A Jänne, S Martin Shreeve, Joshua C Curtin, Bharvin Patel, Michael Gormley, Xuesong Lyu, Jun Chen, Pei-Ling Chu, Janine Mahoney, Leonardo Trani, Joshua M Bauml, Meena Thayu, Roland E Knoblauch, Byoung Chul Cho","doi":"10.1016/j.jtho.2024.12.029","DOIUrl":"10.1016/j.jtho.2024.12.029","url":null,"abstract":"<p><strong>Introduction: </strong>Treatment options for patients with EGFR-mutated NSCLC with disease progression on or after osimertinib and platinum-based chemotherapy are limited.</p><p><strong>Methods: </strong>CHRYSALIS-2 cohort A evaluated amivantamab plus lazertinib in patients with EGFR exon 19 deletion- or L858R-mutated NSCLC with disease progression on or after osimertinib and platinum-based chemotherapy. Primary end point was investigator-assessed objective response rate (ORR). The patients received 1050 mg of intravenous amivantamab (1400 mg if ≥ 80 kg) plus 240 mg of oral lazertinib.</p><p><strong>Results: </strong>In cohort A (N = 162), the investigator-assessed ORR was 28% (95% confidence interval [CI]: 22-36). The blinded independent central review-assessed ORR was 35% (95% CI: 27-42), with a median duration of response of 8.3 months (95% CI: 6.7-10.9) and a clinical benefit rate of 58% (95% CI: 50-66). At a median follow-up of 12 months, 32 of 56 responders (57%) achieved a duration of response of more than or equal to 6 months. Median progression-free survival by blinded independent central review was 4.5 months (95% CI: 4.1-5.8); median overall survival was 14.8 months (95% CI: 12.2-18.0). Preliminary evidence of central nervous system antitumor activity was reported in seven patients with baseline brain lesions and no previous brain radiation or surgery. Exploratory biomarker analyses using next-generation sequencing of circulating tumor DNA revealed responses in patients with and without EGFR- or MET-dependent resistance. The most frequent adverse events were rash (grouped term; 81%), infusion-related reaction (68%), and paronychia (52%). The most common grade greater than or equal to 3 treatment-related adverse events were rash (grouped term; 10%), infusion-related reaction (9%), and hypoalbuminemia (6%).</p><p><strong>Conclusions: </strong>For patients with limited treatment options, amivantamab plus lazertinib demonstrated an antitumor activity with a safety profile characterized by EGFR- or MET-related adverse events, which were generally manageable.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142927287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Phase 2 Open-Label Study of Sacituzumab Govitecan as Second-Line Therapy in Patients With Extensive-Stage SCLC: Results From TROPiCS-03. Sacituzumab Govitecan作为广泛期小细胞肺癌患者的二线治疗的2期开放标签研究:来自tropic -03的结果
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-01-02 DOI: 10.1016/j.jtho.2024.12.028
Afshin Dowlati, Anne C Chiang, Andrés Cervantes, Sunil Babu, Erika Hamilton, Shu Fen Wong, Andrea Tazbirkova, Ivana Gabriela Sullivan, Cédric van Marcke, Antoine Italiano, Jilpa Patel, Sabeen Mekan, Tia Wu, Saiama N Waqar
{"title":"Phase 2 Open-Label Study of Sacituzumab Govitecan as Second-Line Therapy in Patients With Extensive-Stage SCLC: Results From TROPiCS-03.","authors":"Afshin Dowlati, Anne C Chiang, Andrés Cervantes, Sunil Babu, Erika Hamilton, Shu Fen Wong, Andrea Tazbirkova, Ivana Gabriela Sullivan, Cédric van Marcke, Antoine Italiano, Jilpa Patel, Sabeen Mekan, Tia Wu, Saiama N Waqar","doi":"10.1016/j.jtho.2024.12.028","DOIUrl":"10.1016/j.jtho.2024.12.028","url":null,"abstract":"<p><strong>Introduction: </strong>The phase 2 TROPiCS-03 study evaluated the efficacy/safety of sacituzumab govitecan (SG) as second-line treatment in patients with previously treated extensive-stage SCLC (ES-SCLC).</p><p><strong>Methods: </strong>TROPiCS-03 (NCT03964727) is a multicohort, open-label, phase 2 basket study of solid tumors, including ES-SCLC. Adults with ES-SCLC that progressed after one previous line of platinum-based chemotherapy and anti-programmed death-(ligand) 1 (PD-[L]1) therapy received SG 10 mg/kg on days 1 and 8 of a 21-day cycle. The primary end point was the investigator-assessed objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors version 1.1. Key secondary end points included investigator-assessed duration of response (DOR) and progression-free survival (PFS); blinded independent central review-assessed ORR, DOR, and PFS; overall survival (OS); and safety. Efficacy was evaluated in patients with platinum-resistant and platinum-sensitive disease.</p><p><strong>Results: </strong>Among 43 patients (median follow-up, 12.3 [range, 8.1-20.1] mo), investigator-assessed ORR was 41.9% (95% confidence interval [CI]: 27.0%-57.9%), with 18 confirmed partial responses; median (95% CI) DOR, PFS, and OS were 4.73 (3.52-6.70), 4.40 (3.81-6.11), and 13.60 (6.57-14.78) months, respectively. The efficacy results of the blinded independent central review assessments were similar. The investigator-assessed ORR (95% CI) was 35.0% (15.4%-59.2%) in patients with platinum-resistant disease (n = 20) and 47.8% (26.8%-69.4%) in patients with platinum-sensitive disease (n = 23). Furthermore, 32 patients (74.4%) had grade greater than or equal to 3 treatment-emergent adverse events (TEAEs). No TEAE led to SG discontinuation; one treatment-related TEAE (neutropenic sepsis) led to death.</p><p><strong>Conclusions: </strong>SG has promising efficacy as second-line treatment of ES-SCLC, irrespective of platinum sensitivity. Safety was manageable and consistent with that observed in other SG studies.</p>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":" ","pages":""},"PeriodicalIF":21.0,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142927288","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Radiomics-Based Support Vector Machine Distinguishes Molecular Events Driving the Progression of Lung Adenocarcinoma 基于放射组学的支持向量机区分肺腺癌进展的分子事件
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-01-01 DOI: 10.1016/j.jtho.2024.09.1431
Hong-Ji Li MD , Zhen-Bin Qiu MD , Meng-Min Wang MD , Chao Zhang MD, PhD , Hui-Zhao Hong MD , Rui Fu MD, PhD , Li-Shan Peng MD , Chen Huang MD , Qian Cui MD, PhD , Jia-Tao Zhang MD, PhD , Jing-Yun Ren MD, PhD , Lei Jiang MD, PhD , Yi-Long Wu MD , Wen-Zhao Zhong MD, PhD
{"title":"Radiomics-Based Support Vector Machine Distinguishes Molecular Events Driving the Progression of Lung Adenocarcinoma","authors":"Hong-Ji Li MD ,&nbsp;Zhen-Bin Qiu MD ,&nbsp;Meng-Min Wang MD ,&nbsp;Chao Zhang MD, PhD ,&nbsp;Hui-Zhao Hong MD ,&nbsp;Rui Fu MD, PhD ,&nbsp;Li-Shan Peng MD ,&nbsp;Chen Huang MD ,&nbsp;Qian Cui MD, PhD ,&nbsp;Jia-Tao Zhang MD, PhD ,&nbsp;Jing-Yun Ren MD, PhD ,&nbsp;Lei Jiang MD, PhD ,&nbsp;Yi-Long Wu MD ,&nbsp;Wen-Zhao Zhong MD, PhD","doi":"10.1016/j.jtho.2024.09.1431","DOIUrl":"10.1016/j.jtho.2024.09.1431","url":null,"abstract":"<div><h3>Introduction</h3><div>An increasing number of early-stage lung adenocarcinomas (LUAD) are detected as lung nodules. The radiological features related to LUAD progression warrant further investigation. Exploration is required to bridge the gap between radiomics-based features and molecular characteristics of lung nodules.</div></div><div><h3>Methods</h3><div>Consensus clustering was applied to the radiomic features of 1212 patients to establish stable clustering. Clusters were illustrated using clinicopathological and next-generation sequencing. A classifier was constructed to further investigate the molecular characteristics in patients with paired computed tomography and RNA sequencing data.</div></div><div><h3>Results</h3><div>Patients were clustered into four clusters. Cluster 1 was associated with a low consolidation-to-tumor ratio, preinvasion, grade I disease, and good prognosis. Clusters 2 and 3 reported increasing malignancy with a higher consolidation-to-tumor ratio, higher pathologic grade, and poor prognosis. Cluster 2 possessed more spread through air spaces and cluster 3 reported a higher proportion of pleural invasion. Cluster 4 had similar clinicopathological features as cluster 1 except but a proportion of grade II disease. RNA sequencing indicated that cluster 1 represented nodules with indolent growth and good differentiation, whereas cluster 4 reported progression in cell development but still had low proliferative activity. Nodules with high proliferation were classified into clusters 2 and 3. In addition, the radiomics classifier distinguished cluster 2 as nodules harboring an activated immune environment, whereas cluster 3 represented nodules with a suppressive immune environment. Furthermore, signatures associated with the prognosis of early-stage LUAD were validated in external datasets.</div></div><div><h3>Conclusions</h3><div>Radiomics features can manifest molecular events driving the progression of LUAD. Our study provides molecular insight into radiomics features and assists in the diagnosis and treatment of early-stage LUAD.</div></div>","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"20 1","pages":"Pages 52-64"},"PeriodicalIF":21.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142290063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comment on “Consolidation Osimertinib Versus Durvalumab Versus Observation After Concurrent Chemoradiation in Unresectable EGFR-Mutant NSCLC: A Multicenter Retrospective Cohort Study” 评论“巩固奥西替尼与杜伐单抗与同步放化疗后观察不可切除的egfr突变NSCLC:一项多中心回顾性队列研究”。
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-01-01 DOI: 10.1016/j.jtho.2024.07.025
Xiaowei Huang MD, Xian Gu MD, Zhenye Xu PhD
{"title":"Comment on “Consolidation Osimertinib Versus Durvalumab Versus Observation After Concurrent Chemoradiation in Unresectable EGFR-Mutant NSCLC: A Multicenter Retrospective Cohort Study”","authors":"Xiaowei Huang MD,&nbsp;Xian Gu MD,&nbsp;Zhenye Xu PhD","doi":"10.1016/j.jtho.2024.07.025","DOIUrl":"10.1016/j.jtho.2024.07.025","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"20 1","pages":"Pages e1-e2"},"PeriodicalIF":21.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142965548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prognostic Factors After Resection for Thymoma Distant Recurrences 胸腺瘤远处复发切除术后的预后因素。
IF 21 1区 医学
Journal of Thoracic Oncology Pub Date : 2025-01-01 DOI: 10.1016/j.jtho.2024.10.006
Marco Chiappetta MD, Carolina Sassorossi MD, Filippo Lococo MD
{"title":"Prognostic Factors After Resection for Thymoma Distant Recurrences","authors":"Marco Chiappetta MD,&nbsp;Carolina Sassorossi MD,&nbsp;Filippo Lococo MD","doi":"10.1016/j.jtho.2024.10.006","DOIUrl":"10.1016/j.jtho.2024.10.006","url":null,"abstract":"","PeriodicalId":17515,"journal":{"name":"Journal of Thoracic Oncology","volume":"20 1","pages":"Pages e15-e16"},"PeriodicalIF":21.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142965736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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