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A Prospective Observational Study of Physical Activity Levels and Physical Fitness of People at High Risk for Lung Cancer 肺癌高危人群体育活动水平和体能的前瞻性观察研究
JTO Clinical and Research Reports Pub Date : 2024-02-01 DOI: 10.1016/j.jtocrr.2024.100633
Asha Bonney MBBS , Catherine L. Granger PhD , Daniel Steinfort PhD , Henry M. Marshall PhD , Emily Stone PhD , Annette McWilliams PhD , Fraser Brims PhD , Paul Fogarty MBBS , Linda Lin MBBS , Jiashi Li MD , Siyuan Pang MD , Stephen Lam PhD , Kwun M. Fong PhD , Renee Manser PhD
{"title":"A Prospective Observational Study of Physical Activity Levels and Physical Fitness of People at High Risk for Lung Cancer","authors":"Asha Bonney MBBS ,&nbsp;Catherine L. Granger PhD ,&nbsp;Daniel Steinfort PhD ,&nbsp;Henry M. Marshall PhD ,&nbsp;Emily Stone PhD ,&nbsp;Annette McWilliams PhD ,&nbsp;Fraser Brims PhD ,&nbsp;Paul Fogarty MBBS ,&nbsp;Linda Lin MBBS ,&nbsp;Jiashi Li MD ,&nbsp;Siyuan Pang MD ,&nbsp;Stephen Lam PhD ,&nbsp;Kwun M. Fong PhD ,&nbsp;Renee Manser PhD","doi":"10.1016/j.jtocrr.2024.100633","DOIUrl":"https://doi.org/10.1016/j.jtocrr.2024.100633","url":null,"abstract":"<div><h3>Introduction</h3><p>Physical activity (PA) is a potentially modifiable risk factor for lung cancer, with previous research revealing that people who engage in more PA have lower risk of developing lung cancer. PA levels of lung cancer screening participants have not previously been explored.</p></div><div><h3>Methods</h3><p>Participants at a single Australian International Lung Screen Trial site were eligible for assessment of self-reported PA levels (International Physical Activity Questionnaire and Physical Activity Scale for the Elderly) and physical assessments (6-min walk distance, hand grip muscle strength, daily step count, and body composition) at a single time point during lung cancer screening. Statistics were predominantly descriptive, with parametric data presented as mean and SD and nonparametric data presented as median and interquartile range (IQR).</p></div><div><h3>Results</h3><p>A total of 178 participants were enrolled in this study, with a median age of 61 years. Of the participants, 61% were men and 51% were people who currently smoke. The median total International Physical Activity Questionnaire score was 1756 MET/min/wk (IQR 689, 4049). Mean total Physical Activity Scale for the Elderly score was 160 (SD 72), higher than described in healthy sedentary adults. The median daily step count was 7237 steps (IQR 5353, 10,038) and mean 6-minute walk distance was 545 m (SD 92). Median grip strengths were within predicted normal range, with an elevated median percentage body fat and low skeletal muscle mass found on body composition.</p></div><div><h3>Conclusion</h3><p>Almost a quarter of International Lung Screen Trial participants assessed reported low levels of PA and have a potentially modifiable risk factor to improve health outcomes. Larger studies are needed to characterize the burden of inactivity among high-risk lung cancer screening populations.</p></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666364324000031/pdfft?md5=bb55777c15706d0e08b94f39b7f793d0&pid=1-s2.0-S2666364324000031-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139718766","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}
引用次数: 0
Severe Drug-Induced Interstitial Lung Disease After Administration of Osimertinib as Adjuvant Treatment for Resected EGFR-Mutated NSCLC: A Case Report 奥希替尼辅助治疗切除的表皮生长因子受体突变非小细胞肺癌后引发的严重药物性间质性肺病:病例报告
JTO Clinical and Research Reports Pub Date : 2024-02-01 DOI: 10.1016/j.jtocrr.2024.100631
Sho Mitsuya MD , Masahiro Arai MD , Kiyoe Kanaoka MD , Tomoya Funamoto MD , Hiroyuki Tsuji MD , Kenjiro Tsuruoka MD, PhD , Ninso Matsunaga MD , Takahiko Nakamura MD , Yosuke Tamura MD, PhD , Masafumi Imanishi MD, PhD , Soichiro Ikeda MD, PhD , Akihisa Imagawa MD, PhD , Yasuhito Fujisaka MD, PhD
{"title":"Severe Drug-Induced Interstitial Lung Disease After Administration of Osimertinib as Adjuvant Treatment for Resected EGFR-Mutated NSCLC: A Case Report","authors":"Sho Mitsuya MD ,&nbsp;Masahiro Arai MD ,&nbsp;Kiyoe Kanaoka MD ,&nbsp;Tomoya Funamoto MD ,&nbsp;Hiroyuki Tsuji MD ,&nbsp;Kenjiro Tsuruoka MD, PhD ,&nbsp;Ninso Matsunaga MD ,&nbsp;Takahiko Nakamura MD ,&nbsp;Yosuke Tamura MD, PhD ,&nbsp;Masafumi Imanishi MD, PhD ,&nbsp;Soichiro Ikeda MD, PhD ,&nbsp;Akihisa Imagawa MD, PhD ,&nbsp;Yasuhito Fujisaka MD, PhD","doi":"10.1016/j.jtocrr.2024.100631","DOIUrl":"10.1016/j.jtocrr.2024.100631","url":null,"abstract":"<div><p>Osimertinib administration has been approved as an adjuvant treatment after complete surgical resection in patients with EGFR-mutated NSCLC. This article presents the first report of life-threatening postoperative osimertinib-induced interstitial lung disease. An 83-year-old male patient underwent right upper lobectomy (pathologic stage IIA) and osimertinib (80 mg/d) was initiated on postoperative day 75. On day 44 of osimertinib administration, chest computed tomography revealed diffuse ground-glass opacities; accordingly, osimertinib-induced interstitial lung disease was diagnosed. Steroid pulse therapy was initiated using a high-flow nasal cannula to treat dyspnea and hypoxemia, rapidly improving the respiratory status and imaging findings; moreover, the patient’s clinical course was excellent. This case report suggests that the postoperative occurrence of severe osimertinib-induced interstitial lung disease is a crucial factor that must be considered in patient decision-making regarding perioperative treatment.</p></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666364324000018/pdfft?md5=df332c61af156cd7360621cd0b49595e&pid=1-s2.0-S2666364324000018-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139395878","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}
引用次数: 0
A Phase 1/2 Study to Evaluate the Safety and Activity of Nivolumab in Combination With Vorolanib, a Vascular Endothelial Growth Factor Tyrosine Kinase Inhibitor, in Patients With Refractory Thoracic Tumors 评估Nivolumab与血管内皮生长因子酪氨酸激酶抑制剂Vorolanib联合治疗难治性胸部肿瘤患者的安全性和活性的1/2期研究
JTO Clinical and Research Reports Pub Date : 2024-02-01 DOI: 10.1016/j.jtocrr.2023.100619
Kathryn E. Beckermann MD, PhD , Christine M. Bestvina MD , Badi El Osta MD , Rachel E. Sanborn MD , Hossein Borghaei MD , Philip Edward Lammers MD, MSCI , Giovanni Selvaggi MD , Jennifer G. Whisenant PhD , Ellen Heimann-Nichols MBA , Lynne Berry PhD , Chih-Yuan Hsu PhD , Yu Shyr PhD , Leora Horn MD, MSc, MHPE , Heather Wakelee MD, FASCO
{"title":"A Phase 1/2 Study to Evaluate the Safety and Activity of Nivolumab in Combination With Vorolanib, a Vascular Endothelial Growth Factor Tyrosine Kinase Inhibitor, in Patients With Refractory Thoracic Tumors","authors":"Kathryn E. Beckermann MD, PhD ,&nbsp;Christine M. Bestvina MD ,&nbsp;Badi El Osta MD ,&nbsp;Rachel E. Sanborn MD ,&nbsp;Hossein Borghaei MD ,&nbsp;Philip Edward Lammers MD, MSCI ,&nbsp;Giovanni Selvaggi MD ,&nbsp;Jennifer G. Whisenant PhD ,&nbsp;Ellen Heimann-Nichols MBA ,&nbsp;Lynne Berry PhD ,&nbsp;Chih-Yuan Hsu PhD ,&nbsp;Yu Shyr PhD ,&nbsp;Leora Horn MD, MSc, MHPE ,&nbsp;Heather Wakelee MD, FASCO","doi":"10.1016/j.jtocrr.2023.100619","DOIUrl":"10.1016/j.jtocrr.2023.100619","url":null,"abstract":"<div><h3>Introduction</h3><p>Targeting the tumor microenvironment may enhance response to immunotherapy (immune checkpoint inhibitors) and improve outcomes for patients. This study tested the safety and efficacy of vorolanib, a novel tyrosine kinase inhibitor of vascular endothelial growth factor, platelet-derived growth factor, and c-KIT, in combination with programmed cell death protein 1 blockade using nivolumab for refractory thoracic malignancies.</p></div><div><h3>Methods</h3><p>This single-arm multicenter study enrolled patients with extensive-stage SCLC, thymic carcinoma, and NSCLC, either naive or had progressed on previous chemotherapy or immune checkpoint inhibitors (either primary or acquired resistance). The primary objective of phase 1 was to determine the maximum tolerated dose, and the primary end point for each dose-expansion cohort was the objective response rate.</p></div><div><h3>Results</h3><p>A total of 88 patients were enrolled in phase 1 (n = 11) and dose expansion (n = 77) cohorts. Transaminitis was dose-limiting and expansion proceeded with oral vorolanib 200 mg daily combined with intravenous nivolumab 240 mg every 2 weeks. The objective response rate per cohort were as follows: NSCLC naive 33% (five of 15, 95% confidence interval [CI]: 13%–60%), NSCLC primary refractory 5.9% (one of 17, 95% CI: 0%–17.6%), NSCLC acquired resistance 11.1% (two of 18, 95% CI: 0%–27.8%); SCLC 0% (zero of 18), and thymic carcinoma 11% (one of nine, 95% CI: 0%–33%). Disease control rate ranged from 11.1% in SCLC (two of 18, 0%–27.8%) to 66.7 % in thymic carcinoma (six of nine, 95% CI: 33.3%–100%). The most common adverse events were fatigue (32%), aspartate transaminase (27%) and alanine transaminase elevation (25%), and diarrhea (19%). Transaminitis was more common in patients with thymic carcinoma than other tumors.</p></div><div><h3>Conclusions</h3><p>Vorolanib plus nivolumab had a manageable safety profile and may have clinical benefits in various thoracic malignancies. The disease control rate in thymic malignancies warrants further assessment.</p></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666364323001625/pdfft?md5=dccb3d4c2096d1c8b2f2221d50859b62&pid=1-s2.0-S2666364323001625-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139016968","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}
引用次数: 0
Lorlatinib After Alectinib-Induced Pneumonitis: A Case Report 阿来替尼诱发肺炎后的罗拉替尼:病例报告
JTO Clinical and Research Reports Pub Date : 2024-02-01 DOI: 10.1016/j.jtocrr.2023.100591
James A. Fletcher M.B.B.S. , William J. Mullally MBBCh BAO , Rahul Ladwa MPhil , Kenneth J. O’Byrne MD
{"title":"Lorlatinib After Alectinib-Induced Pneumonitis: A Case Report","authors":"James A. Fletcher M.B.B.S. ,&nbsp;William J. Mullally MBBCh BAO ,&nbsp;Rahul Ladwa MPhil ,&nbsp;Kenneth J. O’Byrne MD","doi":"10.1016/j.jtocrr.2023.100591","DOIUrl":"10.1016/j.jtocrr.2023.100591","url":null,"abstract":"<div><p><em>ALK</em> gene rearrangements are detected in approximately 3% to 5% of NSCLC. <em>ALK</em> tyrosine kinase inhibitors, such as third-generation lorlatinib, have exhibited remarkable efficacy in <em>ALK</em>-rearranged NSCLC; however, they have been associated with a low incidence of treatment-limiting and potentially fatal drug-induced interstitial lung disease (ILD). There is concern that this may represent a class effect, a theory that is supported by a number of case reports. Because of clinical trial exclusion criteria, there are limited prospective data to guide decision-making after <em>ALK</em> tyrosine kinase inhibitors–induced ILD. A systematic review of the literature was conducted and only identified four reported cases of lorlatinib safety in this context. Here, we report the successful sequencing of lorlatinib in a patient who discontinued alectinib secondary to grade 3 drug-induced ILD.</p></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666364323001340/pdfft?md5=bd98224b5ca00552f89132e9ae085664&pid=1-s2.0-S2666364323001340-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135922167","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}
引用次数: 0
Long-Term Efficacy and Safety of Lorlatinib in Japanese Patients With ALK-Positive Advanced NSCLC—A Brief Report From the CROWN Study 洛拉替尼对日本 ALK 阳性晚期非小细胞肺癌患者的长期疗效和安全性--CROWN 研究简要报告
JTO Clinical and Research Reports Pub Date : 2024-01-06 DOI: 10.1016/j.jtocrr.2024.100632
Shunsuke Teraoka MD , Hidetoshi Hayashi MD, PhD , Yasushi Goto MD, PhD , Makoto Nishio MD, PhD , Shunichi Sugawara MD, PhD , Takao Inoue MD , Satoshi Oizumi MD, PhD , Shigeyuki Toyoizumi MS , Masakazu Matsumura MS , Rossella Messina PharmD, PhD , Terufumi Kato MD
{"title":"Long-Term Efficacy and Safety of Lorlatinib in Japanese Patients With ALK-Positive Advanced NSCLC—A Brief Report From the CROWN Study","authors":"Shunsuke Teraoka MD ,&nbsp;Hidetoshi Hayashi MD, PhD ,&nbsp;Yasushi Goto MD, PhD ,&nbsp;Makoto Nishio MD, PhD ,&nbsp;Shunichi Sugawara MD, PhD ,&nbsp;Takao Inoue MD ,&nbsp;Satoshi Oizumi MD, PhD ,&nbsp;Shigeyuki Toyoizumi MS ,&nbsp;Masakazu Matsumura MS ,&nbsp;Rossella Messina PharmD, PhD ,&nbsp;Terufumi Kato MD","doi":"10.1016/j.jtocrr.2024.100632","DOIUrl":"10.1016/j.jtocrr.2024.100632","url":null,"abstract":"<div><h3>Introduction</h3><p>Lorlatinib was found to have improved efficacy versus crizotinib in the global phase 3 CROWN study (NCT03052608). Similar results were revealed for the Japanese population as for the overall population. We present results from the unplanned 3-year follow-up from the CROWN study in Japanese patients.</p></div><div><h3>Methods</h3><p>Patients were randomized to either lorlatinib 100 mg once daily (n = 25) or crizotinib 250 mg twice daily (n = 23). The primary end point was progression-free survival assessed by blinded independent central review. Secondary end points included objective and intracranial responses assessed by blinded independent central review and safety.</p></div><div><h3>Results</h3><p>At the data cutoff of September 20, 2021, median progression-free survival was not reached with lorlatinib and 11.1 months with crizotinib (hazard ratio = 0.36). Objective response rate was 72.0% with lorlatinib and 52.2% with crizotinib. For patients with baseline brain metastases, intracranial response rate was 100.0% versus 28.6% with lorlatinib versus crizotinib. Nine patients in the lorlatinib group received more than or equal to 1 subsequent anticancer systemic therapy, with ALK tyrosine kinase inhibitor as the most common first subsequent therapy. The safety profile was consistent with that reported previously, with no new safety signals.</p></div><div><h3>Conclusions</h3><p>This updated analysis in the Japanese population revealed prolonged benefits of lorlatinib over crizotinib in patients with treatment-naive advanced <em>ALK</em>-positive NSCLC with and those without brain metastases.</p></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S266636432400002X/pdfft?md5=c1d5f70304d31cae4c92df694d16ea8e&pid=1-s2.0-S266636432400002X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139395973","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}
引用次数: 0
Quantifying Interrater Agreement and Reliability Between Thoracic Pathologists: Paradoxical Behavior of Cohen’s Kappa in the Presence of a High Prevalence of the Histopathologic Feature in Lung Cancer 量化胸部病理学家之间的相互一致和可靠性:在肺癌组织病理学特征高发的情况下科恩卡帕的矛盾行为
JTO Clinical and Research Reports Pub Date : 2024-01-01 DOI: 10.1016/j.jtocrr.2023.100618
Kay See Tan PhD , Yi-Chen Yeh MD , Prasad S. Adusumilli MD, FACS , William D. Travis MD
{"title":"Quantifying Interrater Agreement and Reliability Between Thoracic Pathologists: Paradoxical Behavior of Cohen’s Kappa in the Presence of a High Prevalence of the Histopathologic Feature in Lung Cancer","authors":"Kay See Tan PhD ,&nbsp;Yi-Chen Yeh MD ,&nbsp;Prasad S. Adusumilli MD, FACS ,&nbsp;William D. Travis MD","doi":"10.1016/j.jtocrr.2023.100618","DOIUrl":"10.1016/j.jtocrr.2023.100618","url":null,"abstract":"<div><h3>Introduction</h3><p>Cohen’s kappa is often used to quantify the agreement between two pathologists. Nevertheless, a high prevalence of the feature of interest can lead to seemingly paradoxical results, such as low Cohen’s kappa values despite high “observed agreement.” Here, we investigate Cohen’s kappa using data from histologic subtyping assessment of lung adenocarcinomas and introduce alternative measures that can overcome this “kappa paradox.”</p></div><div><h3>Methods</h3><p>A total of 50 frozen sections from stage I lung adenocarcinomas less than or equal to 3 cm in size were independently reviewed by two pathologists to determine the absence or presence of five histologic patterns (lepidic, papillary, acinar, micropapillary, solid). For each pattern, observed agreement (proportion of cases with concordant “absent” or “present” ratings) and Cohen’s kappa were calculated, along with Gwet’s AC1.</p></div><div><h3>Results</h3><p>The prevalence of any amount of the histologic patterns ranged from 42% (solid) to 97% (acinar). On the basis of Cohen’s kappa, there was substantial agreement for four of the five patterns (lepidic, 0.65; papillary, 0.67; micropapillary, 0.64; solid, 0.61). Acinar had the lowest Cohen’s kappa (0.43, moderate agreement), despite having the highest observed agreement (88%). In contrast, Gwet’s AC1 values were close to or higher than Cohen’s kappa across patterns (lepidic, 0.64; papillary, 0.69; micropapillary, 0.71; solid, 0.73; acinar, 0.85). The proportion of positive versus negative agreement was 93% versus 50% for acinar.</p></div><div><h3>Conclusions</h3><p>Given the dependence of Cohen’s kappa on feature prevalence, interrater agreement studies should include complementary indices such as Gwet’s AC1 and proportions of specific agreement, especially in settings with a high prevalence of the feature of interest.</p></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666364323001613/pdfft?md5=e7796d919302294aa494a8c9759df615&pid=1-s2.0-S2666364323001613-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139018977","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}
引用次数: 0
A Comparative Study Evaluating the Quality of Life and Survival Outcomes in Patients Receiving Chemotherapy Versus Oral Tyrosine Kinase Inhibitor in the Third Line and Beyond Setting for Advanced NSCLC 晚期非小细胞肺癌三线及三线以上治疗中化疗与口服酪氨酸激酶抑制剂对患者生活质量和生存结果的比较评估研究
JTO Clinical and Research Reports Pub Date : 2024-01-01 DOI: 10.1016/j.jtocrr.2023.100622
Vanita Noronha MBBS, MD, DM , Nandini S. Menon MBBS, MD, DrNB , Vijay Maruti Patil MBBS, MD, DM , M.V. Chandrakanth MBBS, MD, DM , Sucheta More BAMS, MSc , Aditya Dhanawat MBBS, MD , Oindrila Roy Chowdhary MSc , Ajaykumar Chandrabhan Singh MBBS, MD, DM , Supriya Goud BAMS, PGDCR , Srushti Shah BHMS, PGDCR , Naveen Karuvandan MBBS, MD, DM , Kunal Naishadh Jobanputra MBBS, MD, DM , Darshit Kalpeshkumar Shah DM , Minit Jalan Shah MBBS, MD, DM , Rupjyoti Sarma MBBS, MD, DM , Dhwaniben Patel MBBS, MD , Ritam Joarder MBBS, MD , Prashant Kumar MBBS, MD , Anupa John MBBS, MD , Jaspreet Kaur MBBS, MD , Kumar Prabhash MBBS, MD, DM
{"title":"A Comparative Study Evaluating the Quality of Life and Survival Outcomes in Patients Receiving Chemotherapy Versus Oral Tyrosine Kinase Inhibitor in the Third Line and Beyond Setting for Advanced NSCLC","authors":"Vanita Noronha MBBS, MD, DM ,&nbsp;Nandini S. Menon MBBS, MD, DrNB ,&nbsp;Vijay Maruti Patil MBBS, MD, DM ,&nbsp;M.V. Chandrakanth MBBS, MD, DM ,&nbsp;Sucheta More BAMS, MSc ,&nbsp;Aditya Dhanawat MBBS, MD ,&nbsp;Oindrila Roy Chowdhary MSc ,&nbsp;Ajaykumar Chandrabhan Singh MBBS, MD, DM ,&nbsp;Supriya Goud BAMS, PGDCR ,&nbsp;Srushti Shah BHMS, PGDCR ,&nbsp;Naveen Karuvandan MBBS, MD, DM ,&nbsp;Kunal Naishadh Jobanputra MBBS, MD, DM ,&nbsp;Darshit Kalpeshkumar Shah DM ,&nbsp;Minit Jalan Shah MBBS, MD, DM ,&nbsp;Rupjyoti Sarma MBBS, MD, DM ,&nbsp;Dhwaniben Patel MBBS, MD ,&nbsp;Ritam Joarder MBBS, MD ,&nbsp;Prashant Kumar MBBS, MD ,&nbsp;Anupa John MBBS, MD ,&nbsp;Jaspreet Kaur MBBS, MD ,&nbsp;Kumar Prabhash MBBS, MD, DM","doi":"10.1016/j.jtocrr.2023.100622","DOIUrl":"https://doi.org/10.1016/j.jtocrr.2023.100622","url":null,"abstract":"<div><h3>Introduction</h3><p>The outcomes in advanced NSCLC have improved owing to the availability of more effective systemic and improved supportive care. This has increased the number of patients who seek treatment in the third line and beyond setting. We conducted this study to compare the quality of life (QoL), toxicity, and outcomes in patients receiving chemotherapy and EGFR tyrosine kinase inhibitors (TKIs) in this setting.</p></div><div><h3>Methods</h3><p>In this phase 3, randomized, open-label study, patients with stage III or IV NSCLC with disease progression on at least two prior lines of chemotherapy, with a life expectancy of at least 3 months, without prior EGFR TKI exposure, and stable brain metastases (if any) were included. Patients were randomized to receive chemotherapy (gemcitabine or docetaxel or paclitaxel or vinorelbine) or an EGFR TKI (erlotinib or gefitinib). The primary end point was the change in QoL at 8 to 10 weeks; the secondary outcomes were safety and overall survival (OS). Patients underwent clinical evaluation at every visit, and toxicity was assessed as per Common Terminology Criteria for Adverse Events version 4.03. A radiological tumor response assessment was done every 8 to 12 weeks from the start of therapy. The QoL was assessed using the EORTC QLQ C30 and LC13 questionnaires. The change in QoL scores was calculated as the difference between scores at baseline and scores at 8 to 10 weeks (Δ) for each QoL domain. The Mann-Whitney <em>U</em> test was used to compare the mean difference (Δ) for each domain. OS and progression-free survival (PFS) were determined using the Kaplan-Meier method and Cox proportional regression analysis.</p></div><div><h3>Results</h3><p>A total of 246 patients were enrolled in the study, with 123 in each arm. There was a male predominance with 69.1% male patients in the chemotherapy arm and 70.7% in the EGFR TKI arm. The median age of patients in the chemotherapy arm was 54 years and 55 years in the chemotherapy and EGFR TKI arms, respectively. There was no significant difference in the change in QoL at baseline and the second visit (Δ) in both arms in all domains of EORTC QLQ C30 except cognitive function (<em>p</em> = 0.0045) and LC13 except alopecia (0.01249). The mean Δ Global Health Status was −28 in the chemotherapy arm and −26.8 in the EGFR TKI arm; this was not statistically significant (<em>p</em> = 0.973). The median follow-up was 88.1 months (95% confidence interval [CI]: 39.04–137.15). On the intention-to-treat analysis, the median PFS was 3.13 months (95% CI: 2.15–4.11) in the chemotherapy arm and 2.26 months (95% CI: 2.1–2.43) in the EGFR TKI arm, with hazard ratio at 1.074 (95% CI: 0.83–1.38) (<em>p</em> = 0.58). There were 120 deaths in each arm. The median OS was 7.63 months (95% CI: 5.96–9.30) in the chemotherapy arm and 7.5 months in the EGFR TKI arm (95% CI: 5.85–9.14); hazard ratio at 1.033 (95% CI: 0.80–1.33) (<em>p</em> = 0.805). The toxicity profile was simil","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666364323001650/pdfft?md5=bbcca68be73ec522439b03f8d7b0df5d&pid=1-s2.0-S2666364323001650-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139473514","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}
引用次数: 0
Novel BRD2::NUTM1 Fusion in NUT Carcinoma With Exceptional Response to Chemotherapy: A Case Report NUT癌中的新型BRD2::NUTM1融合,对化疗反应特殊:病例报告
JTO Clinical and Research Reports Pub Date : 2024-01-01 DOI: 10.1016/j.jtocrr.2023.100625
Sarah J. Wu MD, PhD , Justin J. Kim GED , Yeying Huang BS , R. Taylor Durall BS , Simone Becker RN , Stephanie Canty CNP, MSN , Stefania Molinaro BS , Evan Pisick MD , Geoffrey I. Shapiro MD, PhD , Christopher A. French MD , Jia Luo MD
{"title":"Novel BRD2::NUTM1 Fusion in NUT Carcinoma With Exceptional Response to Chemotherapy: A Case Report","authors":"Sarah J. Wu MD, PhD ,&nbsp;Justin J. Kim GED ,&nbsp;Yeying Huang BS ,&nbsp;R. Taylor Durall BS ,&nbsp;Simone Becker RN ,&nbsp;Stephanie Canty CNP, MSN ,&nbsp;Stefania Molinaro BS ,&nbsp;Evan Pisick MD ,&nbsp;Geoffrey I. Shapiro MD, PhD ,&nbsp;Christopher A. French MD ,&nbsp;Jia Luo MD","doi":"10.1016/j.jtocrr.2023.100625","DOIUrl":"10.1016/j.jtocrr.2023.100625","url":null,"abstract":"<div><p>We present the first known case of a patient with <em>BRD2::NUTM1</em>-driven NUT carcinoma. A 59-year-old woman presented with poorly differentiated squamous cell lung cancer metastatic to the pleura. Eventually, a positive NUT immunohistochemistry, NUT fluorescence in situ hybridization, and RNA next-generation sequencing with a <em>BRD2::NUTM1</em> fusion led to the diagnosis of NUT carcinoma. She received multiple lines of chemotherapy with response and is still alive at 2 years postdiagnosis. This report expands on the known fusions in NUT carcinoma and highlights potential differences in patient prognosis on the basis of gene fusion partners.</p></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666364323001686/pdfft?md5=5196d7d17fc051b503b55fe9e7f25b4e&pid=1-s2.0-S2666364323001686-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139187958","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}
引用次数: 0
The First Case Report of Effective Treatment With Sotorasib for Metastatic Atypical Lung Carcinoid Harboring KRAS G12C Mutation and Aggressive Disseminated Lung Metastasis: A Case Report 索托拉西布有效治疗携带KRAS G12C突变的转移性非典型肺类癌和侵袭性肺播散转移的首例病例报告;病例报告
JTO Clinical and Research Reports Pub Date : 2024-01-01 DOI: 10.1016/j.jtocrr.2023.100620
Masafumi Saiki MD , Chisa Omori MD , Honami Morikawa MD , Ken Shinohara MD , So Shimamura MD , Hiroki Ohkoshi MD , Yoshinori Uchida MD , Tomohiro Inoue MD, PhD , Tetsuo Kondo MD, PhD , Shinnosuke Ikemura MD, PhD , Kenzo Soejima MD, PhD
{"title":"The First Case Report of Effective Treatment With Sotorasib for Metastatic Atypical Lung Carcinoid Harboring KRAS G12C Mutation and Aggressive Disseminated Lung Metastasis: A Case Report","authors":"Masafumi Saiki MD ,&nbsp;Chisa Omori MD ,&nbsp;Honami Morikawa MD ,&nbsp;Ken Shinohara MD ,&nbsp;So Shimamura MD ,&nbsp;Hiroki Ohkoshi MD ,&nbsp;Yoshinori Uchida MD ,&nbsp;Tomohiro Inoue MD, PhD ,&nbsp;Tetsuo Kondo MD, PhD ,&nbsp;Shinnosuke Ikemura MD, PhD ,&nbsp;Kenzo Soejima MD, PhD","doi":"10.1016/j.jtocrr.2023.100620","DOIUrl":"10.1016/j.jtocrr.2023.100620","url":null,"abstract":"<div><p>Pulmonary neuroendocrine tumors are rare, accounting for approximately 1% to 2% of lung cancers. Atypical carcinoids account for approximately 10% of pulmonary neuroendocrine tumors and are categorized as moderately malignant. Treatment options for advanced-stage atypical carcinoids include everolimus, cytotoxic anticancer agents, and peptide receptor radionuclide therapy. In this report, we present the first case of KRAS G12C mutation-positive atypical carcinoid that was successfully treated with sotorasib. Therapeutically important mutations observed in non-small cell lung cancer are seldom found in atypical carcinoid tumors. Nonetheless, it is worthwhile to search for genetic mutations in atypical carcinoid tumors, considering the potential for molecular targeted therapy to be effective in their treatment as well.</p></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666364323001637/pdfft?md5=7b3bfdd3cada44c5ed61bb8d9850418c&pid=1-s2.0-S2666364323001637-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139017129","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}
引用次数: 0
The Perceived Value of Liquid Biopsy: Results From a Canadian Validation Study of Circulating Tumor DNA T790M Testing—Patient’s Willingness-to-Pay: A Brief Report 避免组织活检的感知价值:加拿大循环肿瘤 DNA T790M 检测验证研究的结果--患者的支付意愿:简要报告
JTO Clinical and Research Reports Pub Date : 2024-01-01 DOI: 10.1016/j.jtocrr.2023.100615
Kaitlin H. Chen BSc , Tristan A. Barnes MD, BS , Janessa Laskin MD , Parneet Cheema MD, MBiotech , Geoffrey Liu MD, MS , Mussawar Iqbal MD , Jeffrey Rothenstein MD , Ronald Burkes MD , Ming-Sound Tsao MD , Natasha B. Leighl MD, MMSc
{"title":"The Perceived Value of Liquid Biopsy: Results From a Canadian Validation Study of Circulating Tumor DNA T790M Testing—Patient’s Willingness-to-Pay: A Brief Report","authors":"Kaitlin H. Chen BSc ,&nbsp;Tristan A. Barnes MD, BS ,&nbsp;Janessa Laskin MD ,&nbsp;Parneet Cheema MD, MBiotech ,&nbsp;Geoffrey Liu MD, MS ,&nbsp;Mussawar Iqbal MD ,&nbsp;Jeffrey Rothenstein MD ,&nbsp;Ronald Burkes MD ,&nbsp;Ming-Sound Tsao MD ,&nbsp;Natasha B. Leighl MD, MMSc","doi":"10.1016/j.jtocrr.2023.100615","DOIUrl":"10.1016/j.jtocrr.2023.100615","url":null,"abstract":"<div><h3>Introduction</h3><p>Liquid biopsy is recommended to diagnose molecular resistance to targeted therapy in patients with lung cancer. Nevertheless, not all jurisdictions provide funding and patient access. We report patients’ perceived value of liquid biopsy in targeted therapy resistance.</p></div><div><h3>Methods</h3><p>Canadian patients participating in a national EGFR T790M liquid biopsy validation study completed structured interviews measuring perceived value and willingness-to-pay for plasma circulating tumor DNA testing as an alternative to tumor biopsy using open-ended and iterative bidding approaches.</p></div><div><h3>Results</h3><p>A total of 60 patients with advanced lung cancer participated with a median age of 64 years (range: 31–87 y); 69% were Asian and 45% female. All had received prior EGFR tyrosine kinase inhibitor; 17% also received chemotherapy. All patients preferred to have plasma testing over repeat tumor biopsy. In the context of the Canadian publicly funded system, patients estimated that a median of 300 (interquartile range: 150–800) Canadian dollars was a reasonable price to pay for liquid biopsy. Patients were personally willing to pay a median 100 (interquartile range: 33–350) Canadian dollars.</p></div><div><h3>Conclusions</h3><p>In a system that covers the cost of standard diagnostic tests, patients with lung cancer indicated high willingness-to-pay out-of-pocket for liquid biopsy in the setting of acquired targeted therapy resistance. Patients have high perceived value of plasma genotyping and prefer it to repeat tumor biopsy.</p></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2666364323001583/pdfft?md5=9fbef08cb153b95102fa9ae907657c95&pid=1-s2.0-S2666364323001583-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139300767","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}
引用次数: 0
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