Pub Date : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101354
Ziqing Ye , Yongyue Wei
Background
A number of lung cancer prediction models have been developed worldwide. However, few validation studies have been conducted on Chinese populations. The objective of this study is to evaluate the feasibility and efficacy of 17 global lung cancer risk prediction models when applied to Chinese healthcare big data.
Methods
The study included individuals with information recorded in the Yinzhou regional health care database from January 1, 2010 to December 31, 2021. Seventeen lung cancer risk prediction models (Bach, Spitz, Hoggart, PLCOm2012, Korean Men, PLCOall2014, Pittsburgh Predictor, LLPi, LCRAT, HUNT, JPHC, Reduced HUNT, LLPv3, LCRS, OWL, UCL-I, Shanghai-LCM) were evaluated for their performance in overall population and subgroups. The discrimination of the 17 models was assessed using the Harrell's C-index and time-dependent area under the curve (AUC) as metrics. The calibration of the models was evaluated using the expected-to-observed ratio (EOR) and calibration curves. Moreover, the models were recalibrated in the Yinzhou population, and the calibration of the recalibrated models was evaluated.
Findings
A total of 907,200 study participants were included in the analysis, comprising 69,263 smokers and 837,937 non-smokers. Of the 17 models initially considered, only 6 (Bach, Hoggart, Pittsburgh Predictor, JPHC, Reduced HUNT, UCL-I) were available in the Yinzhou regional health care database with complete predictor data. Models that predicted risk over a ten-year period (Bach, JPHC, LCRS, and Shanghai-LCM) exhibited C-indices and AUCs of 0.75 or greater in the ever smokers. The majority of models demonstrated an overestimation of incidence risk in the ever smokers and an underestimation in the never smokers. The JPHC and LCRS models exhibited the most optimal calibration curves and the best EOR, whereas the other prediction models had suboptimal calibration. After recalibration, all models showed improved calibration; meanwhile, the JPHC and LCRS models retained the highest level of calibration.
Interpretation
Only six models can be directly applied to the Yinzhou regional health care database. The JPHC model developed for the Japanese population and the LCRS model developed based on the China Kadoorie Biobank (CKB) performed better in the Chinese population than other models.
Funding
This work was supported by the National Natural Science Foundation of China (82473728 to Y.W.) and Medical and Health Science and Technology Project of Zhejiang Province, China.
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Pub Date : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101413
Yuan Yang , Mao-Yao Wen , Yan Huang , Xin-Zu Chen , SIGES Research Group
<div><h3>Background</h3><div>Gastric cancer is a common malignancy in China, while screening and early detection of its precancerous high-risk events might help surveillance of high-risk subpopulation and improve the population survival. Magnetically controlled capsule gastroscopy (MCCG) emerged as a novel, non-invasive, and better compliant diagnostic method for screening gastric cancer and precancerous high-risk conditions, such as atrophic gastritis, gastric ulcer, and gastric polyp. The effectiveness of MCCG and the feasibility of sequential serology-MCCG protocol need to be preliminarily assessed in the aspect of screening precancerous high-risk events of gastric cancer.</div></div><div><h3>Methods</h3><div>This cross-sectional study collected health check-up observations (18-75 years old) at the Health Management Center, West China Hospital of Sichuan University between 2018 and 2020. Demographic data were retrieved including sex, age, ethnicity, education level, body mass index, smoking, alcohol drinking, and family history of cancers. Those observations had undergone MCCG and relevant serologic examinations including pepsinogen-I (PG-I), pepsinogen-II (PG-II), PG-I/-II ratio (PGR), gastrin-17 (G-17), carcinoembryonic antigen (CEA), and carbohydrate antigen 19-9 (CA19-9). Major findings from MCCG concerned tumor and high-risk precancerous events, i.e. chronic atrophic gastritis (CAG), gastric ulcer, and gastric polyp. The primary outcome measure was all high-risk events, while the second outcome measures were any of the above events. The detection rate of MCCG was estimated, and the predictive strengthen of serology on MCCG findings was analyzed.</div></div><div><h3>Findings</h3><div>A total of 1,432 eligible healthy check-up persons were included. MCCG reported none tumor and 114 cases with any precancerous high-risk event. The overall detection rate was 79.6‰ (95% CI 66.7‰-94.8‰) for all high-risk events, while the specific detection rates were 15.4‰ (95% CI 10.1‰-23.2‰) for CAG, 14.7‰ (95% CI 9.6‰-22.4‰) for gastric ulcers, and 55.2‰ (44.5‰-68.3‰) for gastric polyp, respectively. Compared between MCCG-positive (all high-risk events) and MCCG-negative groups, the baselines were generally comparable, with the only exception of age. The elder persons appeared significantly higher rates of high-risk events (P<0.001), particularly increased as ≥60 years old. All the levels of serologic examinations were not significantly different between MCCG-positive and MCCG-negative groups. However, regarding CAG outcome dataset, the levels PG-I (median 58.9 ug/L, IQR 44.3 ug/L-85.2 ug/L, P=0.016) and PGR (median 6.2, IQR 3.4-9.5, P=0.017) were significantly lower in the CAG group, as well as G-17 (P=0.009). The serology couldn’t well predict in all high-risk events dataset, but serologic CAG performed great predictive strength for MCCG CAG (adjusted diagnostic odds ratio [aDOR]=10.40, 95% CI 2.08-51.98; SPE=98.6%; LR+=8.85). Additionally, CA19-9 sero
{"title":"Magnetically controlled capsule gastroscopy and serology for screening precancerous high-risk events of gastric cancer: a cross-sectional study (SIGES)","authors":"Yuan Yang , Mao-Yao Wen , Yan Huang , Xin-Zu Chen , SIGES Research Group","doi":"10.1016/j.lanwpc.2024.101413","DOIUrl":"10.1016/j.lanwpc.2024.101413","url":null,"abstract":"<div><h3>Background</h3><div>Gastric cancer is a common malignancy in China, while screening and early detection of its precancerous high-risk events might help surveillance of high-risk subpopulation and improve the population survival. Magnetically controlled capsule gastroscopy (MCCG) emerged as a novel, non-invasive, and better compliant diagnostic method for screening gastric cancer and precancerous high-risk conditions, such as atrophic gastritis, gastric ulcer, and gastric polyp. The effectiveness of MCCG and the feasibility of sequential serology-MCCG protocol need to be preliminarily assessed in the aspect of screening precancerous high-risk events of gastric cancer.</div></div><div><h3>Methods</h3><div>This cross-sectional study collected health check-up observations (18-75 years old) at the Health Management Center, West China Hospital of Sichuan University between 2018 and 2020. Demographic data were retrieved including sex, age, ethnicity, education level, body mass index, smoking, alcohol drinking, and family history of cancers. Those observations had undergone MCCG and relevant serologic examinations including pepsinogen-I (PG-I), pepsinogen-II (PG-II), PG-I/-II ratio (PGR), gastrin-17 (G-17), carcinoembryonic antigen (CEA), and carbohydrate antigen 19-9 (CA19-9). Major findings from MCCG concerned tumor and high-risk precancerous events, i.e. chronic atrophic gastritis (CAG), gastric ulcer, and gastric polyp. The primary outcome measure was all high-risk events, while the second outcome measures were any of the above events. The detection rate of MCCG was estimated, and the predictive strengthen of serology on MCCG findings was analyzed.</div></div><div><h3>Findings</h3><div>A total of 1,432 eligible healthy check-up persons were included. MCCG reported none tumor and 114 cases with any precancerous high-risk event. The overall detection rate was 79.6‰ (95% CI 66.7‰-94.8‰) for all high-risk events, while the specific detection rates were 15.4‰ (95% CI 10.1‰-23.2‰) for CAG, 14.7‰ (95% CI 9.6‰-22.4‰) for gastric ulcers, and 55.2‰ (44.5‰-68.3‰) for gastric polyp, respectively. Compared between MCCG-positive (all high-risk events) and MCCG-negative groups, the baselines were generally comparable, with the only exception of age. The elder persons appeared significantly higher rates of high-risk events (P<0.001), particularly increased as ≥60 years old. All the levels of serologic examinations were not significantly different between MCCG-positive and MCCG-negative groups. However, regarding CAG outcome dataset, the levels PG-I (median 58.9 ug/L, IQR 44.3 ug/L-85.2 ug/L, P=0.016) and PGR (median 6.2, IQR 3.4-9.5, P=0.017) were significantly lower in the CAG group, as well as G-17 (P=0.009). The serology couldn’t well predict in all high-risk events dataset, but serologic CAG performed great predictive strength for MCCG CAG (adjusted diagnostic odds ratio [aDOR]=10.40, 95% CI 2.08-51.98; SPE=98.6%; LR+=8.85). Additionally, CA19-9 sero","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101413"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427694","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}
Pub Date : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101416
Biyun Wang , Yumeng Li , Yannan Zhao , Die Sang , Peng Yuan , Yanxia Zhao , Zheng Lv , Ning Xie , Nanling Li , Juanjuan Li , Fang Wang
<div><h3>Background</h3><div>Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) approved in China for HER2-positive or HER2-low metastatic breast cancer (MBC) patients. Little real-world evidence is available in China. This study aimed to investigate the real-world effectiveness and safety of T-DXd in Chinese MBC patients.</div></div><div><h3>Methods</h3><div>This study retrospectively enrolled 309 MBC patients treated with T-DXd across 9 institutions nationwide in China between December 2019 and March 2024. T-DXd was administered intravenously at a dose of 5.4 mg/kg on day 1 of a 21-day cycle. Real-world progression-free survival (rwPFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Real-world adverse events (AEs) were graded according to CTCAE 4.0. The study was registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT05594082</span><svg><path></path></svg></span>).</div></div><div><h3>Findings</h3><div>A total of 309 MBC patients were included, with 168 HER2-positive and 141 HER2-negative patients (133 of HER2-low and 8 of HER2 0). Among HER2-positive and HER2-negative patients, median age was 53.5 and 55.0 years, 14.3% and 17.7% ECOG scores of 2, 83.9% and 84.4% patients with visceral metastases, 32.7% and 23.4% patients with brain metastasis, respectively. The median number of lines of therapy (LOT) for MBC patients receiving T-DXd was 4 for both groups. At the cutoff date of 30 July 2024, in patients with HER2-positive MBC, median rwPFS and OS was 12.1 [95% confidence interval (CI): 8.5-14.7] and 22.7 months (95% CI: 16.6-28.8). The longer rwPFS, median 23.3 months, was observed in LOT 1-2, than 12.2 months in LOT 3-5 and 8.2 months in LOT≥6 (P=0.001). In patients with HER2-negative MBC, median rwPFS and OS was 7.7 (95% CI: 6.6-8.8) and 15.7 months (95% CI: 11.4-20.0). The median rwPFS for HR+ and HR- patients was 7.7 and 8.1 months, respectively (P=0.870). Longer rwPFS of 9.5 months was observed in LOT 1-4 compared to 6.4 months in LOT≥6 among HER2-negative patients (P=0.026). Patients with prior ADCs exposure showed significantly shorter rwPFS of T-DXd in both HER2-positive (P=0.032) and negative patients (P=0.039). Brain metastasis did not impact the effectiveness of T-DXd. Incidence of AEs of any grade was 69.3% and severe (grade 3 or above) AEs was 13.9%; no fatal AEs were observed. Interstitial lung disease (ILD) occurred in 23 patients (7.4%), with 15 (4.9%) of grade 1, 4 (1.3%) of grade 2, and 4 (1.3%) of grade 3. 80.7% of ILD patients, including all with grade 1 and one with grade 2, underwent a rechallenge with T-DXd after symptomatic treatments and careful evaluations.</div></div><div><h3>Interpretation</h3><div>In this largest dataset of T-DXd for Chinese patients with MBC to date, encouraging rwPFS of T-DXd was seen in heavily pretreated HER2-positive and HER2-negative MBC patients. Longer rwPFS was observed in MBC patients with fewer LOT and no
{"title":"Real-world multicenter study of T-DXd treatment in Chinese patients with metastatic breast cancer","authors":"Biyun Wang , Yumeng Li , Yannan Zhao , Die Sang , Peng Yuan , Yanxia Zhao , Zheng Lv , Ning Xie , Nanling Li , Juanjuan Li , Fang Wang","doi":"10.1016/j.lanwpc.2024.101416","DOIUrl":"10.1016/j.lanwpc.2024.101416","url":null,"abstract":"<div><h3>Background</h3><div>Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) approved in China for HER2-positive or HER2-low metastatic breast cancer (MBC) patients. Little real-world evidence is available in China. This study aimed to investigate the real-world effectiveness and safety of T-DXd in Chinese MBC patients.</div></div><div><h3>Methods</h3><div>This study retrospectively enrolled 309 MBC patients treated with T-DXd across 9 institutions nationwide in China between December 2019 and March 2024. T-DXd was administered intravenously at a dose of 5.4 mg/kg on day 1 of a 21-day cycle. Real-world progression-free survival (rwPFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Real-world adverse events (AEs) were graded according to CTCAE 4.0. The study was registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT05594082</span><svg><path></path></svg></span>).</div></div><div><h3>Findings</h3><div>A total of 309 MBC patients were included, with 168 HER2-positive and 141 HER2-negative patients (133 of HER2-low and 8 of HER2 0). Among HER2-positive and HER2-negative patients, median age was 53.5 and 55.0 years, 14.3% and 17.7% ECOG scores of 2, 83.9% and 84.4% patients with visceral metastases, 32.7% and 23.4% patients with brain metastasis, respectively. The median number of lines of therapy (LOT) for MBC patients receiving T-DXd was 4 for both groups. At the cutoff date of 30 July 2024, in patients with HER2-positive MBC, median rwPFS and OS was 12.1 [95% confidence interval (CI): 8.5-14.7] and 22.7 months (95% CI: 16.6-28.8). The longer rwPFS, median 23.3 months, was observed in LOT 1-2, than 12.2 months in LOT 3-5 and 8.2 months in LOT≥6 (P=0.001). In patients with HER2-negative MBC, median rwPFS and OS was 7.7 (95% CI: 6.6-8.8) and 15.7 months (95% CI: 11.4-20.0). The median rwPFS for HR+ and HR- patients was 7.7 and 8.1 months, respectively (P=0.870). Longer rwPFS of 9.5 months was observed in LOT 1-4 compared to 6.4 months in LOT≥6 among HER2-negative patients (P=0.026). Patients with prior ADCs exposure showed significantly shorter rwPFS of T-DXd in both HER2-positive (P=0.032) and negative patients (P=0.039). Brain metastasis did not impact the effectiveness of T-DXd. Incidence of AEs of any grade was 69.3% and severe (grade 3 or above) AEs was 13.9%; no fatal AEs were observed. Interstitial lung disease (ILD) occurred in 23 patients (7.4%), with 15 (4.9%) of grade 1, 4 (1.3%) of grade 2, and 4 (1.3%) of grade 3. 80.7% of ILD patients, including all with grade 1 and one with grade 2, underwent a rechallenge with T-DXd after symptomatic treatments and careful evaluations.</div></div><div><h3>Interpretation</h3><div>In this largest dataset of T-DXd for Chinese patients with MBC to date, encouraging rwPFS of T-DXd was seen in heavily pretreated HER2-positive and HER2-negative MBC patients. Longer rwPFS was observed in MBC patients with fewer LOT and no","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101416"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427697","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}
Pub Date : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101315
Ang Zheng , Lei Zhang , Yu Cao , Dian-Long Zhang , Fei Ma , Jian-Yi Li , Fan Yao , Li Ma , Pei-Fen Fu , Jia Wang , Jian-Yun Nie , Ying-Ying Xu , Bao-Liang Guo , Feng Jin , Bo Chen
Background
Given the known complications associated with axillary lymph node dissection (ALND) and the limited application of radiolabeled colloid tracking in China, dye-only sentinel lymph node biopsy (SLNB) is proposed as a feasible and alternative surgical treatment strategy for patients with initially clinically node-positive (cN1) breast cancer to a clinically node-negative (ycN0) status after neoadjuvant therapy (NAT). However, the clinical diagnostic performance of dye-only SLNB needs further verification.
Methods
We conducted a multicenter diagnostic clinical trial from July 2019 to September 2023 by recruiting 230 patients from 12 participating centers across six provinces in China. Adult women with clinical stage T1-4N1M0 breast cancer and ycN0 status after NAT were eligible. SLNB and ALND were performed sequentially for patients, while a single dye was used to guide sentinel lymph nodes during the operation. The primary endpoint was the false-negative rate (FNR) of SLNB after NAT in women with ycN0 disease. Furthermore, subgroup analyses were conducted by age, body mass index (BMI), the number of SLNs removed and tumor subtype. The trial is registered on www.chictr.org.cn (identifier: ChiCTR1900026929) and www.isrctn.com (identifier: ISRCTN31364289).
Findings
The detection rate of single-dye was 95.22% (219/230). Pathological examinations showed positive lymph node findings in 117 of 230 patients. SLNB was successful in 212 out of the 219 patients (96.80%). The FNR of dye-alone SLNB was 5.98% (7/117; 95% CI, 2.44%-11.94%). Furthermore, the FNR was lower in women under 60 years of age (2.33% vs. 16.13% older than 60 years, P=0.0139), with body mass index under 25 kg/m2 (2.60% vs. 12.5%, P=0.0452), and with four or more SLNs (2.53% vs. 13.16% with fewer than four SLNs, P=0.0358). For HR negative/HER-2 positive cases, the FNR was 0%.
Interpretation
SLNB with dye alone in patients with initially cN1 breast cancer and ycN0 after neoadjuvant therapy resulted in clinically acceptable rate of FNR. When four or more SLNs are detected, patients with age ≤ 60 years, BMI<25km/m2 and Her2-positive would derive additional benefit from dye-alone SLNB.
Funding
This trial was funded by Tackling Key Problems and Serving Local Projects of Liaoning Province (ZF20190006, to BC), National Natural Science Foundation of China (82073282 and 82203873, to AZ) and Joint Fund Project of the Science and Technology Program of Liaoning Province (2023012141-JH3/4600, to AZ).
{"title":"Sentinel lymph node biopsy using dye alone in patients with initially cN1 breast cancer and ycN0 status after neoadjuvant therapy: a multicenter diagnostic trial","authors":"Ang Zheng , Lei Zhang , Yu Cao , Dian-Long Zhang , Fei Ma , Jian-Yi Li , Fan Yao , Li Ma , Pei-Fen Fu , Jia Wang , Jian-Yun Nie , Ying-Ying Xu , Bao-Liang Guo , Feng Jin , Bo Chen","doi":"10.1016/j.lanwpc.2024.101315","DOIUrl":"10.1016/j.lanwpc.2024.101315","url":null,"abstract":"<div><h3>Background</h3><div>Given the known complications associated with axillary lymph node dissection (ALND) and the limited application of radiolabeled colloid tracking in China, dye-only sentinel lymph node biopsy (SLNB) is proposed as a feasible and alternative surgical treatment strategy for patients with initially clinically node-positive (cN1) breast cancer to a clinically node-negative (ycN0) status after neoadjuvant therapy (NAT). However, the clinical diagnostic performance of dye-only SLNB needs further verification.</div></div><div><h3>Methods</h3><div>We conducted a multicenter diagnostic clinical trial from July 2019 to September 2023 by recruiting 230 patients from 12 participating centers across six provinces in China. Adult women with clinical stage T1-4N1M0 breast cancer and ycN0 status after NAT were eligible. SLNB and ALND were performed sequentially for patients, while a single dye was used to guide sentinel lymph nodes during the operation. The primary endpoint was the false-negative rate (FNR) of SLNB after NAT in women with ycN0 disease. Furthermore, subgroup analyses were conducted by age, body mass index (BMI), the number of SLNs removed and tumor subtype. The trial is registered on <span><span>www.chictr.org.cn</span><svg><path></path></svg></span> (identifier: ChiCTR1900026929) and <span><span>www.isrctn.com</span><svg><path></path></svg></span> (identifier: ISRCTN31364289).</div></div><div><h3>Findings</h3><div>The detection rate of single-dye was 95.22% (219/230). Pathological examinations showed positive lymph node findings in 117 of 230 patients. SLNB was successful in 212 out of the 219 patients (96.80%). The FNR of dye-alone SLNB was 5.98% (7/117; 95% CI, 2.44%-11.94%). Furthermore, the FNR was lower in women under 60 years of age (2.33% vs. 16.13% older than 60 years, <em>P</em>=0.0139), with body mass index under 25 kg/m<sup>2</sup> (2.60% vs. 12.5%, <em>P</em>=0.0452), and with four or more SLNs (2.53% vs. 13.16% with fewer than four SLNs, <em>P</em>=0.0358). For HR negative/HER-2 positive cases, the FNR was 0%.</div></div><div><h3>Interpretation</h3><div>SLNB with dye alone in patients with initially cN1 breast cancer and ycN0 after neoadjuvant therapy resulted in clinically acceptable rate of FNR. When four or more SLNs are detected, patients with age ≤ 60 years, BMI<25km/m<sup>2</sup> and Her2-positive would derive additional benefit from dye-alone SLNB.</div></div><div><h3>Funding</h3><div>This trial was funded by Tackling Key Problems and Serving Local Projects of Liaoning Province (ZF20190006, to BC), <span>National Natural Science Foundation of China</span> (82073282 and 82203873, to AZ) and Joint Fund Project of the Science and Technology Program of Liaoning Province (2023012141-JH3/4600, to AZ).</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101315"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427796","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}
Extensive-stage small-cell lung cancer (ES-SCLC) continues to have poor outcome despite the survival improvements achieved by chemoimmunotherapy. Controversy exists regarding the survival effectiveness of consolidative thoracic radiotherapy (cTRT), and the role of salvage thoracic radiotherapy (sTRT) remains unexplored in the immunotherapy era. To address these issues, we conducted this retrospective study to investigate the impacts of cTRT and sTRT in ES-SCLC, and to compare the survival benefits of the two treatment regimes. ES-SCLC patients without baseline brain metastases receiving standard first-line chemoimmunotherapy were included in our study, cohorts were divided by treatment with cTRT, sTRT and no TRT. Kaplan-Meier survival curve and log-rank test were performed for comparison of survival between different groups. Univariable and multivariate analyses were carried out for further estimating the survival effectiveness of TRT. A total of 100 ES-SCLC patients without baseline brain metastases were included in our study, with 24 (24.0%) were allocated to the cTRT group, 18 (18.0%) were allocated to the sTRT group, and 58 (58.0%) to the No TRT group. cTRT dramatically decreased the rate of intrathoracic failure compared to sTRT and No TRT (29.4% vs. 60.0%). Moreover, patients who received cTRT had better overall survival (OS) compared to those who did not receive cTRT (median OS, not reached vs. 14.1 months; HR=0.40, 95% CI: 0.22-0.70, P=0.01). However, cTRT did not show significantly superior OS compared to sTRT alone (median OS, not reached vs. 21.0 months; HR=0.67, 95% CI: 0.27-1.66, P=0.39). In contrast, patients with only thoracic oligo-progression receiving sTRT (N=13) harbored better OS compared to patients with the same progression pattern in No TRT group (N=20) (median OS, 28.6 vs. 13.8 months; HR=0.44, 95% CI: 0.20-0.98, P=0.04). In conclusion, our study demonstrated in the chemoimmunotherapy era that cTRT greatly reduced the rate of initial intrathoracic failure and significantly improved the OS of ES-SCLC. Additionally, sTRT showed similar OS benefits with cTRT, and exhibits better OS compared to No TRT.
{"title":"Consolidative and salvage thoracic radiotherapy (TRT) in extensive-stage small-cell lung cancer (ES-SCLC) with first-line chemoimmunotherapy: a retrospective study from a single cancer center","authors":"Aihua Lan , Huiling Dong , Zhiqin Zheng , Xiao Chu , Zhengfei Zhu","doi":"10.1016/j.lanwpc.2024.101373","DOIUrl":"10.1016/j.lanwpc.2024.101373","url":null,"abstract":"<div><div>Extensive-stage small-cell lung cancer (ES-SCLC) continues to have poor outcome despite the survival improvements achieved by chemoimmunotherapy. Controversy exists regarding the survival effectiveness of consolidative thoracic radiotherapy (cTRT), and the role of salvage thoracic radiotherapy (sTRT) remains unexplored in the immunotherapy era. To address these issues, we conducted this retrospective study to investigate the impacts of cTRT and sTRT in ES-SCLC, and to compare the survival benefits of the two treatment regimes. ES-SCLC patients without baseline brain metastases receiving standard first-line chemoimmunotherapy were included in our study, cohorts were divided by treatment with cTRT, sTRT and no TRT. Kaplan-Meier survival curve and log-rank test were performed for comparison of survival between different groups. Univariable and multivariate analyses were carried out for further estimating the survival effectiveness of TRT. A total of 100 ES-SCLC patients without baseline brain metastases were included in our study, with 24 (24.0%) were allocated to the cTRT group, 18 (18.0%) were allocated to the sTRT group, and 58 (58.0%) to the No TRT group. cTRT dramatically decreased the rate of intrathoracic failure compared to sTRT and No TRT (29.4% vs. 60.0%). Moreover, patients who received cTRT had better overall survival (OS) compared to those who did not receive cTRT (median OS, not reached vs. 14.1 months; HR=0.40, 95% CI: 0.22-0.70, P=0.01). However, cTRT did not show significantly superior OS compared to sTRT alone (median OS, not reached vs. 21.0 months; HR=0.67, 95% CI: 0.27-1.66, P=0.39). In contrast, patients with only thoracic oligo-progression receiving sTRT (N=13) harbored better OS compared to patients with the same progression pattern in No TRT group (N=20) (median OS, 28.6 vs. 13.8 months; HR=0.44, 95% CI: 0.20-0.98, P=0.04). In conclusion, our study demonstrated in the chemoimmunotherapy era that cTRT greatly reduced the rate of initial intrathoracic failure and significantly improved the OS of ES-SCLC. Additionally, sTRT showed similar OS benefits with cTRT, and exhibits better OS compared to No TRT.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101373"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427988","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}
Pub Date : 2025-02-01DOI: 10.1016/j.lanwpc.2025.101485
Xiaozhu Liu , Qizhi Yang , Liming Pan , Yanfang Ye , Lirong Kuang , Dandan Xu , Liuhua Wang , Shuang Hu , Yifeng Nie , Jian Huang , Jinxiu Qu , Chenan Liu , Wanyan Tang , Pengpeng Ye , Queran Lin , Ying Hu , Wenyi Jin
<div><h3>Background</h3><div>Respiratory tract cancers emerged as a public health challenge with the highest incidence and mortality among all cancer types in China, despite many national policies in place, such as early cancer screening. It is of outmost importance to monitor the burden of respiratory tract cancers across China and its provinces for refining health strategies.</div></div><div><h3>Methods</h3><div>Based on Global Burden of Disease (GBD) estimates, the present study investigated the age-sex specific pattern alterations of incidence, prevalence, mortality, and disability adjusted life years (DALYs) of respiratory tract cancers in China from 1990 to 2021, as well as its Estimated Annual Percentage Change (EAPC), Age-Standardized Incidence Rate (ASIR), and Age-Standardized Mortality Rate (ASMR).</div></div><div><h3>Findings</h3><div>Between 1990 and 2021, China experienced an escalation in burdens of respiratory tract cancers, with the new cases surging from 274,752 (95% Uncertainty Interval (UI): 234,741–315,112) to 934,704 (750,040–1,136,938), marking an increase of 240.20% (156.05–342.29). Their attributed deaths similarly increased from 278,235 (238,518–322,013) to 814,121 (652,231–994,858). In 2021, the eastern and northeastern regions reported the highest incidence and mortality rates, particularly Shandong, with the highest new cases at 77,225 (58,842–101,352), while Tibet, Qinghai, and Macau observed the lowest. Regarding laryngeal cancer, Guangdong reported the highest incidence at 3466 (2230–4934), with Hainan exhibiting the highest ASIR at 3.46 (2.10–5.11) per 100,000 person-years and ASMR at 2.11 (1.37–3.09) per 100,000 person-years. Over the same timeframe, the EAPC for the ASIR of tracheal, bronchus, and lung cancer was 0.88 (0.63–1.14), and for ASMR, it was 0.29 (0.05–0.62), signifying an upward trend. Conversely, laryngeal cancer exhibited a stable ASIR with an EAPC of 0.04 (−0.22 to 0.30) and a declining ASMR with an EAPC of −1.69 (−1.80 to 1.59). Tracheal, bronchus, and lung cancer burdens exhibited notable sex differences, with their ASIR being 62.63 (46.50–79.90) per 100,000 person-years in males and 28.16 (22.22–34.90) per 100,000 person-years in females. For laryngeal cancer, the ASIR was 3.12 (2.34–4.04) per 100,000 person-years for males and 0.58 (0.35–0.79) per 100,000 person-years for females. Smoking and air pollution emerged as the predominant risk factors contributed to tracheal, bronchus, and lung cancer, accounting for 61.58% (30.00–82.95) and 25.98% (16.94–35.00) of deaths, respectively. In contrast, smoking contributed more to laryngeal cancer-caused deaths (76.70% [65.55–85.15]), followed by alcohol use (14.52% [7.70–20.99]).</div></div><div><h3>Interpretation</h3><div>The burden of respiratory tract cancers in China has increased over the past three decades, and without intervention, the associated health losses could escalate further. This burden predominantly affected the eastern provinces, partic
{"title":"Burden of respiratory tract cancers in China and its provinces, 1990–2021: a systematic analysis of the Global Burden of Disease Study 2021","authors":"Xiaozhu Liu , Qizhi Yang , Liming Pan , Yanfang Ye , Lirong Kuang , Dandan Xu , Liuhua Wang , Shuang Hu , Yifeng Nie , Jian Huang , Jinxiu Qu , Chenan Liu , Wanyan Tang , Pengpeng Ye , Queran Lin , Ying Hu , Wenyi Jin","doi":"10.1016/j.lanwpc.2025.101485","DOIUrl":"10.1016/j.lanwpc.2025.101485","url":null,"abstract":"<div><h3>Background</h3><div>Respiratory tract cancers emerged as a public health challenge with the highest incidence and mortality among all cancer types in China, despite many national policies in place, such as early cancer screening. It is of outmost importance to monitor the burden of respiratory tract cancers across China and its provinces for refining health strategies.</div></div><div><h3>Methods</h3><div>Based on Global Burden of Disease (GBD) estimates, the present study investigated the age-sex specific pattern alterations of incidence, prevalence, mortality, and disability adjusted life years (DALYs) of respiratory tract cancers in China from 1990 to 2021, as well as its Estimated Annual Percentage Change (EAPC), Age-Standardized Incidence Rate (ASIR), and Age-Standardized Mortality Rate (ASMR).</div></div><div><h3>Findings</h3><div>Between 1990 and 2021, China experienced an escalation in burdens of respiratory tract cancers, with the new cases surging from 274,752 (95% Uncertainty Interval (UI): 234,741–315,112) to 934,704 (750,040–1,136,938), marking an increase of 240.20% (156.05–342.29). Their attributed deaths similarly increased from 278,235 (238,518–322,013) to 814,121 (652,231–994,858). In 2021, the eastern and northeastern regions reported the highest incidence and mortality rates, particularly Shandong, with the highest new cases at 77,225 (58,842–101,352), while Tibet, Qinghai, and Macau observed the lowest. Regarding laryngeal cancer, Guangdong reported the highest incidence at 3466 (2230–4934), with Hainan exhibiting the highest ASIR at 3.46 (2.10–5.11) per 100,000 person-years and ASMR at 2.11 (1.37–3.09) per 100,000 person-years. Over the same timeframe, the EAPC for the ASIR of tracheal, bronchus, and lung cancer was 0.88 (0.63–1.14), and for ASMR, it was 0.29 (0.05–0.62), signifying an upward trend. Conversely, laryngeal cancer exhibited a stable ASIR with an EAPC of 0.04 (−0.22 to 0.30) and a declining ASMR with an EAPC of −1.69 (−1.80 to 1.59). Tracheal, bronchus, and lung cancer burdens exhibited notable sex differences, with their ASIR being 62.63 (46.50–79.90) per 100,000 person-years in males and 28.16 (22.22–34.90) per 100,000 person-years in females. For laryngeal cancer, the ASIR was 3.12 (2.34–4.04) per 100,000 person-years for males and 0.58 (0.35–0.79) per 100,000 person-years for females. Smoking and air pollution emerged as the predominant risk factors contributed to tracheal, bronchus, and lung cancer, accounting for 61.58% (30.00–82.95) and 25.98% (16.94–35.00) of deaths, respectively. In contrast, smoking contributed more to laryngeal cancer-caused deaths (76.70% [65.55–85.15]), followed by alcohol use (14.52% [7.70–20.99]).</div></div><div><h3>Interpretation</h3><div>The burden of respiratory tract cancers in China has increased over the past three decades, and without intervention, the associated health losses could escalate further. This burden predominantly affected the eastern provinces, partic","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101485"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143178052","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}
Pub Date : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101352
Junyi Shen, Anqi Lin, Ting Wei, Jian Zhang, Peng Luo
Background
With the widespread application of generative AI (GenAI) models, it is crucial to systematically evaluate their performance in lung adenocarcinoma histopathological assessment. This study aimed to evaluate and compare the performance of three GenAI models with visual capabilities (GPT-4o, Claude-3.5-Sonnet, and Gemini-1.5-Pro) in lung adenocarcinoma histological pattern recognition and grading, and to explore the construction of prognostic prediction models based on GenAI feature extraction.
Methods
This retrospective study extracted 310 diagnostic slides from the TCGA-LUAD database for model evaluation. An additional 87 diagnostic pathology slides from local lung adenocarcinoma surgical patients were used for external validation of the prognostic model. Primary outcomes were GenAI grading accuracy and stability, measured by the area under the receiver operating characteristic curve (AUC) and intraclass correlation coefficient (ICC), respectively. Secondary outcomes included the construction and assessment of machine learning-based prognostic prediction models, utilizing features extracted by GenAI, with model performance evaluated using the Concordance index (C-index).
Findings
Claude-3.5-Sonnet demonstrated the best overall performance, combining high grading accuracy (average AUC = 0.82) with moderate stability (ICC = 0.59) The optimal machine learning-based prognostic model, constructed using features extracted by Claude-3.5-Sonnet and incorporating clinical variables, showed good performance in both internal and external validation, with an average C-index of 0.72. Meta-analysis demonstrated that this prognostic model effectively stratified patients into risk groups, with the high-risk group showing significantly worse outcomes (Hazard ratio = 6.44, 95% confidence interval = 3.42-12.14).
Interpretation
This study demonstrates the potential application value of GenAI models in lung adenocarcinoma histopathological assessment. Claude-3.5-Sonnet demonstrated the highest grading accuracy, and the machine learning-based prognostic model that utilized its feature extraction showed good predictive capabilities. These findings provide new research directions for AI-assisted pathological diagnosis and prognostic prediction, with the potential to improve the management of lung adenocarcinoma patients.
{"title":"Evaluating generative AI models for explainable pathological feature extraction in lung adenocarcinoma: grading assessment and prognostic model construction","authors":"Junyi Shen, Anqi Lin, Ting Wei, Jian Zhang, Peng Luo","doi":"10.1016/j.lanwpc.2024.101352","DOIUrl":"10.1016/j.lanwpc.2024.101352","url":null,"abstract":"<div><h3>Background</h3><div>With the widespread application of generative AI (GenAI) models, it is crucial to systematically evaluate their performance in lung adenocarcinoma histopathological assessment. This study aimed to evaluate and compare the performance of three GenAI models with visual capabilities (GPT-4o, Claude-3.5-Sonnet, and Gemini-1.5-Pro) in lung adenocarcinoma histological pattern recognition and grading, and to explore the construction of prognostic prediction models based on GenAI feature extraction.</div></div><div><h3>Methods</h3><div>This retrospective study extracted 310 diagnostic slides from the TCGA-LUAD database for model evaluation. An additional 87 diagnostic pathology slides from local lung adenocarcinoma surgical patients were used for external validation of the prognostic model. Primary outcomes were GenAI grading accuracy and stability, measured by the area under the receiver operating characteristic curve (AUC) and intraclass correlation coefficient (ICC), respectively. Secondary outcomes included the construction and assessment of machine learning-based prognostic prediction models, utilizing features extracted by GenAI, with model performance evaluated using the Concordance index (C-index).</div></div><div><h3>Findings</h3><div>Claude-3.5-Sonnet demonstrated the best overall performance, combining high grading accuracy (average AUC = 0.82) with moderate stability (ICC = 0.59) The optimal machine learning-based prognostic model, constructed using features extracted by Claude-3.5-Sonnet and incorporating clinical variables, showed good performance in both internal and external validation, with an average C-index of 0.72. Meta-analysis demonstrated that this prognostic model effectively stratified patients into risk groups, with the high-risk group showing significantly worse outcomes (Hazard ratio = 6.44, 95% confidence interval = 3.42-12.14).</div></div><div><h3>Interpretation</h3><div>This study demonstrates the potential application value of GenAI models in lung adenocarcinoma histopathological assessment. Claude-3.5-Sonnet demonstrated the highest grading accuracy, and the machine learning-based prognostic model that utilized its feature extraction showed good predictive capabilities. These findings provide new research directions for AI-assisted pathological diagnosis and prognostic prediction, with the potential to improve the management of lung adenocarcinoma patients.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101352"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427528","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}
Pub Date : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101299
Dandan Zhang , Congyi Ma , Hexiao Ding , Ting Liu , Huan Li
<div><h3>Background</h3><div>Neoadjuvant chemotherapy (NAC) is effective in reducing tumor size and improving surgical outcomes for patients with inflammatory, unresectable, or locally advanced breast cancer (BC). However, malnutrition frequently occurs during NAC, increasing the risk of perioperative complications and hindering progress in enhanced recovery after surgery. The impact of NAC on overall nutritional status, as well as specific nutritional components, throughout the perioperative period in BC patients remains unclear. This study aims to provide insight by longitudinally tracking the nutritional status of BC patients undergoing NAC compared to those who do not.</div></div><div><h3>Methods</h3><div>We conducted a prospective study at a tertiary hospital in China, enrolling BC patients who met the inclusion criteria of a confirmed diagnosis of invasive BC without significant comorbidities. Patients with metastatic disease or a prior history of BC treatment were excluded. After obtaining written informed consent, participants were assigned to either a NAC cohort or a surgery-first cohort based on clinical decision-making factors, such as tumor histology, grade, stage, and estrogen, progesterone, and HER2 receptor status. Baseline data (one day before surgery, T0) and follow-up data (first day after surgery, T1; the seventh day after surgery, T2) were gathered through self-reported questionnaires, blood tests, and InBody 770 (InBody Co., Ltd., Korea) measurements. The primary outcome was nutritional status, assessed by phase angle. Baseline differences between the NAC and surgery-first cohorts were analyzed using independent sample t-tests or the Mann-Whitney U test. Repeated measures ANOVA was used to evaluate changes in the collected data across T0, T1, and T2. This study was approved by the ethics committee of the hospital (No. SL-II2024-199-01).</div></div><div><h3>Findings</h3><div>This study included 32 breast cancer patients, with 13 enlisted in the NAC cohort and 19 in the surgery-first cohort. Phase angle, albumin, and total protein have significant differences in the baseline data (p < 0.001). Moreover, phase angle significantly decreased in both cohorts (p < 0.001), with a greater reduction in the NAC group (T0: 4.52 ± 0.62, T1: 4.09 ± 0.73, T2: 4.34 ± 0.84) compared to the surgery-first group (T0: 5.13 ± 0.46, T1: 4.55 ± 0.49, T2: 4.90 ± 0.39). In the NAC group, the most prominent changes observed from T0 to T2 were in basal metabolic rate (kcal/day) (from 1224.85±109.82 to 1216.62±100.78), arm circumference (cm) (from 29.21±3.24 to 28.99±3.14), and protein levels (g/dL) (from 7.62±1.00 to 7.58±0.92). Meanwhile, in the surgery-first group, the most prominent changes from T0 to T2 included basal metabolic rate (kcal/day) (from 1217.16±98.23 to 1212.05±102.67), percent body fat (%) (from 33.33±8.61 to 32.96±7.95), and fat-free mass (kg) (from 39.23±4.54 to 38.98±4.76).</div></div><div><h3>Interpretation</h3><div>The findin
{"title":"Impact of neoadjuvant chemotherapy on perioperative nutritional status in breast cancer patients: a prospective cohort study","authors":"Dandan Zhang , Congyi Ma , Hexiao Ding , Ting Liu , Huan Li","doi":"10.1016/j.lanwpc.2024.101299","DOIUrl":"10.1016/j.lanwpc.2024.101299","url":null,"abstract":"<div><h3>Background</h3><div>Neoadjuvant chemotherapy (NAC) is effective in reducing tumor size and improving surgical outcomes for patients with inflammatory, unresectable, or locally advanced breast cancer (BC). However, malnutrition frequently occurs during NAC, increasing the risk of perioperative complications and hindering progress in enhanced recovery after surgery. The impact of NAC on overall nutritional status, as well as specific nutritional components, throughout the perioperative period in BC patients remains unclear. This study aims to provide insight by longitudinally tracking the nutritional status of BC patients undergoing NAC compared to those who do not.</div></div><div><h3>Methods</h3><div>We conducted a prospective study at a tertiary hospital in China, enrolling BC patients who met the inclusion criteria of a confirmed diagnosis of invasive BC without significant comorbidities. Patients with metastatic disease or a prior history of BC treatment were excluded. After obtaining written informed consent, participants were assigned to either a NAC cohort or a surgery-first cohort based on clinical decision-making factors, such as tumor histology, grade, stage, and estrogen, progesterone, and HER2 receptor status. Baseline data (one day before surgery, T0) and follow-up data (first day after surgery, T1; the seventh day after surgery, T2) were gathered through self-reported questionnaires, blood tests, and InBody 770 (InBody Co., Ltd., Korea) measurements. The primary outcome was nutritional status, assessed by phase angle. Baseline differences between the NAC and surgery-first cohorts were analyzed using independent sample t-tests or the Mann-Whitney U test. Repeated measures ANOVA was used to evaluate changes in the collected data across T0, T1, and T2. This study was approved by the ethics committee of the hospital (No. SL-II2024-199-01).</div></div><div><h3>Findings</h3><div>This study included 32 breast cancer patients, with 13 enlisted in the NAC cohort and 19 in the surgery-first cohort. Phase angle, albumin, and total protein have significant differences in the baseline data (p < 0.001). Moreover, phase angle significantly decreased in both cohorts (p < 0.001), with a greater reduction in the NAC group (T0: 4.52 ± 0.62, T1: 4.09 ± 0.73, T2: 4.34 ± 0.84) compared to the surgery-first group (T0: 5.13 ± 0.46, T1: 4.55 ± 0.49, T2: 4.90 ± 0.39). In the NAC group, the most prominent changes observed from T0 to T2 were in basal metabolic rate (kcal/day) (from 1224.85±109.82 to 1216.62±100.78), arm circumference (cm) (from 29.21±3.24 to 28.99±3.14), and protein levels (g/dL) (from 7.62±1.00 to 7.58±0.92). Meanwhile, in the surgery-first group, the most prominent changes from T0 to T2 included basal metabolic rate (kcal/day) (from 1217.16±98.23 to 1212.05±102.67), percent body fat (%) (from 33.33±8.61 to 32.96±7.95), and fat-free mass (kg) (from 39.23±4.54 to 38.98±4.76).</div></div><div><h3>Interpretation</h3><div>The findin","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101299"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427543","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}
Mass international gatherings pose significant health security challenges and demand robust preparedness for infectious diseases. Though demanding, this process can leverage heightened political and social attention to fortify core capacities. Despite Japan's advanced public health system for infectious diseases, there were still areas of vulnerabilities. Preparation for the Tokyo 2020 Olympic and Paralympic Games (Tokyo 2020) strategically enhanced the national system for infectious diseases through a three-step approach: (i) assessing risks, readiness, and gaps; (ii) addressing the identified gaps by strengthening or establishing systems; and (iii) performing operational exercises involving multiple stakeholders. COVID-19, which led to the postponement of Tokyo 2020, brought the strict public health measures taken during the event into focus. However, these primary conventional steps need to be further highlighted. Emphasizing their applicability beyond games time, this approach is a model for countries that host large-scale gatherings.
{"title":"Preparedness for infectious diseases during the Tokyo 2020 Olympic and Paralympic Games: advancing the health system beyond the games","authors":"Chiaki Ikenoue , Munehisa Fukusumi , Satoshi Shimada , Tomoe Shimada , Motoi Suzuki , Yoshiyuki Sugishita , Tamano Matsui , Tomimasa Sunagawa , Tomoya Saito","doi":"10.1016/j.lanwpc.2025.101488","DOIUrl":"10.1016/j.lanwpc.2025.101488","url":null,"abstract":"<div><div>Mass international gatherings pose significant health security challenges and demand robust preparedness for infectious diseases. Though demanding, this process can leverage heightened political and social attention to fortify core capacities. Despite Japan's advanced public health system for infectious diseases, there were still areas of vulnerabilities. Preparation for the Tokyo 2020 Olympic and Paralympic Games (Tokyo 2020) strategically enhanced the national system for infectious diseases through a three-step approach: (i) assessing risks, readiness, and gaps; (ii) addressing the identified gaps by strengthening or establishing systems; and (iii) performing operational exercises involving multiple stakeholders. COVID-19, which led to the postponement of Tokyo 2020, brought the strict public health measures taken during the event into focus. However, these primary conventional steps need to be further highlighted. Emphasizing their applicability beyond games time, this approach is a model for countries that host large-scale gatherings.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101488"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143394949","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}
Pub Date : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101306
Yan Xu, Xiaoxing Gao, Minjiang Chen, Xiaoyan Liu, Jing Zhao, Wei Zhong, Mengzhao Wang
Background
Immune checkpoint inhibitor (ICI)-based treatment regimens have become the standard of care for first-line treatment of NSCLC. Once progressed, it is not recommended to continue using ICI monotherapy, and the efficacy of chemotherapy is limited (ORR ∼10% with doc), so there is a high unmet clinical need. Plin is a selective immunomodulating microtubule-binding agent which promotes dendritic cell maturation and enhances anti-tumor T cell response, and have the potential to overcome immunotherapy resistance as a novel regimen in combination with pemb and doc. This phase 2 study was aimed to evaluate the efficacy and safety of pemb plus plin and doc in pts with metastatic NSCLC who had progressed after ICI.
Methods
In this investigator-initiated, single-arm, open-label, phase 2 trial, metastatic NSCLC pts who acquired resistance after ICI treatment were enrolled (Clinical trial information: NCT05599789). Participants received pemb 200 mg D1, plin 30 mg/m2 D1 and doc 75 mg/m2 D1 intravenously for a 21-day cycle. The primary endpoint was investigator-based ORR per RECIST 1.1. The secondary endpoints included PFS, OS, DoR and toxicity. Kaplan-Meier method is used for OS, PFS, and DOR analysis. The study intends to enroll 47 patients with a formal interim analysis at 19 patients enrolled.
Findings
38 pts were enrolled and 35 pts evaluable ITT population were analyzed at data cutoff on 10/10/2024. Median follow-up was 8.8 months (M) and median age was 68.0 (50-83) with 77.1% male and 22.9% female. 65.7% were current or former smokers. Histology included 60% with non-squamous, 40% with squamous cell carcinoma. Confirmed ORR was 18.2%. DCR was 89.7% (defined as PR and SD > 4 M), median DoR was 11.4 M, median PFS was 8.3 M (current 6 M PFS rate was 70.4%, 12 M PFS rate was 42.7%), and OS had not been reached. 48.6% of pts experienced G3 or higher treatment-related AEs.
Interpretation
With good tolerability, pemb plus plin and doc in pts with metastatic NSCLC who progressed after clinical benefit to ICI demonstrated promising efficacy.
{"title":"A phase 2 study of pembrolizumab in combination with plinabulin and docetaxel in previously treated patients with metastatic non-small cell lung cancer and progressive disease (PD) after immunotherapy (Anti-PD-1/PD-L1 inhibitor) alone or in combination with platinum-doublet chemotherapy","authors":"Yan Xu, Xiaoxing Gao, Minjiang Chen, Xiaoyan Liu, Jing Zhao, Wei Zhong, Mengzhao Wang","doi":"10.1016/j.lanwpc.2024.101306","DOIUrl":"10.1016/j.lanwpc.2024.101306","url":null,"abstract":"<div><h3>Background</h3><div>Immune checkpoint inhibitor (ICI)-based treatment regimens have become the standard of care for first-line treatment of NSCLC. Once progressed, it is not recommended to continue using ICI monotherapy, and the efficacy of chemotherapy is limited (ORR ∼10% with doc), so there is a high unmet clinical need. Plin is a selective immunomodulating microtubule-binding agent which promotes dendritic cell maturation and enhances anti-tumor T cell response, and have the potential to overcome immunotherapy resistance as a novel regimen in combination with pemb and doc. This phase 2 study was aimed to evaluate the efficacy and safety of pemb plus plin and doc in pts with metastatic NSCLC who had progressed after ICI.</div></div><div><h3>Methods</h3><div>In this investigator-initiated, single-arm, open-label, phase 2 trial, metastatic NSCLC pts who acquired resistance after ICI treatment were enrolled (Clinical trial information: <span><span>NCT05599789</span><svg><path></path></svg></span>). Participants received pemb 200 mg D1, plin 30 mg/m2 D1 and doc 75 mg/m2 D1 intravenously for a 21-day cycle. The primary endpoint was investigator-based ORR per RECIST 1.1. The secondary endpoints included PFS, OS, DoR and toxicity. Kaplan-Meier method is used for OS, PFS, and DOR analysis. The study intends to enroll 47 patients with a formal interim analysis at 19 patients enrolled.</div></div><div><h3>Findings</h3><div>38 pts were enrolled and 35 pts evaluable ITT population were analyzed at data cutoff on 10/10/2024. Median follow-up was 8.8 months (M) and median age was 68.0 (50-83) with 77.1% male and 22.9% female. 65.7% were current or former smokers. Histology included 60% with non-squamous, 40% with squamous cell carcinoma. Confirmed ORR was 18.2%. DCR was 89.7% (defined as PR and SD > 4 M), median DoR was 11.4 M, median PFS was 8.3 M (current 6 M PFS rate was 70.4%, 12 M PFS rate was 42.7%), and OS had not been reached. 48.6% of pts experienced G3 or higher treatment-related AEs.</div></div><div><h3>Interpretation</h3><div>With good tolerability, pemb plus plin and doc in pts with metastatic NSCLC who progressed after clinical benefit to ICI demonstrated promising efficacy.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101306"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427890","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}