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54. Effect of Radiotherapy Alone vs Radiotherapy With Concurrent Chemoradiotherapy on Survival Without Disease Relapse in Patients With Low-risk Nasopharyngeal Carcinoma

Author

Tang, Ling-Long, primary, Guo, Rui, additional, Zhang, Ning, additional, Deng, Bin, additional, Chen, Lei, additional, Cheng, Zhi-Bin, additional, Huang, Jing, additional, Hu, Wei-Han, additional, Huang, Shao Hui, additional, Luo, Wei-Jun, additional, Liang, Jin-Hui, additional, Zheng, Yu-Ming, additional, Zhang, Fan, additional, Mao, Yan-Ping, additional, Li, Wen-Fei, additional, Zhou, Guan-Qun, additional, Liu, Xu, additional, Chen, Yu-Pei, additional, Xu, Cheng, additional, Lin, Li, additional, Liu, Qing, additional, Du, Xiao-Jing, additional, Zhang, Yuan, additional, Sun, Ying, additional, and Ma, Jun, additional

Published
2022
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55. Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial

Author

Zhang, Yuan, primary, Chen, Lei, additional, Hu, Guo-Qing, additional, Zhang, Ning, additional, Zhu, Xiao-Dong, additional, Yang, Kun-Yu, additional, Jin, Feng, additional, Shi, Mei, additional, Chen, Yu-Pei, additional, Hu, Wei-Han, additional, Cheng, Zhi-Bin, additional, Wang, Si-Yang, additional, Tian, Ye, additional, Wang, Xi-Cheng, additional, Sun, Yan, additional, Li, Jin-Gao, additional, Li, Wen-Fei, additional, Li, Yu-Hong, additional, Mao, Yan-Ping, additional, Zhou, Guan-Qun, additional, Sun, Rui, additional, Liu, Xu, additional, Guo, Rui, additional, Long, Guo-Xian, additional, Liang, Shao-Qiang, additional, Li, Ling, additional, Huang, Jing, additional, Long, Jin-Hua, additional, Zang, Jian, additional, Liu, Qiao-Dan, additional, Zou, Li, additional, Su, Qiong-Fei, additional, Zheng, Bao-Min, additional, Xiao, Yun, additional, Guo, Ying, additional, Han, Fei, additional, Mo, Hao-Yuan, additional, Lv, Jia-Wei, additional, Du, Xiao-Jing, additional, Xu, Cheng, additional, Liu, Na, additional, Li, Ying-Qin, additional, Xie, Fang-Yun, additional, Sun, Ying, additional, Ma, Jun, additional, and Tang, Ling-Long, additional

Published
2022
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60. Disparities in positive results and dissemination of randomized controlled trials in immuno-oncology.

Author

Xu, Cheng, Zhang, Shu, Zhu, Guang-Li, Yang, Kai-Bin, Zhang, Yuan, Mao, Yan-Ping, Tang, Ling-Long, Liu, Qing, Huang, Ying, and Ma, Jun

Subjects
RANDOMIZED controlled trials, IMMUNE checkpoint inhibitors, IMMUNOMODULATORS, CANCER vaccines, CRIME & the press
Abstract

This cross-sectional and longitudinal analysis aimed to demonstrate the disparities in positive results and dissemination patterns of randomized controlled trials (RCTs) in global immuno-oncology (IO). Phase II–IV RCTs with results reported by article publications registered on ClinicalTrials.gov in 2007–2018 studying immune checkpoint inhibitors (ICIs), adoptive cell transfer, cancer vaccines, and immune modulators were included. Twenty-eight percent of trials were positive (72 of 258), most of which were pharma-sponsored and focused on ICI and multiple IO therapies in lung cancer, melanoma, and multiple cancer types. The recent period of trial start year, upfront registration, large sample size, high strictness score on corticosteroid/infection-related criteria, and survival endpoints were associated with positive results. Trials from Mainland China had a faster publication timeline of positive results but lacked study diversity or full reporting of negative results compared with US and multinational trials. Compared with phase II trials, phase III–IV trials had a higher average proportion of positive results (28.9% vs. 22.2%) and a more stable change over the past decade (23.65% vs. 49.24%). Positive trials yielded more secondary manuscripts (10 vs. 4), a shorter publication process of approximately two years (P < 0.001), and a superiority in the dissemination of journals with an h-index >90 (P < 0.001) compared with negative trials. Disparities in positive result dissemination are widespread in IO RCTs and affected by trial features. We proposed improvements in upfront registration, procedural integrity, and adequate inclusion of rival trials reporting negative results within the earlier two years in future reviews. Immuno-oncology (IO) is a novel treatment modality utilizing the natural ability of body's immune system to fight against cancer. The acknowledged standard method to confer the best medical evidence for showing the efficacy of a new intervention is randomized controlled trials (RCTs), and the publication of trial results via journal articles usually modifies medical decisions. A trial labeled negative means that the pre-specified goal was not met, but it deserves more attention rather than a simple interpretation of scientific failure. Previous studies on oncology trials indicated that negative and positive trials have different patterns of result publication and varied trial features. Although IO-related RCTs obtain a continuously increasing number, the extent and tendencies (positive or negative) of their results have not been assessed. To conduct a timely summary and a comprehensive analysis focusing on the publication details and its relationship with the properties of IO trials, we included phase II–IV IO RCTs with results reported by article publications registered on ClinicalTrials.gov in 2007–2018. We found that disparities in positive results and publication are widespread in IO RCTs and severely affected by IO category, cancer type, sponsorship, trial phase, and geographic origin. Positive trials had a significantly shorter publication timeline of approximately two years, more secondary manuscripts, and a superiority in high-quality publications over negative trials. We propose that investigators should complete registration before trial launch, improve procedural integrity, and allow an adequate inclusion of rival trials reporting negative results within the earlier two years in future IO-related reviews. [ABSTRACT FROM AUTHOR]

Published
2023
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63. Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial

Author

Chen, Lei, Hu, Chao-Su, Chen, Xiao-Zhong, Hu, Guo-Qing, Cheng, Zhi-Bin, Sun, Yan, Li, Wei-Xiong, Chen, Yuan-Yuan, Xie, Fang-Yun, Liang, Shao-Bo, Chen, Yong, Xu, Ting-Ting, Li, Bin, Long, Guo-Xian, Wang, Si-Yang, Zheng, Bao-Min, Guo, Ying, Sun, Ying, Mao, Yan-Ping, Tang, Ling-Long, Chen, Yu-Ming, Liu, Meng-Zhong, and Ma, Jun

Published
2012
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64. The immune modulation effects of gemcitabine plus cisplatin induction chemotherapy in nasopharyngeal carcinoma

Author

Li, Xiao‐Min, primary, Zhang, Xiao‐Min, additional, Li, Jun‐Yan, additional, Jiang, Ning, additional, Chen, Lei, additional, Tang, Ling‐Long, additional, Mao, Yan‐Ping, additional, Li, Wen‐Fei, additional, Zhou, Guan‐Qun, additional, Li, Ying‐Qin, additional, Liu, Na, additional, Zhang, Yuan, additional, and Ma, Jun, additional

Published
2022
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65. Additional file 1 of Selection and validation of chemotherapy beneficiaries among elderly nasopharyngeal carcinoma (NPC) patients treated with intensity-modulated radiation therapy (IMRT): a large real-world study

Author

Wu, Yan-Ling, Yang, Kai-Bin, Huang, Ying, Shi, Jing-Rong, He, Qing-Shui, Chen, Lei, Li, Wen-Fei, Huang, Xiao-Dan, Lin, Li, Chen, Yu-Pei, Mao, Yan-Ping, Tang, Ling-Long, and Ma, Jun

Abstract

Additional file 1: Supplementary Methods, Figures and Tables.

Published
2022
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67. Additional file 1 of Radiotherapy interruption due to holidays adversely affects the survival of patients with nasopharyngeal carcinoma: a joint analysis based on large-scale retrospective data and clinical trials

Author

Xu, Cheng, Yang, Kai-Bin, Feng, Rui-Jia, Chen, Lei, Du, Xiao-Jing, Mao, Yan-Ping, Li, Wen-Fei, Liu, Qing, Sun, Ying, and Ma, Jun

Abstract

Additional file 1: Figure S1. Flowchart of the study design and identification of eligible patients. Table S1. Patients with NPC suffering RT interruption during or outside the Spring Festival in the matched cohort from the real-world dataset.

Published
2022
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68. Long-Term Evaluation and Normal Tissue Complication Probability (NTCP) Models for Predicting Radiation-Induced Optic Neuropathy after Intensity-Modulated Radiation Therapy (IMRT) for Nasopharyngeal Carcinoma: A Large Retrospective Study in China

Author

Wu, Yan-Ling, primary, Li, Wen-Fei, additional, Yang, Kai-Bin, additional, Chen, Lei, additional, Shi, Jing-Rong, additional, Chen, Fo-Ping, additional, Huang, Xiao-Dan, additional, Lin, Li, additional, Zhang, Xiao-Min, additional, Li, Jing, additional, Chen, Yu-Pei, additional, Tang, Ling-Long, additional, Mao, Yan-Ping, additional, and Ma, Jun, additional

Published
2022
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70. Expression Profiles and Prognostic Value of Multiple Inhibitory Checkpoints in Head and Neck Lymphoepithelioma-Like Carcinoma

Author

Zou, Wen-Qing, Luo, Wei-Jie, Feng, Yan-Fen, Liu, Fang, Liang, Shao-Bo, Fang, Xue-Liang, Liang, Ye-Lin, Liu, Na, Wang, Ya-Qin, and Mao, Yan-Ping

Subjects
Male, TNM stage, head and neck lymphoepithelioma-like carcinoma, B7 Antigens, Time Factors, multiple inhibitory checkpoints, Immunology, RC581-607, Middle Aged, Prognosis, B7-H1 Antigen, Survival Rate, Head and Neck Neoplasms, Multivariate Analysis, Carcinoma, Squamous Cell, tumor microenvironment, Immunology and Allergy, Humans, Indoleamine-Pyrrole 2,3,-Dioxygenase, Female, Immunologic diseases. Allergy, Original Research, Neoplasm Staging, Proportional Hazards Models, Retrospective Studies
Abstract

BackgroundInhibitory checkpoints are promising antitumor targets and predictive biomarkers in a variety of cancers. We aimed to identify the expression levels and prognostic value of multiple inhibitory checkpoints supported by preclinical and clinical evidence in head and neck lymphoepithelioma-like carcinoma (HNLELC).MethodsThe expression of seven inhibitory checkpoints were evaluated in the tumor nest (TN) and tumor stroma (TS) of 102 HNLELC specimens using immunohistochemistry and digital pathology, and an inhibitory checkpoint-based signature (ICS) was subsequently constructed using the LASSO Cox regression model.ResultsPD-L1, B7H3, and IDO-1 were mostly expressed in the TN, with median H-score of TN vs TS: 63.6 vs 14.6; 8.1 vs 1.0; 61.5 vs 34.7 (all P < 0.001), whereas PD-1, TIM-3, LAG-3, and VISTA were mainly observed in the TS, with median H-score of TN vs TS: 0.2 vs 12.4, 3.4 vs 7.1, 6.2 vs 11.9, 16.4 vs 47.2 (all P < 0.001), respectively. The most common simultaneously expressed combinations consisted of PD-L1 + B7H3 + IDO-1 + TIM-3 + LAG-3 + VISTA and B7H3 + IDO-1 + TIM-3 + LAG-3 in the TN (both occurring in 8.8% of patients) and PD-L1 + B7H3 + IDO-1 in the TS (4.9%). In addition, high-ICS patients had shorter 5-year disease-free (40.6% vs 81.7%; P < 0.001), regional recurrence-free (63.5% vs 88.2%; P = 0.003), and overall survival (73.5% vs 92.9%; P = 0.006) than low-ICS patients. Multivariate analysis revealed that ICS represented an independent predictor, which could significantly complement the predictive performance of TNM stage for 3-year (AUC 0.724 vs 0.619, P = 0.014), 5-year (AUC 0.727 vs 0.640, P = 0.056), and 10-year disease-free survival (AUC 0.815 vs 0.709, P = 0.023).ConclusionsThe expression of inhibitory checkpoints and ICS classifier may increase the prognostic value of the TNM staging system and guide the rational design of personalized inhibitory checkpoint blockade therapy in HNLELC.

Published
2021

71. Selection and Validation of Chemotherapy Beneficiaries among Elderly Nasopharyngeal Carcinoma (NPC) Patients Treated with Intensity-Modulated Radiation Therapy (IMRT): A Large Real-World Study

Author

Wu, Yan-Ling, primary, Yang, Kai-Bin, additional, Huang, Ying, additional, Shi, Jing-Rong, additional, He, Qing-shui, additional, Chen, Lei, additional, Li, Wen-Fei, additional, Huang, Xiao-Dan, additional, Lin, Li, additional, Chen, Yu-Pei, additional, Mao, Yan-Ping, additional, Tang, Ling-Long, additional, and Ma, Jun, additional

Published
2021
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75. Additional file 1 of Validity and reliability of the simplified Chinese patient-reported outcomes version of the common terminology criteria for adverse events

Author

Yang, Shan-Shan, Chen, Lei, Liu, Ying, Lu, Hai-Jun, Huang, Bo-Jie, Lin, Ai-Hua, Sun, Ying, Ma, Jun, Xie, Fang-Yun, and Mao, Yan-Ping

Abstract

Additional file 1 Table S1. Item clusters of the PRO-CTCAE. Table S2. Criteria-related validity: Pearson’s correlation coefficients between PRO-CTCAE items and QLQ-C30 functional domains (N = 1555). Table S3. Criteria-related validity: Pearson correlation coefficients between similar symptom items on the PRO-CTCAE and QLQ-C30 (N = 1555). Table S4. Correlation matrix of factors (N = 1555). Table S5. Cronbach’s alpha of each dimension of the simple Chinese PRO-CTCAE (N = 1555). Table S6. Responsiveness of the Chinese PRO-CTCAE (N = 618)

Published
2021
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76. Additional file 1 of Unraveling tumour microenvironment heterogeneity in nasopharyngeal carcinoma identifies biologically distinct immune subtypes predicting prognosis and immunotherapy responses

Author

Chen, Yu-Pei, Lv, Jia-Wei, Mao, Yan-Ping, Li, Xiao-Min, Li, Jun-Yan, Wang, Ya-Qin, Xu, Cheng, Ying-Qin Li, He, Qing-Mei, Yang, Xiao-Jing, Lei, Yuan, Shen, Jia-Yi, Tang, Ling-Long, Chen, Lei, Zhou, Guan-Qun, Li, Wen-Fei, Du, Xiao-Jing, Guo, Rui, Liu, Xu, Zhang, Yuan, Zeng, Jing, Yun, Jing-Ping, Sun, Ying, Liu, Na, and Ma, Jun

Abstract

Additional file 1: Methods. Figure S1. Study flow. HTA, Human Transcriptome Array; ICI, immune checkpoint inhibitor; NMF, non-negative matrix factorization; NPC, nasopharyngeal carcinoma; PSM, propensity score matching. Figure S2. Identification of an NMF immune factor. (A) We applied NMF (k = 5 factors or expression patterns) to analyze the gene expression profiles of nasopharyngeal carcinoma (NPC) samples in the training cohort (n = 113). One of the five factors (green bar) showed the highest ssGSEA scores in both immune enrichment score and 6-gene IFN-γ signature, as shown in the heatmap, indicating that it is an immune factor (or an immune expression pattern). High and low ssGSEA scores are represented in red and blue, respectively. (B) The top 100 exemplar immune factor genes characterized using DAVID confirmed immune-related functions. (C) NMF consensus-clustering of the training cohort using exemplar immune factor genes was refined by random forest classification. As shown in the heatmap, an immune-enriched subtype and a non-immune subtype. The ssGSEA scores of immune enrichment score and 6-gene IFN-γ signature are indicated; high and low scores are represented in red and blue, respectively. NMF, non-negative matrix factorization; NPC, nasopharyngeal carcinoma; ssGSEA, single-sample gene set enrichment analysis. Figure S3. Association of immune subtypes with tumoural genomic features and survival outcome. (A) Box plot showing similar number of non-synonymous mutations among the immune subtypes. (B) Box plot showing similar numbers of gene-level amplifications and deletions among the immune subtypes. (C) Box plot showing significantly higher cell cycling scores in non-IS. The box plot centre corresponds to the median, with the box and whiskers corresponding to the interquartile range and 1.5× interquartile range, respectively. P-values were based on the Kruskal–Wallis rank-sum test. (D) The proportion of CDKN2A deletions was significantly higher in non-IS. P-values were based on the Fisher’s exact test. (E) Kaplan–Meier curves for progression-free survival according to immune subtypes. A trend of better survival was observed for A-IS compared to E-IS and non-IS in 88 patients with available survival outcomes. P-values were calculated by log-rank test. A-IS, active immune subtype; CD4+ Tconv, conventional CD4+ T cells; CD8+ Tcyt, cytotoxic CD8+ T cells; CD8+ Tdys, dysfunctional CD8+ T cells; CD8+ Tnaï, naïve CD8+ T cells; DCs, dendritic cells; E-IS, evaded immune subtype; NK, natural killer; non-IS, non-immune subtype. Figure S4. Genetic similarity of the immune subtypes in different groups of patients from two melanoma ICI cohorts. (A) SubMap analysis of the immune subtypes in validation cohort 1 and four groups (anti-PD-1 responsive and non-responsive, and anti-CTLA-4 responsive and non-responsive) in melanoma ICI cohort 1. (B) SubMap analysis of the immune subtypes in validation cohort 1 and four groups (CR/PR/SD > 12 months, CR/PR/SD 6–12 months, CR/PR/SD 12 months for anti-PD-1 therapy (P = 0.036). A-IS, active immune subtype; CR, complete response; E-IS, evaded immune subtype; ICI, immune checkpoint inhibitor; non-IS, non-immune subtype; PD, progressive disease; PR, partial response; SD, stable disease. Table S1. Clinical cohorts used in this study. Table S2. Publicly available gene signatures used in this study. Table S7. Clinical characteristics of patients in the validation cohort 1 and validation cohort 2 (ICI).

Published
2021
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80. The Pattern of Time to Onset and Resolution of Immune-Related Adverse Events Caused by Immune Checkpoint Inhibitors in Cancer: A Pooled Analysis of 23 Clinical Trials and 8,436 Patients

Author

Tang, Si-Qi, primary, Tang, Ling-Long, additional, Mao, Yan-Ping, additional, Li, Wen-Fei, additional, Chen, Lei, additional, Zhang, Yuan, additional, Guo, Ying, additional, Liu, Qing, additional, Sun, Ying, additional, Xu, Cheng, additional, and Ma, Jun, additional

Published
2021
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81. Normal tissue complication probability (NTCP) models for predicting temporal lobe injury after intensity-modulated radiotherapy in nasopharyngeal carcinoma: A large registry-based retrospective study from China

Author

Wen, Dan-Wan, primary, Lin, Li, additional, Mao, Yan-Ping, additional, Chen, Chun-Yan, additional, Chen, Fo-Ping, additional, Wu, Chen-Fei, additional, Huang, Xiao-Dan, additional, Li, Zhi-Xuan, additional, Xu, Si-Si, additional, Kou, Jia, additional, Yang, Xing-Li, additional, Ma, Jun, additional, Sun, Ying, additional, and Zhou, Guan-Qun, additional

Published
2021
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83. Evolving landscape and academic attitudes toward the controversies of global immuno‐oncology trials

Author

Xu, Cheng, primary, Zhang, Shu, additional, Zhang, Yuan, additional, Tang, Si‐Qi, additional, Fang, Xue‐Liang, additional, Zhu, Guang‐Li, additional, Peng, Liang, additional, Liu, Jin‐Qi, additional, Mao, Yan‐Ping, additional, Tang, Ling‐Long, additional, Liu, Qing, additional, Lin, Ai‐Hua, additional, Sun, Ying, additional, and Ma, Jun, additional

Published
2021
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84. Combining tumor response and personalized risk assessment: Potential for adaptation of concurrent chemotherapy in locoregionally advanced nasopharyngeal carcinoma in the intensity-modulated radiotherapy era

Author

Luo, Wei-Jie, primary, Zou, Wen-Qing, additional, Liang, Shao-Bo, additional, Chen, Lei, additional, Zhou, Guan-Qun, additional, Peng, Hao, additional, Li, Wen-Fei, additional, Liu, Xu, additional, Sun, Ying, additional, Lin, Ai-Hua, additional, Ma, Jun, additional, and Mao, Yan-Ping, additional

Published
2021
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86. Development and validation of a web‐based calculator to predict individualized conditional risk of site‐specific recurrence in nasopharyngeal carcinoma: Analysis of 10,058 endemic cases

Author

Wu, Chen‐Fei, primary, Lv, Jia‐Wei, additional, Lin, Li, additional, Mao, Yan‐Ping, additional, Deng, Bin, additional, Zheng, Wei‐Hong, additional, Wen, Dan‐Wan, additional, Chen, Yue, additional, Kou, Jia, additional, Chen, Fo‐Ping, additional, Yang, Xing‐Li, additional, Zheng, Zi‐Qi, additional, Li, Zhi‐Xuan, additional, Xu, Si‐Si, additional, Ma, Jun, additional, and Sun, Ying, additional

Published
2020
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96. A Gene-Expression Predictor for Efficacy of Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Author

Lei, Yuan, primary, Li, Ying-Qin, additional, Jiang, Wei, additional, Hong, Xiao-Hong, additional, Ge, Wen-Xiu, additional, Zhang, Yuan, additional, Hu, Wei-Han, additional, Wang, Ya-Qin, additional, Liang, Ye-Lin, additional, Li, Jun-Yan, additional, Cho, William C S, additional, Yun, Jing-Ping, additional, Zeng, Jing, additional, Chen, Jie-Wei, additional, Liu, Li-Zhi, additional, Li, Li, additional, Chen, Lei, additional, Xie, Fang-Yun, additional, Li, Wen-Fei, additional, Mao, Yan-Ping, additional, Liu, Xu, additional, Chen, Yu-Pei, additional, Tang, Ling-Long, additional, Sun, Ying, additional, Liu, Na, additional, and Ma, Jun, additional

Published
2020
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97. Prognostic value of immune score in nasopharyngeal carcinoma using digital pathology

Author

Wang, Ya-Qin, primary, Chen, Lei, additional, Mao, Yan-Ping, additional, Li, Ying-Qing, additional, Jiang, Wei, additional, Xu, Shuo-Yu, additional, Zhang, Yu, additional, Chen, Yu-Pei, additional, Li, Xiao-Min, additional, He, Qing-Mei, additional, He, Shi-Wei, additional, Yang, Xiao-Jing, additional, Lei, Yuan, additional, Zhao, Yin, additional, Yun, Jing-Ping, additional, Liu, Na, additional, Li, Yingqin, additional, and Ma, Jun, additional

Published
2020
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98. Development and validation of a gene expression-based signature predicting efficacy of induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: A multicenter cohort study.

Author

Lei, Yuan, primary, Li, Ying-Qin, additional, Jiang, Wei, additional, Hong, Xiao-Hong, additional, Ge, Wen-Xiu, additional, Zhang, Yuan, additional, Hu, Weihan, additional, Wang, Ya-Qin, additional, Liang, Ye-Lin, additional, Li, Jun-Yan, additional, Chen, Lei, additional, Xie, Fangyun, additional, Li, Wen-Fei, additional, Mao, Yan-Ping, additional, Liu, Xu, additional, Chen, Yu-Pei, additional, Tang, Ling-Long, additional, Sun, Ying, additional, Liu, Na, additional, and Ma, Jun, additional

Published
2020
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99. The pattern of time to onset and resolution of immune-related adverse events caused by immune checkpoint inhibitors in cancer: A pooled analysis of 23 clinical trials and 8,436 patients.

Author

Tang, Si-Qi, primary, Xu, Cheng, additional, Tang, Ling-Long, additional, Mao, Yan-Ping, additional, Li, Wen-Fei, additional, Chen, Lei, additional, Zhang, Yuan, additional, Guo, Ying, additional, Liu, Qing, additional, Sun, Ying, additional, and Ma, Jun, additional

Published
2020
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