External validation of the eighth edition of the TNM classification for lung cancer in small cell lung cancer

Tan, Fengwei; Bi, Nan; Zhang, Hao; Li, Renda; Wang, Zhijie; Duan, Jianchun; Jiang, Feng; Feng, Dan; Zhang, Rongsheng; Bai, Junjun; Cao, Jianzhong; Mao, Naiquan; Liang, Kai Li; Shi-quan, Yin; Shen, Yaxing; Feng, Fenling; Zhao, Jun; Gao, Yushun; Mao, Yousheng; Xue, Qi; Gao, Shugeng; He, Jie

doi:10.1016/j.lungcan.2022.03.011

Cited by 8 publications

(5 citation statements)

References 17 publications

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“…The 8 th TNM staging (with sub-categorisation of ED-SCLC patients in IVA and IVB stages) was not yet developed when the trials were executed, and the LD/ED staging is still largely used to define treatment intention 38 . Previous studies have pointed out significant differences in survival between IVA and IVB patients 38,[44][45][46] . This result may be due to selection bias in RCTs, favouring younger patients with comparably better overall health and lower disease burden, which is only partially captured by the TNM staging.…”

Section: Discussionmentioning

confidence: 98%

“…In previous works, the dominant approach has been the propensity score informed by clinical trial data 10,[24][25][26]30,31,46 . No in-depth examination of differences in operations has been done before.…”

Section: Discussionmentioning

confidence: 99%

“…This can potentially explain why replication was not achieved in previous works. Indeed, in the ideal condition of having two populations with the same support of baseline covariates and sufficient population sample, accounting for the eventual operational differences, should theoretically account for any misalignment in study outcomes 9,11,31,46 . One limitation of the propensity score is that it works from only one direction by selecting RWD patients that match RCTs, thus not accounting for any additional findings and confounders that are only detectable in the RWD population.…”

Section: Discussionmentioning

confidence: 99%

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Exploring the discrepancies between clinical trials and real-world data by accounting for Selection criteria, Operations, and Measurements of Outcome

Marzano,

Darwich,

Dan

et al. 2024

Preprint

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The potential of real-world data to inform clinical trial design and supplement control arms has gained much interest in recent years. The most common approach relies on matching real-world patient cohorts to clinical trial baseline covariates using propensity score techniques. However, recent studies pointed out that there is a lack of replicability, generalisability, and consensus. Further, few studies consider differences in operational processes. Systematically accounting for confounders, including hidden effects related to the clinical treatment process and clinical trial study protocol, would potentially allow for improved translation between clinical trial and real-world data and enable learning across translational activities. In this paper, we propose an approach that aims to explore and examine these confounders by investigating the impact of selection criteria and operations on the measurements of outcome. We tested the approach on small cell lung cancer patients receiving platinum-based chemotherapy regimens (n=1,224). The results showed that the discrepancy between real-world and clinical trial data potentially depends on differences in covariate characteristics and operations (e.g., censoring mechanism, the process of pre-trial patient selection related to ECOG-performance status 2 patients). This work builds on current approaches and suggests areas of improvement for systematically accounting for differences in outcomes between study cohorts. Continued development of the method presented here could pave the way for transferring learning across studies and developing mutual translation between the real-world and clinical trials to inform future studies design.

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Exploring the discrepancies between clinical trials and real-world data by accounting for Selection criteria, Operations, and Measurements of Outcome

Marzano,

Darwich,

Dan

et al. 2024

Preprint

View full text Add to dashboard Cite

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“…The TNM staging system is used to comprehensively evaluate the stage of lung cancer. As stage III non-small cell lung cancer patients have regional lymph node metastasis, they are more likely to have tumor-specific death (19)(20)(21). Lung cancer can invade surrounding tissues, including in the superior vena cava, aorta, pericardium, pleura, and other important tissues of the mediastinum.…”

Section: Discussionmentioning

confidence: 99%

Establishment and validation of a long-term prognosis prediction model for patients with non-small cell lung cancer

Yu¹,

Tan²,

Xu³

2023

J Thorac Dis

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Background: The incidence of non-small cell lung cancer ranks second among malignant tumors, while the mortality rate ranks first. We established a prediction model for the long-term prognosis of lung cancer patients to accurately identify patients with a high risk of postoperative death and provide a theoretical basis for improving the prognosis of patients with non-small cell lung cancer. Methods:The data of 277 non-small cell lung cancer patients who underwent radical lung cancer resection at Shanghai Fengxian District Central Hospital between January 2016 and December 2017 were retrospectively collected. The patients, who were followed up for 5 years, were divided into a deceased group (n=127) and survival group (n=150) according to whether the patients had died 5 years after surgery or not. The clinical characteristics of the two groups were observed, and the risk factors of death within 5 years of surgery in lung cancer patients were analyzed. A nomogram predictive model was then established to analyze the value of the model in predicting the death within 5 years of surgery in patients with non-small cell lung cancer.Results: Multivariate logistics regression analysis showed that carcinoembryonic antigen (CEA) >193.5 ng/mL, stage III lung cancer, peritumor invasion, and vascular tumor thrombus were independent risk factors of tumor-specific death after surgery in patients with non-small cell lung cancer (P<0.05). R 4.0.3 statistical software was used to randomly divide the dataset into a training set and validation set. The sample size of the training set was 194, and the sample size of the validation set was 83. The area under the receiver operating characteristic (ROC) curve was 0.850 [95% confidence interval (CI): 0.796-0.905] in the training set, and it was 0.779 (95% CI: 0.678-0.880) in the validation set. In the validation set, the model was assessed using the Hosmer-Lemeshow goodness-of-fit test, with a chi-square value of 9.270 and a P value of 0.320.Conclusions: Our model could accurately identify high risk of death within 5 years of surgery in nonsmall cell lung cancer patients. Strengthening the management of high-risk patients may help improve the prognosis of these patients.

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“…Compared to the seventh edition, there are significant refinements in the T and M components, decreased size boundaries, and more accurate metastases sites (5)(6)(7). Although these refinements were analyzed from the data of NSCLC patients, they were validated in SCLC in the IASLC database, National Cancer Data Base, and Chinese cohorts (8). However, to our knowledge, prognostic assessments of C-SCLC, another subset of NEC, have not yet been performed on a population level.…”

Section: Introductionmentioning

confidence: 99%

Prognostic significance of eighth edition TNM stage criteria in combined small-cell lung cancer

et al. 2023

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ObjectivesThis study aimed to evaluate the prognostic significance of the eighth edition TNM stage criteria in patients with combined small-cell lung cancer (C-SCLC) on a population level.MethodsUsing the Surveillance, Epidemiology, and End Results (SEER) database, patients diagnosed with C-SCLC (histology code 8245) between the years 2004 and 2015 were identified. We performed a Kaplan–Meier analysis and used the multivariable cox regression proportional hazards model to obtain prognostic overall survival estimates for each group of patients.ResultsA total of 477 patients diagnosed with C-SCLC were identified. The T, N, M, TNM, and combined TNM stage status of the eighth edition were all significant prognostic factors for patients’ overall survivals, with the best discrimination identified in the combined stages. Surgery was also found to be a prognostic factor (HR =1.95, 95%CI =1.49-2.56, p<0.01) for patients with C-SCLC.ConclusionsThe combined eighth edition of the TNM staging criteria shows reliable prognostic significance in patients with C-SCLC. Moreover, surgery might be significant for improving the patients’ prognosis.

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External validation of the eighth edition of the TNM classification for lung cancer in small cell lung cancer

Cited by 8 publications

References 17 publications

Exploring the discrepancies between clinical trials and real-world data by accounting for Selection criteria, Operations, and Measurements of Outcome

Exploring the discrepancies between clinical trials and real-world data by accounting for Selection criteria, Operations, and Measurements of Outcome

Establishment and validation of a long-term prognosis prediction model for patients with non-small cell lung cancer

Prognostic significance of eighth edition TNM stage criteria in combined small-cell lung cancer

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