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Purpose <p>Recent phase III trials demonstrate that survival after segmentectomy is not inferior to that after lobectomy for peripheral small-sized non-small cell lung cancer (NSCLC). However, the influence of patient selection and registration bias remains unclear. This study analyzed real-world data to assess patients who were eligible for the JCOG0802/WJOG4607L trial, but who were not enrolled.</p> Methods <p>We analyzed data on 38 of 61 patients not enrolled in the JCOG0802/WJOG4607L trial, during its enrollment period. Surgical procedures, clinical characteristics, and outcomes of the nonregistered patients were reviewed.</p> Results <p>Lobectomy was performed in 31 patients and segmentectomy was performed in 7 patients. Radiological features of higher-grade malignancy were seen more frequently in the patients who underwent lobectomy. The most common reason for nonregistration in the JCOG0802/WJOG4607L trial was multiple mild comorbidities (<i>n</i> = 11), followed by tumor aggressiveness (<i>n</i> = 6), and concerns about inadequate margins with segmentectomy (<i>n</i> = 6). Recurrence was found in five patients. The 5-year overall and recurrence-free survival rates were 82.9% and 80.2%, respectively.</p> Conclusions <p>Our analysis emphasizes the challenges posed by registration bias in clinical trials. Survival outcomes among the study population were worse than those reported in the JCOG0802/WJOG4607L trial, suggesting a high malignant potential on preoperative imaging, and that registration bias occurs even in large-scale randomized trials.</p>

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Potential bias in the clinical trial registration of patients with peripheral small-sized non-small cell lung cancer: Real-world data in the era of segmentectomy

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月3日

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  • Yuji Nomata,
  • Shota Nakamura,
  • Keita Nakanishi,
  • Yuka Kadomatsu,
  • Harushi Ueno,
  • Taketo Kato,
  • Tetsuya Mizuno,
  • Toyofumi Fengshi Chen-Yoshikawa

摘要

Purpose

Recent phase III trials demonstrate that survival after segmentectomy is not inferior to that after lobectomy for peripheral small-sized non-small cell lung cancer (NSCLC). However, the influence of patient selection and registration bias remains unclear. This study analyzed real-world data to assess patients who were eligible for the JCOG0802/WJOG4607L trial, but who were not enrolled.

Methods

We analyzed data on 38 of 61 patients not enrolled in the JCOG0802/WJOG4607L trial, during its enrollment period. Surgical procedures, clinical characteristics, and outcomes of the nonregistered patients were reviewed.

Results

Lobectomy was performed in 31 patients and segmentectomy was performed in 7 patients. Radiological features of higher-grade malignancy were seen more frequently in the patients who underwent lobectomy. The most common reason for nonregistration in the JCOG0802/WJOG4607L trial was multiple mild comorbidities (n = 11), followed by tumor aggressiveness (n = 6), and concerns about inadequate margins with segmentectomy (n = 6). Recurrence was found in five patients. The 5-year overall and recurrence-free survival rates were 82.9% and 80.2%, respectively.

Conclusions

Our analysis emphasizes the challenges posed by registration bias in clinical trials. Survival outcomes among the study population were worse than those reported in the JCOG0802/WJOG4607L trial, suggesting a high malignant potential on preoperative imaging, and that registration bias occurs even in large-scale randomized trials.