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Background <p>Histological transformation represents an important mechanism of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) in EGFR-mutant lung cancer; however, its incidence, timing, and post-transformation outcomes remain incompletely characterized.</p> Methods <p>We conducted a systematic review and meta-analysis in accordance with PRISMA guidelines and Cochrane recommendations. PubMed, Web of Science and Embase were searched up to November 2025 for studies reporting histological transformation in EGFR-mutant lung cancer following EGFR-TKI resistance. Eligible studies included prospective or retrospective studies and consecutive case series (sample size ≥ 10 or ≥3events). Random-effects models were applied to pool transformation proportions and survival outcomes, and Kaplan–Meier–based methods were used to synthesize time-to-event data.</p> Results <p>A total of 35 studies were included. Among patients with non–small cell lung cancer (NSCLC) who developed resistance to EGFR-TKIs, the pooled proportion of transformation to high-grade neuroendocrine carcinoma (HGNEC) was 6% (95% CI, 5%–8%), while transformation to non-neuroendocrine NSCLC occurred in 2% of cases (95% CI, 2%–3%). The pooled median time from EGFR-TKI initiation to histological transformation was 19.39 months (95% CI, 16.18–22.60). After transformation, the pooled median progression-free survival (mPFS) was 3.93 months (95% CI, 3.14–4.72), and the pooled median overall survival was 10.69 months (95% CI, 8.34–13.04).</p> Conclusions <p>Histological transformation occurs in a clinically relevant proportion of EGFR-TKI–resistant EGFR-mutant lung cancer, and is associated with poor post-transformation outcomes.</p>

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Histological transformation in lung cancer: a single-arm meta-analysis and systematic review

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月21日

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  • Lefei Hu,
  • Xunxia Zhu,
  • Xiaoyu Chen,
  • Fuzhi Yang,
  • Shuai Jiang,
  • Shixiang Guo,
  • Mingfeng Wei,
  • Zheng Li,
  • Xiaoyong Shen

摘要

Background

Histological transformation represents an important mechanism of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) in EGFR-mutant lung cancer; however, its incidence, timing, and post-transformation outcomes remain incompletely characterized.

Methods

We conducted a systematic review and meta-analysis in accordance with PRISMA guidelines and Cochrane recommendations. PubMed, Web of Science and Embase were searched up to November 2025 for studies reporting histological transformation in EGFR-mutant lung cancer following EGFR-TKI resistance. Eligible studies included prospective or retrospective studies and consecutive case series (sample size ≥ 10 or ≥3events). Random-effects models were applied to pool transformation proportions and survival outcomes, and Kaplan–Meier–based methods were used to synthesize time-to-event data.

Results

A total of 35 studies were included. Among patients with non–small cell lung cancer (NSCLC) who developed resistance to EGFR-TKIs, the pooled proportion of transformation to high-grade neuroendocrine carcinoma (HGNEC) was 6% (95% CI, 5%–8%), while transformation to non-neuroendocrine NSCLC occurred in 2% of cases (95% CI, 2%–3%). The pooled median time from EGFR-TKI initiation to histological transformation was 19.39 months (95% CI, 16.18–22.60). After transformation, the pooled median progression-free survival (mPFS) was 3.93 months (95% CI, 3.14–4.72), and the pooled median overall survival was 10.69 months (95% CI, 8.34–13.04).

Conclusions

Histological transformation occurs in a clinically relevant proportion of EGFR-TKI–resistant EGFR-mutant lung cancer, and is associated with poor post-transformation outcomes.