Background <p>Adjuvant imatinib is the standard postoperative treatment for patients with intermediate- and high-risk gastrointestinal stromal tumors (GISTs). However, uncertainty remains regarding the optimal duration of therapy and its long-term effects on recurrence-free survival (RFS) and overall survival (OS). This study aimed to evaluate the efficacy and safety of adjuvant imatinib following complete surgical resection of GISTs and to assess the influence of treatment duration on clinical outcomes.</p> Methods <p>A systematic review and meta-analysis were conducted in accordance with PRISMA guidelines. PubMed, Scopus, and the Cochrane Library were searched from inception to March 2025. Studies evaluating adjuvant imatinib after complete GIST resection were included. The primary outcome was recurrence-based survival (RFS/DFS/RFI), while secondary outcomes included OS and treatment-related adverse events. Randomized and non-randomized studies were synthesized, and pooled hazard ratios (HRs) were calculated using random-effects models.</p> Results <p>Sixteen studies involving 3531 patients met the inclusion criteria, and eight studies provided data suitable for quantitative synthesis. Adjuvant imatinib significantly reduced the risk of recurrence or death compared with surgery alone (pooled HR&#xa0;=&#xa0;0.49, 95% CI: 0.35–0.67). Substantial heterogeneity was observed (I<sup>2</sup>&#xa0;=&#xa0;78%), partly attributable to differences in treatment duration and study design. Duration-stratified analyses demonstrated greater benefit with therapy lasting at least three years (HR&#xa0;=&#xa0;0.41) compared with one-year treatment regimens (HR&#xa0;=&#xa0;0.65). Overall survival benefit was less consistent across studies. Most adverse events were Grade 1–2, whereas severe toxicities were uncommon. Evidence certainty was moderate for RFS, low-to-moderate for OS, and high for safety outcomes.</p> Conclusions <p>Adjuvant imatinib significantly improves recurrence-free survival in patients with resected intermediate- and high-risk GISTs. Treatment durations of at least three years provide greater recurrence prevention than shorter regimens. Although overall survival benefits remain less certain, the therapy demonstrates a favorable safety profile. Extended treatment beyond three years appears promising but requires further investigation in adequately powered prospective studies.</p>

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Duration-dependent effects of adjuvant imatinib on recurrence-free and overall survival after resection of gastrointestinal stromal tumors: a systematic review and meta-analysis

  • Yi Zhou,
  • Juan Li,
  • Jiadan Yang,
  • Rui Long,
  • Yanni Cao,
  • Jun Zhang

摘要

Background

Adjuvant imatinib is the standard postoperative treatment for patients with intermediate- and high-risk gastrointestinal stromal tumors (GISTs). However, uncertainty remains regarding the optimal duration of therapy and its long-term effects on recurrence-free survival (RFS) and overall survival (OS). This study aimed to evaluate the efficacy and safety of adjuvant imatinib following complete surgical resection of GISTs and to assess the influence of treatment duration on clinical outcomes.

Methods

A systematic review and meta-analysis were conducted in accordance with PRISMA guidelines. PubMed, Scopus, and the Cochrane Library were searched from inception to March 2025. Studies evaluating adjuvant imatinib after complete GIST resection were included. The primary outcome was recurrence-based survival (RFS/DFS/RFI), while secondary outcomes included OS and treatment-related adverse events. Randomized and non-randomized studies were synthesized, and pooled hazard ratios (HRs) were calculated using random-effects models.

Results

Sixteen studies involving 3531 patients met the inclusion criteria, and eight studies provided data suitable for quantitative synthesis. Adjuvant imatinib significantly reduced the risk of recurrence or death compared with surgery alone (pooled HR = 0.49, 95% CI: 0.35–0.67). Substantial heterogeneity was observed (I2 = 78%), partly attributable to differences in treatment duration and study design. Duration-stratified analyses demonstrated greater benefit with therapy lasting at least three years (HR = 0.41) compared with one-year treatment regimens (HR = 0.65). Overall survival benefit was less consistent across studies. Most adverse events were Grade 1–2, whereas severe toxicities were uncommon. Evidence certainty was moderate for RFS, low-to-moderate for OS, and high for safety outcomes.

Conclusions

Adjuvant imatinib significantly improves recurrence-free survival in patients with resected intermediate- and high-risk GISTs. Treatment durations of at least three years provide greater recurrence prevention than shorter regimens. Although overall survival benefits remain less certain, the therapy demonstrates a favorable safety profile. Extended treatment beyond three years appears promising but requires further investigation in adequately powered prospective studies.