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<b>Background</b> <p>The aim of this study was to assess the efficacy and safety of pimitespib in real-world clinical settings for tyrosine kinase inhibitor-resistant GISTs.</p> <b>Methods</b> <p>We retrospectively analyzed <b>1</b><b>5</b> patients at Osaka University Hospital. Patients treated with pimitespib as a fourth- or later-line treatment for unresectable or recurrent GISTs were included. Patient background, pimitespib dose, number of courses, adverse events, best response, progression-free survival, and overall survival were analyzed.</p> <b>Results</b> <p>The median overall survival of patients treated with pimitespib was 24.4&#xa0;months（95% confidence interval [CI] 7.2–not reached) and the one-year overall survival rate was <b>70.9</b>%. The median progression-free survival was <b>4.</b><b>6</b>&#xa0;months (95%CI 1.8–7.4), and the one-year progression-free survival rate was <b>15.2</b>%. A partial response was observed in 0 patients, stable disease lasting for ≥ 12&#xa0;weeks in <b>7</b> (<b>46.7</b>%), progressive disease in 7 (<b>40.0</b>%), and a non-evaluable state in <b>2</b> (<b>13.3</b>%). The disease control rate was <b>4</b><b>0</b>%. Treatment-related adverse events were reported in all patients, with the most common being diarrhea (<b>8</b><b>7</b>%), followed by <b>anorexia</b> (<b>27</b>%), <b>nausea (27%),</b> and increased blood creatinine levels (<b>27</b>%). None of the patients discontinued the treatment because of adverse events.</p> <b>Conclusion</b> <p>Pimitespib may offer a tolerable and effective treatment option for patients with unresectable or recurrent GISTs in clinical practice.</p>

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Efficacy and safety of pimitespib in gastrointestinal tumors

  • 期刊论文

  • 发表日期：

    2025年11月19日

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  • Kunihiko Kawai,
  • Tsuyoshi Takahashi,
  • Yukinori Kurokawa,
  • Taroh Satoh,
  • Takaomi Hagi,
  • Takuro Saito,
  • Kazuyoshi Yamamoto,
  • Kota Momose,
  • Kotaro Yamashita,
  • Koji Tanaka,
  • Tomoki Makino,
  • Kiyokazu Nakajima,
  • Hidetoshi Eguchi,
  • Yuichiro Doki

摘要

Background

The aim of this study was to assess the efficacy and safety of pimitespib in real-world clinical settings for tyrosine kinase inhibitor-resistant GISTs.

Methods

We retrospectively analyzed 15 patients at Osaka University Hospital. Patients treated with pimitespib as a fourth- or later-line treatment for unresectable or recurrent GISTs were included. Patient background, pimitespib dose, number of courses, adverse events, best response, progression-free survival, and overall survival were analyzed.

Results

The median overall survival of patients treated with pimitespib was 24.4 months（95% confidence interval [CI] 7.2–not reached) and the one-year overall survival rate was 70.9%. The median progression-free survival was 4.6 months (95%CI 1.8–7.4), and the one-year progression-free survival rate was 15.2%. A partial response was observed in 0 patients, stable disease lasting for ≥ 12 weeks in 7 (46.7%), progressive disease in 7 (40.0%), and a non-evaluable state in 2 (13.3%). The disease control rate was 40%. Treatment-related adverse events were reported in all patients, with the most common being diarrhea (87%), followed by anorexia (27%), nausea (27%), and increased blood creatinine levels (27%). None of the patients discontinued the treatment because of adverse events.

Conclusion

Pimitespib may offer a tolerable and effective treatment option for patients with unresectable or recurrent GISTs in clinical practice.