High-grade uterine LMS: adjuvant chemotherapy fails phase 3 trial

  • Hensley ML & al.
  • J Clin Oncol
  • 5 Oct 2018

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Adjuvant chemotherapy (ACT) failed to extend survival and increased toxicity in patients with high-grade uterine leiomyosarcoma (LMS) who were participating in a prematurely terminated phase 3 study.

Why this matters

  • Observation remains the standard of care in these patients.

Study design

  • Phase 3 randomized study of 38 patients (vs targeted accrual, 216) with uterus-limited high-grade LMS who underwent complete hysterectomy±bilateral salpingo-oophorectomy.
  • Patients received either ≥1 cycle of ACT (gemcitabine+docetaxel followed by doxorubicin; n=17) or observation (n=18).
  • Funding: National Cancer Institute; NRG Oncology; Memorial Sloan Kettering Cancer Center; others.

Key results

  • Median follow-up for was 19.1 months.
  • 47% of patients in the ACT group experienced grade 3/4 adverse events.
  • 1 patient in the observation group had grade 3 hypertension.
  • 5 patients in the ACT group and 1 in the observation group died.
  • The restricted mean estimated OS was 34.3 and 46.4 months in the ACT and observation groups, respectively.
  • The restricted mean estimated recurrence-free survival was 18.1 and 14.6 months, respectively in the ACT and observation group.

Limitations

  • Study terminated prematurely due to slow accrual.

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