Research
Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital
Published

Phase 2 study of the Exportin 1 inhibitor selinexor in patients with recurrent gynecological malignancies

Research output: Contribution to journalJournal articleResearchpeer-review

  1. Recurrence and survival rates in node negative patients after sentinel node biopsy for early-stage vulva cancer - A nationwide study

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Gemcitabine for recurrent ovarian cancer - a systematic review and meta-analysis

    Research output: Contribution to journalReviewResearchpeer-review

  3. The value of surgical staging in patients with apparent early stage epithelial ovarian carcinoma

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. HPV-prevalence in elderly women in Denmark

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. Efficacy and Determinants of Response to HER Kinase Inhibition in HER2-Mutant Metastatic Breast Cancer

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Patterns of treatment failure in patients undergoing adjuvant or definitive radiotherapy for vulvar cancer

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer

    Research output: Contribution to journalJournal articleResearchpeer-review

  • I B Vergote
  • B Lund
  • U Peen
  • Z Umajuridze
  • M Mau-Sorensen
  • A Kranich
  • E Van Nieuwenhuysen
  • C Haslund
  • T Nottrup
  • S N Han
  • N Concin
  • T J Unger
  • Y Chai
  • N Au
  • T Rashal
  • A Joshi
  • M Crochiere
  • Y Landesman
  • J Shah
  • S Shacham
  • M Kauffman
  • M R Mirza
View graph of relations

BACKGROUND: Selinexor is an oral inhibitor of the nuclear export protein Exportin 1 (XPO1) with demonstrated antitumor activity in solid and hematological malignancies. We evaluated the efficacy and safety of selinexor in heavily pretreated, recurrent gynecological malignancies.

METHODS: In this phase 2 trial, patients received selinexor (35 or 50 mg/m2 twice-weekly [BIW] or 50 mg/m2 once-weekly [QW]) in 4-week cycles. Primary endpoint was disease control rate (DCR) including complete response (CR), partial response (PR) or stable disease (SD) ≥12 weeks. Secondary endpoints were progression-free survival (PFS), overall survival (OS) and safety.

RESULTS: 114 patients with ovarian (N = 66), endometrial (N = 23) or cervical (N = 25) cancer were enrolled. Median number of prior regimens for ovarian, endometrial and cervical cancer was 6 (1-11), 2 (1-5), and 3 (1-6) respectively. DCR was 30% (ovarian 30%; endometrial 35%; cervical 24%), which included confirmed PRs in 8%, 9%, and 4% of patients with ovarian, endometrial, and cervical cancer respectively. Median PFS and OS for patients with ovarian, endometrial and cervical cancer were 2.6, 2.8 and 1.4 months, and 7.3, 7.0, and 5.0 months, respectively. Common Grade 3/4 adverse events (AEs) were thrombocytopenia (17%), fatigue (14%), anemia (10%), nausea (9%) and hyponatremia (9%). Patients with ovarian cancer receiving 50 mg/m2 QW had fewer high-grade AEs with similar efficacy as BIW treatment.

CONCLUSIONS: Selinexor demonstrated single-agent activity and disease control in patients with heavily pretreated ovarian and endometrial cancers. Side effects were a function of dose level and treatment frequency, similar to previous reports, reversible and mitigated with supportive care.

Original languageEnglish
JournalGynecologic Oncology
Volume156
Issue number2
Pages (from-to)308-314
Number of pages7
ISSN0090-8258
DOIs
Publication statusPublished - Feb 2020

    Research areas

  • Cervical cancer, Endometrial cancer, Ovarian cancer, Selinexor, XPO1

ID: 58960805