Investigational New Drugs

, Volume 31, Issue 6, pp 1602–1608

Multicenter phase II study of everolimus in patients with metastatic or recurrent bone and soft-tissue sarcomas after failure of anthracycline and ifosfamide

  • Changhoon Yoo
  • Jeeyun Lee
  • Sun Young Rha
  • Kyong Hwa Park
  • Tae Min Kim
  • Yu Jung Kim
  • Hyo Jin Lee
  • Kyung Hee Lee
  • Jin-Hee Ahn
PHASE II STUDIES

DOI: 10.1007/s10637-013-0028-7

Cite this article as:
Yoo, C., Lee, J., Rha, S.Y. et al. Invest New Drugs (2013) 31: 1602. doi:10.1007/s10637-013-0028-7

Summary

This multicenter, phase II trial evaluated the efficacy and safety of everolimus, an mTOR inhibitor, in patients with metastatic or recurrent bone and soft-tissue sarcoma after the failure of anthracycline- and ifosfamide-containing regimens. Everolimus was administered orally as 10 mg once daily. The primary endpoint was the progression-free rate (PFR) at 16 weeks, assessed by computed tomography scan according to RECIST v1.0. Between July 2010 and May 2011, 41 patients were enrolled in this study. Among them, 83 % received two or more regimens of chemotherapy prior to study entry. In 38 patients who the primary endpoint was evaluable, 11 patients reached 16 weeks progression-free (one with partial response and 10 with stable disease), indicating a PFR at 16 weeks of 27 % (95 % confidence interval [CI], 16 − 42 %). The PFR at 16 weeks was highest in patients with angiosarcoma (2 of 3, 67 %). With a median follow-up of 10.9 months (range, 2.3–23.9 months) in living patients, the median progression-free survival was 1.9 months (95 % CI, 1.3–2.4 months) and the median overall survival was 5.8 months (95 % CI, 3.6–8.0 months). Most adverse events were generally mild and tolerable. Grade 3/4 toxicities included hyperglycemia (15 %), stomatitis (7 %), pain (5 %), and asthenia (5 %). Everolimus shows modest antitumor activity with manageable toxicities in heavily pretreated patients with bone and soft-tissue sarcoma.

Keywords

Everolimus mTOR inhibitor Sarcoma 

Copyright information

© Springer Science+Business Media New York 2013

Authors and Affiliations

  • Changhoon Yoo
    • 1
  • Jeeyun Lee
    • 2
  • Sun Young Rha
    • 3
  • Kyong Hwa Park
    • 4
  • Tae Min Kim
    • 5
  • Yu Jung Kim
    • 6
  • Hyo Jin Lee
    • 7
  • Kyung Hee Lee
    • 8
  • Jin-Hee Ahn
    • 1
  1. 1.Department of Oncology, Asan Medical CenterUniversity of Ulsan College of MedicineSeoulSouth Korea
  2. 2.Department of Medicine, Samsung Medical CenterSungkyunkwan University School of MedicineSeoulKorea
  3. 3.Yonsei Cancer CenterYonsei University College of MedicineSeoulKorea
  4. 4.Department of Medicine, Korea University Anam HospitalKorea University College of MedicineSeoulKorea
  5. 5.Department of Internal MedicineSeoul National University Hospital, Seoul National University College of MedicineSeoulKorea
  6. 6.Department of Internal MedicineSeoul National University Bundang Hospital, Seoul National University College of MedicineSeongnamKorea
  7. 7.Department of Internal MedicineChungnam National University Hospital, Chungnam National University College of MedicineDaejeonKorea
  8. 8.Department of Internal MedicineYeungnam University Hospital, Yeungnam University College of MedicineDaeguKorea

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