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

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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.

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Acknowledgment

This research was funded in part by Norvartis Pharmaceuticals.

Conflicts of interest statement

All authors declare no potential conflicts of interest.

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Authors and Affiliations

  1. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea, 138-736

    Changhoon Yoo & Jin-Hee Ahn

  2. Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

    Jeeyun Lee

  3. Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea

    Sun Young Rha

  4. Department of Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea

    Kyong Hwa Park

  5. Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea

    Tae Min Kim

  6. Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea

    Yu Jung Kim

  7. Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea

    Hyo Jin Lee

  8. Department of Internal Medicine, Yeungnam University Hospital, Yeungnam University College of Medicine, Daegu, Korea

    Kyung Hee Lee

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  1. Changhoon Yoo
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Correspondence to Jin-Hee Ahn.

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Yoo, C., Lee, J., Rha, S.Y. et al. Multicenter phase II study of everolimus in patients with metastatic or recurrent bone and soft-tissue sarcomas after failure of anthracycline and ifosfamide. Invest New Drugs 31, 1602–1608 (2013). https://doi.org/10.1007/s10637-013-0028-7

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  • DOI: https://doi.org/10.1007/s10637-013-0028-7

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