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

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1602-1608
Number of pages7
JournalInvestigational New Drugs
Volume31
Issue number6
DOIs
Publication statusPublished - 2013 Dec 1

Fingerprint

Ifosfamide
Anthracyclines
Sarcoma
Bone and Bones
Confidence Intervals
Asthenia
Stomatitis
Hemangiosarcoma
Everolimus
Hyperglycemia
Disease-Free Survival
Tomography
Safety
Drug Therapy
Pain
Survival

Keywords

  • Everolimus
  • mTOR inhibitor
  • Sarcoma

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Oncology

Cite this

Multicenter phase II study of everolimus in patients with metastatic or recurrent bone and soft-tissue sarcomas after failure of anthracycline and ifosfamide. / Yoo, Changhoon; Lee, Jeeyun; Rha, Sun Young; Park, Kyong Hwa; Kim, Tae Min; Kim, Yu Jung; Lee, Hyo Jin; Lee, Kyung Hee; Ahn, Jin Hee.

In: Investigational New Drugs, Vol. 31, No. 6, 01.12.2013, p. 1602-1608.

Research output: Contribution to journalArticle

Yoo, Changhoon ; Lee, Jeeyun ; Rha, Sun Young ; Park, Kyong Hwa ; Kim, Tae Min ; Kim, Yu Jung ; Lee, Hyo Jin ; Lee, Kyung Hee ; Ahn, Jin Hee. / Multicenter phase II study of everolimus in patients with metastatic or recurrent bone and soft-tissue sarcomas after failure of anthracycline and ifosfamide. In: Investigational New Drugs. 2013 ; Vol. 31, No. 6. pp. 1602-1608.
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AU - Park, Kyong Hwa

AU - Kim, Tae Min

AU - Kim, Yu Jung

AU - Lee, Hyo Jin

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AU - Ahn, Jin Hee

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