A phase II trial of second-line pemetrexed in adults with advanced/metastatic osteosarcoma

Florence Duffaud, Gerlinde Egerer, Stefano Ferrari, Hisham Rassam, Ulrike Boecker, B. Bui-Nguyen

Research output: Contribution to journalArticle

Abstract

Background: Osteosarcoma is the most common primary malignant tumour in young adults. An effective treatment strategy for relapsed patients is still not defined. Pemetrexed is a multitargeted antifolate with a mode of action similar to, and a range of action broader than that of methotrexate. The primary objective of this phase II study was to determine tumour response rate in patients with high-grade, advanced/metastatic osteosarcoma. Secondary end-points included progression-free survival (PFS), overall survival (OS) and safety. Methods: Pemetrexed 500 mg/m 2 was administered on day 1 of 21-day cycles with folic acid and vitamin B 12 supplementation. At least 5 tumour responses in a targeted population of 32 were required to consider further investigation. Results: Thirty-two patients (median age, 43.3 years; range, 18.6-76.0) with 1 prior chemotherapy regimen for high-grade advanced/metastatic osteosarcoma were enrolled. Thirty (93.8%) patients had an ECOG performance status ≤1 and 29 (90.6%) had metastases in the lung. One patient had partial response (3.1%) and 5 (15.6%) had stable disease. Median PFS and OS were 1.4 months (95% CI: 1.4-1.7) and 5.5 months (95% CI: 2.3-10.5), respectively. The most common drug-related grade 3/4 toxicities were leukopaenia, asthaenia and elevated alanine aminotransferase in 3 (9.4%) patients each. One patient died due to multi-organ failure considered possibly related to the study drug. Conclusions: Pemetrexed 500 mg/m 2 administered on day 1 of 21-day cycles as second-line treatment to patients with advanced/metastatic high-grade osteosarcoma was generally well tolerated but did not meet minimal response expectations for further investigation in this patient population.

Original languageEnglish
Pages (from-to)564-570
Number of pages7
JournalEuropean Journal of Cancer
Volume48
Issue number4
DOIs
Publication statusPublished - Mar 2012

Fingerprint

Pemetrexed
Osteosarcoma
Disease-Free Survival
Folic Acid Antagonists
Neoplasms
Survival
Leukopenia
Vitamin B 12
Alanine Transaminase
Folic Acid
Methotrexate
Pharmaceutical Preparations
Population
Young Adult

Keywords

  • Clinical trial
  • Osteosarcoma
  • Pemetrexed
  • Phase II
  • Relapse
  • Response
  • Second-line

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Duffaud, F., Egerer, G., Ferrari, S., Rassam, H., Boecker, U., & Bui-Nguyen, B. (2012). A phase II trial of second-line pemetrexed in adults with advanced/metastatic osteosarcoma. European Journal of Cancer, 48(4), 564-570. https://doi.org/10.1016/j.ejca.2011.12.015

A phase II trial of second-line pemetrexed in adults with advanced/metastatic osteosarcoma. / Duffaud, Florence; Egerer, Gerlinde; Ferrari, Stefano; Rassam, Hisham; Boecker, Ulrike; Bui-Nguyen, B.

In: European Journal of Cancer, Vol. 48, No. 4, 03.2012, p. 564-570.

Research output: Contribution to journalArticle

Duffaud, F, Egerer, G, Ferrari, S, Rassam, H, Boecker, U & Bui-Nguyen, B 2012, 'A phase II trial of second-line pemetrexed in adults with advanced/metastatic osteosarcoma', European Journal of Cancer, vol. 48, no. 4, pp. 564-570. https://doi.org/10.1016/j.ejca.2011.12.015
Duffaud, Florence ; Egerer, Gerlinde ; Ferrari, Stefano ; Rassam, Hisham ; Boecker, Ulrike ; Bui-Nguyen, B. / A phase II trial of second-line pemetrexed in adults with advanced/metastatic osteosarcoma. In: European Journal of Cancer. 2012 ; Vol. 48, No. 4. pp. 564-570.
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AU - Boecker, Ulrike

AU - Bui-Nguyen, B.

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