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

Florence Duffaud1, Gerlinde Egerer, Stefano Ferrari

  • 1Marseille and Aix-Marseille University, Marseille, France. florence.duffaud@ap-hm.fr

European Journal of Cancer (Oxford, England : 1990)
|January 17, 2012
PubMed
Abstract

Insights

Pemetrexed did not meet response expectations for advanced osteosarcoma. This phase II study found the drug well-tolerated but ineffective as a second-line treatment for relapsed patients.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Osteosarcoma is the most common primary malignant tumor in young adults.
  • Effective treatment strategies for relapsed osteosarcoma patients remain undefined.
  • Pemetrexed is a multitargeted antifolate with a broad range of action.

Purpose of the Study:

  • To determine the tumor response rate of Pemetrexed in patients with high-grade, advanced/metastatic osteosarcoma.
  • To evaluate progression-free survival (PFS), overall survival (OS), and safety as secondary endpoints.

Main Methods:

  • A phase II study administered Pemetrexed 500mg/m² on day 1 of 21-day cycles with folic acid and vitamin B12 supplementation.
  • Thirty-two patients with advanced/metastatic osteosarcoma and one prior chemotherapy regimen were enrolled.
  • Minimal response expectations required at least 5 tumor responses in the targeted population of 32.

Main Results:

  • One patient (3.1%) had a partial response, and 5 (15.6%) had stable disease.
  • Median progression-free survival (PFS) was 1.4 months, and median overall survival (OS) was 5.5 months.
  • Common grade 3/4 toxicities included leukopenia, asthenia, and elevated alanine aminotransferase; one death was possibly drug-related.

Conclusions:

  • Pemetrexed at 500mg/m² as second-line treatment for advanced/metastatic osteosarcoma was generally well-tolerated.
  • The study did not meet minimal response expectations for further investigation in this patient population.
  • Pemetrexed is not recommended for further investigation in this setting.

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