Final results reported for glioblastoma clinical trial

A final analysis of a large clinical trial spanning two continents confirms that a combination of postoperative radiation therapy and chemotherapy rather than radiation therapy alone better prolongs survival for patients with glioblastoma throughout the remainder of their lives. The report, published in the Lancet Oncology (May 2009, Vol. 10:5, pp. 459-466), confirms the findings of two-year outcomes first reported in 2004.

The randomized phase III trial was performed by the European Organization for Research and Treatment of Cancer (EORTC) and the National Cancer Institute of Canada (NCIC) Clinical Trials Group, and involved 573 patients being treated for brain cancer at 85 hospitals in 15 countries. Between August 2000 and March 2002, 286 patients received radiation therapy alone, and 287 patients received radiation therapy and both concomitant and adjuvant temozolomide.

Researchers identified the first predictive biomarker in brain tumors that identifies which patients will benefit the most from treatment with temozolomide and radiotherapy. The methylation status of the methyl-guanine methyl transferase gene (MGMT) was determined retrospectively from analysis of the tumor tissue of 206 patients.

When the interim report was published in 2005, the long-term effectiveness of the two treatments was unknown. Based on data from the new study, progression-free survival statistics are summarized below.

Survival Radiation therapy
& chemotherapy
Radiation therapy only
2 years 11.2% 1.8%
3 years 6.0% 1.3%
4 years 5.6% 1.3%
5 years 4.1% 1.3%

At the time of the final analysis, 93% of the patients had died after a median follow-up of 61 months, reported principal investigator Dr. Roger Stupp, head of the Multidisciplinary Oncology Center of University Hospital and the Centre Hospitalier Universitaire Vaudois, both in Lausanne, Switzerland.

All clinical prognostic subgroups benefitted from the combined treatment, but it was greatest for patients with favorable characteristics, specifically recursive partitioning analysis prognostic classes III and IV. Patients who had complete tumor resection survived longer than those who had partial resection. For both groups, patients survived a median of six months after tumor recurrence.

The researchers hypothesized that tumor cells that do not express MGMT are probably more susceptible to chemotherapy with alkylating drugs.

Related Reading

Drug boost plus radiotherapy promising in glioblastomas, April 13, 2009

Stereotactic radiosurgery can extend survival in small recurrent glioblastomas, June 20, 2008

Glioblastoma survival rate quadrupled with temozolomide plus radiation, November 1, 2007

Temozolomide plus radiotherapy ups survival in glioblastoma multiforme, June 8, 2004

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