Laser Interstitial Thermal Therapy Cleared for Use in Brain Tumors
May 15, 2009 — A device that can deliver laser interstitial thermal therapy (LITT) into the brain is being investigated in patients with recurrent or progressive glioblastoma multiforme in clinical trials in 2 centers in the United States.
LITT, also referred to as thermocoagulation, offers a way of destroying tissue with laser heat treatment. It has already been explored for use in the treatment of unresectable liver metastases, as previously reported by Medscape Oncology. The same technique has also been used in an outpatient setting for benign prostatic hypertrophy.
Now the AutoLITT device, developed by Monteris Medical Inc (Kalamazoo, MI), has 501k clearance from the US Food and Drug Administration for use in a neurosurgery application. Initial use will be in patients with inoperable brain tumors, the company said. The laser probe is guided by magnetic resonance imaging, and is passed through a small hole in the skull so that the high-intensity laser energy can be applied directly to brain tumor tissue.
The trials will be carried out at the Cleveland Clinic, under the direction of Gene Barnett, MD, FACS, Director of the Brain Tumor and Neuro-Oncology Center, and at the University Hospitals Case Medical Center in Cleveland, Ohio, under the direction of Andrew Sloan, MD, FACS, Director of the Brain Tumor and Neuro-Oncology Center. Patients being recruited to the trial have recurrent or progressive grade 4 glioblastoma multiforme that is progressing despite treatment with surgery, radiation, and/or chemotherapy.
A trial using the same approach, but with different devices, has already been published in the European Journal of Radiology. The trial involved 16 patients with recurrent glioblastoma multiforme, and the researchers, headed by Hans-Joachim Schwarzmaier, MD, from the University of Düsseldorf Medical School in Krefeld, Germany, reported that they had a "comparatively long survival."
The life expectancy of patients with recurrent glioblastoma multiforme is poor, with a natural history predicting survival of 5 months or less, the researchers stated. Approximately 33% of patients can undergo repeat surgery, which adds another 8 weeks to their life expectancy; standard chemotherapy using temozolomide increases the median survival to 5.4 to 7.1 months, they noted.
In the LITT study, the median overall survival time was 6.9 ± 1.7 months (95% confidence interval [CI], 3.7–10.2 months). However, the researchers pointed out that there was a substantial learning curve. For the 10 patients treated during the first phase (2001–2002), the median survival time after LITT was only 5.2 ± 0.6 months (95% CI, 4.1–6.3 months). But for the 6 patients treated in the second phase (2003–2004), the median survival time after the first LITT increased to 11.2 ± 2 months (95% CI, 7.4–15 months). The distributions of the survival time in the 2 periods were significantly different (P = .0267), the researchers pointed out.
The researchers commented that these survival times are longer than have been reported for combination chemotherapy, but they also emphasized the need for controlled clinical trials.
Source: Medscape Medical News
