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NEW YORK SEP 04, 2007 (Reuters Health) - Boron neutron capture therapy (BNCT) is safe and effective in the treatment of inoperable, locally recurrent, and previously irradiated head and neck carcinomas, according to results of a prospective, phase I/II study conducted in Finland.

"Head and neck carcinomas that recur locally after conventional irradiation pose a difficult therapeutic problem," Dr. Heikki Joensuu of Helsinki University Central Hospital and colleagues write in their paper, published in the August issue of the International Journal of Radiation Oncology, Biology and Physics.

The researchers examined the safety and efficacy of BNCT. The treatment comprises IV administration of a nonradioactive boron carrier, such as boronophenylalanine-fructose (BPA-F, 400 mg/kg), which accumulates in cancer tissue. Afterwards, but on the same day, irradiation with neutron beams is directed at the tumor site, causing the release of high-energy particles within the tumor tissue. As a result, a large dose of radiation is directed at the tumor tissue, sparing adjacent normal tissues.

Dr. Joensuu and colleagues included 12 patients with inoperable, locally recurred head and neck cancer in the open-label study. Each patient was scheduled to receive two BNCT treatments, administered 3 to 5 weeks apart.

The patients were followed-up at 4-week to 12-week intervals after BNCT.

Of the 12 patients, 10 received BNCT twice and two were treated once. Ten patients (83%) responded to BNCT. Of these, seven (58%) achieved a complete response and three (25%) achieved a partial response. Two patients (17%) had stabilized disease for 5.5 and 7.6 months. Four of the seven complete responses were ongoing at the time of analysis, with a median duration of 14.0 months. The partial responders had a median duration of 6.8 months.

Disappearance or substantial relief of tumor pain after BNCT was observed in six patients (50%). Four patients (33%) had marked relief of dysphagia, and four patients had less trismus after treatment.

"The median time to disease progression was 9.8 months, and the median overall survival time 13.5 months," Dr. Joensuu and colleagues report. "Five (41%) patients are alive 12.8 to 19.2 months after treatment initiation, and four of these patients are alive without disease recurrence."

Radiation mucositis, fatigue, and oral or neck pain were the most common severe acute adverse effects. Two patients experienced late severe adverse effects. One patient had Grade 3 xerostomia and one had Grade 3 dysphagia.

SOURCE: Int J Radiation Oncology Biol Phys 2007.