LOS ANGELES--In the first positive randomized US trial of hyperthermia
in cancer, glioblastoma multiforme (GBM) patients who received
hyperthermia in addition to bra-chytherapy survived significantly
longer than those who did not get the heat treatment, Penny K.
Sneed, MD, said at the American Society for Therapeutic Radiology
and Oncology (ASTRO) meeting.
The patients who received hyper-thermia for 30 minutes before
and after a brachytherapy boost survived a median of 85 weeks
vs 76 weeks for those getting brachytherapy alone. When analyzed
by intent to treat, the survival difference remained significant
(80 weeks for hyper-thermia vs 76 weeks for controls).
The probability of 2-year survival was 31% for heat-treated patients
vs 14% for the control group.
The phase II/III study from the Departments of Radiation Oncology
and Neurological Surgery at the University of California, San
Francisco, involved 112 adult patients who were eligible for brachytherapy
after surgery and conventional radiotherapy; eligible patients
had a unifocal, circumscribed, supratentorial glioblastoma of
5 cm or less in diameter.
Three-three patients were not randomized, primarily due to tumor
progression during conventional radiotherapy, leaving 40 patients
randomized to hyperther-mia and 39 to the control group. "For
a variety of reasons, not all of the randomized patients proceeded
with treatment as per the protocol," Dr. Sneed said.
In the end, 33 of the no-heat patients had brachytherapy implants,
as did 36 of the heat-treated patients; thus, the results were
analyzed both by intention to treat and according to those who
actually received brachytherapy. Furthermore, four patients in
the hyperthermia arm did not receive heat treatments but were
analyzed on the heat arm.
The median freedom from progression was 33 weeks for the brachytherapy
patients in the no-heat arm versus 49 weeks for those in the heat
arm, a significant difference. Although there were more toxicities
on the heat arm, most of these were mild neurologic toxicities
that were fully reversible, or partial seizures, she said.