Bortezomib
alone or in combination with other therapies shows promise in a wide
range of patients with multiple myeloma including those with renal
damage
Bortezomib alone or in combination with other
therapies shows promise in a wide range of patients with multiple
myeloma, including patients with renal damage and patients with
chromosome 13 deletions, according to two presentations at the annual
meeting of the American Society of Hematology.
The first study presented at the meeting
was a multi-center, retrospective review of safety and efficacy
in patients with relapsed multiple myeloma who had renal failure
requiring hemodialysis, an analysis conducted by Asher Alban Chanan-Khan,
MD, of Roswell Park Cancer Institute in Buffalo, New York.
Analysis was based on data for 24 evaluable
patients. The overall response rate of 78 percent included both
single-agent treatment and various bortezomib-based combination
regimens; 33 percent of patients had either a complete or near-complete
response (median, 7.5 cycles). Of the 24 patients, 3 (12.5 percent)
had a complete response and were able to discontinue dialysis.
The safety profile was favorable. With full-dose
therapy, the rate of serious adverse events was low and was not
increased over rates seen in patients with normal renal function.
"Patients with relapsed, refractory
multiple myeloma often present with renal failure which can greatly
impact their ability to tolerate treatment," said Chanan-Khan.
"These results suggest that bortezomib may enable us to overcome
this challenge and offer a much needed treatment option for these
patients."
The second presentation on bortezomib in
51 patients with poor prognosis was a retrospective analysis of
patients with chromosomal abnormalities (primarily chromosome 13
deletions) who were treated at the Medical University of Vienna,
Austria; Johannes Drach, MD, was lead investigator.
Outcomes were response rate, time to treatment
failure, and overall survival. Patients had received a median of
three prior therapies.
Overall response rates, including complete
and near-complete responses, and duration of response were independent
of chromosome 13 status. In patients with the chromosome 13 deletion,
overall response rate was 50 percent, with 23 percent achieving
a complete response and a 10.4-month duration of response. Median
overall survival was 15 months, and it was also independent of chromosome
13 status.
Response rate and overall survival were also independent of other
poor prognostic factors including 14q abnormality and Beta-2 microglobulin
level.
"The important observation is that with
bortezomib treatment, we do not see a difference in response rate
or duration of response for patients with and without a 13q deletion,"
said Drach. "This is different from the experience with chemotherapy
and even transplantation."
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