CLINICAL NEWS
LBA-5
Azacitidine Combination
Regimens Fail to Improve
Overall Response Rate in
Higher-Risk MDS
The addition of lenalidomide or vorinostat to azacitidine did not improve
overall response rates in patients with
chronic myelomonocytic leukemia
or higher-risk myelodysplastic syndromes, according to an analysis of 276
patients in the phase 2 North American Intergroup (SWOG S1117) study.
Overall response rates were similar
across all treatment arms: 36 percent
in the monotherapy arm, 37 percent
for azacitidine + lenalidomide (p=1.0
vs. monotherapy), and 22 percent for
azacitidine + vorinostat (p=.07 vs.
monotherapy). However, when patients
remained on treatment for six months
or longer, there was a trend toward
greater relapse-free survival in the
combination arms – raising questions
about whether patients in these arms
are remaining on treatment long enough
to benefit from the additional therapy.
More patients in the combination arms
discontinued treatment due to toxicities,
side effects, or complications, and had
non-protocol defined dose reductions,
though, Mikkael Sekeres, MD, MS, first
author, noted during his presentation of
the data. “We have to wonder if combination regimens in MDS are too toxic,
and if we need to manage toxicities better,” Dr. Sekeres said.
LBA-6
Mixed Picture for Vosaroxin in
Improving Overall Survival in
Difficult-to-Treat AML
A combination of cytabarine and vosaroxin failed to improve survival for patients with relapsed or refractory acute
myeloid leukemia (AML) – a setting in
which viable treatment options are sorely lacking. In the phase 3 randomized
VALOR trial, 711 adult AML patients
with relapsed or refractory disease were
randomized to receive cytarabine with
either vosaroxin or placebo. Overall
survival was similar in patients receiving the vosaroxin/cytabarine combination arm compared to those receiving
cytarabine/placebo (7.5 months vs. 6.1
months with placebo; p=0.06). This was
despite patients receiving vosaroxin being more likely to achieve complete response (30.1% vs. 16.3% with placebo).
Survival was marginally improved in
patients receiving vosaroxin when those
undergoing bone marrow transplantation were censored from analyses (6.7
vs. 5.3 months, p=0.02). “The benefit
was particularly visible in older patients,
who experienced manageable added
toxicity,” said lead study author Farhad
Ravandi, MD. ●
ASHClinicalNews.org
Rising Cost of Cancer Drugs:
Is There an End in Sight?
In 2013, U.S. health-care spending continued its relentless climb, reaching $2.9 trillion, far outspending any other
developed nation.1 About $271.1 billion of that – or almost
one out of every 10 dollars spent on healthcare – was spent on
prescription drugs.
A recent example of the skyrocketing prices of treating
hematologic malignancies: In 2012, three new drugs were approved by the FDA to treat chronic myeloid leukemia (CML),
each with an annual price tag of more than $100,000.2
Special Symposium on Quality panelists
At the 2014 ASH Annual Meeting, experts tackled the rising
cost of cancer drugs and their associated “financial toxicity”
in the Special Symposium on Quality with a passionate, and often heated, discussion. As the cost of health care is a
difficult subject that requires the attention of the entire medical community, a diverse panel was invited to discuss these
challenges.
Reducing Burden Without Compromising Outcomes
The rising cost of cancer drugs is a relatively new phenomenon, Hagop Kantarjian, MD, of MD Anderson
Cancer Center, asserted in his presentation – and one that
poses direct harm to patients.
“My first awareness of the high cost of cancer drugs was in
2012, and this was 30 years into my career,” he said. Spending
on cancer drugs can lead to personal bankruptcy, emotional
distress and, potentially, lack of compliance. “I believe that as
physicians, we have to protect our patients at the individual
and society level,” Dr. Kantarjian said. “When drugs are not
affordable, then they are harming the patient.”
So, who are the high prices helping? According to Dr. Kantarjian, big pharma is benefitting from unsustainable pricing,
and many of the justifications for the rising costs of cancer
drugs are unfounded. “You have heard that it costs $1 billion
to develop a drug for the market - I think that statement is a
myth propagated by the pharmaceutical companies,” he said.
Price shouldn’t stifle innovation, he said, “when 85 percent
of basic research is funded by taxpayers and 20 percent of
earned revenue goes to advertisements.”
There are a number of solutions to the problem, Dr.
Kantarjian explained, including establishing mechanisms
for ensuring fair prices, allowing Medicare to negotiate
drug prices, and eliminating the practice of “pay for delay” (in which pharmaceutical companies pay to prevent
generic competitors from becoming available).
A Natural Market Response?
Playing devil’s advocate, Alex W. Bastian, MBA, of GfK
Market Access (a health-care consulting firm), argued that
current drug prices actually do reflect value and are the result of practical market forces. He also maintained that the
cost for cancer care has remain