Vaccine Shows Promise in Treating Cancer that Likes
Attacking Senior Citizens: Melanoma
Currently, the vaccine only can be given to half of
those with melanoma because it has to match a patient's tissue type
June
1, 2009 - A vaccine for one of the most lethal cancers, advanced
melanoma, which is primarily found on senior citizens, has shown
improved response rates and progression-free survival for patients when
combined with the immunotherapy drug, Interleukin-2, according to
researchers from The University of Texas M. D. Anderson Cancer Center.
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The findings, presented at the American Society of
Clinical Oncology (ASCO), mark the first vaccine study in the disease -
and one of the first in cancer overall - to show clinical benefit in a
randomized Phase III clinical trial. Patrick Hwu, M.D., professor and
chair of M. D. Anderson's Department of Melanoma Medical Oncology,
presented the findings on ASCO's press program.
According to the American Cancer Society, melanoma
has one of the fastest growing incidence rates of all cancers. In 2009,
more than 68,720 people in the U.S. are projected to be diagnosed with
melanoma and 8,650 will likely die from the disease. The five-year
survival rates for those with regional and metastatic disease are 65
percent and 16 percent, respectively.
More than half of the deaths from melanoma occur in
men 40 years old or older.
"Obviously, this is a disease, in its advanced
setting, in need of better therapies for our patients," said Hwu, a
co-investigator on the study.
"While more follow up is needed, this study serves
as a proof-of-principle for vaccines' role in melanoma and in cancer
therapy overall. If we can use the body's own defense system to attack
tumor cells, we provide a mechanism for ridding the body of cancer
without destroying healthy tissue."
During their tenure at the National Cancer
Institute (NCI), Hwu and Douglas Schwartzentruber, M.D., who is
currently medical director of the Goshen Center for Cancer Care, were
involved in the vaccine's development and early basic and clinical
studies. The peptide vaccine, known as gp100:209-217 (200M), works by
stimulating patients' T cells, known for controlling immune responses.
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About Melanoma
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Melanoma is the most
serious type of
skin cancer. Often the first sign of melanoma is a change in the
size, shape, color or feel of a mole. Most melanomas have a black or
black-blue area. Melanoma may also appear as a new mole. It may be
black, abnormal or "ugly looking."
Melanoma can be cured if
it is diagnosed and treated early. If melanoma is not removed in its
early stages, cancer cells may grow downward from the skin surface and
invade healthy tissue. If it spreads to other parts of the body it can
be difficult to control.
Melanoma
is one of the rarer types of skin cancer but causes the majority
of skin cancer related deaths.
>>
More information at MedlinePlus
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"This vaccine activates the body's cytotoxic T
cells to recognize antigens on the surface of the tumor. The T cells
then secrete enzymes that poke holes in the tumor cell's membrane,
causing it to disintegrate," explained Hwu.
After an NCI-led Phase II study combining the
vaccine with Interleukin-2 (IL-2) showed response rates of 42 percent in
metastatic melanoma patients, a Phase III randomized trial with the two
agents opened more than a decade ago.
Conducting a large, multi-institutional trial with
IL-2, however, had its own set of unique challenges, explained Hwu, as
not all cancer centers and community hospitals are capable of
administering the immunotherapy.
A highly specialized therapy associated with such
significant side effects as low blood pressure and capillary leak
syndrome, which poses risks to the heart and lung, IL-2 is often
delivered in intensive care units. Just last month, M. D. Anderson
opened a special in-patient unit exclusively designed for the drug's
delivery; before, the institution was offering the therapy in its ICU.
In the Phase III trial, 185 patients at 21 centers
across the country were enrolled in the study. All had advanced
metastatic melanoma and were stratified for cutaneous metastasis, a
known indicator of response to IL-2. Patients were randomized to receive
either high dose IL-2, or IL-2 and vaccine. In the IL-2 arm, 94 patients
were enrolled and 93 were treated and evaluated for response; 91 were
enrolled and 86 treated and evaluated in the IL-2 and vaccine arm.
The study found that those who received the vaccine
had a significant response rate, 22.1 percent, and progression-free
survival, 2.9 months, compared to 9.7 percent and 1.6 months
respectively in those that did not. While not statistically significant,
the median overall survival for those receiving vaccine trended
positive, 17.6 months vs. 12.8 months.
"This is one of the first positive, randomized
vaccine trials in cancer and the findings represent a significant step
forward for treatment of advanced melanoma," said Schwartzentruber, the
study's lead author. "However, we've learned a lot over the last decade,
and we need to incorporate these new discoveries as we proceed with our
validation of this vaccine."
Schwartzentruber, who with Hwu was involved in the
earlier trials and the vaccine's development, will present the findings
on ASCO's plenary session on May 30.
Hwu agreed that more research with the vaccine is
needed, including long-term follow up of the Phase III patients, as well
as researching ways to make the study inclusive of more metastatic
melanoma patients.
"Right now, the vaccine only can be given to half
of those with melanoma because it has to match a patient's tissue type,
or HLA. A major priority for us is to figure out ways to broaden our
approach and use mixtures of peptides so that more patients are
eligible," Hwu said. "We also would like to improve upon it by including
other immune-stimulatory agents, such as anti-CTLA4, an antibody that
can take the breaks off the immune cells."
Background Information
The study was funded, in part, by the National
Cancer Institute and Novartis, the makers of IL-2.
In addition to Hwu and Schwartzentruber, other
collaborators on the study include: David Lawson, M.D., Winship Cancer
Institute; Jon Richards, M.D., Ph. D., Lutheran General Hospital Cancer
Care Center; and Robert M. Conry, M.D., UAHSF Comprehensive Cancer
Center.
About M. D. Anderson
The University of Texas M. D. Anderson Cancer
Center in Houston ranks as one of the world's most respected centers
focused on cancer patient care, research, education and prevention. M.
D. Anderson is one of only 40 comprehensive cancer centers designated by
the National Cancer Institute. For four of the past six years, including
2008, M. D. Anderson has ranked No. 1 in cancer care in "America's Best
Hospitals," a survey published annually in U.S. News & World Report.
