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Vaccine 100 Percent Successful in Stopping Cervical
Cancer
Most cervical cancers found in baby boomers and
senior citizens
Oct. 7, 2005 Gardasil, an investigational vaccine
from Merck & Co., Inc., prevented 100 percent of high-grade cervical
pre-cancers and non-invasive cervical cancers associated with human
papillomavirus (HPV) types 16 and 18 in a new phase III study, according
to a report presented today. The American Cancer Society estimates that
in 2005, about 10,370 cases of invasive cervical cancer will be
diagnosed in the United States. More than 20 percent of these cases will
be women over 65 and almost half will be ages 35 to 55.
Many older women, says the society, do not realize
that the risk of developing cervical cancer is still present as they
age. It is important for older women to continue having regular Pap
tests at least until age 70, and possibly longer. (See information for
older women below this story.)
About 3,710 women will die from cervical cancer in
the United States during 2005. Cervical cancer was once one of the most
common causes of cancer death for American women. Between 1955 and 1992,
the number of cervical cancer deaths in the United States dropped by
74%. The main reason for this change is the increased use of the Pap
test. The 5-year relative survival rate for invasive cervical cancer
that is caught at its earliest stage is nearly 100%.
Now, with the possibility of a vaccine that is 100
percent successful against the most dangerous viruses that cause the
cancer, the medical profession seems to have this deadly cancer in the
sights for extinction.
The Merck analysis compared Gardasil (quadrivalent
human papillomavirus types 6, 11, 16, 18, recombinant vaccine) to
placebo in women who were not infected with HPV 16 and 18 at enrollment
and who remained free of infection through the completion of the
vaccination regimen. Women were followed for an average of two years
after enrollment.
Today, these data will be presented for the first
time at the Infectious Diseases Society of America (IDSA) annual
meeting.
This trial is part of the ongoing phase III program
for Gardasil, which involves over 25,000 people in 33 countries
worldwide. Merck remains on track to submit a Biologics License
Application for Gardasil to the Food and Drug Administration in the
fourth quarter of 2005.
More than 12,000 women from 13 countries
participated in this trial. This phase III study, titled FUTURE II, is a
prospective, randomized, double-blind, placebo-controlled study with two
vaccination groups.
Women aged 16 to 26 years were randomized to
receive a three-dose regimen of either Gardasil or placebo at Day 1,
Month 2, and Month 6. A total of 12,167 women were enrolled from 90
study centers in Brazil, Colombia, Denmark, Finland, Iceland, Mexico,
Norway, Peru, Poland, Singapore, Sweden, the United Kingdom and the
United States (including Puerto Rico) and were equally allocated between
the two groups. A group of 6,082 females received Gardasil and another
group of 6,075 received placebo.
FUTURE II evaluated the incidence of HPV
16/18-related cervical pre-cancers known as CIN (cervical
intraepithelial neoplasia) 2/3 and non-invasive cancers. CIN 2 is a
moderate-grade lesion of the cervix. CIN 3 represents both high-grade
lesions and CIS (carcinoma in situ), the immediate pre-cursor to
invasive squamous cell cervical cancer. AIS (adenocarcinoma in situ) is
the early development of adenocarcinoma (or glandular cancer) of the
cervix. CIN 3 and AIS are defined as Stage 0 cancer according to the
International Federation of Gynecology and Obstetrics (FIGO)
classification.
The primary analysis of this trial evaluated the
incidence of CIN 2/3 and AIS in women who received three doses of
Gardasil, had no major protocol violations and remained free of HPV 16
and/or HPV 18 infection through month 7; this analysis started 30 days
after completion of the vaccination regimen, and followed women for an
average of 17 months after completion of the regimen.
In this group, Gardasil prevented 100 percent of
cases of high-grade pre-cancer and non-invasive cancer (CIN 2/3 or AIS)
associated with HPV types 16 and 18 (p < 0.001); no cases of CIN 2/3 or
AIS were observed in the vaccine group (n=5,301) compared to 21 cases in
the placebo group (n= 5,258).
"These are the first pivotal data to show that
vaccination with Gardasil reduced HPV 16 and18-related cervical
pre-cancer and non-invasive cervical cancer," said Laura Koutsky, Ph.D.,
principal investigator, HPV research group, University of Washington,
Seattle.
A secondary analysis, also being presented,
evaluated the incidence of CIN 2/3 and AIS in a broader group of women.
This analysis started 30 days after administration
of the first dose of Gardasil or placebo, and included all of the women
in the primary analysis group, as well as women who may have become
infected with HPV 16 or HPV 18 during the vaccination period and women
who may have violated the protocol in significant ways (for example, by
missing certain protocol visits).
On average, these women were followed for
approximately two years. In this group, Gardasil reduced the risk of
developing high-grade pre-cancer and non-invasive cancer (CIN 2/CIN 3,
or AIS) associated with HPV types 16 and 18 by 97 percent (n= 5,736);
one case was observed in the vaccine group compared to 36 in the placebo
group (n= 5,766).
There were no discontinuations due to serious
vaccine-related adverse events. Adverse events were higher among those
who received Gardasil compared with placebo recipients. The most common
vaccine-related adverse event reported was local discomfort at the
injection site.
"Merck has been committed to vaccine research and
development for over a century," said Peter S. Kim, Ph.D., president,
Merck Research Laboratories. "We have hope that Gardasil will continue
the great Merck tradition of developing medicines and vaccines that make
a real difference in people's lives."
Gardasil was designed to target HPV types 16 and
18, which account for 70 percent of cervical cancers, and HPV types 6
and 11, which account for 90 percent of cases of genital warts. These
four types also cause benign cervical changes that result in "abnormal"
Pap tests.
Gardasil is one of three late-stage vaccines in
development at Merck. In April, Merck submitted Biologics License
Applications to the FDA for ROTATEQ, a vaccine for rotavirus
gastroenteritis, and ZOSTAVAX, a vaccine for shingles.
Approximately 20 million American men and women are
infected with HPV - HPV has been identified as the cause of cervical
cancer, pre-cancers, benign cervical lesions and genital warts.
Cervical cancer, one of the leading cancers among
women, results in approximately 290,000 deaths worldwide each year.
It is estimated that approximately 20 million men
and women in the United States are infected with HPV. In most people,
HPV goes away on its own. In some, however, certain high-risk or
oncogenic types of HPV can lead to cervical cancer. The virus is also
associated with abnormal Pap tests and genital warts. Each year, about
one million women in the United States are told they have "an abnormal
Pap" - which may trigger additional testing, anxiety, and in some cases
fears of cancer.
In 1995, Merck entered into a license agreement and
collaboration with CSL Limited relating to technology used in Gardasil.
Gardasil is also the subject of other third-party licensing agreements.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company
dedicated to putting patients first. Established in 1891, Merck
discovers, develops, manufactures and markets vaccines and medicines in
more than 20 therapeutic categories. The company devotes extensive
efforts to increase access to medicines through far-reaching programs
that not only donate Merck medicines but help deliver them to the people
who need them. Merck also publishes unbiased health information as a
not-for-profit service. For more information, visit
www.merck.com.
Information on Cervical Cancer for Older Women
by National Cancer Institute
If it has been a number of years since your last
Pap test, or if you have never had a Pap test at all, this information
can help put you more at ease during your appointment with your doctor
or clinician.
-
What is a Pap test?
A Pap test finds problems that can be treated before they turn into
cervical cancer. A Pap test also can find cancer early. If cervical
cancer is found early, it's easier to cure.
-
Could I have cervical cancer and
not know it?
YES--often cervical cancer does not cause pain or other symptoms.
-
If I've gone through menopause, do
I still need a Pap test?
Most women still need to get Pap tests. This decision depends on
your age and past Pap test results. Talk with your doctor about what
is right for you.
- If
I've had a hysterectomy, do I still need a Pap test?
After a hysterectomy, you still need to get Pap tests if:
· You
had a partial hysterectomy (an operation that removed the uterus but not
the cervix)
· You
had a total hysterectomy (an operation that removed the uterus and the
cervix) to treat cervical cancer or a condition that might lead to
cancer
You may not
need to get Pap tests if you have had a total hysterectomy for other
reasons (e.g., fibroids). Talk with your doctor about what is right for
you.
-
If I'm not sexually active now do I
still need a Pap test?
Women who are not currently sexually active may still need a Pap
test. Almost all cervical cancer is caused by a sexually transmitted
virus called the (HPV) Human Papillomavirus that can live in the
body for many years.
-
How often should I get a Pap test?
You should have a Pap test at least once every 3 years. If you are
age 65 or older, talk with your doctor about whether you still need
to get Pap tests. You and your doctor can decide what testing
schedule is right for you based on your past Pap test results.
- Where
do I get a Pap test?
· Doctor's
office
· Medical
clinic
· Local
health department
-
How is a Pap test done?
For a Pap test, you lie on an exam table. A nurse or doctor will use
a plastic or metal instrument called a speculum to look inside your
vagina. He or she then uses a small, soft brush to take a few cells
from your cervix (opening to the uterus). This test takes only a few
seconds. A lab will check these cells for cancer or other problems.
- A Pap
test is important to me because it can:
· Find
abnormal cervical cell changes before they have a chance to become
cancerous.
· Tell
if you have cervical cancer earlywhile it's still easier to cure.
Does Medicare help pay for
Pap tests?
Medicare helps pay for a screening Pap test every two years.
Medicare may pay more often if medically necessary. For Medicare
payment information, visit
www.medicare.gov, or call
1-800-MEDICARE (1-800-633-4227). TTY users call 1-877-486-2048.
Call your doctor or local medical clinic
TODAY for a Pap test
appointment.
Pap tests
can save your life!
For more information on the Pap test, visit the
National Cancer Institute's Web site at
www.cancer.gov or call the
NCI's Cancer Information Service:
· 1-800-4-CANCER
(1-800-422-6237)
· TTY
1-800-332-8615
For Medicare Information, visit the Web site at
www.medicare.gov or call
1-800-MEDICARE (1-800-633-4227). TTY users call 1-877-486-2048.
American Cancer Society on Cervical Cancer click here
National Cancer Institute on Cervical Cancer click here
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