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1)
The Times They Are a Changin'
2) 10
Differences Between Men and Women
that Make a Difference in Women's Health
3) What are the known
risk factors for breast cancer?
4) Mifepristone: The
New Face of Abortion
5) Ovarian Cancer
|
The Times They Are a
Changin'
|
For many women of the baby boomer generation
(people born from 1946-1964) "the change" is happening—menopause.
Menopause is one of the major transitions
in a woman's life, as was menstruation, a first
sexual
experience, and the birth of a child. While often experienced as a
time of renewed freedom and a completely natural life cycle stage,
the transition to menopause does not usually pass unnoticed. The
changes that happen during perimenopause (the period of transition
leading to menopause) can be quite dramatic for many women.
Perimenopause, the gradual period leading up to menopause, produces
a change in a woman's hormone levels, that affect her physically,
mentally, and emotionally. The typical symptoms of
menopause
are:
achy
joints
- difficulty concentrating
- headaches
- hot flashes
- insomnia
- mood changes
- night sweats
- changes in sexual desire
- frequent urination
- vaginal dryness
These symptoms often
occur at the time in a woman's life when other major life changes
are happening: children leaving home, divorce or widowhood,
retirement, responsibility for aging parents, loss of parents, and
loneliness. These major life transitions usually exacerbate the
already existing symptoms and make them even more difficult.
However, there are ways to relieve perimenopausal symptoms, and
make the transition through menopause more comfortable. Hormone
Replacement Therapy (HRT) is a pharmaceutical approach used by many
perimenopausal and menopausal women. HRT, by patch, pill or cream,
restores estrogen and other hormones lowered during this transition.
However, HRT poses both benefits and risks. The benefits include
reducing or eliminating the symptoms associated with menopause,
helping prevent osteoporosis, and probably reducing the risk of
heart disease. The risks, while infrequent, may include increasing
one's risk for breast cancer, endometrial cancer, blood clots and
gall bladder problems. Other considerations include possible side
effects, such as vaginal bleeding, fluid retention, nausea, and
headaches.
Alternative ways of dealing with the symptoms of menopause are
becoming ever more popular, and more widely accepted by the medical
community. Increasingly, research is showing that "natural
therapies" have real benefits.
An effective natural product that may ease the transition
through perimenopause is soy. Soy, which contains isoflavones, is
considered an "estrogen lite" for menopausal women. It comes in
ready-to-drink milk, powdered forms, beans, and tofu (soybean curd).
Experts agree that drinking a powdered concoction containing 40
grams of soy each day can reduce the most common symptoms of
perimenopause; one study found that women who incorporated soy into
their diets experienced a 40 percent reduction of hot flashes.
Soy can also help women maintain and strengthen their bones; in
a six-month study of postmenopausal women who were not on HRT, the
group that received soy saw their spinal bone density increase by
nearly 2 percent. While this may seem like a thin margin, it
indicates that there was an improvement that could increase over
time.
The best way to supplement one's diet with soy is through
foods, such as roasted soynuts, tofu, soy burgers, tempeh, miso,
textured vegetable protein (TVP), and soymilk. If you think making
recipes with soy products are difficult, just check your local
bookstore, as there is a whole host of cookbooks dedicated to
cooking with soy products. A few exceptionally rated books are The
Whole Soy Cookbook, 175 delicious, nutritious, easy-to-prepare
recipes featuring tofu, tempeh, and various forms of nature's
healthiest bean (Patricia Greenberg, Helen Hewton Hartung, February
1998), Tofu Cookery (Louis Hagler, March 1991), and The Art of Tofu
(Akasha Richmond, September 1997).
Other things you can do to help alleviate the symptoms of menopause
are:
- exercise regularly to relieve
hot flashes and night sweats;
- take calcium supplements to
reduce the loss of bone mass and help prevent osteoporosis;
- reduce your intake of tea,
alcohol, coffee, and spicy foods to relieve hot flashes;
- use stress reduction
techniques (meditation, yoga, breathing exercises) as tension may
trigger hot flashes;
- drink eight glasses of water
daily;
- try over-the-counter vaginal
lubricants to relieve vaginal dryness with intercourse (such as
Astroglide®, Slippery Stuff®, or KY Jelly®,
which are all condom compatible); try Replens® for relief
of day-to-day dryness;
- ask a practitioner about
using herbal extracts, capsules and infusions, especially those rich
in phytosterols—plant estrogens and progesterones (such as flax seed
oil, black cohosh, and Dong Quai); and
try
acupuncture treatments to manage stress.
Not all of
these supplements, products, and helpful hints will alleviate every
woman's perimenopausal symptoms. Some will, and so each woman must
examine her options and choose the methods that work best for her
lifestyle. Most importantly, see your doctor to determine what
methods for easing perimenopauseal symptoms (including the natural
alternatives described above) are best for you. As well, your doctor
may recommend HRT even if you don't have symptoms. HRT is used as
prevention for health risks such as low bone density, heart disease
risk and others.
Many women forget that they can still get pregnant late in
life. While it is uncommon, women should check with their doctors
about their pregnancy risk and use contraception if needed.
By Jason Osher
PPFA
Web Site © 1999, Planned Parenthood® Federation of America,
Inc.
10
Differences Between Men and Women
that Make a Difference in Women's Health
After
consuming the same amount of alcohol, women have a higher blood
alcohol content than men, even when you allow for size
differences.
- Women who smoke
are 20 to 70 percent more likely to develop lung cancer than men
who smoke the same amount of cigarettes.
- Women tend to wake
up from anesthesia more quickly than men—an average of 7 minutes
for women and 11 minutes for men.
- Some pain
medications, known as kappa-opiates, are far more effective in
relieving pain in women than in men.
- Women are more
likely than men to suffer a second heart attack within one year of
their first heart attack.
- The same drug can
cause different reactions and different side effects in women and
men—even common drugs like antihistamines and antibiotics.
- Just as women have
stronger immune systems to protect them from disease, women are
more likely to get autoimmune diseases (diseases where the body
attacks its own tissues) such as rheumatoid arthritis, lupus,
scleroderma and multiple sclerosis.
- During unprotected
intercourse with an infected partner, women are 2 times more
likely than men to contract a sexually transmitted disease and 10
times more likely to contract HIV.
- Depression is 2-3
times more common in women than in men, in part because women's
brains make less of the hormone serotonin.
- After menopause women
lose more bone than men, which is why 80 percent of people with
osteoporosis are women.
www.womens-health.org
What are the known risk
factors for breast cancer?
Age
- The risk of breast cancer
increases as a woman gets older. About 85 percent of breast cancers
occur in women aged 50 and older.
The risk is especially
high for women older than age 60. Breast cancer is uncommon in women
younger than 35.
Family
History -
The risk of getting breast cancer increases
for a woman whose mother, sister, daughter, or two or more close
relatives, such as cousins, have had the disease.
Personal
History -
Women who have had breast cancer may develop
it again. Women with a history of breast disease (not cancer but a
condition that may predispose them to cancer) and women having so
much dense breast tissue on a previous mammogram that a clear
reading is difficult are also at increased risk.
Laboratory evidence
that a woman is carrying a specific genetic mutation or change will
also increase her susceptibility to breast cancer.
Other Risk
Factors -
Other risk factors include having a
first child after age 30, or never having children. Current research
is investigating the roles of obesity, hormone replacement therapy,
diet, and alcohol use.
NBCAM
Mifepristone: The New Face of Abortion
For a decade around
the world, several million women have used a pill to end pregnancy in
its earliest weeks. Now mifepristone has crossed US borders. Also
known as RU-486 or the "French abortion pill," the drug should be
ready for widespread use in the US by 2000. Like all abortion methods,
mifepristone has been the subject of controversy, in part because it
promises to make abortion even safer, more effective and more
accessible.
How does it work?
Mifepristone blocks the effects of progesterone,
causing the uterus to shed its lining. This dislodges the fertilized
egg or embryo. A second drug, misoprostol, is given two days after
mifepristone. Misoprostol has the same effect as a specific
prostaglandin produced in the body. The drug combination of
mifepristone and misoprostol is more than 95% effective in terminating
a pregnancy within the first 7 weeks.
Use in other countries
Mifepristone became available for medical
abortion in France during the 1980s. In 1988 Roussel-Uclaf, the
pharmaceutical company that developed the drug and named it RU-486,
reacted to the protests of abortion opponents and removed the drug
from the market. The French government forced Roussel to return the
drug to the market, deeming it the "moral property of women." Since
then, roughly 300,000 women in Europe, and possibly more than 3
million in China have used it.
Implications for abortion in the US
Since it can terminate pregnancy so early — even
before a woman misses her period — medical abortion is more
politically acceptable in the United States. A 1998 New York Times/CBS
poll showed that almost two thirds of American adults believe women
should have the legal right to have abortions performed during the
first three months of pregnancy. 1
Medical abortion also offers women more privacy, away from
anti-choice violence. Mifepristone can be dispensed in the anonymity
of a doctor's office, clinic, or hospital, away from the jibes of
right-to-life picketers.
The drug also promises to make abortion more accessible. In 1996,
86% of all U.S. counties lacked an abortion provider. A 1998 Kaiser
Family Foundation poll, however, showed that 45% of family
practitioners were "very" or "somewhat" willing to prescribe
mifepristone. Fifty-four percent of nurse practitioners and
physician's assistants were also "very" or "somewhat" willing to
prescribe it.
Hurdles for U.S. approval
With support from President Bill Clinton,
feminist organizations jumped high hurdles to bring mifepristone to
this country. Within the first year of preliminary approval from the
U.S. Food and Drug Administration, additional setbacks delayed the
drug's market appearance. Remaining threats to mifepristone even after
it is approved by the FDA include: legislative restrictions on who can
provide it, and limiting its use to doctors' offices. (Clinical
evidence shows that the second drug in the regimen, misoprostol, is
effective when women administer it at home and that most women prefer
to use it this way. The preferred scenario is for clinicians to
dispense mifepristone in their offices and for women to take
misoprostol at home two days later.) The possibility also exists that
the FDA will not be able to protect the anonymity of the drug's
distributors and that abortion opponents will focus terrorist attacks
or boycotts against them.
Other Potential Uses
Mifepristone's potential goes beyond early
abortion. It has proven 99% effective as an emergency contraceptive.
It can also be used as a monthly birth control pill, as well as a
treatment for breast and prostate cancer, meningioma, Cushing's
syndrome, and other conditions.
By Susan Motamed
September 1999
PPFA Web Site © 1999, Planned Parenthood® Federation of
America, Inc.
Ovarian Cancer
She crowned herself "the
Queen of Neurosis," but this time, it was not simply an overactive
imagination that made her fear for her health. It was symptoms of the
ovarian cancer that eventually claimed her life.
Gilda Radner, one of
the original Not Ready for Prime Time Players of television's
"Saturday Night Live," claimed in her book " It's Always Something",
that she could get neurotic over any health problem. "I hated to be
sick and I had an imagination that could turn a stomach ache into the
plague."
So, she wrote, when
a complete physical examination in January 1986 failed to explain the
overwhelming fatigue and general malaise she was feeling, she agreed
with the doctor that her symptoms might just be from depression; she
had, after all, been going through a rough period in both her personal
and professional life. It was not until October--10 months and several
symptoms, diagnoses, and failed therapies later--that cancer of the
ovaries was confirmed.
Delay in diagnosing
ovarian cancer is not unusual. Early detection is difficult because
disease confined to the ovary seldom produces symptoms. When symptoms
do surface, they are often vague and easily mistaken for other, often
minor, ailments.
Radner's cancer was
not discovered until it had spread to her bowel and liver. She
suffered from fatigue, low-grade fever, pelvic cramping, abdominal
bloating, gas, and aches and pains in her upper thighs and legs. Loss
of appetite and a feeling of fullness, indigestion, nausea, weight
loss, and, less often, vaginal bleeding and low back pain are other
symptoms.
As the tumor grows,
it may press on the bowel and bladder, causing constipation and
frequent urination. Malignant cells can break away from the tumor and
spread directly to other organs in the abdomen, such as the stomach,
colon and diaphragm (muscle separating the chest cavity from the
abdomen), causing a fluid buildup that results in swelling and
discomfort. The cells can also enter the bloodstream or lymph system
and spread to other parts of the body.
Radner wrote that
her complaints had been variously attributed to Epstein-Barr virus
infection, depression, stress, and anxiety. She had undergone blood
tests, a barium enema, and ultrasound (pelvic sonogram). According to
Radner, the sonogram, done in the summer of 1986, showed "congestion"
and the "ovaries weren't exactly in the place they were supposed to
be, but that wasn't serious." There was no sign of tumor or bowel
obstruction.
Aspirin to
Acupuncture
Attempting to combat
her ills through both mainstream and holistic medicine, Radner tried
remedies that ran the gamut from aspirin, anti-inflammatories and
antidepressants to health foods, vitamins, acupuncture, and colonics
(unconventional type enemas).
"Suddenly, I began
to wonder how to please so many people," she wrote. "Do I take the
magnesium citrate? What about the coffee enema? Do I do both? Do I do
the abdominal massage or the colonic? Do I tell the doctors about each
other?"
Then, late in
October, an abnormal liver function test prompted more exams. A CAT
scan and analysis of fluid from the abdomen confirmed ovarian cancer.
Diagnosed at age 40,
Radner was younger than most women with the disease. The chance of
developing ovarian cancer increases with age; most cases are found in
women who have gone through natural menopause, with the average age at
diagnosis being 61. As was true with Radner, however, women with a
family history of the disease generally are diagnosed at a younger
age.
Each year in the
United States, ovarian cancer is diagnosed in about 26,000 women and
claims more than 14,000 lives. It is most common in women living in
Europe and North America; Asian women have a relatively low incidence.
Although Chinese and Japanese women living in the United States have
higher rates of ovarian cancer than their counterparts in Asia, the
disease is still less common among this group than among the native
white population in the United States. Rates among black women in all
parts of the world are low.
Certain factors are
associated with an increased risk of getting ovarian cancer. Although
the lifetime risk for most women is 1 in 70, it doubles for women who
have never been pregnant. Also at increased risk are women who have
had breast, intestinal, or rectal cancer. Under investigation as
possible risk factors are: high-fat diet, early onset and late
cessation of menstruation, being of Eastern European Jewish descent,
and use of talcum powder in the genital area.
Women with close
relatives who have had ovarian cancer are also at greater risk,
reaching perhaps a 50 percent chance if they have at least two
first-degree relatives (mother, sister or daughter) with the disease.
This compares with a 1.4 percent chance in women without a family
history. Women who have a first-degree relative and one or more
second-degree relatives (aunt, grandmother) who had ovarian cancer
have a somewhat lesser risk than those with two first-degree
relatives, but are still considered to be at high risk. Radner wrote
that her mother had breast cancer and a cousin had both breast and
ovarian cancer. Later, it was learned that other of her relatives had
ovarian cancer as well.
About 5 to 7 percent
of all ovarian cancer is thought to be inherited. In 1994, scientists
identified a gene, which they named BRCA1, that related to the
development of inherited breast cancer. Changes or abnormalities in
this gene are now also considered responsible for about 80 percent of
inherited ovarian cancer. The abnormal gene can be inherited from
either parent.
The Gilda Radner
Familial Ovarian Cancer Registry, established in 1981 at Roswell Park
Cancer Institute in Buffalo, N.Y., and named for Gilda Radner after
her death in 1989, included 2,946 cases of ovarian cancer in 1,346
families as of January 1997.
Reduced Risk
Factors associated
with a reduced risk of ovarian cancer include: giving birth to more
than one child, breast-feeding, tubal ligation (female sterilization),
and use of birth control pills.
Evidence suggests
that hormones may influence development of the disease. The risk of
ovarian cancer is reduced in women who have had multiple pregnancies
and in those who used birth control pills. The Cancer and Steroid
Hormone Study by the national Centers for Disease Control and
Prevention and the National Institute of Child Health and Human
Services found that use of oral contraceptives for even a few months
reduced the risk of ovarian cancer by 40 percent in women 20 to 54
years old.
The study, published
in the March 12, 1987, New England Journal of Medicine, also found
that the longer a woman used birth control pills, the lower her risk
of ovarian cancer, and that the protective effect persisted long after
stopping the pill. Based on these data, since 1989, the labeling for
oral contraceptives has included decreased incidence of ovarian cancer
among the noncontraceptive health benefits of the pill.
On the reverse side
of the coin, in January 1993, FDA requested that drug firms revise
fertility drug labels to include ovarian cancer as a potential adverse
drug reaction. The action was in response to a report in the November
1992 issue of the American Journal of Epidemiology suggesting a
possible relationship between use of fertility-enhancing drugs and
ovarian cancer. The analysis was based on data from 12 studies
comparing women with ovarian cancer to those without the disease. Only
three of the studies, however, contained data on the use of fertility
drugs and risk of ovarian cancer. (A 1987 article in the same journal
reported no association between the drugs and ovarian cancer.)
FDA urged caution in
interpreting the findings of the 1992 report because the analysis only
included small numbers of women and because the article gave no
information about the fertility drugs prescribed, reasons for the
infertility, or tumor size or stage of disease at diagnosis.
Search for a
Screening Test
According to the
registry, if ovarian cancer is diagnosed while still confined to the
ovaries, the chance for cure is 85 to 90 percent. According to the
American Cancer Society, only 23 percent of all cases are diagnosed at
this early stage. Among women whose cancer has spread beyond the ovary
by the time it's diagnosed, only 20 to 25 percent survive five years.
However, unlike cervical or breast cancer (which may be detected early
by a Pap test or mammogram, respectively), ovarian cancer has no
approved screening test, though some are under investigation.
"The traditional
routine pelvic examination is largely ineffective for early
detection," says Julie Beitz, M.D., a medical oncologist in FDA's
division of oncology and pulmonary drug products. "Often you can't
feel a normal-sized ovary. And even if you can, it's hard to tell if
it's enlarged because ovaries vary in size from person to person and
day to day. Ovarian cancers start very small, and by the time they're
large enough to feel, the cancer is most likely already advanced." The
problem with ovarian cancer, she says, is that "you have to detect
very small changes, and these are hard to detect on a pelvic exam
because it's a very indirect examination."
Researchers are
working on developing an accurate test for the BRCA1 gene. The
American Society of Human Genetics has recommended that testing for
BRCA1 be limited to research in which subjects are members of families
at high risk for either ovarian or breast cancer.
Researchers continue
looking for tumor markers--substances that may appear in abnormal
amounts in the blood or urine--that may prove useful in developing a
screening test.
One such marker is
CA 125, a substance in the blood that is elevated in patients with
advanced ovarian tumors. Doctors now measure CA 125 levels in patients
treated for advanced disease to determine if the tumor has shrunk or
if disease has recurred. Its value in monitoring treatment prompted
scientists to study its potential for early detection. Its use for
screening, however, is investigational.
Transvaginal
ultrasound is also being studied as a screening tool. With ultrasound,
high-frequency sound waves are projected into the body, and the echoes
produced are converted by computer into a picture. Unlike abdominal
ultrasound, in which the sound wave-emitting device is placed on the
outside of the belly, transvaginal ultrasound uses a probe placed in
the vagina that can reach within millimeters of the ovaries, producing
more detailed images.
"There is
uncertainty as to the value of these tools as screening tests and
their ultimate impact on mortality," says John Gohagan, Ph.D., chief
of the National Cancer Institute's Early Detection Branch in the
Division of Cancer Prevention and Control. NCI is conducting a
clinical trial including 74,000 women aged 60 to 74 to clarify the
issue. The trial is designed to assess the value of CA 125 and
transvaginal ultrasound for early detection of ovarian cancer and to
measure their impact on mortality.
Women in the trial
are randomly assigned to either a screening group or a control group
of 37,000 women each. The screening group will have periodic pelvic
examinations along with CA 125 and transvaginal ultrasound tests. The
control group will have routine medical care.
Diagnostic
Procedures
If a woman or her
doctor suspects ovarian cancer, diagnosis begins with a medical
history of the patient, review of her symptoms, and complete physical
examination, including a pelvic exam, in which the physician feels the
vagina, ovaries, fallopian tubes, bladder, and rectum to check for any
growths. A Pap test may also be done because, even though it cannot
reliably detect ovarian cancer, it may detect cancer cells that have
migrated to the uterine cervix from the ovaries.
Blood and urine
tests may also be done, as well other procedures, depending on the
woman's symptoms and results of her physical exam. These procedures
include:
-
abdominal or transvaginal ultrasound--helps
distinguish fluid-filled cysts from a solid tumor
- CAT scan--produces
x-ray images of cross-sections of body tissues
- lower GI
series (barium enema)--visualizes
the bowel on x-ray to detect abnormal areas that may be caused by
ovarian cancer
-
intravenous pyelogram (IVP)--produces
x-ray pictures of the kidneys, bladder and ureters (tubes carrying
urine from the kidneys to the bladder). Often, ovarian cysts or
tumors can cause pressure on these organs, which may show up on an
IVP.
The only sure way to
diagnose ovarian cancer, however, is through microscopic examination
by a pathologist of abnormal-looking fluid or tissue. While fluid can
sometimes be obtained by needle aspiration or other techniques, more
commonly a laparatomy or laparoscopy is done. Laparotomy is an
exploratory operation in which the surgeon examines the abdomen
thoroughly and removes fluid or tissue for examination. In laparascopy,
a flexible, lighted tube is passed through a small incision in the
abdomen, allowing the surgeon to examine the area and extract tissue
for a biopsy.
If cancer is
suspected, the surgeon usually removes the entire affected ovary to
avoid cutting through the outer layer, which might cause the tumor to
spread.
The tissue is sent
to the pathologist for immediate evaluation, and if cancer is
confirmed, the surgeon nearly always removes the second ovary, the
uterus, and the fallopian tubes. Samples are taken of nearby lymph
nodes, the diaphragm, the omentum (a fold of membranous lining in the
abdominal cavity), and fluid from the abdomen to see whether the
cancer has spread. If no fluid is found, several "washings" are taken:
A saline solution is put into the abdomen and then removed to be
examined for cancer cells. If there are suspicious lesions, tissue
samples are also taken from the liver, small intestine, and large
intestine.
Early
Treatment Crucial
Trusting her
instincts may have saved Jessica Marsh's life. Due in part to her own
vigilance and persistence, Marsh (not her real name), a secretary in
Rockville, Md., was diagnosed before her cancer had spread beyond the
ovary, affording her a brighter prognosis.
For three months in
the fall of 1985, Marsh, then 36 years old, had noticed pains in her
right side around the time of her menstrual periods. Although the
pains were brief and not severe, she decided to have her doctor check
it out. A week or so before her appointment, however, a very sharp
pain prompted her to call the doctor again. Her gynecologist was out
of town, but the doctor on call had her come in.
"He told me that my
stomach was distended, gave me a pelvic exam, and then congratulated
me, telling me I was three months pregnant," Marsh recalls. "I told
him I wasn't pregnant, that I already had two children and knew what
it was like to be pregnant, and this was not a pregnancy."
At Marsh's
insistence, the physician arranged for her to have a pelvic sonogram
that day at a local hospital.
"I had the sonogram
and the next thing I knew, the doctor who had examined me at the
office came in, repeated the sonogram, and told me there was a mass
and he wanted to do some more tests. The next morning, I had surgery
to remove my ovaries, uterus, and fallopian tubes."
Although Marsh's
experience may not be typical, it illustrates again the difficulty in
correctly diagnosing the disease early. Yet, early detection and
treatment can mean the difference between life and death.
Treatment Options
Ovarian cancer is
always treated surgically, removing as much tumor as is feasible.
Chemotherapy (drug treatment) or radiation therapy, or both, may also
be given, depending on the extent of disease. Ovarian tumors usually
grow outward, with an irregular, cauliflower-like shape. When the
cancer spreads, parts of the tumor break off and attach to nearby
organs. Cells may then spread to lymph nodes and distant organs.
Cancer limited to
the ovaries may be successfully treated with surgery alone, removing
the ovaries, fallopian tubes, omentum (a fold of tissue attached to
organs in the abdominal cavity), and uterus. Some patients may also
receive chemotherapy or radiation therapy to kill any cancer cells
remaining after surgery.
Disease that has
spread beyond the ovaries almost always requires chemotherapy or
radiation therapy in addition to surgery. Radiation therapy may be
given by placing a radioactive solution into the pelvis and abdomen
through a thin tube, coating the organs and total abdominal contents.
Less commonly, external radiation using high-energy x-rays directed to
the pelvis and abdomen may be prescribed.
The type of drugs
used in chemotherapy depends not only on the extent of disease, but
also on the type of cancer. About 85 to 90 percent of ovarian cancers
arise from epithelial cells, which form the outer layer of the ovary.
The rest derive from other cell types that make up the organ.
FDA has approved
several drugs to treat ovarian cancer. Two of the most commonly used
are Platinol (cisplatin) and Taxol (paclitaxel). Taxol was approved in
April 1998 as a first-line treatment for advanced ovarian cancer. It
has been used since December 1992 to treat advanced ovarian cancer
that has not responded to other therapies or has progressed after
treatment and is being evaluated for first-line treatment. National
Cancer Institute and FDA scientists cooperated in studies to evaluate
the safety and effectiveness of Taxol. FDA's research role in drug
development is a fairly new concept, designed to help speed the
approval process for drugs for life-threatening diseases.
"It's a commitment
by the agency to do more than just wait for packages of data to come
in [from the drug's sponsor] and review them for approval," says Jerry
M. Collins, Ph.D., director of the division of clinical pharmacology
research in the Center for Drug Evaluation and Research. "We can't do
this for every new drug in every therapeutic area," he says, "but for
AIDS and cancer, we have done similar research before."
Since Taxol is given
in combination with several other drugs, there was major concern about
the potential for serious drug interaction. However, according to
Collins, this research demonstrated that "paclitaxel actually had a
lower risk of metabolic interactions than most other drugs."
Other
chemotherapeutic agents used to treat ovarian cancer include Cytoxan
and Neosar (cyclophosphamide), Paraplatin and Adriamycin
(doxorubicin), and Hexalen (altretamine). A recent addition is
Hycamtin (topotecon, approved in 1996 to treat ovarian cancer that
recurs after other chemotherapeutic agents have failed. Hycamtin is
the first of a new class of drugs called topoisomerase I inhibitors.
They kill cancer cells by inhibiting an enzyme essential to the
replication of human DNA.
Side Effects
Surgery, the
first-line treatment for ovarian cancer, requires several days'
hospitalization and a recuperative period of from four to six weeks.
Removing the ovaries, which are the main source of the female hormones
estrogen and progesterone, causes immediate menopause, and the
symptomatic hot flashes are more severe than when menopause occurs
more gradually, as it usually does naturally.
Radiation therapy
can cause mild skin reactions, such as redness and drying in treated
areas, urinary discomfort, diarrhea, and vaginal dryness. (Menopause
can also cause vaginal dryness.) A small percent of patients may
develop bowel obstruction, sometimes requiring surgical correction.
Other possible side
effects of radiation therapy, commonly experienced with chemotherapy
as well, include loss of energy and appetite, nausea, and vomiting.
Chemotherapy may
also cause mouth sores, hair loss, and reduced platelet and blood cell
counts that can lead to infections, anemia or bleeding. The drugs used
to treat ovarian cancer may also have neurologic effects, causing
hearing loss, ringing in the ears, nerve damage, and numbness or
tingling in the face, fingers and toes. There may also be kidney
damage.
Most side effects
are temporary, and sometimes dietary changes or medicines can ease the
symptoms. There are several drugs approved for countering nausea and
vomiting often associated with chemotherapy. They include Zofran (ondansetron
hydrochloride), Reglan (metocloparamide), and Marinol (dronabinol).
Transfusions can
correct red blood cell and platelet deficiencies. Hematopoietic growth
factors such as G-CSF, approved in 1991, stimulate production of
infection-fighting white blood cells. GM-CSF, which also received FDA
approval in 1991 to increase white blood cell counts after bone marrow
transplantation, is now being studied for its effectiveness in
stimulating white cells after cancer chemotherapy. Among other drugs
now under study for their ability to increase white cell counts, and
perhaps platelets as well, are stem cell factor and PIXY 321. PIXY 321
is a genetically engineered product consisting of GM-CSF and another
hematopoietic growth factor, interleukin-3.
When therapy is
completed, the woman continues to have regular checkups that include
pelvic examinations and laboratory tests to measure blood levels of
tumor markers such as CA 125. The doctor may recommend a laparotomy or
laparoscopy after completion of chemotherapy to inspect the abdomen
and pelvis and take multiple tissue biopsies. This "second-look
surgery" helps evaluate the effectiveness of chemotherapy and
determine whether treatment should be continued or stopped. Often a
laparotomy or laparoscopy has been done previously to diagnose ovarian
cancer.
Attempts at
Prevention
The Gilda Radner
Familial Ovarian Cancer Registry advises women with two or more first-
or second-degree relatives who have had the disease to have their
ovaries removed via video laparoscopy as a precautionary measure by
age 35, if they have completed their families. The registry also
advises that there is a small increased risk (1.8 percent) of
developing primary papillary cancer of the peritoneum for women who
have had this prophylactic surgery. The registry also recommends that
women with a family history of ovarian cancer receive genetic
counseling, beginning in their early 20s, and have pelvic and
abdominal examination, CA 125 testing, and transvaginal ultrasound
every six months beginning in their early 30s.
Jessica Marsh, seven
years after her diagnosis, is today free of cancer and feeling fine.
"I've become a much more positive person since my cancer," she says.
"Life is too short to worry about little things. If life deals me
lemons, I'll make lemonade."
Marian Segal is a former member of FDA's public affairs
staff.www.fda.gov
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