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What is Xeloda?
Xeloda is an effective new oral chemotherapy that was introduced
as a new way to target the cancer-killing agent 5-FU (5-fluorouracil)
straight into the cancer. This is a less distressing and less
burdensome way of treating women with breast cancer compared to
chemotherapy - which women receive intravenously (often referred
to as i.v.).
Roche is committed
to women with breast cancer, and believes that Xeloda tablets
will improve the daily lives of women with breast cancer. Women
on Xeloda live longer. Xeloda is among the very few agents that
has demonstrated a survival benefit, and extraordinary tumour
control rates, in women with breast cancer that has spread. This
confirms the effectiveness and power of Xeloda.
How does a woman take
her Xeloda treatment?
Xeloda is taken with water and swallowed. It does not need to
be injected into a woman's body. A woman takes Xeloda twice a
day after food and she is not required to fast. So not only is
Xeloda highly effective, it is also the most convenient form of
chemotherapy for women with breast cancer.
Why was Xeloda developed?
Xeloda was developed to provide women with breast cancer with
an effective but easier and less burdensome way of treating cancer.
It was introduced as a new way to target the cancer-killing agent
5-FU straight into the cancer.
Therefore, the benefits
of Xeloda are:
· Longer life. Women treated with Xeloda live longer. Xeloda
is among the very few agents that has demonstrated a survival
benefit1, and extraordinary tumour control rates2, in women with
breast cancer that has spread;
· It is simple to take, as you take it with water and you
can take it at home - giving you the freedom to carry on with
you life as normal;
· It is also kinder in terms of side effects as it does
not cause side effects commonly associated with i.v. chemotherapy,
such as hair loss;
· It only becomes active when it actually reaches the cancer/tumour
- so it works where it is needed and has less affect the healthy
cells in the body - for example the cells responsible for hair
growth.
How does Xeloda work?
Xeloda has a unique 3-step activation mechanism. Xeloda is inactive
when it is swallowed, and it is absorbed through the stomach into
a woman's bloodstream. The first two steps of the activation process
take place in the liver, where Xeloda begins to be converted into
the cancer-killing agent - 5-FU. The final step of activation
takes place in the cancer cells themselves where Xeloda is finally
converted to 5-FU by an enzyme, found at higher levels in cancer
cells than in healthy cells. This means Xeloda only becomes active
when it reaches the cancer, where it is needed and has less affect
on a woman's healthy cells - for example: cells responsible for
hair growth.
Why is it important
that Xeloda only becomes active when it reaches the cancer, don't
all chemotherapy agents do this?
It is important to note that cancer results when cells in the
body grow out of control, rapidly divide and ultimately spread.
I.v. chemotherapy agents affect all cells that divide rapidly
- including healthy cells. As a result, women on i.v. chemotherapy
are prone to develop infections, bruise easily, have less energy,
experience diarrhoea, nausea, vomiting and develop mouth sores,
as well as the upsetting side effects of hair loss (alopecia).
Importantly, Xeloda
does not cause hair loss and has little effect on blood counts
unlike many other breast cancer treatments, meaning that women
are at less risk for infections. In addition to these facts, Xeloda
is taken with water and swallowed, giving women the freedom to
carry on with their daily lives as normally as possible.
What are the side effects of Xeloda?
As with all chemotherapy, oral and i.v., Xeloda does have side
effects. However, the most dangerous side-effect of i.v. chemotherapy
for breast cancer is the loss of resistance to infection caused
by a fall in the white blood cell counts. Xeloda has little effect
on blood count causing fewer life threatening side effects. Women
treated with Xeloda experience less severe side effects commonly
associated with i.v. chemotherapy such as diarrhoea, fatigue,
nausea and vomiting.
Redness on the palms
of the hands and soles of the feet called "Hand and Foot
Syndrome" is common with Xeloda. However, this is a relatively
minor side effect when properly managed by interrupting treatment
and using soothing creams. Most importantly it is never life threatening.
Xeloda does not cause
hair loss.
What benefits do women
with breast cancer get from Xeloda treatment vs. i.v. chemotherapy?
- Xeloda has a unique
tumour-selective activation which is thought to be responsible
for the enhanced efficacy and improved safety of the treatment.
- Xeloda is taken
with water and swallowed. It does not need to be injected into
a woman's body.
- As Xeloda is a tablet
taken orally, it eliminates the discomfort and burden of i.v.
chemotherapy. Women feel that having chemotherapy administered
via needles and devices under their skin is one of the most
distressing and burdensome aspects of i.v. chemotherapy.
- Xeloda does not
cause the dreaded and upsetting side effect of hair loss and
has little effect on blood counts - unlike many other breast
cancer treatments.
- Xeloda relieves
pain women experience as a result of their breast cancer.
- Women on Xeloda
live longer. Xeloda is among the very few agents that has demonstrated
a survival benefit, and extraordinary tumour control rates,
in women with breast cancer that has spread. This confirms the
effectiveness and power of Xeloda.
- Xeloda can be taken
at home. Women feel taking their medication at home is one of
the main advantages since it provides them with the freedom
to carry on with their daily lives without the disruption of
frequent hospital visits.
- Women can spend
a lot of their time in hospital clinics if they are receiving
i.v. chemotherapy, when they could be spending time at home
with family and friends.
- In addition, nine
out of 10 women prefer oral chemotherapy to i.v. chemotherapy
as they feel it is convenient, avoids problems with i.v. lines
and they can take their treatment at home.
Does Xeloda cure women
with breast cancer?
Breast cancer that has spread to other parts of a woman's body
is generally an incurable disease. Treatment is therefore aimed
at prolonging a woman's life while providing her with the freedom
to carry on with her life as normally and actively as possible.
Women live longer when
treated with Xeloda together with Taxotere® (docetaxel), a
type of i.v. chemotherapy known as a taxane. When Xeloda is added
to Taxotere, it decreases a woman's chance of dying by 23 percent
and on average, women gain three extra months of life. Xeloda
and Taxotere is the first and only combination treatment to improve
a women's chance or survival compared to Taxotere alone. This
confirms the effectiveness and power of Xeloda. The combination
of Xeloda with Taxotere is now the treatment of choice for many
women with breast cancer that has spread.
In women with breast
cancer that has spread to other parts of their body and have no
further treatment, Xeloda treatment by itself showed extraordinary
results in population of women who would have otherwise died,
again confirming the power of Xeloda as an effective oral chemotherapy
agent. As a result, physicians consider Xeloda (by itself ) as
the treatment of choice for these women.
Xeloda has been proven
as an effective and powerful oral chemotherapy treatment in women
with breast cancer that has spread to other parts of their body
. Therefore, in continuing Roche's commitment to women with breast
cancer, Roche has initiated an international trial programme to
investigate the benefits of Xeloda in women with breast cancer
that is confined to the breast (early stage breast cancer). The
aim of these studies is to confirm whether Xeloda treatment by
itself, and in combination with Taxotere, will cure more women
with breast cancer that is confined to breast than are currently
being cured with standard treatment.
Is Xeloda suitable
for me?
Whether Xeloda is suitable for you will depend on what type of
breast cancer you have, at what stage the disease is at, and what
other treatments you have had in the past. You need to discuss
with your doctor whether Xeloda is right for you.
How does Xeloda compare to other treatment options for women with
breast cancer that has spread to other parts of their body?
Women live longer when
treated with Xeloda together with Taxotere, a "taxane".
When Xeloda is added to Taxotere, it decreases a woman's chance
of dying by 23 percent and, on average, women gain three extra
months of life. Xeloda and Taxotere is the first and only combination
treatment to improve a women's chance or survival compared to
Taxotere alone.This confirms the effectiveness and power of Xeloda.
The combination of Xeloda with Taxotere is now the treatment of
choice for many women with breast cancer that has spread.
In women with breast
cancer that has spread to other parts of their body and have no
further treatment, Xeloda treatment by itself showed extraordinary
results in population of women who would have otherwise died,
again confirming the power of Xeloda as an effective oral chemotherapy
agent. As a result, physicians consider Xeloda by itself as the
treatment of choice for these women.
Xeloda For The Treatment
Of Women With Breast Cancer That Has NOT Spread
- Xeloda has been
proven as an effective and powerful oral chemotherapy treatment
in women with breast cancer that has spread . Therefore, in
continuing Roche's commitment to women with breast cancer, Roche
has initiated an international trial programme to investigate
the benefits of Xeloda in women with breast cancer that is confined
to the breast (early stage breast cancer).
- The aim of these
studies is to confirm whether Xeloda treatment by itself and
in combination with Taxotere will cure more women with breast
cancer than are currently being cured with standard i.v. treatment.
- Trials are exploring
the use of Xeloda both before and after breast surgery.
- Results from these
trials will be available in a few years.
- Women with breast
cancer that is confined to the breast who are interested in
participating in these trials should discuss it directly with
their physician.
Is Xeloda being studied
with any other intravenous chemotherapy agents or breast cancer
treatments?
Yes. Xeloda is now being investigated in combination with paclitaxel
(Taxol®) in women with breast cancer that has spread to other
parts of their body. Recent data showed that combining Xeloda
with paclitaxel is an effective, powerful option for women with
breast cancer.
In addition, Xeloda is also being studied in combination with
another chemotherapy called vinorelbine (Navelbine®). Results
demonstrate that Xeloda and vinorelbine is highly effective combination,
with excellent tumour shrinkage. Importantly, this combination
does not cause women with breast cancer the dreaded and upsetting
side effects associated with i.v. chemotherapy - of particular
importance to women, their hair does not fall out.
The benefits of combining
Xeloda with other breast cancer treatments, such as biological
agents are also being investigated. Furthermore, many other combinations
are being studied with all active breast cancer agents.
What happens if I forget
to take my Xeloda?
If you miss a dose of Xeloda, do not take the missed dose at all
and do not double the next one. Instead, continue your regular
dosing schedule and check with your doctor.
What are the licensed
indications for Xeloda?
Xeloda by itself is the only registered treatment for women with
breast cancer who have no further treatment options appropriate
for them when their disease has spread. It is available in more
that 80 countries world-wide.
Xeloda is also licensed
in combination with Taxotere in women with breast cancer that
has spread and whose disease has progressed following chemotherapy
with anthracyclines. The marketing authorisation for the combination
of Xeloda with Taxotere was first granted by the EU in March 2002
and the combination is now available in over 40 countries world-wide.
Furthermore, Xeloda
by itself is more effective than i.v. 5-FU, and is therefore licensed
for the treatment of people with colorectal cancer that has spread
(metastatic or advanced colorectal cancer) in over 60 countries.
In South Korea, Xeloda is licensed for gastric cancer that has
spread (metastatic or advanced gastric cancer), where it provides
an active and convenient substitute for i.v. chemotherapy, 5-FU.
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