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FOUNDATION FOR WOMEN'S CANCER
Moderator: Dr. Mark Einstein
12-18-14/12:00 p.m. ET
Confirmation # 44990331
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FOUNDATION FOR WOMEN'S CANCER
Moderator: Dr. Mark Einstein
December 18, 2014
12:00 p.m. ET
Operator:
Good morning. My name is (Amy) and I will be your conference operator
today. At this time, I would like to welcome everyone to the Cervical Cancer
Conference Call.
All lines have been placed on mute to prevent any background noise. After
the speakers’ remarks, there will be a question-and-answer session. If you
would like to ask a question during this time, simply press star then the
number one on your telephone keypad. If you would like to withdraw your
question, press the pound key. Thank you.
Dina Tizzard, you may begin your conference.
Dina Tizzard:
Good afternoon. I am Dina Tizzard with the Foundation for Women’s Cancer
in Chicago. Thank you for joining us and know that we have a great
workshop planned for you today. The goal for today’s call is to help you
understand and learn more about cervical cancer from the convenience of your
home or office.
Founded by the Society of Gynecologic Oncology in 1991, the Foundation for
Women’s Cancer is a public charity dedicated to expanding public awareness,
education, research and training to improve the prevention, early detection,
and optimal treatment of gynecologic cancers. The Foundation for Women’s
Cancer works diligently to make the pathway of survivorship easier and to
fund research to unlock new knowledge about ovarian and other cancers
unique to women. We encourage you to take a look at our website,
foundationforwomenscancer.org, for updated content about each gynecologic
FOUNDATION FOR WOMEN'S CANCER
Moderator: Dr. Mark Einstein
12-18-14/12:00 p.m. ET
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cancer, new information about cancer and stress, the importance of nutrition,
information for caregivers, and much, much more.
We would like to thank Genentech for their educational grant to support this
workshop today. I would also like to thank the two speakers who volunteer
their time and to share new information and answer your questions today.
This is the 12th telephone workshop offered by the foundation, and it is the
last one scheduled for 2014. Please check our website for future 2015
workshops.
Dr. Mark Einstein is going to begin today’s workshop by talking on the
current treatments for cervical cancer including targeted therapies. Then Dr.
Nicole Nevadunsky will follow and speak on palliative and survivorship
issues following cervical cancer treatment.
We will open the phone lines at approximately 12:45 for questions and
answers. An operator will announce that the lines are open, and the presenters
will do their best to answer as many questions as possible. Please note that
they will not be able to answer specific questions regarding your treatment.
A recording of the call will be available for replay from December 19th
through March 18th of 2015. To access the recording, you can visit our
website where they will provide a dial in number and the conference ID.
On behalf of the Foundation for Women’s Cancer, we would like to thank you
for joining us today and hope that you find this workshop useful and
informative. The foundation programs are only possible because of the
generosity of foundation donors. This generosity is vital if we are to continue
our foundation programs. If you would like to make a donation, you can call
the foundation headquarters at 312-578-1439 or visit our website to make a
donation.
I would now like to turn the program over to Dr. Mark Einstein. Dr. Einstein
is an Associate Professor of Obstetrics and Gynecology and Women’s Health
at Albert Einstein College of Medicine in Montefiore Medical Center in the
Bronx, New York. Dr. Einstein?
FOUNDATION FOR WOMEN'S CANCER
Moderator: Dr. Mark Einstein
12-18-14/12:00 p.m. ET
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Mark Einstein:
Thank you, Dina. And I want to thank everyone for joining us on the call
today. We hope that you’ll find this information informative for yourself or
friends or family, or potentially even for patients that you might be caring for.
We recognized that there’s just a lot of information out there, and we could
really only give more of a broad sort of view on what really is out there for
what are these broad topics. We are happy certainly at the end of this call to
talk about some other broad issues or to bring up other things. But we wanted
to highlight a couple of key issues with regards to treatment in targeted
therapies and also with regards to survivorship and supportive care issues.
And we’re going to touch base on some of those issues.
So I’m going to start with talking a little bit about what has been the backbone
of cancer treatments of the cervix for many, many years, and that’s been this
drug that has been, that was developed many decades ago called cisplatin.
And cisplatin has done a very, very good job in helping us to treat cervical
cancer and limit who suffer from cervical cancer from a primary standpoint
and also in a recurrent standpoint as well.
We made a lot of other huge strides with other treatments outside of the
chemotherapy and that’s some of the surgical treatments. We’ve actually
been able to do a lot more with doing less on patients by doing like minimally
invasive surgeries, by not having to do complete radical surgeries on patients,
and ultimately, you know, women then will be able to maintain their childbearing potential and other things as well. We’ve also made huge strides with
radiation. And we’ve also had some really, really good strides with imaging
so we could actually pick up cancers much earlier. And particularly, with
cervical cancer, this is one of the imaging modalities that we’ve made huge
strides with this thing called PET scans which is – that’s really – has done –
has really changed the way we actually pick up primary and recurrent cervical
cancer.
But to figure all this out, we have to do these things called clinical trials, and
we’ve been able to move the science forward to bring the best treatments that
our scientists who work in labs and find these new targets, we’re able to bring
this novel drugs and therapies to our patients through what is a process these
clinical trials. Many of the things that we expose, you know, women who
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suffer from gynecologic malignancies to today or treat them with today, you
know, it took decades for some of it to actually become reality. And things
that we’re working on now that aren’t necessarily approved or part of
guidelines or part of standard clinical we’re thinking is what’s going to be
state of the art five, 10 years from now.
I mean each year, medical researchers develop a lot of new cancer treatments
or they find new ways for existing treatments. And the goals of the therapy
are, number one, to, you know, that we want them to be highly effective, we
want them to work, and we hope that it is curative. We want them to have
infrequent side effects, you know, minimal toxicity. And we want – we
ultimately want to have – women who suffer from these cancers to have
convenience and we wanted to ultimately be affordable.
So these clinical trials are these pathways that we used to develop and
evaluate is more effective or potentially less toxic therapies. And these are
tested in a series of trials. You’ve heard these faces of sort of trials. And then
ultimately, they’re evaluated and potentially approved by the U.S. Federal
Drug Administration, or the FDA. And that’s typically after a very large,
what we call, randomized trial where patients get, you know, usually some
standard therapy with that drug or some standard therapy without that drug.
And we find out that, you know, women who might have had that drug
actually did better.
Similarly, new surgical approaches are also recommended after, you know,
large trials as well. And there’s a lot of oversight over these trials. And, you
know, clinical trial participants are often given a consent or fully informed of
these risks. And some risks we don’t necessarily know at that time, most we
do, because – usually, before we bring it, you know, to patients we’ve done a
lot of things outside of patients, you know, to learn a lot about these drugs and
these new therapies.
And if any of you are even thinking about a clinical trial, there’s probably a
lot of questions that you might want to be asking such as what is the purpose
of the study, you know, how is it different than standard therapy? How are
these results or the safety of participants being checked? You know, what sort
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of therapies, procedures or tests will I have during the trial. How will the trial
affect my current treatment plan or affect daily life? And, you know, if I need
other medical care, how is that done? Who’s overseeing this sort of thing?
What are the benefits to my health? You know, some of the short term and
long term risks that are connected with that. You know, whether insurance
will cover the cost. I mean there are a lot of questions and hopefully this is
just sort of shortlist of questions. But many more resources and list of these
questions can actually be found on the Foundation for Women’s Cancers
website, including some of these trials.
The National Institutes of Health has sponsored very large and robust clinical
trials group of providers that are across the country that devote its efforts
towards the treatment of gynecologic cancers. This group is called, is
previously called the Gynecologic Oncology Group in a recent sort of
reorganization of the clinical trials groups across the United States that the
NIH sponsors. It is now called NRG Oncology. And through this group, a
number of new therapies have been tested, and they continue to be tested.
And we’re targeting pathways that are known to potentially affect the tumor,
and we work with drug developers to make these new drugs and then test
them.
And some of the pathways that have been tested through the years, they target
specific things like, for instance, pathways that make new blood vessels in the
body, which all tumors use. I mean, part of the sort of the classic tumor
formation is the need for new blood vessels. There are also pathways that are
specific to how the immune system fights cancer. A lot of these are called
immunotherapies. And a lot of these immunotherapies are being actively
being tested in a number of cancers including things like melanoma, breast
cancer, and even cervical cancer as well.
And then there are also pathways that are involved in the body’s internal
checks and balances for repairing abnormal genetic content which often
accumulates with tumor formation. And the development of these agents also
begins decades before they become available to women.
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12-18-14/12:00 p.m. ET
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And just as a small (pod), the Foundation for Women’s Cancer has been
directly involved in funding early grants that produce the information needed
to know whether a pathway or a novel drug might be useful for women who
suffer from a gynecologic cancer. And as an investigator and someone also
runs critical trials, without such funding, many of these drugs that we use
today would not have been discovered. And until we can find a cure, we need
to continue to tirelessly work on this sort of research and we need to continue
to support advocacy organizations such as the Foundation for Women’s
Cancer who tirelessly work to support important scientific investigations.
So, I’d like to spend the rest of my time talking about a very important recent
study that was performed by the NIH-sponsored Gynecologic Oncology
Group. (This trial) investigated are targeted therapy that targeted new vessel
growth that happens in a lot of cancers including cervical cancer. And this
sort of mechanism is known as angiogenesis.
So angiogenesis, there is a lot of evidence to support that the consultative
angiogenesis plays a central role in cervical cancer and also in other disease
formation. And there has been a targeted therapy that has gone from the labs
and into the formation of a new drug that has been taken into patients. And
this drug was approved for use in a number of other cancers but it hadn’t yet
been tested in some gynecologic cancers including cervical cancer. This drug
is known as bevacizumab or Avastin. And so, the GOG took on a very large
study, studying this drug, this new drug in patients that have, in women that
have suffered from recurrence of their cervical cancer or women that had
persistence of this cervical cancer after initial therapy which is typically
radiation-based therapy. And patients who are randomized to a number of
different standard agents, all – you know, many of them with the backbone of
that cisplatin, the thing that we’ve been using for a long, long time, and some
of them with a cisplatin-like agent something called (suplatican) with the
addition of another agent that’s used for a number of gynecologic
malignancies called Taxol or paclitaxel. And half the patients got
bevacizumab and the other half of the patients take bevacizumab. And this
trial was, again, a very large file looking to see if the addition of this
bevacizumab to standard chemotherapy improves survival. I mean that’s what
we’re trying to do. We’re trying to push that bar higher so that more women
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will live longer if they have a recurrence of their cancer. And hopefully more
and more women will be cured of their cancer. And that’s really what we’re
shooting for here, OK?
And we also wanted to see whether the addition of this added drug actually
might increase, you know, the potential for quality of life because that’s a
very, very important part of survivorship. And my colleague Dr. Nevadunsky
will talk a little bit about that. Sometimes, you know, to some degree, we
have to live on chemotherapy and we want patients to live very well if they’re
on chemotherapy.
So, the trial lasted for what was a relatively short amount of time because, you
know, a lot of patients ended up going on the trial. And what we had actually
found was that the addition of this drug to standard chemotherapy or the
chemotherapy that we’ve been using now for close to two decades resulted in
over 30 percent increase in survival. I mean a lot of times we get excited, as
researchers, if we have like, maybe, 10 percent more or 15 percent more of an
increase in survival. In the case of this very, very large trial, we had over
three times what we normally expect in terms of survival. And this is very,
very significant and this is a great thing for women who suffered from
cervical cancer.
And there was also an increase in improvement and quality of life while some
patients might have had some added toxicity during their therapy, their overall
quality of life improved over time. OK? And this was really the first targeted
agent that has been found to improve survival in a gynecologic cancer, OK.
And this is an important finding. So, it’s not just your standard toxic,
cytotoxic sort of therapies, like cisplatin, like Taxol. This is a very targeted
therapy targeting a very specific pathway and the kind of thing that, you
know, that we’re doing a lot of testing on right now, OK.
So moving forward, we’re looking to see if we could actually use this therapy
upfront, maybe it works, not just works in a recurrent setting, maybe it works
upfront. This is something that is actively going on right now. So, in order to
improve actually some of the toxicities from this drug, actually looking at, you
know, some different doses of bevacizumab, looking at other classes of
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similar sort of digest agents, OK, and this class of agents maybe we could do
better with other similar targeted therapies, OK, but really going after the
vascular disrupting agents, OK, an anti-angiogenesis agents.
And also there’s a big push while we’re coming to targeted therapy to look at
these immunotherapies in this realm because what we have found is that, you
know, we need our immune system not only to fight infection and colds and
other things, but we also need our immune system to help fight tumors as
well. And while we’re aware of some of the trees, we’re not completely
understanding the whole forest. We need to work towards that. That being
said, we now have these drugs that help to regulate the immune system, and
that there’s a lot of testing going on with regards to these targeted therapies as
well in cervical cancer. And ultimately, until we actually have cure, we’re
going to tirelessly work to really try to use some of these new agents and
bring them to our patients in order to try and fight what can be a very, very
difficult cancer.
I’m going to stop there and then certainly if any of you have any questions
later on, please write them down, and we’re looking forward to talking about
it in our question-and-answer session. And I’m going to turn the program
over to my colleague, Dr. Nevadunsky.
Nicole Nevadunsky: Good afternoon, everyone. I hope everyone can hear me well enough. I
really appreciate Mark going over the new therapies and different treatments
that we’re using. From my portion of the talk today, I’m going to be speaking
about survivorship and some of the issues that affect women after their
diagnosis and treatments for cervical cancer. I really appreciate everyone
participating in the call today.
So just to serve off, the most important predictor of survival for women with
squamous cell carcinoma of the cervix is speech followed by whether lymph
nodes are involved by cancer or not. Just to let you know, after radical
hysterectomy and lymph node removal, women with stage 1B or 2A, in other
words, early stage cancer with negative lymph nodes, will have a five-year
survival of 88 to 96 percent. This is important. The meaning of this is the
overwhelming majority of these women will survive their diagnosis in
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treatment. And it is our responsibility as cancer care deliverer to make sure
that their qualities of life are as bets as they can be during this time.
Now, for women with similar stage that spreads to lymph nodes, the survival
is impacted, and it’s generally thought as a 50 to 74 percent in general.
However, survival can be more negatively impact is depending upon which
lymph nodes are involved. Even with this poor prognosis, there is a huge
amount of women that will be surviving their cancer, and we need to pay
attention to their survivorship and the symptoms that they may develop from
treatments as well as the cancer diagnosis itself.
Now, quality of life can be negatively impacted by cervical cancer diagnosis
and treatment. And these impacts can last for years. For any diagnosis of
cancer or even any serious medical problems, they were effects on
psychological, social, financial, and physical well-being for the patient, not to
mention, the long term effects on familial relationships with children, life
partners, spouses, and even peers.
Medicine mostly focuses on physical symptoms caused by cervical cancer and
its treatments. And these other things are important, too. However, for the
extent of our call today, I am going to focus on what we know about the
physical symptoms that survivors have to deal with.
So, to give you an idea of how prevalent these symptoms can be, in a study of
cervical cancer survivors that had been diagnosed and treated with radiation
and chemotherapy, even five to 15 years previously, one-third of them
reported pelvic pain that persisted. Thirty-five percent said that they had
sexual dysfunction. Forty-two percent said they had problems with bowel
movement. And 20 percent reported that they have problems with urinary
incontinence.
These symptoms summaries are important information. But what’s more
important is how these symptoms affect quality of life (location). In another
study, (ask any) survivor that were treated within the last seven years, patients
treated with radiation therapy have (reported) improved quality of life support
compare to women who did not have radiation. They reported more nausea,
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vomiting, pain, and appetite loss. This is why the treatments mentioned by
Dr. Einstein are so very important. We need treatments that are going to cure
this disease but also prevent some of the side effects.
Some symptoms that arise for survivors are directly related to treatments and
others are more indirectly related, and they are more closely tied to lots of
hormonal functioning. That is loss of estrogen from ovarian failure secondary
to cervical cancer and its treatment. This is very important because almost
half of women diagnosed with cervical cancer are under the age of 45. And
what that means is that when they’re diagnosed and treated, their hormones
are still functioning.
Some women will have radical hysterectomy for their cervical cancer and
their doctors will leave their ovaries in place. But even if the ovaries are left
in place and there is no further treatment with radiation, the ovaries can stop
working because of damages – the damaged changes in blood supply. And
that would decrease estrogen for these patients.
Now conversely, almost all women who have radiation to the pelvis will lose
ovarian function because of the dose of radiation that is needed to save their
life. Ovarian failure causes complications of infertility or the loss of the
ability to become pregnant, premature menopause, and sexual dysfunction. It
is important for survivors to know that there are treatments that help with
some of these problems.
The first problem of fertility is something, though, that often comes up before
the treatments are given. But women of reproductive age, there are sometimes
options for fertility preserving surgery. These must, however, be cautiously
considered and are individualized for each patient and her particular cancer
with the treating oncologist. Ovaries may also be surgically removed in a
procedure called transposition to potentially avoid some of the damaging
effect of radiation. Again, these are very complex issues that should be
discussed with the patient and with her oncologist.
Now, the second problem, the menopausal symptom is also very important.
These symptoms include hot flushing and night sweats. This is when the
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patient suddenly feels or the survivor suddenly feels acute overwhelmed
(repeat) and could even wake up with her bed completely soaked every night
from hot flushing. Patients with low estrogen will have vaginal dryness and
can have painful intercourse. It is important to know before these symptoms
there were both non-hormonal and hormonal medications that can be used.
These medications, though, and their potential side effects should be carefully
discussed with the patient and her oncologist.
There are limited studies from the available reports that that hormone
replacement (before) the current information that we know in the laboratory
estrogen does not cause the HPV virus which is thought to cause cervical
cancer to grow. There is also evidence that used of these medications doesn’t
increase the risk for cervical cancer to come back. Again, because these
drivers can have side effects that are related to growth of cervical cancer as
well as to other medical problems that the survivor could have, it’s really
important to discuss these things with the treating oncologist and potentially
the medical doctors that patients are seeing.
Now, the last problem that can arise from estrogen deficiency and also from
the cancer diagnosis in itself is problems with sex. There is a physical link to
problems with sex for cervical cancer survivors. Sometimes doctors think this
is related to shortening of the vagina from surgery and also decreased
lubrication. In some studies, almost 100 percent of women report that their
vaginas are short, vaginas were shorter after treatment for cervical cancer and
up to 60 percent of women reported decreased lubrication.
Now, some of these studies have also dealt into orgasm. And studies suggest
that women who have had treatment for cervical cancer have problems
achieving orgasm. But these problems can resolve within six months to a
year. Now, there is also a link to painful intercourse, and it is thought that this
problem can persist for many years after treatment for cervical cancer.
There are many different modalities that can be used to address sexual
dysfunction. And as I mentioned earlier, I’m focusing more on the physical
symptoms. As we know, there are psychological and emotional things that are
related to sexual dysfunction. The treatment of painful intercourse can
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include vaginal lubricants, moisturizers, vaginal estrogen therapy, which
again, I suggest that you need to discuss with your treating oncologist because
there can be side effects in these medications. And also something called a
vaginal dilator. Vaginal dilator, they are extremely important after radiation
therapy because they can be used to help maintain a longer vaginal length and
prevent some of the sexual dysfunction.
Again, sexual dysfunction may be related to psychological, emotional, and
relationship factor. These problems should be discussed with healthcare
provides to personalize the treatment that is best for each survivor.
In summary for survivorship, there are growing number of women that will
survive their cervical cancers and treatments for many years. Physical,
psychological, and social problems are very common. They’re real and often
they are very treatable. I encourage survivors to discuss these problems with
their healthcare provider as well as locally available outreach group and peer
mentoring support systems that are in place.
I hope I haven’t ended my part of this talk too early, but I want to make sure
we have time for questions.
Mark Einstein:
You know, while we have some time, Dr. Nevadunsky and Dina, and maybe
for the audience members, I just also want to just touch base about, you know,
some other developments for cervical cancer. You know, as Ben Franklin had
said, you know, “An ounce of prevention is worth a pound of cure,” you
know. And while we might be spending our workshop talking about
treatments and targeted treatments and survivorship, you know, there is some
very encouraging news for those of you who might suffer from cervical cancer
for, you know, your family members, for your friends and (ask that we made),
you know, a lot of strides with regards to prevention. In fact, we feel that we
actually have the tools today to really be able to prevent cervical cancer. And
that is where, you know, a lot of the focus is now to really try to, you know,
put a lot of efforts into preventing cervical cancer.
We have a couple of (modalities) to be able to do it. One of the things that
we’ve known is that all cervical cancers caused by this incredibly common
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virus that everyone has been exposed to, and this is called human
papillomavirus. However, very few people get this virus. Actually, you can
get cancer or get anything that actually, shall we say, is clinically relevant,
OK. Most people will get this virus don’t even know they have it. There are
no symptoms to this virus. And then it goes away in most people. And that’s
women and men.
However, in women, sometimes it can stick around and persist. And that
persistence actually, ultimately can lead to, what is that, precancerous
condition and ultimately can lead to cancer as well if we don’t treat the
precancerous condition. Now, there is available vaccines to prevent human
papillomavirus. And it is routinely recommended to be able to give this
vaccine to 11- and 12-year old girls and boys just as routine as vaccines.
You’ve heard of like Tdap, and MMR, and other sort of vaccines. And this
leads to a very large potential for prevention of the precancerous lesions as
well as cancer, and with early vaccination, as long as the secondary way we
do things and that’s screening, and that’s with a Pap test generally.
However, there have also been big strides with this other thing where we’re
actually looking for HPV. We know that women who have persistent other
HPV or more at risk of actually even harboring something that is clinically
relevant or a cancer at the time that they have HPV. So if we test for HPV, we
actually could hone in on the women that are most at risk potentially for
getting cervical cancer. So with early vaccination, along with regular Pap test
and HPV test that is recommended, it’s really the best way we can prevent
cervical cancer. And with that combination, we could probably prevent most
cervical cancers.
And while this might be a generational thing, this might be something that
we’re shooting for down the line. You know, we have to start somewhere.
And right now, there has been big pushes and, you know, throughout the
country and many areas and regions and big cities in the United States, not
just in the U.S. but globally, in many areas like U.K., Western Europe,
Australia, these vaccines have now found themselves into most 11- and 12year olds.
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That has not been the case in the United States yet. There are some issues of
policy and politics and other various things that are probably some of the
various behind it. That being said, you know, with continued education and
about the best way that we can prevent cervical cancer with local folks such as
the providers, as a provider of women who takes care of women with cervical
– as a provider of care to women who have cervical cancer, I would be very,
very happy to see the day that I don’t have to take care of anyone with
cervical cancer again. And we do have those tools. I think with a big push
from our advocacy groups such as those of you who might – who are eager to
try to cure cervical cancer, there are some folks that are out there that need to
be educated about the roles of primary and secondary prevention for cervical
cancer.
And so, you know, that is good news for those who are suffering cervical
cancer that maybe we could actually really try to, you know, push for
prevention. You know, we probably do have those tools now to do that.
Anyways, I’m going to – I do want to leave some time for questions and any
comments that anyone might have.
Nicole Nevadunsky: Mark, can I just add one other thing to our discussion?
Mark Einstein:
Absolutely.
Nicole Nevadunsky: And that would be that I just really want to make it clear to our survivors
that so many times I’ll see patients in the office and they’ll be saying they’re
having problems with energy levels. So they’re saying they have come with
sleep disturbance. You know, even as an anecdotal (inaudible), I had a very
young woman who just got married and, you know, she had her diagnosis of a
cervical cancer. And then about a year later, she came back and said, well,
I’m going to be getting divorced because I don’t think I love my husband
anymore. And in discussing with her, what it was, it was that she said she
didn’t have any sex drive, and she felt that, that really meant she didn’t love
him and she could be getting – she should be getting a divorce.
In reality, this has been an effect from her cervix cancer treatment and her
hormonal levels were extremely low. And just the knowledge that this was a
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physiologic occurrence and this wasn’t something – I mean, obviously, there
were some psychological issues with, you know, that the cancer diagnosis in
and of itself. It was very meaningful to her. And I think so many survivors,
they don’t want to talk about it. It’s, you know, it’s a taboo subject. And the
relationship changes (inaudible). So just to really be aware that if you’re
having these symptoms, survivors are having these symptoms, that it’s
important to talk about it with their healthcare providers or even in support
groups because sometimes things can be done. And sometimes even if things
can’t be fixed or the patient decides like, “Oh, hey, I don’t want to take that
medication because there are so many other side effects that are related to it
for my health,” just the knowledge for that survivor that this is something that
is real, it is physiologic and it’s not in her head, it’s not about the fact that she
doesn’t love her husband anymore, her partner, it’s something real and
physiologic that has happened.
Mark Einstein:
Thank you for that, Dr. Nevadunsky. So I think, Dina, we could open up for
questions and maybe further discussion with those that are on the call.
Dina Tizzard: OK, great. So, operator, if we could open the lines for the questions.
Operator:
At this time, I would like to remind everyone in order to ask a question, press
star then the number one on your telephone keypad. We’ll pause for just a
moment to compile the Q&A roster.
Again, if you would like to ask a question, press star then the number one on
your telephone keypad.
Mark Einstein:
So, you know, I think while we’re waiting for some questions, Dr.
Nevadunsky, if it’s OK with you, I’ve got a question or two that …
Nicole Nevadunsky: OK.
Mark Einstein:
… you know, is it – so, you know, I think some of our survivors are
sometimes hesitant about talking about things like sexual function or maybe,
you know, intimacy, you know, with their partners to their providers. You
know, I was wondering if you can maybe share, you know, how you as a
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provider bring that up or how you’ve heard patients kind of bring that up so
that they don’t feel uncomfortable with it.
Nicole Nevadunsky: Well, Mark, I think what’s really important for the providers is always to
make sure it’s a safe place to talk about it and to ask patients if it’s OK to
bring up the discussion to help to normalize that, to help them know that it’s,
you know, a really safe place for them to be talking about it. Sometimes
patients really feel comfortable and they want to have their partner to be there
with them to have discussions along these lines. I think that that’s very
helpful. You know, I think doctors, we often, you know, (direct) physiologic
symptoms to start kind of initiating the conversation, “So, you know, are you
having any problems with, you know, vaginal lubrication or dryness?” I think
that that help things – and it’s really – it’s complicated because people come
to the exam room with their own – they’re fearful, they can’t keep coming
back. And these things sometimes take a second (feat) through this.
And like I said before, you know, this simple story. This woman really
thought that it was, you know – that there was something wrong with her that
was not related to the cancer. And probably, it was a huge part related to the
cancer. I think it’s also very important for patients to feel comfortable in
talking about these things if they want to have peer mentorship. There are
some very good programs that are related to cancer survivor talking to other
cancer survivors about these types of things. I think the vaginal dilators are
extremely important part of this in some ways even just for surveillance to (do
test). I invite patients to bring their dilators to the office so I can make sure
that they’re using them, you know, if they want to and to make sure that
they’re using them in a way that that is going to help them the most if they
have any questions about it. And some of these other things – and it’s
definitely – it’s been evolving relationship. These are complicated topics even
for people who don’t have cancers sometimes.
Mark Einstein:
Great. And what I also hope that our audience recognizes that this is
something that providers are used to discussing with patients and they
shouldn’t be afraid to actually bring it up. And for those that are suffering
from some sexual side effects of treatment, this is quite common and
something that actually potentially, you know, we could help and hopefully
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that, that conversation can happen because that is part of, you know, quality of
life.
Also, you know, Dr. Nevadunsky, we have a lot of patients that struggle with
pain. You know, they struggle with thinking, “Oh, gosh, I have pain.” And
pain sometimes can be debilitating and some feel that they don’t want to take
some of these medications or take some of this stuff because they worry that
they’re going to, you know, that they might need more or they might have
developed some sort of dependency. I was wondering what your opinion is
and how you discuss this with patients.
Nicole Nevadunsky: So I think that that’s very important as well. And I would say that pain
can be dealt with in several different modalities. Obviously, first and
foremost, if any cancer survivor is experiencing more (public) pain, it’s really
important for the physician to do a good exam, make sure that this isn’t cancer
recurrence or something else going along those lines. I would say that there
are certainly multi modality methods to deal with pain. You know, we work
here at Montefiore. I certainly have a psychosocial oncology working group.
We have programs in exercise and yoga. We have programs for (drum circle),
for spiritual healing and (inaudible). They’re all things that are
complementary and that most medical center will have available for patients.
In addition to that, there are specialists in pelvic floor rehab. I don’t think that
many patients or many survivors are aware that there are actually even or
specialists that deal with rehabilitation for patients after they have had these
sort of procedures and treatments. But I think that, you know, these therapies
that address not just, you know, a pill to take, therapies that are going to, you
know, change lifestyle through exercise and through other nutritional and with
other different modalities are just as important as pills.
Although I will say that opioid pain medications are extremely effective. And
if there is a way to stigmatize that for patients because sometimes patients will
have pain for many, many years related to nerve damages that can happen
during surgeries and from radiation and chemotherapy. And really for those
patients, the only therapy – the only drug – the only thing (that opioid) will be
helpful to them are these opioid pain medication. And that if they are
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managed appropriately, it’s not a question of addiction, it’s the question of
tolerance and of really treating pain that is real.
Mark Einstein:
Thank you, Dr. Nevadunsky. I was wondering if there are any questions from
our audience today.
Operator:
Your first question comes from the line of a participant whose information
was unable to be gathered. Caller, please state your first name. Your line is
open.
Pamela Goetz:
That might be me, I’m not sure. My name is Pam Goetz and I work at Sibley
Memorial Hospital. And I have a question about, I guess, quality of life and
cost of care. I’m aware that Avastin is kind of an expensive medication. And
I’m just wondering what your presenters have to say about kind of the role of
the medical oncologist in looking at financial toxicity and making sure
patients understand kind of the cost of the care because that affects quality of
life as well.
Mark Einstein:
Absolutely. That’s an excellent question. And this is one of the – and to the
rest of the audience, one of the interesting phenomenon that’s happening with
regards to development of these targeted therapies is because they are
relatively new, some of these are like, what we consider, first of class agents.
It’s a long path to get to ultimately to an approval or an FDA approval. And
bevacizumab is FDA approved for cervical cancer. But the path to get to that
took a lot of time, a lot of money, a lot of patience that actually got to that
point. And the drug itself in terms of its development and manufacturing is
not cheap to make. Remember these are very specific therapies, and there is –
you know, a lot went in to these sort of developments.
So these drugs do cost a lot of money. Most new targeted therapies, you
know, do cost a lot of money. And ultimately – and to the – you know, to –
and thank you very much for that excellent question. There is a
pharcomoeconomics behind this, you know. Is the amount be added survival
or the added, you know, quality of life, is that, you know, “worth it”? And,
you know, we are in a time of very interesting change in healthcare, and we
have to make some tough decisions with things.
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That being said, because of the strength of the data from this study, GOG 240,
and because of that strength of data, the FDA had approved that drug. And
our large guidelines organizations, National Comprehensive Care Network, or
NCCN, has also given at a very, very high recommendation. And a lot of
times those recommendations and those guidelines feed right into how payers
or insurers actually think about how – whether or not to actually adopt and use
that drug.
And because of that combination, most payers are allowing this to be used in
the setting, and that, I think, continues to grow. We actually had very – in our
system, we have a very, very high managed care patient-payer mix including
many patients with Medicaid and Medicare, and they are paying for Avastin
in the recurrent setting. We do hope that most patients don’t have to have any
high deductibles or anything with that. That being said – that said, you know,
it would be nice if we had, you know, a better sort of mechanisms to be able
to provide this, you know, for patients if they aren’t – if they aren’t being paid
for. And those I would recommend looking into locally through your payers.
Pamela Goetz:
Thank you.
Operator:
Your next question comes from the line of a participant whose information
was unable to be gathered. Caller, please state your first name. Your line is
open.
(Melissa Carter): Hello, my name is (Melissa Carter). And I wanted to ask a little bit more
about Avastin. My understanding is that there have been some stronger
responses with cancer re-growth off the patients have ceased using Avastin.
And I want to know what your take on that is and whether that risk is worth
taking.
Mark Einstein:
Now, that’s an excellent question. And I think your question actually goes to
a broader sort of question or what sometimes happens with therapies
especially when we’re giving therapies regularly. So sometimes we do what
we call consolidation or maintenance therapies where we give a therapy on a
regular basis over time. And what we found is that when we stop giving that
maintenance therapy or stop giving that therapy after a little while, the tumors
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that do come back not only do they come back but they come back kind of
with a vengeance. They come back, you know, rather, you know, rather more
aggressively.
I think it’s very hard for us to figure out which came first, the chicken or the
egg, you know, in the sense that if we weren’t giving a therapy, we don’t
know if that tumor would have come back aggressive sooner, for instance. I
think most of us in the field do not believe that these are actually – these
actually activate, you know, more aggressive natures of tumors. But what we
think is actually probably happening is that when we kind of turn off these
drugs or turn off these sort of maintenance therapies, that whatever cells are
still surviving, they’ve – you know, these are tough. And I don’t mean to
personalize a cancer because it is the enemy here, though. And these sort of
cancers have a tendency to become very aggressive.
You know, I feel – and this is my opinion and we don’t really have data
behind this, but my opinion is that by having some of these maintenance
therapies, or what we call consolidation sort of therapies, we are, you know, at
least, delaying that sort of aggressive, sort of approach. And so, you know –
and without having that, we think that that sort of aggressive approach would
have come back even sooner.
(Melissa Carter): OK, thank you very much.
Operator:
Your next question comes from the line of (Natasha). Your line is open.
(Natasha):
Hello, my name is (Natasha) and I am the chapter leader for the National
Cervical Cancer Coalition in Jacksonville, Florida. I have a question
pertaining the testing hotlines. I know that it states that women should start
having cervical cancer screenings at the age of 21. And also it depends on the
women’s age and health history. Now if you have a health history of your
mother or your grandmother had cervical cancer, is it going to be like where
the daughter go sooner than 21? Or is it, you know, you just wait until 21 if,
you know – let’s say, for instance, my – I’m a survivor, a three-year survivor
and I have a 18-year-old daughter, does she wait until she’s 21 to be screened
or can she go sooner?
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Mark Einstein:
Right. (Natasha), it’s an excellent question. And although we didn’t discuss
it today, we did kind of touch on the fact that we have had a lot of changes
with regards to how we prevent cervical cancer, and this is one of those
changes. And there has been a lot of updates with regards to the guidelines.
One thing that comes up over and over again with regards to cancers is, is
there a family history for this? You know, is there some sort of susceptibility?
And we do know for some cancers, there are most certainly is for some breast
cancers, for some ovarian cancers, for some colon cancers, for even some
uterine cancers, there is some genetic susceptibility. But even at most for
some of those cancers, at most maybe only about 10 percent that have suffered
from those cancers, there is a potentially genetic or something in their genes
that was passed down from generations that would make them susceptible to
these cancers. This cancer historically has not been shown to be something
that is a familial risk. There isn’t like a familial or genetic predisposition to
this. At least not that we know off, we don’t know of any specific genes that
were predisposed someone to getting this cancer.
So that’s – so to that point, so we don’t increase your frequency of screening
as a result of a family history because this kind of cancer is not linked to
genes. That being said, the reasons – some of the other reasons why we start –
we have to, you know, start, we don’t start screening until women are of a
certain age is because of the, you know, relative rarity of the development of
these sort of cancers. And while this often is worked upon as a cancer
unfortunately of young women and even the pre-cancer stage peaked in
women that are between the ages of 25 and 29. And so, this is – you know,
this is a woman that’s in the prime of their reproductive life, they are often
working, going to school, raising a family. So, you know, they have a lot
going on and sometimes, they might delay their child-bearing. So having had
a diagnosis of a pre-cancer or even, God forbid it, cancer at a young age is a
major, major life (speed bump) for someone.
That being said, under the age of 21, the risk of getting cervical cancer is less
than one in 100,000. It is incredibly rare. And a lot of those kinds of cancers
aren’t like the typical run-of-the-mill sort of cervical cancer diagnoses. These
are kind of these very odd histologic diagnoses that probably won’t be
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Page 22
amenable to screening anyways. So, after a while of iterative discussions
among scientific and patient advocacy groups, the decision was made to not
screen women under the age of 21 because a lot of times (RS) screening does
is just pick up these incredibly common human papillomavirus infection, and
it subjects the young woman to anxiety-provoking added procedures without
really picking up cancer.
So, that is the primary reason. And, no, we don’t that change that as a result
of a family history. I hope that answers your question, (Natasha).
(Natasha):
Yes, thank you.
Operator:
There are no further questions at this time. I will turn the call back over to the
presenters.
Dina Tizzard:
Oh, at this time, unless Dr. Einstein or Dr. Nevadunsky has anything else to
add, we would like to thank you for joining us again today on the call. And
on behalf of the Foundation for Women’s Cancer, thank you for your support
and happy holidays.
Mark Einstein:
Thank you, everyone.
Nicole Nevadunsky: Thanks, everyone.
Dina Tizzard: Thank you.
Operator:
This concludes today’s conference call. You may now disconnect.
END
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