New Chemo Trial Significantly Improves
Survival Rates
00:00 ExteriorUniversity
of Birmingham Institute for Cancer Studies
Man
crosses shot and enters building
Sign
for Chemotherapy at Hospital
Chemotherapy
being administered to patient
c.u.
chemotherapy solution entering patient’s arm
c.u.
saline drip
c.u.
chemotherapy solutions in syringes
Guide Voice: The results of a major clinical
trial, run at the University of Birmingham, examining the effects
of chemotherapy on early phase breast cancer seem likely to have
significant implications for the treatment of women with this
condition.
The researchers have discovered that by adding Epirubicin to
established cocktails of chemotherapy drugs they can noticeably
improve survival rates in early stage breast cancer, reducing the
risk of death by approximately 30%.
One of the key challenges for doctors has to be to integrate the
best possible chemotherapy with newer drugs – Epirubicin an
anthracycline, was already known to kill cancer cells in a
different way from traditional chemotherapy drugs.
00:40 SOT: Dr. Christopher Poole, Senior Lecturer
in Medical Oncology, University of
Birmingham. - “There were two
Anthracylcins in common use and circulation at the time. One
was Doxorubicin, one was Epirubicin. Epirubicin was the newer
of the two drugs and, in fact, it’s an analogue of
Doxorubicin, but there was evidence emerging that Epirubicin was
significantly less cardiotoxic. And what – the
importance there is that many of the women we were treating in this
study have got early stage disease, some aren’t going to
relapse with breast cancer and safety has to be a huge priority
when you’re treating patients with early breast cancer, so
Epirubicin looked better from a toxicological point of view.
“
01:17 c.u.
preparing arm to receive chemotherapy
c.u.
Epirubicin injection, pull out to reveal medical tray
arm
being prepped for chemo
Guide Voice: The trial, involving more than
2000 women from 65 centres across the UK, is the largest ever study
of this approach to chemotherapy. The National Epirubicin Adjuvant
Trial set out to examine the effects of the chemotherapy drug
Epirubicin when combined with traditional chemotherapy drugs in
women with early stage breast cancer.
The trial compared the established combination of chemotherapy
drugs, CMF, with CMF chemotherapy in combination with four cycles
of Epirubicin.
01:48 SOT: Dr. Poole -
“Epirubicin had been introduced into practice in the
1980s and by the time we designed this study in the early
‘90s it had become an established part of chemotherapy for
women with advanced breast cancer, for which read metastatic breast
cancer. So we knew its place in the treatment of women
who’d developed secondaries, perhaps after early treatment
with one of the standard Adjuvant regiments such as CMF. So
we knew about its safety, we knew about its side effects, we knew
how to handle it, but, we knew it was less toxic than
Doxorubicin”.
02:20 Wide –
patient being placed in MIR Scanner *
c.u.
radiographer *
Radiographer
at MIR controls *
Patient
in Scanner *
Tumor
comparison on X-Rays *
* These shots courtesy of Pfizer archive; cleared for news
usage
Wide
– BioStatisticsDept.University of Birmingham
Statistician
at computer
Guide Voice: Patients in the study were
followed up over a period of five years with patients receiving
Epirubicin, as well as traditional chemotherapy, showing
significantly better survival rates and less recurrence of tumours
than patients receiving traditional chemotherapy. The results of
the study were collected and collated at the University’s
Clinical Trials Unit, where the statisticians have been monitoring
data throughout the trial.
02:44 SOT: Doctor Lucinda Billingham, Head of Bio
Statistics, Cancer Research UK Clinical Trials Unit, University of
Birmingham - “The primary measures on which the
treatments in the NEAT trial were being assessed were the relapse
free survival time, so the time, the amount of time you can delay
the disease coming back and the overall survival time, those were
the two key outcome measures. And for both of those the
results showed that there was about a 30 percent reduction in the
risk of those events happening, either relapse or death, on the
ECMF compared to CMF alone. So that’s a staggering
reduction in the risk of death, we will often see sort of maybe 15,
20 percent reductions in the risk of the events happening, but this
was a particularly large effect that we saw in this trial and those
were probably the two key results.”
03:34 Wide
– exterior Birmingham Women’s Hospital
c.u.Hospital
sign
GVs
Breast Cancer Advice pamphlets
Guide Voice: The results of the trial have
shown conclusively that the addition of Epirubicin to traditional
chemotherapy has a significant impact on survival in early stage
breast cancer.
Over the years the combination of chemotherapy drugs has been
refined to help prevent the recurrence of tumours but it’s
unusual to see such a dramatic improvement in survival with
relatively small changes in the package of drugs.
03:57 SOT: Dr. Poole - “Without
trials like this we just cannot progress things. These are called,
generically, randomised phase three trials.
They’re comparing a modification of standard treatment with
standard treatment. They are the evidence base, they
provide the evidence base, they provide the data that enable us to
say that some modification of standard treatment is better than
standard treatment alone. Without those data you’re in
the world of value judgement, so this randomised phase
three trial, or maybe a confirmatory randomised phase three trial,
is the cornerstone of evidence based medicine”.
04:31
Chemotherapy solution being administered
Guide Voice: With this particular trial it
seems that a significant step has been taken in the treatment of
early stage Breast Cancer.
04:40 End of
Cut
Additional
Material
Additional Soundbites
Elizabeth Seakins, Cancer Patient and Trial
Participant
04:47
“I knew that there were no differences, as far as was known,
in the two treatment arms, so that whichever side I was allocated
to, I was getting the best available treatment and that I
wasn’t going to be losing out. Also, I did know that
anybody who goes into a trial probably does a little bit better
then people who don’t go into a trial, they need to do a
trial about that but – so even just being in a trial seems to
confer a positive outcome and, when you’ve been told that
you’ve got breast cancer, then you want to do absolutely
everything that’s going to maximises your chances of
surviving”.
05:34
“The situation that I was in, I can’t think of anything
negative about it. I suppose perhaps, ‘cause I had
studied trials and what it means to be in a trial, then I knew that
it’s not, you’re not testing something to see if it
works, you know that the two different sides work at least as well
as each other and they’re just looking for a positive
improvement over and above that.”
Dr. Lucinda Bellingham
06:10
“Generally with, what we’re trying to do is,
we’re trying to assess the outcome of patients to certain
treatments. So with cancer treatments often the outcome
measures that we will be involved in or interested in collecting
are survival type outcomes, the time, can we extend patients’
survival time. But, other types of measures that we would be
interested in are the, trying to prevent a disease from occurring,
so the sort of relapse free survival time. But also the
toxicity of treatment, how the patient’s quality of life is
with certain treatments and a lot of these aspects we will be
collecting data on so that we can then make some definitive
conclusions as to how these – treatment affects the
patients”.
Dr. Chris Poole
07:03
“We decided to compare a sequential combination of Epriubicin
followed by CMF with CMF alone; And the reason for going down that
route was some very, very elegant and laudable work undertaken by
the Milan Group. And they’d shown sequential, block
sequential regiments of Anthracyclins, followed by CMF were rather
better than alternating regimens that offered exactly the same
amounts of the same drugs over the same time duration. So
they’d been very clever in providing prima facie evidence
that Anthracyclin schedule mattered, not just choice of
Anthracyclin, not just dose of Anthracyclin, and we integrated
Epirubicin into a block sequential schedule developed by the Milan
Group. We bastardised it a bit, we truncated it down, we made
it a bit more feasible but, essentially, we took an established
Milan regimen and we used that as the research arm in our study
against what we considered to be the best possible control,
properly dosed, properly scheduled, classical CMF”.
Additional B-Roll
08:21 c.u.
Syringe being filled with Epirubicin
08:30 pan along arm
with bandage
08:42 END
