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New Chemo Trial Imroves Survival Rate of Breast Cancer



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

Page contact: Kelly Newton Last revised: Wed 1 Nov 2006
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