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(1)

Improving survival and Clinical

Trials

Janyne Afseth

(2)

Aims

Identify the factors which may link to improved

survival to clinical trials in cancer

Describe some of impact of clinical trials on survival

Discuss some variables that affect participation in

clinical trials

Reflect on the challenges for clinical trials in the

coming decade

(3)

Clinical trials – how common are they?

Who knows anyone who has participated on a

clinical trial?

Do you think it was a good idea?

Do you know what the result of the clinical trial

(4)

Cancer and Clinical trials in the UK

In England, the National Cancer Research Network (and

equivalents in Scotland, NI and Wales) was formed

approximately a decade ago to increase accrual to cancer clinical trials.

 These networks were implemented to improve infrastructure

and access to all patients to clinical trials including those in smaller centres or with less common cancers

 It would also allow an increased focus on academic trials

The UK is the most heavily funded EU country for Cancer Research

(5)

Success?

 More patients in trials

 4% in 2001, 18% in 2010. US by comparison has 3%

(NCRN, 2011)

 Research outside major cancer centres

 All cancer research (including basic) has gone from 12.5% in

major centres in 1995 and increased to 25% by 2004

(Sullivan et al 2010)

Less common cancers

 Breast Cancer has approximately 20% of cancer specific

spend (16% incidence) – lung cancer just over 5% (13% incidence) - but this is up from 3% in 2001.

overall spend has doubled in this period

(6)

Do patients do better in clinical trials?

Some evidence that patient who participate in centres

where clinical trials are the norm do better

The American Federation of Clinical Oncologic Societies

maintains that

– “treatment in a clinical trial is often a cancer patient’s best option”.

 Discussed in UK cancer research network literature

(7)

Why might patients do better?

Some treatments might work

Centres where trials are done may have access and

knowledge for newer treatments – for example

Intensity Modulated Radiotherapy (IMRT)

More surveillance (increased follow-up – sooner

diagnosis of progression)

Increased healthcare input – more time with

clinicians, research nurses

(8)
(9)

Breast Cancer – A Short History of Success

 In 1895 a surgeon discovered that the ovaries if taken out to

could decrease breast cancer growth

 President Nixon declared a war on Cancer and in the 70’s and

80’s trials with Tamoxifen started (initially developed a birth control)

 1980s the UKs Early Breast Trialists Collaborative Group was

formed an pulled together all trials – and results of Tamoxifen preventing the return of breast cancer were accepted –

reduced death by 1/5th

 They also found chemotherapy in younger women (<50)

(10)

Other success

ATAC – aromatase inhibitors further improved survival

reported early this century – reduced recurrence by

26%

(ATAC Trialists group, 2005)

Taxanes improve reduce recurrence

(Ferguson et al, 2007)

HERA trial – Herceptin in her-2 positive women

decreases recurrence by 50%

(Gianni et al., 2011)

(11)

Lung Cancer - successes

How many people lived for at least a year

 14% vs.. 16%

5.9 months vs. 6.3 months progression free

(CRUK, 2011)

Some success in extending life by a week or two

BUT

QALY Quality Adjusted Life Year – if only extending by

a short time and expensive – will it be funded?

(12)

Have we improved outcomes?

Lung Cancer – survival at 5 years has not changed

since 1971 – has gone from 4% to 8%

Why? – late diagnosis, fast growing, doesn’t respond to

treatments

Breast Cancer 5 year survival – 52% in 1971, now is

82%

Why? Screening programme, Better surgery, improvements

(13)

Why aren’t more patients on trials?

Clinician motivation, preference and resources

 Breast and colorectal more likely to recruit patients,

oncologist more likely than surgeons and those in cancer centre more likely than district hospitals (Ford et al, 2011)

Patients views

 83% of cancer patients would participate in an ‘Randomised

controlled trial’ using a general survey of attitudes (Jenkins et al., 2010)

 Informed voluntary consent is required by law

(14)

Why aren’t more patients on trials?

Patients often excluded

 Patients with poor performance status  Patients with significant comorbidities  The elderly are under represented

Those in residential care

Patients who don’t want to

travel

(15)

Where is cancer research headed

NCRI cancer spend doubled from 2001 to 2010

Improved recruitment to trials

BUT in the last decade targeted therapy and

treatments are emerging

Genetic variations determining targeted treatments,

trials more selective = decreased recruitment

(16)

What are the challenges

Now need to assess for molecular targets and can

only test after consent

Less patients eligible for each trial – needs to run

longer

As survival increments smaller need more patients to

prove statistical significance

NHS resources stretched

 Treatment resources  New technology

(17)

Why we need to keep doing research

Evidence based care

Quality of life

Enriching the NHS as dynamic cutting edge

environment

AND MOST OF ALL

To improve the outcomes of the patients who are

affected by cancer

(18)

References

 ATAC Trialists' Group (2005) Results of the ATAC (Arimidex, Tamoxifen, Alone or in

Combination) trial after completion of 5 years' adjuvant treatment for breast cancer, The

Lancet, Volume 365 (9453) 60-62

 Cancer Research UK (2011) http://info.cancerresearchuk.org [accessed 21 November 2011]

 Ferguson T, Wilcken N., Vagg R., Ghersi D., Nowak A K. (2007) Taxanes for adjuvant treatment of early breast cancer. Cochrane Database of Systematic Reviews Issue 4 John Wiley & Sons, Ltd Chichester, UK

 Ford, E., Jenkins, V., Fallowfield, L., Stuart, N., Farewell, D., & Farewell, V. (2011). Clinicians' attitudes towards clinical trials of cancer therapy. British Journal Of Cancer, 104(10), 1535-1543

 GIANNI, L., DAFNI, U., GELBER, R. D., AZAMBUJA, E., MUEHLBAUER, S., GOLDHIRSCH, A., UNTCH, M., SMITH, I., BASELGA, J., JACKISCH, C., CAMERON, D., MANO, M., PEDRINI, J. L., VERONESI, A., MENDIOLA, C., PLUZANSKA, A., SEMIGLAZOV, V., VRDOLJAK, E., ECKART, M. J., SHEN, Z., SKIADOPOULOS, G., PROCTER, M., PRITCHARD, K. I., PICCART-GEBHART, M. J. & BELL, R. (2011) Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. The Lancet Oncology, 12, 236-244.

(19)

References (continued)

Jenkins, V., Farewell, D., Batt, L., Maughan, T., Branston, L., Langridge, C., & Fallowfield, L.

(2010) The attitudes of 1066 patients with cancer towards participation in randomised clinical trials. British Journal Of Cancer, 103(12), 1801-1807.

 MITCHELL, C., RICHARDS, S., HARRISON, C. J. & EDEN, T. (2009) Long-term follow-up of the United Kingdom medical research council protocols for childhood acute lymphoblastic leukaemia, 1980-2001. Leukemia, 24, 406-418.

 National Cancer Research Network (2011) ncrn.org.uk [accessed 14 November 2011]

National Institute for Health and Clinical Excellence (2011)

http://www.nice.org.uk/newsroom/features/measuringeffectivenessandcosteffectivenesstheq

aly.jsp [accessed 21 November 2011]

SULLIVAN, R., LEWISON, G. & PURUSHOTHAM, A. D. (2011) An analysis of research activity in

References

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