Prospective Study of Outcome in Sporadic versus Hereditary Breast Cancer: pros and cons of running a cohort study

Background

The Prospective Study of Outcome in Sporadic versus Hereditary Breast Cancer (POSH) first started recruiting in June 2001 and will stop recruiting in December 2007. Follow-up is funded until December 2009. There are 2,665 participants recruited to the study by 10 October 2007. All participants were diagnosed with a first primary invasive breast cancer since January 2000 and were ≤ 40 years old at diagnosis. Eligibility criteria also allow inclusion of those with known BRCA gene diagnosed at ≤ 50 years of age.

Method

Recruitment has been mainly through oncology centres across the UK and was greatly facilitated by adoption into the National Cancer Research Network in November 2002. Data collection points are at diagnosis, 6 months, 12 months and annually to 5 years.

Results

Pros

• Patients like the study, as it usually only involves patient contact at the point of consent and at the first annual follow-up. Very few decline to participate.

• Clinical trials practitioners like the study as it is easy to recruit to, and fits with routine follow-up regimes.

• The study gives enormous potential for translational studies improving the understanding of not only genetic aspects but the basic pathobiology of young-age breast cancer.

Cons

• It can be difficult to obtain funding for cohort studies.

• Some clinical trials practitioners dislike the follow-up forms and the quantity of data requested.

• Postal strikes have an impact on recruitment timing and can lead to additional patient appointments for blood donation.

• Changes in ethics regulations over a 6-year period have resulted in inconsistent and confused responses to protocol amendments with consequent delays.

• The UK Cancer Research Network point system changed, with treatment trials given higher points.

Conclusion

The mechanics of running this study and some early summary data about the cohort will be presented and will be of interest to researchers already involved in the study or who may be considering starting a similar study or with a specific interest in collaborative studies around young-onset breast cancer.