Background

30,000 people are treated with pelvic radiotherapy annually in the UK. Rectal bleeding is a common side effect. One of the main causes is RP.

Radiation causes ischaemia and fibrosis, leading to neovascularisation with friable blood vessels, the source of bleeding.

6% develop severe bleeding from RP, which can cause anaemia requiring iron replacement +/- blood transfusion. There are few safe, effective, evidence-based treatments.

Purastat is a haemostatic agent licenced for bleeding from small vessels in the GI tract. This self-assembling peptide forms a molecular mesh in contact with blood, sealing blood vessels.

We report the first data for the use of Purastat for the treatment of RP.

Method

Consecutive patients attending pelvic radiation disease clinic with severe RP (rectal bleeding into the pan +/- clots +/- anaemia with no response to rectal sucralfate +/- hyperbaric oxygen therapy) were offered treatment with Purastat.

Purastat (3-5mls) was applied endoscopically at 4 weekly intervals.

Severity of bleeding was recorded using patient diaries.  Severity of RP was graded using the Zinicola score (1).

Results

All 21 patients offered Purastat accepted treatment.

Baseline patient characteristics are shown in Table 1.

Median number of Purastat treatments was 3 (2-7).

Number of episodes of rectal bleeding into the toilet bowl reduced from median 4.5 (range 0–27) to 2 (range 0–16) from the 7 days pre- first treatment to the 7 days pre- third treatment.

Eight patients had no rectal bleeding following treatment (38%) and 14 patients had reduced rectal bleeding episodes (67%).

Improvement in endoscopic grading in 12 patients (no change in 9 patients).

Mean haemoglobin increased by 3.7 g/L between baseline to post third treatment values and by 6.7 g/L between baseline and follow-up.

No complications.

Conclusion

Even in this cohort of the most severe cases of RP, there was an improvement in rectal bleeding and endoscopic grade.

A randomised controlled trial is planned to determine the safety and efficacy of Purastat in this patient group to address this ongoing significant area of unmet clinical need and reduce associated morbidity and healthcare costs.

Impact statement

Purastat is a novel, safe treatment for patients with severe RP.