Purastat therapy for bleeding radiation proctopathy

Abstract

There are limited data as to the effectiveness of Purastat to treat bleeding radiation proctopathy. We present prospectively collected data from a consecutive series of 11 patients with severely symptomatic bleeding radiation proctopathy treated with Purastat. Bleeding reduced after treatment and became very minor or occasional or stopped completely, in all patients after a median of 3 treatments. Two thirds of patents improved with each treatment, one third needed two or more treatments before bleeding reduced. Nuisance scores before treatment were a median 8.5/10 and fell to 0.5/10 at last follow up. The improvement seen was sustained over time.

Core Tip: New data on the effectiveness of Purastat. There are limited data as to the effectiveness of Purastat to treat bleeding radiation proctopathy. Purastat reduced bleeding and improved nuisance scores in 11 patients with severely symptomatic bleeding radiation proctopathy.

TO THE EDITOR

I read with interest the review of Purastat (RADA16, self-assembling peptide) therapy[1]. Its role in radiation-induced bleeding may be particularly valuable as radiation proctopathy is predominantly an ischaemic condition[2] and the risk from using thermal therapies in ischaemic tissue although sometimes advocated[3], is high[4,5].

As the optimal time-interval or total number of treatments with Purastat for bleeding radiation proctopathy is not known and the published outcomes from endoscopic treatment are limited[6], I present preliminary data from a prospective service evaluation conducted in patients with radiation-induced bleeding.

Other causes for bleeding were excluded. If rectal bleeding - after optimisation of any disordered bowel function - continued to cause anaemia or require blood transfusion or iron therapy or incontinence of blood was occurring or bleeding interfered with daily activities or the patient reported that the bleeding was affecting their quality of life, treatment with Purastat was offered.

Patients were treated with 3-5 mL intrarectal Purastat after full bowel preparation. Up to 5 sessions of treatment were offered at 2 weekly intervals or until adequate symptom improvement. Patients completed a symptom questionnaire before each treatment and during telephone follow up.

Eleven men treated for prostate cancer, median age 77 (range 68-84) underwent Purastat therapy, median 3 (range 1-13) years after radiotherapy. Nine were taking anti-platelet agents or anti-coagulants. Two had required repeated transfusion. Two had grade 1, four, grade 2, five, grade 3 radiation proctopathy[7]. Patients required median 3 (range 1-5) treatments for adequate improvement. 8 patients reported progressive improvement after each treatment, 3 had a sudden improvement, one after their 3^rd and two after their 4^th treatments. Bleeding nuisance (using a visual analogue scale) improved from median 8/10 (5-10) to 0.5/10 (0-7) at last follow up which is 1-14 months and ongoing. There were no treatment complications. Two patients died from unrelated causes. Purastat was provided free for this study by 3D Matrix.

CONCLUSION

Purastat reduced bleeding and improved nuisance scores in all patients. Time to improvement in this small study was not obviously related to grade of proctopathy or use of anticoagulation. Improvement were sustained over time. As individual units see only small number of affected patients, to obtain better data a registry to record outcomes prospectively from Purastat therapy for bleeding radiation-proctopathy has been set up (details available from author).