1. NECN S/C Herceptin Reactions October 2014 Wendy Anderson Macmillan Nurse Consultant Chemotherapy STNHSFT Melanie Robertson Nurse Consultant Oncology CHS

2. Background IV Herceptin administration requires – 6 hours observation post first cycle – 2 hours observation post subsequent cycles Network protocol for IV Herceptin administration requires – 6 hours observation post first cycle – 2 hours observation post second cycle – Subsequent treatments no observation S/C Herceptin licence recommends observation as per IV Local experience within SafeHer clinical trial suggested observation may not be required.

3. Objectives Monitor the number of patients without administration reactions to S/C Herceptin To specify reactions that were observed or patient reported Report the type severity and timing of any observed reactions Make recommendations re observation requirements following S/C Herceptin administration

4. Method All NECN cancer centres and units were invited to participate in audit Seven out of nine Trust submitted patient details to the Network Information was collected retrospectively on previous administered cycles

5. Audit sample 110 number patients received S/C Herceptin 618 doses (at least) of S/C Herceptin were administered in total 87% received S/C Herceptin as single agent 13% received S/C Herceptin concurrently with chemotherapy 78% received S/C Herceptin as adjuvant treatment

6. Results

8. Treatment intent

9. Treatment type

10. Reactions Of the 618 treatments given to 110 patients – 3 patient reactions were seen – 2.7% of patients had a reaction to S/C Herceptin – Reactions were seen in 0.4% of overall treatments administered. The audit had expected to document what proportion of patients were observed for the required time period but unfortunately failed to do so.

11. Reactions Of 110 patients and 618 doses given 3 patients had an observed reaction no patients self reported a reaction Reactions as below Subsequent management – Reaction 1 subsequent treatment given IV – Reaction 2 Continued without intervention – Reaction 3 subsequent treatment given with Paracetamol and Chlorampheniramine pre meds ReactionCycleReaction TypeReaction type Other please stateSeverityDrugsReaction time 13RashblisteringpainSeverenonduring admin 29Rasherythema Mildnon2 hours 31FeverfeverdizzinessmoderateParacetamol3 mins

12. Recommendations NECN Chemotherapy group to consider the following options regarding observation schedule post S/C Herceptin administration Option1 - Observe in accordance with licence Option 2 – Observe as per current NECN guidelines (6 hrs first treatment, 2hrs second) Option 3 – No observation recommended