Authorisation of Lung Systemic Anti-Cancer Therapy (SACT) Protocols Authorisation of Lung SACT Protocols Signature Print name/Title Written by: Ms M McGrady Pharmacist Regional Lead Cancer Services Pharmacist (job share) Approved by Dr P Scullin Systemic Medical Oncologist Guidelines Author
Date February 2011
February 2011
Approved by Clinical Lead
Dr J McAleese Clinical Oncologist
February 2011
Approved by Clinical Director
Dr S McAleer Clinical Director
February 2011
Review Date
February 2013
These SACT protocols are accepted as regimens for the treatment of lung cancer as stated in the Lung SACT Guidelines. Consultant Oncologist Signature
Valid on date of printing only
Print Name/Title Dr Lynn Campbell Consultant Medical Oncologist Dr Ruth Eakin Consultant Clinical Oncologist Dr Gerry Hanna Consultant Clinical Oncologist Dr Jacqui Harney Consultant Clinical Oncologist Dr Fionnuala Houghton Consultant Clinical Oncologist Dr Jonathan McAleese Consultant Clinical Oncologist Dr Darren Mitchell Consultant Clinical Oncologist Dr Paula Scullin Consultant Medical Oncologist
Page 2 of 67
NSCLC001/10
Non Small Cell Lung Cancer Systemic Anti-Cancer Therapy Protocols Cisplatin/Vinorelbine Indication: First line adjuvant treatment of Non Small Cell Lung Cancer. Treatment intent: Curative. Eligibility criteria: Consider adjuvant therapy for post operative patients with: Tumour >4cm or node positive disease Performance status – ECOG PS 0-1 Adequate renal, liver and bone marrow function Staging carried out pre op with CT scan and PET scan is adequate. Pre-treatment evaluation: Informed consent, provision of verbal and written information Assessment of performance status Height, weight and BSA Chest X ray on every other cycle or as clinically indicated Brain scan not required unless symptomatic CT scan prior to cycle 1 treatment Clinical assessment of cardiac function first visit Clinical assessment of hearing and neurological function each visit Day 1: FBP, DWCC, U&E, Ca, Mg, LFTs, calculated GFR Day 8: FBP, DWCC.
Mannitol 20% Sodium chloride 0.9%* Cisplatin 75mg/m2 Post hydration
Metoclopramide
Fluids or bolus
Time
Days
Sequence
Route
Bolus Bolus 50ml sodium chloride 0.9% 1000ml sodium chloride 0.9% and 20mmol potassium chloride and 4mmol magnesium sulphate 100ml bolus
2 mins 5 mins 5 mins
1 1 1&8
1 2 3&9
IV IV IV
2 hours
1
4
IV
10 mins 30 mins 2 hours 2 hours
1
5
IV
2 mins
500ml
10mg
1000ml sodium chloride 0.9% 1000ml sodium chloride 0.9% and 20mmol potassium chloride and 4mmol magnesium sulphate Bolus
IV 1
6
IV
1
7
IV
8
8
IV
* NB Only give 500ml sodium chloride 0.9% over 30 mins pre cisplatin if urine output 90%)
Valid on date of printing only
Page 4 of 67
NSCLC001/10
Is GCSF indicated? Yes- secondary prophylaxis pegfilgrastim to be given 24 hours after chemotherapy completed. Adverse effects/ Precautions & contraindications: Cisplatin see SPC Vinorelbine see SPC Available at: http://emc.medicines.org.uk/ Extravasation risk category: Available at: www.cancerni.net/extravasation Investigations prior to subsequent cycles: Chest X ray on every other visit or as clinically indicated. Clinical assessment of hearing and neurological function each visit Audiogram after cumulative dose of 360mg/m2 cisplatin. Day 1: FBP, DWCC, U&E, Ca, Mg, LFTs, calculated GFR Day 8: FBP, DWCC. Dose modifications: Haematological: Use up to date FBC Day 1 ANC (x109/L) ≥ 1.5