Classical CMF (Cyclophosphamide, Methotrexate, 5

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Classical CMF (Cyclophosphamide, Methotrexate, 5-Fluorouracil
Cumbria, Northumberland, Tyne & Wear Area Team
DRUG ADMINISTRATION SCHEDULE
Day
Day 1
24 hours
after chemo
Day 8
24 hours
after chemo
Drug
Daily Dose
Route
Diluent & Rate
Sodium Chloride 0.9%
250/500ml
Infusion
Fast Running
Dexamethasone
8mg
Ondansetron**
8mg
Oral
Oral /Slow bolus/15 min infusion
Cyclophosphamide*
600 mg/m2
IV Bolus
Via saline drip
Methotrexate
40 mg/m2
IV Bolus
Via saline drip
5-Fluorouracil
600 mg/m2
15mg QDS for 1/7
(see notes)
IV Bolus
Via saline drip
Sodium Chloride 0.9%
250/500ml
Infusion
Dexamethasone
8mg
Ondansetron
8mg
Cyclophosphamide*
600 mg/m2
IV Bolus
Via saline drip
Methotrexate
40 mg/m2
IV Bolus
Via saline drip
5-Fluorouracil
600 mg/m2
15mg QDS for 1/7
(see notes)
IV Bolus
Via saline drip
Folinic Acid
Folinic Acid
oral
Fast Running
Oral
Oral /Slow bolus/15 min infusion
oral
*Cyclophosphamide can also be given orally at 100 mg/m2/day from day 1 to day 14
**Ondansetron IV must be infused over 15 minutes in patients over 65 years of age.
CYCLE LENGTH AND NUMBER OF DAYS
28 DAYS, for 6 cycles
APPROVED INDICATIONS
• Metastatic or adjuvant therapy for breast cancer for patients unsuitable
for anthracyclines
PREMEDICATION
As above
RECOMMENDED TAKE HOME MEDICATION
Metoclopramide 10 mg three times daily as required
INVESTIGATIONS / MONITORING REQUIRED
FBC Prior to Day 1 and Day 8
LFT’s & U&E's every 28 days
CRP09-CMF-protocol-CRP09-B017-v1.3
Issued 29 May 2014
Page 1 of 3
Expiry Date: 29 May 2016
Classical CMF (Cyclophosphamide, Methotrexate, 5-Fluorouracil
Cumbria, Northumberland, Tyne & Wear Area Team
ASSESSMENT OF RESPONSE
There will be no visible disease to monitor as this is adjuvant treatment.
REVIEW BY CLINICIAN
To be reviewed by either a Nurse, Pharmacist or Clinician before every cycle.
NURSE / PHARMACIST LED REVIEW
On cycles where not seen by clinician.
ADMINISTRATION NOTES
• Folinic Acid used as rescue therapy as either a single 30mg dose or 15mg QDS
given orally 24 hours after chemotherapy
EXTRAVASATION See NECN / Local Policy
TOXICITIES
•
•
•
•
•
•
•
Myelosuppression.
Haemorrhagic cystitis due to cyclophosphamide. Encourage patient to drink 2 to 3
litres of fluid a day.
Occasionally patients with heart disease may experience coronary artery spasm
with 5-FU
Metallic taste in mouth during administration of cyclophosphamide
Alopecia (worse with oral cyclophosphamide)
Pulmonary toxicity due to Methotrexate
Stomatitis / Mucositis
DOSE MODIFICATION / TREATMENT DELAYS
Haematological Toxicity:



Delay 1 week if WBC<3.0, ANC <1.0 Platelets <100
No dose modification for CTC grade I/II ANC
Grade III/IV ANC → delay chemotherapy until recovered. On recovery give 20% dose
reduction
Non- Haematological Toxicity:
If patient has Grade III/IV nausea & vomiting give Oral Ondansetron 8mg BD for 5 days
& Dexamethasone 4mg QDS for 1 day and then Dexamethasone 4mg once daily for a
further 4 to 5 days. Alternatively consider adding in Aprepitant (or refer to NECN antiemetic guideline).
CRP09-CMF-protocol-CRP09-B017-v1.3
Issued 29 May 2014
Page 2 of 3
Expiry Date: 29 May 2016
Classical CMF (Cyclophosphamide, Methotrexate, 5-Fluorouracil
Cumbria, Northumberland, Tyne & Wear Area Team
Renal Dysfunction:
Methotrexate
Dose
100%
65%
50%
CI
CI
5FU Dose
>60ml/min
45-60ml/min
30-45ml/min
20-30ml/min
10-20ml/min
Cyclophosphamide
Dose
100%
100%
100%
100%
75%
<10ml/min
50%
CI
100%
CrCl (or GFR)
Hepatic Dysfunction:
Bilirubin µmol/l
<50
51-85
>85
AND
OR
AST
<180
>180
100%
100%
100%
100%
100%
Methotrexate Dose
100%
75%
CI
TREATMENT LOCATION
Can be administered in either Cancer Centre or Cancer Unit
REFERENCE:
• Bonadonna G, Valagussa P, Moliterni A et al. (1990) Milan adjuvant and neoadjuvantstudies in Stage l and II respectable breast cancer. In ES Salmon (ed.).
Adjuvant Therapy of Cancer VI. WB Saunders, Philadelphia,PA.
• A-CMF Buzzoni R, Bonadonna G, Valagussa P, et al: J Clin Oncol 9:2134–2140,
1991.
Document Control
Document Title:
CMF protocol CRP09 B017
Document No:
CRP09 B017
Author:
Approved by:
Current
Version:
1.3
Steve Williamson, Consultant Pharmacist
Approval
Signature*
Calum Polwart, Cancer Pharmacist
Alison Humphreys, Consultant Oncologist
29 May 2014
Date
Approved:
Due for Review:
29 May 2016
Summary of
Changes
1.1
Reformatted from old NCN/CCA version
1.2
Protocol reviewed. Indications amended. Anti-emetic advice reviewed. Renal
and hepatic impairment dose advice added.
1.3
Protocol reviewed and reissued, Antiemetic advice updated
CRP09-CMF-protocol-CRP09-B017-v1.3
Issued 29 May 2014
Page 3 of 3
Expiry Date: 29 May 2016
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