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Clair Clark, Cancer Care Pharmacist Beatson West of Scotland Cancer Centre

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(1)

An audit of neutropenic complications in

breast cancer patients receiving adjuvant or

neo-adjuvant chemotherapy with FEC-D in

the West of Scotland (WoS)

Clair Clark, Cancer Care Pharmacist

(2)

Introduction

• Background

• Aims and Objectives

• Criteria and Standards

• Methodology

• Results

• Limitations

(3)

Background

1.

Aaprol, M.S., Cameron D.A. et al (2006) “EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy induced febrile neutropenia in adult

patients with lymphomas and solid tumours” European Journal of Cancer 42: 15: pp 2433-2453

2.

Smith, T.J., Khatcheressian, J. et al (2006) “2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline” Journal of Clincal

Oncology 24: 19: pp 3187-3205

3.

Fraser, J., Steele, N. et al (2010) Non trial experience of FEC-D chemotherapy in node positive breast cancer patients and associated toxicity

4.

Roche, H., Fumoleau, P. et al (2006) “Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 Trial” Journal of Clinical

Oncology, 24: 36: pp 5564-5671

5.

O’Connor, P. (2010) A study of the haematological tolerability of FEC-D as adjuvant chemotherapy treatment of early breast cancer in the West of Scotland, MSc in Clinical Pharmacy, The Robert

(4)

Aims and Objectives

Aim

• To monitor the rate of significant neutropenic

events in breast cancer patients receiving

adjuvant or neo-adjuvant chemotherapy with

FEC-D, following amendment of protocol to

remove GCSF for primary prophylaxis for

(5)

Aims and Objectives

Objectives

To determine;

• The incidence of neutropenic complications in patients

receiving FEC-D chemotherapy

• The proportion of patients receiving GCSF as primary

prophylaxis with FEC phase of FEC-D

• The indication for primary prophylaxis with GCSF during FEC

• The proportion of patients receiving GCSF as secondary

prophylaxis

• The GCSF preparation prescribed and dose / duration / start

date of GCSF

(6)

Criteria

Standard Exceptions

1. During FEC phase of FEC-D treatment;

patients will not receive GCSF for primary

prophylaxis of neutropenia (defined as

neutrophil count <1)

100%

Patients with additional risk

factors for developing

neutropenia as defined by the

WoSCAN GCSF policy.

2. Patients will not have a delay in treatment

of > 7 days as a result of a neutropenic

event (neuts.<1) during FEC phase

80%

3. Patients will not have a delay in treatment

of > 7 days as a result of a neutropenic

event (neuts.<1) during D phase

90%

4. During treatment patients receiving GCSF

will not develop neutropenic sepsis

(neuts.<1 and temp > 38.5

o

C)

90%

5. Patients will only be prescribed GCSF for

secondary prophylaxis following a

neutropenic event

100%

Patients who develop additional

risk factors as defined in primary

prophylaxis GCSF guidelines.

(7)

An audit of neutropenic complications in breast cancer patients receiving

adjuvant/ neo-adjuvant* chemotherapy with FEC-D** in the West of Scotland

* Please mark if patient receiving Adjuvant or Neo-Adjuvant treatment

**Fluorouracil 500mg/m2

Epirubicin 100mg/m2

Cyclophosphamide 500mg/m2

every 21 days for 3 cycles followed by Docetaxel

100mg/m2

every 21 days for 3 cycles

Please return completed forms to: J Laskey, Pharmacy Department, Beatson West of Scotland cancer Centre Page 1 of 2

Section 1: Patient / Hospital details

Patient identifier: Weight (kg):

Hospital site (please tick): Ayr  BWOSCC  CrossH  Forth valley  Hairmyres  InverC  Monks  NVH  RAH  Wishaw  VoL

Section 2: Therapy Details

Cycle 1 FEC Cycle 2 FEC Cycle 3 FEC

Date

2.1a Has full dose been

prescribed as per footnote? If ‘YES’ go to question 2.2 YES / NO If ‘YES’ go to question 2.2 YES / NO If ‘YES’ go to question 2.2 YES / NO 2.1b What dose was

prescribed? Dose: ………. Dose: ………. Dose: ………. 2.2 Has GCSF been prescribed as primary prophylaxis? YES / NO YES / NO If ‘No’ go to question 2.4 YES / NO If ‘No’ go to question 2.4 2.3 Reason for primary

prophylaxis?

Pre-existing neutropenia  Poor performance status  Open wound  Tissue infection  Other, please state ________________

Pre-existing neutropenia  Poor performance status  Open wound  Tissue infection  Other, please state ________________

Pre-existing neutropenia  Poor performance status  Open wound  Tissue infection  Other, please state ________________ 2.4 Neutropenic sepsis

since last cycle?

i.e. neuts < 1.0 and temp ≥ 38.5◦C

N/A YES / NO YES / NO 2.5 Delay of ≥ 7 days in

chemo due to neutrophils < 1?

N/A YES / NO YES / NO 2.6 Has GCSF been

prescribed as secondary

prophylaxis?

N/A YES / NO If ‘Yes’ please state reason: Neut sepsis  Neut delay  Other:_____________

YES / NO If ‘Yes’ please state reason: Neut sepsis  Neut delay  Other:____________ 2.7 Dose of GCSF prescribed? Filgrastim 300mcg  Filgrastim 480mcg  Pegfilgrastim 6mg  Other___________ Filgrastim 300mcg  Filgrastim 480mcg  Pegfilgrastim 6 mg  Other ____________ Filgrastim 300mcg  Filgrastim 480mcg  Pegfilgrastim 6mg  Other ____________ 2.8 Duration of GCSF? One dose 

5 days  7 days  10 days  Other __________ One dose  5 days  7 days  10 days  Other __________ One dose  5 days  7 days  10 days  Other __________ 2.9 Start day? Day 2 

Day 3  Day 5  Other ___________ Day 2  Day 3  Day 5  Other ___________ Day 2  Day 3  Day 5  Other ___________

Methodology

Prospective and retrospective data

were collected by Clinical Pharmacists

using piloted data collection form

All hospital sites which deliver breast

cancer chemotherapy in the West of

Scotland were included

Only patients who were commenced

on the amended FEC-D regimen were

included

(no FEC GCSF 1

o

prophylaxis)

Patients were recruited over 6 months

and followed up at each cycle until

end of their FEC-D chemotherapy

(8)

No. of patients included

111

Patient Population

6

excluded for not

meeting inclusion criteria

10 Hospital sites

included

Ayr

4

BWOSCC

29

CrossH

12

H.myers

10

IRH

7

Monklands

Wishaw 20

NVH

14

VoL

1

2

50%

12

41%

2

17%

1

14%

5

25%

1

100%

FV

14

6

43%

5

36%

4

40%

38 patients

(34.2%) weighed

> 80kg

67 Adjuvant

Patients

40 Neo-adjuvant

Patients

4 Intent not

recorded

No. of forms returned

(9)

Results

Criteria (100%)

1. During FEC portion

of FEC-D treatment;

patients will not

receive GCSF for

primary prophylaxis

of neutropenia

100%

• 6 patients were

prescribed GCSF

from #1 FEC

• All had risk factors

included in GCSF

protocol

(10)

Results

Criteria (80%)

2. Patients will not

have a delay in

treatment of > 7

days) as a result of a

neutropenic event

during FEC portion of

treatment

92.1%

• Total number of

FEC treatments

recorded, n=327

• Number of cycles

delayed by > 7 days

due to neutropenic

event, n= 26 or

7.9%

(11)

Results

Criteria (90%)

3. Patients will not

have a delay in

treatment of > 7 days)

as a result of a

neutropenic event

during D portion of

treatment

99.4%

• Total number of

Docetaxel

treatments = 330

• 2 patients

developed N. Sepsis

after #2 D = 0.6%

• No other

neutropenic delays

recorded

(12)

Results

Criteria (90%)

4. During treatment

patients receiving

GCSF will not develop

neutropenic sepsis

• Total number of

treatments with

GCSF = 374

( 52 FEC; 322 D)

• Number resulting in

neutropenic sepsis

= 5 (3 patients)

98.6%

(13)

Results

Criteria (100%)

5. Patients will only be

prescribed GCSF for

secondary prophylaxis

following a

neutropenic event.

100%

• 1 patient received

GCSF following #2

FEC who had not

developed low

neutrophil count

• Wound reopened 

(14)

Incidences of N. Sepsis

Per

cen

tag

e

of

cy

cles

r

esul

ting

in

neut

ropenic

sep

si

s

du

ri

ng

FE

C

-D

1.7

4.2

7.7

0

0

5.4

0

1

2

3

4

5

6

7

8

9

no GCSF

with GCSF

Weight at cycle 1

< 70kg

71-79 kg

> 80kg

4 = pegfilgrastim

1 = filgrastim

480mcg daily

for 7 days

from day 3

70.5% of n. sepsis

events were in the

>80kg population

(15)

Limitations

• No data following final cycle of treatment

• Weight not monitored at each cycle, height not

recorded

– unclear level of obesity in cohort/ unclear if doses were

amended for weight change at each cycle

• Dose only documented as % of full dose

– Site variation in dose capping

• Insufficient baseline characteristics obtained

– unable to determine other causes of increased risk of

neutropenic events (e.g. age)

(16)

Conclusion

Discussion

All criteria and standards are being met across the West of

Scotland network

Rates of neutropenic events following removal of GCSF

primary prophylaxis during FEC treatment were acceptable,

although seem higher in the obese population

Recommendations

Maintain the FEC-D protocol, restricting GCSF use to

secondary prophylaxis during FEC

Further study into obese patients receiving FEC-D

References

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