Alberta Breast Cancer Program
Adjuvant Systemic Therapy Guidelines
(Stages I & II)
Reviewed and approved 20
June 2008.
-
Risk Categories for Lymph
Node Negative Breast Cancer
| Risk
Category |
Risk
Factors |
| NEGATIVE RISK
FACTORS |
-
Age < 35 years
- cerB2 (HER2)
over-expression
- presence of
lymph/vascular invasion
- Grade 3
- Hormone receptor
negative (ER/PR negative)
|
| Lower risk |
-
< 1 cm with no negative risk factors
-
1-2 cm, grade 1, no other negative risk factors |
| Intermediate risk |
- All other combinations
of factors that do not fit into either the low or high risk
criteria
|
Higher
risk |
- 1 - 2 cm with
any 2 or more Negative risk factors,
- >2-3 cm with
any 1 or more Negative risk factors,
- >3 cm (regardless
of other Negative risk factors)
- special consideration
for HER2+ tumors (see below)
|
| |
Hormone Receptor (+) |
Hormone Receptor (-) |
| Lower
risk |
Observation*
OR
Hormonal
Rx |
Observation |
| Intermediate
risk |
Hormonal
Therapy
+/-
Chemotherapy |
Chemotherapy |
| Higher
risk |
Chemotherapy
+/-
Hormonal
Therapy |
Chemotherapy |
*No
systemic therapy may be offered to patients in cases where:
- Tumor is less
than 1 cm or
- If the patient
has other significant co-morbidities which precludes the safe
administration of systemic adjuvant therapy or
- Patient has limited
life expectancy |
| Chemotherapy
Options for Lymph Node Negative Breast Cancer |
| HER2(-)
LN(-) |
|
Lower risk
Intermediate risk:
Higher risk: |
No
systemic therapy recommended
CMF or AC
CMF or AC or DC
or FEC x 6 |
| HER2(+)
LN(-) |
|
Size considerations:
<0.5 cm:-
- no further systemic therapy recommended
0.5 cm to 1 cm:
- - ER (+) - endocrine therapy only
- - ER (-) - discuss chemotherapy/trastuzumab
> 1 cm: discuss
chemotherapy/trastuzumab +/- endocrine therapy (if applicable) |
|
Chemotherapy
options for HER2+/lymph node negative:
- Anthracycline based option: AC x 4 or FEC X 6, followed
by sequential trastuzumab
- Non-Anthracycline based options (if concerned about cardiac
risk): DCbH or DC- followed by sequential trastuzumab
|
|
2.
Risk Categories for Lymph Node Positive Breast Cancer
| |
Hormone
Receptor (+) |
Hormone Receptor (-) |
| HER2(-) |
Chemotherapy
+
Hormonal
Therapy |
Chemotherapy |
| HER2(+) |
Chemotherapy
+
Trastuzumab
+
Hormonal
Therapy |
Chemotherapy
+
Trastuzumab |
*no
systemic therapy may be offered to patients in cases where:
- the patient has other significant co-morbidities which
precludes the safe administration of systemic adjuvant therapy
or
- Patient has limited life expectancy
|
| Lymph Node Positive Guidelines |
| Chemotherapy
- Taxane based therapy is a preferred treatment option in cases
of LN+ breast cancer wherever medically appropriate
- HER2+ - optimal duration of trastuzumab has not been completely
eludicated. Based on the available data to date, 1 year of trastuzumab
therapy (concurrent or sequential) is preferred.
|
| HER2(+) |
Preferred:
- FEC-DH*
* timing of trastuzumab addition (in relation to preceding anthracycline
exposure) is at the discretion of the treating physician, in cases
where concern about potentiating cardiotoxicity risk exist
- DCbH
Other evidence based options
include:
- AC - DH
- AC - PH
- Any chemo - Trastuzumab
(HERA)
Special considerations
- Cardiac risk - DCbH or DC followed by
sequential trastuzumab |
| HER2(-) |
Preferred:
- FEC - D
Other evidence based options
include:
- TAC (with G-CSF support)
- AC - D
- AC - P (dose dense)
- FEC x 6
- DC
- AC - P (standard)
Special considerations
(Cardiac Risk) - DC or CMF |
Endocrine Therapy (for
hormone receptor positive disease only)
Drug information sheets
for the medications mentioned can be found here.
| Patient
Group |
|
| Premenopausal |
Tamoxifen
x 5 years*
*In pre-menopausal
patients who develop amenorrhea post chemotherapy
- No clinical trial
information is currently available to guide us in the use
of AIs in this population as these types of patients were
not included in the adjuvant AI trials
- Standard hormonal
assays and/or monitoring algorithms are currently inadequate
or unavailable to ensure that these types of patients are
truly postmenopausal while on AIs
- Patients having
had bilateral oophorectomy should be considered to be post-menopausal
(see below) |
| Postmenopausal |
De
novo treatment
(i.e. no prior
adjuvant hormonal therapy)
-Preferred option=
Tam x 2-3 years - AI x 3-2 years (exemestane or anastrozole)
- (total 5 years
adjuvant hormonal therapy)
Alternative option
= Upfront AI x 5 years
(anastrozole or
letrozole)
- If contraindication
(absolute or relative) to tamoxifen exists
- Or clinical preference
For patients with
early stage, hormone receptor positive tumors having completed
5 years of Tamoxifen
- LN(+) or high
risk LN(-)
- AI x 3-5 years (letrozole) after completing Tamoxifen
In the cases of
AI intolerance - an alternate AI may be used
At this time, no
evidence exists for the standard use of fulvestrant in the
adjuvant setting |
| |
Chemotherapy
Legend:
CMF = cyclophosphamide,
methotrexate, 5-FU
AC = adriamycin,
cyclophosphamide
FEC = 5-FU, epirubicin,
cyclophosphamide
FEC-D = FECx3-Dx3
TAC = docetaxel,
adriamycin, cyclophosphamide
DC = Docetaxel,
Cyclophosphamide
Cb= Carboplatin
D= Docetaxel
P= Paclitaxel
H= Trastuzumab
(Herceptin®)
|
| |
|
|
