Transcript Axillary Clearance – Is It Still the Standard of Care? - SGPGI

Basis and Outcome of Axillary
Dissection for Node Negative Axilla
Gurpreet Singh
Dept. Of Surgery
P.G.I.M.E.R.
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• Moynihan stated at the turn of the
last century that "surgery of
malignant disease is not the surgery
of organs; it is the anatomy of the
lymphatic system...“
Rationale for ALND in Breast Cancer
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Accurate staging
Regional control of the disease
Prognostic information
Influence of the information on the
adjuvant therapy
• Improved survival
Need for Revaluation of ALND
• Screening mammography
• Adjuvant systemic therapy to
node negative patients
• Financial implications of ALND
– Saving of OT time
– Saving in admission costs
• Complications of ALND
Complications of ALND
50% to 70% of patients
undergoing ALND will have some
complaints
Early
• Skin erythema
• Seroma
• Wound infection
Complications of ALND
Delayed
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Shoulder motion (17%)
Arm edema (16%)
Pain (25%)
Intercostobrachial nerve
numbness (78%)
Patients Perception of
Complications of ALND
Ann Surg 2004;240: 1–6
Staging
Frequency of Tumor + Nodes
No. of
patients
Silverstein
1031
T1a
T1b T1c
T2
3
17
32
44
McGee
3077
12
23
33
54
Giuliano
259
10
13
30
-
Cady
570
-
17
31
44
Average
4937
7
19
32
51
World J Surg 2001; 25:761–766
Staging of the Axilla
• Clinical examination
• Imaging methods
• Preoperative prediction of nodal
involvement
• Axillary node sampling
• Sentinel lymph node biopsy
Local Control
Axillary Failure in Clinically Node –
Patients: No Axillary Treatment
Axillary Failure in Clinically Node –
Patients: Axillary RT
Adjuvant Treatment
Will ALND Change Treatment
• Two hundred eighty-two women with
clinically negative axillae were
analyzed using a model treatment
algorithm
• Systemic therapy was assigned with
and without data from axillary
dissection
• Treatment shifts based on axillary
dissection data were scored
Will ALND Change Treatment
• For women 50 to 60 years of age,
– 10% with tumors <1 cm,
– 17% with tumors 1 to 2 cm with positive
prognostic features
– 4% with poor prognostic features
• For women older than 60 years
– 3% of those with tumors <1 cm
– none of those with tumors >1 cm
Ann Surg 1997, 226: 279-287
Is Axillary Lymph Node Dissection
Indicated for Early-Stage Breast Cancer? A
Decision Analysis
Two examples
• Patient A is 60 years old, with a primary
tumor size between 0.5 and 1 cm
• Patient B is 38 years old, with a primary
tumor size between 3 and 4 cm
• Both have ER-positive tumors and
clinically negative axillae
Parmigiani; J Clin Oncol 1999, 17:1465
Additional Life Expectancy
Survival
• Halsted
– centrifugal spread of breast cancer
– radical surgical approach to encompass
all local and regional disease
• Fisher
– “breast cancer is a systemic disease
involving a complex spectrum of hosttumor interactions and variations in
effective local treatment are unlikely to
affect survival substantially”
Long Term Survival
• In radical mastectomy series, it has been shown
that long-term survival is possible in patients
who do not receive adjuvant systemic treatment
– Among 1458 patients, 43% were free of
cancer at 30-years follow-up
– Among 1425 patients with positive axillary
nodes, 30% of patients were alive at 25 years
follow-up
Cancer 1974; 33: 1145–50
Mastologı´a Dina´mica 1995: 421–30
Long Term Survival
• Mammographic screening for
women > 50 years reduces breast
cancer mortality by around 30%
• Post-operative radiotherapy reduces
mortality rates
Lancet 2000; 355:1757-70
J Clin Oncol 2000; 18:1220-29
NSABP – 04 Trial (1971-1974)
• 1079 women with clinically negative axillae
– radical mastectomy
– total mastectomy without axillary dissection
but with postoperative irradiation
– total mastectomy plus axillary dissection only
if their nodes became positive
• None of the women received adjuvant
systemic therapy
N Engl J Med 2002;347:567-75
Distribution of All First Events
Criticism of NSABP-04
• 35% of the patients randomized to receive
total mastectomy alone had a limited
axillary dissection as well. Of the patients
who actually had a total mastectomy, 21%
had an axillary recurrence compared with
12% of patients who had 1-5 nodes
removed and 0% for those who had 6 or
more nodes removed
Breast Cancer Res Treat 1985; 5:17
Criticism of NSABP-04
• The conclusion to be derived from the
B-04 study is not that ALND does not
have any effect on survival but that
the study does not have enough
patients to detect this benefit
Curr Probl Surg 1995; 32: 257
Breast Cancer Survival According to
Number of Nodes Removed
• SEER database of 72,102 patients with breast
cancer who
– had been diagnosed in 1988 or later
– were aged 40–79 years at diagnosis
– had a single primary lesion
– had 0 to 3 positive lymph nodes
• Cases were separated into
– age groups (40 to 49 and 50 to 79 years)
– node-negative cases and those with 1-3
positive nodes
Krag, Ann Surg Oncol 2003 10:1152
Survival According to Nodes Excised
Hazard Ratio Per 5 Nodes Removed
The Impact of Prophylactic Axillary
Node Dissection on Breast Cancer
Survival—A Bayesian Meta-Analysis
• Six randomized controlled trials were
identified, consisting of nearly 3000
patients and spanning four decades
Orr, Ann Surg Oncol, 1999 6:109
The Impact of Prophylactic Axillary
Node Dissection on Breast Cancer
Survival—A Bayesian Meta-Analysis
TRIAL
YEAR
No.
% St-I
%N+
Copenhagen
1951-57
425
68
-
Guy’s I
1961-71
370
60
54
SES
1964-71
498
55
41
B-04
1971-74
727
100
39
Guy’s II
1971-75
258
100
31
Curie
1982-87
658
100
18
The Impact of Prophylactic Axillary
Node Dissection on Breast Cancer
Survival—A Bayesian Meta-Analysis
• All six trials showed that prophylactic
axillary node dissection improved survival,
ranging from 4% to 16%, corresponding to
a risk reduction of 7%-46%
• Combining the six trials showed an average
survival benefit of 5.4% (95% CI 5 2.7-8.0)
Orr, Ann Surg Oncol, 1999 6:109
• Hellman - Spectrum Theory
– Breast cancer is a heterogeneous
disease presenting a spectrum ranging
from a disease that remains
locoregional throughout its course to a
disease which is systemic when first
detected
– Based on this assumption, prophylactic
axillary dissection seems to be
beneficial to a certain proportion of
patients
Conclusions
• Significant number of clinically N0
patients are pN1
• Adjuvant therapy may be different
for N0 and N1 patients
• Excellent local control with ALND or
RT
• Possibility of survival advantage
Maximizing Benefits
• Identify patients who are pN1 and
treat them with ALND
• SLNB is one method for doing this
• Drawbacks
– False negative