1
Ongoing Controversies in Surgical Management
Terry Mamounas, M.D., M.P.H., F.A.C.S.Medical Director, Comprehensive Breast Program
UF Health Cancer Center at Orlando HealthProfessor of Surgery, University of Central Florida College of Medicine
Clinical Professor of Clinical Sciences,Florida State University College of Medicine
Outline
• Optimal Management of the Clinically Negative Axilla with Positive SLN(s)
• Optimal Management of the Axilla in Patients Treated with Neoadjuvant chemotherapy
• Adequate Margin Width in Breast Conserving Surgery
• Role of Surgical Excision of the Primary Breast tumor in Patients Presenting with Stage IV Disease
2
Clinically Negative Axillary NodesN=5611
GROUP 1Sentinel Node
Biopsy
Axillary Dissection
GROUP 2Sentinel Node
Biopsy*
Randomization
Stratification• Age
• Clinical Tumor Size• Type of Surgery
*Axillary node dissection only if the SN is positive
NSABP B-32: RCT of SLNB +/- ALND
• ID Rate: 97%• FN Rate: 9.8%
• Average # SLNS: 2.9• Factors significantly
affecting ID rate:– Age, Tumor Size and Tumor Location
• Factors significantly affecting FN rate:
– Type of Biopsy and Number of Removed SNs
Krag D et al: Lancet Oncology 2007
3
NSABP B-32: False-Negative Rate According to Number of Removed SNs
Krag D et al: Lancet Oncology 2007
_
4
NSABP B-32 Sentinel Node-Negative PatientsDFS, OS and LRR
0
20
40
60
80
100
0 2 4 6 8 10
% D
ises
e-Fr
ee
Years after Randomization
Julian T, et al: SABCS 2013, Abst. S2-05
Treatment N EventsSNR+AD 1975 455SNR 2011 475
HR=1.02 p=0.720
20
40
60
80
100
0 2 4 6 8 10
% S
urvi
ving
Years after Randomization
Treatment N DeathsSNR+AD 1975 228SNR 2011 252
HR=1.09 p=0.35
SN+AND (N=1975) SN (N=2011)Local 75 (3.8%) 66 (3.3%) Axillary 4 (0.2%) 11 (0.5%) Extra-axillary 5 (0.3%) 4 (0.2%)
5
Optimal Management of the Clinically Negative Axilla with
Positive SLN(s)
6
ACOSOG Z0011
Giuliano AE et al: JAMA 2011
EndpointSLNBAlone
SLNB +
ALND
Pvalue
Additional Positive Nodes on ALND
N/A??
27.3%97 pts
5-Year In-Breast Recurrence
2.1% 3.7% 0.16
5-Year Axillary Nodal Recurrence
1.3% 0.6% 0.44
5-Year Overall Survival
92.5%(90-95.1)
91.8%(89.1-94.5)
HR: 0.870.25
5-Year DFS 83.9%(80.2-87.9)
82.2%(78.3-86.3)
HR: 0.880.14
Completion ALND
(n=445)
No Further Surgery(n=446)
Randomization
Lumpectomy+
Breast XRT
Included in Primary Analysis
N=420 N=436
Clinically Negative Patients1-2 Positive SNs by H & E
7
IBCSG 23-01 Trial• Tumor Size < 5 cm• Clinically Node
Negative • > 1 Micrometastases in
the Sentinel Node
RandomizeN=934
ALND
No ALND
9% had mastectomy
13% +NSNs
HR (no ALND vs. ALND)HR=0.87; 80% CI (0.67‐1.12);
below non‐inferiority boundary of 1.25
N 5-Yr DFS %
No ALND 467 88.4% 0.48
ALND 464 87.3%
N 5-Yr OS % P
No ALND 467 98.0% 0.35
ALND 464 97.6%
Median FU 57 months
8
Impact of Z0011 on Number of Axillary Nodes Removed for Patients with ESBC (NCDB)
Yao K, et al: J Am Coll Surg, 2015
Proportion of Lumpectomy Patients Meeting Z0011 Criteria Receiving SNB
p < 0.001
Criterion % of SLNB Alone
> 5 cm 54%No XRT or APBI 52.5%
Clinically (+) Nodes 35.9%
Mastectomy 22.3%> 3 Positive Nodes 12.9%
Patients Outside of Z0011 Criteria also
had SNB Alone
9
AMAROS Trial:Axillary Dissection vs. Axillary XRT After (+) SLN
cT1-2N0 R
• Primary Objective: To demonstrate non-inferiority in axillary recurrence rate with axillary XRT vs. ALND
ALND
AxRT
SNB AxSN+
Donker M. Et al: Lancet Oncol, 2014
17-18% had mastectomy33% +NSNs
10
AMAROS: Endpoints
Donker M. Et al: Lancet Oncol, 2014
HR:1.17; P = 0.18 HR:1.17; P = 0.34
Overall SurvivalDisease-Free Survival
0
10
20
30
40
1 3 5
ALND
AxRT
28.0%40.0%
29.8%
21.7% 16.7%13.6%
Years after Randomization
Lymphedema
5-year Axillary Recurrence Rate
ALND 0.43%AxRT 1.19%
Design Assumption: 2% for ALND
Planned Comparison is Underpowered
11
ACOSOG Z0011: A Randomized Trial of Axillary Node
Dissection in Women with Clinical T1-2 N0 M0 Breast Cancer who have a
Positive Sentinel Node
Giuliano AE, McCall L, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt K,
Brennan M, Ballman KV, Morrow M
Giuliano A. et al., ASCO 2016
ALND (N=420)
10-Yr Locoregional Recurrence
Local 19 (5.6%) 12 (3.8%)
Regional 2 (0.5%) 5 (1.5%)
Total loco-regional 21 (6.2%) 17 (5.3%)
SLND (N=436)
0.13
0.28
0.36
P value
By Treatment Arm
Median follow-up = 9.25 years (111 mos)
Giuliano A. et al., ASCO 2016
By 5 yrs
Comparison of 10-Year Regional Recurrence to Initial 5-Year Report
ALND 2 (0.5%)
SLND 4 (0.9%)
Nodal recurrence
Only one additional regional recurrence was seen after 5 years
By 10 yrs
2 (0.5%)
5 (1.5%)*% Kaplan-Meier estimate
Giuliano A. et al., ASCO 2016
ACOSOG Z11: DFS and OS
0
10
20
30
40
50
60
70
80
90
100
0 1 2 3 4 5 6 7 8 9 10Time (years)
ALNDSLND only
HR=0.85P=0.32
0102030405060708090
100
0 1 2 3 4 5 6 7 8 9 10Time (years)
ALNDSLND only
HR=0.85P=0.40
DFS OS
Giuliano A. et al., ASCO 2016
Conclusion
SLND alone provides excellent 10-year loco-regional
control and survival comparable to completion ALND for these
selected patients even with long-term follow-up
Giuliano A. et al., ASCO 2016
How Do We Incorporate the Recent SNB Data into Clinical Practice?
• For lumpectomy patients (who meet Z11 criteria) intraoperative assessment on the SN(s) can be omitted– If 1-2 SN(s) are positive consider no further
surgery vs. axillary XRT• For mastectomy patients, and patients who do
not meet Z11 criteria, intraoperative assessment could be helpful– If the SNs are positive, consider completion
ALND vs. axillary XRT
17
Management of the Axilla in Patients Treated with
Neoadjuvant Chemotherapy
18
• Neoadjuvant chemotherapy down-stages axillary nodes in 20-40% of the patients
• Even higher rates (> 50%) in HER-2 + patients with chemo + Anti-HER 2 therapy
• Potential for decreasing the extent of axillary surgery with SLNB
ACNSABP B-18
40
30
20
10
0
% ConversionFrom Node (+)
To Node (-)
ATCMFECTO
3037
FECEORTC
19
ACTXTNSABP B-27*
43
*Assuming 30% nodal down-stagingwith neoadjuvant AC
Effect of Neoadjuvant Chemotherapy on Axillary Nodal Metastases
19
Decreasing the Extent of Axillary Surgery With NC
• This concept is currently applicable to patients with operable breast cancer (cT1-3N0-cN1)
• Most available data on the performance of SNB before or after NC have been obtained in patients with operable BC
• Feasibility and accuracy of SNB after NC is questionable in patients with LABC (T4, cN2, IBC)
20
• Ultrasound of the axilla with FNA of indeterminate/suspicious nodes:– Simple, minimally invasive– Can provide useful clinical information (avoid
SNB, demonstrate direct chemosensitivity)
• Sentinel node biopsy before NC is controversial
Clinical Assessment of Axillary Nodal Status Before NC
21
Management of the Clinically NegativeAxilla in Patients Treated with NC
• After a decade of fierce debate SLNB after NC has become the arguable standard in patients with operable BC
• This approach capitalizes on the down staging effect of NC in sub-clinically involved axillary nodes)
• Feasibility and accuracy have been shown in multiple settings
• IR is somewhat lower than with upfront SLNB but no differences in FNR between the two approaches
22
SNB After NCMeta-Analysis of Single-Institution and
Multi-Center Studies
• 24 studies• 1779 patients• Identification Rates: 63-100%
–Pooled estimate: 89.6%• False Negative Rates: 0-33%
–Pooled estimate: 8.4%
Conclusion:SNB is a reliable tool for
planning treatment after NC
Kelly A et al: Acad Radiol 2009
23
• Conclusion: SLN surgery after NC is as accurate as SLN surgery prior to chemotherapy, results in fewer positive SLNs and decreases unnecessary axillary dissections
SNB After NC: MD Anderson Experience
Hunt K et al: Ann Surg Oncol, 2009
SNB After NC (n=575)
SNB Upfront (n=3171)
P-value
Identification Rates 97.4% 98.7% 0.017False Negative Rates 5.9% 4.1% 0.39Nodal Positivity Rates
T1 12.7% 19.0% 0.2T2 20.5% 36.5% <0.0001T3 30.4% 51.4% 0.04
24
• Retrospective studies: Variability in SLN IR (78%-98%) and SLN FNR (5%-30%)
• Three prospective trials were recently published (ACOSOC Z1071, SENTINA, SN FNAC)–IRs were lower with SLNB after NC (80-93%)
compared to upfront SLNB (>95%)–FNRs ranged between 9.6%-14% and were
mainly affected by number of removed SNs
SLNB After NC in Patients with Documented (+) Axillary Nodes
25
SLNB After NC in Patients with + NodesFNR According to Number of Removed SLNs
ACOSOG Z1071
FN SNAC SENTINA Across studies
# of patients 756 153 592 1501
FNR withsingle SLN
31.5%17/54
18.2%4/22
24.3%17/70
26.0%38/146
FNR if 2 or more SLNs
12.6%39/310
4.9%3/61
9.6%15/156
10.8%57/527
FNR with dual tracer
10.8%27/251
- 8.6%6/70
10.3%33/321
FNR if >2 SLNs 9.1%20/220
- 4.9%5/102
7.8%25/322
26
Re-Analysis of Z1071: Role of IHCBoughey J: SABCS 2014
• Re-analysis of 470 patients (90% of total) with cN1 and ≥ 2 SNs for which pathologic evaluation with IHC was available
• The FNR was 8.7% (95%CI, 5.6-11.8)• Increase in unnecessary CLND (dissecting
the nodes because of a (+) SN with ITCs and not finding non-SNs with metastases > 0.2 mm) was only 2.1% (10/470)
27
Re-Analysis of Z1071: Role of IHCBoughey J: SABCS 2014
• An unplanned subgroup analysis of Z1071 examined patients who had a clip placed in the positive node at time of biopsy (32% of the total)
• FNR was 6.8% when the clip was retrieved in the SLNs
• If the clip was not identified in the SLNs, the FNR was much higher: 39%
28
• Appropriate candidate selection for SLNB (T1-3,N1)• Dual agent lymphatic mapping (isotope + dye)• Identification and removal of >2 SNs
• Clip placement in the positive node with radiologic clip localization and retrieval
• Consideration of performing IHC staining in the SLN and consider completion ALND even with N0i+ disease
Optimizing SLNB After NC in Patients with Documented (+) Axillary Nodes Before NC
29
• Helpful if the SN is negative• Patients with large operable breast cancer
have high likelihood of positive nodes• Does not take advantage of the down-staging
effects of neoadjuvant chemotherapy on nodes: 30-40% conversion from (+) to (-)
• May remove the only positive node(s) (interferes with direct assessment of chemosensitivity
• Requires two surgical procedures
SLNB Before NC: Pros and Cons30
• Breast XRT: Should be always given after lumpectomy
• Chest Wall and Regional Nodal XRT: Consider factors predicting local-regional recurrence after NC (baseline clinical characteristics + pathologic response to NC)
• These factors significantly predict rates of local-regional recurrence after NC
Can We Use Tumor and Nodal Response to NC in Order to
Individualize the Use of L-R XRT?
SNB Before NC:Selection of Loco-Regional XRT?
31
Adequate Margin Width in Breast Conserving Surgery
32
The Margin Width Controversy in BCS• This controversy is as old as the procedure itself• Two divergent techniques with diametrically
opposed approaches to margin width• Lumpectomy (NSABP): Removal of tumor with limited
normal surrounding tissue; path negative margins: “no ink on tumor” on microscopic assessment
• Quadrantectomy (Milan Group): Removal of the affected quadrant + overlying skin + underlying fascia en block; generally wider margins; originally intended to avoid XRT
• Benefit from XRT demonstrated with both procedures, further fueling the margin width debate
33
SSO-ASTRO: Margins Consensus Guideline
• A multidisciplinary consensus panelconsidered:• Large, study level meta-analysis of margin
width and IBTR (33 studies, 28,162 pts)• Results of randomized trials• Reproducibility of margin assessment• Current patterns of multimodality care
Moran M, et al: J Clin Oncol, 2014
34
SSO-ASTRO:Margins Consensus Guideline
• Recommendations:• Use of no ink on tumor as the standard for
an adequate margin in IBC in the era of multidisciplinary Rx results with low rates of IBTR
• This approach has the potential todecrease re-excision rates, improve cosmetic outcomes, and decrease healthcare costs
Moran M, et al: J Clin Oncol, 2014
35
• Clinical observations that provide assurance when applying the recommendations:• Dramatic decline in the rates of IBTR• 5-year IBTR: 5.3% in the meta-analysis
SSO-ASTRO: Margins Consensus Guideline
Strengths
36
• Applies to invasive BC treated with whole breast XRT
• The findings cannot be extrapolated to patients with pure DCIS or after neoadjuvant chemo
• Based on study-level meta-analysis• Close margins: increased risk of IBTR• Strength of evidence: “no tumor on ink” vs.
> 1 mm
37
SSO-ASTRO: Margins Consensus Guideline
Limitations
• 235 patients, stage 0 to III BC• BCS +/- resection of selective margins• Intraoperative Randomization:
• Cavity Shave Margins vs. Not• Primary Outcome: Rate of (+) margins• Secondary Outcomes: Cosmesis and
Volume of tissue resected
A Randomized, Controlled Trial of Cavity Shave Margins
Chagpar A, et al: N Engl J Med 2015
• Results: Shave group associated with: • Lower rates of (+) margins: 19% vs. 34%, P = 0.01
Lower re-excision rates: 10% vs. 21%, P = 0.02 • No differences in complications, cosmesis and rates of
complex tissue rearrangements
38
Management of the Breast Primary in Patients Presenting
with Stage IV BC
39
• Conventional wisdom is that once metastases have occurred, aggressive local therapy provides no survival advantage and should not be pursued except to prevent local complications (bleeding, ulceration, infection)
• Several retrospective studies have shown significantly better outcomes for women who had surgical removal of their tumor vs. those who did not (particularly for those who had negative margins)
Primary Surgical Therapy in Patients Presenting with Stage IV BC
40
• Surgery of the primary tumor appeared to be an independent factor for an improved survival in the multivariate analyses from the individual studies, with an HR of 0.69 (p<0.00001)
• Most studies adjusted for imbalances in known prognostic factors (such as number of mets, location of mets, type of systemic therapy or use of radiotherapy)
• Most studies concluded that unrecognized selection bias may have accounted for the observed benefit of surgery and only large prospective RCTs could reliably answer the question
Primary Surgical Therapy in Patients Presenting with Stage IV BC
42
Tata Memorial Center Randomized Phase III Trial
R
Loco-Regional
Treatment*Anthracyclines +/- Taxanes
(CR /PR ) No Loco-Regional
Treatment
Stage IV BC At Presentation
Stratification by: • Hormone-Receptor Status• Site of metastases (visceral vs. bone vs. both)• Number of metastatic lesions (< 3 vs. > 3)
*LRT: BCS or Mastectomy + AND followed by radiation therapy (RT), as per standard adjuvant guidelines
Badve R et al: SABCS 2013, Abstract S2-02
N=350
Median F/U:17 mos
Tata Memorial Center Phase III TrialResults: Overall Survival
• The median OS in LRT and No-LRT arms were 18.8 and 20.5 months (HR=1.04, p=0.79)
• Corresponding 2-year OS were 40.8% and 43.3%, respectively
• No significant difference in OS between the two groups after adjusting for age, ER status, HER2 status, site and number of mets (HR=1.00, 95%CI=0.76-1.33, p=0.98).
Badve R et al: SABCS 2013, Abstract S2-02
MF07-01 Turkish Study: Design
Soran A, et al: SABCS 2013, Abstract S2-03
• Chemotherapy to all patients either after randomization in the ST treatment arm or after surgical resection the surgery arm
• Hormone therapy for HR positive BC and trastuzumab for HER-2 positive BC
• Surgery-RT at discretion of investigator
MF07-01 Turkish Study: ResultsOverall Survival
Soran A, et al: SABCS 2013, Abstract S2-03
Atilla Soran, MD, MPH, FACS, Magee-Womens Hospital of UPMC Vahit Ozmen, Serdar Ozbas, Hasan Karanlik, Mahmut Muslumanoglu, Abdullah Igci, Zafer Canturk, Zafer Utkan, Cihangir Ozaslan, Turkkan Evrensel, Cihan Uras, Erol Aksaz, Aykut Soyder, Umit Ugurlu, Cavit Col, Neslihan Cabioğlu, Betül Bozkurt, Efe Sezgin, Ronald Johnson, Barry LemberskyOn behalf of the Turkish Federation of Societies for Breast DiseasesClinicalTrials.gov identifier number is NCT00557986
A Randomized Controlled Trial Evaluating Resection of the Primary Breast Tumor in Women Presenting with de Novo Stage IV
Breast Cancer: Turkish Study (Protocol MF07-01)
Soran A. et al., ASCO 2016
312 Recruited
19 Exclusions
293 Eligible
293 Eligible19
Withdraw or Failure to Follow-
up
274 Evaluable
274 Evaluable138
Initial Local Therapy plus
Systemic Therapy
136Systemic Therapy
Soran A. et al., ASCO 2016
Surgery
ST
Ove
rall
Surv
ival
Follow-up Time (months)
N Death Median (mos)
Surgery 138 76 46
ST 136 101 37
SurgeryST
Number at Risk
5-year Survival
41.6%
24.4%
HR: 0.66P=0.005
Soran A. et al., ASCO 2016
0.1 1 10
Subgroup
ER/PR PositiveER/PR NegativeHER2 PositiveHER2 NegativeTriple Negative
Age<55Age≥55
Bone only MetOther Mets noBoneSolitary Bone MetMultiple Bone Met
Solitary Pulmonary/Liver MetMultiple Pulmonary/Liver Mets
Favors surgery Favors No Surgery
Survival OR 95%CI
Soran A. et al., ASCO 2016
N Death Median (mths)
Surgery 136 75 46
ST 121 92 33
Patients with no Loco-regional Progression
Surgery
ST
Ove
rall
Surv
ival
Follow-up Time (months)LR progression Surgery=1% (2) ST=11% (15) P=0.001
Soran A. et al., ASCO 2016
• Survival was similar in 36 months with or without primary breast surgery
• Longer follow up revealed statistically significant improvement in median survival with surgery (46 vs 37 months; HR:0.66) and 5 year OS was 41.6% vs 24.4%, respectively
• Patients with a more indolent form of metastatic BC such as ER (+), HER2 neu (-), solitary bone metastasis, and patients < 55 years old have a significant survival benefit with initial surgery
MF07-01: Summary
Soran A. et al., ASCO 2016
A Prospective Analysis of Surgery and Survival in Stage IV Breast Cancer (TBCRC 013)
King TA, Lyman JP, Gonen M, Reyes S, Boafo C, Plichta J, Hwang ES, Rugo HS, Liu M, Boughey JC, Jacobs LK, Krontiras H, McGuire K, Storniolo A, Nanda R, Golshan M, Isaacs C, Meszoely IM, Van Poznak C, Babiera G, Norton L, Morrow M, Wolff AC, Winer EP, Hudis CA
Translational Breast Cancer Research Consortium
King TA. et al., ASCO 2016
TBCRC 013: Prospective Registry
• Characterize patients presenting with stage IV breast cancer in the modern era:– Response to first-line therapy– Proportion of patients who undergo surgery of
the primary tumor– Surgical decision-making process*
Presented by:
*Presented ASBrS 2016
King TA. et al., ASCO 2016
TBCRC 013: Prospective Registry
• Correlate molecular characteristics of the primary tumor with conventional prognostic factors, surgery and survival
• Determine the incidence of uncontrolled local disease and the frequency with which surgical palliation is needed
• Perform correlative molecular studies
Presented by: King TA. et al., ASCO 2016
TBCRC 013: Cohort A
• 112 pts with de novo Stage IV disease and intact primary
• 1st line systemic therapy per treating physician
• Responders to 1st line therapy offered opportunity to discuss elective surgery (absence of local symptoms or need for local control)
Presented by: King TA. et al., ASCO 2016
TBCRC 013 Cohort APatient Characteristics
Presented by:
Tumor Subtype
HR+HER2‐ 71 (63%)
HR+HER2+ 24 (21%)
HR‐HER2+ 9 (8%)
Triple Negative 8 (7%)
Site of Mets at dx
Bone Only 51 (46%)
Visceral Only 26 (23%)
Both 27 (24%)
Other 8 (7%)
# Met Sites at dx
Single Organ 64 (57%)
>1 Organ 48 (43%)
Median Patient Age: 51 yrs (21-77yrs)
Median Tumor Size: 3.2cm (0.8-15cm)
ECOG score 0: 56 (50%)1: 51 (46%)>1: 5 (4%)
King TA. et al., ASCO 2016
TBCRC 013 Cohort AOverall Survival
Presented by:
N=112
3yrs OS 70% (95%CI 63-79%)
Median Survival69 mos (51 – NR)
Median follow‐up 54 mos (34‐78mos)
King TA. et al., ASCO 2016
TBCRC 013 Cohort AResponse to 1st line therapy
Presented by:
N=112*
94 (85%)Responders (R)
17 (15%)Non‐Responders (NR)
*1 lost to f/u
• ER + was the only baseline difference between Responders (88%) and Non‐Responders (65%), p=0.02
King TA. et al., ASCO 2016
Survival: Responders vs Non-RespondersLandmark Analysis at 6 months
Presented by:
Non-responders (NR)
Responders (R)
N median survival, mos 30 mo survival (95%CI) P
R 90 65 mos (52‐NR) 78% (70‐87) < 0.001
NR 16 13 mos (9‐31) 24% (10‐55)
6 mos, surrogate for time to response assessment after 1stline therapy, per treating physician
King TA. et al., ASCO 2016
TBCRC 013: Surgical Uptake
Presented by:
N=112*
94 (85%)**responders
39 (43%) elective surgery
51 (57%) no surgery
17 (15%)non‐responders
* 1 lost to f/u** 4 lost to f/u
Median time to elective surgery 7 mos (3‐20mos)
King TA. et al., ASCO 2016
TBCRC 013 Cohort A Characteristics by Surgery
Presented by:
Surgery N=39
No SurgeryN=51
p
Median Age 49yrs (21-73) 52yrs (29-74) 0.17
Tumor Size 3.8cm (1.6-12) 3.2cm (0.8-15) 0.01
Tumor Subtype (ER+ vs other) 34 (87%) 46 (90%) 0.26
Site of Mets at Dx (bone vs other) 19 (49%) 22 (43%) 0.45
Single Organ Metastatic Disease 30 (77%) 21 (41%) 0.001
1st line chemotherapy 15 (39%) 9 (17%) 0.002
Race, marital status, employment status, income level, education and co-morbidities did not differ by use of surgery
King TA. et al., ASCO 2016
Multivariate Analysis: Survival
Presented by:
Stepwise Cox regression: includingage, size, ECOG, HR, Her2, tumor grade, response and surgery
N Median Survival, mos 30 mos survival (95%CI)
Non‐Responders 16 13 mos (9‐31) 24% (10‐55)
Responders, No Surgery (red) 51 65 mos (50‐NR) 76% (66‐89)
Responders, Surgery (green) 39 71 mos (46‐NR) 77% (65‐91)
King TA. et al., ASCO 2016
TBCRC 013: Palliative Surgery
Presented by:
N=112*
94 (85%)**responders
39 (43%) elective surgery
51 (57%) no
surgery
Palliative surgery 2 (4%)
17 (15%)non‐
responders
Palliative surgery 3 (18%)
* 1 lost to f/u** 4 lost to f/u
Median time to palliative surgery 17 mos (8-35 mos)
King TA. et al., ASCO 2016
TBCRC 013: Conclusions• In this prospective registry study, 3yr overall survival
among patients presenting with de novo stage IV disease is 70%
• The majority of patients (85%) responded to 1st line therapy and response was significantly associated with survival
• Among patients who respond to systemic therapy – the need for palliative surgery is uncommon– progression free survival is not negatively impacted
by surgery
Presented by: King TA. et al., ASCO 2016
• Until more RCT data become available showing improved outcomes with surgical resection of the primary, not removing the primary tumor remains the standard
• Surgery can be entertained in selected cases (before or after systemic therapy) for local control if local manifestations are more likely to contribute to morbidity than distant ones
• In such cases, BCS surgery is preferable if it can encompass the scope of the surgical resection
• Axillary node surgery or breast XRT are generally not advisable
Primary Surgical Therapy in Patients Presenting with Stage IV BC
66
Questions?
67