The Treatment of the Axilla in the North of England Cancer Network – Prospective Audit Complete Data Andrew Pieri Henry Cain Sebastian Aspinall On behalf of the Breast NSSG
Audit Aims • Summarise and audit compliance with local and national guidelines • Investigate the role of ALNC for micro ‐ metastases • Investigate the role of SLNB in T3 tumours • Analyse predictive factors of nodal disease
Audit Standards • National Guidelines – ABS 2009 • Local Guidelines – NECN 2013
Standards Consistent in Local & National Guidelines • All patients with invasive cancer should have pre ‐ op axillary staging • Patients with pre ‐ op diagnosis of axillary mets should have ALNC • If SLNB positive for macro ‐ mets then ALNC or RTx
Standards Inconsistent in Local & National Guidelines • If SLNB positive for micro ‐ mets then ALNC or RTx (ABS) • NECN states, “With just micro ‐ mets, the value of further axillary surgery may not outweigh the morbidity in all except the highest risk cases” • ALNC is preferred (over RTx) as offers additional staging info (NECN) • Combined blue dye/radioisotope should be used (ABS) • ALNC should retrieve ≥ 10 nodes (ABS)
Region ‐ wide Data Collected Number of cases per Trust 300 250 Number of Cases 200 150 100 50 0 e a d s m d s a e l i e i e n n r a t r a s e a b b e e y h a m T m T T l h r r c e s u u h u h h w d e D C h t t t r n e u t u t a o N o r o u o G N S S S N
Audit Data – Demographics • 1142 patients – 866 SLNB, 120 SLNB + ALNC and 156 ALNC • Age range 20 ‐ 94, mean 60.3, median 61
Tumour Characteristics Tumour Characteristics Interim Analysis Final Analysis Tumour Type DCIS 38 (8%) 84 (8%) Invasive Ductal 350 (76%) 846 (76%) Invasive Other 73 (16%) 175 (16%) Benign 0 (0%) 1 (0.1%) Tumour Size 0 ‐ 19 mm 221 (47%) 556 (50%) 20 ‐ 50mm 205 (44%) 479 (43%) >50mm 43 (9%) 83 (7%) Tumour Grade 1 62 (14%) 164 (15%) 2 216 (49%) 525 (49%) 3 165 (37%) 382 (36%)
Pre ‐ op Axillary Staging Every patient with suspected breast cancer should have US axilla 1 st Cycle 2 nd Cycle Combined Results Not recorded 90 Total Recorded 450 602 1052 USS staging 445 (99%) 599 (99.5%) 1044 (99.2%) performed USS staging not 5 (1%) 3 (0.5%) 8 (0.8%) performed
Sentinel Node Biopsy Technique Combined blue dye/radioisotope technique is recommended 1 st Cycle 2 nd Cycle Method Combined Total Dual 277 (69%) 365 (65%) 642 (66%) Blue dye only 33 (8%) 64 (11%) 97 (10%) Radio ‐ isotope only 90 (22%) 137 (24%) 227 (24%) Total SLNBs 400 566 966
Sentinel Node – Number Excised • 986 SLNB cases performed • Range of nodes retrieved = 0 – 16 • Mean = 2.4 • Median = 2
Results of SLNB 1 st Cycle 2 nd Cycle Results Combined Total Available SLNB Negative 307 (77%) 473 (80%) 780 (79%) Positive 91 (23%) 115 (20%) 206 (21%) Pathology of ITC 4 (4%) 4 (3%) 8 (4%) positive nodes Micro 26 (29%) 27 (24%) 53 (26%) Macro 61 (67%) 84 (73%) 145 (70%)
Treatment of positive SLNB With micro ‐ mets, the benefit of ALNC may not outweigh the morbidity (NECN Guidelines) If SLNB positive for macro ‐ mets then ALNC or RTx (ABS & NECN) Micro ‐ mets Macro ‐ mets 1 st Cycle 2 nd Cycle 1 st Cycle 2 nd Cycle SLNB result (n) No Treatment 5 (19%) 7 (26%) 4 (7%) 7 (8%) ALNC 16 (61%)* 5 (22%)* 40 (66%) 52 (62%) RTx 4 (15%)* 14 (52%)* 17 (28%) 20 (24%) ALNC & RTx 1 (4%)* 0* 0 5 (6%) * p = 0.001 (Fisher’s exact)
Axillary Clearance – Number Excised • 272 ALNC performed • Range of nodes retrieved = 0 – 46 • Mean = 13 • Median = 13 • 95% confidence interval = 12.9 – 14.6
Indications for ALNC 1 st Cycle (n=125) 2 nd Cycle (n=147) Indication Combined Totals Pre ‐ op +ive 58 (46%) 80 (54%) 138 (51%) SLNB +ive 50 (40%) 60 (40%) 109 (40%) Intra Op Assess +ive 4 (3%) 1 (0.7%) 5 (2%) Other 13 ( 11%) 6 (5%) 20 (7%)
Adequacy of ALNC – should retrieve ≥ 10 nodes 1 st Cycle 2 nd Cycle Combined Total (n=125) (n=147) (n=272) < 10 nodes retrieved 26 (20%) 45 (31%) 71 (26%)
Summary of Audit Standards • Rate of pre ‐ op staging > 99% • Dual method of SLN localisation used in only 66% • 21% of micro ‐ mets do not receive ALNC or RTx • Significant shift away from ALNC and towards RTx for micro ‐ mets in 2 nd cycle • 8% of macro ‐ mets did not receive ANC or RTx • 26% of ALNC yielded < 10 nodes
What Pre ‐ operative factors predict a positive SLNB?
SLNB (%)+ve SLNB ‐ ve P value Overall 195 752 Mean age (yrs) 57.3 61.1 <0.0001 T1 84 (16%) 433 0.0001 T2 93 (25%) 279 T3 15 (38%) 24 Symptomatic 126 (25%) 388 0.0002 Screened 57 (15%) 335 G1 19 (12%) 140 0.0035 G2 111 (25%) 339 G3 62 (22%) 222 NST 154 (22%) 554 ns ST 33 (22%) 120
What factors predict non ‐ SLN metastases at ALND following positive SLNB?
Significant increase in risk of non ‐ SLN mets on ALNC ALND +ve ALND ‐ ve P value Overall 34 68 LVI +ve 23 (48%) 25 0.006 LVI ‐ ve 12 (21%) 44 ECS +ve 16 (53%) 14 0.01 ECS ‐ ve 18 (25%) 55 T1 9 (23%) 31 0.04 T2 19 (38%) 31 T3 6 (50%) 6
No significant increase in risk of non ‐ SLN mets on ALNC ALND (%) +ve ALND ‐ ve P value Overall 34 68 NST 25 (30) 58 0.15 ST 8 (50) 8 Screened 10 (45) 12 0.21 Symptomatic 22 (31) 50 G1 1 (12.5) 7 0.31 G2 19 (39) 30 G3 14 (31) 31 Mean age (yrs) 55.3 55.6 0.92
Does the number or type of SLN mets affect the risk of non ‐ SLNB mets at ALND?
Number of SLN mets SLNB status ANC +ve ANC ‐ ve Total 1 of 2+ SLNB +ve 7 (20%) 27 34 1 of 1 SLNB +ve 9 (39%) 14 23 2 of 2+ SLNB +ve 14 (54%) 12 26
Memorial Sloane ‐ Kettering (MSK) Nomogram
Should we treat the axilla in T3 tumours differently to T1 ‐ 2 tumours?
Differences between axillary LN status of T1 ‐ 2 and T3 tumours T1 & T2 T3 P value Overall 954 64 Number of patients 280 (29%) 39 (61%) <0.0001 with LN mets Number of LN mets present on ALND: ‐ Range 1 ‐ 21 2 ‐ 18 ‐ Median 2 3.5 ‐ Mean (95% CI) 3.6 (3.0 ‐ 4.2) 5.5(3.9 ‐ 7.0) 0.008 Number having SLNB 850 44 SLNB +ve 176 (21%) 19 (43%) 0.0011
Summary of Analysis • Factors that affect risk of SLN mets: – Age – Tumour size and grade – Mode of presentation • Factors that affect risk of non ‐ SLN mets on ALNC: – Tumour LVI – Nodal ECS – Tumour size – Number of SLN mets • Factors which don’t affect risk of non ‐ SLN mets on ALNC: – Type of SLN • The majority of T3 tumours have LN mets • LN mets are twice as prevalent in T3 vs T1/2 tumours
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