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Nomogram based estimate of axillary nodal involvement in acosog z0011

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Nomograms can outperform experts in predicting additional axillary nodal metastases in clinical N0 breast cancer patients with a positive sentinel node biopsy.

In ACOSOG Z0011, prior analysis showed radiation (RT) fields showed that half of all patients with confirmed RT fields used high tangents and 19% include regional nodal irradiation. We sought to evaluate two hypotheses in this secondary analysis:

1. Nomograms are valid in Z0011 and confirm similar distribution of nodal risk in two treatment arms;

2. Radiation fields including lymph nodes were not in the highest risk patients despite best clinical judgment.

I presented this research October 24, 2018 at the American Society for Radiation Oncology (ASTRO) Annual Meeting in San Antonio, Texas.

Published in: Health & Medicine

Nomogram based estimate of axillary nodal involvement in acosog z0011

  1. 1. Patient Characteristics by Radiation Treatment Received (MDACC nomogram cohort) MDACC and MSKCC nomogram estimates of additional positive axillary nodes by treatment arm and observed nodal involvement in the axillary dissection arm Distribution of LN risk estimate for MDACC and MSKCC nomograms LN risk estimate by ALND versus SLNBx with MDACC nomogram•  We used the nomograms from M.D. Anderson Cancer Center (MDACC) and Memorial Sloan-Kettering Cancer Center (MSKCC) available on their websites summer 2017 •  We compared MDACC and MSKCC nomogram estimates in both treatment arms •  We used logistic regression to evaluate associations between nomogram estimates and radiation fields •  We included radiation field design in multivariable Cox- models for associations of radiation fields with 10-year local-regional failure (LRF), disease-free survival (DFS), and overall survival (OS) estimates BACKGROUND RESULTS •  MDACC and MSKCC nomogram estimates are associated with additional axillary lymph node risk in ACOSOG Z0011 •  Findings at axillary dissection were similar to the mean estimated risk of additional metastases using both nomograms •  Risk estimates were evenly distributed between treatment arms •  Use of a supraclavicular field was associated with worse survival, likely related to clinical use in patients with differences in clinical risk not captured by nomogram score alone AIMS •  To evaluate nomogram accuracy in the axillary lymph node dissection (ALND) arm •  To assess distribution of lymph node risk in both arms •  To determine whether patients radiation fields with nodal irradiation had higher nomogram-based risk estimates or different 10-year clinical outcomes METHODS CONCLUSIONS Nomograms can outperform experts in predicting additional axillary nodal metastases in clinical N0 breast cancer patients with a positive sentinel node biopsy. In ACOSOG Z0011, prior analysis showed radiation (RT) fields showed that half of all patients with confirmed RT fields used high tangents and 19% include regional nodal irradiation. We sought to evaluate two hypotheses in this secondary analysis: 1. Nomograms are valid in Z0011 and confirm similar distribution of nodal risk in two treatment arms; 2. Radiation fields including lymph nodes were not in the highest risk patients despite best clinical judgment. • Nomogram-Based Estimate of Axillary Nodal Involvement in ACOSOG Z0011: Validation and Association with Radiation Protocol Variations and Outcomes • Matthew S. Katz,1 Linda McCall,2 Karla Ballman,3 Bruce G. Haffty,4 Reshma Jagsi,5 Armando E. Giuliano6 • 1Department of Radiation Medicine, Lowell General Hospital, Lowell, MA; 2 Alliance Statistics and Data Center, Duke University, Durham, NC; 3 Department of Biostatistics, Weill Medical College, New York, NY; 4 Department of Radiation Oncology, • Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; 5 Department of Radiation Oncology, University of Michigan Medical Center, Ann Arbor, MI; 6 Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA 0 5 10 15 20 25 30 0-5 5-10 10-15 15-20 20-25 25-30 30-40 40-50 50-70 70-100 %ofpatients Nomogram Risk of Additional Positive LN MDACC MSKCC 0 5 10 15 20 25 30 0-5 5-10 10-15 15-20 20-25 25-30 30-40 40-50 50-70 70-100 %ofpatients MDACC Nomogram Risk of Additional Positive LN ALND No ALND RESULTS MDACC MSKCC AD (n=283) SLND (n=269) p-value AD (n=251) SLND (n=249) p-value Estimated risk (%) 0.16 0.054 Mean (95% CI) 23.8% (21.8-25.8) 21.9% (20.1-23.7) 23.1% (21.2 – 24.9) 20.7% (19.1 – 22.4) Median (range) 20.4% (0.0 – 91.3) 19.0% (0.3 – 78.9) 19.0% (1.8– 88) 17.0% (2.8 – 79.5) Histologically confirmed mean risk (%) 25.9% N/A 23.4% N/A     Radiation Treatment Received p-value   Confirmed Breast / High Tangents RT (n=140) Confirmed Supraclavicular (SCV) RT (n=25) Confirmed No RT (n=65) Confirmed RT NOS (n=204) Age (years) 0.061 Median (range) 53 (36 – 80) 54 (32 – 90) 52 (30 – 87) 58 (25 – 85) Tumor size (cm) 0.084 Median (range) 1.7 (0.3 – 6.0) 2.2 (0.0 – 4.0) 1.8 (0.1- 7.5) 1.7 (0.1 – 17.0) Histologic type 0.040 Ductal 110 (78.6%) 24 (96.0%) 54 (83.1%) 172 (84.3%) Lobular 9 (6.4%) 0 5 (7.7%) 18 (8.8%) Mixed 12 (8.6%) 0 6 (9.2%) 5 (2.4%) Other 9 (6.4%) 1 (4.0%) 0 9 (6.4%) Missing/Unknown 0 0 0 0 ER/PR Status 0.91 Negative 24 (17.1%) 5 (20.0%) 9 (13.8%) 34 (16.7%) Positive 90 (64.3%) 14 (56.0%) 40 (61.5%) 124 (60.8%) Missing/Unknown 26 6 16 46 Modified Bloom-Richardson Score 0.11 1 29 (20.7%) 4 (16.0%) 9 (13.8%) 45 (22.1%) 2 63 (45.0%) 10 (40.0%) 34 (52.3%) 72 (35.3%) 3 24 (17.1%) 8 (32.0%) 16 (24.6%) 57 (27.9%) Missing/Unknown 24 3 6 30 Lymphovascular invasion 0.041 No 90 (64.3%) 16 (64.0%) 29 (44.6%) 128 (62.8%) Yes 50 (35.7%) 9 (36.0%) 36 (55.4%) 76 (37.2%) Missing/Unknown 0 0 0 0 Number of SLN removed 0.20 0 1 (0.7%) 0 0 0 1 21 (15.0%) 7 (28.0%) 15 (23.1%) 50 (24.5%) 2 35 (25.0%) 5 (20.0%) 16 (24.6%) 64 (31.4%) 3 or more 83 (59.3%) 13 (52.0%) 34 (52.3%) 90 (44.1%) Missing/Unknown 0 0 0 0 Number of positive SLN <0.0001 0 1 (0.7%) 1 (4.0%) 0 5 (2.5%) 1 105 (75.0%) 11 (44.0%) 43 (66.1%) 159 (77.9%) 2 29 (20.7%) 6 (24.0%) 17 (26.2%) 26 (12.7%) 3 or more 1 (0.7%) 6 (24.0%) 2 (3.1%) 7 (3.4%) Missing/Unknown 4 1 3 7 Number of positive nodes on ALND (ALND arm only) 0.001* 0 50 (35.7%) 6 (24.0%) 23 (35.3%) 76 (37.3%) 1 8 (5.7%) 1 (4.0%) 2 (3.1%) 11 (4.9%) 2 1 (0.7%) 3 (12.0%) 2 (3.1%) 8 (3.9%) 3 or more 0 5 (20.0%) 3 (4.6%) 9 (4.4%) Missing/Unknown 81 10 35 100 Multivariable analysis: No radiation or supraclavicular radiation is associated with worse 10-year clinical outcomes MSKCC Nomogram Score MDACC Nomogram Score HR (95% CI) p-value HR (95% CI) p-value Overall Survival Nomogram Score 1.01 (0.99 – 1.03) 0.27 1.00 (0.99 – 1.02) 0.66 Arm 1.12 (0.62 – 2.02) 0.71 1.06 (0.62 – 1.83) 0.82 RT Arm* No RT 1.80 (0.84 – 3.86) 0.002 1.87 (0.88 – 3.96) 0.027Confirmed SCV RT 3.25 (1.19 – 8.88) 2.72 (1.03 – 7.18) Confirmed Radiation NOS 0.63 (0.30 – 1.31) 0.85 (0.43 – 1.65) Disease-free Survival Nomogram Score 1.01 (0.99 – 1.03) 0.24 1.00 (0.99 – 1.02) 0.54 Arm 0.95 (0.57 – 1.59) 0.85 0.89 (0.56 – 1.40) 0.61 RT Arm* No RT 1.70 (0.87 – 3.32) 0.002 1.54 (0.81 – 2.93) 0.045Confirmed SCV RT 2.58 (1.05 – 6.37) 1.83 (0.77 – 4.36) Confirmed RT NOS 0.64 (0.34 – 1.19) 0.73 (0.42 – 1.27) Local-Regional Recurrence Nomogram Score 1.03 (0.99 – 1.06) 0.075 1.02 (0.99 – 1.04) 0.24 Arm 0.69 (0.25 – 1.92) 0.47 0.58 (0.23 – 1.48) 0.26 RT Arm* No RT 6.47 (1.29 – 32.43) 0.065 3.37 (1.02 – 11.12) 0.12Confirmed SCV RT -- Confirmed RT NOS 1.97 (0.41 – 9.42) 1.06 (0.35 – 3.24) MSKCC MDACC HR (95% CI) p-value HR (95% CI) p-value Overall Survival Nomogram Score 1.02 (1.00 – 1.06) 0.089 1.01 (0.99 – 1.04) 0.31 RT Arm* No RT 1.11 (0.37 – 3.33) 0.019 1.11 (0.35 – 3.54) 0.75Confirmed SCV RT 6.57 (1.40 – 30.82) 2.04 (0.42 – 9.82) Confirmed Radiation NOS 0.50 (0.18 – 1.37) 0.86 (0.36 – 2.08) Disease-free Survival Nomogram Score 1.02 (0.99 – 1.04) 0.23 1.01 (0.99 – 1.03) 0.21 RT Arm* No RT 0.82 (0.29 – 2.35) 0.074 0.77 (0.25 – 2.33) 0.90Confirmed SCV RT 4.41 (0.98 – 19.85) 1.35 (0.30 – 6.21) Confirmed RT NOS 0.57 (0.24 – 1.35) 0.86 (0.41 – 1.80) Local-Regional Recurrence Nomogram Score 1.05 (1.00 – 1.10) 0.066 1.04 (1.00 – 1.08) 0.046 RT Arm* No RT 1.02 (0.09 – 11.44) 0.99 1.07 (0.11 – 10.36) 0.99Confirmed SCV RT --- --- Confirmed RT NOS 0.91 (0.15 – 5.65) 0.75 (0.15 – 3.87) Multivariable analysis: Association of RT treatment type and nomogram risk estimate 10-year clinical outcomes for SLND alone patients RESULTS * Confirmed Breast/High Tangents = Reference To access the poster, scan the QR code Questions or comments: Email Matthew.Katz@lowellgeneral.org or @subatomicdoc on Twitter

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