Validation study in younger breast cancer patients who meeting the criteria of ACOSOG Z0011 trial based on the SEER database_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

CHEN Maoshan ¹ , LI Fangfang ² , HOU Lingmi ³ , YANG Yahan ⁴ , FAN Li ¹ , YIN Heng ¹ , MOU Dewu ¹ , HUANG Yunhui ¹ , WANG Dasong ¹ ,  YANG Hongwei ¹

1. Department of Breast and Thyroid Surgery, Sui’ning Central Hospital, Sui’ning, Sichuan 629000, P. R. China;
2. Department of Operation Room, Sui’ning Central Hospital, Sui’ning, Sichuan 629000, P. R. China;
3. Department of Breast and Thyroid Surgery, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan 637000, P. R. China;
4. Clinical Medicine, Queen Mary College, Nanchang University, Nanchang 330000, P. R. China;

Corresponding?author：

YANG Hongwei, Email: yhwsnch@163.com

Keywords：

younger breast cancer; sentinel lymph node biopsy; axillary lymph node dissection; breast-conserving surgery; radiotherapy; SEER database

DOI：

10.7507/1007-9424.202105024

Video：

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Objective To explore the axillary lymph node dissection (ALND) could be safely exempted in younger breast cancer patients (≤40 years of age) who receiving breast-conserving surgery combined with radiotherapy in metastasis of 1–2 sentinel lymph node (SLN) and T1–T2 stage. Methods The data of pathological diagnosis of invasive breast cancer from 2004 to 2015 in SEER database were extracted. Patients were divided into SLN biopsy group (SLNB group) and ALND group according to axillary treatment. Propensity matching score (PSM) method was used to match and equalize the clinicopathological features between two groups at 1∶1. Multivariate Cox proportional risk model was used to analyze the relationship between axillary management and breast cancer specific survival (BCSS), and stratified analysis was performed according to clinicopathological features. Results A total of 1 236 patients with a median age of 37 years (quartile: 34, 39 years) were included in the analysis, including 418 patients (33.8%) in the SLNB group and 818 patients (66.2%) in the ALND group. The median follow-up period was 82 months (quartile: 44, 121 months), and 111 cases (9.0%) died of breast cancer, including 33 cases (7.9%) in the SLNB group and 78 cases (9.5%) in the ALND group. The cumulative 5-year BCSS of the SLNB group and the ALND group were 90.8% and 93.4%, respectively, and the log-rank test showed no significant difference (χ²=0.70, P=0.401). After PSM, there were 406 cases in both the SLNB group and the ALND group. The cumulative 5-year BCSS rate in the ALND group was 4.1% higher than that in the SLNB group (94.8% vs. 90.7%). Multivariate Cox proportional hazard analysis showed that ALND could further improve BCSS rate in younger breast cancer patients [HR=0.578, 95%CI (0.335, 0.998), P=0.049]. Stratified analyses showed that ALND improved BCSS in patients diagnosed before 2012 or with a character of lymph node macrometastases, histological grade G3/4, ER negative or PR negative. Conclusions It should be cautious to consider the elimination of ALND in the stage T1–T2 younger patients receiving breast-conserving surgery combined with radiotherapy when 1–2 SLNs positive, especially in patients with high degree of malignant tumor biological behavior or high lymph node tumor burden. Further prospective trials are needed to verify the question.

Citation： CHEN Maoshan, LI Fangfang, HOU Lingmi, YANG Yahan, FAN Li, YIN Heng, MOU Dewu, HUANG Yunhui, WANG Dasong, YANG Hongwei. Validation study in younger breast cancer patients who meeting the criteria of ACOSOG Z0011 trial based on the SEER database. CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY, 2022, 29(2): 196-204. doi: 10.7507/1007-9424.202105024 Copy

1.	Kim H, Lee SB, Nam SJ, et al. Survival of breast-conserving surgery plus radiotherapy versus total mastectomy in early breast cancer. Ann Surg Oncol, 2021, 28(9): 5039-5047.
2.	Krag DN, Anderson SJ, Julian TB, et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol, 2010, 11(10): 927-933.
3.	中國抗癌協會乳腺癌專業委員會. 中國抗癌協會乳腺癌診治指南與規范(2019年版). 中國癌癥雜志, 2019, 29(8): 609-679.
4.	Burstein HJ, Curigliano G, Loibl S, et al. Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Ann Oncol, 2019, 30(10): 1541-1557.
5.	Giuliano AE, Hunt KK, Ballman KV, et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA, 2011, 305(6): 569-575.
6.	Giuliano AE, Ballman KV, McCall L, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: The ACOSOG Z0011 (Alliance) randomized clinical trial. JAMA, 2017, 318(10): 918-926.
7.	Cardoso F, Kyriakides S, Ohno S, et al. Early breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol, 2019, 30(8): 1194-1220.
8.	Giuliano AE, Ballman K, McCall L, et al. Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: long-term follow-up from the American College of Surgeons Oncology Group (Alliance) ACOSOG Z0011 randomized trial. Ann Surg, 2016, 264(3): 413-420.
9.	Paluch-Shimon S, Cardoso F, Partridge AH, et al. ESO-ESMO 4th International Consensus Guidelines for Breast Cancer in Young Women (BCY4). Ann Oncol, 2020, 31(6): 674-696.
10.	Singletary SE, Connolly JL. Breast cancer staging: working with the sixth edition of the AJCC Cancer Staging Manual. CA Cancer J Clin, 2006, 56(1): 37-47.
11.	劉淼, 王殊, 彭媛, 等. ACOSOG Z0011試驗標準用于中國前哨淋巴結陽性乳腺癌患者以避免腋窩淋巴結清掃的可行性研究. 中國癌癥雜志, 2015, 25(2): 135-140.
12.	劉淼, 王殊, 楊后圃, 等. ACOSOG Z0011試驗結果對中國乳腺外科醫生臨床實踐影響的調查. 腫瘤防治研究, 2016, 43(1): 48-53.
13.	Livingston EH, Li HC. Breast cancer surgery: less is more. JAMA, 2017, 318(10): 909-911.
14.	Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med, 2018, 379(2): 111-121.
15.	Ong CT, Thomas SM, Blitzblau RC, et al. Patient age and tumor subtype predict the extent of axillary surgery among breast cancer patients eligible for the American College of Surgeons Oncology Group Trial Z0011. Ann Surg Oncol, 2017, 24(12): 3559-3566.
16.	Poodt IGM, Spronk PER, Vugts G, et al. Trends on axillary surgery in nondistant metastatic breast cancer patients treated between 2011 and 2015: A dutch population-based study in the ACOSOG-Z0011 and AMAROS era. Ann Surg, 2018, 268(6): 1084-1090.
17.	Liu M, Wang S, Cui S, et al. The feasibility of the ACOSOG Z0011 criteria to Chinese breast cancer patients: a multicenter study. Sci Rep, 2015, 5: 15241. doi: 10.1038/srep15241.
18.	Nayyar A, Strassle PD, Shen MR, et al. Survival analysis of early-stage breast cancer patients undergoing axillary lymph node dissection and sentinel lymph node dissection. Am J Surg, 2018, 216(4): 706-712.
19.	Nowikiewicz T, Zegarski W, Pagacz K, et al. Does the presence of sentinel lymph node macrometastases in breast cancer patients require axillary lymph node dissection? Single-center analysis. Breast J, 2018, 24(5): 724-729.
20.	Wang J, Mittendorf EA, Sahin AA, et al. Outcomes of sentinel lymph node dissection alone vs. axillary lymph node dissection in early stage invasive lobular carcinoma: a retrospective study of the surveillance, epidemiology and end results (SEER) database. PLoS One, 2014, 9(2): e89778. doi: 10.1371/journal.pone.0089778.
21.	Peristeri DV, Harissis HV. Axillary lymph node dissection vs sentinel biopsy only among women with early-stage breast cancer and sentinel node metastasis: a systematic review and meta-analysis. Breast J, 2021, 27(2): 158-164.
22.	Jagsi R, Chadha M, Moni J, et al. Radiation field design in the ACOSOG Z0011 (Alliance) trial. J Clin Oncol, 2014, 32(32): 3600-3606.
23.	Colleoni M, Sun Z, Price KN, et al. Annual hazard rates of recurrence for breast cancer during 24 years of follow-up: results from the international breast cancer study group trials Ⅰ to Ⅴ. J Clin Oncol, 2016, 34(9): 927-935.
24.	Dutta SW, Volaric A, Morgan JT, et al. Pathologic evaluation and prognostic implications of nodal micrometastases in breast cancer. Semin Radiat Oncol, 2019, 29(2): 102-110.
25.	Wu P, Zhao K, Liang Y, et al. Validation of breast cancer models for predicting the nonsentinel lymph node metastasis after a positive sentinel lymph node biopsy in a chinese population. Technol Cancer Res Treat, 2018, 17: 1533033818785032. doi: 10.1177/1533033818785032.
26.	Loza CM, Mandó P, Ponce C, et al. Predictive factors for non-sentinel lymph node metastasis in patients with ACOSOG Z0011 Criteria. Breast Care (Basel), 2018, 13(6): 434-438.
27.	Qiu PF, Liu JJ, Wang YS, et al. Risk factors for sentinel lymph node metastasis and validation study of the MSKCC nomogram in breast cancer patients. Jpn J Clin Oncol, 2012, 42(11): 1002-1007.

1. Kim H, Lee SB, Nam SJ, et al. Survival of breast-conserving surgery plus radiotherapy versus total mastectomy in early breast cancer. Ann Surg Oncol, 2021, 28(9): 5039-5047.
2. Krag DN, Anderson SJ, Julian TB, et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol, 2010, 11(10): 927-933.
3. 中國抗癌協會乳腺癌專業委員會. 中國抗癌協會乳腺癌診治指南與規范(2019年版). 中國癌癥雜志, 2019, 29(8): 609-679.
4. Burstein HJ, Curigliano G, Loibl S, et al. Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Ann Oncol, 2019, 30(10): 1541-1557.
5. Giuliano AE, Hunt KK, Ballman KV, et al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA, 2011, 305(6): 569-575.
6. Giuliano AE, Ballman KV, McCall L, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: The ACOSOG Z0011 (Alliance) randomized clinical trial. JAMA, 2017, 318(10): 918-926.
7. Cardoso F, Kyriakides S, Ohno S, et al. Early breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol, 2019, 30(8): 1194-1220.
8. Giuliano AE, Ballman K, McCall L, et al. Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: long-term follow-up from the American College of Surgeons Oncology Group (Alliance) ACOSOG Z0011 randomized trial. Ann Surg, 2016, 264(3): 413-420.
9. Paluch-Shimon S, Cardoso F, Partridge AH, et al. ESO-ESMO 4th International Consensus Guidelines for Breast Cancer in Young Women (BCY4). Ann Oncol, 2020, 31(6): 674-696.
10. Singletary SE, Connolly JL. Breast cancer staging: working with the sixth edition of the AJCC Cancer Staging Manual. CA Cancer J Clin, 2006, 56(1): 37-47.
11. 劉淼, 王殊, 彭媛, 等. ACOSOG Z0011試驗標準用于中國前哨淋巴結陽性乳腺癌患者以避免腋窩淋巴結清掃的可行性研究. 中國癌癥雜志, 2015, 25(2): 135-140.
12. 劉淼, 王殊, 楊后圃, 等. ACOSOG Z0011試驗結果對中國乳腺外科醫生臨床實踐影響的調查. 腫瘤防治研究, 2016, 43(1): 48-53.
13. Livingston EH, Li HC. Breast cancer surgery: less is more. JAMA, 2017, 318(10): 909-911.
14. Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med, 2018, 379(2): 111-121.
15. Ong CT, Thomas SM, Blitzblau RC, et al. Patient age and tumor subtype predict the extent of axillary surgery among breast cancer patients eligible for the American College of Surgeons Oncology Group Trial Z0011. Ann Surg Oncol, 2017, 24(12): 3559-3566.
16. Poodt IGM, Spronk PER, Vugts G, et al. Trends on axillary surgery in nondistant metastatic breast cancer patients treated between 2011 and 2015: A dutch population-based study in the ACOSOG-Z0011 and AMAROS era. Ann Surg, 2018, 268(6): 1084-1090.
17. Liu M, Wang S, Cui S, et al. The feasibility of the ACOSOG Z0011 criteria to Chinese breast cancer patients: a multicenter study. Sci Rep, 2015, 5: 15241. doi: 10.1038/srep15241.
18. Nayyar A, Strassle PD, Shen MR, et al. Survival analysis of early-stage breast cancer patients undergoing axillary lymph node dissection and sentinel lymph node dissection. Am J Surg, 2018, 216(4): 706-712.
19. Nowikiewicz T, Zegarski W, Pagacz K, et al. Does the presence of sentinel lymph node macrometastases in breast cancer patients require axillary lymph node dissection? Single-center analysis. Breast J, 2018, 24(5): 724-729.
20. Wang J, Mittendorf EA, Sahin AA, et al. Outcomes of sentinel lymph node dissection alone vs. axillary lymph node dissection in early stage invasive lobular carcinoma: a retrospective study of the surveillance, epidemiology and end results (SEER) database. PLoS One, 2014, 9(2): e89778. doi: 10.1371/journal.pone.0089778.
21. Peristeri DV, Harissis HV. Axillary lymph node dissection vs sentinel biopsy only among women with early-stage breast cancer and sentinel node metastasis: a systematic review and meta-analysis. Breast J, 2021, 27(2): 158-164.
22. Jagsi R, Chadha M, Moni J, et al. Radiation field design in the ACOSOG Z0011 (Alliance) trial. J Clin Oncol, 2014, 32(32): 3600-3606.
23. Colleoni M, Sun Z, Price KN, et al. Annual hazard rates of recurrence for breast cancer during 24 years of follow-up: results from the international breast cancer study group trials Ⅰ to Ⅴ. J Clin Oncol, 2016, 34(9): 927-935.
24. Dutta SW, Volaric A, Morgan JT, et al. Pathologic evaluation and prognostic implications of nodal micrometastases in breast cancer. Semin Radiat Oncol, 2019, 29(2): 102-110.
25. Wu P, Zhao K, Liang Y, et al. Validation of breast cancer models for predicting the nonsentinel lymph node metastasis after a positive sentinel lymph node biopsy in a chinese population. Technol Cancer Res Treat, 2018, 17: 1533033818785032. doi: 10.1177/1533033818785032.
26. Loza CM, Mandó P, Ponce C, et al. Predictive factors for non-sentinel lymph node metastasis in patients with ACOSOG Z0011 Criteria. Breast Care (Basel), 2018, 13(6): 434-438.
27. Qiu PF, Liu JJ, Wang YS, et al. Risk factors for sentinel lymph node metastasis and validation study of the MSKCC nomogram in breast cancer patients. Jpn J Clin Oncol, 2012, 42(11): 1002-1007.

CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Validation study in younger breast cancer patients who meeting the criteria of ACOSOG Z0011 trial based on the SEER database

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