Khan SA, Schuetz S, Hosseini O. Primary-site local therapy for patients with de novo metastatic breast cancer: an educational review. Ann Surg Oncol. 2022;29(9):5811–20.

Article  PubMed  Google Scholar 

Lane WO, Thomas SM, Blitzblau RC, et al. Surgical resection of the primary tumor in women with de novo stage IV breast cancer: contemporary practice patterns and survival analysis. Ann Surg. 2019;269(3):537–44.

Article  PubMed  Google Scholar 

Thomas A, Khan SA, Chrischilles EA, et al. Initial surgery and survival in stage IV breast cancer in the United States, 1988–2011. JAMA Surg. 2016;151(5):424–31.

Article  PubMed  PubMed Central  Google Scholar 

Xiao W, Zou Y, Zheng S, et al. Primary tumor resection in stage IV breast cancer: a systematic review and meta-analysis. Eur J Surg Oncol. 2018;44(10):1504–12.

Article  PubMed  Google Scholar 

Harris E, Barry M, Kell MR. Meta-analysis to determine if surgical resection of the primary tumour in the setting of stage IV breast cancer impacts on survival. Ann Surg Oncol. 2013;20(9):2828–34.

Article  PubMed  Google Scholar 

Badwe R, Hawaldar R, Nair N, et al. Locoregional treatment versus no treatment of the primary tumour in metastatic breast cancer: an open-label randomised controlled trial. Lancet Oncol. 2015;16(13):1380–8.

Article  PubMed  Google Scholar 

Soran A, Ozmen V, Ozbas S, et al. Randomized trial comparing resection of primary tumor with no surgery in stage IV breast cancer at presentation: protocol MF07-01. Ann Surg Oncol. 2018;25(11):3141–9.

Article  PubMed  Google Scholar 

Soran A, Ozmen V, Ozbas S, et al. Primary surgery with systemic therapy in patients with de novo stage IV breast cancer: 10-year follow-up; protocol MF07-01 randomized clinical trial. J Am Coll Surg. 2021;233(6):742-751.e745.

Article  PubMed  Google Scholar 

Fitzal F, Bjelic-Radisic V, Knauer M, et al. Impact of breast surgery in primary metastasized breast cancer: outcomes of the prospective randomized phase III ABCSG-28 POSYTIVE Trial. Ann Surg. 2019;269(6):1163–9.

Article  PubMed  Google Scholar 

Khan SA, Zhao F, Goldstein LJ, et al. Early local therapy for the primary site in de novo stage IV breast cancer: results of a randomized clinical trial (EA2108). J Clin Oncol. 2022;40(9):978–87.

Article  CAS  PubMed  Google Scholar 

Saphner T, Tormey DC, Gray R. Annual hazard rates of recurrence for breast cancer after primary therapy. J Clin Oncol. 1996;14(10):2738–46.

Article  CAS  PubMed  Google Scholar 

Anderson WF, Chen BE, Jatoi I, et al. Effects of estrogen receptor expression and histopathology on annual hazard rates of death from breast cancer. Breast Cancer Res Treat. 2006;100(1):121–6.

Article  CAS  PubMed  Google Scholar 

Murata T, Jinno H, Takahashi M, et al. Clinicopathologic features of hormone-receptor-positive breast cancer patients with late recurrence. Breast J. 2019;25(1):9–15.

Article  CAS  PubMed  Google Scholar 

Khan SA, Zhao F, Goldstein L et al. Reply to B. Ulas Kahya et al. and A. Soran et al. J Clin Oncol 2022:JCO2200861.

Soran A, Aytac O, Ozbas S. Locoregional therapy for intact primary tumor in de novo stage IV breast cancer. J Clin Oncol. 2022:JCO2200802.

Newell DJ. Intention-to-treat analysis: implications for quantitative and qualitative research. Int J Epidemiol. 1992;21(5):837–41.

Article  CAS  PubMed  Google Scholar 

Fisher LD, Dixon DO, Herson J, Frankowski RK, Hearron MS, Peace KE. Intention to treat in clinical trials. In: KE Peace, editor. Statistical issues in drug research and development. New York, NY: Marcel Dekker; 1990. p. 331–50.

Google Scholar 

Abraha I, Montedori A. Modified intention to treat reporting in randomised controlled trials: systematic review. BMJ. 2010;340:c2697.

Article  PubMed  PubMed Central  Google Scholar 

Sainani KL. Making sense of intention-to-treat. PM R. 2010;2(3):209–13.

Article  PubMed  Google Scholar 

Matilde Sanchez M, Chen X. Choosing the analysis population in non-inferiority studies: per protocol or intent-to-treat. Stat Med. 2006;25(7):1169–81.

Article  CAS  PubMed  Google Scholar 

D’Agostino RB Sr, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues—the encounters of academic consultants in statistics. Stat Med. 2003;22(2):169–86.

Article  PubMed  Google Scholar 

Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010;7(3):e1000251.

Article  PubMed  PubMed Central  Google Scholar 

Schumi J, Wittes JT. Through the looking glass: understanding non-inferiority. Trials. 2011;12:106.

Article  PubMed  PubMed Central  Google Scholar