NSABP B-04 trial 25 years later: lessons for oncologists

This critical analysis of the article of B. Fisher et al. “Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation” (2002) was written for physicians interested in learning how evidence based oncology has challenged the Halstedian model of breast cancer progression and the radical loco-regional treatment as the way to stop this progression. The 25-year update of the NSABP B-04 study is unique in its design and the remarkable length of follow-up. Our detailed analysis of the article provides an example how oncologists learn about biology of the disease, test the hypothesis of the metastatic spread of the tumor, and what the bases of the modern principles of loco-regional treatment of breast cancer are. Also, the modern clinical recommendations are written using similar systematic analysis of the available literature. The presented analysis explains the logic behind using various end-points. This analysis illustrates how the study helps to dismantle the stereotype that super radical surgical treatment of breast cancer was effective and to promote research in less aggressive loco-regional treatments of other tumors. To our knowledge this type of analysis has never been published before in Russian oncology literature.

1. Fisher B., Montague E., Redmond C. et al. Comparison of radical mastectomy with alternative treatments for primary breast cancer. A first report of results from a prospective randomized clinical trial. Cancer 1977;39: 2827–39.

2. Fisher B., Redmond C., Fisher E.R. et al. Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation. N Engl J Med 1985;312: 674–81.

3. Fisher B., Montague E., Redmond C. et al. Comparison of radical mastectomy with alternative treatments for primary breast cancer. A first report of results from a prospective randomized clinical trial. Cancer 1977;39:2827–39.

4. Fisher B., Jeong J.H., Anderson S. et al. Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation. N Engl J Med. 2002;347(8):567–75.

5. Faries M.B., Thompson J.F., Cochran A.J. et al. Completion dissection or observation for sentinel-node metastasis in melanoma. N Engl J Med 2017;376(23):2211–22. DOI: 10.1056/NEJMoa1613210.

6. Sim F.H., Taylor W.F., Ivins J.C. et al. A prospective randomized study of the efficacy of routine elective lymphadenectomy in management of malignant melanoma. Preliminary results. Cancer 1978;41(3):948–56.

7. Hartgrink H.H., van de Velde C.J., Putter H. et al. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial. J Clin Oncol 2004;22(11):2069– 77. DOI: 10.1200/JCO.2004.08.026.

8. Angioli R., Plotti F., Palaia I. et al. Update on lymphadenectomy in early and advanced ovarian cancer. Curr Opin Obstet Gynecol 2008;20(1):34–9. DOI: 10.1097/GCO.0b013e3282f2fd68.

9. Panici P.B., Maggioni A., Hacker N. et al. Systematic aortic and pelvic lymphadenectomy versus resection of bulky nodes only in optimally debulked advanced ovarian cancer: a randomized clinical trial. J Natl Cancer Inst 2005;97(8):560–6. DOI: 10.1093/jnci/dji102.

10. Harter P., Sehouli J., Lorusso D. et al. LION: Lymphadenectomy in ovarian neoplasms – a prospective randomized AGO study group led gynecologic cancer intergroup trial. J Clin Oncol 2017;35(15 suppl):5500. DOI: 10.1200/JCO.2017.35.15_suppl.5500.

11. ASTEC The writing committee on behalf of the ASTEC study group. Efficacy of systematic pelvic lymphadenectomy in endometrial cancer (MRC ASTEC trial): a randomised study. Lancet 2009;373(9658):125–36. DOI: 10.1016/S0140-6736(08)61766-3.

12. Giuliano A.E., Ballman K.V., 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):918–26. DOI: 10.1001/jama.2017.11470.