How nescience may obscure evidence

Abstract

limitations of the study were recognized and let to some critical comments [7], current guidelines [8,14] rapidly adopted the omission of ALND in these selected patients.Unreckoned insights about the quality of evidence generated by the Z0011-trial were provided by a recent publication on behalf of the Alliance for Clinical Trials in Oncology by Jagsi et al. Briefly, the study [3] (published in 2011) comprised 891 women from 115 institutions with a clinically negative axilla who underwent sentinel node dissection (SLND), revealing 1-2 pathologically affected nodes. Tumor characteristics were pT1 (70 %) or pT2 invasive carcinomas, mostly ER +, well-differentiated tumors. Patients were randomized to either axillary dissection (ALND) or During the last decade, treatment trends for early breast cancer have been fluctuating between opposite extremes. More aggressive regional nodal irradiation (RNI) has been suggested by several recent studies [10,17], on the other side, the previously unquestioned dogma of axillary dissection as an important part of breast cancer management was gradually abandoned in favor of sentinel node dissection (SLND). While consensus was rapidly achieved for pathologically negative SN, the management of patients with one or two positive SN remained controversial up to the first publication of a randomized study of the American College of Surgeons Oncology Group [3] which specifically addressed the outcome of such patients with ALND vs. none. Even though Editorial on Jagsi et al. Radiation field design in the ACOSOG Z0011 (Alliance) Trial.

Radiotherapy of the lymphatic drainage pathways in breast carcinoma: time for a reassessment

“…However, the study has substantial methodological weaknesses: recruitment was interrupted prematurely, and a total of 103 patients could not be analyzed. In violation of the explicit protocol requirements, additional RNI was carried out in around 15 % of them [21,22], With regard to the prognosis when there is sentinel node involvement, a countertrend emerged in a subgroup analysis in the NSABP-B-32 study [23]. Fifteen percent of the lymph nodes initially evaluated as histopathologically negative were found to have occult LN metastases at an additional histological examination.…”

DEGRO practical guidelines for radiotherapy of breast cancer VI: therapy of locoregional breast cancer recurrences

“…The Early Breast Cancer Trialists’ Collaborative Group analysis revealed a 10-year risk of an isolated locoregional recurrence as the first event after mastectomy of 20.3 % for patients with 1–3 positive axillary lymph nodes, and of 32.1 % for patients with ≥ 4 positive nodes. The addition of radiotherapy significantly reduced the risk to 3.8 and 13 %, respectively [ 2 , 49 , 50 ]. In cohorts treated with modern systemic therapies, the total locoregional recurrence rate is substantially lower; however, the relative risk reduction after radiotherapy remains unchanged [ 51 ].…”

Current Treatment of Isolated Locoregional Breast Cancer Recurrences

“…The Early Breast Cancer Trialists' Collaborative Group analysis revealed a 10-year risk of an isolated locoregional recurrence as the first event after mastectomy of 20.3% for patients with 1-3 positive axillary lymph nodes, and of 32.1% for patients with 4 or more positive nodes. The addition of radiotherapy significantly reduced the risk to 3.8 and 13%, respectively [2,44,45,46]. In a retrospective study, Katz et al [47] reported on the local recurrence patterns of 1,031 women treated in 5 prospective trials with mastectomy and adjuvant chemotherapy without radiation therapy.…”