Showing posts with label clinical trials. Show all posts
Showing posts with label clinical trials. Show all posts

Thursday, 2 February 2023

 

Omission of axillary sentinel lymph node biopsy in early invasive breast cancer

 

by Toralf Reimer 

 

The Breast: Published: January 09, 2023

 

Abstract

 Local treatment of the axilla in clinically node-negative (cN0) early breast cancer patients with routine sentinel lymph node biopsy (SLNB) is debated after publication of ACOSOG Z0011 data in 2010. Currently, prospective randomized surgical trials investigating the omission of SLNB in upfront breast-conserving surgery (BCS) and in the neoadjuvant setting, respectively. Several prospective randomized trials (SOUND, INSEMA, BOOG 2013–08, and NAUTILUS) with axillary observation alone versus SLNB in cN0 patients and primary BCS have primary objectives to evaluate oncologic safety when omitting SLNB. The Italian SOUND trial was the earliest to open in 2012 and has completed accrual in 2017. First oncologic outcome data are expected soon for SOUND and at the end of 2024 for INSEMA. Improvements in systemic treatments for breast cancer have increased the rates of pathologic complete response (pCR) in patients receiving neoadjuvant systemic therapy (NAST), offering the opportunity to de-escalate surgery in patients who have a pCR. Two prospective single-arm trials (EUBREAST-01, ASICS) include only patients with the highest likelihood of having a pCR after NAST (triple-negative or HER2-positive breast cancer) and type of surgery will be defined according to the response to NAST rather than on the classical T and N status. The ongoing trials will hopefully help us to understand whether we might take the best therapeutic decisions without the pathologic evaluation of nodal status.

Thursday, 22 October 2020

Eligibility of real-world patients with metastatic breast cancer for clinical trials

 

Eligibility of real-world patients with metastatic breast cancer for clinical trials

 

by Atul Batra, Shiying Kong, Winson Y. Cheung 

 

The Breast: Open Access: Published: October 17, 2020

 

The results of clinical trials in metastatic breast cancer (MBC) are generalized to real-world patients. This study determines the proportion of real-world patients who would be eligible for clinical trials and compares outcomes in eligible versus ineligible patients.

Highlights

•One third of patients with metastatic breast cancer are clinical trial ineligible.

•Renal dysfunction and prior immunosuppression are common reasons.

•Ineligible patients are less likely to receive chemotherapy, but not hormonal therapy.

•Systemic treatment, but not eligibility, is associated with overall survival.

•Eligibility criteria should be broadened to represent more real-world patients.