Minimally Invasive Complete Response Assessment of the Breast After Neoadjuvant Systemic Therapy for Early Breast Cancer (MICRA trial): Interim Analysis of a Multicenter Observational Cohort Study.

BACKGROUND: The added value of surgery in breast cancer patients with pathological complete response (pCR) after neoadjuvant systemic therapy (NST) is uncertain. The accuracy of imaging identifying pCR for omission of surgery, however, is insufficient. We investigated the accuracy of ultrasound-guided biopsies identifying breast pCR (ypT0) after NST in patients with radiological partial (rPR) or complete response (rCR) on MRI. METHODS: We performed a multicenter, prospective single-arm study in three Dutch hospitals. Patients with T1-4(N0 or N +) breast cancer with MRI rPR and enhancement ≤ 2.0 cm or MRI rCR after NST were enrolled. Eight ultrasound-guided 14-G core biopsies were obtained in the operating room before surgery close to the marker placed centrally in the tumor area at diagnosis (no attempt was made to remove the marker), and compared with the surgical specimen of the breast. Primary outcome was the false-negative rate (FNR). RESULTS: Between April 2016 and June 2019, 202 patients fulfilled eligibility criteria. Pre-surgical biopsies were obtained in 167 patients, of whom 136 had rCR and 31 had rPR on MRI. Forty-three (26%) tumors were hormone receptor (HR)-positive/HER2-negative, 64 (38%) were HER2-positive, and 60 (36%) were triple-negative. Eighty-nine patients had pCR (53%; 95% CI 45-61) and 78 had residual disease. Biopsies were false-negative in 29 (37%; 95% CI 27-49) of 78 patients. The multivariable associated with false-negative biopsies was rCR (FNR 47%; OR 9.81, 95% CI 1.72-55.89; p = 0.01); a trend was observed for HR-negative tumors (FNR 71% in HER2-positive and 55% in triple-negative tumors; OR 4.55, 95% CI 0.95-21.73; p = 0.058) and smaller pathological lesions (6 mm vs 15 mm; OR 0.93, 95% CI 0.87-1.00; p = 0.051). CONCLUSION: The MICRA trial showed that ultrasound-guided core biopsies are not accurate enough to identify breast pCR in patients with good response on MRI after NST. Therefore, breast surgery cannot safely be omitted relying on the results of core biopsies in these patients.

Femoral component rotation in patellofemoral joint replacement: a study protocol for a prospective observational study.

Patellofemoral joint replacement is a successful treatment option for isolated patellofemoral osteoarthritis. The short and mid-term outcomes are related to malposition and unexplained pain. Whether external rotation of the femoral component in isolated patellofemoral joint replacement is required is unclear. The primary aim of this study is to determine the CT-measured femoral component rotation of patellofemoral joint replacement relative to the transepicondylar axis. The secondary aim is to correlate the CT-measured femoral component rotation with the clinical outcomes at 1-year follow-up as assessed with the KOOS questionnaire. We designed a prospective observational study with medical research ethics committee and institutional review board approval. A total of 40 patients who will be treated with patellofemoral joint replacement for isolated patellofemoral osteoarthritis will be included. Intra-operatively, rotation of the femoral component will be assessed using anatomical landmarks including the epicondylar axis, Whiteside's line, and lower leg axis. The aim is to insert the femoral component between 3 and 6 degrees external rotation relative to the transepicondylar axis. Two experienced musculoskeletal radiologists will measure the angle between the transepicondylar axis and the femoral component, two to three days after surgery. The primary outcome is the CT-based femoral component rotation of the prosthesis relative to the transepicondylar axis. The secondary outcome is the patient reported KOOS questionnaire at 1-year follow-up. Successful completion of this study will provide data on the actual amount of femoral component rotation in patellofemoral joint replacement, and its relationship with clinical results. (Netherlands Trial Register NTR4175).