Randomized Trial Comparing Resection of Primary Tumor with No Surgery in Stage IV Breast Cancer at Presentation: Protocol MF07-01.

BACKGROUND: The MF07-01 trial is a multicenter, phase III, randomized, controlled study comparing locoregional treatment (LRT) followed by systemic therapy (ST) with ST alone for treatment-naïve stage IV breast cancer (BC) patients. METHODS: At initial diagnosis, patients were randomized 1:1 to either the LRT or ST group. All the patients were given ST either immediately after randomization or after surgical resection of the intact primary tumor. RESULTS: The trial enrolled 274 patients: 138 in the LRT group and 136 in the ST group. Hazard of death was 34% lower in the LRT group than in the ST group (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.49-0.88; p = 0.005). Unplanned subgroup analyses showed that the risk of death was statistically lower in the LRT group than in the ST group with respect to estrogen receptor (ER)/progesterone receptor (PR)(+) (HR 0.64; 95% CI 0.46-0.91; p = 0.01), human epidermal growth factor 2 (HER2)/neu(-) (HR 0.64; 95% CI 0.45-0.91; p = 0.01), patients younger than 55 years (HR 0.57; 95% CI 0.38-0.86; p = 0.007), and patients with solitary bone-only metastases (HR 0.47; 95% CI 0.23-0.98; p = 0.04). CONCLUSION: In the current trial, improvement in 36-month survival was not observed with upfront surgery for stage IV breast cancer patients. However, a longer follow-up study (median, 40 months) showed statistically significant improvement in median survival. When locoregional treatment in de novo stage IV BC is discussed with the patient as an option, practitioners must consider age, performance status, comorbidities, tumor type, and metastatic disease burden.

Predicting the likelihood of nonsentinel lymph node metastases in triple negative breast cancer patients with a positive sentinel lymph node: Turkish Federation of Breast Disease Associations protocol MF09-01.

BACKGROUND: Triple negative (TN) tumor has a relatively high rate of recurrence and distant metastasis, but results of studies revealed that triple positive tumor is an independent predictor of axillary lymph node involvement. Our aim was to evaluate the frequency of nonsentinel lymph node metastasis (NSLNM) involvement in operable TN breast cancer with positive sentinel lymph node (SLN) and predicting the likelihood of NSLNM in this cohort of patients by using 4 different nomograms. METHODS: A total of 128 patients with TN and SLN(+) underwent complete axillary lymph node dissection in 14 different centers in Turkey. For comparison, we used our previous multicenter MF08-01 Protocol, which identified 441 patients with estrogen receptor (ER(+)) who had a positive SLN biopsy and underwent subsequent complete axillary lymph node dissection. Turkish, Cambridge, and Stanford nomograms and the Tenon Score system were used to calculate the probability of NSLNM. RESULTS: Patients with TN tumor had a larger tumor size. The actual percentage of NSLN positivity was 41% in the TN group and 47.1% in patient with ER(+). The Tenon Score was ≤3.5 in 12% of patients with TN and ER(+); the area under the curve in the receiver operating characteristics curve were 0.53 and 0.59, respectively. Based on the Turkish, Cambridge, and Stanford nomograms, areas under the curve were 0.54, 0.53, and 0.61, respectively in patients with TN, and were 0.79, 0.72, and 0.70, respectively, in patients with ER(+). CONCLUSION: Using the Tenon Score system underestimates NSLN positivity, and tested nomograms are not good discriminators of NSLNM in patients with TN and positive SLN.