Extrapolation of ACOSOG Z0011 trial results—A survey of breast cancer providers

We surveyed breast providers from a national oncology cooperative group to evaluate axillary management recommendations for patients with 1–2 positive sentinel lymph nodes (+SLNs) with scenarios not explicitly included in the Z0011 trial. These scenarios included patients underrepresented (premenopausal, HER2+/triple-negative tumors, and invasive lobular carcinoma) or excluded (treated with mastectomy or neo-adjuvant chemotherapy [NAC]) from the ACOSOG Z0011 trial. Survey response rate was 94/149 (64%). For patients in underrepresented groups, 45–63% of providers recommended no further axillary treatment. For mastectomy patients, 45–55% recommended multi-disciplinary discussion. 83% felt more data are needed to change practice, but 41% believed there would be significant accrual challenges to a clinical trial. For patients treated with NAC, recommendations varied widely. 85% felt more data are needed to change practice, but 26% felt there would be significant accrual challenges. For all scenarios, 86–100% of radiation oncologists recommended axillary radiation, while surgeons more often recommended no further axillary treatment. Traditional randomized trials are likely not feasible to provide answers to these critical management questions, so more pragmatic or big data studies may be needed.     

Assessment of the performance of the Stanford Online Calculator for the prediction of nonsentinel lymph node metastasis in sentinel lymph node‐positive breast cancer patients

BACKGROUND:

Several models for the prediction of nonsentinel lymph node (NSLN) metastasis in sentinel lymph node (SLN)‐positive breast cancer patients have been proposed. In this study, the authors evaluate the Stanford Online Calculator (SOC), which was designed to predict the likelihood of NSLN metastasis using only 3 variables: primary tumor size, SLN metastasis size, and angiolymphatic invasion status. They compared it with the Mayo and Memorial Sloan‐Kettering Cancer Center (MSKCC) nomograms.

METHODS:

The SOC was used to calculate the probability of NSLN metastasis in 464 breast cancer patients with SLN metastasis who underwent completion axillary lymph node dissection at the Mayo Clinic. The area under the receiver operating characteristic curve (AUC) was calculated for each model. Mean probabilities of patients with and without NSLN metastasis were compared. Patients with ≤5%, ≤10%, and 100% NSLN metastasis probabilities were examined.

RESULTS:

The AUCs of the Stanford, MSKCC, and Mayo models were 0.72, 0.74, and 0.77, respectively (P = .13). The mean Stanford probabilities for patients with and without NSLN metastasis were 0.75 (range, 0.06‐1.0) and 0.50 (range, 0.05‐1.0), respectively (P < .0001). The false‐negative rates for patients with a Stanford probability of ≤5% and ≤10% were 0% and 13%, respectively. Of the patients with a Stanford probability of 100%, 26% did not have NSLN metastasis.

CONCLUSIONS:

Despite using only 3 variables, the Stanford nomogram appears to perform on a par with, but not better than, the MSKCC and Mayo nomograms. Further validation in other patient populations is needed. Cancer 2009. © 2009 American Cancer Society.     

The Feasibility of Breast-Conserving Surgery for Multiple Ipsilateral Breast Cancer: An Initial Report from ACOSOG Z11102 (Alliance) Trial

Background

Historically, multiple ipsilateral breast cancer (MIBC) has been a contraindication to breast-conserving therapy (BCT). We report the feasibility of BCT in MIBC from the ACOSOG Z11102 trial [Alliance], a single arm noninferiority trial of BCT for women with two or three sites of malignancy in the ipsilateral breast.

Methods

Women who enrolled preoperatively in ACOSOG Z11102 were evaluated for conversion to mastectomy and need for reoperation to obtain negative margins. Characteristics of women who successfully underwent BCT and those who converted to mastectomy were compared. Factors were examined for association with the need for margin reexcision.

Results

Of 198 patients enrolled preoperatively, 190 (96%) had 2 foci of disease. Median size of the largest tumor focus was 1.5 (range 0.1–7.0) cm; 49 patients (24.8%) had positive nodes. There were 14 women who underwent mastectomy due to positive margins, resulting in a conversion to mastectomy rate of 7.1% (95% confidence interval [CI] 3.9–10.6%). Of 184 patients who successfully completed BCT, 134 completed this in a single operation. Multivariable logistic regression analysis did not identify any factors significantly associated with conversion to mastectomy or need for margin reexcision.

Conclusions

Breast conservation is feasible in MIBC with 67.6% of patients achieving a margin-negative excision in a single operation and 7.1% of patients requiring conversion to mastectomy due to positive margins. No characteristic was identified that significantly altered the risk of conversion to mastectomy or need for reexcision.

ClinicalTrials.gov Identifier

NCT01556243.

     

Simple Prediction Models for Breast Cancer Patients with Solitary Positive Sentinel Nodes––are they Valid?

Abstract:  Identification and prediction of breast cancer patients with metastases isolated to the sentinel lymph node(s) would potentially allow avoidance of axillary dissection and its complications. In this study, we evaluate the performance of two recently published models (Alkhatib et al. and Chagpar et al.) that attempt to predict patients who have isolated sentinel lymph node metastases. Both of these models reported a 5% rate of positive nonsentinel nodes in their respective lowest risk category. From 1997 to 2004, 465 breast cancer patients had a positive sentinel node and underwent axillary lymph node dissection at Mayo Clinic. To evaluate the Alkhatib model, patients were assigned to the following groups: group 1: 1 positive sentinel node and ≥1 negative sentinel node(s); group 2: >1 positive sentinel node and ≥1 negative sentinel node(s); group 3: 1 positive sentinel node and no negative sentinel node(s); group 4: >1 positive sentinel node and no negative sentinel node(s). To evaluate the Chagpar model, patients were assigned a score based on the sum of three factors: tumor size (T1a = 1, T1b or T1c = 2, T2 = 3, and T3 = 4 points), number of positive sentinel nodes (>1 positive sentinel node = 1 point), and ratio of positive/total sentinel nodes (>50% positive = 1 point). The chi-square test was used to compare our results to those of the original studies. For the Alkhatib model, we found that 30% (p < 0.0001) of Group 1 patients had nonsentinel node metastases. Using the Chagpar model, the percentage of patients with a cumulative score of 1 with a nonsentinel node metastasis was 17% (p = 0.19). In our cohort, neither model accurately predicted which patients have a ≤ 5% chance of having nonsentinel metastases. These models are not adequate to identify patients in whom axillary dissection can be omitted.