Substantial Reduction in Adjuvant Chemotherapy With the Use of the 21-Gene Test to Manage Early Breast Cancer in a Public Hospital in Brazil.

PURPOSE: We evaluated the impact of 21-gene test results on treatment decisions for patients with early-stage breast cancer treated under the public health care system in Brazil, Sistema Único de Saúde. METHODS: Eligible patients treated at Hospital Pérola Byington and Santa Casa de Misericórdia de São Paulo in Brazil were required to have the following characteristics: postsurgery with hormone receptor-positive, human epidermal growth factor 2-negative, node-negative and node-positive, and T1/T2 breast cancer and patients with these characteristics were candidates for adjuvant systemic therapy. Treatment recommendations, chemotherapy plus hormonal therapy (CT + HT) or HT alone, were captured before and after 21-gene test results. RESULTS: From August 2018 to April 2019, 179 women were enrolled. The mean age was 58 years (29-86 years), 135 (76%) were postmenopausal, and 58 (32%) had node-positive breast cancer. Most patients (61%) had a tumor > 2 cm, including 7% with tumors > 4 cm. Using Recurrence Score (RS) result cut points on the basis of the TAILORx trial, 40 (22%) had RS 0-10, 91 (51%) had RS 11-25, and 48 (27%) had RS 26-100. Before 21-gene testing, 162 of 179 (91%) patients were recommended for CT. After testing, 117 of 179 patients (65%) had changes in CT recommendation: 112 (63%) who were initially recommended CT received HT alone and five (3%) who were initially recommended HT alone received CT + HT. After 21-gene testing, 99% of physicians reported strong confidence in their treatment recommendations. CONCLUSION: The change in clinical practice at these public hospitals was greater than expected: 66% of initial treatment recommendations were changed to omit CT with 21-gene test results. Clinicopathologic features did not correlate well with 21-gene test results and did not adequately identify those most likely to benefit from CT.

Automated screening of conventional gynecological cytology smears: feasible and reliable.

OBJECTIVES: We tested the ability of automated screening in processing conventional gynecological cytology smears and its efficacy in assessing sample adequacy and stratifying cases for risk of malignancy. STUDY DESIGN: Cases were retrospectively selected, including unsatisfactory samples and slides with various sorts of artifacts. Automated screening was performed using the FocalPoint GS Imaging System (Becton Dickinson, Franklin Lakes, N.J., USA), with classification into five quintiles. For agreement purposes, cases were grouped into high risk for malignancy (quintiles 1 and 2) and low risk for malignancy (quintiles 3, 4 and 5). RESULTS: A total of 120 cases (median age 37.5 years, range 18-85) were included in the study. Eighty-three cases (69.2%) could be successfully classified into quintiles. When divided by risk, 31 cases were placed in the high-risk and 52 in the low-risk group. The overall sensitivity and specificity of the automated analysis was 100 and 70.3%, respectively. CONCLUSIONS: Automated analysis could analyze the majority of conventional smears, including one case previously screened as unsatisfactory. All malignant and high-grade lesions were correctly classified into the high-risk group. Broad use of this automation system could potentially decrease screening time and augment the efficacy in detecting precursor neoplastic changes in cervical cytology smears.