Prospective Study of the Effect of the 21-Gene Assay on Adjuvant Clinical Decision-Making in Japanese Women With Estrogen Receptor-Positive, Node-Negative, and Node-Positive Breast Cancer

AbstractBackgroundIn this study we investigated if the 21-gene assay result affects adjuvant decision-making in Japanese women with ER+ invasive EBC.Patients and MethodsA total of 124 consecutive eligible patients with ER+, HER2-negative EBC and 0 to 3 positive lymph nodes were enrolled. Treatment recommendations, physicians' confidence and patients' decisional conflict before and after knowledge of the Recurrence Score results of the 21-gene assay were recorded.ResultsOne-hundred four patients (84%) had N0 disease, including micrometastases, and 20 (16%) had N+ disease. Overall, recommendations changed in 33% (95% CI, 24%-43%) of N0 and 65% (95% CI, 41%-85%) of N+ patients. In 27 of 48 (56%) of N0 and 13 of 15 (87%) of N+ patients an initial recommendation for chemohormonal therapy was revised to only hormonal therapy after assay results, and in 7 of 56 (13%) of N0 and 0 of 5 N+ patients from only hormonal to combined chemohormonal therapy. Decisions appeared to follow the Recurrence Score results for low and high values. For patients with intermediate Recurrence Score values, overall recommendations for chemohormonal treatment tended to decrease after assay results. Physicians' confidence increased in 106 of 124 (85.5%; 95% CI, 78%-91%) cases. Patients' decisional conflict significantly improved as indicated by changes in the total score and the 5 defined subscores (P = .014 for Informed Subscore; P < .001 for all others).ConclusionResults from this prospective study in a Japanese population confirm an effect of the 21-gene assay results on adjuvant treatment decision-making, consistent with reported experiences from the United States and Europe

A multicenter survey of temporal changes in chemotherapy-induced hair loss in breast cancer patients.

PurposeMany breast cancer patients suffer from chemotherapy-induced hair loss. Accurate information about temporal changes in chemotherapy-induced hair loss is important for supporting patients scheduled to receive chemotherapy, because it helps them to prepare. However, accurate information, on issues such as the frequency of hair loss after chemotherapy, when regrowth starts, the condition of regrown hair, and the frequency of incomplete hair regrowth, is lacking. This study aimed to clarify the long-term temporal changes in chemotherapy-induced hair loss using patient-reported outcomes for chemotherapy-induced hair loss.MethodsWe conducted a multicenter, cross-sectional questionnaire survey. Disease-free patients who had completed adjuvant chemotherapy consisting of anthracycline and/or taxanes for breast cancer within the prior 5 years were enrolled from 47 hospitals and clinics in Japan. Descriptive statistics were obtained in this study. The study is reported according to the STROBE criteria.ResultsThe response rate was 81.5% (1511/1853), yielding 1478 questionnaires. Hair loss occurred in 99.9% of patients. The mean time from chemotherapy until hair loss was 18.0 days. Regrowth of scalp hair occurred in 98% of patients. The mean time from the completion of chemotherapy to the beginning of regrowth was 3.3 months. Two years after chemotherapy completion, the scalp-hair recovery rate was ConclusionsOur survey focused on chemotherapy-induced hair loss in breast cancer patients. We believe these results to be useful for patients scheduled to receive chemotherapy