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Background: The OSNA (One Step Nucleic acid Amplification) assay is a semi-automated lymph node examination method using molecular biological technique. The OSNA assay has been validated for breast cancer patients without receiving preoperative systemic therapy (PST) by several clinical studies and has currently become more popular as sentinel lymph node (SLN) examination method with the following two main advantages; 1) to allow examination of the whole portion of a node, 2) to allow intraoperative judgment of metastasis positive or negative. However, the feasibility of the OSNA assay in breast cancer patients treated by PST has never been confirmed. In this multi-central clinical study, we compared the judgments of the OSNA assay and of pathological examination on lymph nodes dissected after receiving PST to evaluate the performance of the OSNA assay. Material & Methods: Three hundred two nodes dissected from the 80 breast cancer patients who received PST were examined. Each lymph node was divided at 2mm intervals and the slices were alternately applied to the OSNA assay and pathological examination with H&E staining and CK19 immunohistochemical staining of permanent-section. In pathological examination, judgments of metastasis positive or negative were determined by one central-review pathologist according to the criteria of AJCC 7th edition ("positive" if >0.2mm metastases were detected). Result: The overall concordance rate between the OSNA assay and pathological examination was 91.1% (275/302) with sensitivity of 88.3% (53/60) and specificity of 91.7% (222/242) (Table). These results are very similar to those of the Japanese clinical validation study in breast cancer patients without receiving PST which was conducted by the almost same protocol (Tamaki Y, et al. Clin Cancer Res, 2009, 15: 2879-2884). Conclusion & Discussion: These results indicate the OSNA assay can be applicable for breast cancer patients after receiving PST as well as breast cancer patients without receiving PST. The OSNA assay will enable to examine the whole portion of nodes, leading to more detection of metastases (especially micrometastases) and more exact nodal staging for breast cancer patients treated by PST. Also, for the patients who receive sentinel lymph node biopsy after PST, the OSNA assay will be useful as intraoperative examination method of SLNs because it is expected to provide more correct judgments than current intraoperative methods such as frozen-section or touch-print cytology. [ABSTRACT FROM AUTHOR]

Background: Molecular genomic profiling currently plays a major role in treatment decisions for breast cancer patients. The 21-gene signature (Oncotype DX® [ODX]) is one of the most well-validated assays. Herein we evaluated the associations between high Recurrence Score (RS) measured by the ODX and pathological factors. Methods: From October 2007 to October 2010, the ODX assay was performed for 139 hormone-receptor-positive invasive breast cancer patients at single institution. Correlations between the RS and the following pathological factors were analyzed: tumor size (T), lymph node metastasis (N), nuclear atypia (NA), mitotic counts (MC), nuclear grade (NG), lymphatic and vascular invasion (LI and VI), estrogen receptor (ER), progesterone receptor (PgR), HER2, and Ki-67. Expression of ER, PgR, HER2, and Ki-67 was examined by immunohistochemistry. The Ki-67 labeling index was automatically counted with an Ariol-SL50 instrument (APPLIED IMAGING). The other pathological factors were estimated under the supervision of one experienced pathologist. Spearman rank correlation coefficients were calculated for the analyses. When the r was >0.4 or <-0.4 for two factors, they were determined to be well correlated. Results: Of 139 patients, the ODX assay revealed 68 (49%) low RS cases, 52 (37%) intermediate RS cases, and 19 (14%) high RS cases. Moderate positive or negative correlations were noted between the RS and PgR (r = -0.53), the RS and Ki-67 (r = 0.42), and the RS and NG (r = 0.41). No patients had high RS with PgR (3+) or NG1. The rate of high RS with Ki-67 (<20%) was one patient (2%). The number of cases who did not show PgR (3+) or NG1 or Ki-67 (<20%) was only 34 (25%). Among high RS cases, the correlation between PgR (0) and NG3 was 83%, the correlation between PgR (0) and NG2 was 75%, and the correlation between PgR (1+) and NG3 was 75%. The rate of high RS with PgR (0) and Ki-67 (≥20%) was 70%, that of PgR (1+) and Ki-67 (≥20%) was 58%, and that of PgR (2+) and Ki-67 (≥20%) was 21%. Correlations with T, N, NA, MC, LI, VI, ER, and HER2 were smaller (r ranging from -0.33 to 0.38). Conclusion: This study demonstrated that PgR, NG, and Ki-67 tend to be strongly correlated with the RS. Judging from PgR (3+), NG1, and Ki-67 (≥20%), we could select the patients who were proposed to perform the ODX. Among these factors, the correlation with PgR was particularly robust. PgR expression is a known marker of a functional ER and represents ER activity. In addition, the absence of PgR may reflect hyperactive cross-talk between ER and growth factor signaling pathways. We consider that these mechanisms could enhance the value of PgR in predicting the RS. [ABSTRACT FROM AUTHOR]

Background: Invasive micropapillary carcinoma (IMPC) has been classified as a special type of breast cancer and has a high incidence of lymph node metastases and lymphatic invasion with poor prognosis. IMPC is often mixed with other histological types. This study examined whether the prognosis is correlated with proportion of the IMPC. Methods: The subjects included 124 patients with IMPC that were surgically resected at St. Luke's International Hospital between February 2000 and January 2011. The resected specimens were reviewed histopathologically to determine the proportion of IMPC lesion. Patients were classified into two groups based on three cut-points of the proportion of IMPC lesion, 25%, 50%, and 75%. For each of these dichotomous classifications, we examined overall survival (OS), recurrence rate (RR) and pathological histology between the two groups. We used the Kaplan-Meier curve method and log-rank test to evaluate overall and disease-free survival time and the chi-squared test for pathological histology. Results: The subjects were 124 cases, and two of them were male breast cancer. The patient's age at presentation ranged from 29 to 83 years (mean 54.5 years). At a median follow-up of 52 months (interquartile range, 7 to 115 months). For all cut off points, there was no significant difference in survival rate and recurrence rate. We observed high-rates of lymphatic invasion and lymph node metastasis even in patients with a low proportion of IMPC lesion. Conclusion: Our results provide no evidence to support a relationship between proportion of IMPC lesion and breast cancer prognosis. However, lymphatic invasion and lymph node metastasis was a high frequency with low proportion of the IMPC. [ABSTRACT FROM AUTHOR]

Background: Breast cancer incidence and breast-cancer mortality have been increasing in Japan. In estrogen-receptor-positive breast cancer, adding chemotherapy as adjuvant treatment is not definitive benefit for all women. Primary data on the clinical validity and decision impact of the 21-gene Recurrence Score for guiding the use of adjuvant chemotherapy has been studied among a Japanese population. Objective: The cost-effectiveness of the clinically validated 21-gene Recurrence Score for estrogen-receptor-positive, lymph-node-negative, early-stage breast cancer (ESBC) was assessed from a Japanese societal perspective. Method: The proportion of patients with low, intermediate, and high risk of recurrence by the 21-gene Recurrence Score and the influence of the Recurrence Score on use of adjuvant chemotherapy were obtained in a study of 104 patients. A Markov model was used to track time until distant recurrence and time from distant recurrence to death. Effect of adjuvant chemotherapy based on 21-gene Recurrence Score was based on published clinical validation studies. Direct and indirect medical costs were obtained from the referral center. Utilities associated with progression and adverse events associated with chemotherapy were extracted from the literature. Sensitivity analyses were performed to assess the key drivers of cost-effectiveness and the robustness of the findings to variations in the input estimates. Results: Forty-eight percent of patients were identified by the 21-gene Recurrence Score as low-risk, 36% as intermediate-risk, and 16% as high-risk. In treatment decision by using the 21-gene Recurrence Score, chemotherapy use overall decreased by 19%, resulting in an average increase of 0.235 QALYs. Testing with the 21-gene Recurrence Score cost ¥350,000 per patient with ¥153,490 lower acute costs because fewer women were treated with adjuvant chemotherapy. Eighteen percent more women who were identified as high risk were recommended adjuvant chemotherapy, which results in longer progression-free survival. On average across all risk groups, cost of monitoring until recurrence per patient increased by ¥3,572 and costs associated with recurrence declined by ¥43,687. Use of the 21-gene Recurrence Score resulted in a net cost of ¥665,455 ($8,386) per QALY gained. Conclusions: The change in decisions resulting from use of the 21-gene Recurrence Score in women with estrogen-receptor-positive, lymph-node-negative, ESBC is projected to be societally cost-effective in Japan. [ABSTRACT FROM AUTHOR]

Background: Although a docetaxel and cyclophosphomide (TC) regimen without anthracycline as adjuvant therapy became one of the standard regimens especially for ER-positive (ER + )/human epidermal growth factor receptor 2-negative (HER2 - ) primary breast cancer, the efficacy of TC as neoadjuvant chemotherapy (NAC) is not known. We conducted the prospective trial to assess the efficacy of a TC regimen in the neoadjuvant setting for stage II to III ER + /HER2 - primary breast cancer., Patients and Methods: A TC regimen that included 75 mg/m 2 of docetaxel and 600 mg/m 2 of cyclophosphamide for 4 cycles every 3 weeks was administered as NAC. Primary endpoints are the rate of clinical response (clinical partial response and clinical complete response) and pathologic complete response; secondary endpoints are the disease-free survival and overall survival rates., Results: Thirty (71.4%) of 42 tumors had clinical response. No patient achieved pathologic complete response. At the median follow-up period of 105.2 months (range, 12.1-119.7 months), the disease-free survival rate was 81.6%, and the distant disease-free survival rate was 86.8%. In terms of survival, only 1 patient died during the study period. The overall survival rate was 97.4% during the study period. Patients who developed distant recurrence had a trend to have progesterone receptor-negative or weakly positive compared with those who did not develop any recurrence (85.7% vs. 45.2%; P = .05)., Conclusions: Our prospective study showed that a TC regimen as NAC achieved a high clinical response rate in stage II to III ER + /HER2 - breast cancer. A TC regimen without anthracycline as NAC might be one of the options for patients with ER + /HER2 - breast cancer without high-risk factors including progesterone receptor negativity., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Purposes: The clinical behavior of multifocal and multicentric breast cancers (MMBCs) is not well characterized. We conducted this study to ascertain whether patients with MMBCs have a worse prognosis than patients with unifocal breast cancers (UBC)., Methods: The subjects of this retrospective study were 734 consecutive patients who underwent definitive surgery for invasive breast carcinoma at our hospital between January 2004 and December 2006. MMBC was defined as ≥ 2 separate invasive unilateral breast tumors and pathological T stage was redefined based on the sum of the maximum diameter of each tumor. We evaluated disease-free survival (DFS) using the Kaplan-Meier method and Cox proportional hazards models., Results: Of the 734 patients, 136 (18.5%) had MMBC. The pathological T stage of 36 of the patients with MMBC was upstaged by adopting the sum of each focus. MMBC did not have any survival impact, but MMBC upstaged by the modified pathological T stage was associated with worse DFS than non-upstaging MMBC (P = 0.004). Multivariate analysis revealed that upstaging MMBC was an independent factor for poor prognosis and worse DFS (HR 2.757, P = 0.043)., Conclusions: MMBC itself may not be predictive of a worse prognosis; however, the sum of the invasive diameters of MMBC might be an important prognostic factor. Further studies are needed to confirm the prognosis associated with MMBC, taking into consideration the biological characteristics of each invasive focus.

Purpose: Many 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., Methods: We 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., Results: The 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 <30% in approximately 4% of patients, and this rate showed no improvement 5 years after chemotherapy. Eighty-four percent of the patients initially used wigs, decreasing to 47% by 1 year after chemotherapy and 15.2% after 2 years. The mean period of wig use was 12.5 months. However, a few patients were still using wigs 5 years after completing chemotherapy., Conclusions: Our survey focused on chemotherapy-induced hair loss in breast cancer patients. We believe these results to be useful for patients scheduled to receive chemotherapy., Competing Interests: The authors have declared that no competing interests exist.

Introduction: The influence of breast cancer (BC) subtype in discrepancies between pathologic complete response (pCR) and complete response by magnetic resonance imaging (MRI-CR) after neoadjuvant chemotherapy (NAC) have not been discussed well. We evaluated the association between BC subtype and pCR or only residual in situ lesion without invasive cancer (pCR/in situ + ) in patients with MRI-CR (positive predictive value [PPV])., Material and Methods: From the data of 716 patients with primary BC who were diagnosed with invasive cancer and treated with NAC and then surgery from January 2009 to May 2014 at St. Luke's International Hospital, 180 patients were determined to have MRI-CR by retrospective chart review. BC subtypes at baseline were classified into 6 subtypes, as strong estrogen receptor (ER ++ ), moderately positive ER (ER + ), negative ER (ER - ), and HER2 status expression., Results: Three subtypes had PPV (pCR) ≥ 50%: ER - /HER2 + (56.3%, 27/48), ER - /HER2 - (57.6%, 34/59), and ER + /HER2 +  (56.2%, 9/16). However, PPV (pCR) for the ER ++ /HER2 - and ER ++ /HER2 + subtypes was < 30%; notably, only 12.0% (3/25) for the ER ++ /HER2 - subtype, which was significantly low (P < .001) compared with ER ++ /HER2 - and other subtypes. PPV (pCR/in situ + ) was significantly low at 20.0% in the ER ++ /HER2 - subtype (P < .001 compared with other subtypes). PPV (pCR/in situ + ) in other subtypes was collectively greater than 60%, and was 91.7% in the ER - /HER2 + subtype., Conclusion: We should interpret carefully MRI-CR of NAC to evaluate residual disease for ER ++ /HER2 - BC., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Interruptions of the anterior interfaces between adipose tissues and mammary glands ultrasonographically are considered highly indicative of invasive ductal carcinoma. However, ultrasonography (US) revealed sustained interruptions in some cases of complete pathological remission (pCR) after neoadjuvant chemotherapy (NAC), although invasive carcinomas remained absent. Thus, in the present study, we examined the influences of interruptions on pathology observations after pCR after NAC for primary breast cancer., Patients and Methods: A total of 337 patients received NAC at St Luke's International Hospital from April 2004 to September 2006, and 46 had pCRs despite residual in situ lesions (pCR ratio, 13.6%). Subsequently, the medical records of these 46 patients were retrospectively reviewed and US findings were compared with pathological findings., Results: On US, interruptions remained in 18 of 46 pCR patients. Complete fibril formations were detected in 15 cases and associated in situ lesions were detected in 4 cases., Conclusion: US findings of interruptions of the anterior interface between adipose tissues and mammary glands were pathologically correlated with fibril formations and might not always indicate the presence of residual invasive cancer after NAC., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Purpose: To assess the joint symptoms and the impact on patients' health-related quality of life (HRQOL) due to 5 years of anastrozole from the baseline data in the N-SAS BC 05 trial, a randomized clinical trial was designed to assess the efficacy of 5 additional years of anastrozole among women with breast cancer., Methods: Joint symptoms and HRQOL were evaluated using an original questionnaire for joint symptoms, the Short Form 36-item Health Survey (SF-36), the EuroQol EQ-5D-3L, and a subscale of the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES)., Results: Baseline joint symptom and HRQOL data were collected from 330 patients between November 2007 and March 2010. Joint pain and joint stiffness were reported by 61.6 and 59.1 % of patients, respectively, although these symptoms did not affect the activities of daily living in 96.0 and 97.9 % of patients, respectively. Joint pain was reported in the knee by 61.0 % of patients and in the hand by 36.0 % of patients. Joint stiffness mainly affected the hand (67.9 %), especially the proximal interphalangeal joint, and typically occurred upon waking up or in the morning. Most SF-36 domains had good average scores, although slight decreases in physical functioning and role-physical were observed (compared to the national standard scores). The mean EQ-5D utility score was 0.86, and the total FACT-ES subscale score was 62.2/76., Conclusions: After 5 years of anastrozole, many of the patients reported joint pain and stiffness in mainly the hand and knee with mild symptoms and good HRQOL.

Cardiac metastasis of malignant phyllodes tumor is very rare. We herein report a rare case that developed cardiac metastasis from malignant phyllodes tumor. A 38-year-old woman underwent lumpectomy, and the final pathological findings showed the 5-cm malignant phyllodes tumor partially containing 1 cm of squamous cell carcinoma. Four months after the first surgery, a local recurrence of malignant phyllodes tumor and distant metastases to the bone, lung, pulmonary main trunk, and right ventricle were detected. Mass reduction surgery of cardiac metastasis of the malignant phyllodes tumor was performed to avoid sudden death. In immunohistochemical findings, the tumor was suspected to be originated in myoepithelial cells because of the expression of smooth muscle lineage including α-smooth muscle actin and Calponin1 and highly malignant characteristics showing MIB-1 and p53 highly positive with angiogenesis. Further studies are needed to clarify the effective treatment to these tumors.

Objective: The purpose of this study was to evaluate the psychological impact of breast cancer screening by use of mammography and/or ultrasound, and to reveal factors related to psychological distress., Methods: Three hundred and twenty women were recalled to our hospital because of suspicious malignant findings from breast cancer screening between March and November 2012. They were asked to complete three questionnaires: the Hospital Anxiety and Depression Scale (HADS) for anxiety and depression, the Brief Coping Orientations to Problems Experienced scale (Brief COPE) for coping styles, and an original questionnaire for personal information., Results: Complete data were available for 312 of 320 women (97.5 %). The median age was 45 years (range 23-73). The HADS revealed borderline or clinically significant anxiety for 70 % of the women. Family history of breast cancer, area of residence, number of times screened, number of recalls, and the period before the first visit were significantly related to psychological distress (p < 0.05). Brief COPE scores showed that self-blame, behavioral disengagement, self-distraction, use of emotional support, venting, denial, and less acceptance were related to increased anxiety., Conclusion: Seventy percent of women who were recalled after breast cancer screening experienced psychological distress. Thus, negative psychological impact should be regarded as an adverse effect of breast cancer screening.

Background: The aims of this study were to determine clinicopathological factors associated with postoperative upstaging to invasive carcinoma in patients preoperatively diagnosed with ductal carcinoma in situ (DCIS) and to develop a model to predict the risk of upstaging., Methods: Pre- and post-operative pathological diagnoses and radiological findings were assessed for 1,187 consecutive patients., Results: Of the patients, 306 (25.8%) were upstaged on the surgical specimen. In multivariate analysis, the following four factors were significantly associated with upstaging: 1) the presence of sclerosing adenosis on the preoperative biopsy specimen (odds ratio [OR] 0.46, P = 0.013); 2) pleomorphic calcifications on the mammogram (OR 1.68, P = 0.009); 3) a mass suspicious for invasive carcinoma on ultrasonography and/or MRI (OR 2.13, P < 0.001); 4) tumor size ≥2 cm on ultrasonography (OR 1.80, P = 0.032). HER2-positive (OR 1.54, P = 0.062) and comedo necrosis (OR 1.42, P = 0.056) demonstrated a trend towards significance. A prediction model incorporating these variables demonstrated that the risk of upstaging was 5.1% with score 0-2 and was 58.1% with score 10., Conclusions: The prediction model incorporating clinicopathological features may be used to guide the selection of patients with DCIS for sentinel lymph node biopsy., (© 2015 Wiley Periodicals, Inc.)

Background: OncotypeDX(®) (ODX) is a well-validated assay for breast cancer treatment planning. We explored whether the conventional pathological factors could pick up high risk patients without the help of the ODX., Methods: The ODX was performed on 139 hormone receptor-positive invasive breast cancers in a single Japanese institution. The recurrence risk was compared between the ODX and the St. Gallen Consensuses. The correlations were analyzed between the Recurrence Score (RS) measured by ODX and the pathological factors. In addition, we performed a follow-up survey and examined the association of the RS with the confirmed recurrence or death., Results: The ODX classified 68 (49 %) as low RS, 52 (37 %) as intermediate RS, and 19 (14 %) as high RS cases. Correlations were noted between RS and progesterone receptor (PR) (r = -0.53), Ki-67 (r = 0.42), and nuclear grade (NG) (r = 0.41). None had a high RS with PR(3+) or NG1. Only one high RS patient had a Ki-67 (<20 %). The combinations of high RS with PR(0)/Ki-67 (≥20 %) and PR(1+)/Ki-67 (≥20 %) were 70 and 58 %, respectively. The combinations with high RS and PR(0)/NG3, PR(0)/NG2, and PR(1+)/NG3 were 83, 75, and 75 %, respectively. The median follow-up was 39.1 months (range 24.0-67.8). There were one low RS (1 %), four intermediate RS (8 %), and three high RS patients (16 %) who developed local or distant recurrence., Conclusion: Hormone receptor-positive invasive breast cancers are stratified with the combinations of PR/Ki-67 or PR/NG. Some of the high recurrence risk cases might be identified without the ODX.

In use of a claims database for a study, an inaccurate diagnosis of breast cancer based on claims data may lead to invalid study results. The aim of this study was to assess the accuracy of definitions for identifying breast cancer cases from the Japanese claims database. The study cohort consisted of women with no prior cancer-related history, from the claims data at a single institution between January 1 and December 31, 2011. We developed 14 definitions for identifying breast cancer based on claims data, using a combination of diagnosis codes and treatment procedure codes. We calculated the sensitivity, specificity, and positive predictive value (PPV) of each definition, compared to cases identified from the standardized hospital-based cancer registry as a standard reference. A total of 50056 women were included in the study cohort from the claims database. We identified 633 breast cancer cases from the cancer registry. Of 14 definitions, 12 exhibited higher sensitivity than 90%, while the others exhibited lower sensitivity than 40%. The specificities of all definitions were high (≥ 99%), and the PPVs were between 65.8 and 90.7%. We selected the most optimal definition obtained from combinations of diagnosis and cancer treatment codes (surgery, chemotherapy, medication, radiation procedure), which had high values for sensitivity (90.4%), specificity (99.8%), and PPV (87.3%). Definitions obtained via combinations of the diagnosis codes and procedure codes could be used to accurately identify breast cancer cases from the claims database. Further studies in a multi-institutional setting are planned to confirm our results.

Background: Breast-cancer incidence and mortality have been increasing in Japan. Japanese-specific clinical validity and utility data for the 21-gene assay (Oncotype DX® Breast Cancer Assay; Genomic Health, Inc., Redwood City, USA) are now available. The objective of this study was to evaluate the cost-effectiveness of the 21-gene assay for the guidance of adjuvant chemotherapy decisions in estrogen-receptor-positive, lymph-node-negative, early-stage breast cancer patients, from the Japanese societal perspective., Methods: The recurrence risk group distribution by the 21-gene assay result and the assay's influence on adjuvant chemotherapy recommendations were obtained from a study of 104 patients. A state-transition cohort (Markov) model tracked time from surgery until distant recurrence and from distant recurrence to death. Adjuvant chemotherapy benefit by 21-gene assay risk group was based on published clinical validation studies. Direct and indirect medical costs were obtained from the referral centers. Utilities associated with progression and chemotherapy-related adverse events were extracted from literature. Sensitivity analyses assessed the key drivers and robustness of the primary outcomes., Results: The 21-gene assay identified 48% of patients as low-risk, 36% as intermediate-risk, and 16% as high-risk. Total acute chemotherapy-related costs decreased by ¥154,066 due to less adjuvant chemotherapy usage. In the high-risk group, adjuvant chemotherapy use increased 18%, leading to survival benefits. Chemotherapy use overall decreased by 19%. Monitoring costs increased by ¥3,744 but recurrence costs declined by ¥46,113 per patient. Use of the 21-gene assay increased quality-adjusted-life-years (QALYs) by 0.241 per patient on average; the net cost per QALY gained was ¥636,752 ($6,368)., Conclusions: The 21-gene assay for women with estrogen-receptor-positive, lymph-node-negative, early-stage breast cancer is projected to be cost-effective in Japan.

Background: We sought to develop and validate a predictive model of locoregional recurrence (LRR) in patients who underwent breast-conserving therapy (BCT) after neoadjuvant chemotherapy (NAC)., Patients and Methods: The clinicopathological characteristics of 520 consecutive primary breast cancer patients with residual tumor who underwent BCT after NAC between 2001 and 2008 were evaluated. Predictive variables of LRR were determined using a multivariate Cox proportional hazards model. The model was validated for discrimination and calibration by bootstrap re-sampling., Results: At a median follow-up period of 51 months, 64 patients (12%) had developed LRR. Clinical stage T3 or T4, lymphovascular invasion, nuclear grade >3, and ≥4 positive lymph nodes metastasis were positively correlated with LRR. The nomogram for predicting LRR developed by using these four-clinicopathologic variables demonstrated high concordance. Patients with score 0-1 derived by the prediction model had significantly low LRR rate compared with patients with score 2 or higher (P < 0.001)., Conclusions: This nomogram may be useful to predict LRR in primary breast cancer patients who underwent BCT after NAC with high reproducibility. This model is useful to conduct a study-identifying patients who may need an additional treatment to standard adjuvant therapy because of a high probability of LRR., (© 2014 Wiley Periodicals, Inc.)

Background: In this study we investigated if the 21-gene assay result affects adjuvant decision-making in Japanese women with ER+ invasive EBC., Patients and Methods: A 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., Results: One-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)., Conclusion: Results 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., (Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.)