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Adjuvant therapy for patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer (EBC) remains challenging. The prognostic significance of HER2-low positivity in these patients is not fully understood. In our retrospective study, we analyzed 647 patients with HR-positive, HER2-negative, node-positive EBC, stratifying them into three cohorts based on axillary lymph node involvement, tumor size, and characteristics. Cohort 1 included patients with either ≥ 4 positive axillary lymph nodes or 1-3 positive nodes with histological grade 3 or tumor size ≥ 5 cm. Cohort 2 consisted of patients with 1-3 positive nodes, histological grade < 3, tumor size < 5 cm, and Ki-67 ≥ 20%. Cohort 3 comprised patients with 1-3 positive nodes, histological grade < 3, tumor size < 5 cm, and Ki-67 < 20%. We compared invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) between HER2-low (IHC1+ or IHC2+/FISH-) and HER2-zero (IHC0) groups in each cohort. In cohort 1, HER2-low patients exhibited significantly better 5-year IDFS (84.2% vs. 73.6%, p = 0.0213) and DRFS (88.2% vs. 79.8%, p = 0.0154). However, no significant differences were observed in cohorts 2 and 3. Our findings suggest HER2-low positivity as a prognostic factor in HR-positive, HER2-negative, and node-positive EBC., (© 2023. The Author(s).)

Background: Histological grade (HG) has been used in the MonrachE trial to select patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive high-risk early breast cancer (EBC). Although nuclear grade (NG) is widely used in Japan, it is still unclear whether replacing HG with NG can appropriately select high-risk patients., Methods: We retrospectively reviewed 647 patients with HR-positive, HER2-negative, node-positive EBC and classified them into the following four groups: group 1: ≥ 4 positive axillary lymph nodes (pALNs) or 1-3 pALNs and either grade 3 of both grading systems or tumors ≥ 5 cm; group 2: 1-3 pALNs, grade < 3, tumor < 5 cm, and Ki-67 ≥ 20%; group 3: 1-3 pALNs, grade < 3, tumor < 5 cm, and Ki-67 < 20%; and group 4: group 2 or 3 by HG classification but group 1 by NG classification. We compared invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) among the four groups using the Kaplan-Meier method with the log-rank test., Results: Group 1 had a significantly worse 5-year IDFS and DRFS than groups 2 and 3 (IDFS 80.8% vs. 89.5%, P = 0.0319, 80.8% vs. 95.5%, P = 0.002; DRFS 85.2% vs. 95.3%, P = 0.0025, 85.2% vs. 98.4%, P < 0.001, respectively). Group 4 also had a significantly worse 5-year IDFS (78.0%) and DRFS (83.6%) than groups 2 and 3., Conclusions: NG was useful for stratifying the risk of recurrence in patients with HR-positive, HER2-negative, node-positive EBC and was the appropriate risk assessment for patient groups not considered high-risk by HG classification., (© 2023. The Author(s).)

Purpose: The impact of progesterone receptor (PR) status on the prognosis of breast cancer after isolated locoregional recurrence (ILRR) remains unclear. This study evaluated the impact of clinicopathologic factors, including PR status of ILRR, on distant metastasis (DM) after ILRR., Methods: We retrospectively identified 306 patients with ILRR diagnosed at the National Cancer Center Hospital between 1993 and 2021 from the database. Cox proportional hazards analysis was performed to examine factors associated with DM after ILRR. We developed a risk prediction model based on the number of detected risk factors and estimated survival curves using the Kaplan-Meier method., Results: During a median follow-up time of 4.7 years after ILRR diagnosis, 86 patients developed DM, and 50 died. Multivariate analysis revealed that seven risk factors were associated with poor distant metastasis-free survival (DMFS): estrogen receptor-positive/PR-negative/human epidermal growth factor receptor 2-negative ILRR, short disease-free interval, recurrence site other than ipsilateral breast, no-resection of ILRR tumor, chemotherapy for the primary tumor, nodal stage in the primary tumor, and no endocrine therapy for ILRR. The predictive model classified patients into 4 groups based on the number of risk factors: low-, intermediate-, high-, and the highest-risk groups with 0 to 1, 2, 3 to 4, and 5 to 7 factors, respectively. This revealed significant variation in DMFS among the groups. A higher number of the risk factors was associated with poorer DMFS., Conclusion: Our prediction model, which considered the ILRR receptor status, may contribute to the development of a treatment strategy for ILRR., (© 2023. The Author(s).)

Background: There are currently no scoring-type predictive models using only easily available pre- and intraoperative data developed for assessment of the risk of advanced axillary lymph node metastasis (ALNM) in patients with breast cancer with metastatic sentinel lymph nodes (SLNs). We aimed to develop and validate a scoring system using only pre- and intraoperative data to distinguish between non-advanced (≤ 3 lymph nodes) and advanced (> 3 lymph nodes) ALNM in patients with breast cancer with metastatic SLNs., Methods: We retrospectively identified 804 patients with breast cancer (cT1-3cN0) who had metastatic SLNs and had undergone axillary lymph node dissection (ALND). We evaluated the risk factors for advanced ALNM using logistic regression analysis and developed and validated a scoring system for the prediction of ALNM using training (n = 501) and validation (n = 303) cohorts, respectively. The predictive performance was assessed using the receiver operating characteristic (ROC) curve, area under the curve (AUC), and calibration plots., Results: Ultrasound findings of multiple suspicious lymph nodes, SLN macrometastasis, the ratio of metastatic SLNs to the total number of SLNs removed, and the number of metastatic SLNs were significant risk factors for advanced ALNM. Clinical tumor size and invasive lobular carcinoma were of borderline significance. The scoring system based on these six variables yielded high AUCs (0.90 [training] and 0.89 [validation]). The calibration plots of frequency compared to the predicted probability showed slopes of 1.00 (training) and 0.85 (validation), with goodness-of-fit for the model. When the cutoff score was set at 4, the negative predictive values (NPVs) of excluding patients with advanced ALNM were 96.8% (training) and 96.9% (validation). The AUC for predicting advanced ALNM using our scoring system was significantly higher than that predicted by a single independent predictor, such as the number of positive SLNs or the proportion of positive SLNs. Similarly, our scoring system also showed good discrimination and calibration ability when the analysis was restricted to patients with one or two SLN metastases., Conclusion: Our easy-to-use scoring system can exclude advanced ALNM with high NPVs. It may contribute to reducing the risk of undertreatment with adjuvant therapies in patients with metastatic SLNs, even if ALND is omitted., (© 2022. The Author(s).)

Background: It has been determined that axillary lymph node dissection after the detection of limited axillary lymph node metastasis does not improve the prognosis of patients with breast cancer. Thus, a need exists for less-invasive axillary surgery. However, it remains unclear whether a predictive model based on preoperative data would be sufficient to accurately predict the probability of pN2-N3 (> 3 lymph node metastases). We sought to develop an easy-to-use scoring system to distinguish between pN0-N1 (0-3 lymph node metastases) and pN2-N3 using only preoperative data and validate its predictive performance., Patients and Methods: We retrospectively identified 2687 patients diagnosed with cT1-3cN0-N1 who had undergone surgery in our hospital from 2013 to 2019. We evaluated the risk factors associated with pN2-N3 by logistic regression analysis and developed a scoring system. Predictive performance was assessed by calculating the receiver operating characteristic area under the curve (AUC) and was validated using K-fold cross-validation., Results: We identified 1987 patients with stage pN0, 522 with pN1, and 178 with pN2-N3. Multivariate analysis revealed tumor size, number of suspicious lymph nodes on axillary ultrasound examination, histologic type, histologic grade, and receptor status were significant risk factors for pN2-N3. The AUC value was 0.87, and the mean AUC of the 10-fold cross-validation was 0.88. When the cutoff score was set at 6, the negative predictive value for excluding patients with pN2-N3 was 98.4%., Conclusion: Our easy-to-use scoring system could be useful to preoperatively identify patients at lower risk of pN2-N3 and avoid unnecessary axillary lymph node dissection., (Copyright © 2020 The Author(s). Published by Elsevier Inc. All rights reserved.)

We report a case of synchronous unilateral triple breast cancers comprising invasive ductal carcinoma (IDC), invasive lobular carcinoma (ILC), and Paget's disease. A 57-year-old woman with a left breast mass was referred to our hospital. Mammography revealed only an isodense area with foci of microcalcification in the lateral area of the left breast. Ultrasonography revealed 2 hypoechoic masses in the outer lower and inner upper areas, and these 2 lesions were diagnosed by core needle biopsy as ILC and IDC, respectively. Left total mastectomy with sentinel lymph node biopsies was performed. In addition to the ILC and IDC, histological examination also identified Paget's disease. Breast cancer often manifests as multiple unilateral lesions; however, it is sometimes difficult to determine whether these tumors have developed multicentrically or have multifocally invaded from an intraductal carcinoma. This case was clearly diagnosed to have occurred multicentrically because of the absence of continuity among the 3 tumors, the presence of a non-invasive component in all 3 tumors, and different histopathological findings. The synchronous unilateral development of ILCs is well known. Cases of synchronous unilateral triple or more breast cancers were reviewed, and their histopathological characteristics, including the incidence of Paget's disease, is discussed.

Purpose: To reveal the rate of complete therapeutic effect of radiofrequency ablation (RFA) and its correlation with tumor size by the histopathological examination of surgically resected early breast cancers., Methods: For 28 patients who received RFA and subsequent surgical therapies for early breast cancer treatment, the effect of RFA was evaluated by both histopathological examination and nicotinamide adenine dinucleotide (NADH)-diaphorase staining of resected tumor specimens according to the criteria described by Seki et al. (this issue). The correlation of 100% RFA effect with tumor parameters including tumor size and the presence of extensive intraductal component (EIC) was examined., Results: The mean size and invasive size of the primary tumors were 2.21 cm (ranging from 0.6 to 5.0 cm) and 1.44 cm (ranging from 0 to 5.0 cm), respectively. By examining hematoxylin-eosin (HE) sections, the effectiveness of RFA was found to be 100% in 16 tumors (57%). However, the effectiveness of RFA was found to be 100% in 22 cases (79%) examined by NADH-diaphorase staining of frozen sections containing part of tumorous and nontumorous tissues. The accuracy of diagnosis of complete RFA effect using NADH-diaphorase staining with reference to HE was 79% (22 of 28) with 100% (16 of 16) sensitivity and 50% (6 of 12) specificity. The rate of 100% RFA effect by HE examination was higher in EIC(-) tumors (13 of 17, 76%) than in EIC(+) tumors (1 of 9, 11%) (P = 0.0022), and was higher in tumors of ≤ 1.5 cm (10 of 11, 91%) than in tumors of >1.5 cm (6 of 17, 35%; P = 0.0034). All five tumors of ≤ 1.0 cm showed 100% RFA effect, but 3 (27%) of 11 tumors of >1.0 and ≤ 2.0 cm and 9 (75%) of 12 tumors of > 2.0 cm showed suboptimal RFA effect by HE., Conclusions: Tumor size of ≤ 1.5 cm, strictly ≤ 1.0 cm, could be an indication for RFA if a complete histological therapeutic effect is mandatory.

Purpose: To evaluate the safety and efficacy of radiofrequency ablation (RFA) as a local therapy for early breast carcinomas, we performed a phase I/II study at our institution., Patients and Methods: Fifty patients with core-needle biopsy-proven breast carcinoma that was ≤ 3 cm in diameter on ultrasonography were enrolled in this study. Under ultrasound (US) guidance, the tumor and surrounding breast tissue were ablated with a saline-cooled RF electrode followed by immediate surgical resection. Resected specimens were examined by hematoxylin and eosin (H&E) staining and nicotinamide adenine dinucleotide (NADH) diaphorase staining to assess tumor viability., Results: Forty-nine patients completed the treatment. The mean tumor size was 1.70 cm. The mean ablation time was 8.7 min using a mean power of 48.5 W. Of the 49 treated patients, complete ablation was recognized in 30 patients (61%) by H&E staining and/or NADH diaphorase staining. The NADH viability staining was available for 38 patients, and in 29 (76.3%), there was no evidence of viable malignant cells. Of the 29 treated patients with breast carcinomas ≤ 2 cm in diameter examined by pathological examination, complete ablation was achieved in 24 patients (83%). Of the 26 treated patients with breast carcinomas without an extended intraductal component (EIC) according to pathological examination, complete ablation was determined in 22 patients (85%). RFA-related adverse events were observed in five cases: two with skin burn and three with muscle burns., Conclusion: RF ablation is a safe and promising minimally invasive treatment for small breast carcinomas with pathological tumor size ≤ 2 cm in diameter and without EIC.

Radiofrequency ablation (RFA) therapy is expected to be applicable to small breast cancers, but no criteria for its histopathological effect have yet been established. Using samples obtained from 15 patients who had undergone RFA and subsequent mastectomy, we compared the histopathological changes in the ablated area with the results of histochemical staining based on the reduction of nitroblue tetrazolium chloride (NBT) by nicotinamide adenine dinucleotide (NADH) diaphorase in frozen tissue sections, and looked for histological changes indicative of the effect of RFA on breast cancer. Grossly, the ablated area in most of the tumors was rough, gritty, less moist, and surrounded by a red congestive limbic zone. The ablated area showed no staining by the NADH diaphorase reaction, and cancer cells in the area showed marked destruction characterized by an unclear intercellular boundary, elongated eosinophilic cytoplasm, pyknotic "streaming" nuclei, and a poorly defined nuclear and cytoplasmic texture. At the same time, fibrous connective tissue also showed degenerative changes, becoming densely homogeneous with loss of its delicate wavy structure. The area in which RFA appeared to have been histopathologically effective was mostly concordant with the area in which the NADH diaphorase reaction was negative. In the periphery of the ablated area, however, cellular changes caused by RFA were less marked, although the NADH diaphorase reaction was visualized with NBT. A larger number of cases should be examined in order to establish criteria for the histopathological effect of RFA on breast cancer.

Background: The present study was conducted to assess the clinical usefulness of multidetector-row CT (MDCT) in determining the extent of invasive lobular carcinoma (ILC) and especially the extent of residual tumor after neoadjuvant chemotherapy (NAC)., Patients and Methods: The subjects were 24 patients with primary ILC who underwent surgery without NAC and 17 patients with ILC who underwent surgery after NAC at National Cancer Center Hospital (NCCH) between April 1999 and December 2005. The extent of primary ILC was assessed by ultrasound, mammography, and MDCT before surgery, and the results obtained using each modality were compared with the results of pathological examination after surgery. In addition, the characteristic findings of ILC obtained by MDCT were assessed. Similarly, the extent of residual tumor after NAC was evaluated using ultrasound, mammography, and MDCT before surgery in the subjects who underwent NAC, and the results obtained by each modality were compared with the results of pathological examination after surgery., Results: The findings of primary ILC obtained by MDCT showed that the carcinoma was the non-localized type rather than the localized type in 63% of the subjects. In addition, with regard to the pattern of time-sequential contrast enhancement, the persistent pattern (in which tumor enhancement is strong in the late phase rather than in the early phase) was observed in 46% of the subjects, and the plateau pattern (in which contrast enhancement is weak in both the early phase and the late phase) was observed in 38% of the subjects. These trends were significant in the subjects who underwent NAC and in whom tumor enhancement could not be clearly observed by MDCT. Assessment of the extent of carcinoma showed that the diagnostic accuracy of MDCT was 79%, as compared with 71% for either ultrasound or mammography. Assessment of the extent of carcinoma after NAC also showed that the diagnostic accuracy of MDCT was 71%, as compared with 48% for ultrasound and 53% for mammography, indicating that MDCT provided the highest accuracy. It should be noted that for all modalities, the extent of ILC was not overestimated as compared with the tumor diameter measured during pathological examination., Conclusion: Assessment by MDCT showed that ILC tends to be diffuse, tumor enhancement tends to be very weak, and the rate of enhancement tends to be low. In addition, MDCT was found to be useful for determining the extent of carcinoma, and the diagnostic accuracy of MDCT, especially in determining the extent of carcinoma after NAC, was much higher than that of ultrasound or mammography.

Background: Tumor markers are frequently used for screening and monitoring in oncology. We investigated the use of preoperative tumor marker (carcinoembryonic antigen [CEA] and carbohydrate antigen [CA] 15-3) levels in estimating the prognosis of breast cancer patients., Methods: We conducted a retrospective study in patients who underwent breast cancer surgery at National Cancer Center Hospital between 1975 and 1994 and whose serum CEA (n=1663) and CA 15-3 (n=1500) levels were measured prior to operation. When we excluded patients with stage IV disease from the study, the CEA level was within the normal range in 1470 patients, while 150 patients had an elevated CEA level. For CA 15-3, 1395 patients were within the normal range, while 70 patients exhibited an elevated level., Results: The 5-year and 10-year survival rates for patients with normal CEA levels were 87% and 76%, respectively. However, the 5-year and 10-year survival rates for patients with elevated CEA levels were 76% and 65%, respectively. At both time points, patients with normal CEA levels had higher survival rates (P<0.05). The 5-year and 10-year survival rates for the patients with normal CA 15-3 levels were 86% and 76%, respectively, while only 71% and 52% patients with elevated CA 15-3 levels survived at 5 and 10 years, respectively. These differences were also significant (P<0.05). However, there were no significant differences in disease-free survival (DFS) according to CEA or CA 15-3 levels., Conclusion: There was a positive correlation between CEA levels and CA 15-3 levels and patient prognosis. Thus, the levels of these tumor markers may help to determine prognosis in breast cancer patients.

Background: In recent years, the surgical management of patients with breast cancer has shifted to a locoregional approach, and evaluating the patient's axillary lymph node status is of the greatest importance in determining the appropriate treatment strategy. We evaluated on the efficacy of preoperative axillary staging using contrast-enhanced computed tomography (CE-CT)., Methods: Between 2000 and 2003, 235 patients with operable breast cancer who underwent CE-CT before surgery and 137 patients who received neoadjuvant chemotherapy (NAC) and underwent CE-CT before NAC and surgery were enrolled in this study. The axillary status was evaluated based on three criteria (short-axis diameter, shape, and enhancement type), and the diagnosis was correlated with the histopathological results., Results: In patients who did not receive NAC, the size criterion of a short-axis diameter of more than 5 mm provided a sensitivity of 78%, a specificity of 75%, and an accuracy of 76% in predicting node-positive status. According to the size criterion of a short-axis diameter of more than 5 mm and the shape criterion of the absence of intranodal fat density, the specificity and accuracy were 90% and 81%, respectively, and according to the enhancement type criterion of early enhancement, the corresponding values were 89% and 78%. Evaluation was more difficult in patients who received NAC and the sensitivity of the size-based criterion in the patients who received NAC was lower than in those who did not., Conclusion: These findings suggest that CE-CT based on size criteria is useful for evaluating the preoperative axillary status of breast cancer patients, but that evaluation is more difficult and the sensitivity is reduced in patients who have received NAC.

Background: The feasibility and accuracy of sentinel lymph node (SLN) biopsy examination for breast cancer patients with clinically node-negative breast cancer after neoadjuvant chemotherapy (NAC) have been investigated under the administration of a radiocolloid imaging agent injected intradermally over a tumor. In addition, conditions that may affect SLN biopsy detection and false-negative rates with respect to clinical tumor response and clinical nodal status before NAC were analyzed., Methods: Seventy-seven patients with stages II and III breast cancer previously treated with NAC were enrolled in the study. All patients were clinically node negative after NAC. The patients then underwent SLN biopsy examination, which involved a combination of intradermal injection over the tumor of radiocolloid and a subareolar injection of blue dye. This was followed by standard level I/II axillary lymph node dissection., Results: The SLN could be identified in 72 of 77 patients (identification rate, 93.5%). In 69 of 72 patients (95.8%) the SLN accurately predicted the axillary status. Three patients had a false-negative SLN biopsy examination result, resulting in a false-negative rate of 11.1% (3 of 27). The SLN identification rate tended to be higher, although not statistically significantly, among patients who had clinically negative axillary lymph nodes before NAC (97.6%; 41 of 42). This is in comparison with patients who had a positive axillary lymph node before NAC (88.6%; 31 of 35)., Conclusions: The SLN identification rate and false-negative rate were similar to those in nonneoadjuvant studies. The SLN biopsy examination accurately predicted metastatic disease in the axilla of patients with tumor response after NAC and clinical nodal status before NAC. This diagnostic technique, using an intradermal injection of radiocolloid, may provide treatment guidance for patients after NAC.

A 30-year-old woman presented with a right breast tumor. Mucinous carcinoma was diagnosed by core needle biopsy (T2: 5 cm N1 M0). Despite receiving a neoadjuvant anthracycline and taxane regimen, the patient demonstrated no clinical response (NC). Based on the patient's strong preference, we performed breast-conserving surgery. On histological examination, we observed widespread mucus and a few viable malignant cells, a Grade 2 therapeutic response. Neither optimal management procedures nor guidelines for chemotherapy for primary mucinous carcinoma of the breast have been established. It is a reasonable assumption, however, that discordance between the clinical response and therapeutic response to neoadjuvant chemotherapy may occur in cases of mucinous carcinoma.

Aims: To evaluate the expression of common biological markers and the epidermal growth factor receptor (EGFR) in mammary high grade ductal carcinomas with myoepithelial differentiation (DCMDs)., Materials/methods: Thirty DCMDs were clinicopathologically and immunohistochemically analysed and compared with 36 control cases of high grade conventional invasive ductal carcinoma (IDC)., Results: EGFR, HER2/neu, oestrogen receptor, progesterone receptor, and p53 expression was seen in 21, one, three, four, and 20 of the 30 DCMDs, compared with eight, nine, 18, 17, and five of the 36 conventional IDCs (p<0.05), respectively. In 16 of the 30 DCMDs, metastases were found in the brain, lung, bone, and liver, within a maximum of 47 months (mean, 13.9) after initial surgery, whereas only four of the 36 conventional IDCs metastasised to the lung and bone within a maximum of 27 months (mean, 18.0) after initial surgery (p=0.0001). There was a significant difference in disease free survival between DCMD and conventional IDC (p=0.001). EGFR was frequently overexpressed in DCMD compared with conventional IDC, whereas the expression of HER2/neu and hormone receptors was lower in DCMD. Fluorescent in situ hybridisation revealed that the mean EGFR to chromosome 7 centromere (CEP7) ratio of the 24 DCMD cases available for evaluation was 1.03, and EGFR gene amplification was not detected in the 21 DCMD cases with EGFR overexpression., Conclusion: Immunohistochemistry for myoepithelial markers and EGFR is useful for the accurate diagnosis and molecular target treatment of high grade DCMD.

Advances in the therapeutic agents used for neoadjuvant chemotherapy (NAC) have recently achieved higher response rates and induced a greater number of pathologic complete responses (pCR) than ever before. The aim of this study is the diagnosis of pCR after NAC by diagnostic imaging of clinical complete response (cCR) patients. This study included 35 breast cancer patients who demonstrated cCR after receiving NAC with a combination of anthracycline and taxane from May 1998 to August 2003. Surgical treatment included breast-conserving therapy followed by radiotherapy or mastectomy. The identity of post-NAC lesions as either a complete response (CR) or partial response (PR) were made by mammography, ultrasonography, and contrast-enhanced computed tomography (CT). Among the 35 patients, 11 achieved pCR, including the disappearance of both invasive and intraductal components. Of the patients achieving pCR, eight were defined as CR and three were determined to be PR by CT. There was a significant relationship between the pCR and the determination of CR by CT. The determination of CR by ultrasonography was indicative of the disappearance of pathologic invasive components. While mammography appeared to reflect the observed histologic results, we did not observe any statistical differences. A subset of cases exhibited discrepancies between the imaging and pathologic results, likely due to the replacement of destroyed tumor cells by fibrosis and granulomatous tissue. The evaluation of CR by CT was significantly indicative of pCR. The positive predictive value, however, was not large enough to avoid surgical treatment. Further studies will be needed to establish a diagnosis of pCR.

Informed consent (IC) is the process by which a patient can make choices about his/her health care; therefore it is considered to be a voluntary authorization given by the patient to the physician. To ensure the patient's right to self-determination, what can the physicians do? When treating breast cancer, there are several specific issues that must be clarified by the IC. We have selected and evaluated the basic elements of IC and mentioned the basic concepts of IC in details. First of all, complete information must be disclosed to the patient (physician's responsibility for medical accountability). The information to be disclosed is summarized in the following three elements: 1) The nature of the treatment/procedure, 2) The relevant risks/benefits, and 3) Reasonable alternatives to the proposed intervention (alternative treatments/procedures). However, the physician is not obliged to persuade the patient to accept the proposed intervention. IC information should be documented in detail on the patient's chart without delay. These issues include IC regarding surgical procedures (mastectomy or breast conservation treatment), IC regarding clinical studies (description of randomized controlled trials), IC regarding genetic diagnosis (ethical issues), and the like. IC means informed decision-making, close relationships between physicians and patients are needed.

Breast cancer patients were classified in the family history positive (FHP) group when they had at least one second-degree relative who was a breast cancer patient. The results of a comparative study with patients classified in the family history negative (FHN) group showed the prognosis of the FHP group was significantly better than that of the FHN group. However, when those patients were classified according to their menopausal status at onset, there were no significant differences in survival rates between the FHP and FHN groups with onset before menopause, whereas the survival rate of the FHP group was significantly higher than that of the FHN group with onset after menopause. The same results were found when the FHP group was subgrouped into the FHP group with first-degree relatives and the FHP group with second-degree relatives. Further investigations on background factors revealed that the patients with onset before menopause showed no significant differences between the FHP and FHN groups in age at surgery, diameter of the tumor, histologic grade, the number of metastatic lymph nodes, body weight, estrogen receptor (ER) status, and the values of CEA and CA15-3 before surgery. On the other hand, the FHP patients with onset after menopause showed significantly lower numbers of metastatic lymph nodes and trends showing higher ER values and lower CA15-3-values. Therefore the favorable prognosis in the FHP group seems to be attributable to the higher survival rate of the FHP patients with onset after menopause.

Objective: To select suitable candidates for breast-conserving treatment (BCT) after neoadjuvant chemotherapy (NAC), based on the classification of tumors into localized or diffuse types using contrast-enhanced computed tomography (CE-CT)., Summary Background Data: A relatively high rate of loco-regional failure after BCT has been reported with breast cancer downstaged by NAC. Accurate assessment of the suitability of BCT and the response to NAC, before the initiation of NAC, will allow the optimal selection of an appropriate therapeutic course., Methods: We evaluated 110 consecutive patients with operable breast carcinomas measuring 3-cm or more in diameter by CE-CT after NAC treatment with doxorubicin and docetaxel at National Cancer Center Hospital, Tokyo, from May 1998 to November 2001. Lesions were classified as either localized or diffuse types by mammography (MMG), ultrasonography (US), and CE-CT., Results: Tumors designated as localized type by MMG, US, and CE-CT were reduced to tumors less than 3.0 cm (P < 0.0001) in a concentric circle (P < 0.0001). Localized tumors by CE-CT were treated safely with BCT maintaining a negative margin status (P = 0.01). In contrast, diffuse type tumors shrunk into a mosaic pattern consisting of tumors larger than 3.1 cm. Tumors classified as localized by CE-CT responded better pathologically than diffuse tumors (P = 0.0365). Multivariate analysis demonstrated that morphologic type by CE-CT and histologic type were significant predictors of candidates for safe BCT., Conclusions: The classification of tumors into either localized or diffuse types, using CE-CT before NAC administration, accurately predicts which tumors will be suitable candidates for BCT after NAC.

The objectives of this study were to investigate the long-term results of T1a, T1b and T1c Japanese invasive breast cancer patients defined by the UICC classification. The subjects were T1a (38), T1b (256) and T1c (1405) Japanese invasive breast cancer patients. Ten- and 20-year disease-free survival (DFS) and overall survival (OS) rates were analyzed by the UICC T1 subgroups (T1a, T1b, T1c). At 10 years, the respective DFS and OS rates of T1a, T1b and T1c patients were 91.9 and 91.9%, 86.1 and 86.8% and 82.4 and 83.9%, respectively. At 20 years, the respective DFS and OS rates of T1a, T1b and T1c patients were 70.7 and 70.7%, 76.7 and 76.7% and 69.1 and 70.1%. The differences of DFS and OS between T1a and T1c patients were not statistically significant. The DFS of patients with T1c breast carcinoma showed a statistically significant difference from that of T1b patients (p = 0.03). The validation of the T1 subgroup classification in Japanese breast cancer patients was confirmed, particularly for the T1c subgroup.

Background: The objectives of this study were to confirm the favorable outcome of invasive breast cancer in Japanese patients without lymph node metastasis who did not receive adjuvant therapies and to validate the St-Gallen recommendations in this population., Methods: The subjects were a consecutive series of 920 node-negative invasive breast cancer patients who underwent surgery between 1987 and 1994 at our hospital. These patients did not receive adjuvant chemotherapy. Ten-year disease-free (DFS) and overall survival (OS) rates were analyzed by the St-Gallen risk categories (Minimal/Low, Intermediate, High)., Results: The median age of the patients at surgery was 52 years and the median follow-up period of patients was 10.2 years. At 10 years, the respective DFS and OS rates of all patients were 84.6 and 86.7%. The DFS and OS of patients in the Minimal/Low risk category (25 patients) both showed 100%. The DFS and OS of patients in the Intermediate risk category (356 patients) showed 92.0 and 93.1%, respectively. The DFS and OS of patients in the High risk category (539 patients) showed 79.4 and 82.2%, respectively, indicating a significant difference between those in the Minimal/Intermediate risk category (381 patients) (p < 0.001, p < 0.001, respectively). The DFS and OS of patients who had one pathological lymph node metastasis (775 patients) showed 72.7 and 75.2%, respectively, which indicated a non-significant difference between those in the High risk category (381 patients) (p = 0.10). These data support the validation of adjuvant therapy for high-risk node-negative breast cancers in Japanese patients. However, quality control is needed to define the histological grade included in the risk categories., Conclusion: Japanese patients with invasive breast cancer without lymph node metastasis showed a survival advantage compared with their Caucasian counterparts. However, patients in the High risk group as defined by St-Gallen recommendations should be indicated for adjuvant therapy.