Pathological Complete Response Patients after Neoadjuvant Chemotherapy in Breast Cancer.

Cases of breast cancer metastasis after achieving a pathological complete response (pCR) with neoadjuvant chemotherapy (NAC) are sometimes encountered in clinical practice. We investigated the prognostic factors for pCR in patients with breast cancer after NAC. This retrospective cohort study included patients with localized breast cancer who underwent NAC followed by surgery between 2004 and 2020 and achieved a pCR. The associations between clinical factors and distant metastasis-free survival rate were statistically analyzed. We analyzed data for 127 patients. Twelve patients (9.4%) had distant metastases, and seven (5.5%) died. For estrogen receptor (ER)-positive patients, the distant metastasis-free survival rate was 94.6% for both 5 and 8 years. In contrast, ER-negative patients had a distant metastasis-free survival rate of 87.6% and 85.4% for 5 and 8 years (p=0.094), respectively. In cT0-2 patients, the distant metastasis-free survival rate was 92.4% for 5 years and 90.5% for 8 years, whereas in cT3-4 patients, the distant metastasis-free survival rate was 83.5% for 5 years and 83.5% for 8 years (p=0.301). This study suggested that patients with ER-negative, pre-NAC cT3 or T4 breast cancer who had achieved a pCR after NAC tended to have a worse prognosis.

The efficacy and safety of pertuzumab plus trastuzumab and docetaxel as a first-line therapy in Japanese patients with inoperable or recurrent HER2-positive breast cancer: the COMACHI study.

PURPOSE: In the CLEOPATRA study of patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer, the Japanese patient subgroup did not demonstrate the improved progression-free survival (PFS) of pertuzumab plus trastuzumab and docetaxel vs. placebo that was seen in the overall population. Therefore, COMACHI was conducted to confirm the efficacy and safety of this treatment regimen in this patient subgroup. METHODS: This was a phase IV study of pertuzumab plus trastuzumab and docetaxel in Japanese patients with histologically/cytologically confirmed inoperable or recurrent HER2-positive breast cancer. All patients received pertuzumab, trastuzumab, and docetaxel intravenously every 3 weeks until disease progression/unacceptable toxicity. The primary endpoint was investigator-assessed PFS. Secondary endpoints were overall survival (OS), investigator-assessed objective response rate, and duration of response (DoR). Safety was also assessed. RESULTS: At final analysis, median investigator-assessed PFS was 22.8 months (95% CI 16.9-37.5). From first dose, OS rate at 1 year was 97.7%; and at 2 and 3 years were 88.5% and 79.1%, respectively. Of the 118 patients with measurable disease at baseline, response rate was 83.9% (95% CI 77.3-90.5) and median investigator-assessed DoR was 26.3 months (95% CI 17.1-not evaluable). Treatment was well tolerated, with no new safety signals detected. CONCLUSIONS: Our results suggest similar efficacy and safety for pertuzumab plus trastuzumab and docetaxel in Japanese patients compared with the overall population of CLEOPATRA, providing further support for this combination therapy as standard of care for Japanese patients with inoperable or recurrent HER2-positive breast cancer.

Multicenter retrospective study on the use of Curebest™ 95GC Breast for estrogen receptor-positive and node-negative early breast cancer.

BACKGROUND: The benefits of postoperative chemotherapy in patients with estrogen receptor (ER)-positive breast cancer remain unclear. The use of tumor grade, Ki-67, or ER expression failed to provide an accurate prognosis of the risk of relapse after surgery in patients. This study aimed to evaluate whether a multigene assay Curebest™ 95GC Breast (95GC) can identify the risk of recurrence and provide more insights into the requirements for chemotherapy in patients. METHODS: This single-arm retrospective multicenter joint study included patients with ER-positive, node-negative breast cancer who were treated at five facilities in Japan and had received endocrine therapy alone as adjuvant therapy. The primary lesion specimens obtained during surgery were analyzed using the 95GC breast cancer multigene assay. Based on the 95GC results, patients were classified into low-risk (95GC-L) and high-risk (95GC-H) groups. RESULTS: The 10-year relapse-free survival rates were 88.4 and 59.6% for the 95GC-L and 95GC-H groups, respectively. Histologic grade, Ki-67, and PAM50 exhibited a significant relationship with the 95GC results. The segregation into 95GC-L and 95GC-H groups within established clinical factors can identify subgroups of patients using histologic grade or PAM50 classification with good prognosis without receiving chemotherapy. CONCLUSIONS: Based on the results of our retrospective study, 95GC could be used to evaluate the long-term prognosis of ER-positive, node-negative breast cancer. Even though further prospective validation is necessary, the inclusion of 95GC in clinical practice could help to select optimal treatments for breast cancer patients and identify those who do not benefit from the addition of chemotherapy, thus avoiding unnecessary treatment.

Prospective study of hair recovery after (neo)adjuvant chemotherapy with scalp cooling in Japanese breast cancer patients.

PURPOSE: Scalp cooling during chemotherapy infusion to mitigate alopecia for breast cancer patients is becoming widespread; however, studies regarding hair recovery after chemotherapy with scalp cooling are limited. We conducted a prospective study of hair recovery after chemotherapy with scalp cooling. PATIENTS AND METHODS: One hundred and seventeen Japanese female breast cancer patients who completed planned (neo)adjuvant chemotherapy using the Paxman Scalp Cooling System for alopecia prevention were evaluated for alopecia prevention in our prospective study. We evaluated their hair recovery 1, 4, 7, 10, and 13 months after chemotherapy. Primary outcomes were grades of alopecia judged by two investigators (objective grades) and patients' answers to the questionnaire regarding the use of a wig or hat (subjective grades). RESULTS: Of 117 patients, 75 completed scalp cooling during the planned chemotherapy cycles (Group A), but 42 discontinued it mostly after the first cycle (Group B). Objective and subjective grades were significantly better in Group A than in Group B throughout 1 year, and at 4 and 7 months after chemotherapy. When we restricted patients to those with objective Grade 3 (hair loss of > 50%) at 1 month, Group A exhibited slightly faster hair recovery based on the objective grades than Group B. There was less persistent alopecia in Group A than in Group B. CONCLUSIONS: Scalp cooling during chemotherapy infusion for Japanese breast cancer patients increased the rate of hair recovery and had preventive effects against persistent alopecia.

Scalp cooling for hair loss prevention in female Japanese breast cancer patients receiving (neo)adjuvant chemotherapy.

PURPOSE: Scalp cooling during chemotherapy infusion has been recently reported to have moderate efficacy in the mitigation of chemotherapy-induced alopecia; however, there are few reports on Asian patients. We aimed to clarify the effects of scalp cooling in Japanese women. PATIENTS AND METHODS: Female Japanese breast cancer patients who planned to receive (neo)adjuvant chemotherapy participated in this prospective study on the efficacy of scalp cooling using the Paxman Scalp Cooling System for alopecia prevention. The primary outcomes were the rates of patients with Grade 3 alopecia (defined as hair loss of > 50%) and the rates of patients who used a wig or hat to conceal hair loss 1 month after the last infusion of chemotherapy. The subjects were given a brief questionnaire regarding headaches, bad mood, fatigue, and chills shortly after each cooling. RESULTS: One hundred and forty-three patients participated in the study and used the cooling cap at least once. The mean and median ages of the subjects were 50.6 and 50, respectively (age range 28-76). One hundred and twenty-nine patients completed the planned chemotherapy of 4 to 8 cycles. Among them (7 patients were not evaluable), 74 patients (60.7%) had Grade 3 alopecia 1 month after chemotherapy. Of 80 patients who used the scalp cooling system throughout the planned chemotherapy (1 patient was not evaluable), 36 patients (45.6%) experienced Grade 3 alopecia. CONCLUSION: The efficacy of scalp cooling during chemotherapy infusion for hair loss mitigation in Asian women is similar to that in Caucasian women.

Durable complete response in HER2-positive breast cancer: a multicenter retrospective analysis.

PURPOSE: Though advanced and metastatic epidermal growth factor receptor 2 (HER2)-positive disease is not curable, a small proportion of patients with HER2-positive metastatic breast cancer remain in prolonged complete remission with anti-HER2 treatment. We hypothesized that some cases of HER2-positive metastatic breast cancer may be curable. In this large, multicenter retrospective study, we aimed to assess the long-term outcomes for patients with a durable response to trastuzumab. METHODS: We retrospectively evaluated the data of patients diagnosed with HER2-positive metastatic breast cancer who received trastuzumab for more than 2 years as the first-line treatment. Patients diagnosed between April 1, 2001 and December 31, 2014 at 19 institutions in Japan were included in the analysis. From 124 potential subjects, 16 were excluded and 108 were evaluated. RESULTS: The median follow-up length was 7.7 years. Disease progression occurred in 44/108 (40.7%) patients and 13/108 (12%) patients died. The median progression-free survival was 11.2 years, and as more than 80% of patients were alive 10 years after metastatic breast cancer diagnosis. Of the 108 patients, 57 achieved a clinical complete response. Trastuzumab therapy was interrupted for 27 (47.4%) of these patients (based on the doctor's recommendation for 19 patients, owing to adverse events for 4 patients, owing to unknown reasons for 3 patients, and at the request of 1 patient). Disease progression occurred in 4 of the 27 patients after the interruption of trastuzumab treatment. The median duration of trastuzumab therapy for all 27 patients was 5.1 years (0.9-9.3 years). CONCLUSION: We found that some patients showed no evidence of disease after the interruption of trastuzumab therapy. Discontinuation of maintenance trastuzumab in this patient population after a limited time should be explored cautiously while awaiting a global collaborative effort for a randomized trial.

Patritumab plus trastuzumab and paclitaxel in human epidermal growth factor receptor 2-overexpressing metastatic breast cancer.

Human epidermal growth factor receptor 3 (HER3) expression in lung and breast cancers has a negative impact on survival. Patritumab, a human anti-HER3 mAb, has shown anticancer activity in preclinical models. This study examined the safety and pharmacokinetics of patritumab in combination with trastuzumab and paclitaxel in patients with HER2-overexpressing metastatic breast cancer. In this open-label, multicenter, dose-escalation, phase Ib study, patients received patritumab 9 or 18 mg/kg plus trastuzumab and paclitaxel at known tolerated doses. Safety and tolerability were assessed based on dose-limiting toxicities and other non-life threatening adverse events. The pharmacokinetic profile for patritumab was determined based on the target trough level. Clinical efficacy was evaluated based on the overall response rate and progression-free survival. Six patients received patritumab 9 mg/kg and 12 received 18 mg/kg. The most common adverse events were diarrhea, alopecia, leukopenia, neutropenia, and maculopapular rash. No dose-limiting toxicities were observed. The target trough serum concentration was achieved in all patients at a dose of 18 mg/kg. Overall response rate was 38.9% and median progression-free survival was 274 days. In conclusion, patritumab plus trastuzumab and paclitaxel was tolerable and efficacious at both doses. We recommend the dose level of 18 mg/kg for future phase II studies. (Clinical trial registration: JapicCTI-121772.).

Prognostic factors of HER2-positive breast cancer patients who develop brain metastasis: a multicenter retrospective analysis.

The clinical course and prognostic factors of HER2-positive breast cancer patients with brain metastases are not well known because of the relatively small population. The aim of this study was to determine prognostic factors associated with HER2-positive patients who develop brain metastases. This retrospective study assessed the largest dataset to date of 432 HER2-positive patients who were diagnosed with brain metastases from 24 institutions of the Japan Clinical Oncology Group, Breast Cancer Study Group. The median age of the 432 patients was 54 years (range, 20-86 years). Of the patients, 162 patients (37.5 %) had ER-positive/HER2-positive (ER+HER2+) breast cancer, and 270 (62.5 %) had ER-negative/HER2-positive (ER-HER2+) breast cancer. The median brain metastasis-free survival period from primary breast cancer was 33.5 months in both groups. The median survival after developing brain metastasis was 16.5 and 11.5 months in the ER+HER2+ and ER-HER2+ groups, respectively, (p = 0.117). Patients with >3 brain metastases had significantly shorter overall survival in both ER+HER2+ (p < 0.001) and ER-HER2+ (p = 0.018) groups. Treatment with trastuzumab before developing brain metastases was not associated with survival duration after developing brain metastases (p = 0.571). However, patients treated with both trastuzumab and lapatinib after developing metastasis had significantly longer survival than patients treated with trastuzumab alone, lapatinib alone, or no HER2-targeting agent (p < 0.001). For HER2-positive patients with brain metastases, regardless of the use of trastuzumab before developing brain metastasis, treatment with both trastuzumab and lapatinib might improve survival.

Treatment outcomes and prognostic factors for patients with brain metastases from breast cancer of each subtype: a multicenter retrospective analysis.

To define prognostic factors for breast cancer patients with brain metastases, compare their clinical courses and prognoses according to breast cancer subtypes, and analyze the causes of death in such patients. We retrospectively analyzed 1,466 patients diagnosed with brain metastases between April 1, 2001 and December 31, 2012, from 24 institutions of the Japan Clinical Oncology Group. Overall, 1,256 patients with brain metastases were included. The median overall survival (OS) was 8.7 months (95 % confidence interval [CI] 7.8-9.6 months). Univariate and multivariate analyses revealed that patients diagnosed with brain metastasis within 6 months of metastatic breast cancer diagnoses, asymptomatic brain disease, or HER2-positive/estrogen receptor-positive tumors had increased OS. Median OS after the development of brain metastases was 9.3 months (95 % CI 7.2-11.3) for the luminal type, 16.5 months (95 % CI 11.9-21.1) for the luminal-HER2 type, 11.5 months (95 % CI 9.1-13.8) for the HER2 type, and 4.9 months (95 % CI 3.9-5.9) for the triple-negative type. Luminal-HER2 type patients had significantly longer OS than patients with the luminal type (hazard ratio [HR] = 1.50, P < 0.0001) and triple-negative type (HR = 1.97, P < 0.0001); no significant differences were noted compared to HER2-type patients (HR = 1.19, P = 0.117). The prognosis and clinical course of patients with brain metastasis from breast cancer before and after developing brain metastases vary according to subtype. Focusing on the subtypes of breast cancer can optimize the prevention, early detection, and improved treatment of brain metastases.

[Clinical experience with gemcitabine treatment for metastatic breast cancer].

It is difficult to cure recurrent or metastatic breast cancer (MBC). Therefore, it is important to continue treatment for MBC with maintenance of quality of life (QOL). Gemcitabine has been approved for MBC since February 2010. We administered gemcitabine to 39 patients with MBC between February 1, 2010 and March 31, 2012. Depending on the case, taxane or trastuzumab was added. Almost all patients had received prior chemotherapy or hormonal therapy. The median age of patients was 61 years (range, 33-82 years), and the median number of previous treatment regimens was 3 (range, 0-6). The response rate was 15.4%, the disease control rate was 56.4%, and the clinical benefit rate was 33.3%. The main hematological adverse event was neutropenia, and the main non-hematological adverse event was fatigue. Neutropenia could be managed by reducing the gemcitabine dose or withdrawing treatment. Adverse events requiring hospitalization were not observed. These findings suggest that gemcitabine-based regimens are feasible in terms of efficacy and maintenance of QOL for patients with MBC.

Detection of isolated ipsilateral regional lymph node recurrences by F18-fluorodeoxyglucose positron emission tomography-CT in follow-up of postoperative breast cancer patients.

Imaging diagnostic methods except for mammograms are not recommended for follow-up of postoperative breast cancer patients in order to detect small recurrences because of the poor survival improvement in earlier randomized trials. However, the use of new imaging modalities may improve survival by detection of small isolated regional lymph node recurrences which are potentially curable. Between April 2006 and December 2008, we used PET-CT to find small recurrences in follow-up of 1,907 postoperative breast cancer patients. A total of 3,280 PET-CT imagings were performed. The median age at PET-CT imaging was 58 years, with a median 48-month interval from definitive surgery to the PET-CT imaging. Twenty-two patients were found to have isolated ipsilateral regional recurrences only by PET-CT (axillary node recurrences in 6, infraclavicular node recurrences in 5, supraclavicular node recurrences in 6, and parasternal node recurrences in 5). All of those recurrences were missed by palpation or were nonpalpable. The pathological lymph node status at the definitive surgery for the primary breast cancer of 22 patients with the isolated ipsilateral regional lymph node recurrences was positive in 17 patients. If patients are limited to those who had pathologically positive node(s) at definitive surgery, the incidence of patients with isolated regional lymph node recurrences found only by PET-CT would be 2.6% (17/663 patients). Seventeen other asymptomatic cancers including contralateral breast cancers were found only by PET-CT. Early detection of isolated loco-regional recurrences of breast cancer is suggested to result in improved survival. Therefore, the use of PET-CT in follow-up of postoperative node-positive breast cancer patients may improve their survival because of early detection of isolated regional lymph node recurrences which are still potentially curable, and screening of other asymptomatic cancers.

[Efficacy and safety of aprepitant in patients with breast cancer].

We retrospectively analyzed the efficacy and safety of aprepitant in breast cancer patients who were treated with FEC(5- fluorouracil, epirubicin, cyclophosphamide)or EC(epirubicin, cyclophosphamide). We divided patients into two groups according to the aprepitant approval period. The rate of severe nausea(@Grade 2)was significantly less in patients with aprepitant(acute 10. 0%, delayed 15. 0%)than those without aprepitant(acute 29. 1%, delayed 30. 9%). Complete response( no vomiting and no use of rescue therapy)in the acute phase was significantly higher in the aprepitant pretreated group than in the no aprepitant group(82. 5% vs 61. 8%, respectively). Moreover, complete response in the delayed phase was also higher in the aprepitant group than in the no aprepitant group(82. 5%vs 58. 2%, respectively). Pre-treatment with aprepitant did not increase adverse events including constipation and elevation of alanine transaminase. The aprepitant was effective in terms of prevention of chemotherapy-induced nausea and vomiting in patients treated with an anthracycline- based regimen.

A Case of Multiple Liver Metastases after Surgery in Elderly HER2-Positive Breast Cancer in Which Anastrozole + Trastuzumab Was Ineffective but T-DM1 Was Effective.

Chemotherapy is often difficult to treat human epidermal growth factor receptor 2 (HER2)-positive metastatic recurrent breast cancer in the elderly, and no standard treatment has been established at this point. We experienced a case in which trastuzumab (Tmab) + anastrozole (ANA) was ineffective (progressive disease; PD) in elderly HER2-positive breast cancer with postoperative multiple liver metastases, but T-DM1 was significantly effective (complete response; CR), and treatment could be continued safely. An 82-year-old woman was referred to our department with a right breast mass. A close examination revealed right breast cancer cT1bN0M0 cStage I, and total mastectomy and sentinel lymph node biopsy were performed. The postoperative pathological result was pT1bN0M0 pStage I (luminal HER2 type). The patient was elderly and had no adjuvant treatment after the operation. Approximately 2 years after the operation, multiple liver metastases were observed, and treatment with ANA and Tmab was started. Four months later, MRI showed that the number of multiple liver metastases increased. The patient was diagnosed with PD, and the anti-HER2 drug was changed from trastuzumab to trastuzumab emtansine (T-DM1). The dose was reduced due to vomiting (grade 3). Two months later, MRI showed that the multiple liver metastases shrank and became obscure after 5 months. After that, T-DM1 was continued, and the disease did not worsen. In elderly people with difficulty in administering chemotherapy, T-DM1 may have a safe and sufficient therapeutic effect by adjusting the dose and managing side effects appropriately.

Four magnetic resonance imaging surveillance-detected breast cancer cases in cancer-free BRCA1/2 mutation carriers.

BACKGROUND: Hereditary breast and ovarian cancer (HBOC) syndrome is a susceptibility syndrome for cancers, such as breast and ovarian cancer, and BRCA1/2 are its causative genes. Annual breast-enhanced magnetic resonance imaging (MRI) is recommended for BRCA1/2 mutation carriers aged over 25 years as a secondary prevention of breast cancer. However, breast MRI surveillance is rarely performed in Japan, and only four cases of breast cancer diagnosis triggered by MRI surveillance have been reported. CASE PRESENTATION: At our hospital, MRI triggered the diagnosis of breast cancer in four cancer-free BRCA1/2 mutation carriers. In one of our four cases, although MRI showed only a 3-mm focus, we could diagnose breast cancer by shortening the surveillance interval considering the patient's high-risk for developing breast cancer. CONCLUSIONS: Image-guided biopsy, including MRI-guided biopsy, depending on the size of the lesion, and shorter surveillance intervals are useful when there are potentially malignant findings on breast MRI surveillance for cancer-free patients with HBOC.

Efficacy and safety of S-1 in patients with metastatic breast cancer: retrospective review in a single institution.

BACKGROUND: It is extremely difficult to bring about a complete cure of metastatic breast cancer: the purpose of treatment is to prolong the patient's survival while maintaining their quality of life (QOL). The current retrospective study was conducted to find whether S-1, an orally administered 5-FU agent, can produce a therapeutic result in patients with recurrent metastatic breast cancer while maintaining their QOL. METHODS: Among the patients who were diagnosed at our institution to have recurrent metastatic breast cancer between November 2001 and December 2008, those who were treated with S-1 were selected and their records retrospectively reviewed. RESULTS: The analysis was conducted on 33 patients. The median number of regimens that these patients underwent was 2 (range 0-6). The overall response rate (ORR), clinical benefit rate (CBR), median time to treatment failure and overall survival were 30%, 42%, 152 days and 338 days, respectively. Among the 11 patients who were treated with S-1 in the first or the second line, ORR and CBR were 45.5 and 63.6%, respectively. Toxicity more than grade 3, leucopenia, neutropenia diarrhea, mucositis, and hand-foot syndrome were found in only 3%. CONCLUSION: S-1 is well-tolerated by patients, promising a therapy while maintaining their QOL. When applied in the early stage of a disease in particular, the agent promises a very effective anti-tumor effect.

Factors associated with health-related quality-of-life in breast cancer survivors: influence of the type of surgery.

OBJECTIVE: To determine if health-related quality-of-life (QOL) differences existed between breast cancer (BC) survivors receiving mastectomy and those receiving breast-conserving treatment (BCT). Factors associated with QOL in long-term BC survivors were also identified. METHODS: One hundred patients who had previously undergone BC surgery and were alive without recurrence for >5 years were asked to answer the patient-administered questionnaires to assess their QOL (Functional Assessment of Cancer Therapy scale-Breast: FACT-B) and psychological distress (Hospital Anxiety and Depression Scale: HADS). Of them, 93 responded to the questionnaires affirmatively. RESULTS: Although none of the QOL scores were related to the surgical procedures, statistically significant relationships were found between age and the scores of FACT-General and social/family well-being (SWB), and between the educational status and scores of SWB in univariate analyses. There was no statistically significant relationship between psychological distress and each factor examined. In multivariate analyses, significant correlations were established between scores of the FACT-BC subscale (FACT-BCS) and the type of surgery and between those on the FACT SWB subscale and age at study or educational status. Namely, patients who had undergone BCT, younger patients and patients with higher educational background scored higher QOL. CONCLUSIONS: Among the BC survivors, those who underwent BCT experienced significantly but slightly better QOL than those who received mastectomy in FACT-BCS assessments. Younger patients and patients with higher educational backgrounds experienced significantly better SWB.

Feasibility study of docetaxel with cyclophosphamide as adjuvant chemotherapy for Japanese breast cancer patients.

OBJECTIVE: The 7-year follow-up of the US oncology 9735 trial demonstrated the superiority of TC [docetaxel (DTX)/cyclophosphamide (CPA)] to doxorubicin/CPA therapy. To introduce TC therapy in Japan, the verification of the safety and tolerability is essential. We performed a collaborative prospective safety study with Okayama University to introduce TC therapy. METHODS: The subjects were 53 patients aged from 33 to 67 years at intermediate risk based on the St Gallen risk classification who underwent radical surgery for primary breast cancer between August 2007 and December 2008. As post-operative adjuvant chemotherapy, four cycles of TC (DTX 75 mg/m(2) + CPA 600 mg/m(2)) were administered at 3-week intervals. Adverse events were evaluated based on National Cancer Institute-Common Terminology Criteria for Adverse Events ver. 3.0. The safety and completion rate were evaluated as the primary and secondary endpoints, respectively. RESULTS: Regarding hematological toxicity, Grade (G) 4 neutropenia occurred in 71.7% and G3 in 26.4%. G3-4 leukopenia developed in 32.1% and 56.6%, respectively, G4 anemia in 1.9% and G1-2 anemia in 26.4%. Regarding non-hematological toxicity, systemic malaise, skin eruption, edema, myalgia, arthralgia and nausea were noted in most patients. The completion rate was 94.3%, dose reduction was necessary in 7.5% and granulocyte colony-stimulating factor (G-CSF) support was required in 17.0%. On comparison between patients aged 65 years or older and younger than 65 years, the completion rate, dose reduction and incidence of febrile neutropenia (FN) were higher in the elderly patients. G-CSF support was more often needed in this subgroup. CONCLUSIONS: TC therapy is tolerable for Japanese patients, but attention should be paid to the development of FN and neutropenia. The completion rate was lower in the elderly patients, showing that tolerability was not necessarily favorable.

Determination of indication for sentinel lymph node biopsy in clinical node-negative breast cancer using preoperative 18F-fluorodeoxyglucose positron emission tomography/computed tomography fusion imaging.

OBJECTIVE: Sentinel node biopsy (SNB) is indicated for axillary lymph node metastasis-negative cases (N0), but clarification of the indication may increase treatment efficiency. Fluorine-18-labeled 2-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) may have a high positive predictive value in diagnosis of axillary lymph node metastasis. METHODS: Ninety-two breasts/axillae were analyzed retrospectively in 90 patients (median age 54.6-year old, median primary tumor 1.7 cm). FDG-PET/computed tomography was used to indicate SNB in N0 cases. Axillary lymph node dissection (ALND) was performed in cases that were axillary lymph node metastasis-positive (PET N+) on FDG-PET/CT. RESULTS: Seventy-four (80.4%) and 18 (19.6%) of the 92 axillae were diagnosed as metastasis-negative (PET N0) and PET N+, respectively, by FDG-PET/CT. SNB was performed in 51 of the 74 PET N0 axillae. ALND was performed in 23 PET N0 axillae (at the patients' request) and in all 18 PET N+ axillae. Of the 74 PET N0 axillae, 14 were metastasis-positive (pN+) and 60 were pN0 pathologically, and of the 18 PET N+ axillae, 13 were pN+ and five were pN0. The sensitivity and specificity of FDG-PET/CT for diagnosis of axillary metastasis were 48.1 and 92.3%, respectively, and the positive and negative predictive values were 72.2 and 81.1%, respectively. CONCLUSION: The positive detection rate on FDG-PET/CT was insufficient for determining an indication of SNB. However, use of an appropriate cut-off for SUV(max) (the positive rate was 90.9% with a cut-off of 2.0) and exclusion of surgically biopsied cases may achieve a clinically applicable positive detection rate.

[A case of recurrent breast cancer with extensive liver metastasis successfully treated with endocrine therapy].

A 5 6-year-old woman, who underwent breast-conserving surgery and radiation (60 Gy) therapy in July, 1992, at the age of 40, was diagnosed with pT1aN0M0, pStage I. She was administered tamoxifen (TAM) as adjuvant therapy. However, she underwent microdochectomy for DCIS in her contralateral breast in June, 1998. TAM was given till August, 1999. In June, 2006, at the age of 54, 14 years after initial surgery, CT revealed extensive liver masses which were diagnosed as liver metastasis by liver biopsy. Receptor status was positive for ER and PgR, and negative for HER2. AC was started as a first-line chemotherapy ( 4 courses), but did not prove effective. She refused second-line chemotherapy, so letrozole was selected, and subsequently resulted in PR of the liver metastasis. However, 8 months later, with a liver metastasis relapse, exemestane followed by tamoxifen, medroxyprogesterone acetate, and high-dose toremifene were administered sequentially, resulting in long-time disease control. In conclusion, endocrine therapy might be an effective option even in a visceral crisis, if metastatic tumors have showed slow growth and there is positive hormone receptor status.

[Correlations between hormonal receptor and HER2 status or nuclear grades and response rate in breast cancer treated with neoadjuvant chemotherapy of docetaxel alone].

BACKGROUND: Neoadjuvant chemotherapy has been considered the standard care in locally advanced breast cancer. However, about 10-35% of the patients don't benefit from this treatment. This study was designed to evaluate predictive values of biological markers in response of breast cancers treated with docetaxel alone as neoadjuvant chemotherapy. METHODS: 36 patients received the planned four courses of preoperative docetaxel(60-75 mg/m(2)) every 3 weeks. We evaluated the relationship between the response rate to neoadjuvant chemotherapy and hormonal receptor, HER2 status or nuclear grades. RESULTS: Clinical response rate was 57.2%. Pathological complete response rate was 5.6%. Clinical response rate by each factors were as follows; 9(50%)in ER-positive tumors, 10(66.7%)in ERnegative( p=0.27), 7(50%)in PgR-positive, 12(63.3%)in PgR-negative(p=0.34), 5(55.6%)in HER2-positive, 14 (58.3%)in HER2-negative(p=0.71), 4(50%)in tumors of low nuclear grade and 13(65%)in ones of high nuclear grade(p=0.38). CONCLUSION: The possibility that tumors with negative hormonal receptors or of high nuclear grade tend to respond to neoadjuvant chemotherapy with docetaxel alone more likely was suggested. It is thought breast cancers respond to neoadjuvant chemotherapy of docetaxel alone regardless of HER2 status.