Postoperative Adjuvant Anastrozole for 10 or 5 Years in Patients With Hormone Receptor-Positive Breast Cancer: AERAS, a Randomized Multicenter Open-Label Phase III Trial.

PURPOSE: Treatment with an aromatase inhibitor for 5 years is the standard treatment for postmenopausal hormone receptor-positive breast cancer. We investigated the effects of extending this treatment to 10 years on disease-free survival (DFS). PATIENTS AND METHODS: This prospective, randomized, multicenter open-label phase III study assessed the effect of extending anastrozole treatment for an additional 5 years in postmenopausal patients who were disease-free after treatment with either 5 years of anastrozole alone or 2-3 years of tamoxifen followed by 2-3 years of anastrozole. Patients were allocated randomly (1:1) to continue anastrozole for an additional 5 years or stop anastrozole. The primary end point was DFS, including breast cancer recurrence, second primary cancers, and death from any cause. This study is registered with University Hospital Medical Information Network, Japan (UMIN) clinical trials registry (UMIN000000818). RESULTS: We enrolled 1,697 patients from 117 facilities between November 2007 and November 2012. Follow-up information was available for 1,593 patients (n = 787 in the continue group, n = 806 in the stop group), who were defined as the full analysis set, including 144 patients previously treated with tamoxifen and 259 patients who underwent breast-conserving surgery without irradiation. The 5-year DFS rates were 91% (95% CI, 89 to 93) in the continue group and 86% (95% CI, 83 to 88) in the stop group (hazard ratio, 0.61; 95% CI, 0.46 to 0.82; P < .0010). Notably, extended anastrozole treatment reduced the incidence of local recurrence (continue group, n = 10; stop group, n = 27) and second primary cancers (continue group, n = 27; stop group, n = 52). There was no significant difference in overall or distant DFS. Menopausal or bone-related all-grade adverse events were more frequent among patients in the continue group than those in the stop group, but the incidence of grade ≥3 adverse events was <1% in both groups. CONCLUSION: Continuing adjuvant anastrozole for an additional 5 years after 5 years of initial treatment with anastrozole or tamoxifen followed by anastrozole was well tolerated and improved DFS. Although no difference in overall survival was observed as in other trials, extended anastrozole therapy could be one treatment choice in postmenopausal patients with hormone receptor-positive breast cancer.

[A Case of Recurrent Breast Cancer Detected with Diplopia Caused by Sphenoid Bone Metastasis].

We report a case of sphenoid bone metastasis from breast cancer detected with diplopia, as first site of recurrence. Forty- year-old woman with left breast cancer underwent breast-conserving surgery and sentinel lymph node biopsy. The diagnosis was papillotubular carcinoma, pT1pN0, ER(+), PgR(+), HER2(-). Tweleb years later, the examination of diplopia revealed left abducens nerve palsy for sphenoid bone metastasis from breast cancer. Radiation therapy(a total dose of 36 Gy with VMAT)was administrated as topical treatment, but diplopia did not improve. After that, systemic treatment was performed, and 2 years and 6 months have passed since the recurrence was found, she is still alive. We need to be careful of orbital metastasis as a symptom of metastasis from breast cancer.

[Five Patients with Gastric Metastasis from Breast Cancer-A Case Report].

Five patients with gastric metastasis from breast cancer were treated in our hospital. About the histopathological types of primary breast cancer, 4 patients were invasive ductal carcinomas and 1 was invasive lobular carcinoma. One patient was found by gastrointestinal fiberscopy for a detailed examination of her high CEA, 2 for stenosis, 1 for bleeding and 1 for epigastralgia. After the diagnosis of gastric metastasis, 2 patients were treated with chemotherapies, 1 with hormone therapy and 2 with palliative treatments. One of them was treated with gastroduodenal stenting for pyloric stenosis, but she was died by bleeding from gastric lesion. Based on the results, constriction and bleeding with gastric metastasis is considered to be severe condition in the treatment of metastatic breast cancer.

Indices of peripheral leukocytes predict longer overall survival in breast cancer patients on eribulin in Japan.

BACKGROUND: It was reported that eribulin regulates the tumor microenvironment, including the immune system, by inducing vascular remodeling. Lymphocyte counts are a critical index of immune response in patients. The non-Asian, global EMBRACE study has suggested that baseline absolute lymphocyte count (ALC) may be a predictor of the survival benefit of eribulin in breast cancer patients. We examined whether the baseline ALC is a potential predictor of overall survival (OS) in Japanese patients with HER2-negative advanced breast cancer treated with eribulin. METHODS: This was a post hoc analysis of data from a post-marketing observational study of eribulin in Japan. The OS by baseline ALC was estimated using the Kaplan-Meier method, with the cut-off value of 1500/µL for ALC. The OS by baseline neutrophil-to-lymphocyte ratio (NLR), a general prognostic index in breast cancer patients, was also estimated, with the cut-off value of 3. RESULTS: The median OS was longer in patients with an ALC of ≥ 1500/µL than in those with an ALC of < 1500/µL (19.4 vs. 14.3 months; hazard ratio [HR]: 0.628; 95% confidence interval [CI]: 0.492, 0.801). Patients with an NLR of ≥ 3 showed shorter OS than those with an NLR of < 3 (13.2 vs. 18.8 months; HR: 1.552; 95% CI 1.254, 1.921), and NLR also separated OS in patients with an ALC of < 1500/µL. CONCLUSIONS: Consistent with the findings of a previous study involving a non-Asian, Western population, our study suggested that baseline ALC may be a predictive factor for the survival benefit of eribulin in Japanese patients.

[A Case of GIST That Recurred More Than 30 Years after Surgery and Could Be Resected].

The patient was a 77-year-old woman. She underwent a partial gastrectomy at the age of 40, and a partial colectomy at the age of 75 following a diagnosis of a carcinoid. In November 2019, a 1.5 cm mass with a clear boundary was found in the pancreatic tail, which was strongly stained uniformly. And furthermore, multiple masses between 2 cm and 3 cm with a clear boundary was found inside liver segment S1 and S6 and S7 and S8 on CT, which was strongly stained at the edge in the early phase and was seen as a low density area in the late phase. At a result of image examination, it was diagnosed as a pancreatic tail neuroendocrine tumor and its multiple liver metastases. The distal pancreatectomy, posterior segmentectomy, and partial S1 lt and S8 liver resection were performed. With postoperative pathological diagnosis, the pancreatic tumor was accessory spleen, and liver tumor were epithelioid type GIST which were positive for CD34 and PDGFRA and negative for c- kit. The pathology specimen of colectomy was re-examined, and the diagnosis from the previous surgery was changed to GIST from a carcinoid. Epithelioid type GIST was associated with a PDGFRA gene mutation and was known to have many gastric origins. Based on the clinical course, it was diagnosed as recurrence of gastric GIST at 40 years after 30 years or more.

[A Case of Late Recurrence of Breast Cancer with Chest Wall Recurrence 43 Years after Surgery].

The patient is an 85-year-old female who had previously undergone a mastectomy for right breast cancer at the age of 42 years. In September 2020, she visited our hospital with a chief complaint of a chest wall tumor. Physical examination revealed a 3×3 cm ulcerative lesion on the right side of the center chest wall. She underwent a skin biopsy of the tumor under local anesthesia and was diagnosed with a recurrence of right breast cancer(ER positive, PR positive, HER2 negative). PET-CT revealed localized skin thickening on the right side of the sternum and FDG accumulation in the same area, with no other findings suggestive of distant metastasis. Treatment was started with anastrozole and is still ongoing. In this article, we report a very rare case of recurrence 43 years after surgery.

[Occult Breast Cancer Presenting with a Swelling Axillary Lymph Node-A Case Report].

The patient was a 56-year-old woman. who was aware of a tumor in her left axilla and consulted a nearby doctor. She was referred to our hospital for a detailed examination. No abnormalities were found in the breast by visual inspection, mammography, or breast ultrasound examination. One 29 mm swollen lymph node was found in the axilla. Fine needle aspiration cytology revealed malignant lymphoma; thus, so axillary lymph node excision biopsy was performed, and a diagnosis of axillary lymph node metastasis of breast cancer was made. However, no abnormalities were found. Based on the information presented above, the patient was diagnosed with occult breast cancer cT0N1M0, Stage ⅡA, and breast preservation plus axillary lymph node dissection up to level Ⅱ was performed. No metastases were found in the dissected lymph nodes. The treatment policy for occult breast cancer has not yet been established. We report this case with a review of the literature.

[A Case of Solitary Fibrous Tumor of the Liver].

Most solitary fibrous tumors(SFT)occur in the thoracic cavity and reports on liver SFT are very rare. We encountered a case of SFT of the liver, and thus, decided to report it with a review of literature. A 70-year-old man was informed of a liver tumor by his previous doctor and referred to us for further examination and treatment. Contrast-enhanced CT revealed a 3.5 cm cyst in the S2/3 of the liver and a 3.2 cm tumor with an early staining within the cyst. Laparoscopic lateral segmentectomy was performed and a diagnosis of hepatic cystic adenocarcinoma was made. Macroscopically, the tumor was white and welldefined. Histopathological examination revealed round chromatin-enriched tumor cells proliferated with round fibrillar cells or intercalated structures consisting of round or short spindle-shaped cells. Immunohistochemistry yielded negative results for CAM5.2, HepPar1, CD31, CD99, SMA, and HMB45 but positive results for CD34, Factor Ⅷ, Bcl-2, and STAT6; therefore, the patient was further diagnosed with liver SFT. Although liver SFT is rare, it was considered a differential diagnosis when multiple bloody liver tumors were detected. In addition, since there were reports of recurrence, careful follow-up in future, was deemed necessary.

[A Case of Stage â £ Breast Cancer Treated with Mastectomy after Spontaneous Removal of a Cosmetic Breast Implant].

A 51-year-oldwoman came to our hospital complaining of a skin ulcer in the left breast. She hadpreviously undergone cosmetic breast augmentation by placement of a bag prosthesis under each mammary gland. She was diagnosed with Stage Ⅳ(T4bN1M1)breast cancer with multiple bone metastases. Following the diagnosis, 3 regimens of hormonal therapy were sequentially administered. The treatment was then switched to chemotherapy following confirmation of tumor progression in the left breast tumor. After 3 cycles of paclitaxel andbevacizumab as the second-line of chemotherapy, the size of the left breast tumor was remarkably reduced. Mastectomy with axillary lymph node sampling and removal of the implant were scheduled for local control. However, due to gradual exposure of the implant under the left breast, it was spontaneously removedfrom the original position when the patient was waiting for the surgery. Therefore, only mastectomy with axillary lymph node sampling was performed, followed by 45 Gy/25 times of postmastectomy and locoregional lymph node irradiation. Six months after the surgery, the patient is alive with no signs of local recurrence.

Baseline neutrophil-to-lymphocyte ratio and c-reactive protein predict efficacy of treatment with bevacizumab plus paclitaxel for locally advanced or metastatic breast cancer.

The effect of bevacizumab plus paclitaxel therapy on progression-free survival (PFS) is prominent; however, no overall survival (OS) benefit has been demonstrated. Our aim was to study the predictive efficacy of peripheral immune-related parameters, neutrophil-to-lymphocyte ratio (NLR), absolute lymphocyte count (ALC), and c-reactive protein (CRP) in locally advanced and metastatic breast cancers. A total of 179 patients treated with bevacizumab plus paclitaxel were recruited from three institutes in the test cohort. The cut-off values of NLR, ALC, and CRP were set at 3, 1500/µL, and 1.0 mg/dL, respectively, and baseline values of these factors were measured. The PFS of patients with NLR-low was significantly longer than that of patients with -high (median, 12.6 vs. 7.2 months; hazard ratio (HR), 0.48, 95% confidence interval (95% CI), 0.31-0.73; p = 0.0004). OS of patients with NLR-low was significantly better than those with-high (22.2 vs. 13.5 months; HR, 0.57, 95% CI, 0.39-0.83; p = 0.0032). Similarly, improved PFS and OS were recognized in patients with CRP-low as compared with patients with -high (HR, 0.44, 95% CI, 0.28-0.68; p = 0.0001 and HR, 0.39, 95% CI, 0.26-0.61, p < 0.0001, respectively). In the validation cohort from two institutes (n = 57), similar significant improvements in PFS and OS were confirmed for patients with NLR-low (p = 0.0344 and p = 0.0233, respectively) and CRP-low groups (p < 0.0001 and p = 0.0001, respectively). Low levels of NLR and CRP at baseline were significantly associated with improved prognosis in patients treated with bevacizumab plus paclitaxel.

Effectiveness and safety of eribulin in Japanese patients with HER2-negative, advanced breast cancer: a 2-year post-marketing observational study in a real-world setting.

Background Data on eribulin as the first- or second-line treatment in a clinical setting, especially the overall survival (OS) of patients, are scarce. Therefore, we assessed the effectiveness and safety of eribulin as the first-, second-, and third- or later-line treatments in patients with human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in Japan. Methods This multicenter, prospective, post-marketing, observational study enrolled patients from September 2014 to February 2016 in Japan and followed them for 2 years. Patients were categorized by eribulin use into the first-, second-, and third- or later-line treatment groups. Results Of 651 registered patients, 637 patients were included in the safety and effectiveness analysis. In all, first-, second-, and third or later-line treatment groups, median OS (95% confidence interval) were 15.6 (13.8-17.6), 22.8 (17.3-31.0), 16.3 (12.4-19.9), and 12.6 (11.2-15.1) months and time to treatment failure (TTF) (95% confidence interval) were 4.2 (3.7-4.4), 5.2 (3.7-5.9), 4.2 (3.7-5.1), and 3.8 (3.5-4.2) months, respectively. Prolonged TTF was associated with complications of diabetes and the development of peripheral neuropathy after eribulin treatment, according to multivariate Cox regression analysis. Grade ≥ 3 adverse drug reactions (ADRs) were reported in 61.7% of the patients. Neutropenia (49.5%) was the most common grade ≥ 3 ADR in all groups. Conclusions The effectiveness and safety results of eribulin as the first- or second-line treatment were favorable. Thus, these suggest eribulin may be a first-line treatment candidate for patients with HER2-negative advanced breast cancer in Japan.

[A Case Report of Conversion Surgery for Pancreatic Ductal Adenocarcinoma with Liver Metastasis after Chemotherapy].

Pancreatic ductal carcinoma is one of the leading causes of cancer deaths in Japan. However, with remarkable progress in chemotherapy, studies have reported successful resection of initially unresectable pancreatic adenocarcinoma after chemotherapy. We report a case of curative surgery of pancreatic ductal adenocarcinoma with liver metastasis after chemotherapy. A 66-year-old man presenting with jaundice and weight loss was admitted to our hospital for an evaluation of pancreatic lesions. Computed tomography revealed a hypoattenuating mass in the head of the pancreas. We diagnosed this cancer as cT4(SMA>1/2)N1M0, cStage Ⅲand performed chemoradiotherapy for this locally advanced pancreatic cancer. Because of the appearance of liver metastasis, we treated this patient with GEM plus nab-PTX chemotherapy. There were no serious adverse events. After 3 therapy courses, the existing liver metastasis disappeared, and no new metastases were noted. Therefore, radical subtotal stomach-preserving pancreatoduodenectomy was performed. The tumor was diagnosed as moderately differentiated adenocarcinoma, ypT1a ypN0 ypM0, ypStage ⅠA, R0.

[A Middle-Term Survival Case of Pancreas Tail Cancer with Colonic Obstruction].

A 63-year-old man had abdominal pain and sequential constipation and diarrhea. He complained of abdominal pain and vomiting, and was admitted to the hospital with a diagnosis of ileus. CT demonstrated a colonic obstruction at the splenic flexure, which was suspected to be colon cancer. Ileostomy was performed in March 2015, and he underwent radical resection in May 2015. Cancer of the pancreas tail had invaded the spleen, colon, stomach, and left renal capsule. Distal pancreatectomy was performed, along with extended right hemicolectomy, left nephrectomy, partial gastrectomy, and stoma closure. He received adjuvant chemotherapy for 6 months after the operation. He is alive without recurrence of pancreatic cancer for over 3 years.

[Sustained Complete Response of Hepatocellular Carcinoma with Multiple Intrahepatic Metastases following the Discontinuation of Sorafenib].

Sorafenib is an oral multi-targeted tyrosine kinase inhibitor used in cases of unresectable advanced HCC that significantly improves progression-free and overall survival. Complete response(CR)is uncommon; however, if major or complete radiological response are obtained, the issue of the discontinuation of sorafenib remains unresolved. The present study reported a case of a 75-year-old man with non-hepatitis B and C virus-related cirrhosis and multiple recurrent HCCs followingresection. In December 2010, a CT scan revealed multiple intrahepatic recurrence after TACE. Laboratory testingshowed Child-Pugh class A cirrhosis and an alpha-fetoprotein level of over 20,000 ng/mL. Sorafenib(800mg/day)was started in December 2010. The subsequent dynamic CT performed at the 6th month of therapy showed a partial response accordingto RECIST criteria and a complete response accordingto mRECIST. The AFP had decreased to within normal levels. In May 2012, the sorafenib dose was reduced(200 mgtwice daily)due to side effects(skin reaction). In December 2013, treatment was stopped after confirmation of a CR associated with shrinkage of the HCC. The patient maintained this remission until June 2018, more than 54 months after the discontinuation of sorafenib therapy. The adverse events of sorafenib were reversible. Further reportingof similar cases should help in the design of treatment strategies after CR to sorafenib therapy.

Significance of baseline neutrophil-to-lymphocyte ratio for progression-free survival of patients with HER2-positive breast cancer treated with trastuzumab emtansine.

The efficacy of trastuzumab emtansine (T-DM1) is prolonged for some patients; however, the predictive factors remain unknown. We focused on a peripheral blood biomarker, the neutrophil-to-lymphocyte ratio (NLR), regarding T-DM1 treatment efficacy. Fifty-three advanced or metastatic breast cancers treated with T-DM1 were retrospectively recruited from three institutes. The NLR in the peripheral blood was measured at baseline and after one cycle. The cutoff value of the NLR was set at median value 2.56. The progression-free survival (PFS) of patients with NLR-low at baseline (n = 26; median, not reached) was significantly better than that of patients with NLR-high (n = 27; median, 4.13 months; hazard ratio [HR], 0.226; 95% confidence interval [CI], 0.112-0.493; p = 0.0001). Longer overall survival was significantly associated with a low NLR (HR, 0.384; 95% CI, 0.170-0.910; p = 0.0296). In the subgroup analysis, patients with NLR-low consistently had longer PFS compared to those with NLR-high irrespective of the number of prior chemotherapy regimens, prior trastuzumab, visceral metastasis, estrogen receptor status, and human epidermal growth factor receptor 2 (HER2) score. Although detailed mechanisms remain unknown, treatment efficacy of T-DM1 may be partly mediated by activation of the immune system. Low baseline NLR appears to be beneficial for treatment with T-DM1 in HER2-positive breast cancers.

[A Case of Liver Metastases of Ampullary Carcinoma with Clinical Complete Response Treated with Gemcitabine plus Cisplatin].

We report a case of liver metastases of ampullary carcinoma that achieved clinical complete response after gemcitabine plus cisplatin(GC)combination chemotherapy. A 69-year-old man with obstructive jaundice was diagnosed with ampullary carcinoma and underwent laparoscopic pancreaticoduodenectomy. Postoperative histopathological examination revealed pT3aN0M0, Stage ⅡA adenocarcinoma of the papilla of Vater. Five months after surgery, multiple liver metastases were identified by CT and MRI. The patient received GC chemotherapy intravenously at doses of 1,000 and 25mg/m2 on days 1 and 8, respectively, every 3 weeks. After 3 courses of GC chemotherapy, a CT scan revealed that the liver metastases reduced in size, and PR was achieved based on the RECIST standard. However, Grade 3 neutropenia appeared. After 7 courses, the liver metastases disappeared, and the patient had achieved CR. After 9 courses, the clinical CR continued. Approximately 14 months have passed since the recurrence, and the patient is currently alive.

[Long-Term Survival in a Case of Breast Cancer with Brain Metastases and No Other Distant Metastases Treated by Surgical Removal and Gamma Knife Radiosurgery].

A 44-year-oldwoman was diagnosedwith right breast cancer andund erwent mastectomy andaxillary lymph node dissection in February 2006. She was pathologically diagnosed with invasive ductal carcinoma without lymph node metastasis. Immunohistochemical examination showedthat the tumor was estrogen receptor positive, progesterone receptor negative, andhada HER2 status score of 0. She received 4 cycles of AC, followedby leuprorelin andtamoxifen. Several metastases were identified in the right supraclavicular lymph nodes in August 2008 during the endocrine therapy. Then, she received S-1 as the first-line chemotherapy. Although metastases showed complete response, she developed an eye disorder caused by S-1 and thus the treatment agent was changedto leuprorelin andanastrozole. She complainedof headache andright homonymous hemianopsia in November 2013. MRI showeda 42mm diameter tumor in the left occipital lobe, suspectedto be brain metastasis from breast cancer. Craniotomy was performedto remove the brain tumor, which was pathologically diagnosedas metastasis from breast cancer. In the brain tumor, the estrogen receptor status hadchangedto negative, but the HER2 status remained unchanged, showing a score of 0. Vinorelbine was administered after the brain surgery. Unfortunately, brain metastasis was foundin the dura mater near the surgical cavity, andgamma knife radiosurgery was performedin January 2014. Thereafter, brain metastases were repeatedly found, and gamma knife radiosurgery was again performed in January 2015, September 2016, and February 2017. In addition, a large tumor appearedin the left occipital lobe andwas surgically removed in June 2016. No other distant metastases were found, andvinorelbine was continueduntil February 2018. Because the patient developed dyslexia caused by gamma knife-induced radiation necrosis, bevacizumab was administered between November 2018 and April 2019. MRI showed that the edema due to radiation necrosis reduced and dyslexia symptoms improved. As of now, she has survivedfor 5 years and 6 months after the diagnosis of brain metastases.

[Experience of Treatment with Lenvatinib in Patients with Advanced HCC-A in a Single Institution].

The efficacy of lenvatinib was evaluated in 7 patients with advanced hepatocellular carcinoma(HCC), between March 2018 and February 2019. Their mean age was 74.3 years, and 6 of them were men. All patients had an Eastern Cooperative Oncology Group(ECOG)performance status(PS)of 0. The median number of treatment days was 185. The relative dose intensity was 87.5%. The major Grade was 3, and the overall toxicity events were AST elevation(14.3%)and hypertension (14.3%). The 6-month progression-free and overall survival rates were 71.4% and 100%, respectively. The overall response rate was 57.1%, and the disease control rate was 71.4%. Lenvatinib can be used as a standard treatment for patients with advanced HCC.

Predictive impact of absolute lymphocyte counts for progression-free survival in human epidermal growth factor receptor 2-positive advanced breast cancer treated with pertuzumab and trastuzumab plus eribulin or nab-paclitaxel.

BACKGROUND: Although peripheral blood-based parameters (PBBPs) are reported as prognostic indicators in patients with breast cancers, their utility has not been studied in human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer (ABC). Tumor-infiltrating lymphocytes (TILs) might be a predictive factor in patients with HER2-positive ABC treated with pertuzumab and trastuzumab (PT) plus docetaxel. We aimed to evaluate whether PBBPs could have predictive value in HER2-positive ABC treated with pertuzumab and trastuzumab (PT) combined with eribulin (ERI) or nab-paclitaxel (Nab-PTX). METHODS: Data from 51 patients included in two single-arm, phase II trials were included in this retrospective-prospective study; the ERI + PT (N = 30) and Nab-PTX + PT (N = 21) combinations were registered under clinical trials number UMIN000012375 and UMIN000006838, respectively. We assessed PBBPs using prospectively collected data and investigated the association with progression-free survival (PFS); we evaluated absolute lymphocyte count (ALC), neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR). The cutoff values for ALC, NLR, and PLR were set at 1000 or 1500 cells/µL, 2, and 250, respectively. RESULTS: PFS was significantly improved in patients with ALC ≥1500/µL compared to those with ALC 1000-, <1500/µL or ALC < 1000/µL (P = 0.0106). High baseline ALC was significantly associated with improved PFS (≥1500/µL; hazard ratio [HR]: 0.3715; 95% confidence interval [CI]: 0.1735-0.7955; P = 0.0108). In contrast, improved PFS was not significantly associated with NLR or PLR. Improved PFS in patients with ALC ≥1500/µL was observed irrespective of visceral metastasis or chemotherapy regimen. CONCLUSIONS: Our results showed that baseline ALC was a predictive factor for PFS in HER2-positive ABC treated with PT irrespective of combined chemotherapy regimen. Anti-tumor effects might be mediated not only by the tumor microenvironment, but also by systemic peripheral circulating lymphocytes. Baseline systemic parameters such as peripheral lymphocyte count might be beneficial in addition to disease extent for predicting the efficacy of PT treatment. TRIAL REGISTRATION: UMIN000012375 , registration date: 21NOV2013, and UMIN000006838 , registration date: 6DEC2011.

[A Case of Stage IV Metaplastic Breast Cancer in Which Primary Tumor Was Removed after Treatment with Anti-HER2 Systemic Therapy].

The patient was a 58-year-oldpostmenopausal woman. Vacuum assistedbiopsy of the left breast tumor revealedinvasive ductal carcinoma. Immunohistochemical examination was negative for estrogen receptor(ER), negative for progesterone receptor(PgR), andshowedan HER2 score of 3+. FDG-PET/CT revealedmultiple metastases to the left supracravicular and axillary lymph nodes and lungs. She was diagnosed with HER2-positive T3N3M1, Stage IV breast cancer. A 2-year regimen of chemotherapy with trastuzumab andvinorelbine achieveda complete response with regardto the metastatic sites; however, the size of the primary tumor increasedd espite the chemotherapy, andsurgical resection of the left breast with axillary lymph node dissection was performed for local control. Pathological examination of the surgical specimen revealed metaplastic carcinoma with sarcoma component surrounded by non-invasive ductal carcinoma. No component of invasive ductal carcinoma was found. Immunohistochemically, metaplastic carcinoma was negative for ER, negative for PgR, andrevealedan HER2 score of 0. There was discordance of HER2 status between pre- andpost -chemotherapy. The patient receivedno further chemotherapy following surgery andhas been without disease progression for 6 years. We suggest there is heterogeneity, that is, the metastatic sites andthe partial primary tumor were HER2-positive invasive ductal carcinoma and the remainder of the primary tumor was triple negative metaplastic carcinoma. As a result, the patient was able to discontinue chemotherapy with higher quality of life.