A multicenter Phase II study evaluating the efficacy, safety and pharmacokinetics of trastuzumab emtansine in Japanese patients with heavily pretreated HER2-positive locally recurrent or metastatic breast cancer.

Objective: Trastuzumab emtansine significantly improved progression-free survival and overall survival when compared with lapatinib-capecitabine in pretreated human epidermal growth factor receptor 2-positive advanced breast cancer. However, data in Japanese populations are limited.

Methods: In the single-arm Phase II JO22997 study, Japanese patients with human epidermal growth factor receptor 2-positive inoperable locally advanced/recurrent or metastatic breast cancer previously treated with at least one prior chemotherapy regimen for locally advanced/recurrent or metastatic breast cancer and trastuzumab in any setting received 3.

Efficacy and safety of ixabepilone in taxane-resistant patients with metastatic breast cancer previously treated with anthracyclines: results of a phase II study in Japan.

Purpose: Anthracycline and taxane resistance is a key issue in the treatment of metastatic breast cancer (MBC), particularly in Asian patients who often present with advanced disease. The objective of this study was to investigate the efficacy and safety of ixabepilone monotherapy in Japanese patients with taxane-resistant MBC previously treated with anthracycline.

Patients And Methods: Japanese patients with taxane-resistant MBC previously treated with anthracycline were treated with 40 mg/m(2) ixabepilone every 3 weeks.

Promotion of quality-controlled mammography alone as a screening modality in Japan.

Background: The rate of breast cancer screening in Japan has not increased, and it is thought that one of the reasons is the principle that mammography (MMG) and clinical breast examination (CBE) be carried out in combination. Nationwide, there is a shortage of physicians qualified to perform CBE, and in some regions mass-screening is performed by MMG alone out of a mobile MMG bus. In Shikoku, MMG is performed alone as a screening examination in Kochi and Ehime Prefectures.

Phase III randomized trial of toremifene versus tamoxifen for Japanese postmenopausal patients with early breast cancer.

Background: Toremifene, a selective estrogen receptor modulator, is used as adjuvant therapy for postmenopausal patients with breast cancer in Japan. For Japanese patients, however, only limited data are available on the efficacy and safety profile of toremifene. To establish the long term efficacy and safety of toremifene for Japanese patients, we conducted a prospective, multicenter, randomized phase III trial comparing toremifene and tamoxifen.

Are there high-risk subgroups for isolated locoregional failure in patients who had T1/2 breast cancer with one to three positive lymph nodes and received mastectomy without radiotherapy?

Background: To define the factors associated with increased risk of isolated locoregional failure that may justify postmastectomy radiotherapy in patients with T1/2 breast cancer and 1-3 positive lymph nodes.

Methods: Between 1990 and 2002, 248 patients who had pT1-2 breast cancer and 1-3 positive lymph nodes were treated with mastectomy without radiotherapy (age 32-84, median 54).

Results: Median follow-up time was 82 months (range 2-189 months).

Impact of aggregate of risk factors for isolated locoregional failure in breast cancer patients treated with mastectomy without radiotherapy.

Background: The impact of aggregate of risk factors on isolated locoregional failure after mastectomy without radiotherapy was assessed.

Methods: We reviewed 1091 patients who had stage I-III unilateral breast cancer and received mastectomy between 1990 and 2002.

Results: Median follow-up time was 67 (1-175) months.

Identification of candidates for postmastectomy radiotherapy in patients with pT3N0M0 breast cancer.

Background: There is still controversy concerning the indication of postmastectomy radiotherapy (PMRT) for pT3N0M0 breast cancer. To identify the candidates for PMRT in this subset, we investigated failure patterns, and searched for risk factors for isolated locoregional failure in pT3N0M0 breast cancer after mastectomy without PMRT.

Methods: Among 1,176 patients who received mastectomy without PMRT for untreated unilateral breast cancer between 1990 and 2002, 64 patients (5%) had pT3N0M0 breast cancer (age 30-81 years; median 52.

First-line bevacizumab in combination with weekly paclitaxel for metastatic breast cancer: efficacy and safety results from a large, open-label, single-arm Japanese study.

Unlabelled: Despite extensive evaluation of first-line bevacizumab-containing therapy in randomized trials in locally recurrent/metastatic breast cancer (LR/mBC), data from Japanese populations are limited. We conducted a phase II study exclusively in Japanese patients to evaluate bevacizumab combined with weekly paclitaxel. Patients with HER2-negative measurable LR/mBC who had received no prior chemotherapy for LR/mBC received bevacizumab 10 mg/kg, days 1 and 15, in combination with paclitaxel 90 mg/m(2), days 1, 8, and 15, repeated every 4 weeks, until disease progression, unacceptable toxicity, or patient/physician decision.

Long-term gemcitabine administration in heavily pretreated Japanese patients with metastatic breast cancer: additional safety analysis of a phase II study.

Background: Recently gemcitabine has been approved for treatment of metastatic or recurrent breast cancer in Japan; however, no systematically investigated safety study of long-term gemcitabine monotherapy has been reported despite its wide use globally for multiple indications.

Patients And Methods: In a previously reported phase II study, 62 Japanese metastatic breast cancer patients with progressive disease after treatment with anthracyclines and taxanes were treated with gemcitabine 1250 mg/m(2) on days 1 and 8 of a 21-day cycle. For this report we re-analyzed the safety profiles for the 13 patients who received 10 or more cycles of the therapy.

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.

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.

Metastatic Breast Cancer to the Stomach Resembling Early Gastric Cancer.

Breast cancer metastases to the stomach are very rare. As characteristics of breast cancer metastases to the stomach, metastases of lobular carcinoma, mainly with signet ring cells, are frequently observed, and they are often difficult to distinguish from a primary gastric cancer with signet ring cells. Moreover, because no characteristic symptoms are shown and they involve a submucosal lesion, it is difficult to make a radiographic diagnosis.

Endometrial Metastasis from Breast Cancer during Adjuvant Endocrine Therapy.

It is well-known that tamoxifen increases the risk of endometrial cancer. Although metastasis to the uterus from breast cancer is uncommon, there have been some case reports on uterine metastasis. If an endometrial abnormality is detected, the differential diagnosis of whether the uterine tumor is metastatic or primary is very important to determine the course of treatment.

The efficacy and safety of gemcitabine plus paclitaxel combination first-line therapy for Japanese patients with metastatic breast cancer including triple-negative phenotype.

Purpose: Gemcitabine (GEM)-paclitaxel combination therapy has been confirmed as a standard therapy for metastatic/recurrent breast cancer (MBC) in Western countries. This study was conducted to assess the efficacy and safety of GEM-paclitaxel combination therapy in Japanese MBC patients.

Methods: Patients were administered paclitaxel 175 mg/m(2) on day 1, and GEM 1,000 or 1,250 mg/m(2) on days 1 and 8 of 21-day cycle.

Effects of toremifene and tamoxifen on lipid profiles in post-menopausal patients with early breast cancer: interim results from a Japanese phase III trial.

Objective: Toremifene and tamoxifen have been used for adjuvant therapy in post-menopausal patients with breast cancer in Japan. Dyslipidemias are common in post-menopausal women. However, limited data are available on the effects of these agents on lipid profiles in Japanese patients.

Suspicious calcifications in benign breast lesions: a radio-pathologic correlation.

Background: Breast cancer screening by mammography (MMG) has recently increased in Japan. Suspicious lesions are therefore being detected more and more by MMG and the number of benign biopsies is increasing. It is thus important to examine which pathologically benign lesions were read as suspicious on MMG to reduce the number of biopsies in the case of benign breast lesions.

Pulmonary angioplastic procedure for lung cancer surgery.

Purpose: Although bronchoplasty for the treatment of lung cancer is widely accepted as a reliable, safe procedure for the preservation of lung function, there have been only a few reports on pulmonary artery (PA) resection and reconstruction.

Methods: Retrospectively, we reviewed our medical records of pulmonary angioplastic procedures and assessed the results.

Results: A total of 25 patients (5 women, 20 men) with a mean age of 68 years (range 44-85 years) underwent a pulmonary angioplastic procedure for lung cancer surgery.

[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.

Phase II study of gemcitabine monotherapy as a salvage treatment for Japanese metastatic breast cancer patients after anthracycline and taxane treatment.

Objective: This Phase II study was conducted to evaluate efficacy and safety of gemcitabine monotherapy in anthracycline and taxane pre-treated Japanese metastatic breast cancer patients.

Methods: At Step 1, twelve patients were divided into two groups of six patients each and the dose-limiting toxicity was evaluated at gemcitabine 1000 and 1250 mg/m(2) to determine the dose for Step 2. At Step 2, an additional 56 patients were assessed for efficacy and safety of gemcitabine monotherapy.

Efficacy and tolerability of weekly paclitaxel in combination with high-dose toremifene citrate in patients with metastatic breast cancer.

Toremifene citrate is expected to prevent drug resistance in cancer patients by inhibiting p-glycoprotein activity. The safety and efficacy of combination therapy with high-dose toremifene citrate and paclitaxel were investigated. Between December 2003 and June 2004, 15 women with a mean age of 53 years old with metastatic breast cancer were enrolled.

Randomized trial of cyclophosphamide, epirubicin, and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate, and fluorouracil with node-positive breast cancer in Japan.

Background: To compare the cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy and the anthracycline-containing regimen cyclophosphamide, epirubicin, and fluorouracil (CEF) to evaluate the efficacy and safety of the latter.

Methods: A total of 294 patients with axillary node-positive primary breast cancer of STAGE I-IIIa were randomly assigned to either CEF [cyclophosphamide (CPA) 500 mg/m(2) i.v.

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).

Primary extranodal non-Hodgkin's lymphoma of the common bile duct manifesting as obstructive jaundice: report of a case.

Primary non-Hodgkin's lymphoma (NHL) of the common bile duct (CBD) manifesting as obstructive jaundice is extremely rare: to our knowledge, only 22 cases of primary NHL arising from the CBD have been reported. The patient in this case report was a 63-year-old man who presented with obstructive jaundice. Abdominal sonography, positron emission tomography, and computed tomography showed a mass with abnormal 18-fluorodeoxyglucose uptake in pancreatic head.

[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.

Oral uracil and tegafur compared with classic cyclophosphamide, methotrexate, fluorouracil as postoperative chemotherapy in patients with node-negative, high-risk breast cancer: National Surgical Adjuvant Study for Breast Cancer 01 Trial.

Purpose: The primary aim of this study was to compare the effectiveness of oral uracil-tegafur (UFT) with that of classical cyclophosphamide, methotrexate, and fluorouracil (CMF) given as postoperative adjuvant treatment to women with node-negative, high-risk breast cancer.

Patients And Methods: Women with node-negative, high-risk breast cancer were randomly assigned to receive either 2 years of UFT or six cycles of CMF after surgery. The primary end point was relapse-free survival (RFS).