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1.
Gan To Kagaku Ryoho ; 45(7): 1101-1103, 2018 Jul.
Article in Japanese | MEDLINE | ID: mdl-30042281

ABSTRACT

Metaplastic carcinoma is a rare type of breast carcinoma, which tends to be chemo-resistant. We report a case of metaplastic squamous cell carcinoma of the breast diagnosed after neoadjuvant chemotherapy(NAC). A 56-year-old woman was diagnosed as having right-sided breast cancer(invasive ductal carcinoma[IDC], triple negative), cT1cN1M0, stage II A. NAC with 5-fluorouracil, epirubicin, and cyclophosphamide(FEC)followed by docetaxel(DTX)was administered. Tumor progression occurred during both the FEC and DTX regimens. We discontinued NAC and performed breast conserving surgery with axillary lymph node dissection. Histological findings of the resected specimen showed mixed IDC and widely spread squamous metaplasia. Weekly paclitaxel and radiotherapy were administered and the patient is alive with no recurrence 3 years after surgery.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Carcinoma, Ductal, Breast/drug therapy , Carcinoma, Squamous Cell/drug therapy , Neoadjuvant Therapy , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Carcinoma, Ductal, Breast/surgery , Carcinoma, Squamous Cell/surgery , Female , Humans , Mastectomy, Segmental , Middle Aged , Treatment Outcome
2.
Gan To Kagaku Ryoho ; 45(12): 1725-1728, 2018 Dec.
Article in Japanese | MEDLINE | ID: mdl-30587728

ABSTRACT

The criteria for biological postmenopause have not been clearly defined, although determining the menopausal status is crucial for selecting agents for adjuvant endocrine therapy for patients with breast cancer. The long-term effects of adjuvant toremifene(TOR)and anastrozole(ANA)on serum follicle-stimulating hormone(FSH)and estradiol(E2)levels in Japanese women were examined using data from a prospective randomized study that mainly studied serum lipids and bone metabolism for 2 years. The study medications were administered orally daily at 40 mg and 1 mg for TOR and ANA, respectively. Sixty-nine patients were randomly assigned to the TOR group(n=36)or ANA group(n=33). FSH and E2 levels were measured using chemiluminescent immunoassay. The mean ages of the patients in the TOR and ANA groups were 62.5 and 60.0 years, respectively. None of the patients experienced menstruation during the course of the study. The baseline serum FSH level in the TOR group(69.6mIU/mL)decreased to 59.2%, 54.6%, and 50.0% at 6, 12, and 24 months, respectively, after therapy commencement. The FSH levels ranged from 8.6 to 68.1mIU/mL and were<20mIU/mL in 2 patients(9.5%; 8.6 and 14.4mIU/mL). The serum FSH levels in the ANA group did not change markedly over 24months. The baseline serum E2 level in the ANA group(11.6 pg/mL)decreased to 72.4%, 70.7%, and 61.2%at 6, 12, and 24months, respectively, after therapy commencement. The serum E2 level in the TOR group did not change markedly over 24 months. When switching to other endocrine agents as adjuvant therapy for patients with breast cancer treated with TOR, the serum FSH level decreased to half of the preinitiation level, and one-tenth of the FSH levels was<20mIU/mL, while the postmenopausal serum E2 level was maintained.


Subject(s)
Anastrozole , Breast Neoplasms/drug therapy , Estradiol , Follicle Stimulating Hormone , Toremifene , Anastrozole/therapeutic use , Aromatase Inhibitors/therapeutic use , Estradiol/blood , Female , Follicle Stimulating Hormone/blood , Humans , Prospective Studies , Randomized Controlled Trials as Topic , Retrospective Studies , Toremifene/therapeutic use
3.
Oncology ; 93(1): 51-61, 2017.
Article in English | MEDLINE | ID: mdl-28478451

ABSTRACT

OBJECTIVE: The aim of this study was to investigate the correlation between human epidermal growth factor receptor 2 (HER2)-related biomarkers and the treatment outcomes using lapatinib plus capecitabine (LC) and to evaluate the influence of the estrogen receptor (ER) status in trastuzumab-refractory HER2-positive advanced breast cancer. METHOD: Eighty patients were enrolled in this study. Total HER2, p95HER2, and total HER3 expression were quantified using the VeraTag assays. PTEN (phosphatase and tensin homolog) and p95 expression was evaluated using immunohistochemistry and PIK3CA mutation using direct sequencing. RESULTS: The response rate to LC was 30%, clinical benefit rate was 51.3%, and the median progression-free survival (PFS) was 174.5 days. ER negativity significantly correlated with higher HER2 and p95HER2. The lower HER2 and PIK3CA mutations were often observed in the nonresponders. A high p95HER2 expression correlated with longer PFS especially in the high HER2- and ER-positive cases. Patients without the PIK3CA mutation showed longer PFS in the same subset. Overall survival after LC significantly correlated with the number of recurrence organs. CONCLUSION: LC therapy is effective in trastuzumab-refractory HER2-positive breast cancer. Moreover, the biomarker expression differed depending on ER status, and a high p95HER2 expression and wild-type PIK3CA gene correlated with longer PFS especially in the ER-positive cases.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Antineoplastic Combined Chemotherapy Protocols , Biomarkers, Tumor/metabolism , Breast Neoplasms/drug therapy , Capecitabine/therapeutic use , Quinazolines/therapeutic use , Receptor, ErbB-2/metabolism , Trastuzumab/therapeutic use , Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal, Humanized/administration & dosage , Breast Neoplasms/metabolism , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Capecitabine/administration & dosage , Disease-Free Survival , Female , Gene Expression Regulation, Neoplastic/drug effects , Humans , Lapatinib , Middle Aged , Neoplasm Recurrence, Local , PTEN Phosphohydrolase/drug effects , Quinazolines/administration & dosage , Trastuzumab/administration & dosage , Treatment Outcome , Young Adult
4.
Surg Today ; 46(9): 1045-52, 2016 Sep.
Article in English | MEDLINE | ID: mdl-26689209

ABSTRACT

PURPOSE: The aim of this study was to investigate the validity of the management strategy for intraductal papillary mucinous neoplasms (IPMNs) advocated by the international consensus guidelines 2012 (ICG2012). METHODS: The medical records of 49 patients who underwent pancreatectomy for IPMN were retrospectively reviewed. RESULTS: According to preoperative imaging, 10 patients (20 %) had main-duct IPMNs, 20 (41 %) had mixed IPMNs, and 19 (39 %) had branch-duct IPMNs, with malignancy frequencies of 80, 15, and 37 %, respectively. Twenty-seven patients had high-risk stigmata and 21 had worrisome features, with malignancy frequencies of 59 and 10 %, respectively. The sensitivity, specificity, and positive and negative predictive values of high-risk stigmata for malignancy were 88, 65, 59, and 91 %, respectively. Lesions were malignant in 88 % of patients with an enhanced solid component, which was significantly correlated with the prevalence of malignancy (P < 0.01). However, of the 10 patients who underwent pancreatectomy solely due to a main pancreatic dilation of ≥10 mm, 9 (90 %) had benign IPMNs. CONCLUSIONS: Many mixed IPMNs defined according to ICG2012 are benign. Although the management strategy advocated by ICG2012 has been improved relative to the Sendai criteria, the different high-risk stigmata carry unequal weights. Consequently, ICG2012 remains suboptimal for predicting malignant IPMN.


Subject(s)
Adenocarcinoma, Mucinous/surgery , Carcinoma, Pancreatic Ductal/surgery , Pancreatic Neoplasms/surgery , Practice Guidelines as Topic , Adenocarcinoma, Mucinous/diagnostic imaging , Adult , Aged , Aged, 80 and over , Carcinoma, Pancreatic Ductal/diagnostic imaging , Diagnostic Imaging , Female , Humans , Male , Middle Aged , Pancreatectomy , Pancreatic Neoplasms/diagnostic imaging , Retrospective Studies , Risk
5.
Gan To Kagaku Ryoho ; 42(1): 45-50, 2015 Jan.
Article in Japanese | MEDLINE | ID: mdl-25596678

ABSTRACT

This study examined the pathological complete response (pCR )rate and safety of induction chemotherapy with 12 cycles of weekly paclitaxel (80 mg/m²) followed by 4 cycles of 5-fluorouracil (500 mg/m²), epirubicin (100 mg/m²), and cyclo- phosphamide (500 mg/m²). The study medication was administered to female patients (n=31)with a mean age of 51 years, diagnosed with stage II A (n=18), II B (n=11) and III A (n=2) disease and with an estrogen receptor positive rate of 65% (20/31). No patient was HER2-IHC [human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC)](3+) or HER2-FISH (fluorescence in situ hybridization) positive. Twenty-eight patients completed the treatment regimen. Treatment was halted in 2/31 patients due to progression of disease in one patient and a Grade 3 non-hematological adverse effect of skin eruption and itching in the other patient. A third patient died of causes unrelated to the study medication. Central review ascertained a pCR in 6 patients. In patients with triple-negative disease we observed a pCR rate of 67% (6/9). In patients with the Luminal (A+B) subtype, 0% (0/19) had a pCR. Grade 3/4 toxicity included leucopenia (58%), neutropenia (58%), febrile neutropenia (26%), fatigue (10%), and ALT elevation (7%). In terms of pCR, patients presenting with triple-negative disease and manageable safety profiles appear to respond well to this treatment regimen, while only a modest response was observed in patients with Luminal subtype disease.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Neoadjuvant Therapy , Triple Negative Breast Neoplasms/drug therapy , Adult , Aged , Cyclophosphamide/administration & dosage , Epirubicin/administration & dosage , Fluorouracil/administration & dosage , Humans , Middle Aged , Paclitaxel/administration & dosage
6.
Surg Case Rep ; 9(1): 152, 2023 Sep 01.
Article in English | MEDLINE | ID: mdl-37656266

ABSTRACT

BACKGROUND: Few reports of inflammatory myofibroblastic tumor (IMT) of the breast have been published worldwide. Furthermore, primary anaplastic lymphoma kinase (ALK)-positive IMT of the breast is extremely rare. To date, only six patients with ALK-positive IMT have been reported in the literature. CASE PRESENTATION: A 52-year-old woman underwent a medical examination, and a left breast mass was detected. She did not feel a mass in her chest. Mammography showed a focal asymmetric density at the lower outer portion of the left breast. Breast ultrasonography showed a 1.2-cm hypoechoic lesion with relatively clear boundaries and poor blood flow. Magnetic resonance imaging and computed tomography revealed a solitary heterogeneous mass in the left breast. Pathologic examination revealed a fibrosing lesion with proliferation of fibroblastic cells arranged in a storiform pattern and admixed inflammatory cells. Immunohistochemical examination showed that the tumor cells were positive for ALK. Under the preoperative diagnosis of IMT, we performed partial mastectomy with adequate margins. The postoperative diagnosis was pathologically confirmed as IMT. Immunohistochemical staining also showed overexpression of ALK-1 in the tumor. The patient had a good clinical course for 24 months postoperatively, without recurrence or metastasis. CONCLUSIONS: IMT of the breast shows nonspecific imaging findings, making preoperative diagnosis difficult. Nevertheless, IMT has the characteristics of low-grade neoplasms with recurrence, invasion, and metastatic potential. Our report emphasizes the importance of determining a treatment plan as soon as possible based on an accurate diagnosis to improve the prognosis of this disease.

7.
Surg Case Rep ; 9(1): 205, 2023 Nov 28.
Article in English | MEDLINE | ID: mdl-38015377

ABSTRACT

BACKGROUND: Primary angiosarcomas of the breast are rare and highly aggressive. We herein report a rare case of multiple angiosarcomas detected concurrently in both breasts. CASE PRESENTATION: A 49-year-old woman visited a doctor after noticing a lump in her right breast. At that time, mammography and ultrasonography revealed no abnormal findings in either breast. She was referred to our hospital 5 months later, because screening mammography had revealed a focal asymmetric density in her right breast. Ultrasonography showed ill-defined hyper- and hypo-echoic lesions in both breasts. Magnetic resonance imaging disclosed five heterogeneously enhanced masses (5.8 cm in maximum diameter) in the right breast and six enhanced masses (approximately 1-3 cm in diameter) in the left breast. Histological examination of core needle biopsies revealed proliferation of irregularly shaped vascular channels lined by atypical endothelial cells throughout the adipose tissue and lobules of the breasts, leading to a diagnosis of well-differentiated angiosarcoma. The lesions were assumed to be primary angiosarcomas, because she had neither a history of breast surgery nor of radiation therapy. She underwent bilateral mastectomies and postoperative chest wall irradiation. Computed tomography 11 weeks after the surgery revealed multiple, small, subcutaneous nodules in the chest wall that were suspected of being angiosarcoma metastases. We started chemotherapy (weekly paclitaxel 80 mg/m2), which achieved shrinkage of these nodules within 2 months. CONCLUSIONS: Early diagnosis, immediate initiation of local and systemic therapies, and intensive follow-up are important in improving the prognosis of angiosarcomas.

8.
Cancer Sci ; 103(3): 491-6, 2012 Mar.
Article in English | MEDLINE | ID: mdl-22136317

ABSTRACT

The present study examined long-term efficacy outcomes in a subgroup of postmenopausal, estrogen receptor-positive Japanese breast cancer patients from the Pre-Operative "Arimidex" Compared with Tamoxifen trial, following pre-operative (3 months) and post-operative (5 years) adjuvant treatment with either anastrozole or tamoxifen. Patients with large, potentially operable, locally-advanced breast cancer were randomized to receive anastrozole (1 mg/day) plus tamoxifen placebo or tamoxifen (20 mg/day) plus anastrozole placebo pre-operatively. After surgery at 3 months, patients continued on the same study medication as adjuvant therapy for up to 5 years or until recurrence, intolerable toxicity or withdrawal of patient consent. Recurrence-free survival and overall survival were measured from the date of randomization to the date of recurrence or death, whichever occurred first. Patients were monitored for adverse events throughout the study period and up to 30 days following administration of the last study medication. During post-operative adjuvant therapy, 4/48 (8%) anastrozole and 25/49 (51%) tamoxifen patients experienced recurrence. There was a significant difference in recurrence-free survival between the two groups (hazard ratio 0.14; 95% confidence interval 0.05-0.41; P = 0.0003). There was a significant increase in overall survival with anastrozole (0.21; 0.05-0.96; P = 0.0436) and there were 2/48 (4%) and 10/49 (20%) deaths with anastrozole and tamoxifen, respectively. Most patients responding to pre-operative therapy remained recurrence-free. Sequential pre-operative/post-operative treatment with anastrozole resulted in lower recurrence and death rates, compared with tamoxifen.


Subject(s)
Antineoplastic Agents, Hormonal/administration & dosage , Breast Neoplasms/drug therapy , Nitriles/administration & dosage , Tamoxifen/administration & dosage , Triazoles/administration & dosage , Adult , Aged , Aged, 80 and over , Anastrozole , Asian People , Breast Neoplasms/mortality , Chemotherapy, Adjuvant/methods , Disease-Free Survival , Double-Blind Method , Female , Humans , Kaplan-Meier Estimate , Middle Aged , Neoadjuvant Therapy/methods , Postoperative Period
9.
Gan To Kagaku Ryoho ; 39(7): 1075-9, 2012 Jul.
Article in Japanese | MEDLINE | ID: mdl-22790042

ABSTRACT

We evaluated the efficacy and safety of the epirubicin plus docetaxel(ET)regimen, which is a combination of active agents given to patients with inflammatory breast cancer(IBC)as a primary therapy. Nineteen patients received ET(60, 60mg/m2) every 3 weeks for 4 courses, and appropriate surgery was offered unless disease progression occurred. Seventeen patients completed the ET regimen and 1 patient was excluded because of no diffuse erythema, leaving 18 patients evaluable for the response and safety profile of this regimen. Grade 3/4 hematological toxicities were neutropenia in 15 patients(79%), febrile neutropenia in 8 patients(42%)and anemia in 3 patients(16%). Six patients(63%)received granulocyte colony-stimulating factor for febrile neutropenia. Febrile neutropenia was observed only for 1 course in all 6 patients and progression to apparent infection was not observed. Grade 3/4 non-hematological toxicities were constipation in 3, nausea in 2, anorexia in 2, fatigue in 1, vomiting in 1, diarrhea in 1, and stomatitis in 1 patient. The ET regimen was given to 16 patients(89%)as planned. The median number of courses was 4(range: 2-4). The clinical response rate was 44%. The median time to progression was 9 months, and median overall survival was 26 months. It is concluded that the ET regimen was well tolerated and effective as a primary chemotherapy for IBC.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Inflammatory Breast Neoplasms/drug therapy , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Combined Modality Therapy , Docetaxel , Epirubicin/administration & dosage , Epirubicin/adverse effects , Female , Humans , Inflammatory Breast Neoplasms/surgery , Middle Aged , Taxoids/administration & dosage , Taxoids/adverse effects
10.
Gan To Kagaku Ryoho ; 39(5): 747-52, 2012 May.
Article in Japanese | MEDLINE | ID: mdl-22584325

ABSTRACT

This study examined the efficacy and tolerability of docetaxel(DOC)in combination with epirubicin(EPI)as the first-line treatment for patients with advanced and recurrent breast cancer. A total of 56 female patients with metastatic breast cancer not previously treated for metastatic disease received DOC(60mg/m²)and EPI(60mg/m2)on day 1 every 3 weeks. The patient characteristics included a median age of 53 years. Advanced disease was present in 86% of patients, and recurrent disease was found in 14%; 3 or more metastatic sites had been diagnosed in 38% of patients, and 59% patients were ER+. The median number of courses administered was 6. The median dose intensity was 18. 7mg/m²week for DOC and EPI, and the relative dose intensities were 93. 5%and 93. 3%, respectively. The clinical responses included a complete response in 5%, a partial response in 54%, and stable disease in 33% of patients, with a disease control rate of 92%. The progression-free survival was 78. 3%, and the overall survival was 91. 9% at 1 year. Grade 3/4 toxicities included neutropenia in 82%, leukopenia in 71%, febrile neutropenia in 16%, anorexia in 9%, and anemia in 7%of the patients. Neither congestive heart failure nor toxic death occurred. The D and E combination with doses of 60mg/m2 is an active and generally well-tolerated regimen that can be used as first-line chemotherapy for patients with metastatic breast cancer.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/pathology , Docetaxel , Epirubicin/administration & dosage , Epirubicin/adverse effects , Female , Humans , Middle Aged , Neoplasm Metastasis/drug therapy , Recurrence , Taxoids/administration & dosage , Taxoids/adverse effects
11.
Breast Cancer Res Treat ; 128(3): 775-81, 2011 Aug.
Article in English | MEDLINE | ID: mdl-21638048

ABSTRACT

The potential long-term adverse effects on quality of life have to be considered when selecting agents for adjuvant hormonal treatment for postmenopausal patients with estrogen receptor-positive breast cancer. We performed a 2-year multicenter randomized study to assess the differences in the time course effects between toremifene (TOR) and anastrozole (ANA) on serum lipid profiles and bone metabolism. This study assessed the serum levels of triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein A-1 (Apo A1), and apolipoprotein B (Apo B) as lipid profiles and bone-specific alkaline phosphatase (BAP) and the N-telopeptide of type-I collagen (NTX) as bone turnover markers in patients who received daily doses of 40 mg and 1 mg for TOR and ANA, respectively. A decreased serum level of TC, LDL-C, and Apo B was, respectively, observed at 6 months in 6.2, 12.9, and 13.8% of the patients who received TOR compared with the baseline. These decreases were maintained for at least 24 months. These lipid levels were not changed in those who received ANA. In the TOR patients, there was an increase in the serum level of HDL-C and Apo A1 at 6 months in 17.1 and 16.3%, respectively, which was maintained for at least 24 months, whereas these levels were almost stable in the patients who received ANA. Serum BAP decreased by 12.1% at 12 months and further decreased at 24 months and the serum NTX decreased by 22.0% at 6 months, which was maintained for at least 24 months in the patients who received TOR. In contrast, the serum BAP was increased by 26.0% at 6 months and by 29.2% at 12 months and the serum NTX increased by 21.3% at 24 months compared with baseline in those received ANA. However, the serum BAP increase was not significant at 24 months. TOR provides better effects than ANA in terms of lipid profiles and bone metabolism in postmenopausal females with early breast cancer.


Subject(s)
Antineoplastic Agents, Hormonal , Bone and Bones , Breast Neoplasms , Lipids/blood , Nitriles , Receptors, Estrogen/metabolism , Toremifene , Triazoles , Adult , Aged , Aged, 80 and over , Anastrozole , Antineoplastic Agents, Hormonal/pharmacology , Antineoplastic Agents, Hormonal/therapeutic use , Bone and Bones/drug effects , Bone and Bones/metabolism , Breast Neoplasms/blood , Breast Neoplasms/drug therapy , Breast Neoplasms/metabolism , Female , Humans , Lipid Metabolism/drug effects , Middle Aged , Nitriles/pharmacology , Nitriles/therapeutic use , Postmenopause , Toremifene/pharmacology , Toremifene/therapeutic use , Triazoles/pharmacology , Triazoles/therapeutic use
12.
Breast Cancer Res Treat ; 121(2): 379-87, 2010 Jun.
Article in English | MEDLINE | ID: mdl-20390343

ABSTRACT

Clinical trials conducted in Western countries have shown that aromatase inhibitors are associated with better disease-free survival (DFS) than tamoxifen in postmenopausal early breast cancer. Because pharmacogenetic differences in drug-metabolizing genes may cause ethnic differences, assessment of the efficacy and tolerability of aromatase inhibitors in non-white women is warranted. This open-label, randomized clinical trial included 706 postmenopausal Japanese women with hormone-receptor-positive breast cancer, who had received tamoxifen for 1 to 4 years as adjuvant therapy. This study was closed early after entry of approximately 28% of the initially planned patients. They were randomly assigned to either switch to anastrozole or to continue tamoxifen for total treatment duration of 5 years. Primary endpoints were DFS and adverse events. At a median follow-up of 42 months, the unadjusted hazard ratio was 0.69 (95% confidence interval, 0.42-1.14; P = 0.14) for DFS and 0.54 (95% CI, 0.29-1.02; P = 0.06) for relapse-free survival (RFS), both in favor of anastrozole. The incidence of thromboembolic events in the tamoxifen group and bone fractures in the anastrozole group was not excessively high. Switching from tamoxifen to anastrozole was likely to decrease disease recurrence in postmenopausal Japanese breast cancer patients. Ethnic differences in major adverse events may be attributable to a low baseline risk of these events in Japanese.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Nitriles/administration & dosage , Tamoxifen/administration & dosage , Triazoles/administration & dosage , Anastrozole , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Chemotherapy, Adjuvant , Disease-Free Survival , Female , Humans , Japan , Kaplan-Meier Estimate , Neoplasm Staging , Nitriles/adverse effects , Postmenopause , Tamoxifen/adverse effects , Triazoles/adverse effects
13.
Anticancer Drugs ; 21(4): 453-8, 2010 Apr.
Article in English | MEDLINE | ID: mdl-20075712

ABSTRACT

Capecitabine (Xeloda, X) and cyclophosphamide (C) can be given orally and they have synergistic effects with nonoverlapping toxicities in preclinical studies. A phase I study of the XC combination therapy was conducted in patients with metastatic breast cancer (MBC) and determined the recommended dose and schedule of 1657 mg/m/day capecitabine and 65 mg/m/day cyclophosphamide given orally for 2 weeks at a 3-week interval. A phase II study of the oral XC regimen was then conducted. This study enrolled patients with HER2-negative MBC who were earlier treated with anthracyclines. XC was given at the recommended doses on a 3-week schedule for at least six courses unless disease progression or unacceptable toxicities occurred. The primary endpoint was the response rate. Progression-free survival, overall survival, and adverse events were investigated as secondary endpoints. Forty-eight patients with the median age of 58 (range 32-72 years) years were registered. Three patients withdrew by choice before starting the treatment. A complete response was obtained in two of the 45 evaluable patients, and partial response in 14, resulting in an overall response rate of 35.6%. The median progression-free survival and overall survival were 199 (115-231) days and 677 (437 approximately ) days, respectively. Grade 3 neutropenia and leukopenia developed in 11%, and that of anemia and thrombocytopenia in 2% patients. Nonhematological toxicities were mild. Hand--foot syndrome was observed in 14 patients but no one had grade 3-4 toxicity. Oral XC combination is effective with acceptable toxicities in patients with MBC.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Cyclophosphamide/therapeutic use , Deoxycytidine/analogs & derivatives , Fluorouracil/analogs & derivatives , Administration, Oral , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Capecitabine , Cyclophosphamide/administration & dosage , Cyclophosphamide/adverse effects , Deoxycytidine/administration & dosage , Deoxycytidine/adverse effects , Deoxycytidine/therapeutic use , Disease-Free Survival , Dose-Response Relationship, Drug , Drug Synergism , Female , Fluorouracil/administration & dosage , Fluorouracil/adverse effects , Fluorouracil/therapeutic use , Humans , Middle Aged , Neoplasm Metastasis
14.
Jpn J Clin Oncol ; 40(8): 811-4, 2010 Aug.
Article in English | MEDLINE | ID: mdl-20462978

ABSTRACT

This randomized controlled trial will compare oral 5-fluorouracil derivatives, TS-1, with intravenous standard chemotherapy such as taxanes in women with metastatic or recurrent breast cancer. Patients with hormone-resistant breast cancer are assigned to either TS-1 (40-60 mg twice daily for 28 consecutive days, followed by a 14-day rest period) or standard chemotherapy (docetaxel 60-75 mg/m(2) at 3- or 4-week intervals, paclitaxel 175 mg/m(2) at 3- or 4-week intervals or paclitaxel 80-100 mg/m(2) weekly, followed by a 1-week rest period). Treatment will be repeated until tumor progression or > or =4 courses for TS-1 and > or =6 courses for taxanes. The primary endpoint is overall survival. Secondary endpoints are progression-free survival, time to treatment failure, adverse events, health-related quality of life and cost-effectiveness. A threshold hazard ratio of 1.333 will be used to determine whether overall survival in the TS-1 group is equivalent (not inferior) to that in the taxane group. The target number of registered patients is 600.


Subject(s)
Breast Neoplasms/drug therapy , Neoplasm Recurrence, Local/drug therapy , Oxonic Acid/therapeutic use , Paclitaxel/administration & dosage , Taxoids/administration & dosage , Tegafur/therapeutic use , Administration, Oral , Adult , Aged , Antimetabolites, Antineoplastic/therapeutic use , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/economics , Breast Neoplasms/economics , Breast Neoplasms/mortality , Cost-Benefit Analysis , Disease Progression , Disease-Free Survival , Docetaxel , Drug Administration Schedule , Drug Combinations , Female , Humans , Middle Aged , Neoplasm Metastasis , Quality of Life , Survival Rate
15.
Anticancer Res ; 40(8): 4779-4785, 2020 Aug.
Article in English | MEDLINE | ID: mdl-32727805

ABSTRACT

BACKGROUND/AIM: Irinotecan is rarely used on the metastatic breast cancer (MBC) setting. S-1 is an oral mixture of tegafur, gimeracil and oteracil. We conducted this pilot study to assess efficacy and safty of chemotherapy with combined irinotecan and S-1 (IRIS). PATIENTS AND METHODS: Irinotecan was given intravenously at 80 mg/m2 on days 1 and 8 and S-1 was given orally at 80-120 mg/day depending on body surface area for 2 weeks, repeating the cycle every 3 weeks. RESULTS: Twenty-two patients were enrolled in the study. Median age was 50.5 years (range=26-72). Nineteen patients were evaluable for response. Median overall survival and progression-free survival were 672 days (95% CI=420-967) and 166 days (95% CI=76-814), respectively. CONCLUSION: The IRIS regimen has an acceptable safety profile and modest efficacy against MBC in patients previously heavily treated with chemotherapy. This regimen has potential to treat MBC.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Adult , Aged , Disease-Free Survival , Drug Combinations , Female , Humans , Irinotecan/therapeutic use , Middle Aged , Oxonic Acid/therapeutic use , Pilot Projects , Progression-Free Survival , Tegafur/therapeutic use
16.
Chemotherapy ; 54(5): 379-85, 2008.
Article in English | MEDLINE | ID: mdl-18758179

ABSTRACT

BACKGROUND: Anthracyclines and taxanes are major cytotoxic drugs against breast cancer. To develop a combination of epirubicin (EPI) and docetaxel (DTX) in Japan, dose escalation and pharmacokinetic studies were performed in patients with advanced or recurrent breast cancer. METHODS: Twenty patients received EPI (40, 50 or 60 mg/m(2)) as 5-min intravenous infusion, followed by DTX infusion (50 or 60 mg/m(2)) over 1 h in cohorts of 3-6 patients. The maximum tolerated dose (MTD) was defined during the first cycle when more than 2 of 3 or 3 of 6 patients suffered a dose-limiting toxicity (DLT). The DLT was based on febrile neutropenia (FN), prolonged neutropenia, thrombocytopenia and grade 3-4 nonhematological toxicity during the first cycle. Plasma sampling was performed to assess the pharmacokinetic study of these drugs. RESULTS: The second level (EPI/DTX 50/50 mg/m(2)) was found to be a maximum tolerated dose because of a short duration of FN with no distress. Subsequently, the protocol was modified to permit a new DLT definition including FN lasting for more than 72 h. At the following levels of EPI/DTX 50/50, 50/60 or 60/60 mg/m(2), the dose escalation study revealed a high incidence of grade 4 neutropenia (100%) and FN (67%), which did not reach DLT. However, the safety committee decided not to go further because of too high an incidence of FN lasting 3 days, although a little less than 72 h. The pharmacokinetic study with a combination of EPI and DTX showed comparable blood levels of DTX and EPI in relation to those seen when given alone. CONCLUSION: For further evaluation, the recommended dose and schedule of this combination is EPI 60 mg/m(2) and DTX 60 mg/m(2), given every 3 weeks to patients without prior chemotherapy and EPI 50 mg/m(2) and DTX 50 mg/m(2) given to patients with prior chemotherapy, respectively. The pharmacokinetic study indicates no interaction between EPI and DTX.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Epirubicin/therapeutic use , Neoplasm Recurrence, Local/drug therapy , Neoplasm Recurrence, Local/pathology , Taxoids/therapeutic use , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics , Docetaxel , Dose-Response Relationship, Drug , Epirubicin/adverse effects , Epirubicin/pharmacokinetics , Female , Humans , Middle Aged , Neoplasm Staging , Taxoids/adverse effects , Taxoids/pharmacokinetics
17.
Gan To Kagaku Ryoho ; 35(7): 1217-20, 2008 Jul.
Article in Japanese | MEDLINE | ID: mdl-18633267

ABSTRACT

In October 2004, a 73-year-old man underwent loop ileostomy because of unresectable peritoneal disseminated sigmoid colon cancer with liver metastasis. The oral chemotherapy by S-1 was administered(80 mg/day for 4 weeks followed by a 2-week rest period). A half year later, the primary lesion was remarkably diminished on barium enema, and peritoneal dissemination and liver metastasis disappeared on CT. Because he was unwilling to have an ileostomy, we decided to resect the primary lesion and close the ileal stoma in May 2005. There was no obvious peritoneal dissemination, and operation was successful. He died without intestinal stoma one year after second operation. This therapy can be orally administered at home, and is considered to be useful from the viewpoint of QOL as well. S-1 is expected to be an effective agent for the treatment of colon cancer.


Subject(s)
Liver Neoplasms/drug therapy , Liver Neoplasms/secondary , Oxonic Acid/therapeutic use , Peritoneal Neoplasms/drug therapy , Peritoneal Neoplasms/secondary , Sigmoid Neoplasms/drug therapy , Sigmoid Neoplasms/pathology , Tegafur/therapeutic use , Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Biomarkers, Tumor/blood , Drug Combinations , Humans , Liver Neoplasms/blood , Liver Neoplasms/diagnostic imaging , Male , Peritoneal Neoplasms/blood , Peritoneal Neoplasms/diagnostic imaging , Sigmoid Neoplasms/blood , Sigmoid Neoplasms/surgery , Tomography, X-Ray Computed , Treatment Failure
18.
Gan To Kagaku Ryoho ; 35(8): 1399-401, 2008 Aug.
Article in Japanese | MEDLINE | ID: mdl-18701858

ABSTRACT

A 69-year-old female patient underwent a choledochojejunostomy for unresectable duodenal papilla cancer with para-aortic lymph node metastases. Both tegafur-uracil(UFT) and cyclophosphamide were given orally every day after surgery. Twenty-eight months from the initiation of the chemotherapy the tumor had remarkably reduced and the objective response was evaluated as a PR. The patient is now doing well. Lymph node metastasis is considered an important prognostic factor of papilla Vater carcinoma, and especially with para-aortic lymph node metastases the long-term prognosis is poor. Combination chemotherapy using UFT and cyclophosphamide would be a therapeutic option for elderly or high-risk patients.


Subject(s)
Adenoma/drug therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Cyclophosphamide/therapeutic use , Duodenal Neoplasms/drug therapy , Tegafur/therapeutic use , Uracil/therapeutic use , Adenoma/pathology , Administration, Oral , Aged , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Biomarkers, Tumor/blood , Cyclophosphamide/administration & dosage , Duodenal Neoplasms/blood , Duodenal Neoplasms/diagnostic imaging , Duodenal Neoplasms/pathology , Duodenoscopy , Female , Humans , Tegafur/administration & dosage , Time Factors , Tomography, X-Ray Computed , Uracil/administration & dosage
19.
Gan To Kagaku Ryoho ; 35(9): 1519-23, 2008 Sep.
Article in Japanese | MEDLINE | ID: mdl-18799904

ABSTRACT

We evaluated the feasibility of epirubicin plus cyclophosphamide(EC)followed by weekly paclitaxel (wPTX) as an adjuvant therapy for node-positive breast cancer in a variety of practice settings. Thirty-two patients received EC (twenty-two: 75, 600 mg/m(2), ten: 90, 600 mg/m(2))every 3 weeks for 4 cycles. Twenty-eight of them received wPTX for 4 cycles subsequently, which were 3 consecutive weekly administrations with a following week pause per cycle. Grade 3 or 4 hematologic toxicity included leukopenia(5 for E75C600, 6 for E90C600, 2 for wPTX), neutropenia(6 for E75C600, 8 for E90C600, 4 for wPTX), febrile neutropenia (1 for E90C600), anemia (1 for wPTX), and GOT/GPT elevation (1 for wPTX). Non-hematologic toxicity of more than grade 3 was not seen. There were seven treatment discontinuations, including four patients' refusal, two allergic reactions to paclitaxel, and one liver dysfunction. EC followed by wPTX can be safely performed with a little toxicity at doses of 75/90 mg/m(2), 600 mg/m(2) and 80 mg/m(2), respectively.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Cyclophosphamide/therapeutic use , Epirubicin/therapeutic use , Paclitaxel/therapeutic use , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/epidemiology , Chemotherapy, Adjuvant/adverse effects , Cyclophosphamide/adverse effects , Epirubicin/adverse effects , Feasibility Studies , Female , Humans , Japan , Lymphatic Metastasis/pathology , Middle Aged , Paclitaxel/adverse effects , Time Factors
20.
Breast Cancer ; 25(4): 470-478, 2018 Jul.
Article in English | MEDLINE | ID: mdl-29460095

ABSTRACT

BACKGROUND: Breast carcinoma arising in a benign fibroepithelial tumor is rare, and is usually discovered incidentally during examination of the breast mass. METHODS: We evaluated the clinicopathological features, treatment, and prognosis of seven women with breast carcinomas within benign fibroepithelial tumors, diagnosed and treated at a single institution between 2011 and 2015. RESULTS: Seven women, aged 21-64 years, visited our hospital complaining of a breast mass detected by self-checking or screening examination. All patients had well-demarcated movable breast masses. Ultrasonography showed circumscribed masses suggesting benign tumors in all cases, and mammography revealed well-defined, high-density masses, with or without calcification. The masses progressed in two patients. A preoperative histological diagnosis of carcinoma was made following needle biopsy in four patients. Tumorectomy, breast-conserving surgery, and mastectomy were performed in three, two, and two patients, respectively. One patient underwent lymph node dissection and another underwent sentinel node biopsy. Histologically, the masses were diagnosed as invasive ductal carcinoma, ductal carcinoma in situ or lobular carcinoma in situ, arising in a benign phyllodes tumor, fibroadenoma, or fibroadenomatoid mastopathy. Lymph node metastasis was detected in two patients. There was no recurrence in any of the patients. CONCLUSIONS: Although a carcinoma within a preexisting benign fibroepithelial tumor is extremely rare, it is important to be aware of the possibility of invasive and metastatic disease.


Subject(s)
Breast Neoplasms/diagnosis , Breast Neoplasms/surgery , Neoplasms, Fibroepithelial/diagnosis , Neoplasms, Fibroepithelial/surgery , Adult , Biopsy, Large-Core Needle , Breast Neoplasms/pathology , Carcinoma, Intraductal, Noninfiltrating/diagnosis , Carcinoma, Intraductal, Noninfiltrating/pathology , Carcinoma, Intraductal, Noninfiltrating/surgery , Female , Fibroadenoma/diagnosis , Fibroadenoma/pathology , Fibroadenoma/surgery , Humans , Mastectomy , Mastectomy, Segmental , Middle Aged , Neoplasms, Fibroepithelial/pathology , Phyllodes Tumor/diagnosis , Phyllodes Tumor/pathology , Phyllodes Tumor/surgery , Ultrasonography, Mammary
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