Biomedical subjects

Hideo Inaji

Publications and source records attributed to Hideo Inaji.

30 records · Page 2Linked to original sources

PubMed2003

Phase II study of concurrent administration of doxorubicin and docetaxel as first-line chemotherapy for metastatic breast cancer.

OBJECTIVE: To evaluate the efficacy and toxicity of concurrent administration of doxorubicin and docetaxel, without prophylactic use of granulocyte colony-stimulating factor, as first-line chemotherapy in patients with metastatic breast cancer (MBC). METHODS: This multi-institutional study enrolled 40 women; 37 were assessable for efficacy and all 40 patients were evaluated for toxicity. Treatment consisted of 50 mg/m(2) doxorubicin and 60 mg/m(2) docetaxel on day 1 every 3-4 weeks. RESULTS: Patients received a total of 251 cycles of chemotherapy (median, 5 cycles; range, 1-13 cycles). Of the 37 patients assessable for efficacy, 2 had a complete response and 24 had partial responses, which accounted for a 70% objective response rate (95% confidence interval, 53-84%). The median time to treatment failure was 30.1 weeks (range, 3.3-80.7 weeks). Grade 4 neutropenia was observed in 88% of patients and was the most frequent haematological toxicity. Febrile neutropenia was seen in 40% of patients, but no severe infections were observed. Non-haematological toxicity was generally tolerable. There were 2 grade 4 adverse events, which included 1 bleeding duodenal ulcer and 1 hypersensitivity reaction, but grade 3 episodes were infrequent. None of the patients developed congestive heart failure or asymptomatic decrease of left ventricular ejection fraction to less than 50%. Fluid retention syndrome <or= grade 2 was observed in 25% of patients at a median cumulative dose of docetaxel of 270 mg/m(2). CONCLUSION: Concurrent administration of 50 mg/m(2) doxorubicin and 60 mg/m(2) docetaxel is active with a manageable toxicity profile as first-line chemotherapy for MBC.

Adult↗

PubMed2002

Prediction of chemotherapeutic response by collagen gel droplet embedded culture-drug sensitivity test in human breast cancers.

Collagen gel droplet embedded culture-drug sensitivity test (CD-DST) is the newly developed in vitro chemosensitivity test that has several advantages over the conventional ones. The aim of the present study is to examine the clinical usefulness of this test in the prediction of response to chemotherapy in breast cancer patients. Seventy patients with primary (n = 45) or locally recurrent (n = 25) breast cancers were recruited, and each patient underwent tumor biopsy before chemotherapy. The biopsy specimens were used for CD-DST and immunohistological examination of 6 biological markers (P-gp, erbB2, p53, BCL2, MIB1 and ER-alpha). As chemotherapy, cyclophosphamide 600 mg/m(2) plus epirubicin 60 mg/m(2) q3w (CE, n = 28) or docetaxel 60 mg/m(2) q3w (DOC, n = 42) was given. Interpretable results using the CD-DST assay were obtained from 84.3% (59/70) of tumor specimens studied. Of the 18 tumors diagnosed as CE sensitive by CD-DST, 15 (83.3%) exhibited a response to CE therapy and none of the 5 tumors diagnosed as CE resistant by CD-DST exhibited a response to CE therapy. Of the 14 tumors diagnosed as DOC sensitive by CD-DST, 13 (92.9%) exhibited a response to DOC therapy and only one of the 22 tumors diagnosed as DOC resistant by CD-DST exhibited a response to DOC therapy. P-gp expression was found to exhibit a significant (p < 0.05) association with the resistance to CE therapy but not to DOC therapy. Diagnostic accuracy (72.7%) achieved by P-gp was lower than that (87.0%) achieved by CD-DST in CE therapy. Expressions of other biological markers (erbB2, p53, BCL2, MIB1 and ER-alpha) were not significantly associated with response to CE or DOC therapy. These results demonstrate that CD-DST can predict the response to CE and DOC therapy with a high accuracy in breast cancer patients and seems to be superior to the conventional predictors.

Adult↗

PubMed2002

Breast-conserving treatment after neoadjuvant chemotherapy in large breast cancer.

Several recent trials have demonstrated that neoadjuvant chemotherapy can allow more patients to successfully undergo breast-conserving treatment (BCT), and does not confer a survival disadvantage compared with standard adjuvant chemotherapy. In addition, the pathological response of primary breast tumors to neoadjuvant chemotherapy appears to be a surrogate marker for patient outcome. In our series, during the period from May 1995 to December 2000, 86 patients with tumors between 3.1 and 6.0 cm in diameter received epirubicin-based neoadjuvant chemotherapy. There were 55 (64.0%) responders and ultimately 64 patients (74.4%) were treated with BCT. The margin positive rate was 14.1%(9/64), similar to the rate after BCT for early-stage breast cancers, the largest diameter of which was smaller than 3 cm. At a median follow-up of 30 months, only 3 patients in the BCT group have developed local recurrence; the local recurrence rate appears to be comparable to that after BCT for early stage breast cancers. Long term follow-up is required, however, to establish whether this procedure is a safe alternative to mastectomy for patients with large breast cancers.

Antineoplastic Agents↗

PubMed2002

Long-term results of breast conserving surgery for stages I and II breast cancer: experiences at Osaka Medical Center for Cancer and Cardiovascular Diseases.

PURPOSE: The purpose of this study is to summarize the long-term results of breast conserving surgery (BCS) for Japanese patients with stage I and II breast cancer at a single institute and to identify risk factors for local recurrence after BCS. PATIENTS AND METHODS: Between October 1986 and June 2000, 979 women underwent BCS with or without radiation therapy (RT). Overall survival, disease free survival and local recurrence rates were calculated by the Kaplan-Meier method. Risk factors for local recurrence were examined by multivariate analysis using the Cox proportional regression model. RESULTS: The 10-year overall survival rates were 90.9% for the surgery and radiation therapy (RT group) and 89.3% for the surgery only group with a median follow-up time of 46 months. The 10-year disease free survival rates were 85.1% in the RT group and 69.2% in the surgery only group (p=0.0001). The positive margin rate was 14.1% (138/979). The 10-year overall survival rate of the patients with positive margins was 87.9%, compared with 90.8% for patients with negative margins (N.S.). The cumulative incidence of local recurrence at 10 years was significantly lower in the RT group (7.2% ) than in the surgery only group (27.5% ) (p<0.0001). Multivariate analysis showed that positive margins and lack of post-operative irradiation or adjuvant endocrine therapy were risk factors for non-inflammatory local recurrence. CONCLUSIONS: Our study indicates that BCS can be performed for Japanese women with early breast cancer. The margin status and post-operative irradiation had no influence on overall survival while but were significantly related to local recurrence.

Adult↗

PubMed2002

Sentinel node biopsy to avoid axillary lymph node dissection in breast cancer.

The role of sentinel node biopsy in breast cancer has increased over the last few years. Sentinel nodes can predict the status of all axillary lymph nodes precisely and select patients with negative nodes for whom axillary dissection is unnecessary. Many problems remain, such as the ideal injection technique, ideal agents, and ideal histological detection of sentinel node metastases, and must be addressed before sentinel node biopsy becomes the standard of care for patients with breast cancer.

Axilla↗

PubMed2002

Patient age affects identification rate of sentinel nodes in breast cancer.

BACKGROUND: The aim of this study was to investigate whether clinicopathological features affect the success rate of identifying sentinel nodes using a combination method of dye and radioisotope in breast cancer patients. METHODS: Sentinel node biopsy was performed in patients (n = 154) with stage I and II breast cancer using a combination method. The association between the clinicopathological features of breast cancer and the success rate in the identification of sentinel nodes was investigated. RESULTS: Sentinel nodes were successfully identified in 147 (95.5%) of the 154 patients. There was a concordance between the sentinel-node and axillary-node status in 146 (99.3%) of 147 cases. The false negative rate of the sentinel node biopsy was 2.4% (1/42). The identification rate of sentinel nodes was significantly (P = 0.005) lower in patients > or = 60 years (84.4%) than in those < 60 years (98.4%). The tumor size, histological node status, lympo-vascular invasion, history of previous surgical biopsy, operative procedure, tumor location, and histological type were not related with the identification rate of sentinel nodes. The mean count ratio of all hot nodes was 14.0 (range 2.0-73.6) in patients > or = 60 years and 73.4 (2.0-1700.6) in patients < 60 years, and this difference was statistically significant (P < 0.0001). In addition, the mean number of sentinel nodes was significantly (P = 0.0006) lower in patients > or = 60 years (1.3; range one to four) than in patients < 60 years (2.1; range one to 12). CONCLUSIONS: Patient age affects the identification rate of sentinel nodes using a combination method in breast cancer.

Adult↗

PubMed2002

[The role of neoadjuvant chemotherapy for breast cancer treatment].

Neoadjuvant chemotherapy is being used increasingly in the management of patients with breast cancer, especially locally advanced cases. Such treatment is administered with the aim of of reducing the size of the primary tumor to increase the possibility of breast-conserving treatment (BCT). In our series, during the period from May 1995 to December 2000, 86 patients with tumors between 3.1 and 6.0 cm in diameter received epirubicin-based neoadjuvant chemotherapy. There were 55 (64.0%) responders and ultimately 64 patients (74.4%) were treated with BCT. With a median follow-up time of 39 months, 9 patients in the BCT group had developed local recurrence. Long-term follow-up is required to establish whether this procedure is a safe alternative to mastectomy for patients with large breast cancers.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2002

[Assessment of complications in a randomized controlled study on multimodality therapy for patients following breast-conserving surgery: Kansai Breast Cancer Radiotherapy Research Group (5'-KBR)].

PURPOSE: We conducted a randomized controlled study to evaluate the safety and usefulness of a combined treatment of radiotherapy and chemotherapy with doxifluridine (5'-DFUR) plus tamoxifen (TAM) as an adjuvant therapy for breast cancer patients after conservative surgery. The complications observed in this trial are reported herein. METHODS: A total of 550 patients were registered and randomized (based on factors such as T, N, with/without radiotherapy) to groups A and B. Drug regimens were: group A, 5'-DFUR 600 mg/body/day for 6 months and TAM 20 mg/body/day for 2 years; group B, 5'-DFUR 600 mg/body/day for 2 years and TAM 20 mg/body/day for 2 years. Radiotherapy (2 Gy x 5 times/week, for 5 weeks) was administered to 88.6% of evaluable patients (481/543). Radiation-related acute adverse reactions occurred in 28.5% of the 481 patients and moderate to severe reactions occurred in 1.5% of the patients. Delayed radiation-related adverse reactions occurred in 23.8% of the patients but none were severe. Chemo-endocrine therapy-related adverse reactions occurred in 17.9% of group A patients and 25.6% of group B patients. Grade 3 reactions occurred in 6 of the group A patients (2.4%) and in 5 of the group B patients (1.9%); all adverse reactions subsided after dose reduction or discontinuation. These findings suggest that the combination therapy of irradiation and 5'-DFUR with TAM is safe for patients after breast conserving surgery.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2002

[Late phase II study of exemestane in postmenopausal patients with breast cancer resistant to anti-estrogenic agents].

A multi-center trial of exemestane 25 mg, an oral aromatase irreversible inactivator, was conducted to evaluate its efficacy and safety in 33 postmenopausal patients, and to investigate the pharmacokinetics/serum hormone levels in 16 postmenopausal patients, respectively, with breast cancer and anti-estrogen resistance. Exemestane 25 mg was given once daily for up to 48 weeks (maximum). The objective of this study was to confirm the reproducibility of the results shown in two studies in other countries with similar patients, to investigate the possibility of extrapolating the overseas data to Japanese. The response rate (CR + PR) was 24.2% (8.33%), which exceeded the minimum number (6 cases) required to evaluate efficacy. The response rate in this study was very similar to that observed in the two international open studies. Adverse events (subjective/objective symptoms), in which a causal relationship with exemestane administration could not be excluded, were observed in 26 cases (78.8%). Of these, hot flushes, increased sweating, fatigue, and insomnia occurred in more than 10% of patients, which was similar to that observed in the two international open studies. Abnormal laboratory results occurring in more than 10% of patients, in which a causal relationship with exemestane administration could not be excluded, were as follows: lymphocyte count decrease, alkaline phosphate increase, GOT increase, GPT increase, gamma-GTP increase, triglyceride increase, and inorganic phosphate increase, most of which were either grade 1 or 2. A remarkable decrease in serum hormone concentration was observed only for estrogen. The values of AUC0-infinity at day 1 and AUC0-24 h at day 29 (steady state) were similar, suggesting no accumulative effect of exemestane. These results demonstrate the anti-tumor effect and safety of exemestane in postmenopausal anti-estrogen resistant breast cancer patients. The reproducibility of the results of the two foreign studies was verified in Japanese patients, and it is concluded that the foreign trial data on exemestane can be extrapolated to Japanese.

Adult↗

PubMed2002

[Wide excision as a method of breast-conserving surgery for breast cancer].

Breast-conserving treatment has become the standard treatment for early breast cancer, not only in Western countries but also in Japan. Wide excision is perferred to quadrantectomy because the former results in better cosmesis than the latter. However, the margin status may be positive more frequently in the former than in the latter. The results of our study indicated that positive margins and the absence of radiotherapy or endocrine therapy proved to be independent risk factors for local recurrence. Because margin status influences local control, tumor margins after wide excision should be accurately determined, and higher doses of radiotherapy and adjuvant therapy are indicated for patients with positive margins.

Breast Neoplasms↗

PubMedDate not supplied

Phase II study of weekly paclitaxel for docetaxel-resistant metastatic breast cancer in Japan.

The purpose of the study was to evaluate the efficacy of weekly paclitaxel (PTX) against metastatic breast cancer (MBC) that was resistant to docetaxel (DTX) given every 3 weeks. A multicenter phase II study was performed. Women with MBC resistant to DTX were eligible for enrollment. DTX resistance was defined as no tumor response to DTX and stable disease, partial response, or complete response to DTX preceding disease progression. PTX 80 mg/m(2) was administered over 1 hour once a week for 3 weeks per 4-week cycle. Among 47 enrolled patients, 46 patients were assessable for response and toxicity. The overall objective response rate (complete responses [CRs] and partial responses [PRs]) was 17.4% and overall clinical benefit rate (CRs, PRs, and stable disease >or=24 weeks) was 26.1%. The median time to progression was 11 weeks. There were a few severe hematologic toxicities related to the therapy, with grade 4 neutropenia (4.3%) and thrombocytopenia (2.2%). Grade 3 anaphylaxis and grade 3 neuropathy were observed in one patient (2.2%) each. The median delivered dose intensity was 77.6 mg/m(2)/week, 97.1% of the planned dose intensity. Weekly PTX has activity in patients with MBC resistant to DTX every 3 weeks.

Adult↗

PubMedDate not supplied

Fulvestrant for the treatment of advanced breast cancer in postmenopausal women: a Japanese study.

BACKGROUND: Fulvestrant ('Faslodex') is a new type of oestrogen receptor (ER) antagonist that down-regulates the ER and has no known agonist effects. PATIENTS AND METHODS: In this open-label, Phase II trial, 30 postmenopausal Japanese women with hormone-sensitive advanced breast cancer, who had progressed on tamoxifen/toremifene following an initial response, received fulvestrant (250 mg; once-monthly intramuscular injection). Primary endpoints were objective tumour response rate (complete or partial response) and assessment of tolerability; secondary endpoints included clinical benefit (objective response, or stable disease > or = 24 weeks), duration of response and pharmacokinetic analysis. RESULTS: The objective response rate was 23.3% and 60.0% of patients experienced clinical benefit. Adverse events were generally mild; the most common were pharyngitis (26.7%), headache (23.3%) and nausea (20.0%). Pharmacokinetic data were similar to a Western study of postmenopausal patients. CONCLUSION: Fulvestrant 250 mg/month is effective and well-tolerated in Japanese patients who have relapsed after one prior endocrine treatment.

Adult↗