Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 34
Filter
Add more filters

Country/Region as subject
Affiliation country
Publication year range
1.
Breast Cancer Res Treat ; 196(3): 635-645, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36273358

ABSTRACT

PURPOSE: We aimed to determine the prognosis and potential benefit of postoperative chemotherapy according to subtype of medullary breast carcinoma (MedBC), a very rare invasive breast cancer. METHODS: A cohort of 1518 female patients with unilateral MedBC and 284,544 invasive ductal carcinoma (IDC) cases were enrolled from the Japanese Breast Cancer Registry. Prognosis of MedBC was compared to IDC among patients with estrogen receptor (ER)-negative and HER2-negative subtype (553 exact-matched patients) and ER-positive and HER2-negative subtype (163 MedBC and 489 IDC patients via Cox regression). Disease free-survival (DFS) and overall survival (OS) were compared between propensity score-matched adjuvant chemotherapy users and non-users with ER-negative and HER2-negative MedBC. RESULTS: Among ER-negative and HER2-negative subtype patients, DFS (hazard ratio (HR) 0.45; 95% confidence interval (95% CI), 0.30-0.68; log-rank P < 0.001) and OS (HR 0.51; 95% CI 0.32-0.83; log-rank P = 0.004) were significantly better in MedBC than IDC. Patients treated with postoperative chemotherapy showed better DFS (HR 0.27; 95% CI 0.09-0.80; log-rank P = 0.02) and OS (HR 0.27; 95% CI 0.09-0.80; log-rank P = 0.02) compared to those without. For the ER-positive and HER2-negative subtype, the point estimate for HR for DFS was 0.60 (95% CI 0.24-1.22) while that for OS was 0.98 (95% CI 0.46-1.84) for MedBC. CONCLUSION: In ER-negative and HER2-negative MedBC, the risk of recurrence and death was significantly lower than that of IDC, about half. Postoperative chemotherapy reduced recurrence and mortality. ER-positive and HER2-negative MedBC may have a lower risk of recurrence compared to IDC.


Subject(s)
Breast Neoplasms , Carcinoma, Ductal, Breast , Humans , Female , Receptor, ErbB-2 , Breast Neoplasms/pathology , Carcinoma, Ductal, Breast/drug therapy , Carcinoma, Ductal, Breast/pathology , Prognosis , Chemotherapy, Adjuvant
2.
Acta Med Okayama ; 76(6): 661-671, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36549768

ABSTRACT

Chemotherapy-induced peripheral neuropathy (CIPN) is an important clinical challenge that threatens patients' quality of life. This sub-study of the ABROAD trial investigated the influence of single nucleotide polymorphisms (SNPs) on CIPN, using genotype data from a randomized study to determine the optimal dose of a 3-week-cycle regimen of nab-paclitaxel (q3w nab-PTX) in patients with metastatic breast cancer (MBC). Patients with HER2-negative MBC were randomly assigned to three doses of q3w nab-PTX (SD: 260 mg/m2 vs. MD: 220 mg/m2 vs. LD: 180 mg/m2). Five SNPs (EPHA4-rs17348202, EPHA5-rs7349683, EPHA6-rs301927, LIMK2-rs5749248, and XKR4-rs4737264) were analyzed based on the results of a previous genome-wide association study. Per-allele SNP associations were assessed by a Cox regression to model the cumulative dose of nab-PTX up to the onset of severe or worsening sensory neuropathy. A total of 141 patients were enrolled in the parent study; 91(65%) were included in this sub-study. Worsening of CIPN was significantly greater in the cases with XKR4 AC compared to those with a homozygote AA (HR 1.86, 95%CI: 1.00001-3.46, p=0.049). There was no significant correlation of CIPN with any other SNP. A multivariate analysis showed that the cumulative dose of nab-PTX was most strongly correlated with CIPN (p<0.01).


Subject(s)
Breast Neoplasms , Peripheral Nervous System Diseases , Humans , Female , Breast Neoplasms/drug therapy , Breast Neoplasms/genetics , Breast Neoplasms/pathology , Quality of Life , Genome-Wide Association Study , Taxoids/adverse effects , Peripheral Nervous System Diseases/chemically induced , Peripheral Nervous System Diseases/genetics , Polymorphism, Single Nucleotide , Antineoplastic Combined Chemotherapy Protocols
3.
Acta Med Okayama ; 72(4): 369-374, 2018 Aug.
Article in English | MEDLINE | ID: mdl-30140084

ABSTRACT

The Hormonal therapy resistant estrogen-receptor positive metastatic breast cancer cohort (HORSE-BC) study is a multicenter observational study evaluating the efficacy and safety of secondary endocrine therapy (ET) for postmenopausal cases of metastatic breast cancer (MBC) with poor response to primary ET. In this initial report we analyze the HORSE-BC baseline data to clarify the current status of treatment selection for MBC in Japan. Baseline data for the 50 patients enrolled in HORSE-BC were analyzed, including patient characteristics, types of secondary ET, and reasons for selecting secondary ET. Postoperative recurrence was detected in 84% of patients (42/50) and de novo stage IV breast cancer in 16% (8/50). Forty-one patients (41/50; 82%) received fulvestrant, 5 patients (10%) received selective estrogen receptor modulators (SERMs), 3 patients (6%) received ET plus a mammalian target of rapamycin (mTOR) inhibitor, and 1 patient received an aromatase inhibitor (AI) as the secondary ET. Forty-five patients selected their secondary ET based on its therapeutic effect, while 14 patients selected it based on side effects. Most patients with progression after primary ET selected fulvestrant as the secondary ET based on its therapeutic and side effects. We await the final results from the HORSE-BC study.


Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Breast Neoplasms/drug therapy , Receptors, Estrogen/analysis , Adult , Aged , Aged, 80 and over , Breast Neoplasms/chemistry , Breast Neoplasms/pathology , Cohort Studies , Drug Resistance, Neoplasm , Female , Health Care Costs , Humans , Middle Aged , Neoplasm Metastasis , TOR Serine-Threonine Kinases/antagonists & inhibitors
4.
Gan To Kagaku Ryoho ; 42(8): 1019-21, 2015 Aug.
Article in Japanese | MEDLINE | ID: mdl-26321722

ABSTRACT

The POEMS reportedan effect of goserelin for fertility preservation. The Clinical Practice Guideline for Breast Cancer by The Japanese Breast Cancer Society indicates that the use of the LHRH agonist (LHRHa) for preventing chemotherapy-induced early menopause is a grade C-1 recommendation, and its use for fertility preservation is a grade C-2 recommendation. Results from previous studies on the effects of LHRHa for fertility preservation have varied owing to differences in chemotherapy regimens, definitions of ovarian failure, and dosages of tamoxifen. In the POEMS, the primary endpoint of ovarian failure at 2 years was significantly lower, and the secondary endpoint of pregnancy outcomes was better in the combination group; however, precise interpretation is difficult because many cases were excluded. Currently, it is not necessary to revise The Clinical Practice Guideline; however, desirable results from future studies may allow the recommendation of a specific dosage of LHRHa for fertility preservation.


Subject(s)
Fertility Preservation , Gonadotropin-Releasing Hormone/agonists , Clinical Trials as Topic , Female , Humans , Practice Guidelines as Topic , Pregnancy
5.
Breast Cancer Res Treat ; 148(2): 337-43, 2014 Nov.
Article in English | MEDLINE | ID: mdl-25318924

ABSTRACT

Aromatase inhibitors are superior to tamoxifen as adjuvant therapy in postmenopausal patients with hormone-responsive breast cancer. We report the follow-up efficacy results from the N-SAS BC 03 trial (UMIN CTRID: C000000056) where anastrozole was compared with tamoxifen as adjuvant therapy in postmenopausal Japanese patients with hormone-responsive early breast cancer. The full analysis set contained 696 patients (anastrozole arm, n = 345; tamoxifen arm, n = 351). The log-rank test was used to compare the two groups in terms of disease-free survival (DFS) and relapse-free survival (RFS); Kaplan-Meier estimates were calculated. The treatment effects were estimated by Cox's proportional hazards model. To examine time-varying effect of hazard ratios, we estimated time-varying hazard ratios at time t [HR(t)] using data from time t up to 12 months. After a median follow-up of 98.5 months, hazard ratios (95% CIs) were 0.90 (0.65-1.24; log-rank p = 0.526) for DFS and 0.83 (0.56-1.23; log-rank p = 0.344) for RFS. Hazard ratios (95% CIs) for DFS and RFS up to 36 months were 0.69 (0.40-1.17) and 0.54 (0.27-1.06) and those after 36 months were 1.06 (0.70-1.59) and 1.05 (0.64-1.73), respectively. Time-varying hazard ratios for both DFS and RFS showed that hazard ratios were initially in favor of anastrozole and approached 1.0 at around 36 months. Superior efficacy of anastrozole to tamoxifen suggested by the initial analysis was not confirmed in the present analysis after a long-term follow-up period. Advantage of anastrozole was the greatest immediately after switching from tamoxifen and then decreased thereafter.


Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Biomarkers, Tumor/metabolism , Breast Neoplasms/drug therapy , Neoplasm Recurrence, Local/drug therapy , Nitriles/therapeutic use , Tamoxifen/therapeutic use , Triazoles/therapeutic use , Adult , Aged , Aged, 80 and over , Anastrozole , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Female , Follow-Up Studies , Humans , Immunoenzyme Techniques , Middle Aged , Neoplasm Recurrence, Local/mortality , Neoplasm Recurrence, Local/pathology , Neoplasm Staging , Prognosis , Receptor, ErbB-2/metabolism , Receptors, Estrogen/metabolism , Receptors, Progesterone/metabolism , Survival Rate
6.
EClinicalMedicine ; 74: 102715, 2024 Aug.
Article in English | MEDLINE | ID: mdl-39109189

ABSTRACT

Background: Eribulin prolongs overall survival (OS) of patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC), particularly in later chemotherapy (ChT) treatment. However, the health-related quality of life (HRQoL) and efficacy of first or second-line therapy in eribulin-treated patients remain unknown. Using eribulin in the first- or second-line may demonstrate the non-inferiority of HRQoL compared to S-1, an oral 5-fluorouracil derivative, while maintaining OS. Methods: This randomised, controlled, open-label, phase III trial was conducted at 50 hospitals in Japan. Patients were enrolled from June 2016 and October 2019. Patients with HER2-negative MBC once under or no previous ChT were randomly assigned (1:1) to receive eribulin or S-1. HRQoL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) every six weeks until week 24 and every nine weeks until week 42. The primary endpoint was the deterioration defined as more than 10 points worsening of the general health score of QLQ-C30 or death within one year after randomisation. The secondary endpoints included OS. (Trial ID: UMIN000021398). Findings: Three hundred and two patients were enrolled, with 152 and 148 assigned to the eribulin and S-1 groups, respectively. The questionnaire compliance rate was 85.6%. Risk difference of global health status deterioration through one year wasĀ -0.66% (95% CI:Ā -12.47-11.16; non-inferiority PĀ =Ā 0.077) for eribulin compared to S-1 groups. Median time to first deterioration for global health status score was 5.64 (95% CI: 3.51-8.00) and 5.28 months (95% CI: 3.28-7.80) in the eribulin and S-1 groups, respectively. The median OS was 34.7 and 27.8 months, (HR: 0.72, 95% CI: 0.54-0.96; PĀ =Ā 0.026); the median progression-free survival was 7.57 and 6.75 months in the eribulin and S-1 groups, (HR: 0.88, 95% CI: 0.67-1.16; PĀ =Ā 0.35), respectively. No new adverse events occurred. Interpretation: The time of the first clinical deterioration was similar between the two groups and OS significantly increased in eribulin-treated patients. Funding: This study was funded by CSPOR-BC and Eisai CO., Ltd.

7.
PLoS One ; 17(11): e0278344, 2022.
Article in English | MEDLINE | ID: mdl-36445924

ABSTRACT

BACKGROUND: The HORSE-BC study previously demonstrated that second-line endocrine therapy (ET) for patients with acquired endocrine-resistant metastatic breast cancer (MBC) still provided a clinically meaningful benefit. Herein, we investigated the health-related quality of life (HRQOL) in the HORSE-BC study. METHODS: Patients with acquired endocrine-resistant MBC who were scheduled for second-line ET were recruited. The HRQOL was assessed at baseline, and 1 and 3 months after second-line ET initiation. To investigate the minimally important difference (MID) in the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES), we evaluated the means and standard deviations for the distribution-based method, and differences in the change in HRQOL for the anchor-based method. We also investigated the association between FACT-ES total scores and clinical benefit. RESULTS: Overall, 56 patients were enrolled. Of these, 47 were analyzed. When defined as 1/3 standard deviation estimates based on the distribution method, the calculated MID was 5.9. The MIDs of the FACT-ES total scores based on the anchor method were 7.7 for decline and 4.1 for improvement. The MID decline proportions were 6.1% and 14.7% lower in patients who experienced clinical benefits than in those who did not at 1 and 3 months, respectively. The ratios of MID improvement in patients who experienced clinical benefits were 18.3% and 3.2% higher, respectively; the mean change in the FACT-ES total score from baseline improved in patients who experienced clinical benefits. CONCLUSIONS: Maintaining the HRQOL as determined by FACT-ES may be associated with clinical benefits in patients with acquired endocrine-resistant MBC treated with ET.


Subject(s)
Neoplasms , Quality of Life , Humans , Postmenopause , Cognition
8.
World J Oncol ; 13(4): 216-221, 2022 Aug.
Article in English | MEDLINE | ID: mdl-36128594

ABSTRACT

Background: Combination therapy with cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors and hormonal therapy as the first-line and second-line treatments has already been shown to be effective in patients with hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) in clinical trials. On the other hand, in clinical practice, CDK4/6 inhibitors are used not only as first-/second-line but also as later-line hormonal therapies, or for patients receiving prior chemotherapy in metastatic setting. However, the efficacy and safety of combination therapy in these patients remain unclear. In this study, we evaluate the clinical efficacy and safety of combination therapy with abemaciclib and hormonal therapy for chemotherapy-treated patients with HR+ HER2- MBC. Methods: This multi-institutional prospective cohort study will involve a total of 300 chemotherapy-treated patients with HR+ HER2- MBC. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival, time to treatment failure, response rate, clinical benefit rate, and adverse events. The preplanned subpopulation analysis is the number of chemotherapy regimens for HR+ HER2- MBC (two or less vs. three or more), prior treatment history with CDK4/6 inhibitors other than abemaciclib (presence vs. absence) and menopausal status (pre vs. post). We also planned to determine PFS of the subpopulation treated with abemaciclib as maintenance therapy after chemotherapy. Discussion: In this multi-institutional prospective cohort study, we evaluate the clinical efficacy and safety of combination therapy with abemaciclib and hormonal therapy for chemotherapy-treated patients with HR+ HER2- MBC. We also evaluate this combination therapy as maintenance therapy in patients who respond to early-line chemotherapy.

9.
Breast Cancer ; 29(1): 131-143, 2022 Jan.
Article in English | MEDLINE | ID: mdl-34491513

ABSTRACT

BACKGROUND: To report our findings on quality of life (QoL) in a randomized phase II study to determine the optimal dose of 3-week cycle nab-paclitaxel (q3w nab-PTX) in patients with metastatic breast cancer (MBC). METHODS: Patients with HER2-negative MBC were randomly assigned to three different doses of q3w nab-PTX (SD 260Ā mg/m2 vs. MD: 220Ā mg/m2 vs. LD 180Ā mg/m2). QoL was assessed at baseline and during the second, fourth and sixth courses of treatment using the Functional Assessment of Cancer Therapy-Taxane (FACT-Taxane), Cancer Fatigue Scale (CFS) and EuroQol 5-Dimension (EQ-5D). Comparisons were performed with mixed-model repeated measures (MMRM). RESULTS: A total of 141 patients were enrolled in the parent study, and 136 (96%) (44, 45 and 47 in the SD, MD, and LD groups) were included in the analysis. MMRM analysis showed that the difference from the baseline FACT-Taxane trial outcome index at MD and LD were significantly higher than that at SD (MD vs. SD P < 0.001, LD vs. SD P < 0.001). Differences from baseline for FACT-Taxane total, physical and emotional well-being, and taxane subscale scores at MD and LD were also higher than at SD. The difference from baseline for the CFS score at LD was lower than at SD (P = 0.013) and those for EQ-5D utility scores at MD and LD were higher than at SD (MD vs. SD P = 0.011, LD vs. SD P < 0.001). CONCLUSION: QoL of patients treated with 220 or 180Ā mg/m2 of q3w nab-PTX was significantly better than that of patients treated with 260Ā mg/m2. TRIAL REGISTRATION: The protocol was registered at the website of the University Hospital Medical Information Network (UMIN), Japan (protocol ID: UMIN000015516), on 01/11/2014. Details are available at the following address: https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017916.


Subject(s)
Albumins/administration & dosage , Antineoplastic Agents, Phytogenic/administration & dosage , Breast Neoplasms/drug therapy , Paclitaxel/administration & dosage , Quality of Life , Dose-Response Relationship, Drug , Female , Humans , Japan , Middle Aged
10.
Breast Cancer Res Treat ; 127(1): 143-52, 2011 May.
Article in English | MEDLINE | ID: mdl-21347648

ABSTRACT

To investigate whether the health-related quality of life (HRQOL) of patients switching from tamoxifen to anastrozole in a randomized trial is identical to that of those who continued tamoxifen after 1-4 years of adjuvant tamoxifen in Japanese postmenopausal breast cancer patients. Eligible patients for the randomized trial, the National Surgical Adjuvant Study of Breast Cancer 03, were recurrence-free postmenopausal women who had received definitive surgery for primary breast cancer with positive hormone receptor(s), and had been taking tamoxifen for 1-4 years postoperatively. They were randomly assigned to continue tamoxifen or to switch to anastrozole for a total duration of five years. Subjects were asked to reply to a self-administered QOL questionnaire survey to assess HRQOL (FACT-B [breast cancer scale], FACT-ES [endocrine symptom scale]) and psychological distress (CES-D: Center for Epidemiologic Studies Depression scale) at randomization (baseline), 3 months, 1, and 2 years after randomization, respectively. At baseline 694 patients (346 in the tamoxifen group and 348 in the anastrozole group) responded to the survey. The total scores of FACT-G, FACT-ES, and those of the FACT-G physical well-being subscale were statistically significantly better in the tamoxifen group than in the anastrozole group (P = 0.042, 0.038, and 0.005, respectively). However, there was no statistically significant difference between the treatment groups in the CES-D scores. Continuation of tamoxifen treatment after adjuvant tamoxifen for 1-4 years may provide Japanese breast cancer patients with better HRQOL than by switching to anastrozole.


Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/psychology , Nitriles/therapeutic use , Quality of Life , Tamoxifen/therapeutic use , Triazoles/therapeutic use , Aged , Anastrozole , Breast Neoplasms/surgery , Female , Humans , Middle Aged , Treatment Outcome
11.
Breast ; 56: 70-77, 2021 Apr.
Article in English | MEDLINE | ID: mdl-33631458

ABSTRACT

BACKGROUND: As Asians are more vulnerable to febrile neutropenia (FN) than Caucasians, evaluations of FN incidence and risk factors in Asians are important for the appropriate use of primary pegfilgrastim (PEG-G). PATIENTS AND METHODS: Japanese breast cancer patients receiving standard adjuvant chemotherapies were prospectively enrolled in multicenter institutions from August 2015 to July 2017. FN was evaluated from 2 treatment policies: true FN (T-FN): ≥37.5Ā Ā°C, grade 4 neutropenia, mandatory hospital visit (visiting); surrogate FN (S-FN): ≥37.5Ā Ā°C, oral antibiotic, no mandatory visit (non-visiting). PEG-G was used at the physicians' discretion. The primary endpoint was FN incidence during all cycles. Multivariate logistic regression analysis was performed to identify T-FN risk factors. RESULTS: Of 1005 enrolled patients, 980 women treated with FEC, E(A)C, and TC were analyzed. The FN incidence proportions in all patients were 22.5%, 27.5%, and 33.9% for FEC, E(A)C, and TC, respectively. Those of T-FN were 27.7%, 22.4%, and 36.6%; those of S-FN were 17.3%, 32.4%, and 31.5% with more frequent primary PEG-G usage. The relative dose intensity (RDI) of the 3 regimens was ≥0.85 in both groups. In the analysis of risk factors, TC (odds ratioĀ =Ā 2.67), ageĀ ≥Ā 65 years (2.24), and pretreatment absolute neutrophil count (ANC)/1000Ā Āµl (0.8) remained significant. CONCLUSIONS: FN incidences were above 20% in the 3 regimens, with TC showing the highest. RDI was maintained at a high level in both visiting and non-visiting groups. Patient-related risk factors were age and pretreatment ANC.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/drug therapy , Febrile Neutropenia/chemically induced , Neoadjuvant Therapy/adverse effects , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/complications , Breast Neoplasms/pathology , Febrile Neutropenia/epidemiology , Female , Granulocyte Colony-Stimulating Factor/therapeutic use , Humans , In Situ Hybridization, Fluorescence , Japan , Middle Aged , Prospective Studies , Retrospective Studies , Risk Factors
12.
Breast ; 55: 63-68, 2021 Feb.
Article in English | MEDLINE | ID: mdl-33341707

ABSTRACT

BACKGROUND: Chemotherapy-induced peripheral neuropathy is commonly observed in patients treated with nanoparticle albumin-bound paclitaxel (nab-PTX). We conducted a multicenter randomized controlled study to evaluate the optimal dose of nab-PTX. METHODS: We compared three different doses of q3w nab-PTX (Standard: 260Ā mg/m2 [SD260] vs Medium: 220Ā mg/m2 [MD220] vs Low: 180Ā mg/m2 [LD180]) in patients with HER2-negative metastatic breast cancer (MBC). Primary endpoint was progression-free survival (PFS). Grade 3/4 neuropathy rates in the three doses were estimated using the logistic regression model. The optimal dose was selected in two steps. Initially, if the hazard ratio (HR) for PFS was <0.75 or >1.33, the inferior dose was excluded, and we proceeded with the non-inferior dose. Then, if the estimated incidence rate of grade 3/4 neurotoxicity exceeded 10%, that dose was also excluded. RESULTS: One hundred forty-one patients were randomly assigned to SD260 (nĀ =Ā 47), MD220 (nĀ =Ā 46), and LD180 (nĀ =Ā 48) groups, and their median PFS was 6.66, 7.34, and 6.82 months, respectively. The HRs were 0.73 (95% confidence interval [CI]: 0.42-1.28) in MD220 vs SD260, 0.77 (95% CI 0.47-1.28) in LD180 vs SD260, and 0.96 (95% CI 0.56-1.66) in LD180 vs MD220. SD260 was inferior to MD220 and was excluded. The estimated incidence rate of grade 3/4 neurotoxicity was 29.5% in SD260, 14.0% in MD220, and 5.9% in LD180. The final selected dose was LD180. CONCLUSIONS: Intravenous administration of low-dose nab-PTX at 180Ā mg/m2 q3w may be the optimal therapy with meaningful efficacy and favorable toxicity in patients with MBC.


Subject(s)
Breast Neoplasms , Albumins/adverse effects , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/drug therapy , Drug Administration Schedule , Female , Humans , Paclitaxel/adverse effects , Treatment Outcome
13.
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
14.
Breast Cancer ; 27(5): 973-981, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32394413

ABSTRACT

PURPOSE: Second-line endocrine therapy (ET) for estrogen receptor (ER)-positive and human epidermal growth factor 2 (HER2)-negative metastatic breast cancer (MBC) is offered based on the response to first-line ET. However, no clinical trials have evaluated the efficacy and safety of secondary ETs in patients with poor responses to initial ET. This study evaluated the efficacy of second-line ET in ER-positive and HER2-negative postmenopausal MBC patients with low or very low sensitivity to initial ET. METHODS: This multicenter prospective observational cohort study evaluated the response of 49 patients to second-line ETs in postmenopausal MBC patients with low or very low sensitivity to initial ET. The primary endpoint was the clinical benefit rate (CBR) for 24Ā weeks. RESULTS: Of the 49 patients assessed, 40 (82%) received fulvestrant in the second line, 5 (10%) received selective estrogen receptor modulators, 3 (6%) received aromatase inhibitors (AIs) alone, and 1 received everolimus with a steroidal AI. The overall CBR was 44.9% [90% confidence interval (CI): 34.6-57.6, p = 0.009]; CBR demonstrated similar significance across the progesterone receptor-positive (n = 39, 51.3%, 90% CI: 39.6-65.2, p = 0.002), very low sensitivity (n = 17, 58.8%, 90% CI: 42.0-78.8, p = 0.003), and non-visceral metastases (n = 25, 48.0%, 90% CI: 34.1-65.9, p = 0.018) groups. The median progression-free survival was 7.1Ā months (95% CI: 5.6-10.6). CONCLUSION: Second-line ET might be a viable treatment option for postmenopausal patients with MBC with low and very low sensitivity to initial ET. Future studies based on larger and independent cohorts are needed to validate these findings.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/pharmacology , Breast Neoplasms/drug therapy , Postmenopause , Receptors, Estrogen/antagonists & inhibitors , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Aromatase Inhibitors/pharmacology , Aromatase Inhibitors/therapeutic use , Breast/pathology , Breast Neoplasms/diagnosis , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Estrogen Receptor Modulators/pharmacology , Estrogen Receptor Modulators/therapeutic use , Everolimus/pharmacology , Everolimus/therapeutic use , Female , Humans , Middle Aged , Neoplasm Staging , Progression-Free Survival , Prospective Studies , Receptor, ErbB-2/metabolism , Receptors, Estrogen/metabolism , Receptors, Progesterone/metabolism
17.
Gan To Kagaku Ryoho ; 33(2): 243-6, 2006 Feb.
Article in Japanese | MEDLINE | ID: mdl-16484865

ABSTRACT

for over 3 years. A 67-year-old woman underwent distal gastrectomy for advanced gastric cancer. Histological examination of several nodules in the posterior gastric wall led to suspicion of peritoneal dissemination. Low-dose FP treatment was performed for only 5 days after surgery. Peritoneal dissemination was diagnosed at the time of surgery for postoperative abdominal hernia 20 months after the gastrectomy. TS-1 was administered postoperatively, and recurrence or progression has not been detected for 3 years 4 months. Another patient, a 68-year-old woman,underwent distal gastrectomy for advanced gastric cancer with multiple lymph node metastasis and peritoneal dissemination. TS-1 was administered after surgery, and no recurrence or progression has been detected for 3 years and 7 months. These cases suggest that TS-1 is a promising treatment for gastric cancer with peritoneal dissemination.


Subject(s)
Antimetabolites, Antineoplastic/therapeutic use , Lymph Nodes/pathology , Oxonic Acid/therapeutic use , Peritoneal Neoplasms/secondary , Pyridines/therapeutic use , Stomach Neoplasms/drug therapy , Stomach Neoplasms/surgery , Tegafur/therapeutic use , Aged , Combined Modality Therapy , Drug Administration Schedule , Drug Combinations , Female , Gastrectomy , Humans , Lymph Node Excision , Lymphatic Metastasis , Stomach Neoplasms/pathology
18.
Gan To Kagaku Ryoho ; 33(2): 255-7, 2006 Feb.
Article in Japanese | MEDLINE | ID: mdl-16484868

ABSTRACT

We report a case of gastric cancer with peritoneal recurrence that responded to chemotherapy with paclitaxel and TS-1. A 62-year-old woman, who underwent total gastrectomy for advanced gastric cancer 2 years and 6 months ago, was admitted to our hospital with a chief complaint of abdominal distention and intestinal obstruction due to a large amount of ascites. Cytology of ascites revealed peritoneal dissemination, and chemotherapy with bi-weekly paclitaxel (90 mg/body) was begun. Clinical symptoms, including ascites and intestinal obstruction, were improved only after the second administration of paclitaxel. As she was able to take food orally, she was placed on combined chemotherapy consisting of tri-weekly paclitaxel (9 0 mg/body-120 mg/body: day 1) and TS-1 (80 mg/day: day 1-14) and 1 or 2 weeks rest. The patient had no signs or symptoms of peritoneal metastasis or toxicity except for general fatigue and watery eyes 1 year and 8 months after the diagnosis of peritoneal metastasis. Paclitaxel and TS-1 therapy was thought to be an effective chemotherapy against recurrent gastric cancer with peritoneal dissemination.


Subject(s)
Adenocarcinoma/drug therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Peritoneal Neoplasms/secondary , Stomach Neoplasms/drug therapy , Adenocarcinoma/secondary , Adenocarcinoma/surgery , Combined Modality Therapy , Drug Administration Schedule , Drug Combinations , Female , Humans , Middle Aged , Oxonic Acid/administration & dosage , Paclitaxel/administration & dosage , Pyridines/administration & dosage , Quality of Life , Stomach Neoplasms/pathology , Stomach Neoplasms/surgery , Tegafur/administration & dosage
19.
Nihon Rinsho ; 64(3): 575-80, 2006 Mar.
Article in Japanese | MEDLINE | ID: mdl-16529052

ABSTRACT

It tends to crisis situation that age of the women in whom marriage, pregnancy and childbirth are possible receives the treatment of a breast cancer also developmental task. We understand patient psychology from viewpoints, such as a developmental task and moratorium, and support for decision-making, which considered a patient's mental suffers is desired.


Subject(s)
Breast Neoplasms/psychology , Marriage , Parturition , Pregnancy , Decision Making , Female , Humans
20.
Gan To Kagaku Ryoho ; 32(11): 1855-8, 2005 Oct.
Article in Japanese | MEDLINE | ID: mdl-16315962

ABSTRACT

Unresectable advanced gall bladder cancer has a very poor prognosis. No good chemotherapeutic regimen is available. We report two cases of unresectable advanced gall bladder cancer patients who received the combination of intermittent hepatic arterial infusion chemotherapy and external radiation therapy. A 45-year-old male was alive for 576 days, and a 69-year-old male was alive for 246 days after the first diagnosis. They have been able to maintain a good quality of life without any severe adverse effects.


Subject(s)
Antimetabolites, Antineoplastic/administration & dosage , Fluorouracil/administration & dosage , Gallbladder Neoplasms/therapy , Aged , Combined Modality Therapy , Hepatic Artery , Humans , Infusions, Intra-Arterial , Male , Middle Aged , Quality of Life , Stents
SELECTION OF CITATIONS
SEARCH DETAIL