Oral Bis improves BMD of the FN in patients with osteoporosis. Five-year EXE treatment with proper addition of Bis helps maintain the BMD of the LS and FN at the sixth year.
Non-muscle invasive bladder cancer (NMIBC) is a common urological malignancy, and bacillus Calmette-Guérin (BCG) therapy is the gold standard treatment in intermediate and high-risk groups. However, BCG failure occurs in a significant proportion of patients, emphasizing the need for effective alternative treatment modalities to address this burden. These treatments include immunotherapy, enhanced drug delivery, targeted therapy, device-assisted chemotherapy, vaccine therapy, and gene therapy, which show varying degrees of safety and efficacy. The objective of this review is to summarize the current evidence and ongoing research on these emerging therapies, offering insight into their potential for improving patient outcomes and quality of life. Although radical cystectomy remains the standard of care for high-risk NMIBC patients unresponsive to BCG, novel treatment modalities hold promise for the future management of this challenging patient population.
Purpose: Although a survival benefit with chemotherapy (CT) is obtained over all among patients with estrogen receptor-positive (ER+) breast cancer, the degree of benefit differs among the subtypes. The 21-gene Recurrence Score assay is a validated prognostic/predictive tool for early ER+ breast cancer. However, genomic assays have not been approved in Japan and most other countries, except in some developed countries. Based on the St. Gallen 2015, 1-3 positive nodes are not an absolute indication for CT among patients with ER+/HER2-negative breast cancer. In contrast, it is better for CT to be performed except for low-risk groups, based on genomic tests according to the St. Gallen 2017. In fact, no prospective study has proven the survival benefit of CT specifically for luminal-A breast cancer. Therefore, we analyzed the survival benefit of CT for ER+/HER2-negative breast cancer by propensity score matching (PSM). Patients and methods: Between 2000 and 2015, 895patients with stage I-III ER+/HER2-negative breast cancer who had underwent surgery in our hospital were examined. Patients with bilateral breast cancer, ER<10%, and preoperative treatment were excluded. The primary end point was the 5-year recurrence-free survival (RFS) and overall survival (OS) in patients matched by propensity score that estimated by a logistic regression model that included factors likely to influence the decision of whether or not to administer CT (tumor size, nuclear grade [NG], progesterone receptor status and nodal status). Results: In the entire cohort, the median age was 59 (28-95) years; 223 patients (24.9%) were node positive and 126 patients (14.1%)had NG3 disease. Overall, all patients received endocrine therapy, and 24.1% received additional CT. After a median follow-up of 68.8 months, the 5-year RFS rate was 94.3% in CT-untreated patients (non-CT group) and 90.1% in CT-treated patients (CT group; hazard ratio [HR] for recurrence, 1.47; 95% confidence interval [CI], 0.90 -2.33; p=0.106). The 5-year OS rate was 97.5% in the non-CT group and 95.6% in the CT group (HR for death, 1.80; 95% CI, 0.99-3.21; p=0.047). Using PSM, 236 patients were selected (1:1 matching between non-CT and CT groups). After matching, the 5-year RFS rate was higher in the CT group than in the non-CT group (96.8% vs. 82.7%; HR for recurrence, 0.29; 95% CI, 0.11-0.68; p=0.003), and the 5-year OS rate was higher in the CT group than in the non-CT group (100% vs. 91.9%; HR for death, 0.06; 95% CI, 0.003-0.35; p<0.001). Among PSM patients, with node-negative/NG3 and 1-3 node positive/NG2 disease, the 5-year RFS rate was significantly higher in the CT group than in the non-CT group (p=0.041 and p=0.006, respectively). Conclusion: No significant benefit of CT was observed when considering the entire cohort because of the treatment bias. When clinical and tumor features were matched by propensity score, the addition of CT significantly improved both RFS and OS of ER+/HER2-negative breast cancer patients, especially for patients with node- negative/NG3 and 1-3 node positive/NG2 disease. Citation Format: Tanaka N, Ogura K, Kamimura M, Hattori A, Inoue H, Yukawa H, Sakaguchi S, Matsuoka A, Kodera A, Hirano A. Effect of adjuvant chemotherapy for patients with ER-positive/HER2-negative breast cancer assessed by the propensity score matching: Significance of nuclear grade and nodal status [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-13-07.
Background Chemotherapy for breast cancer causes alopecia as a side effect. Some patients refuse chemotherapy because of alopecia, resulting in the omission of a standard therapy. It is believed that a scalp cooling device can prevent alopecia by promoting vasoconstriction of the scalp and reducing exposure of the hair root cells to anticancer agents. There are phenotypic differences of the efficacy of a scalp cooling device for alopecia. In fact, a Dutch scalp cooling registry reported that the success rate of scalp cooling was 51% in European women and 33% in Asian women. Therefore, we aimed to investigate the efficacy of scalp cooling device for chemotherapy-induced alopecia among Asian women with breast cancer. Trial design This is a phase II trialto evaluate the efficacy and safety of scalp cooling device for risk reduction of alopecia in women with stage I/II/III breast cancer treated with adjuvant/neoadjuvant chemotherapy in a single institute. Eligibility criteria Women diagnosed with Stage I to III breast cancer who are scheduled to receive preoperative or postoperative adjuvant chemotherapy containing anthracycline and/or taxanes are enrolled. Patients who have blood malignancies (leukemia, non-Hodgkin lymphoma, other systemic lymphoma), and cold allergy, are excluded. Specific aims The primary endpoint is the proportion of patients with Common Terminology Criteria for Adverse Events (CTCAE) grade 0-1 alopecia after the completion of all cycles of chemotherapy (success rate). Secondary endpoints are safety, quality of life, use of wig or cap, and success rates after the completion of all cycles of chemotherapy distinguished by anthracycline(AC) and taxane. The cooling device is the Paxman scalp cooling system. Scalp cooling was performed from 30 mins before initiation until 90 mins (25 min for taxane) after chemotherapy. Pictures of the scalp were taken at the time of the initiation of each course. Statistical methods Successful treatment was defined as the presence of less than 50% of hair-loss area. The sample size was calculated using the Simon method, with a type I error of 10% (two-sided) and a study power of 80%.The expected success rate is 30%, with a threshold success rate of 10%, and the required number of patients was estimated to be 19. Present and target accrual Patient accrual was started in April 2018 and present accrual is 3. We plan to enroll a total of 20 patients in the trial. Citation Format: Kodera A, Ogura K, Hattori A, Yukawa H, Sakaguchi S, Matsuoka A, Tanaka N, Kamimura M, Jibiki N, Naritaka Y, Hirano A. Efficacy and safety of scalp cooling device for prevention of alopecia in patients with breast cancer [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr OT1-05-03.
We report two cases of pyogenic spondylodiscitis caused by bacteremia following gastric surgery. [Case 1] An 85-year-old male patient underwent total gastrectomy for gastric cancer. After the surgery, leukocytosis and elevated C reactive protein (CRP) were sustained; however, there was no surgical site infection (SSI). His lumbar pain was present; therefore, we performed magnetic resonance imaging (MRI). Thereafter, he was diagnosed with L3 spondylitis, L2/3 discitis, and bilateral iliopsoas abscess on postoperative day (POD) 33. He has been treated with daptomycin (DAP). [Case 2] A 72-year-old male patient was admitted to our department for post-distal gastrectomy reflux esophagitis. After admission, conservative therapy was continued; however, severe symptoms appeared many times. Then, surgical treatment was scheduled to reduce reflux. When his body temperature (BT) was elevated to 39.1°C before the surgery, vancomycin (VCM) was administered because of suspected catheter infection. Once his BT normalized, fundoplication was performed. On POD 19, his BT elevated again, and the central vein (CV) catheter was removed. On POD 27, he complained of back pain. He was diagnosed with pyogenic spodylodiscitis using MRI. He was treated conservatively with VCM followed by sulbactam/ampicillin (SBT/ABP) based on the result of the culture. Physicians should be alert regarding possible occurrence of pyogenic spondylitis in patients with back pain or lumbago who have undergone gastric surgery.
Background Paclitaxel (PTX) is a standard treatment for metastatic breast cancer (MBC) and it is often used as adjuvant and neoadjuvant chemotherapy for patients with early-stage disease. Nanoparticle albumin-bound (Nab)-PTX was also effective in patients with metastatic and early-stage. A comparison of weekly and triweekly nab-PTX regimens suggested that weekly nab-PTX resulted in superior progression-free survival. However, the optimal dose and schedule of weekly nab-PTX have not been determined. The efficacy and tolerability of epirubicin/cyclophosphamide (EC) followed by weekly nab-PTX (125 mg/m2) ± trastuzumab in node-positive breast cancer was determined in our previous trial. A high pathologic complete response (pCR) rate was obtained in HER2-positive patients. However, because nab-PTX administration was frequently postponed and discontinued, the optimal dose needs to be determined. In the previous trial, the median relative dose intensity of nab-PTX was 80% among patients with pCR. Therefore the dose of nab-PTX was reduced by 20% in this newly designed trial. Trial design This phase II trial aimed to evaluate the efficacy and toxicity of neoadjuvant EC followed by weekly nab-PTX with trastuzumab in patients with HER2-positive breast cancer. Patients will receive 4 cycles of epirubicin (90 mg/m2) and cyclophosphamide (600 mg/m2) every 3 weeks, followed by 4 cycles of nab-PTX (100 mg/m2) on days 1, 8, and 15, over a 28-day cycle. Fifteen cycles of trastuzumab (2 mg/kg, loading dose: 4 mg/kg) will be added to the nab-PTX regimen. Eligibility criteria Surgery and chemotherapy-naïve patients with pathologically confirmed T2-4 N0-3 invasive breast cancer, as diagnosed by core needle biopsy, are included. Eligibility criteria include age 20–70 years, a performance status of 0–2, and adequate organ function. Specific aims The primary endpoint is the pCR rate in the breast and axilla. Secondary endpoints include the breast conservation rate, toxicities, relative dose intensities, feasibility, and overall survival. A pCR is defined as the disappearance of invasive cancer cells, including in the axilla; residual intraductal cancer is acceptable. Statistical methods The sample size was calculated using the Simon method, with a type I error of 5% and a study power of 80%. The expected rate of pCR is 72% with a threshold pCR rate of 45%. The required number of patients was estimated to be 25. Present and target accrual Patient accrual within two medical centers began in May 2014. A final study population of 30 patients is expected (Trial registration: UMIN000013886). Citation Format: Kodera A, Hirano A, Inoue H, Ogura K, Hattori A, Sakaguchi S, Yukawa H, Matsuoka A, Tanaka N, Kamimura M, Jibiki N, Fujibayasi M, Naritaka Y, Shimizu T. A phase II trial of neoadjuvant epirubicin/cyclophosphamide followed by weekly nanoparticle albumin-bound paclitaxel with trastuzumab for HER2-positive breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT1-01-03.
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