Efficacy and feasibility of dose-dense neoadjuvant chemotherapy versus conventional neoadjuvant chemotherapy in patients with HER2-negative breast cancer: A single-center retrospective study

Background: Dose-dense chemotherapy (DDCT) is a standard treatment for patients with high-risk breast cancer. Although there are numerous reports regarding DDCT, it is unclear whether sequential DDCT is effective or feasible as preoperative treatment for Japanese patients. We evaluated the efficacy and safety of neoadjuvant DDCT for patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer.Methods: This retrospective study evaluated 39 patients with breast cancer, who were preoperatively treated with anthracyclinecontaining regimens and taxanes. According to the chemotherapy regimens patients were divided into the DDCT group (ddgroup) and the conventional chemotherapy (CCT) group (q3w-group). The efficacy of neoadjuvant chemotherapy was evaluated based on the pathological complete response (pCR) rate. Adverse events were evaluated according to the Common Terminology Criteria for Adverse Events version 5.0.Results: There were no apparent differences in tumor stage, histopathological subtype, or surgical procedure. There was not significant difference in the pCR rate (dd-group, 17.6%; q3w-group, 22.7%). Three-year disease-free survival rates were similar in two groups. The rates of dose reduction, delay of treatment, and discontinuation of treatment in the two groups did not differ to a statistically significant extent. There were no significant differences in the adverse events of the two groups

The impact of no placement of drains in hemithyroidectomy on the postoperative course: A single-institutional study in Japanese patients

Background: Recently, the placement of drains in thyroidectomy has been debated. In this study, we evaluated the efficacy and safety of no placement of drains in hemithyroidectomy. Methods: After obtaining approval from the Institutional Review Board, we started not placing drains during surgery in adult patients who underwent hemithyroidectomy with or without central neck lymph node dissection for benign thyroid nodules or well-differentiated thyroid cancer, with informed consent being obtained. We compared the clinical data of the patients without drain placement (n=19) to the historical data of consecutive patients with a suction drain (n=20). Results: The operative wound and amount and characteristics of the drainage fluid were monitored every 2 h after the operation until the following morning, in addition to monitoring the oxygen saturation and an electrocardiogram. The proportion of patients undergoing cervical lymph node dissection was identical between the groups. The drain was removed on Day 1 after surgery in 19 patients and on Day 2 after surgery in 1 patient. The patients without a drain showed a significantly shorter postoperative hospital stay than those with a drain (4.0 vs. 4.5 days, respectively, p=0.03). No patients in either group experienced postoperativebleeding or seroma or wound infection. Conclusion: The hemithyroidectomy patients without a drain were able to be discharged earlier than those with a drain and without any adverse events, provided they received close monitoring after surgery

The preoperative prediction of postoperative symptomatic hypocalcemia in patients with Graves\u27 disease.

In Graves\u27 disease, one of the postoperative complications of surgical treatment is symptomatic hypocalcemia, which is defined as symptoms of hypocalcemia such as tetany, paresthesia, and muscle cramps. The aim of this study was to evaluate the preoperative factors predicting the development of symptomatic hypocalcemia after thyroidectomy in Graves\u27 patients. One hundred nine patients with Graves\u27 disease underwent surgery between January 2005 and August 2010 in our department. We investigated the relationship between postoperative symptomatic hypocalcemia and the serum levels of preoperative thyroid hormones, preoperative biochemical tests, and operating states in these patients. A univariate analysis determined that the preoperative serum free triiodothyronine (T3), free thyroxin (T4), and alkaline phosphatase (ALP) levels before the administration of potassium iodide were significantly higher in the symptomatic hypocalcemia patients. A multivariate analysis shows the preoperative serum free T4 level before the administration of potassium iodide to also be significantly higher in the symptomatic hypocalcemia patients. In conclusion, the preoperative serum free T4 level before the administration of potassium iodide was thus determined to be a risk factor for developing postoperative symptomatic hypocalcemia

Study Protocol for Assessing the Efficacy of Compression Therapy Using Stockings and Sleeves to Prevent Docetaxel-Induced Peripheral Neuropathy in Breast Cancer Patients

Taxanes are key drugs for patients with breast cancer. A major adverse effect associated with the administration of the taxane docetaxel is chemotherapy-induced peripheral neuropathy (CIPN). We are conducting a singlecenter, single-arm, open-label historical control trial to evaluate the ability of compression therapy using stockings or sleeves to prevent CIPN due to docetaxel treatment. The primary endpoint is the incidence of all-grade CIPN according to patients’ records until 3 weeks after the fourth docetaxel administration. This study’s results will clarify whether compression therapy using stockings or sleeves can prevent CIPN in breast cancer patients

An Evaluation of the Efficacy of Compression Therapy Using Sleeves and Stockings to Prevent Docetaxel-induced Peripheral Neuropathy in Breast Cancer Patients

Taxanes are key drugs for patients with breast cancer. A major adverse effect of taxanes is peripheral neuropathy (PN). To investigate the ability of compression therapy using sleeves and stockings to prevent PN due to the taxane docetaxel, we conducted a single-center historical control trial. Patients receiving docetaxel at 75 mg/m2 every 3 weeks for 4 cycles as first-line chemotherapy for breast cancer were eligible. PN was evaluated using the common terminology criteria for adverse events version 4.0. The primary endpoint was the incidence of allgrade PN until 3 weeks after the fourth docetaxel administration. We evaluated 26 patients in the intervention group and compared their data to those collected retrospectively from 52 patients treated with docetaxel without compression. Neither the incidence of all-grade PN until 3 weeks after the fourth docetaxel administration (63.5% in the control group vs. 76.9% in the intervention group, p=0.31) nor that of PN grade ≥ 2 (13.5% vs. 15.4%, p=0.99) differed between the groups. In this study, the efficacy of compression therapy using sleeves and stockings to prevent PN induced by docetaxel was not demonstrated. Further clinical studies including medications or intervention are needed to reduce the incidence and severity of PN induced by chemotherapy

The preoperative thyroid function and perioperative course in patients with Graves\u27 disease

Graves\u27 disease is an autoimmune disorder that induces increase in thyroid hormone production and release. Although euthyroidshould be desirable to ensure a safe operation, some patients still undergo thyroidectomy with hyperthyroidism. The aimof this study was to evaluate our preoperative strategies in patients with Graves\u27 disease. A total of 186 patients underwent thyroidectomy for Graves\u27 disease between 2003 and 2017. We gave all of these patients potassium iodide (KI) in order todecrease their thyroid hormone levels. We compared the clinical factors among three groups defined by the value of serumfree triiodothyronine (FT3) after the administration of KI: (1) the good control group (n=126) with ?6.0 pg/mL, (2) the fair control group (n=35) with >6.0 but ?10.0 pg/mL, and (3) the poor control group (n=25) with >10.0 pg/mL. KI decreased the serumlevels of thyroid hormone. However, some patients still had hyperthyroidism, and the subsequent administration of corticosteroidreduced FT3 but not thyroxine. Regarding the intraoperative course, the heart rate at 1 h after beginning general anesthesiawas higher in the poor control group than in the good control group (p<0.05), and the proportion of patients givenadrenergic beta-blocker was higher in the poor control group than in the other groups (p<0.01 each). One patient in the faircontrol group experienced suspected thyroid storm after total thyroidectomy. The occurrence rate of other deteriorations wasidentical among the three groups. With preparative KI and corticosteroid administration, almost all patients with Graves\u27 disease were able to undergo thyroidectomy safely

Is it practical to determine the therapeutic strategy for breast cancer by evaluating pathological findings in core needle biopsy specimens?

Background; Core needle biopsy (CNB) specimens have been widely used not only for the diagnosis of breast cancer, but also for assessing biomarkers, including lymphovascular invasion (ly and v), nuclear grading, the estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER-2) and Ki-67. We herein compared the pathological biomarkers of ER+/HER2- invasive breast cancers in CNB with those in the subsequent surgical specimens.　Methods; Patients with ER+/HER2- invasive breast cancer who presented to our department from August 2011 to July 2013 who had CNB and subsequent surgery were included. Lymphovascular invasion (ly, v) and nuclear grading were determined by hematoxylin and eosin staining, and the ER, PgR, HER-2, and Ki-67 status were evaluated by immunohistochemistry.　Results; The concordance rates between CNB and surgical specimens for the ly, v, nuclear grading, ER and PgR were 2.4%, 2.9%, 63.0%, 96.4% and 82.1%, respectively. Lymphovascular invasion and nuclear grading tended to be underestimated with CNB in discordant cases. The Ki-67 labeling index in CNB specimens was strongly correlated with that in surgical specimens (correlation coefficient 0.75, p<0.0001). Consequently, there was a reasonable level of agreement between CNB and surgical specimens for surrogate subtyping (82.1%).　Conclusions; CNB provided reliable information on the expression of hormone receptors, Ki-67 in ER+/HER2- invasive breast cancers. However, because of the substantial discordance between CNB and surgical specimens, the status of lymphovascular invasion and nuclear grading should not be concluded based on CNB specimens

The Efficacy of Software to Help Patients Understand Drug for Adjuvant Treatment for Breast Cancer: A Pilot Randomized Controlled Trial

We assessed the usefulness of ChemoCalc, a software package for calculating drug costs, in helping patients understand these costs. We randomly assigned, in a 1 : 1 ratio, 20 women who had undergone surgery for early breast cancer to a group that discussed adjuvant treatment with their physicians using the ChemoCalc software (ChemoCalc group) or a group that discussed adjuvant treatment without ChemoCalc (Usual Explanation group). The participants completed a five-grade evaluation questionnaire after these discussions. The primary endpoint was the intergroup comparison of the questionnaire scores regarding participants’ understanding of their treatment-associated drug costs. Median age was not significantly different between the ChemoCalc group and Usual Explanation group (57 vs. 50, respectively; p=0.27). Patients in the ChemoCalc group had a significantly higher perceived level of understanding of the drug cost than those in the Usual Explanation group (5 [4-5] vs. 2.5 [1-5], respectively; p=0.002). Scores related to the patients’ perception that understanding drug costs is an important part of breast cancer treatment were also higher in the ChemoCalc group than the Usual Explanation group (5 [2-5] vs. 3 [1-5], respectively; p=0.049). ChemoCalc was found to be useful for understanding drug costs

Predictive factors for intraoperative excessive bleeding in Graves\u27 disease

Background: In Graves\u27 disease, because a thyroid tends to have extreme vascularity, the amount of intraoperative blood loss (AIOBL) becomes significant in some cases. We sought to elucidate the predictive factors of the AIOBL. Methods: A total of 197 patients underwent thyroidectomy for G raves\u27 disease between 2002 and 2012. We evaluated clinical factors that would be potentially related to AIOBL retrospectively. Results: The median period between disease onset and surgery was 16 months (range: 1-480 months). Conventional surgery was performed in 125 patients, whereas video-assisted surgery was performed in 72 patients. Subtotal and near-total/total thyroidectomies were performed in 137 patients and 60 patients, respectively. The median weight of the thyroid was 45 g (range: 7.3-480.0 g). Univariate analysis revealed that the strongest correlation of AIOBL was noted with the weight of thyroid (p < 0.001). Additionally, AIOBL was correlated positively with the period between disease onset and surgery (p < 0.001) and negatively with preoperative free T4 (p < 0.01). Multivariate analysis showed that only the weight of the thyroid was independently correlated with AIOBL (p < 0.001). Four patients (2.0%) needed blood transfusion, including two requiring auto-transfusion, whose thyroids were all weighing in excess of 200 g. The amount of drainage during the initial 6 hours and days until drain removal was correlated positively with AIOBL (p < 0.001, each). Occurrences of postoperative complications, such as recurrent laryngeal nerve palsy or hypoparathyroidism, and postoperative hospital stay were not correlated with AIOBL. Conclusion: A huge goiter presented as a predictive factor for excessive bleeding during surgery for Graves\u27 disease, and preparation for blood transfusion should be considered in cases where thyroids weigh more than 200 g

Study protocol for efficacy and safety of steroid-containing mouthwash to prevent chemotherapy-induced stomatitis in women with breast cancer: a multicentre, open-label, randomised phase 2 study

INTRODUCTION: Stomatitis is a frequent adverse event in patients undergoing chemotherapy for breast cancer. Stomatitis can hamper oral nutrition resulting in malnutrition, reduce quality of life and introduce the need for dose reductions and interruption of chemotherapy; however, there is currently no standard approach for preventing chemotherapy-induced stomatitis. We aimed to assess the safety and efficacy of a dexamethasone-based elixir mouthwash for preventing chemotherapy-induced stomatitis in patients with early breast cancer. METHODS AND ANALYSIS: In this multicenter, randomised, controlled phase 2 trial, we will randomly assign 120 women with early breast cancer undergoing chemotherapy to use of a dexamethasone-based elixir or standard oral care, to compare their preventive effects on chemotherapy-induced stomatitis. Patients will be assigned in a 1:1 ratio. Patients in the intervention group will receive chemotherapy, oral care and a dexamethasone-based elixir (10?mL 0.1?mg/mL; swish for 2?min and spit, four times daily for 9 weeks), and patients in the control group will receive chemotherapy and oral care. The primary endpoint is the difference in incidence of stomatitis between the two groups. The sample size allows for the detection of a minimum difference of 20% in the incidence of stomatitis between the two groups. Secondary endpoints are severity of stomatitis, duration of stomatitis, completion rate of chemotherapy and adverse events. ETHICS AND DISSEMINATION: All participants signed a written consent form, and the study protocol has been reviewed and approved by the Clinical Research Review Board of Nagasaki University (CRB7180001). TRIAL REGISTRATION NUMBER: UMIN Clinical Trials Registry (UMIN000030489)