Nayuko Sato

Breast Conserving Surgery Using Volume Replacement with Oxidized Regenerated Cellulose: A Cosmetic Outcome Analysis

We evaluated the cosmetic outcome of volume replacement with oxidized regenerated cellulose (ORC) after breast‐conserving surgery (BCS) and also examined factors that may have influenced the results. Ninety‐four patients who underwent BCS with ORC replacement between January 2010 and August 2012 participated in this study. The cosmetic outcomes of these patients were evaluated using scores based on the criteria of the Japan Breast Cancer Society. We evaluated cosmetic scores with regards to several clinical factors and the occurrence of complications after this procedure. The mean score of the cosmetic outcome of all patients was 9.5 points of 12 points. Thirty‐seven patients were categorized as “Excellent,” 34 were “Good,” 22 were “Fair,” and 1 was “Poor.” Patient age, body mass index, weight of the specimen, and ORC amount were not significantly different between patients with favorable cosmetic scores and those without. However, the weight of the removed specimen was slightly higher in patients with an unfavorable cosmetic score. Although acute dermatitis and eczema was observed in 15% and 3% of patients, all of them were improved with conservative treatment. Cosmetic scores were significantly higher in patients without complications than in patients with complications. In conclusion, ORC replacement after BCS is a simple and reliable procedure. The selection of indication and prevention of complications are important for obtaining a better cosmetic outcome. This is the first report to cosmetically evaluate a relatively large number of patients that have undergone ORC replacement after BCS.

Safety of nanoparticle albumin‑bound paclitaxel administered to breast cancer patients with clinical contraindications to paclitaxel or docetaxel: Four case reports

Taxanes, including paclitaxel (PTX) and docetaxel (DOC), are poorly soluble in water due to their hydrophobic properties and thus, require solvents. However, use of these solvents has been associated with toxic responses, including a hypersensitivity reaction (HSR). Nanoparticle albumin-bound paclitaxel (nab-PTX) is a novel formulation of PTX, which allows reconstitution of the agent with a saline solution instead of solvents and administration without premedication for HSRs. The current study reports the safe administration of nab-PTX to four breast cancer patients considered clinically to have contraindications to PTX or DOC. Two of the patients had previously experienced HSRs to PTX or DOC and the other two patients had contraindications to steroids as a premedication for HSRs, since one patient suffered from diabetes and the other was a carrier of the hepatitis B virus. All 4 patients were safely administered nab-PTX. In conclusion, administration of nab-PTX appears to be effective for patients that have previously experienced HSRs to other taxanes or in those with contraindications to steroids.

Validation of online calculators to predict the non-sentinel lymph node status in sentinel lymph node-positive breast cancer patients

PurposeThis study evaluated and compared the predictive values of the Memorial Sloan-Kettering Cancer Center (MSKCC) nomogram and the Stanford nomogram for predicting non-sentinel lymph node (SLN) metastasis in patients with SLN metastasis, which were the only nomograms available online, and verified their usefulness in the macrometastasis or micrometastasis/isolated tumor cell (ITC) subgroups.MethodsEighty-nine patients with a positive SLN biopsy who underwent axillary lymph node dissection were analyzed. The predicted probability of non-SLN metastasis was calculated using a computerized model from the websites for each nomogram. The results were compared using the area under the curve (AUC) of the receiver operating characteristics curve for each model. The false-negative and false-positive rates were also calculated.ResultsThe AUC for the entire population was 0.701 with the MSKCC nomogram and 0.756 with the Stanford nomogram. The AUCs of macrometastasis and micrometastasis/ITC groups were 0.680 and 0.469 with the MSKCC nomogram, and were 0.676 and 0.574 with the Stanford nomogram, respectively. Although false-negative cases were not identified, the false-positive rates were high in both subgroups when using these nomograms.ConclusionsThis independent comparison found no significant difference between the two nomograms. In this study, these nomograms could not reliably predict positive non-SLN in patients with SLN micrometastasis/ITC.

Esthetic result of rhomboid flap repair after breast-conserving surgery for lower quadrant breast cancer lesion with skin invasion: Report of two cases

Breast-conserving surgery (BCS) has been increasingly performed as a standard operative strategy for patients with breast cancer. The primary purpose of BCS is to acquire both local control and good cosmetic results. An insignificant difference in cancer treatment results has been shown between BCS and total mastectomy. However, achieving sufficiently cosmetic results can be difficult, particularly in patients with tumors that are large or localized to the lower quadrant. To avoid breast deformities and asymmetries after BCS, immediate reconstruction using autologous tissue has been accepted as the standard option. Rhomboid skin and adipose flap repair is a simple, less invasive procedure than the myocutaneous flap, which has primarily been performed in patients with upper quadrant lesions. We herein report the cases of two patients with lower quadrant breast cancer with skin invasion, who underwent BCS with immediate breast repair using a rhomboid flap. This procedure is therefore worth considering as one of the first options for immediate repair after BCS.

Abstract OT1-02-01: Phase II neoadjuvant trial of nanoparticle almumin-bound paclitaxel and trastuzumab in patients with node-negative, Her-2 positive breast cancer (OMC-BC04)

Background: Neoadjuvant chemotherapy plus trastuzumab results in a 30% to 50% pathologic complete response (pCR) rate in HER-2 positive breast cancer and has been associated with improved therapeutic outcomes. Thus, the pCR rate can be useful in evaluating novel agents in this patient population. Albumin-bound (nab)-paclitaxel can reduce the toxicity of Paclitaxel while maintaining its efficacy. We reported that neoadjuvant therapy using Anthracycline based regimens (EC,AC,FEC) followed by a combination with nab-Paclitaxel and Trastuzumab was effective and safe by OMC-BC01 Study (Tanaka et al. Clin Breast Cancer 15:191-196). The pCR rate was 36% and 71% in the patients with estrogen receptor-positive and negative cancer, respectively. In addition, Tolaney et al. showed that adjuvant Paclitaxel and Trastuzumab for node-negative, HER-2 positive tumors measuring up to 3 cm in greatest dimension was associated with patients outcomes that were better than expected on the basis of historical data (Tolaney et al. N Engl J MED.2015 Jan 8:372(2):134-141). We conducted a clinical Phase II, multicenter, neoadjuvant trial of combination with nanoparticle albumin-bound Paclitaxel and Trastuzumab in patients with node-negative, Her-2 positive, estrogen receptor-negative breast cancer measuring up to 3 cm in greatest dimension. Patients and Methods: nab-Paclitaxel and Trastuzumab as neoadjuvant therapy in patients with Her-2 positive, node-negative, estrogen receptor-negative breast cancer measuring up to 3 cm in greatest dimension. Patients are treated with neoadjuvant nab-Paclitaxel (260mg/m2) and Trastuzumab q21d x 4, and undergo surgery 4-6 weeks later from completing chemotherapy. The primary endpoint, pCR is defined as no evidence of invasive tumors in the final surgical sample both in the breast and axillary lymph nodes. Secondary endpoints include objective clinical response rate, histological response rate, disease-free interval, rate of breast conserving surgery, and the safety of the treatment. Accrual: Presently, a total number of 1 patient have been included since start of the study. The expected end of accrual of 30 patients will be the last quarter 2018. Citation Format: Iwamoto M, Tanaka S, Koda C, Kawaguchi K, Terasawa R, Sato N, Fujioka H, Kimura K, Uchiyama K. Phase II neoadjuvant trial of nanoparticle almumin-bound paclitaxel and trastuzumab in patients with node-negative, Her-2 positive breast cancer (OMC-BC04) [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 OT1-02-01.

Abstract OT3-02-01: Randomized phase II study of Hangeshashinto (TJ-14) for chemotherapy induced oral mucositis in patients with breast cancer (Hangesha-B study)

Background: Oral mucositis is a common complication of systemic chemotherapy for cancer, and is associated with higher risk of infection, pain, chemotherapy dose reduction. Severe mucositis impairs oral function and seriously affects nutrition and quality of life of the patients. Hangeshashinto (TJ-14) is a traditional Japanese herbal (Kampo) medicine reduces the level of prostaglandin E2 and affects the cyclooxygenase activity, and alleviates chemotherapy induced oral mucositis. We conducted a randomized phase II trial to investigate whether Hangeshashinto (TJ-14) prevents or controls chemotherapy induced oral mucositis. Patients and Methods: Patients who develop moderate to severe chemotherapy induced oral mucositis (WHO grade>1) during any cycle of chemotherapy are randomly assigned to receive either Hangeshashinto (TJ-14) (n=25) or placebo (n=25). Patients receive the administration of Hangeshashinto (TJ-14) or placebo for 3 weeks at the beginning of the next course of chemotherapy. The patients are advised to dissolve 2.5g of Hangeshashinto (TJ-14) or placebo in 50ml drinking water, and divide it into twice or three times in an oral cavity. Patients rinse their oral cavity with it three times daily. The signs of oral mucositis is assessed by the investigator during the screening cycle. The CTCAE v4.0 grading is used to assess the severity of oral mucositis. The primary endpoint is duration time of oral mucositis, and secondary endpoints include incidence of oral mucositis, incidence of diarrhea, blood levels of CRP, The change of body weight, and blood levels of albumin. Accrual: This study began in June 2015. The expected end of accrual of 50 patients will be the last quarter 2017. Citation Format: Iwamoto M, Umezaki N, Matsuda J, Kawaguchi K, Terasawa R, Sato N, Fyjioka H, Kimura K, Tanaka S, Uchiyama K. Randomized phase II study of Hangeshashinto (TJ-14) for chemotherapy induced oral mucositis in patients with breast cancer (Hangesha-B study). [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT3-02-01.

Abstract P2-19-06: Breast conserving surgery using volume replacement with oxidized regenerated cellulose: A cosmetic outcome analysis

We evaluated the cosmetic outcome of volume replacement with oxidized regenerated cellulose (ORC) after breast-conserving surgery (BCS) and also examined factors that may have influenced the results. Ninety-four patients who underwent BCS with ORC replacement between January 2010 and August 2012 participated in this study. The cosmetic outcomes of these patients were evaluated using scores based on the criteria of the Japan Breast Cancer Society. We evaluated cosmetic scores with regards to several clinical factors and the occurrence of complications after this procedure. The mean score of the cosmetic outcome of all patients was 9.5 points of 12 points. Thirty-seven patients were categorized as “Excellent,” 34 were “Good,” 22 were “Fair,” and 1 was “Poor.” Patient age, body mass index, weight of the specimen, and ORC amount were not significantly different between patients with favorable cosmetic scores and those without. However, the weight of the removed specimen was slightly higher in patients with an unfavorable cosmetic score. Although acute dermatitis and eczema was observed in 15% and 3% of patients, all of them were improved with conservative treatment. Cosmetic scores were significantly higher in patients without complications than in patients with complications. In conclusion, ORC replacement after BCS is a simple and reliable procedure. The selection of indication and prevention of complications are important for obtaining a better cosmetic outcome. This is the first report to cosmetically evaluate a relatively large number of patients that have undergone ORC replacement after BCS.

Abstract P3-02-02: Use of contrast-enhanced computed tomography in clinical staging of asymptomatic breast cancer patients to detect asymptomatic distant metastases.

The use of computed tomography (CT) with regards to the clinical staging of patients with asymptomatic breast cancer has been on the increase in clinical practice. However, the benefits of routine CT have yet to be fully clarified. This study investigated the value of employing contrast-enhanced CT (CECT) to screen for distant metastases in patients with asymptomatic breast cancer. The clinical records of 483 patients with asymptomatic breast cancer who underwent CECT at a single institution between April 2006 and January 2011 were reviewed retrospectively. The CECT results were classified into normal, true-positive (metastases) or false-positive findings. Abnormal CECT findings, including true- and false-positive results, were detected in 65 patients (13.5%). Of these, 26 patients (5.4%) showed confirmed true metastatic disease, including 18 lung metastases, 11 liver metastases and 13 bone metastases. Upstaging to stage IV due to the results of the CECT scan occurred in 0 of 155 patients at stage I, 5 of 261 patients (1.9%) at stage II and 21 of 67 patients (31.3%) at stage III. The false-positive rates were 7.7, 9.0 and 8.7% in stages I, II and III, respectively. The size of the lung or liver metastasis was significantly larger than the false-positive lesion. Routine CECT did not appear to be useful for detecting distant metastases in completely asymptomatic patients. Conversely, a small number of patients were upstaged from early to stage IV and a predictive factor beyond T and N stage alone appears to be needed in order to predict which asymptomatic patients have distant metastases.

P3-07-35: Validation of Online Calculators To Predict Non-Sentinel Lymph Node Status in Sentinel Lymph Node-Positive Breast Cancer Patients.

Purpose: Axillary lymph node dissection (ALND) is recommended for breast cancer patients with sentinel lymph node (SLN) metastasis, but further nodal disease is not always present. Several models exist for predicting non-sentinel lymph node (non-SLN) metastasis in SLN metastasis. This study evaluated and compared the predictive values of the Memorial Sloan-Kettering Cancer Center (MSKCC) nomogram and the Stanford nomogram, which were conveniently available online, and clarified their usefulness for the micrometastasis or isolated tumor cell (ITC) subgroup. Methods: Data from 89 patients with positive SLN biopsy who underwent ALND were used, including 59 patients with macrometastasis and 30 with micrometastasis/ITC. The predicted probability of non-SLN metastasis was calculated using a computerized model from the websites for each nomogram. Results were compared using area under the curve (AUC) of the receiver operating characteristics curve for each model. False-negative and false-positive rates were also calculated. Results: AUC for the entire population was 0.701 with the MSKCC nomogram and 0.756 with the Stanford nomogram. AUCs of macrometastasis and micrometastasis/ITC were 0.680 and 0.469 with the MSKCC nomogram and 0.676 and 0.574 with the Stanford nomogram, respectively. Conclusions: This independent comparison found no significant difference between the two nomograms. In our results, these nomograms could not reliably predict positive non-SLN in cases with SLN micrometastasis/ITC. Further validation in other patient populations is needed. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-07-35.