Effect of dietary patterns differing in carbohydrate and fat content on blood lipidand glucose profiles based on weight-loss success of breast-cancer survivors

INTRODUCTION: Healthy body weight is an important factor for prevention of breast cancer recurrence. Yet, weight loss and weight gain are not currently included in clinical-practice guidelines for posttreatment of breast cancer. The work reported addresses one of the questions that must be considered in recommending weight loss to patients: does it matter what diet plan is used, a question of particular importance because breast cancer treatment can increase risk for cardiovascular disease. METHODS: Women who completed treatment for breast cancer were enrolled in a nonrandomized, controlled study investigating effects of weight loss achieved by using two dietary patterns at the extremes of macronutrient composition, although both diet arms were equivalent in protein: high fat, low carbohydrate versus low fat, high carbohydrate. A nonintervention group served as the control arm; women were assigned to intervention arms based on dietary preferences. During the 6-month weight-loss program, which was menu and recipe defined, participants had monthly clinical visits at which anthropometric data were collected and fasting blood was obtained for safety monitoring for plasma lipid profiles and fasting glucose. Results from 142 participants are reported. RESULTS: Adverse effects on fasting blood lipids or glucose were not observed in either dietary arm. A decrease in fasting glucose was observed with progressive weight loss and was greater in participants who lost more weight, but the effect was not statistically significant, even though it was observed across both diet groups (P = 0.21). Beneficial effects of weight loss on cholesterol (4.7%; P = 0.001), triglycerides (21.8%; P = 0.01), and low-density lipoprotein (LDL) cholesterol (5.8%; P = 0.06) were observed in both groups. For cholesterol (P = 0.07) and LDL cholesterol (P = 0.13), greater reduction trends were seen on the low-fat diet pattern; whereas, for triglycerides (P = 0.01) and high-density lipoprotein (HDL) cholesterol (P = 0.08), a decrease or increase, respectively, was greater on the low-carbohydrate diet pattern. CONCLUSIONS: Because an individual's dietary preferences can affect dietary adherence and weight-loss success, the lack of evidence of a negative effect of dietary pattern on biomarkers associated with cardiovascular risk is an important consideration in the development of breast cancer practice guidelines for physicians who recommend that their patients lose weight. Whether dietary pattern affects biomarkers that predict long-term survival is a primary question in this ongoing clinical trial

A retrospective study of the impact of 21-gene recurrence score assay on treatment choice in node positive micrometastatic breast cancer.

To assess clinical utility of the 21-gene assay (Oncotype DX® Recurrence Score®), we determined whether women with HER2(−)/ER+ pN1mi breast cancer with low ( vs. 57.9% in the intermediate-risk group and 100% in the high-risk group (p \u3c 0.001). A total of 80.2% of the low-risk group were recommended endocrine therapy alone, while 77.8% of the high-risk group were recommended both endocrine and chemotherapy (p \u3c 0.001). The Oncotype DX Recurrence Score result provides actionable information that can be incorporated into treatment planning for women with HER2(−)/ER+ pN1mi breast cancer. The Recurrence Score result has clinical utility in treatment planning for HER2(−)/ER+ pN1mi breast cancer patients

Sunitinib plus paclitaxel versus bevacizumab plus paclitaxel for first-line treatment of patients with advanced breast cancer: A phase III, randomized, open-label trial

Introduction: A multicenter, open-label phase III study was conducted to test whether sunitinib plus paclitaxel prolongs progression-free survival (PFS) compared with bevacizumab plus paclitaxel as first-line treatment for patients with HER2− advanced breast cancer. Patients and Methods: Patients with HER2− advanced breast cancer who were disease free for ≥ 12 months after adjuvant taxane treatment were randomized (1:1; planned enrollment 740 patients) to receive intravenous (I.V.) paclitaxel 90 mg/m2 every week for 3 weeks in 4-week cycles plus either sunitinib 25 to 37.5 mg every day or bevacizumab 10 mg/kg I.V. every 2 weeks. Results: The trial was terminated early because of futility in reaching the primary endpoint as determined by the independent data monitoring committee during an interim futility analysis. At data cutoff, 242 patients had been randomized to sunitinib-paclitaxel and 243 patients to bevacizumab-paclitaxel. Median PFS was shorter with sunitinib-paclitaxel (7.4 vs. 9.2 months; hazard ratio [HR] 1.63 [95% confidence interval (CI), 1.18-2.25]; 1-sided P = .999). At a median follow-up of 8.1 months, with 79% of sunitinib-paclitaxel and 87% of bevacizumab-paclitaxel patients alive, overall survival analysis favored bevacizumab-paclitaxel (HR 1.82 [95% CI, 1.16-2.86]; 1-sided P = .996). The objective response rate was 32% in both arms, but median duration of response was shorter with sunitinib-paclitaxel (6.3 vs. 14.8 months). Bevacizumab-paclitaxel was better tolerated than sunitinib-paclitaxel. This was primarily due to a high frequency of grade 3/4, treatment-related neutropenia with sunitinib-paclitaxel (52%) precluding delivery of the prescribed doses of both drugs. Conclusion: The sunitinib-paclitaxel regimen evaluated in this study was clinically inferior to the bevacizumab-paclitaxel regimen and is not a recommended treatment option for patients with advanced breast cancer

Profound Chemopreventative Effects of a Hydrogen Sulfide-Releasing NSAID in the APC(Min/+) Mouse Model of Intestinal Tumorigenesis

Canadian Institutes of Health Research grant to JL

ASTRO suitability criteria assessment in early-stage breast cancer patients treated with intraoperative radiation therapy (IORT) plus 21 gene recurrence score (RS) assay result guided adjuvant medical therapy.

e12598 Background: A patient subset consented in an institutional review board-approved single institution clinical trial designed to determine the efficacy and outcome of single fraction IORT received adjuvant medical therapy recommendations based on their RS results. Patients were categorized according to American Society for Radiation Oncology (ASTRO) suitability criteria for accelerated partial breast irradiation. Comparison was made between ASTRO suitability criteria, RS and post-IORT outcomes. Methods: Outcome of pts completing single fraction (20Gy) IORT per protocol using disposable balloon electronic brachytherapy and RS assessment were reviewed. Data collection included demographics, pathology, RS, medical therapy, local (LR) and axillary (AR) recurrences, and survival. Results: From Nov 2011 – Jan 2016, 115 pts (aged 43 – 84, mean 63 years) completed both IORT per protocol and RS assessment. Pts with estrogen receptor positive invasive carcinomas (range 0.2 – 2.4 cm, median size 0.9 cm) and RS results were categorized by ASTRO suitability criteria, LR and AR, as shown in Table 1. The recurrence rate at mean follow-up of 6.8 years was 3.5%. There were 3 LR (RS 0, 17, 18) and 1 AR (RS 19). There has been no breast cancer related death. Adjuvant endocrine therapy was recommended to all pts. Twenty-three (20%) patients received chemotherapy, including 12 (71%) pts in the high RS (RS &gt;25) groups. Chemotherapy was not given to any pt with a RS &lt;18. One LR (RS 0, ASTRO Suitable, age 65, 1.5 cm) declined endocrine therapy. Ten (19%) pts with RS of 11 – 25 received chemotherapy. One LR (RS 17, ASTRO suitable, age 64, 1.5 cm) and 1 axillary recurrence (RS 19, ASTRO Suitable, age 66, 1.3 cm), neither receiving chemotherapy, were compliant with endocrine therapy. One LR (RS 18, ASTRO Suitable, age 51, 0.6 cm) was treated with cyclophosphamide and docetaxel. Seven (78%) pts with RS of 26 - 30 and 5 (63%) pts with RS &gt;30 received chemotherapy, with no recurrences in these groups. Conclusions: One hundred fifteen pts treated with single fraction IORT per protocol and RS guided adjuvant medical therapy at a single institution were found to have a 3.5% recurrence rate at mean follow-up of 6.8 years. ASTRO suitability criteria and high RS results (RS &gt; 25) did not correlate with recurrence. The success of IORT observed in this trial as local therapy for early-stage breast cancer patients was independent of genomic factors or patient suitability criteria. Recurrence rates were comparable to those reported in IORT peer-reviewed published data and treatments using breast conserving surgery plus whole breast radiation therapy. [Table: see text] </jats:p