Top Breast Cancer News of 2016

FDA Expands Palbociclib Approval for Breast Cancer:

The FDA has granted an expanded indication for the cyclin-dependent kinase 4/6 inhibitor palbociclib (Ibrance). The drug is now approved for use in combination with fulvestrant in women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer whose disease progressed following endocrine therapy. In a study of 521 patients, women who received palbociclib plus fulvestrant had a median progression-free survival of 9.5 months, compared with 4.6 months in the fulvestrant plus placebo group, for a hazard ratio of 0.461 (95% CI, 0.360–0.591;

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Substantial Variation in Breast Biopsy Diagnoses for Atypia, DCIS Cases:

There was substantial diagnostic variability from pathologists when analyzing a single breast biopsy slide, according to results from the B-Path Study where a single slide from a biopsy was used to estimate how many diagnoses would be verified by a reference group of three pathologists. The study included 6,000 interpretations from 240 distinct cases analyzed by 115 practicing pathologists. Overall, analysis of a single slide was confirmed 92.3% of the time; 4.6% slides were overinterpreted, and 3.2% were underinterpreted. Looking specifically at diagnoses of atypia, the reference panel interpreted 53.6% as benign without atypia and 8.6% of them as ductal carcinoma in situ (DCIS). For DCIS, disagreement was also high with the reference panel interpreting 9.5% of slides as benign without atypia, 9% as atypia, and 11.8% as invasive breast cancer.

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Biosimilar Matches Trastuzumab in Metastatic HER2-Positive Breast Cancer:

A randomized, double-blind, phase III study of 95 patients with metastatic HER2-positive breast cancer showed that the investigational biosimilar MYL-1401O had comparable efficacy and safety to the branded, US Food and Drug Administration (FDA)-approved trastuzumab (Herceptin). Patients in the HERITAGE study were randomly assigned to receive taxane chemotherapy with either trastuzumab or MYL-1401O for at least 8 cycles followed by trastuzumab alone until disease progression. The overall response rates were 69.6% for patients in the biosimilar study arm compared with 64% for patients assigned trastuzumab. The ratio of overall response rates was 1.09 (95% CI, 0.954–1.237), falling within the study’s pre-defined equivalence. Results were presented by Hope Rugo, MD, at the 2016 ASCO Annual Meeting in Chicago.

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Study Offers Limited Support for Mediterranean Diet’s Effect on Breast Cancer Incidence:

Adherence to a Mediterranean diet that is mostly plant-based and characterized by a high ratio of monounsaturated fats may reduce the incidence of breast cancer, but evidence is limited, according to the results of a meta-analysis of 90 papers on the topic. Results from the primary prevention PREDIMED trial showed that consuming a Mediterranean diet significantly decreased the risk for breast cancer compared with a control group (hazard ratio, 0.43; 95% CI, 0.21–0.88). However, a pooled analysis of 13 cohort trials of breast cancer data showed similar incidences of breast cancer at the highest and lowest levels of adherence to a Mediterranean diet (relative risk, 0.96; 95% CI, 0.90–1.03).

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One in Five Older Women With Breast Cancer Had Functional Decline:

Using the Vulnerable Elders Survey (VES-13), a self-administered tool to predict functional decline or death at 12 months, researchers found that about 22% of women older than 65 years who underwent treatment for early-stage breast cancer had a functional decline and/or died within 1 year of initiating treatment for the disease. The study looked at 206 women recruited from 2008 to 2013 with 184 available for follow-up at 1 year. At baseline, there was a significant difference in the mean VES-13 scores among women who experienced functional decline or death and those who did not (

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IVF Did Not Increase Breast Cancer Incidence:

There was no increased risk for breast cancer among women who underwent in vitro fertilization (IVF) compared with other fertility treatments or with women in the general population, according to results of a cohort study. Looking at more than 19,000 women who underwent IVF between 1993 and 1995 and almost 6,000 women who underwent other fertility treatment between 1980 and 1995, researchers found that the rate of breast cancer per 100,000 women was 163.5 for IVF, 167.2 for non-IVF, and 163.3 for the general population. The study found a significant decrease in breast cancer among women who did not bear children (standard incidence ratio, 0.86), and lower risk among women who had undergone 7 or more IVF cycles (hazard ratio [HR], 0.55) compared with women who underwent 1 to 2 cycles (HR, 0.77).

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High Variability in Diagnosis of Dense Breasts:

When examining mammograms, radiologists’ interpretation of whether a woman had dense breasts varied widely from a rate of 6.3% to 84.5%, according to the results of a multicenter observational study. The study compiled data from 83 radiologists, each of whom interpreted at least 500 mammograms between 2011 and 2013. The study included 216,783 mammograms from more than 145,000 women. Overall, the study found that 36.9% of mammograms showed dense breasts. Certain woman in the study had multiple mammograms evaluated by different radiologists and 17.2% had disagreeing results.

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Guidelines Establish Minimum Negative Margins in DCIS:

A panel of experts from the American Society of Clinical Oncology, the Society of Surgical Oncology, and the American Society for Radiation Oncology recommended the use of 2-mm margins as a standard in breast conserving surgery for ductal carcinoma in situ (DCIS). The recommendation was based on margin width and ipsilateral breast tumor recurrence data from 20 published studies, and on the statistically significant decrease in ipsilateral breast tumor recurrence with 2 mm compared with 0 to 1 mm (odds ratio, 0.51;

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= .01).

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Breast Cancer CTCs Can Flip Between HER2 Negativity and Positivity:

Results of a small study showed that HER2-negative breast cancer tumors spontaneously flipped with populations of circulating HER2-positive cells. In a study of 19 women with ER-positive/HER2-negative disease, 84% had HER2-positive circulating tumor cells after multiple courses of therapy. The fraction of HER2-positive cells increased with disease progression. A subsequent mouse study showed that the combination of paclitaxel and either of two gamma secretase inhibitors significantly delayed the onset of tumor recurrence compared with paclitaxel alone.

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Genetic Test Could Identify Breast Cancer Patients at High Risk of VTE:

A population-based cohort study was able to identify breast cancer patients who were at high risk for venous thromboembolism (VTE) by stratifying patients by chemotherapy and genetic susceptibility. The study analyzed 4,261 women diagnosed with invasive breast cancer between 2001 and 2008 in Stockholm and followed patients until 2012. VTE occurred in 276 patients. Study researchers showed that chemotherapy (hazard ratio [HR],1.98; 95% CI, 1.40–2.80) and a polygenic risk score that included nine established VTE loci in the top 5% (HR, 1.90; 95% CI, 1.24-2.91) were independently associated with risk of VTE. The cumulative incidence was 9.5% in patients with both risk factors compared with 1.3% in those who had neither (

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Burden of Breast, Cervical Cancer Falls Mostly to Low-, Middle-Income Countries:

Although breast cancer is the most commonly diagnosed cancer in women in 140 countries, breast cancer survival in low- and middle-income countries is lower than in high-income countries. Cervical cancer is less common, but in countries in Sub-Saharan Africa it is the most common cancer diagnosed in women. Using data from long-standing high-quality population-based cancer registries, researchers have predicted that if rates are maintained at the level of 2012, the number of women diagnosed with breast cancer will increase to 2.4 million cases per year and those diagnosed with cervical cancer to 700,000 women per year by 2030.

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