FDA Approves High-Tech Breast Imaging System

“After more than a decade of development and data-gathering—including breast scans on nearly 700 women and 79 patents issued—the U.S. Food and Drug Administration has approved a breast-cancer imaging system invented by a University of Rochester Medical Center professor.

“FDA approval of the breast scanner is the latest in a long line of URMC technologies that have been licensed and marketed, including cancer and pediatric vaccines.

“The professor, Ruola Ning, Ph.D., is president and founder of Koning Corporation, a URMC startup company. The FDA’s action allows Koning to begin commercial distribution of its Koning Breast CT (KBCT) system. Koning’s medical device passed the FDA’s most stringent premarket approval process, which requires extensive clinical study.

“Currently, the KBCT is not intended to be used for breast cancer screening, or to replace mammography. It is for diagnosing cancer in women who have signs or symptoms of the disease, or who have abnormal findings after a standard screening mammogram. For these more complex cases, the KBCT was found to be safe and effective for diagnostic use.”


Better Mammography Technique for Women with Dense Breast Tissue

“A new breast imaging technique pioneered at Mayo Clinic nearly quadruples detection rates of invasive breast cancers in women with dense breast tissue, according to the results of a major study published this week in the American Journal of Roentgenology.

“Molecular Breast Imaging (MBI) is a supplemental imaging technology designed to find tumors that would otherwise be obscured by surrounding dense breast tissue on a mammogram. Tumors and dense breast tissue can both appear white on a mammogram, making tumors indistinguishable from background tissue in women with dense breasts. About half of all screening-aged women have dense breast tissue, according to Deborah Rhodes, M.D., a Mayo Clinic Breast Clinic physician and the senior author of this study.

“MBI increased the detection rate of invasive breast cancers by more than 360 percent when used in addition to regular screening mammography, according to the study. MBI uses small, semiconductor-based gamma cameras to image the breast following injection of a radiotracer that tumors absorb avidly. Unlike conventional breast imaging techniques, such as mammography and ultrasound, MBI exploits the different behavior of tumors relative to background tissue, producing a functional image of the breast that can detect tumors not seen on mammography.”


Breast Cancer Diagnoses, Survival Varies by Race, Ethnicity

The gist: A recent study found that a breast cancer patient’s race and ethnicity might affect whether they are diagnosed at an early stage. Race and ethnicity might also affect how long a patient survives after a stage I diagnosis.

“Among nearly 375,000 U.S. women diagnosed with invasive breast cancer, the likelihood of diagnosis at an early stage, and survival after stage I diagnosis, varied by race and ethnicity, with much of the difference accounted for by biological differences, according to a study in the January 13 issue of JAMA.

“In the United States, incidence rates of breast cancer among women vary substantially by racial/ethnic group. Race/ethnicity and sociodemographic factors may influence a woman’s adherence to recommendations for clinical breast examination, breast self-examination, or screening mammogram and the likelihood of her seeking appropriate care in the event that a breast mass is noticed. A growing body of evidence suggests that biological factors may also be important in determining stage at diagnosis (i.e., the growth rate and metastatic potential of small-sized breast cancer tumors may vary between women due to inherent differences in grade and other or unknown pathological features), according to background information in the article…

“The authors write that much of the difference in diagnosis and survival could be statistically accounted for by intrinsic biological differences such as lymph node metastasis, distant metastasis, and triple-negative behavior of tumors…

” ‘Access to the use of genetic or molecular markers to guide choice of targeted therapy and reduce the costs of care can be made more equitable. For women with triple-negative disease, access to prompt diagnosis and initiation of chemotherapy can be lifesaving because these tumors metastasize early. Closing the survival gap will only occur once health care leaders initiate system changes that improve access to high-quality care along with a more comprehensive study of breast cancer biology through inclusion of a substantial number of minority patients in ‘omics’ research and in clinical trials.’ “


Novel Imaging Technique Improves Prostate Cancer Detection

The gist: A new imaging technique might help doctors more accurately diagnose the severity of prostate cancer. This could help them more effectively choose the right treatment for a patient.

“In 2014, prostate cancer was the leading cause of newly diagnosed cancers in men and the second leading cause of cancer death in men. Writing in the January 6, 2015 issue of the journal Prostate Cancer and Prostatic Disease, a team of scientists and physicians from the University of California, San Diego School of Medicine, with counterparts at University of California, Los Angeles, describe a novel imaging technique that measurably improves upon current prostate imaging – and may have significant implications for how patients with prostate cancer are ultimately treated.

” ‘This new approach is a more reliable imaging technique for localizing tumors. It provides a better target for biopsies, especially for smaller tumors,’ said Rebecca Rakow-Penner, MD, PhD, a research resident in the Department of Radiology and the study’s first author.

“The technique is also valuable in surgical planning and image staging, said David S. Karow, MD, PhD, assistant professor of radiology at UC San Diego and the study’s corresponding author. ‘Doctors at UC San Diego and UCLA now have a non-invasive imaging method to more accurately assess the local extent of the tumor and possibly predict the grade of the tumor, which can help them more precisely and effectively determine appropriate treatment.’ “


'Screen More' for Cancer Risk Genes

“Mutations in BRCA genes can give women up to an 80% chance of developing breast cancer.

“A trial involving 1,034 Ashkenazi Jews, who are at high risk, suggested more than half of their cases were not being picked up under the current NHS guidelines.

“The Eve Appeal charity said wider testing would save lives and money.

“Mutations in BRCA genes stop DNA repairing itself and increase the risk of cancer developing.

“As well as breast cancer, they are also linked to ovarian and prostate cancers.”


Super Patient: Wade Hayes Beats Stage IV Colon Cancer—Twice


Country musician Wade Hayes had no idea he had colon cancer until it was almost too late. He’d had telltale signs: bleeding and lethargy—which is caused by anemia due to blood loss—for a couple of years. But these symptoms began when he was only 40 years old, a decade younger than when initial colon cancer screening is recommended. And he had no family history of the disease. Taking all of this into account, a doctor friend attributed Wade’s bleeding to his heavy weightlifting. Continue reading…


PCA3 May Have Role Predicting Prostate Biopsy Outcome

“The use of a prostate cancer antigen 3 (PCA3) urine test could help men avoid undergoing unnecessary repeat biopsies, and could help physicians predict which men undergoing initial biopsy will be positive for cancer.

“John T. Wei, MD, of the University of Michigan, and colleagues published the results of the National Cancer Institute Early Detection Research Network validation of PCA3 trial in the Journal of Clinical Oncology.

“According to Wei, how physicians decide to send a patient for prostate biopsy is continuing to evolve. Although in the past, an abnormal PSA test resulted in an order for a biopsy, the discovery and validation of new biomarkers is changing that precedent.

“ ‘Prostate cancer tests such as the PCA3, an FDA approved, commercially available urine assay for prostate cancer, are allowing doctors to more accurately determine if a man has prostate cancer prior to a biopsy,’ Wei told Cancer Network. ‘Based on our findings, using PCA3, many fewer men will need to undergo a repeat prostate biopsy. On the other hand, PCA3 may also indicate an elevated risk of prostate cancer in other men, prompting them to undergo a prostate biopsy when its needed.’

“In the study, Wei and colleagues evaluated 859 men scheduled for diagnostic prostate biopsy between 2009 and 2011. The researchers evaluated whether the PCA3 urine test had a high positive predictive value at initial biopsy and a high negative predictive value at repeat biopsy.”


When Fighting Lung Cancer, Every Cancer Is Personal

“Larry Dry’s lung cancer was discovered by accident. The husky, physically active 69-year-old had no cough, no breathing problems, only a little tingling in one hand. When his doctor ordered an X-ray before surgery for a pinched nerve, he wasn’t thinking lung cancer. Dry hadn’t smoked in 40 years and a chest X-ray taken less than a year earlier had been perfectly clear. But the new X-ray contained ghostly images of large nodules. Non-small cell lung cancer. Stage IV, the most advanced kind. Eight months of gut-wrenching chemotherapy shrank the tumors, but they quickly rebounded. A second, less toxic drug didn’t work.

“Kathy Dry, a former CDC employee, asked the doctor if there wasn’t something else for her husband, perhaps something at Emory. And that was how, in July 2013, Dry met Winship Cancer Institute oncologist Suresh Ramalingam, professor and director of Winship’s Lung Cancer Program. Dry quickly entered one of the 20 to 30 ongoing lung cancer clinical trials underway at Winship, thanks to Winship’s status as Georgia’s only National Cancer Institute-designated cancer center. Dr. Ram, as his patients call him, is principal investigator of a multi-institutional Phase II trial testing the efficacy of a new class of immunotherapy cancer drugs, drugs that stimulate the immune system to attack cancer cells while sparing healthy ones.

“Every two weeks, Dry met with Ramalingam and Colleen Lewis, nurse practitioner in Winship’s busy clinical trials unit, and spent an hour in Winship’s infusion center. A huge benefit of the new immunotherapy treatments, says Ramalingam, is how well they are tolerated. Dry’s previous chemotherapy caused constant diarrhea. The new treatment only caused occasional gastrointestinal upset and he was able to regain lost pounds and his trademark energy. His tumors shrank by more than half and stayed that way for 11 months.

“Thanks to their experience at Winship, Kathy Dry encourages people with lung cancer not to give up. There is hope, she says.”


Patients with Lung, Colon Cancers Often Not Informed about Clinical Trials

The gist: Clinical trials are research studies with volunteer patients. They can be important treatment options for some people with lung cancer, but a recent survey shows that many doctors do not discuss them with newly diagnosed patients.

“The majority of patients with newly diagnosed lung or colorectal cancers do not have discussions with their care team about clinical trial participation, according to survey results.

“The finding suggested limited patient awareness may be a considerable barrier to trial enrollment, researchers wrote.

“Kenneth L. Kehl, MD, and colleagues surveyed a multiregional cohort of patients with lung or colorectal cancers 3 to 6 months after diagnosis.

“Researchers asked patients or their surrogates whether they learned clinical trial participation might be an option and, if so, with whom they discussed that possibility. The investigators also evaluated the associations between specific patient characteristics and the likelihood they had discussions with providers about clinical trial participation.

“The analysis included data from 7,887 survey participants. Of them, 1,114 (14.1%) indicated they had discussed the possibility of clinical trial participation, and the majority indicated they learned of that option from their physicians.”