Additional Cancers Linked to Breast Implants

 The FDA issued a safety communication that cancer cases, including squamous cell carcinomas (SCC) and other lymphomas, have been linked to scar tissue around breast implants.

The pathology of these cases differs than that of anaplastic large lymphomas linked to breast implants a decade ago.

A preliminary review of published literature found fewer than 20 cases of SCC and fewer than 30 cases of various lymphomas in the scar tissue around the implant.

Women who have had implants should be aware of symptoms of cancer, which include swelling, pain, lumps or skin changes, the FDA said, noting that some cases emerged years after women received their implants. The SCC cases were linked to both textured and smooth implants, and saline and silicone implants.

FDA warns breast implants linked to rare form of cancer

The Food and Drug Administration (FDA) issued a letter warning health care professionals to check women with breast implants for Anaplastic Large Cell Lymphoma (BIA-ALCL) a rare cancer that usually arises in the scar tissue that forms around implants.

The FDA said at least 457 women in the United States have so far been diagnosed with anaplastic large cell lymphoma, and nine women have died from the disease. Though the number of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL.

In most of the cases the patients were diagnosed with BIA-ALCL due to symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid, or masses surrounding the breast implant. Cytological examination of the fluid and histologic examination of the capsule surrounding the breast implant can lead to the BIA-ALCL diagnosis.

The FDA is asking health care providers to report cases of BIA-ALCL in patients with breast implants. The FDA request health care providers with questions to either email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, or call 1-800-638-2041 or 301-796-7100.

Top Three Posts

In the past three years I uploaded 101 posts in Radiology Weekly.  The top three in order of viewing frequency were:

Risk of Stroke due to Intracranial Atherosclerosis

http://radiologyweekly.blogspot.com/2014/05/risk-of-stroke-due-to-intracranial.html

iPad is Accurate in the Diagnosis of Bone Fractures

http://radiologyweekly.blogspot.com/2014/08/ipad-is-accurate-in-diagnosis-of-bone.html

Circulating Tumor Cells Culture Promises Individualized Testing and Treatment 

http://radiologyweekly.blogspot.com/2014/07/circulating-tumor-cells-culture.html

Most visitors to my blog were from United States, Greece, Russia, France, Poland, Ukraine, Turkey, United Kingdom, Ireland and China in that order. 

I am sure some of you have noticed that I am not true to my original intention of posting weekly.  Starting with this post and into the future I will continue uploading on the 1^st of each  month. 

I wish you all and your families a Happy New Year.

MR–guided Focused Ultrasound a Palliative Treatment for Painful Bone Metastases

In a study published by the Journal of National Cancer Institute Hurwitz et al report on findings of a multicenter phase III trial regarding the efficacy and safety of magnetic resonance-guided focused ultrasound (MRgFUS), for palliation of pain due to bone metastases.

One hundred forty-seven patients were enrolled, with 112 and 35 randomly assigned to MRgFUS and placebo treatments, respectively. The 147 patients were treated in 17 centers in the U.S., Canada, Israel, Italy and Russia. Response rate for the primary endpoint, improvement in self-reported pain score without increase of pain medication 3 months after treatment, was 64.3% in the MRgFUS arm and 20.0% in the placebo arm (P < .001). MRgFUS was also superior to placebo at 3 months on the secondary endpoints assessing worst score Numerical Rating Scale for pain (NRS) and morphine equivalent daily dose intake (P < .001) and Brief Pain Inventory (BPI-QoL), a measure of functional interference of pain on quality of life (P < .001). The most common treatment-related adverse event was sonication pain, which occurred in 32.1% of patients. Two patients had pathological fractures, one patient had third-degree skin burn, and one patient suffered from neuropathy. Overall 60.3% of all treatment-related adverse events resolved on same day the sonication treatment was delivered.

The authors concluded that MRgFUS, a non-invasive technique, can relieve pain and improve function in most patients with skeletal metastases who have failed standard treatment such as radiation therapy.

Monitoring Metastatic Breast Cancer with Circulating Tumor DNA

Dawson et al in a NEJM article report on their research on monitoring tumor burden on patients with metastatic breast cancer by means of detecting circulating cell-free DNA carrying tumor specific alterations.

A total of 52 women with metastatic breast cancer were recruited, 30 of whom had genomic alterations suitable for monitoring. Serial blood samples were collected at intervals of 3 or more weeks. Computed tomography (CT) was performed to document response to treatment. They compared the radiographic imaging of tumors with the assay of circulating tumor DNA, CA 15-3, and circulating tumor cells in the 30 women who were receiving systemic therapy. They used targeted or whole-genome sequencing to identify somatic genomic alterations and designed personalized assays to quantify circulating tumor DNA in collected plasma specimens. CA 15-3 levels and numbers of circulating tumor cells were measured at identical time points.

Circulating tumor DNA was successfully detected in 29 of the 30 women (97%) in whom somatic genomic alterations were identified; CA 15-3 and circulating tumor cells were detected in 21 of 27 women (78%) and 26 of 30 women (87%), respectively. Circulating tumor DNA levels showed a greater dynamic range, and greater correlation with changes in tumor burden, than did CA 15-3 or circulating tumor cells. Among the measures tested, circulating tumor DNA provided the earliest measure of treatment response in 10 of 19 women (53%).

Metastatic breast cancer remains an incurable but treatable disease.  Effective monitoring of treatment response is essential in order to avoid continuing ineffective therapies and to prevent side effects.  Their research showed that circulating tumor DNA is an informative, specific, and sensitive biomarker of metastatic breast cancer.

Breast Conservation Therapy provides Better Survival for Early Stage Breast Cancer

Reseach by Agarwal S, et al published in JAMASurgery reports on an analysis of 132 149 patients who were followed between the years 1998 and 2008.  

Breast conservation therapy (lumpectomy and radiation therapy) was used to treat 70% of patients, mastectomy alone was used to treat 27% of patients, and mastectomy with radiation was used to treat 3% of patients. The 5-year breast cancer–specific survival rates of patients who underwent BCT, a mastectomy alone, or a mastectomy with radiation were 97%, 94%, and 90%, respectively (P < .001); the 10-year breast cancer–specific survival rates were 94%, 90%, and 83%, respectively (P < .001). Multivariate analysis showed that women undergoing BCT had a higher survival rate than those undergoing mastectomy alone (hazard ratio, 1.31; P < .001) or mastectomy with radiation (hazard ratio, 1.47; P < .001). 

The authors conclude that patients who underwent BCT versus mastectomy alone or mastectomy and radiation therapy for early stage invasive ductal cancer- defined as having a tumor size of 4 cm or smaller and 3 or less positive lymph nodes- have higher breast cancer specific survival.

Agarwal S, Pappas L, Neumayer M et al; Effect of Breast Conservation Therapy vs Mastectomy on Disease-Specific Survival for Early-Stage Breast Cancer.  JAMA Surg. Published online January 15, 2014

doi:10.1001/jamasurg.2013.3049