nccn

FDA Update on Rare Breast Implant-Associated Type of Lymphoma

Posted by

0


The US Food and Drug Administration (FDA) has provided an update on breast implant–associated anaplastic large cell lymphoma.

In January 2011, the agency identified a possible associationbetween breast implants and the development of anaplastic large cell lymphoma (ALCL).

 Since then, “we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants,” the FDA said in a statement March 21.

Over 350 Cases, 9 Deaths

The FDA notes that most data suggest that BIA-ALCL occurs more often after implantation of breast implants with textured surfaces rather than those with smooth surfaces.

As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including 9 deaths. Of the 231 reports that included information on the implant surface, 203 concerned textured implants and 28, smooth implants.

Of the 312 reports that included information on implant fill types, 186 described implants filled with silicone gel and 126, implants filled with saline.

“It is important to note that details on breast implant surface and fill type are limited. While the MDR system is a valuable source of information, it may contain incomplete, inaccurate, untimely, unverified, or biased data,” the FDA says.

 During the last 6 years, a “significant body” of literature has been published on BIA-ALCL, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of the disease, the agency notes.  “All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants.”

Most cases of BIA-ALCL are treated by removal of the implant and the capsule surrounding the implant, and some cases have been treated by chemotherapy and radiation. However, because BIA-ALCL has “generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended,” the FDA said.

The exact number of cases of BIA-ALCL worldwide is unknown.

The FDA is continuing to collect and evaluate information about BIA-ALCL. For now, the agency recommends that clinicians who have patients with breast implants take the following action:

  • Be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast implants. Provide the manufacturer’s labeling as well as any other educational materials to your patients before surgery and discuss with them the benefits and risks of the different types of implants.
  • Consider the possibility of BIA-ALCL in a patient with late-onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. A patient with suspected BIA-ALCL should be referred to an appropriate specialist for evaluation. When testing for BIA-ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytologic evaluation of seroma fluid with Wright-Giemsa–stained smears and cell block immunohistochemistry testing for cluster of differentiation and anaplastic lymphoma kinase markers.
  • Develop an individualized treatment plan in coordination with the patient’s multidisciplinary care team. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation  or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach.
  • Report all confirmed cases of ALCL in women with breast implants to the FDA’s MedWatch system.

Source:medscape.com

Clinicians Face Challenges in the Management of Cancer-Related Anemia

Posted by

0



The management of anemia in patients with cancer presents challenges from a clinical, operational, and economic perspective.  Over the past several years, new paradigms have emerged for the treatment of cancer- and chemotherapy-induced anemia, specifically regarding the use of blood transfusions, erythropoiesis stimulating agents (ESAs), and iron supplementation.  In a recent report by NCCN, which will be featured this fall in a Special Pharmacy Edition of JNCCN – The Journal of the National Comprehensive Cancer Network, these clinical and operational issues are examined and recommendations and best practices to address these areas are considered.

The management of blood products is a priority for NCCN Member Institutions (as well as other institutions), as they are associated with risks and significant monetary cost. The report details an NCCN Member Institution’s initiative to reduce the use of blood products, which resulted in a decrease in the total cost of blood products from $12.2 million to $9.8 million, a savings of $2.4 million over the course of three years.  Results from a survey of NCCN Member Institutions regarding practice patterns and policies for the use of blood products are also included in the report.

The use of ESAs in the management of cancer-related anemia is a major challenge for clinicians in this changing landscape.  Recent modifications to both clinical and reimbursement models have limited the use of these agents in the United States and ultimately lead to the Food and Drug Administration (FDA) requiring ESAs to have a Risk Evaluation and Mitigation Strategy(REMS).  According to a recent NCCN Trends™ Survey, clinicians in the United States report an overall decrease in the use of ESAs over the past two years; conversely, international respondents report an overall increase or no change in ESA use during that same time period.  NCCN previously reported a more detailed summary of these results.  An interesting finding, further described in the report, is that utilization of supplemental iron and blood products appears to have increased in light of recent restrictions on ESA use.

A survey of NCCN Member Institutions Pharmacy Directors intended to identify patterns and challenges for the use of ESAs and blood products is detailed in the report.  Further, the NCCN Pharmacy Directors provide their insights on the current practice of iron supplementation in patients with cancer-related anemia and barriers to adequate supplementation.

SOURCE: NCCN