Monday, September 10, 2018

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): "Where we are, and aren’t"

By: Constantine Kaniklidis Medical Research (Cancer Knowledge network) & Director of No Surrender Breast Cancer Foundation (NSBCF)-- circa 2018, September

Here some reflections, and a plea for further, more systematized and coordinated action and consensus:

First, the just published LYSA Registry data from the French Cancer Agency [reported at ASCO 2018] has shed some further light on two prognostically distinct classes of BIA-ALCLs (based on effusion, breast tumor mass, and lymph node involvement), with in situ BIA-ALCLs exhibiting an indolent clinical course that enables complete remission typically after implant removal, in contrast to infiltrative BIA-ALCLs exhibiting a more aggressive clinical course, with in fact a prognosis virtually identical to systemic anaplastic large cell lymphoma (ALCL), despite real differences. Further clarification was provided in AU-NZ studies [especially Loch-Wilkinson, Plast Reconstr Surg. 2017 Oct], higher-surface-area (HAS) textured implants significantly increased the risk of BIA-ALCL (over 14 times higher with Biocell textured implants and almost 11 times higher with polyurethane (Silimed) textured implants compared with Siltex textured implants, so there clearly is a risk hierarchy at play here.

Second, being mindful of overtreatment (always a concern), nonetheless given that BIA-ALCL related death, although rare, is predominantly due to uncontrolled local disease progression, there is a role in patients with more advanced local disease – particularly in the minority of patients whose disease extends beyond the capsule – for chemotherapeutic intervention, and at this time the best evidenced first-line therapy apart from the strongly toxic CHOP family of regimens is the monoclonal antibody brentuximab vedotin (Adcetris) based on its role in refractory in ALCL, despite the limited but still positive data of its off-label use in BIA-ALCL; and I have seen some cases of patients progressing on CHOP therapy but achieving pathological complete response (pCR) with brentuximab vedotin in the second line. Given its comparatively favorable side effect profile and higher tolerability over traditional chemotherapies, it retains some considerable appeal.

Third, for myself, given that:
(1) the NF-kB) pathway is commonly deregulated in lymphomas, and that
(2) curcumin can inhibit growth of these cell lines and increase their chemosensitivity to cisplatin, and given also that
(3) it (curcumin) increases apoptosis and differentiation of vitamin D-treated tumor cells, with direct binding of curcumin to the vitamin D receptor (VDR), and that
(4) curcumin modulates the well-known overexpression of EZH2 in anaplastic lymphomas and can down-regulate the  JAK/STAT pathway that is also incriminated in BIA-ALCL, then I have (strictly ad hoc-ly and off-label) counseled the deployment, with provisional but promising success, of a regimen of high-penetrance curcuminoids (either phytosomal or nanoparticulate) and optimal-dosed Vitamin D3 (achieving 25(OH)D assay levels of at least 66 ng/ml and above), in the small number of BIA-ALCL cases I have consulted on, but clearly this requires validation in clinical trial. And Mark Clemens' recent findings suggesting that some BIA-ALCL are associated with a chronic allergic immune response to currently undetermined antigen(s) - with IL-13 activity (associated with allergic inflammation) as well as eosinophils and mast cells surrounding the BIA-ALCL tumors plus the presence of IgE – is tantalizing in this connection of anti-inflammatory interventions.

Going Forward, Work Still To Do:
1.     I am also looking to press for the expansion of the European Commission Medical Device Expert Group (VMDEC) Task Force with respect to collection and analysis of EU-based BIA-ALCL cases, but VMDEC registry data must be coordinated with other non-EU entities – like the PROFILE Registry maintained by the The Plastic Surgery Foundation here in the States, the Australian Breast Device Registry,  among many others – if we are to establish a larger and more comprehensive cross-boundary collaborative BIA-ALCL surveillance initiatives to advance our knowledge and better serve the many women affected (and often overlooked and sometimes misdiagnosed as Hodgkin lymphoma or other entities).

2.     It is disconcerting that we still, even in 2018, lack consistent standardization and reporting regarding pathological examination of mammary implants (most institutions often continue to recommend gross examination alone).

3.     Furthermore, we are not doing enough to educate patients and their health professionals on the importance of routine surveillance after implantation.

4.     And we must finally – long overdue -bring explicit consent issues to the fore to assure fairness to patients. It would appear that most breast-focused plastic surgeons in the U.S. and the UK fail to consistently include risk of BIA-ALCL and that uniform informed-consent documents lack widespread adoption and use, so a model BIA-ALCL informed consent is required and effective efforts made to assure that the patient is not simply “allowed” to read and decipher the information as it is found in the informed consent agreement as is all too commonly the case, but that health professionals first openly and candidly discuss not only the risk of BIA-ALCL but also the common presenting symptoms (a mass, breast swelling/pain, or delayed-presentation seroma / effusion) of BIA-ALCL the patient should be on guard for which would trigger a mandated evaluation. I call this the need for “informed discussion” in addition to mere “informed consent”, and that need was best put by the UK High Court (Judgement in Montgomery ‘v’ Lanarkshire Health Board) that stated that “risk shouldn't be a numbers game, it should be part of dialogue”.

Constantine Kaniklidis of
Director, Medical Research, No Surrender Breast Cancer Foundation (NSBCF)
Oncology Reviewer, Current Oncology
Member, Society for Integrative Oncology (SIO)
European Association for Cancer Research (EACR)

Thursday, August 9, 2018

To Reconstruct or NOT to Reconstruct... That is the Question

An excerpt from "​Breast Cancer Survival Guide" by: Lisa Vento Nielsen

When you are preparing for a mastectomy, part of the process is meeting with a plastic surgeon as one of the "benefits" of getting breast cancer is new boobs. Even if just one boob is trying to kill you, you can get the poisoned one replaced and the other one can be lifted and improved, too - all covered by insurance (if you are lucky enough to have insurance, of course).

I kind of felt from before I was even diagnosed at each screening mammo that I would not reconstruct. I always felt just the idea of boobs and dealing with the screening was work enough and often thought we should all just get the boobs removed because what is the point of carrying around things that so obviously is unclear as to what causes them to get diseased. As I mentioned,  I have no history of the disease and no known risk factors and yet here I am someone with dealing with breast cancer.

I am lucky though - lucky that I had screening mammos that began at 34 and not the new ruling of 40 and up because I was diagnosed literally on the eve of my 40th birthday after some inflamed ducts at my screening at 38 put me on the 6 month squeeze plan. From my previous scan at 38 that showed minor inflammation in the duct of my right breast, which is common to breast feeding and too small to biopsy oh and had a 99% chance of staying benign was within 6 months a tumor and definitely malignant.

It would ultimately turn out to be 5.6cm of cancer with 5 of 25 lymph nodes infections - otherwise knows as Stage 3 Cancer. From diagnosis to surgery, I had only 17 days. 17 days to figure out what exactly was going on in my body - all of which was truly not known until I was operated on but more on that journey in another post.

For now, the perks of breast cancer is getting that appointment with the surgeon to pick out your new boobs. I was first told about this new process by which they take fat from other parts of your body to reconstruct your breast and when the surgeon asked to see me disrobed, her first words were "You are obviously not a candidate for the fat shifting procedure." And I said, "Why because I am too skinny??" Note: I have never been too skinny for anything. She stared at me and said, "No - it is just too risky for you with xyz condition."

On that note, I was shown before and after pictures of her work and although impressive, I did not see me in those pictures. As someone who since puberty did enjoy having boobs and wearing low cut tops now as a mom of 2 and someone whose decollete was trying to kill me, I was really in the flat camp for boobs.

I did not think it through as clearly as I could have as I was going to still have a boob - and be uneven in an extreme way. I always had one boob that was bigger than the other but I did not really process how I would now just have one boob. Period.

The nurse in the office did try to get me to see the error of my ways - she said the normal about how I was so young and would want to have the appearance of two breasts and even the office acknowledges that the surgery does not give you a normal breast - just the appearance in clothes of having normal breasts.

It seems all selfish of me to put myself under for a longer amount of time, to delay my chemotherapy and to go in for additional surgeries just to have the appearance of breasts. I was ultimately at peace with refusing the reconstruction of the diseased boob and makeover of the other.

Now, I will not say I regret it but having to do these extra steps to be people-ready is very annoying. I would often run out without wearing a bra even though my boobs were not perky and camera ready and one thing I really do lament is not getting a picture of my boobs when I had the pair I was born with but you do not get to where I have been in life without learning the issues of leaked nude photos so I just have the pics of cleavage that I often showed and no real idea of what the missing boob really looked like besides a faint memory.

Over all, I am happy with my one boob and my prosthetic but I do see maybe down the road going for the reconstruction (one other perk is you can do it at a later date, if you so choose so the window on my reconstructing is not yet closed).

The key is beating the disease, of course, but sometimes, you really want to look hot doing it and it can be hard to look hot when you are lopsided because your prosthetic won't sit right in its pocket. Just something else to manage in the time between.


Lisa Vento Nielsen, MBA, PMP is a speaker, author, career expert and cancer survivor. She has expertise and first hand experience in how to get back to “normal” after illness. Her blogs and writings are read by over 2000 people per week. She created a nonprofit foundation focused on educating cancer survivors on getting their balance after cancer.  Lisa is also a volunteer and ambassador of NYCRA (NY Cancer Resource Alliance), a contributing writer in the 911Cancer Resource website and has recently been elected to co-manage the Awareness for a Cure's post- cancer educational program.

Tuesday, July 31, 2018

Cancer Alert: Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

From Fios1 /9-7-2018

Note: This article is an overview reflecting a recent health alert from various medical centers and clinicians about a possible cancer risk resulting from a specific type of breast implant.  If you may recognize yourself to be a candidate or have received a similar notice from your reconstructive surgeon, please contact your physician to get more details.

Press Release PDF

Since 2011, the FDA identified a confirmed link to a specific type of breast implant and breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL - a form of cancer of the immune system called non-Hodgkin’s lymphoma.  The World Health Organization (WHO) describes BIA-ALCL as a T-cell lymphoma that may arise within 7-8 years after the insertion of breast implants with textured surfaces.  Half of the reported cases were diagnosed with persistent SEROMA, a buildup of fluid around the implant region (see image) and presenting symptoms of swelling, pain, and redness and breast asymmetry of the affected breast.

By 2017, 359 cases of ALCL has been reported thus far and 9 deaths (2.5%) have been identified since the inception of this study where the majority of cases reported had textured implants versus smooth implants.  The very texture of the implant's coating has been said to cause inflammation and scarring that can led to lymphoma, while others attribute the texture to trap bacteria which leads to cancer.

According to the FDA, certain manufacturers have been reviewed and connected with implant-specific risks since 1999 associating their textured implants with ALCL.  Worldwide, approximately 1.4 million breast augmentations were performed in 2015. In the United States, 290,467 breast augmentations were performed in 2016; this represented a 37% increase from 2000.  BIA-ALCL most commonly occurs in patients of a median age of 52 years. The median time interval between breast implant and diagnosis is 9 years and ranges from 1 to 32 years.

Jennifer Cook, a diagnosed victim-turned advocate of BIA-ALCL awareness is promoting a global mission and educational program to support all women who are potential sufferers of this problem. "...there is extreme urgency because this disease can go from being curable with surgery to a disease that may take your life quickly-- because it's advanced...(in) a matter of a few months." In a private interview, she detailed her personal research and her actual experience of self-checking and finding anomalies and unusual feelings that breast surgeons addressed only with minimal concern. Her pro-activeness and perseverance led her to a powerful direction of self-preservation. "it was the biopsy of that lump that led to my diagnosis. I actually had a mass that was diagnosed before the explant ... like most cancers, you know the sooner you get to it, the much better chances you have.  The situation is obviously a huge concern because currently experts are advising women who test negative, that their seromas are benign and that they do not necessarily need to have their implants removed. We feel that this is misleading given the fact that at least five women we know of have recently had negative fluid but positive capsules."

Because BIA-ALCL has generally only been identified in patients with late onset of symptoms, implant removal in patients without signs or symptoms is not recommended.  Clinicians like Dr. Robert Bard (Bard Cancer Diagnostics, NYC) recommends a regular monitoring schedule for any adjustments or shifts in the current stasis of the implant and its surrounding area. "Fluid build up may be easily imaged by 3D sonography although it can be detected by MRI scans as well (9). Under ultrasound guidance, fluid may be aspirated and analysed in real time without rupturing the implant or puncturing nearby arteries."

It has been noted that among operable patients, total capsulectomy with removal of suspicious lymph nodes is the first line of treatment and complete surgical excision (capsulectomy and implant removal) resulted in better overall survival and event-free survival compared to patients who underwent a limited surgery or treatment with systemic chemotherapy or radiation therapy.

Crusader Spotlight: 
By Jennifer Hunt

In 2010, I was diagnosed with DCIS breast cancer contained within my milk ducts. Though not an aggressive cancer, I proactively elected to pursue the route of a double mastectomy over the arduous process of a lumpectomy and radiation and 5 years of Tamoxifen- knowing the risk of recurrence.  After surgery, I was encouraged by a plastic surgeon to the direction of taking on these new textured silicone implants; they don’t rupture and don’t move around once implanted.

Now 8 years later I received a letter from my plastic surgeon saying that the  textured type of implants I received can cause ALCL cancer around 7-8 years after implantation. They recommend waiting and seeing if it happens then remove and treatment would be chemotherapy. That seemed crazy to me (waiting until I get cancer) and I didn’t want to have a risk of getting cancer again now the implants I got for reconstruction could cause a whole new cancer. Had I been told there was a risk of this when I chose to get implants, I would have never picked them. And the second part of my problem is my plastic surgeon no longer takes my insurance and won’t see me unless I pay out of pocket and I don’t think it’s fair that I should have to pay out of pocket to fix a problem that I didn’t cause. After doing research on BIA-ALCL, they have apparently known about this since 2011- and I was just notified in June 2018.   I don’t believe all women who have these implants know about this yet.  What's more, they are still selling them and I don’t know why someone is not putting a stop to this.  I hope that sharing my story will help other women to be aware of this. 

About the Writer:
Mrs. Jennifer Hunt of Long Island is an 8 year breast cancer survivor turned advocate for breast cancer awareness and a fundraiser for LI2DAY.  She is also the co-founder of a Long Island based patient support resource (Fight Cancer Like a Girl Group) working with newly diagnosed women on Long Island.   Also see: Survivor Stories (Feature story of Jennifer Hunt)










9) Bard R, 8th International Workshop on PET in lymphoma, Menton, France 2018

10) ALCL In Women With Breast Implants BIA-ALCL:


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Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): "Where we are, and aren’t"

By: Constantine Kaniklidis  Medical Research ( Cancer Knowledge network ) & Director of No Surrender Breast Cancer Foundation (NSBCF) --...