Herceptin and HER2 Positive Breast Cancer – Is It Effective – Part Two
Because I like to keep you updated with the latest information and research, this post is a follow up to my post “Herceptin and HER2 + Breast Cancer – Is It Effective?” dated 2/18/2014. Since writing that post, I have read some newer research and I wanted to share this with you.
A Synopsis Of My Last Post…
In my February 2014 post I referred to one study done in 2002 1 in which 114 women, all of whom had metastases to other parts of their bodies, were given only Herceptin to treat their HER2 positive breast cancer. The researchers reported that seventeen (57%) out of thirty patients had an objective response (which means either a partial or complete response) and twenty-two (51%) out of forty-three patients had what was termed a clinical benefit, an informal term which generally means anything other than progression of disease. These patients also did not experience progression of disease at the follow-up appointment scheduled 12 months later. Loosely translated, this means that roughly fifty percent of women with metastatic, HER2 positive breast cancer, treated only with Herceptin, remained alive after twelve months.
An Update Of The HERA Trial
The other article I referenced which appeared on the National Cancer Institute website 2 in 2011 discussed the Herceptin Adjuvant (HERA) trial, run by the Breast International Group beginning in 2001. At the time of reporting the HERA trial was not complete. We now have the final results of the HERA trial which was carried out for 8 years.
After finishing surgery, chemotherapy and/or radiotherapy, 5102 women with HER2 positive breast cancer were randomly assigned to one of three groups. In the first group 1703 patients received trastuzumab (Herceptin) every 3 weeks for 1 year, a second group of 1701 patients were treated with Herceptin for 2 years, and in the third group 1698 patients were merely observed and given no Herceptin. After the initial results of the study were released in 2005 the observation group was offered the chance to be moved into one of the two groups receiving Herceptin.
One of the reasons the HERA trial was conducted was to decide how long Herceptin should be given to achieve the best, disease free survival. In terms of percentages, 75.8% of women who took Herceptin for two years were still alive, and 76% of women who took Herceptin for one year were still alive. So taking the drug for an additional year conferred no extra benefits. As a result of this study, most oncologists recommend that Herceptin be taken for one year.
The Latest Research
In my previous article about the efficacy of Herceptin I didn’t give a very glowing report and indeed, the statistics weren’t all that impressive, at least not to my eyes.
Unfortunately we don’t have any research indicating what a good healthy diet and specific supplements would do for women with HER2 positive breast cancer, no one will be funding THAT study.
In the meantime I have had some newer research put in front of me by an interested reader, which study was reported in the New England Journal of Medicine earlier this year. 3 This research study followed 406 node-negative (meaning cancer had not spread to their lymph nodes) women with stage 1, HER2 positive breast cancer. These women had tumors up to 3 cm in size and were treated with a combination of paclitaxel (Taxol) and Herceptin weekly for 12 weeks, followed by 9 months of Herceptin alone. The 3 year survival rate was 98.7%, a much more impressive figure.
To see the full results of the trial, check out “Clinical practice-changing trials: the HERA study paradigm”4 below. It’s a downloadable PDF file. See especially Table 1 Efficacy Results Of The Herceptin Adjuvant Study With Different Follow-Up Times, page 3 of that document. You can draw your own conclusions.
Word Of Caution
I’d like to insert a couple of things here, just a tiny word of precaution. Take into account, please, that the research was supported by Genentech, the company that stands to gain the most by the research. Also please note that in the 2015 research the women who took part in the study were considered stage 1, their tumors were small and the disease had not spread elsewhere in the body. These are the women who have the best chance of survival anyway, their disease being caught early.
Another thing to consider is that both Taxol and Herceptin can be very hard on the heart. Nine patients (true, a relatively small percentage, only 0.54%, but if you’re one of those women…) in the HERA trial who received Herceptin developed severe congestive heart failure. Even the researchers in the 2015 study 3 stated “the decision to use trastuzumab and chemotherapy is influenced by the toxicity of the treatment regimen.”
This cardiotoxicity may or may not be reversible. If you are considering going on this drug, it might be wise to consult a naturopath for correct dosages of cardio-protective supplements, such as CoQ10, garlic and grapeseed extract.
1. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer – http://www.ncbi.nlm.nih.gov/pubmed/11821453
2. Trastuzumab after Chemotherapy Is Effective in HER2-Positive Breast Cancer – http://www.cancer.gov/types/breast/research/trastuzumab-after-chemo
3. Adjuvant Paclitaxel and Trastuzumab for Node-Negative, HER2-Positive Breast Cancer – http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4313867/
4. Clinical practice-changing trials: the HERA study paradigm — http://www.researchgate.net/profile/Dimitrios_Zardavas2/publication/258057600_Clinical_practice-changing_trials_the_HERA_study_paradigm/links/53d64f740cf2a7fbb2ea9b1b.pdf
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Continuing my series of articles on dietary recommendations for particular types of breast cancer, this one is for those of you who have been diagnosed with HER2 Positive (HER2+) breast cancer.
What Exactly is HER2 Positive Breast Cancer?
HER2 positive refers to a type of breast cancer that overexpresses the HER2/neu gene. About 15-20% of breast cancers are HER2+, meaning the cancer is fueled by over-production of the human epidermal growth factor receptor 2 protein. HER2+ breast cancers contain excess copies of this gene, leading to dramatically more HER2 protein on the surface of cancer cells. Because of this protein, which produces signals that tell the cells to grow, they do so out of control, causing this form of breast cancer.
Many women are told that a HER2+ diagnosis is associated with a significantly higher chance of local breast cancer recurrence (that means the cancer often returns in the same breast as the original tumor). Before the late 1990s, women with HER2+ breast cancer had poorer survival rates. Today, however, because of targeted therapies like Herceptin, this is no longer the case and it is a much more treatable disease. Herceptin works by attaching to HER2 receptors on cancer cells, blocking signals that cause growth, and alerting the immune system to destroy the cancer.
Can Diet Make A Difference?
Please know that there are plenty of things you can eat and supplements you can take which will make a big difference for you and will assist your return to wellness.
Research shows that there are some foods and spices that are especially potent in inhibiting HER2+ breast cancer cell growth and proliferation and in promoting the process known as apoptosis (programmed cell death). In addition, some foods have been found to amplify the effects of Herceptin.
Food That You Should Include In Your Diet If You Have HER2+ Breast Cancer
Wherever possible, try to ensure that the items from the list below are organic, because if you are trying to heal from cancer you need to stay away from conventionally grown produce and meats as much as possible due to the pesticide and herbicide residues. You really need to keep the toxin load at a minimum to give your body a better chance to heal.
Here’s the list of foods and spices (or their components) which have been found to inhibit the growth or proliferation of HER2+ breast cancer cells. Many of these things also help to counteract the toxicity of Herceptin:
bell peppers (capsicum), black pepper, blueberries, red cabbage, green cabbage, cauliflower, bok choy/Chinese cabbage, broccoli, brown rice, Brussels sprouts, purple carrots, cherries (particularly sour cherries), celery, cranberries, red grapes, green tea, horseradish, herring, hot peppers, lake trout, mackerel, mustard and mustard greens, extra virgin olive oil, red onions, parsley, pomegranates, raspberries, black rice, wild caught salmon, sardines, tomatoes, turmeric, turnips and turnip greens, walnuts, watercress. See also my article Study Shows Curcumin Works as Well as Herceptin In Some Cases.
This is not an exhaustive list – indeed, there are many other foods which are known to have anti-cancer benefits – but this is the list that we have research for which indicates a potent anti-HER2+ activity. See my page Diet and Cancer for a list of other foods that have anti-cancer activity.
I recommend that breast cancer patients and survivors with HER2+ breast cancer include as many of the things on the “good” list above and limit or avoid the “please avoid” things that appear below.
Please Avoid These
No food list is complete without mentioning the things that should be avoided for HER2+ breast cancer because they have been shown to promote HER2+ breast cancer growth or increase HER2+ expression. Those things are: alcohol, folic acid supplements, genistein supplements (but whole soy foods are fine), the Chinese herb ligusticum chuanxiong, the Chinese herb Si-Wu-Tang (may interfere with the effectiveness of Herceptin), soy protein isolate, cigarette smoking.
If you are taking Herceptin or Lapatinib, it’s best to avoid grapefruit, Seville oranges and star fruit as well, as they can increase your risk of side effects. Source of info:
The following foods have been found to assist the effects of Herceptin against HER2+ breast cancer:
açaí berries, blackberries, boysenberries, cherries (particularly sour or tart), blackcurrants, cruciferous vegetables (broccoli, cabbage, cauliflower, kale, Brussels sprouts etc), flaxseed, green tea, extra virgin olive oil, passion fruit, purple or red plums, pomegranates, black raspberries, black or purple rice, strawberries, purple sweet potatoes, walnuts
There are also quite a number of essential oils and other supplements which research has indicated are helpful against HER2 positive breast cancer so be sure to check out those resources on my website.
Thanks for some of the dietary recommendations in this article goes out to http://foodforbreastcancer.com/ – written by Sarah Charles, also a breast cancer survivor and a woman of sharp intellect, Sarah has a mathematics degree from UCLA and is a Harvard graduate.
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Herceptin and HER2 + Breast Cancer – Is It Effective?
I have had a couple of questions about HER2 positive (“HER2 +”) breast cancer and the drug known as Herceptin, or trastuzumab, and its effectiveness. I did a bunch of research, here’s what I found out.
HER stands for human epidermal growth factor, and it is a protein that can affect the growth of some breast cancer cells. It is actually found on the surface of healthy breast cells — in a healthy breast there will be approximately 20,000 HER2 receptors, but when the cells are creating too many copies of this protein, known as overexpression, which occurs in approximately 25% of patients, there can be over 2 million receptors and that’s important because overexpression of the HER2 protein, as well as amplification of the HER2 gene, have been associated with impaired prognosis in patients with both early and advanced breast cancer.
How HER2 + Breast Cancer Is Different
In the late 1990’s researchers and doctors, being faced with an aggressive form of breast cancer that did not respond as well to the usual chemotherapeutic drugs, observed that for some breast cancer patients, overexpression of a particular gene known as HER2 meant that that patient often had a more aggressive form of breast cancer.
The HER2 gene makes a protein which creates a receptor that sits on the outside of a cell. HER2 receptors act like antennae on the surface of cells and they receive signals that stimulate the cell to grow and multiply. Breast cancer cells with too many HER2 receptors receive too many growth signals and thus start growing and multiplying too quickly. Left untreated, this form of breast cancer can progress rapidly.
How Herceptin Works
Herceptin is a monoclonal antibody, or MAB, made by Genentech BioOncology. MABs are a type of biological therapy made in a laboratory. Monoclonal just means all one type. MABs are designed to recognize and attach to specific proteins on the surface of cells. Each MAB recognizes one very particular protein, in this case, the HER2 receptor.
Once Herceptin attaches itself to the HER2 receptor on the outside surface of breast cancer cells, it blocks them from receiving growth signals and flags it for destruction by the immune system. It also blocks HER2 signalling within the cell, thus slowing or stopping the growth of the breast cancer. According to Genentech BioOncology, the drug can also increase the effectiveness of other chemotherapeutic agents and it is designed to be used in combination with other chemotherapeutic drugs.
The second article appeared on the National Cancer Institute website: Trastuzumab after Chemotherapy Is Effective in HER2-Positive Breast Cancer which discusses the Herceptin Adjuvant (HERA) trial reported in Lancet Oncology on February 25, 2011. In this Italian study, 1,703 women received one year of adjuvant therapy with Herceptin (trastuzumab) while another 1,698 women were placed in an observation group. Four years later, 79% of women in the Herceptin group were disease-free, compared with 72% in the observation group.
The Down Side
Am I crazy or is that only a difference of 7%? Not exactly huge, is it? Especially considering that a one year course of Herceptin treatment costs about $70,000 in the United States, and that it comes with a long list of side effects, which include flu-like symptoms such as fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, muscle pain and, in 5-30% of patients, heart damage, especially when combined with the chemo drug Adriamycin.
Cobleigh MA, Vogel CL, Tripathy NJ, et al. Efficacy and safety of Herceptin (humanized anti-HER2 antibody) as a single agent in 222 women with HER2 overexpression who relapsed following chemotherapy for metastatic breast cancer. Program and abstracts of the American Society of Clinical Oncology 34th Annual Meeting; May 16-19, 1998; Los Angeles, California. Abstract 376
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Photo courtesy of freedigitalphotos.net and antpkr
T-DM1 Approved For Her2 Breast Cancer
Further to my post of August 15, 2012, New Chemotherapy Drug for HER2 – Genentech’s T-DM1, I have an update for you. The FDA has finally approved T-DM1, now known as the brand-name Kadcyla, for women with HER2+, metastatic breast cancer. The new therapy has been approved for use in patients who have already undergone unsuccessful treatment with a combination of trastuzumab (Herceptin) and a taxane.
An Interesting Method of Delivery
Kadcyla is a conjugate – it combines the drug trastuzumab, better known by the brand name Herceptin, and a powerful chemotherapy drug called DM1. The trastuzumab portion targets HER2+ cells, then the attached chemotherapeutic molecule – the DM1, which is too toxic to deliver directly into the patient’s bloodstream – is delivered and attacks the cancer cell. T-DM1 has helped inspire a new generation of antibody + drug conjugates.
FDA approval was based on a study known as EMILIA, in which patients with HER2+, metastatic breast cancer who had failed treatment with a combination of trastuzumab and taxane were randomized to ado-trastuzumab emtansine or conventional therapy with lapatinib and capecitabine (Xeloda). The patients given ado-trastuzumab emtansine resulted in significant improvements in both progression-free survival (9.6 vs 6.4 months) and overall survival (30.9 vs 25.1 months).
The Down-Side (Why Is There Always A Down-Side?)
This sounds like really great news, however, the drug is not without risk (what else is new?). The FDA requires labeling on Kadcyla to warn of risks of liver toxicity, reductions in left ventricular ejection fraction for the heart, and death. In addition, there is risk of severe birth defects, so a woman’s pregnancy status should be determined before starting treatment, the FDA said. The most common side effects associated with the drug were nausea, fatigue, musculoskeletal pain, thrombocytopenia, elevated liver enzymes, headache, and constipation.
As if all of that weren’t enough, the drug will cost $9,800 a month, or about $94,000 for a 9.5-month course of therapy. Let’s hope it can keep people alive.
I send my love to everyone taking this journey right now. If you would like my help with getting through breast cancer in an inspiring and ultra-healthy way, please sign up for my free e-newsletters on the right, or “like” me on Facebook (MarnieClark.com) and I’ll do my utmost to keep you informed and empowered on your healing journey… and beyond.
Today I want to share with you two studies that both show that flaxseed oil enhances the effect of Herceptin for those with HER2 positive breast cancer.
Admittedly, the studies ,  were carried out with mice. However, I feel compelled to share this information with you because if it happens with humans as well, it is clinically relevant. And adding a little flaxseed oil (or freshly ground flaxseed) to your diet is non-toxic, easy to do, and wonderfully healthy for you.
The research examined the effects of flaxseed oil on breast cancer cells and how it reacted with the targeted drug Herceptin, created especially to battle HER2-overexpressing cancers.
The 2010 Study Results
The 2010 study  looked at how flaxseed oil interacts with the drug Trastuzumab, better known as Herceptin. Researchers implanted HER2+ human breast cancer cells in immune-deficient mice. The mice were given flaxseed oil as part of their diet, along with various doses of Herceptin. In the control group of mice who received neither oil nor drug, the tumors grew unchecked, some increasing in size by 187% over the four weeks the experiment lasted.
For the other two groups, Herceptin was given at two different doses. The tumors in the mice receiving the lower dose (2.5 mg/kg body weight) did not grow, staying the same size through the course of the study. The higher dose of Herceptin (5mg/kg body weight) worked better than the low dose – the tumors decreased by 75%. That’s remarkable enough, but read on.
The mice who received flaxseed oil did even better. The tumors in the mice who got Herceptin at low doses but also received flaxseed oil regressed by 89%. For mice receiving Herceptin at the high dose plus flaxseed oil, the tumors regressed 84%. So for these mice, more Herceptin was not necessarily better.
The tumor sizes were tracked for several weeks after the drugs were stopped and the results got more interesting. The benefit seen in the low dose Herceptin plus flaxseed oil mice continued to increase even after stopping the drug, so that two weeks after the drug was stopped the tumors in the low Herceptin dose plus oil mice were 87% smaller than in the mice that only received the Herceptin at low doses. They tied with the mice that had been given the drug in high doses.
The study concluded: “Flaxseed oil did not interfere with Trastuzumab but rather enhanced its tumor-reducing effects and combined flaxseed oil and low dose Trastuzumab was as effective as high dose Trastuzumab treatment.”
That’s very good news – it appears as though a person could tolerate a lower dose of Herceptin if they combined it with flaxseed oil – thus reducing toxicity and increasing effectiveness.
The 2015 Study Results
If you’re wondering how the tumors would have fared using flaxseed oil on their own, a study carried out in 2015  looked at that as well. Again using immune-deficient mice, researchers split the mice into three groups – those receiving flaxseed oil alone, those receiving flaxseed oil and Herceptin at 1 mg/kg, and those receiving flaxseed oil and a higher dose of Herceptin at 2.5 mg/kg.
The results of the 2015 study showed that the mice receiving flaxseed oil alone had no difference in tumor growth. However, the group that fared the best and had the largest reduction in tumor size were the mice that had the flaxseed oil and the higher dose of Herceptin (2.5 mg/kg). The combination of flaxseed oil and Herceptin not only reduced tumor size but led to reductions in HER2 signaling which also reduced cell proliferation (rapid growth) and increased apoptosis (planned cell death – a good thing in cancer cells).
Now obviously we would much rather see the results of a human trial but since flaxseed oil (or freshly ground flaxseed) is so good for you anyway, there seems little reason to wait until such data has been published. If you have been diagnosed with HER2+ breast cancer, my advice would be “Get it in you!” (organically grown, of course)
It’s extremely difficult to translate dosing information from mice to humans, as you can imagine. However, if the data obtained in this study were to hold true in humans, adding flaxseed oil to your regimen could very well enhance the anti-tumor effects of Herceptin. I would recommend dosing at 1-2 tablespoons per day for an average-sized person.
 Flaxseed oil-trastuzumab interaction in breast cancer — https://www.ncbi.nlm.nih.gov/pubmed/20580760
 Flaxseed oil enhances the effectiveness of trastuzumab in reducing the growth of HER2-overexpressing human breast tumors (BT-474) – https://www.ncbi.nlm.nih.gov/pubmed/25441844
I have quite a few more articles about HER2 positive breast cancer – visit this link to see them all.
I send my love to everyone taking this journey right now. If you would like my help with getting through breast cancer in an inspiring and ultra-healthy way, please sign up for my free e-newsletters on the right, or “like” me on Facebook (Marnie Clark, Breast Health Coach) and I’ll do my utmost to keep you informed and empowered on your healing journey… and beyond.
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