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Drug based immune therapies – be informed before committing!

There has been a lot of excitement and hype in the media as well as in the medical journals about the new drug based immune therapies. Oncologists worldwide have been interested and motivated by convincing pharmaceutical company literature and some of the spectacular remissions that have occurred.

There are now many clinical trials available. Some patients have been able to pay to access these very expensive drugs. Initially there were just a few but now the number is increasing. These drugs are Keytruda, Yervoy, nivolumab (called antiPD1 therapies) plus the newer CAR-T CELL therapy. More are in the pipeline.

Patients get excited about immune therapy thinking it is a more natural way for treatment of their cancer; however, in the USA and Europe warnings are appearing in the medical literature with details of severe and unpredictable side effects from drug based immune therapies. Deaths have been reported and long-term side effects have been severe. See side effects picture left

One of the reasons why we refer to our Asian immunotherapy specialist, is that he is a pioneer of cell based immune therapies – different to drug based immune therapies.

We know that cancer patients are interested in the most effective and minimally invasive cancer treatments; BUT knowledge and a dash of caution is required before considering taking treatment with a drug based immune therapy. Be INFORMED! There have been both short and long-term successes in treating melanomas, some kidney cancers and some lung cancers.

Testing for suitability for drug based immune e therapies:  Most patients are not informed that there is a test called Tumour Mutational Load (TML) – performed at genomic laboratories which can give them and their oncologist a particular measurement, that indicates whether or not a drug based immune therapy will work for you (popularly known as anti-PD1 immune therapy). It is highly likely the test will not be offered to you by your oncologist.  

The other issue is cost. Many of these treatments begin around $5000/ dose a with CAR-T-CELL therapy 

The most common procedure for CAR-T cell therapy starts with the extraction of T cells from the own patient. The T cells are then genetically modified to express a CAR and expanded in the Laboratory. Finally, they are reinfused into the patient, ready to fight the tumour. Unlike the unblocking effect of the immune system to find and destroy cancers; immunotherapies based on CAR-T cells go one step further by engineering the T cells themselves to enhance the response from the immune system against a specific tumour antigen.

Please read on and inform yourself about the difference between drug based immune therapy and cell based immune therapy (immune therapy made from components of your own immune system). See Safe Immune Therapies

The flip side of the benefit of drug-based immunotherapy, which is a long-term response against the cancer, is that toxicities can happen at the beginning of treatment or long after their last dose.” (GGI Note: up to 4 years later) Sandip P. Patel, MD (from ASCO Post – American Society of Clinical Oncology)

We are playing with fire,” said Dr. John Timmerman, an oncologist and immunotherapy researcher at the University of California, Los Angeles, who recently lost a patient to side effects. The woman’s immunotherapy drugs had successfully “melted away” her cancer, he said, but some weeks later, she got cold and flulike symptoms and died in the emergency room from an inflammatory response that Dr. Timmerman described as “a mass riot, an uprising” of her immune system – Immune System, Unleashed by Cancer Therapies, Can Attack Organs

 

Patients treated for skin or lung cancer cancer using newer, potent immunotherapies appeared to be at an increased risk of developing thyroid-related adverse events, researchers reported here. Of 93 patients treated with pembrolizumab (Keytruda), 14 developed thyroid dysfunction.  These drugs release the brakes on the immune system, and by releasing those brakes, of course, you can get autoimmune diseases. It can cause problems with the colon; it can be the liver; it can be the thyroid.”

Cabanillas said that the Mayo researchers are reporting on thyroiditis with pembrolizumab “which is usually what we see with this class of checkpoint inhibitors but there are other types of checkpoint inhibitors, such as ipilimumab, [that]…cause more pituitary adverse events.” Solid Tumor Immunotherapy May Impact Thyroid


Immune-based therapies in oncology present challenges in recognising & managing treatment-related toxic effects. Although many oncologists know of their adverse-effect profile, treatment remains limited to specialised centres with experienced & highly-skilled clinical care teams, capable of providing the supportive care required for patients undergoing such therapy, owing to the risk of severe hypotension and organ failure during treatment. Managing the Side Effects of Novel Cancer Immunotherapeutics


Toxicities of Immunotherapy for the Practitioner

During the last years several cases of fatal heart failure have been documented in melanoma patients treated with checkpoint inhibitors. Checkpoint Inhibitors & Cardiac Toxicity: An Emerging Issue 


ASCO – Although (drug-based) immunotherapies can be effective in boosting the body’s natural defence against cancer in some patients, providing durable remissions in a small percentage of cases, they can also result in myriad immune-related adverse events due to misdirected stimulation of the immune system. E.G. only a small percentage of patients—between 15% and 20%—receive some benefit from checkpoint inhibitors that target CTLA-4 or the PD-1 and PD-L1 pathways for the majority of tumor types. They can also cause immune-related adverse events in which the immune system starts attacking normal tissue – some patients experience the side effects and none of the benefit. ASCO – Meeting the Challenges of (drug-based) Immunotherapy-Related Toxicities


Dangers with Car T Cell therapies – the popular new immune treatment 

Car T Cell therapies – worrisome, and sometimes fatal, side effects –  e.g. cytokine-release syndrome (CRS). 

Car T Cell Therapies – Revolutionary new cancer therapies come with big risks. Drug makers must be prepared 


Sudden severe side effects – can take a small army of top specialists to keep patients alive while their newly engineered immune systems attack their cancer cells. Remains so risky, so complex, so difficult to manage that experts warn it’ll be years… –  Car T Cell Therapies 


Keytruda immunotherapy deaths higher than control group.The decision was taken after independent safety monitors observed more deaths in patients receiving the Keytruda combination than in the control groups in two of the studies… FDA stops Merck Trial 


Cytokine release syndrome (CRS)  The hallmark of CRS is immune activation resulting in elevated inflammatory cytokines. Clinical and laboratory measures range from mild CRS (constitutional symptoms and/or grade-2 organ toxicity) to severe CRS (sCRS; grade ≥3 organ toxicity, aggressive clinical intervention, and/or potentially life threatening). Clinical features include: high fever, malaise, fatigue, myalgia, nausea, anorexia, tachycardia/hypotension, capillary leak, cardiac dysfunction, renal impairment, hepatic failure, and disseminated intravascular coagulation – often requiring treatment in ICU… Toxicities of CAR T-Cell Therapy 

Financial Costs of Drug Based Immune Therapies

According to a research letter published in JAMA Oncology, patients treated with CAR T-cell therapy will incur on average $30,000 to $36,000 (USD) in additional costs aside from drug expenses. (e.g. $500/dose) 

Patients who present with side effects from severe cytokine release syndrome may pay up to $56,000 (USD) more.

“To our knowledge, this study provides the first estimates of the total costs of chimeric antigen receptor [CAR] T-cell immunotherapies in the United States,” Inmaculada Hernandez, PharmD, PhD, assistant professor of pharmacy and therapeutics at University of Pittsburgh, and colleagues wrote
Last year, FDA approved the first two CAR T-cell therapies.
Tisagenlecleucel (Kymriah, Novartis) is approved for treatment of patients aged up to 25 years with refractory B-cell precursor acute lymphoblastic leukemia, as well as those whose disease is in second or later relapse.
Axicabtagene ciloleucel (Yescarta, Kite Pharma) is approved for adults with relapsed or refractory large B-cell lymphoma who underwent two or more lines of systemic therapy.

Treatment with tisagenlecleucel has been priced at $475,000 and axicabtagene ciloleucel has been priced at $373,000. However, these prices do not account for costs associated with treatment, including hospital stays and treatment for related toxicities”.

SOURCE: goo.gl/27TP9R  ( Check the URL- original URL below.