Melanoma, Immunotherapy, Side Effects, Serious Collateral Damage

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“These side effects can happen and, when they happen, they can be severe and lethal,” Ryan J. Sullivan, MD,

Living with incurable cancer since 1994 has taught me that conventional oncology understates the many side effects caused by chemotherapy and radiation. I don’t blame oncologists. Conventional oncology thinks more about treating cancer and less about living with cancer. A good example stared me right in the face in the face when I read the study linked below. Oncology talks about FDA approvals leading to “more durable responses among patients living with cancer.” The article talks about durable responses

So when conventional oncology is suspicious of treating cancer…well, something has to be seriously wrong.

There is no question that immunotherapy can be a benefit to cancer patients. The purpose of this post is to highlight the risk/reward proposition, the pros and cons of immunotherapy to patients.

I am a cancer survivor and cancer coach. Like all conventional therapies, there are evidence-based methods of reducing the risk of side effects. To learn more about these therapies scroll down the page, post a question or comment and I will reply to you ASAP.

Thank you,

David Emerson

  • Cancer Survivor
  • Cancer Coach
  • Director PeopleBeatingCancer

Toxicities associated with immunotherapy warrant ‘very high level of suspicion’

“Since 2011, the FDA has approved six immune checkpoint inhibitors designed to reverse the course of multiple cancers.

Those approvals — along with oncologists’ willingness to combine immunotherapies — has led to more durable responses among patients with cancer…

However, many oncologists say the toxicities associated with immunotherapies, especially those used in combination, pose a greater risk to patients than often reported in clinical trials funded by the pharmaceutical companies that develop and distribute these drugs…

Toxicities from combination immunotherapy can range from skin rashes, mucositis and diarrhea to colitis, sepsis, hypothyroidism, hyperthyroidism, pneumonitis, myocarditis, arrhythmia, type 1 diabetes, and hypophysitis. These can occur within weeks after initiation…

“These side effects can happen and, when they happen, they can be severe and lethal,” Ryan J. Sullivan, MD,

Checkpoint inhibitors targeting cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and the programmed death-1 receptor (PD-1) and its ligand PD-L1 have become standards of care for an increasing number of indications, including:

  • metastatic melanoma,
  • non-small cell lung cancer,
  • renal cell carcinoma,
  • Hodgkin lymphoma,
  • urothelial cell carcinoma and
  • squamous cell carcinoma of the head and neck

FDA-approved checkpoint inhibitors include

  • ipilimumab (Yervoy, Bristol-Myers Squibb),
  • nivolumab (Opdivo, Bristol-Myers Squibb),
  • pembrolizumab (Keytruda, Merck),
  • atezolizumab (Tecentriq, Genentech),
  • avelumab (Bavencio; EMD Serono, Pfizer) and
  • durvalumab (Imfinzi, AstraZeneca).

In a separate study, also published in The New England Journal of Medicine, Johnson and colleagues reported that 40% of patients treated with advanced melanoma discontinued combination immunotherapy because of adverse events. The study — which used data from Bristol-Myers Squibb’s corporate safety databases — also showed only 18 of 20,594 patients (0.09%) receiving nivolumab alone or with ipilimumab experienced myocarditis — potentially fatal inflammation of the heart muscle. However, the incidence of myocarditis was higher among those assigned the combination than nivolumab alone (0.27% vs. 0.06%).

“But, I can tell you, in my practice, I had three patients last year who developed myocarditis out of about 100 treated,” said Puzanov, who also was an author on that study. “That’s still only 3%, but it’s well over 0.27%. If you are one of those three patients, it’s 100% for you.

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