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Thursday, January 31, 2019

FDA approves new drug for men at high risk of prostate cancer spread

Extraordinary because a decade ago I was told I had three to five months left to live. Diagnosed with non-small cell lung cancer (NSCLC) three years earlier, the removal of most of my left lung followed by chemotherapy had done little to slow down the cancer. Too diffuse for radiation, we had run out of options.

And so, I did what the dying do. Grieving as preparations began, I bid adieu to friends and family, held my children even closer, and sought the help of a thoracic social worker. The day I walked through her door, my first words were, “I need you to help me learn how to die.”

Life can be so strange, so surprising. I never thought I’d be diagnosed with lung cancer at the age of 45 and that I’d be facing death at 48. But the biggest surprise was yet to come.

Obviously, I didn’t die. Just in the nick of time medical science intervened, as I was found to have a newly identified driver in lung cancer, an ALK (anaplastic lymphoma kinase) mutation. On October 1, 2008, I became the fourth person in the world with NSCLC to enroll in a first-in-human trial targeting ALK. And, to all of our surprise, I had an amazing response.

In the years hence, I have returned to chemotherapy, but also enrolled in two more phase I clinical trials. And life has gone on. My youngest child was only 7 when I was diagnosed; two years ago I had the immense privilege of seeing him graduate cum laude from Phillips Exeter Academy. He is now in his second year at MIT, and my other two adult children are thriving in both their relationships and careers.

Four years ago my own marriage ended, in no small part because of the differences in the way we approached my cancer, which, though still considered terminal, had also become a chronic illness.

Living alone has had its challenges, but I can truly say that I have never been happier. For the first time since my early 20s, I am focusing on my own goals. Upon leaving my marriage, I moved to a converted mill housing a community of creatives. I call it the art dorm, and my loft the art fort. I recently had my first solo art show, and it was a big success. It is safe to say I’m on a creative roll. I am also working on a book (or two), a DIY MFA (that’s another blog post), and I devote more time than ever to patient advocacy, with a focus on clinical trial participation and medical research.

Last year a little white Shiba Inu came into my life — a rescue that I actually helped rescue — and we walk several miles every day. Five months ago I also started online dating and, contrary to the experience of many, I’m having a blast. I attribute that to my extraordinary (yes) self-confidence and my willingness to go all in, without regard to being hurt. These are qualities that I did not possess prior to my diagnosis with cancer.

It’s such an odd and unexpected paradigm — living with a terminal illness. The downsides are obvious, and yet I have learned so very much. Forced to face my greatest fears, I have become far more courageous; in fact, there is little I fear now. This means my anxiety has gone way, way down and my ability to enjoy life way, way up. Because I have learned to sit with uncertainty, I am no longer married to outcomes. It’s all good. I liken this to loving/living life unconditionally; I simply cannot be disappointed. Each new morning is opened like a present — a gift I simply did not expect to receive.

Perhaps it is this awareness that has sharpened both my perception and my appreciation; I refuse to waste a moment. And although I would prefer to not have an illness that is terminal, I would wager that I am infinitely more alive than many who do not. I play poker in a weekly game hosted by an 80-year-old man named Mort. During a recent game, I noticed a stack of composition books, scribbled-over yellow pads, and Bic pens spread over his dining table.

What was he up to? Mort said he had lost his sense of purpose and identity, so he turned to something he knew a lot about — his life story — and began to write his memoirs.

Mort’s reaction is quite common among older adults, as is his response. As people age, they may begin to feel irrelevant to those around them, especially their families, which often leads to low self-esteem, greater isolation, and a higher risk of depression.

But engaging yourself in an endeavor like writing your memoirs can be rewarding for you and others.

“You would be surprised at how interested your peers and family members are in your stories and personal history,” says Brendan Kearney, Vitalize 360 Wellness Coach at Harvard-affiliated Hebrew SeniorLife. “You have a unique firsthand account of your culture and history that others don’t, and leaving a recorded history of your life can be an important gift to both you and your descendants.”
Words of wisdom

Writing your memoirs offers many benefits beyond simple storytelling. For instance, they can be an opportunity to pass along specific wisdom and life lessons. “Even if you write about parts of your life that you have never told anyone because they were unhappy or painful memories, revisiting them can show others the strength it takes to overcome life barriers when they face their own,” says Kearney.

The actual writing aspect also can be a therapeutic tool as you explore issues that may still trouble you. A study published in the March 2018 JAMA Psychiatry found that writing about a specific upsetting memory was just as effective as traditional cognitive processing therapy in treating adults with post-traumatic stress disorder.
A walk down memory lane

Where should you begin your life story? You don’t have to follow a straight year-by-year account. Instead, Kearney recommends creating a timeline of your life based on the places you have lived. “Begin with writing about your homes,” says Kearney. “Think about the house you grew up in, or the first house you owned. The places you’ve lived often invoke a wealth of visual memories and long-forgotten stories that are tied to those places.”

Another way to trigger ideas is to look through photo albums. Focus on a single picture and write about the story behind it. Or use writing prompts, by asking yourself questions such as, “One of my fondest memories of my best friend was …”; or “The time I was happiest or most scared was …” Or write about your favorite hobbies or sports. A recently published clinical guideline on vitamin and mineral supplements reinforces every other evidence-based guideline, research review, and consensus statement on this topic. The bottom line is that there is absolutely no substitute for a well-balanced diet, which is the ideal source of the vitamins and minerals we need.

The brief article, co-authored by nutrition guru Dr. JoAnn Manson, cites multiple large clinical trials studying multiple nutritional supplements’ effects on multiple end points. The gist of it is, our bodies prefer naturally occurring sources of vitamins and minerals. We absorb these better. And because commercially available vitamins, minerals, herbs, etc. are lumped together as “supplements,” the FDA doesn’t regulate them. When we ingest processed, concentrated, and artificially packaged “supplements,” we may be doing ourselves harm. They may be toxic, ineffective, or contaminated (all of which are not uncommon).

In other words: Most people who eat a healthy diet are unlikely to benefit from nutritional supplements.

Note the very important qualifiers. We’re talking about most people (not all) who eat a healthy, well-balanced diet.
Does anyone need vitamin and mineral supplements? Well, yes

There are medical conditions that put people at high risk for certain nutritional deficiencies, and there are medical conditions that can be treated with certain nutritional supplements. This is important, and is why the authors support targeted supplementation. But who needs what and where to acquire these are important discussions to have.

There are guidelines for specific groups, such as pregnant women. Folic acid is especially important for healthy fetal development, and a deficiency can cause spina bifida, a neurologic condition. I advise my patients to start either a prenatal vitamin with folic acid, or at the very least folic acid itself, ideally before they begin trying to conceive. As pregnancy advances, mom needs to provide her growing fetus with everything, and so she will benefit from a prenatal vitamin (either by prescription or a well-vetted over-the-counter one) which contains things like iron and calcium.

Older adults can have difficulty absorbing vitamin B12, and I have a low threshold when checking this level; if someone is taking an acid-reducing medication, it is very likely that they will become deficient in B12, as well as iron, vitamin D, and calcium, among other things. These folks may very well benefit from a quality multivitamin.

Of course, there’s a long list of medical issues that predispose people to vitamin deficiencies. For example, people who have had weight-loss surgery may require a number of supplements including A, D, E, K, and B vitamins, iron, calcium, zinc, copper, and magnesium, among other things. People with inflammatory bowel disease (like Crohn’s or ulcerative colitis) may have similar requirements. People who have or are at risk for osteoporosis may greatly benefit from vitamin D and, depending on the quality of their diet and other factors, possibly also calcium supplements.

There are other medical conditions that can be treated with supplements. One that immediately comes to my mind is inflammatory arthritis (or other inflammatory conditions) and turmeric. While quality scientific studies are lacking, there are plenty of smaller studies as well as historical experience suggesting that turmeric has anti-inflammatory properties, and I see some of our rheumatologists routinely recommending this to patients for pain relief. Then there’s prediabetes/diabetes and cinnamon, which has blood sugar-lowering properties. With these compounds, I advise that people use the regular spice in normal culinary amounts, not a processed/concentrated packaged supplement.
Not all vitamins are created equal

And here is another key point that bears repeating: Manson suggests choosing vitamins that have been tested by independent labs such as US Pharmacopeia, Consumer Lab, and NSF International, and certified to have the labeled dosage of the correct ingredient, and not have toxins or contaminating organisms. Many commercially available supplements here in the US will bear a label from one of these labs.

On that point, gummy vitamins are often not certified and often do cause cavities. Yes, everyone loves them, because they’re basically candy. I do not recommend gummy vitamins for anyone, but especially not for pregnant women.

I’ll also add a warning: I often hear about providers who are selling supplements or other products directly to their patients. This is a conflict of interest, and it’s unethical, as well as fraught with all sorts of potential problems. Please use caution if purchasing anything directly from the provider who is prescribing it. A newly approved drug called apalutamide is giving hope to thousands of men confronting a tenacious problem after being treated for prostate cancer. Prostate-specific antigen (PSA) levels should plummet to zero after surgery, and to near zero after radiation therapy, but in some men, they continue rising even when there’s no other evidence of cancer in the body. Doctors typically respond to spiking PSA with drugs that block the production of testosterone, which is the male sex hormone that fuels prostate cancer. However, this type of medically induced castration, called hormonal therapy, doesn’t always reduce PSA. Moreover, prostate cancer cells can become resistant to hormonal therapy, after which PSA resumes its upward march. This is called non-metastatic castration resistant prostate cancer (nmCRPC), and it often precedes the appearance of metastatic tumors that show up later.

The dearth of approved treatments for nmCRPC has long frustrated patients and their doctors alike. But in February, the US Food and Drug Administration approved apalutamide for men who have nmCRPC after results from the SPARTAN clinical trial showed the drug could delay metastases by up to two years. “Based on these clinical trial results, apalutamide should be considered the new standard of care for nmCRPC,” said Dr. Matthew Smith, a medical oncologist at Massachusetts General Hospital who led the study. “The drug addresses a great clinical need and holds the promise of longer survival for men whose cancer defies hormonal therapy.”

The SPARTAN trial enrolled 1,207 men whose PSA levels doubled within 10 months or less after initial treatment despite ongoing hormonal therapy. Enrolled men were assigned to either daily apalutamide tablets combined with hormonal therapy, or to hormonal therapy combined with placebo. Doctors usually stick with hormonal therapy even after PSA levels rise, since it prevents the body from recovering its ability to make testosterone. Men continued on the study until the first metastases were detected, and then they were given other drugs used for treating metastatic prostate cancer.

According to the results, those taking apalutamide avoided metastases for a median of 40.5 months (meaning half were free of metastases for longer than that, and the other half for less). The placebo-treated men, meanwhile, remained free of metastases for a median of 16.2 months, about two years less. Furthermore, apalutamide treatment “delayed symptomatic progression, pain, and other symptoms that patients experience as a consequence of their cancer,” Smith said. But apalutamide, which prevents testosterone from interacting with its receptor on cancer cells, was also associated with more frequent significant side effects, such as fatigue, rash, weight loss, falls, and skeletal fractures.

Based on accumulating evidence, Smith anticipates that longer freedom from metastases equates with longer overall survival in men with nmCRPC. However, whether that’s true remains to be seen. “So far, outcomes suggest men will live longer on apalutamide,” said Dr. Marc Garnick, the Gorman Brothers Professor of Medicine at Harvard Medical School and Beth Israel Deaconess Medical Center, and editor in chief of HarvardProstateKnowledge.org. “The anxiety most patients experience when PSA increases after what was thought to be curative is significant. Continuing with this new therapy should be considered between appropriately selected patients and their doctors after a full discussion of the potential benefits and risks.”

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