No Such Thing as “Risk-Free”

In a recent guest editorial that I penned for BioCentury, I referenced that a parent’s choice whether or not to vaccinate their child against the human papillomavirus (HPV) isn’t a “risk-free” choice. Every drug has risks – consider the following statement by the U.S. Food and Drug Administration (FDA): “although medicines can make you feel better and help you get well, it’s important to know that all medicines, both prescription and over-the-counter, have risks as well as benefits.” I would also point out that there are risks in forgoing a medication.

Let’s take a look at the HPV vaccine’s side-effects according to the prescribing information for Gardasil® 9 (Human Papillomavirus 9-valent Vaccine, Recombinant). The most common side effects include pain, swelling, redness, itching, bruising, bleeding, and a lump where your child got the shot, headache, fever, nausea, dizziness, tiredness, diarrhea, abdominal pain, and sore throat. These are adverse events disclosed by the sponsor (Merck & Co., Inc.) to the FDA from completed clinical trials of Gardasil 9. Since licensure in 2006, over 270 million doses of HPV vaccines have been distributed and the sponsors are obligated to report any new side effects to the FDA.

What’s that you say? You don’t trust the pharmaceutical industry? The Global Advisory Committee on Vaccine Safety (GACVS), an independent expert clinical and scientific advisory body that provides the World Health Organization (WHO) with scientifically rigorous advice on vaccine safety issues of potential global importance, first reviewed the safety data for HPV vaccines in 2007 and subsequently in 2008, 2009, 2013, 2014, 2015, and 2017. In each period, the GACVS examined various vaccine specific safety issues, such as links to Guillain-Barré syndrome (GBS) and other autoimmune safety issues. No other adverse reactions have been identified and GACVS considers HPV vaccines to be extremely safe. According to the WHO, there are now accumulated safety studies that include several million persons and which compare the risks for a wide range of health outcomes in vaccinated and unvaccinated subjects.

Early on, the GACVS was presented with signals related to anaphylaxis and syncope related to the HPV vaccines. According to the GACVS, the risk of anaphylaxis from HPV vaccines has been characterized as less than 2 cases per 1,000,000 doses, and syncope was established as a common anxiety or stress- related reaction to the injection. Anaphylaxis is a severe allergic reaction that needs to be treated right away with an epinephrine (adrenaline) shot. Anaphylaxis is rare, and most people recover from it. Syncope, also known as fainting, is a loss of consciousness and muscle strength characterized by a fast onset, short duration, and spontaneous recovery. It is caused by a decrease in blood flow to the brain, usually from low blood pressure. For these reasons, the prescribing information for Gardasil 9 recommends observation of the individual for 15 minutes after administration.

Next, let’s consider the risks of not getting vaccinated against HPV. Again, according to the prescribing information for Gardasil 9, the vaccine helps protect girls and women ages 9 to 26 against cervical, vaginal, vulvar, and anal cancers and genital warts caused by 9 types of HPV. Gardasil 9 also helps protect boys and men ages 9 to 26 against anal cancer and genital warts caused by those same HPV types. Accordingly, individuals who do not get vaccinated against HPV are at risk for the aforementioned cancers and genital warts.

In addition, the 9 types of HPV that infect the genital areas can also infect the mouth and throat (called oropharyngeal cancers). HPV is thought to cause 70% of oropharyngeal cancers in the United States, with HPV type 16 causing 60% of all oropharyngeal cancers. The HPV vaccine was originally developed to prevent cervical and other less-common genital cancers and has been shown in clinical studies to prevent cervical and other precancers. However, HPV vaccines could also prevent oropharyngeal cancers because the vaccines prevent infection with HPV types that can cause oropharyngeal cancers.

HPV vaccines were not available until I was age 38, which is well-beyond the upper age limit of 26 when the vaccines are considered effective. In late 2015, I was diagnosed with poorly differentiated, oropharyngeal squamous cell carcinoma, HPV type 16 related. My three treatment regimens thus far have included: chemoradiation, immunotherapy and currently chemotherapy.

Side-effects that Michael Becker has experienced from cancer and its treatment (click image to enlarge)

My diagnosis is terminal, so “death” would be the primary side effect from the disease that I would gladly forgo in favor of any of the aforementioned HPV vaccine side effects. Setting my grim humor aside for the moment, there are more than a dozen other side-effects that I have personally experienced to date from either cancer or its treatment (see accompanying image for details). And these side-effects don’t include others that I haven’t personally experienced, such as kidney damage.

I’m an advocate of HPV vaccination and strongly encourage parents to speak with a physician when it comes to deciding whether or not to vaccinate a child. The purpose of this blog post is to underscore that deciding not to vaccinate against HPV isn’t a risk-free decision. In my experience, the diagnosis of any one of the six cancers resulting from HPV infection is associated with plenty of important risks for parents to also consider.

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The Space Between

The purpose of my blog and entries is multifaceted. Some are designed to entertain, while others focus on education and enlightenment for those suffering from cancer and the people who surround them. Others are simply updates on my disease for family and friends.

I don’t consider myself an optimist or pessimist, but rather a realist. Accordingly, I prefer to let the facts in my blog speak for themselves and let you, the reader, decide if the glass is half full or half empty.

For me, life is usually viewed in absolutes. Things are either black or white; rarely, if ever, shades of gray. And I like it this way…nice and neat. This is probably why uncertainty, which falls into the shades of gray zone, doesn’t sit well with me. Unfortunately, living with a terminal cancer diagnosis introduces a fair amount of uncertainty – almost from day one.

It starts with waiting for the initial diagnosis. Is it cancer or not? Usually this is a black or white analysis. The diagnosis of cancer then leads to a myriad of uncertainties. The patient wants to know details about the treatment options, their side effects and quality of life, and whether the potential for cure exists. Lots of gray zone issues suddenly appear.

Although clearly outside of my comfort zone, I’ve been able to successfully navigate the sea of uncertainties for the past two years with one notable exception: how much time do I have remaining? Or at the very least, how much time remaining where my quality of life allows me to function as a productive member of society?

Right now, life isn’t horrible. Sure, I suffer side effects from weekly chemotherapy treatment, such as loss of appetite and fatigue. And I lost my hair but save a ton of money on haircuts and shampoo. Nevertheless, I’m able to enjoy time with family and friends and keep busy with my mission to help raise awareness of the human papillomavirus (HPV), six cancers that are directly linked to HPV, and the available vaccines that could prevent such cancers for others in the future.

Enduring weekly chemotherapy is made easier given the fact that my tumors decreased in size according to my last imaging procedure. Exactly what the tumor regression means in terms of extending my life is unknown. Reality check – published scientific literature still favors that celebrating the New Year isn’t a likely event for me.

However, every patient is different – and there is one absolute truth in life: no one knows exactly when or how they will die. While perhaps the exception versus the norm, we’ve all heard dramatic stories about people living longer than originally expected. My realist nature makes me reject such anecdotes, but it does allow me to consider the fact that progress in treating cancer is advancing at a rapid pace and perhaps my existing treatments will buy me just enough time to receive some new exciting approach that keeps my disease in check.

In the interim, my greatest challenge is what to do with the “space between.” I’m talking about the period between now and when I eventually die, which could be measured in as little as one, two, or three months or as many as several years. No one knows for sure.

For example, I could start to write a new book. Although having recently gone through that process, it is a tremendous investment of time and focus away from spending quality time with family and friends. While it could be a worthwhile sacrifice, I just couldn’t bear the thought of embarking down that road again without knowing that I had sufficient time to finish it.

My other passion, photography, is made challenging since I really don’t know how much energy or how I’m going to be feeling on any given day. This makes scheduling photo sessions weeks in advance to allow adequate preparation time a risky proposition at best. For example, I never could have predicted ending up in the hospital on three separate occasions in July/August (including a trip to the intensive care unit). While life has been quite calm as of late (thank goodness…) there is always the chance that something else is lurking around the corner.

Besides, I was already able to complete two significant bucket-list items this year with the publication of both my memoir A Walk with Purpose and large format, high-quality, coffee table photography book, Strength, Confidence, & Beauty. In the near future, could I really top what I’ve already accomplished in each area?

Equally important to projects that produce legacy materials of a life well-lived, there is that pesky task of providing income to help support my family. I haven’t quite found an appropriate place on my resume for “terminal cancer patient” and I suspect few employers would find that an attractive attribute. On the flip side, freelance work or part-time positions might be workable solutions.

Don’t get me wrong, I’m not laying on the couch every day pondering the “space between” and wallowing in depression. I’ve been keeping plenty busy promoting my books and taking advantage of the plethora of amazing media outlets that express an interest in helping me with my HPV awareness mission. Perhaps that is simply how I’m meant to fill the space between?

At first, I thought if I could simply touch one person’s life through my efforts then I made a difference. But I’ve been inundated with messages from family, friends, and complete strangers who share personal stories about having their children vaccinated for HPV as a direct result of my efforts. Is there anything else I could do that would be as gratifying?

If you or a loved one is affected by cancer, I’d love to hear how you deal with the space between. Rather than messaging me directly, please feel free to comment on this post so that others can benefit from your shared experience.

Calm

It’s been a few weeks since my last blog post, so I wanted to provide a brief update. The good news is that life has been rather uneventful – no trips to the emergency room, no new side effects, etc. Let’s face it, we were due for a break!

Last week was not only the Labor Day Holiday but also a scheduled break from chemotherapy to allow my blood counts, etc. to recover. As a result, as of Monday morning I was feeling better than any time in recent memory. My appetite has been good and my energy level afforded us an opportunity to take our puppy Humphrey with us to walk around a local art fair this past weekend.

This week, however, I’m back to week #1 of my treatment schedule starting with a doublet of chemotherapies (paclitaxel and carboplatin). For me, the carboplatin results in greater side effects, particularly stomach upset, decreased appetite, and fatigue. My typical four week treatment “cycle” looks like this:

Week #1: paclitaxel + carboplatin
Week #2: paclitaxel only
Week #3: paclitaxel only
Week #4: holiday/break (no treatment)
Lather, rinse & repeat

Before this week’s chemo appointment, I had time and energy to visit with another one of my social media connections for the first time (@BursatilBiotech). She traveled from Argentina to New York with a relative for vacation and we had arranged a brief meeting in the morning while she was in town.

@BursatilBiotech and Michael Becker

My next chemo break falls during the first week of October. At that time, I’ll have my periodic imaging procedure to see if the cancer is continuing to respond favorably to the treatment. Based on improved air flow to my lungs, I’m hopeful for some continued good news.

In the meantime, I’ve been keeping busy with my mission to raise awareness for the human papillomavirus (HPV), its direct link to six cancers, and the available vaccines that can prevent HPV. For example, my guest editorial on the topic appears in this week’s issue of BioCentury and is freely available to view on their website by clicking here. In addition, last Thursday I did a television interview with CURE Today and you can view the first segment on their website by clicking here. I’m so very grateful to these and other media outlets that have provided me with a platform to advance my mission!

Most importantly, today is another gift that I will truly treasure…as I get to celebrate my youngest daughter’s birthday. Happy 17th birthday Megan!!

Back on Track

Bacterial cultures from the tips of two chest tubes that were recently removed revealed growth of a pseudomonas organism on one of them. These are fairly common pathogens involved in infections acquired in a hospital setting. Whether or not this was the source of my fevers, I was prescribed an antibiotic (levofloxacin, 500mg daily) since pseudomonas can lead to other nasty conditions.

I continued running fevers for a few days after starting the antibiotic, but was free of fever for the 48-hours leading up to my next scheduled chemotherapy round. Aside from the mystery fever, my blood counts have been good throughout the three weeks of chemotherapy that I received thus far. Accordingly, my medical oncologist (Dr. Pfister) supported resuming treatment.

Michael Becker receiving chemotherapy at Memorial Sloan-Kettering Cancer Center

On Tuesday, August 15, 2017, Lorie and I took the early morning train to NY so I could receive an intravenous infusion of paclitaxel and then carboplatin as planned. I was quite anxious to resume treatment after a one week break – especially after seeing the decrease in tumor size from the recent CT scan.

I looked at my blood test results from that morning and noticed my magnesium level was again low. Knowing that this “could” have played a role in the recent cardiac event, and that my daily oral magnesium isn’t keeping up, I requested an additional intravenous course of magnesium just to be safe and the medical staff agreed.

Michael Becker asleep on the Amtrak train home. Although my blood counts are okay, Lorie is appropriately cautious and likes me to wear a mask when on the train or in other public spaces.

The chemotherapy infusions went well and we were able to take an afternoon Amtrak train back home. Benedryl® is one of the pre-medications they give me, so I slept a good portion of the trip home. Lorie was kind enough to capture me asleep with her phone.

After postponing their prior trip due to my hospitalization, my sister and her family are planning to visit us this weekend. Hopefully life is uneventful and we all get to spend some time together.

It was surreal that exactly one week after being in the intensive care unit (ICU) at Memorial Sloan-Kettering Cancer Center (MSKCC), I felt good enough to participate in a scheduled radio interview conducted in Philadelphia on August 10, 2017. Just goes to show there are good days and there are bad days. NPR member radio station WHYY host Dave Heller knew an awful lot about my book “A Walk with Purpose: Memoir of a Bioentrepreneur” and it was so great working with him during my first experience in a radio recording studio. Please take a moment to listen to a replay of this 20-minute segment and other events, along with reading newspaper and other media reprints, under the “In the News” menu tab at my memoir website by clicking here.

Michael Becker with WHYY’s Dave Heller. (WHYY photo)

Hopefully I continue to feel okay the next couple of days and look forward to seeing family while in town. It should take a week or so for the latest treatment effects to materialize. If not, however, I’m sure Humphrey will provide them with endless hours of amusement!

I would be remiss if I didn’t mention in closing that the start of the new school season is a great time to schedule an appointment with your pediatrician to talk about an important immunization that could prevent 6 cancers in boys/girls. You can learn more about this vaccine in an earlier blog post by clicking here. Had this vaccine been available when I was a child, it could have prevented the cancer that’s killing me. Start the discussion with your doctor – today! And help spread the word by using the #DiscussHPV hashtag in your social media posts.

Thankful for Cancer?

In recent blog posts, I discussed my interest in trying new things, such as transcendental meditation, acupuncture, sound therapy, etc. I connected with other terminal cancer patients and found that some of them were pursuing similar avenues.

Through these interactions, I was introduced and started reading The Tibetan Book of Living and Dying by Sogyal Rinpoche, Patrick D. Gaffney, and Andrew Harvey (thank you @StacieChevrier). I haven’t read much of the book yet, but so far it is chock full of valuable insights and memorable quotes. For example:

“Tibetan Buddhists believe that illnesses like cancer can be a warning, to remind us that we have been neglecting deep aspects of our being, such as our spiritual needs. If we take this warning seriously and change fundamentally the direction of our lives, there is a very real hope for healing not only our body, but our whole being.”

The quote implies that cancer could actually be a good thing. Similarly, in the past I’ve come across posts from other cancer survivors talking about the various ways they were actually “thankful” for getting cancer. I must admit, at the time I found such notions absolutely ludicrous. I certainly wasn’t thankful for having cancer. F@ck cancer!

However, I am starting to perhaps better understand and appreciate the nature of such remarks. For example, as stated in the quote above “…cancer can be a warning, to remind us that we have been neglecting deep aspects of our being.”

In the past, I was very skeptical of meditation, acupuncture, and other spiritual needs. Cancer opened my eyes to at least try new techniques, and now I am a believer and realize the void that they can fill.

By writing and publishing my memoir A Walk with Purpose along with my photography book Strength, Confidence & Beauty: A Collection of Female Portraits, I learned a lot about myself and my life’s journey. Tackling these activities were always in the back of my mind, but somehow there was never enough time to focus on them. Cancer provided both the motivation and a sense of urgency.

Left to right: Michael, Sheff, Brad (and, of course, Humphrey). Click to enlarge.

Through my cancer diagnosis, I also started connecting with amazing individuals and received overwhelming support from mere acquaintances to complete strangers. Just yesterday, a few of my Twitter buddies (@bradloncar and @SheffStation) made the long trip to rural Pennsylvania just to spend some quality time together. To be fair, it’s completely possible they just came to see our new adorable puppy Humphrey – but, hey, I’ll still take it. (In all seriousness, many thanks to Brad, Sheff, and others that have visited in recent weeks and months!)

I learned to “live in the moment,” appreciate the little things, and slow my life down a bit. Of course, some of this didn’t come by choice, but rather the diminished energy and fatigue of battling cancer.

Before cancer, I was wandering aimlessly with no real goal in life other than a desire for material wealth. Now, I am on a mission – to raise awareness of the human papillomavirus (HPV) and its link to six different cancers with the hope of getting more children vaccinated so they don’t suffer my same fate. I am someone with a deep motivation, a purpose in life, a definite direction, and an overpowering conviction that there will be a reward at the end of it all.

And so, I asked myself: “Am I thankful for getting cancer?” At this point, the fears and future uncertainties prevent me from answering with a resounding “yes.” But, I am warming up to the idea that cancer has changed me for the better, and for that – it is hard not to be thankful.

Help Eradicate Six Cancers Caused by HPV

As a sexually transmitted disease, discussions surrounding human papillomavirus (HPV) can understandably be uncomfortable and/or embarrassing. Interestingly, according to the Centers for Disease Control and Prevention (CDC), HPV is so common that nearly ALL sexually active men and women get the virus at some point in their lives. About 79 million Americans (~25% of the U.S. population) are currently infected with some type of HPV. About 14 million people in the United States become newly infected each year. Accordingly, I thought that a more detailed blog post on the subject was warranted.

HPV is a virus with the ability to infect skin and mucous membranes, or mucosa, that lines various cavities in the body and surrounds internal organs. It can cause normal cells in infected areas to turn abnormal. Most of the time, you cannot see or feel these cell changes. In the majority of cases, the body fights off the HPV infection naturally and infected cells then go back to normal.

There are approximately 179 distinct HPV genotypes, which can be divided into “low risk” and “high risk” groups based on their capacity to drive cancer transformation. Most people with HPV never develop symptoms or health problems; 9 out of 10 HPV infections go away by themselves within two years. Sometimes HPV infections will last longer and can cause certain cancers, warts, and other diseases. There is currently no test to find out a person’s “HPV status.”

The “high risk” HPV subtypes most clearly implicated in cancer are HPV16, 18, 31, 33, 35, 45, 51, 52, and 56, which are capable of causing cancers of the cervix, head and neck, anus, vagina, vulva, and penis. Every year in the United States, HPV causes 30,700 such cancers in men and women.

Most of the time, people get HPV from having vaginal and/or anal sex with an infected partner. In fact, “genital HPV” is the most common sexually transmitted infection (STI) in the U.S.

However, the same types of HPV that infect the genital areas can also infect the mouth and throat. HPV found in the mouth and throat is called “oral HPV.” Only a few studies have looked at how people get oral HPV, and some of these studies show conflicting results. Some studies suggest that oral HPV may be passed on during oral sex (from mouth-to-genital or mouth-to-anus contact) or simply open-mouthed (“French”) kissing, others have not. The likelihood of getting HPV from kissing or having oral sex with someone who has HPV is not known. According to the CDC, more research is needed to understand exactly how people get and give oral HPV infections.

Oral HPV is about three times more common in men than in women. Overall, HPV types 2, 4, 6, 11, 13 and 32 have been associated with benign oral lesions while HPV types 16 and 18 have been associated with malignant lesions, especially in cancers of the tonsils and elsewhere in the oropharynx. The most commonly implicated subtype in oropharyngeal cancer is HPV16, accounting for over 80% of HPV positive cases. Not surprisingly, my initial biopsy results showed that tumor cells were positive for HPV16.

Patients with oral HPV cancer present at a younger age and are less likely to partake in excess alcohol consumption or heavy tobacco use that are associated with corresponding HPV-negative cancers. Additionally, HPV-related tumors more frequently arise in the oropharynx – the part of the throat at the back of the mouth behind the oral cavity. It includes the back third of the tongue, the soft palate, the side and back walls of the throat, and the tonsils (where my cancer started). Smoking-related tumors arise more commonly in the oral cavity, larynx, or hypopharynx.

Oral HPV tumors are more likely to be smaller and poorly differentiated, with a higher incidence of advanced lymph node metastases in comparison to HPV negative tumors. Despite a more aggressive clinical presentation, HPV status is the best independent predictor of survival in these patients.

Signs and symptoms of oral HPV may include persistent sore throat, earaches, hoarseness, enlarged lymph nodes, pain when swallowing, and unexplained weight loss. In my case, the first sign of disease in November 2015 was an enlarged (3-4cm) lymph node on the right side of my neck where the cancer had spread from my right tonsil. Some people have no signs or symptoms.

While there is currently no cure for the virus, there are commercially available prophylactic vaccines against HPV available today: the bivalent (HPV16 and 18) Cervarix®, the tetravalent (HPV6, 11, 16 and 18) Gardasil®, and newer Gardasil 9 (HPV6, 11, 16, 18, 31, 33, 45, 52, 58). Since the HPV subtype 16 was included in each of these vaccines, and this subtype was found in my tumor cells, it is very likely that my cancer could have been prevented had such vaccines been available to me when I was younger.

The HPV vaccine was initially developed to prevent cervical and other less common genital cancers, which raised questions regarding the ability to also prevent oral cancers. In one of the first large studies to explore the possible impact of HPV vaccination on oral HPV infections, researchers found it may confer a high degree of protection. The study of young adults in the U.S. showed that the prevalence of high-risk HPV infection was 88% lower among those who reported getting at least one vaccine dose than among those who were not vaccinated. Researchers reported the results at the recent American Society of Clinical Oncology (ASCO) 2017 annual meeting.

To be an effective preventive strategy, HPV vaccination should start before “sexual puberty.” The CDC recommends routine HPV vaccination for girls and boys at age 11 or 12 (two doses six months apart, a 2016 revision of guidelines that previously recommended three doses). People who get vaccinated later (up to age 26 for young women and up to age 21 for young men) will need three.

The same research reported at ASCO 2017 found that from 2011 through 2014 fewer than 1 in 5 (18.3%) young adults in the U.S. reported receiving at least one dose of the HPV vaccine before age 26. The vaccination rate was much lower among men than women (6.9% vs. 29.2%) at this time.

“The HPV vaccine has the potential to be one of the most significant cancer prevention tools ever developed, and it’s already reducing the world’s burden of cervical cancers,” said ASCO President-Elect Bruce E. Johnson, MD, FASCO. “The hope is that vaccination will also curb rising rates of HPV-related oral and genital cancers, which are hard to treat. This study confirms that the HPV vaccine can prevent oral HPV infections, but we know it only works if it’s used.”

More research is needed to understand exactly how people get and give oral HPV infections that resulted in my oropharyngeal cancer. Recent studies confirm that the HPV vaccine can prevent such oral HPV infections, but only when they are used – and vaccination rates are extremely low. This is disappointing, as vaccination is widely considered one of the greatest medical achievements of modern civilization. Childhood diseases that were commonplace less than a generation ago are now increasingly rare because of vaccines (although the measles are making a comeback since elimination was first documented in the U.S. in 2000). In order to be effective at eliminating communicable diseases, vaccines must be administered to sufficient levels of persons in the community.

If you have a son or daughter, please talk to your doctor about the HPV vaccine. HPV has become a recognized driver of six cancers affecting more than 30,000 people each year, yet there are available vaccines to prevent the majority (about 28,000) of these cases from ever occurring.

 

Sources:

American Cancer Society. Cancer Facts & Figures 2017. Atlanta: American Cancer Society; 2017.

From HPV-positive towards HPV-driven oropharyngeal squamous cell carcinomas. Cancer Treat Rev. 2015 Oct 31.

Centers for Disease Control and Prevention: Human Papillomavirus (HPV) Statistics

J Clin Oncol 35, 2017 (suppl; abstr 6003)

Watching the Calendar

Earlier this week, Lorie and I made our biweekly visit to the National Institutes of Health (NIH) for my infusion of the experimental agent M7824. The two day trip was uneventful and included a variety of imaging and other diagnostic tests, including an ultrasound of my spleen and a chest x-ray to monitor the pleural effusion in my left lung.

Fortunately, all of the tests came back fine and I was cleared to receive my regular infusion of M7824. As with all the previous treatments, there were no adverse reactions and we returned home later that evening.

However, with the month of July rapidly approaching, I can’t help but start to feel quite anxious. This is due to the published results from Bristol-Myers Squibb’s “CheckMate 141” phase 3 trial with Opdivo® (nivolumab), an anti-programmed death 1 (PD-1) monoclonal antibody also known as a checkpoint inhibitor. In that study, 361 patients with recurrent squamous-cell carcinoma of the head and neck (SCCHN) whose disease had progressed within 6 months after platinum-based chemotherapy were assigned, in a 2:1 ratio, to receive Opdivo every 2 weeks or standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab). The primary end point was overall survival.

Treatment with Opdivo resulted in longer overall survival than treatment with standard, single-agent therapy. The median overall survival was 7.5 months (95% confidence interval [CI], range 5.5 months to 9.1 months) in the Opdivo group versus 5.1 months (95% CI, 4.0 months to 6.0 months) in the group that received standard therapy.

Recall from prior posts that M7824 is a completely novel, first-in-class, bispecific fusion protein of an avelumab-like, anti-PD-L1 antibody linked to two molecules of TGF-beta trap. Therefore, I always viewed M7824 as a “potentially” superior alternative to Opdivo given its added mechanism of action, hence my strong interest in participating in the M7824 clinical trial.

Assuming for a moment that M7824’s treatment effect is at least comparable to Opdivo, and considering that my disease recurred around December 2016, an expected survival of 7.5 months would translate to the July/August 2017 timeframe.

To be fair, an apples-to-apples comparison of Opdivo and M7824 isn’t possible. However, the results of Bristol-Myers Squibb’s “CheckMate 141” trial serve as a contemporary data set for checkpoint inhibitors in the treatment of recurrent SCCHN and are definitely something that I keep my eye on.

Lorie and Michael Becker enjoying ice cream in Bethesda, MD

Barring any surprises, I’ll continue biweekly treatment with M7824 and then repeat imaging in July to see whether or not my disease has progressed. In the meantime, I’ll continue to savor simple moments like enjoying ice cream on a warm summer evening with my wife (see photo).