Livingston mom battles breast cancer with experimental treatments to help other patients

Detroit Free Press - 4/22/2018

April 22--What if ... she would have insisted on a mammogram as soon as she felt the lump in her right breast six years ago?

What if ... her cancer would have been caught earlier?

What if ... the chemo would have worked the first time? The second time? The third time? The fourth?

What if the double mastectomy and radiation would have been enough?

Kimberlie Newton can't wallow in the agony of regret. All the 45-year-old Livingston County mom can do now is focus on the time she has left.

She has enrolled in a clinical trial at the Barbara Ann Karmanos Cancer Institute, hoping that by trying experimental drugs and therapies that have yet to be approved by the U.S. Food and Drug Administration, she might find something new that will give her more time with her husband and son.

But even if the trial medication doesn't help her, she thinks maybe, just maybe, a breakthrough will come of the research or an effective treatment -- if not in time to save her life, then to save the lives of the other 1 in 8 women who will be diagnosed with the disease.

For now, Newton is a survivor, and she intends to live every day she has left that way.

She'll take the mound at Comerica Park on Mother's Day, throwing out a ceremonial first pitch along with two other survivors during the Detroit Tigers game as part of an annual Pink out the Park event to honor those whose lives have been affected by breast cancer.

Newton grins when she thinks about the May 13 game. Her friends and family are coming from the Upper Peninsula to watch her, and they're renting a limo bus to take them all to the ballpark.

Her aunt owns a screen-printing company in Marquette is making them all matching pink sweatshirts that say, "Team Kim Newton."

She says she is confident her right arm, the good one, will deliver come game day. Still, there's a hint of hesitation.

When you're living with stage IV cancer, the bad days can sometimes outnumber the good.

"But I have many good days, and then I have some days when I have some fatigue and some nausea," Newton said. "But it's manageable."

Newton is used to disappointment. She replaces the negative thoughts, the doubts, by thinking of herself as a pioneer.

"I want to do my part," she said. "Without the people that have been before me, the last 10, 15 years, the strides that we've made in breast cancer research, and the drugs that have come out and been made available wouldn't have happened without the patients before me willing to put their fear aside and take the chance and take part in these phased studies."

She's among the few.

The American Cancer Society reports that fewer than 5% of adults -- not quite 1 in 20 -- with cancer take part in clinical trials. Often, that's because many patients don't know about trials open to them. Others don't meet the requirements of trials for their cancer type.

But another reason, Newton said, is driven by fear. People "don't want to be treated like a lab rat," she said. There's also the fear that the trial drug won't work.

"In reality, any treatment you get for cancer is a gamble, and you have all kinds of side effects, some of which might be deadly," said Dr. Tareq Al Bagdhadi, Newton's oncologist at St. Joseph-Mercy Hospital in Ann Arbor.

"The only way we generate knowledge in oncology is through clinical trials. ... When you are sick and facing your own mortality, sometimes benefit to others Is not the first thing you think about."

That, Dr. Al Bagdhadi said, is what makes Newton so phenomenal. She's not afraid of the biggest what if of all -- what if the trial medication doesn't work? -- because she's focused so much on helping to advance the science, on helping others.

"Kim is a remarkable person," he said. "Even in the most difficult of scenarios, we're dealing here with a very special person."

Finding a lump

In the last six years, Newton has become a master at handling the disappointment of treatments that don't work, or don't work for long.

The hard knocks started coming when she was 39.

That's when a nurse practitioner told her not to worry too much about the lump she felt in her right breast. She was so young, cancer was unlikely, the nurse told her. It was probably a cyst. Newton believed her.

A few months passed, but Newton couldn't stop worrying about the lump.

"Eventually, that little voice that you have inside your head said, 'I don't know. I don't know if I feel comfortable with this,' " she said. It nagged at her enough to take action. "I said, 'I think I would like a referral to get a mammogram.' They gave me a referral, and I went and had a mammogram."

"Later that day, they were like, 'The radiologist wants to talk to you.' "

It was breast cancer. More tests revealed later that it had metastasized to her bones.

"My lesson learned from that ... is that if you have something, make sure you get it checked out," said Newton, who lives in Handy Township near Fowlerville with her husband, Jason Newton, and their two French bulldogs, Bella and Stella. "Appease your mind, is what I would say, because you just don't know. Maybe it was small, and in her mind, given my age, it wasn't a concern, but we know that people are getting diagnosed younger and younger now.

"And I do have cancer in the family. ... My mother's sister was 38 when she got diagnosed with breast cancer. My grandmother had two sisters who passed away from it."

She started chemotherapy in October 2012, followed by 36 rounds of radiation and a double mastectomy. Long-term hormonal treatments kept the cancer at bay three more years. But by October 2016, the medicine stopped working and Newton tried several different types of chemotherapy. Some of the drugs worked for a little while, slowing the cancer's progression. Others didn't work at all.

Cancer spread through her body like the roots of an aggressive weed, invading her ribs, her lymph nodes, liver, the bone of her left arm, the bone of her sacrum.

It shifted and changed over time, developing new qualities to resist the chemicals her doctors used to try to kill it.

"Cancer is so smart," she said. "It's just like these therapies that stop working when you get too many antibiotics, then your body becomes resistant. It's the same thing with these cancer tumors. ... The cancer gets smart and it stops working and it becomes immune to the drug I'm taking. ... It can change its makeup, which is crazy."

Newton could tell when her treatments weren't working before CT scans or bone scans proved her suspicions right. She would develop fevers, her body racked by teeth-chattering chills as her temperature rose.

And she ached. She could feel the tumors embedded in her bones and getting bigger, stronger. A cough developed, too, one that nagged at her, keeping her awake at night and making it hard to hold a conversation.

"Anytime she would say she had a problem, it ended up being something serious," Dr. Al Bagdhadi said. "So she would have those unexplained fevers, unexplained cough, unexplained shortness of breath and you would do a scan, you would do a tumor marker and everything indicates it is stable. But it keeps going on, and you check again and again and ultimately something shows up to explain her symptoms."

In February 2017, she quit the job she loved as practice manager for a dental office in Howell because she was too sick to work.

"My cancer had progressed, and I was not feeling good," Newton said. "And being in charge of 27 people, I didn't feel it was fair to my employer or the employees or the office.

"I stepped down and that was hard," she said. "I would say work was my distraction, something to look forward to. It was my therapy, I think. It's important to have something to look forward to or to do to keep your mind off of what you're going through."

Dr. Al Baghdadi asked whether she'd be willing to enroll in a clinical trial, testing a cutting-edge treatment that had yet to get FDA approval.

"I said, 'You know what? Just go meet with the group at Karmanos for a possible trial. And then once we confirm progression, and I think we will based on your symptoms, you can start the trial right away. We won't waste any time.'

"We had kind of almost exhausted standard treatment. So you end up in a situation where any additional treatments I can give her -- and there are other chemotherapy drugs she can receive. There are agents we have not used -- but the chance that she would benefit is 10% or less, and then the toxicity rate would be much higher than 10% given the fact that she's been exposed to multiple treatments, especially chemotherapy. The risk-benefit ratio wasn't there. It wasn't in her best interest."

Newton met Dr. Amy Weise, a Karmanos oncologist, and talked about whether Newton might qualify for one of the more than 800 cancer-related investigations and clinical trials the Detroit-based cancer center runs each year.

By early fall, Dr. Weise had submitted Newton's case for consideration in several. But yet again, there was disappointment.

Three pharmaceutical companies rejected Newton because she'd been through so many previous rounds of chemotherapy and radiation. Two other trials were closed.

Finally, Newton matched well with a new Phase 1 clinical trial about to start in mid-October. This one would specifically target patients with estrogen-positive breast cancer like hers.

At age 44, Newton was poised to be the first person in the world to try a new medication in the form of a cobalt blue capsule that had the potential to slow the growth of her cancer, maybe even knock it back -- the best she could hope for.

Trial patient pioneer

"She was going to be the first human being in the world to get this drug," Dr. Weise said. "I can't imagine what that feels like as a patient to know that this medication has only been studied in animals and now you're the first human being on the planet to take it.

"The courage it takes to be that person, or to be the second person or the third person. That takes a lot of courage and trust and faith. You know, and I think that's important, too, for other patients to know. Someone else did it. I can do it, too."

As a Phase 1 clinical trial, only three people in the U.S. would be eligible in the beginning.

"I'm so excited because if you think about all the people before me, I call them pioneers, that were willing to take part in all these different Phase 1 studies. Without them, we wouldn't have any advancements," Newton said.

"And for me, I feel like I'm doing my part. I'm happy to give back and I'm hoping that it works. It would be great if I can stay on it and it's working for me, then there is hope for other patients with my same scenario that they would be able to have hope and be able to maybe partake in the next phase that comes up with this drug."

But on the eve of her initial tests and very first treatment -- on Oct. 17 -- Newton fell.

She and her husband had booked a downtown hotel room so they wouldn't be rushed the next morning trying to get to her first day of treatment at Karmanos.

"We were dropping off our dogs at a friend's house," she said. "I had gotten my purse strap caught on my feet and went to get out of the car, got tangled up and ended up falling.

"Your first reaction is to put your hands out."

Although Newton has a high tolerance for pain, her left arm really hurt after the fall. Her husband asked whether he should take her to the emergency room.

"I was like, 'Nah! I don't want to go to the emergency room.' I didn't want to miss the study. Nothing was going to make me miss the study," Newton said. "It was sore. I already had some things going on with the arm prior to that. I was doing some physical therapy because my arm was sore."

By the next morning, her arm was worse, much worse. Still, she and Jason arrived at Karmanos in time to start the testing and the new medication.

"When I went into clinic, I mentioned to them that it was hurting more. I told them what was going on," Newton said. "They took an X-ray, and they were like, 'Oh yeah. Your arm is broken.' So we weren't able to start the pills that day.

"Come to find out, there was a tumor there on my humerus exactly where the break happened. So I had a tumor on the left arm."

Newton needed surgery to insert a titanium rod into the arm to secure the bone.

She had to delay her start of the trial medication for a week, but by then, another patient had already begun as patient No. 1. She no longer got to be the first person in the world to try this new potential treatment, which had shown promise in lab and animal tests.

"I'm the second patient by a couple days," Newton said, adding that she was let down "a little bit because I wanted to be the first."

Every morning after that, Newton took two blue capsules at 10:48 a.m.

"You have a scheduled time, and you try not to deviate from it," she said.

She couldn't eat for two hours before she took the medication.

As the days passed on the new regimen, Newton kept a journal of her symptoms. She wrote about feeling nauseated most of the day, every day.

"A lot of times when you start these medications, you'll have a few weeks of not feeling good," Newton said. "You may get nausea, and certain symptoms. And then, within a month or a few weeks, you become adjusted to it."

But Dr. Weise wasn't convinced her nausea was entirely due to the medication. It might have been because she broke her arm.

"A lot of times, when you have a tumor and it gets broken, it can leach calcium into your bloodstream," Newton said.

Newton's blood calcium levels were too high, and her liver enzymes were off, too. She was given medication to lower the level of blood calcium in her body.

It helped.

She noticed her coughing got better on the trial medication, her fevers subsided, and so did the pain and achy feeling she often gets when her tumors are growing.

"I still have little twinges where the tumors are, a little pain here and there, but not anything like before," Newton said in November, a month after starting the treatments. "No severe pain that is making me cry or waking me up or anything."

Hope swelled, but Newton tried not to think about it too much.

She and her husband went out to dinner in early December to celebrate her 45th birthday. There was cake.

"Not anything too spectacular," she said. Her next set of scans were the week before Christmas. The best gift, she said, would be to learn that the new treatment was working.

Early indications suggested it was.

"They saw a 3% decrease in all of the tumors," Newton said. "And no new cancer spots. ... Three percent is 3%. I was wishing for a little bit more, but I'll take it. We might see some more yet."

A holiday trip

The Newtons went to Up North to visit family for the holidays. Their son, Gerritt Newton, 23, lives near Marquette with his girlfriend. Kimberlie Newton's massive extended family lives nearby in Negaunee.

"My son got a job up there in September and was unable to come home. So we stayed up there and spent time with him," Kimberlie Newton said. "We went to Christmas dinner at my grandma's house and there were 47 of us -- and that's with some people missing."

As the trial progressed, more patients were added, and the dosage of the medication increased at regular intervals.

"We start patients at a low dose of medication, and then we observe them for a period of time to make sure they don't have any bad side effects. And as long as they're doing OK, we go up to the next dose level," Weise said.

It's typically four to six weeks before doctors increase the dose. Each time the dosage rises, Weise said each of the participating cancer centers adds another patient to the trial.

"We continue to go up and up and up on the dose until somebody at some center has a significant side effect," she said. "And then we either add three more patients or go backwards to the next lower dose. That's the standard for Phase 1."

No one on a trial like this gets placebo, Weise said. And if at any time treatment is shown not to work or if the cancer progresses, the patient drops out of the trial.

In addition, all the trial medications are covered by the pharmaceutical company, along with any tests required above what would be needed for normal cancer treatment.

Details about the drugs being tested are top secret for myriad reasons. Among them is to prevent insider trading with pharmaceutical companies that might have a promising new treatment in the pipeline.

"What I can tell you is it's a hormonal treatment," Weise said of Newton's blue capsules. "This specific one affects the androgen receptor. Kim qualified because our other standard anti-estrogen treatments stopped working for her, and so when our standard treatments stop working for patients, that's when we really look for clinical trials as the next best option.

"In her case, this particular drug was a good option because her tumor has a certain mutation that we're hoping this drug will overcome. It's called ESR1. That mutation is in the tumor."

What's tricky is that cancer cells have been known to change as the treatments change.

"Cancer is a living thing," Weise said. "Like all living things, its main goal is surviving, and it's capable of adaption. ... If we hit it with a chemical or a drug, they adapt, and become resistant to that medication."

It's so changeable, she said, some of the cells within a single tumor might have one type of genetic mutation, and other cells could have a different mutation altogether.

By February, Newton was feeling quite a bit better. Her arm had healed up well so she didn't need the sling as much for support. Her hair had begun to grow back thick and wavy as ever -- she was five months post-chemo.

Newton was confident the blue capsules she was taking every day were having a positive effect on her cancer because she wasn't feeling all the telltale signs of progression. She wasn't hurting and there weren't unexplained fevers, either.

But a Feb. 12 CT-scan showed that her tumors were growing again.

The medicine wasn't working -- either because the dosage wasn't high enough or because her cancer had grown wise to it, or because it simply wasn't effective for her.

She was pulled off the study.

Dr. Weise suggested that Newton meet with Dr. Al Bagdhadi again to discuss what they should do next while she looked for new trials that might be options.

"It's part of my job to always have a Plan B," Weise said. "You never want to give a patient bad news without having a follow-up. This is what we do next."

Newton appreciated that.

"It's a comfort to know that, yeah, my doctor already planned for the worst and hoped for the best."

She thought about others with cancer who don't have as many treatment options.

"I think to myself, things could be a whole lot worse," she said. "I know people who've had cancer who are dealing with much worse scenarios. I feel fortunate for the days that I feel great. I'll take my lumps as they come because there are people suffering a lot worse than me."

She thinks of a friend who died two years ago of uterine cancer, who didn't have the kinds of options Newton has had for treatment.

She fought a good battle, but, unfortunately, it didn't work out for her," Newton said. "Her name was Cindy. She was my inspiration. You know when you meet somebody and it's like you've known her forever and she has that positive attitude? You gravitate to someone like that."

Newton feels lucky that there are so many choices for her and other breast cancer patients, and so many clinical trials.

There was another for her, this time using immunotherapy.

Another trial option

The thing about clinical trials is that pharmaceutical companies like patients to be off all other drugs for at least 28 days to ensure whatever new treatment they're testing gets a fresh start. It's called a washout period.

"I've been off medication for a month now, so the cancer has kind of had its way with my body for the last month," Newton said on March 12, the day she was to undergo testing at Karmanos for the new trial. "My liver has been enlarged. I can feel my liver. It's causing all kinds of pain in different areas. I've been feeling really tired. I definitely have noticed not having any type of medication."

She was so sick to her stomach, just getting to the hospital that day wasn't easy. Newton needed to use the barf bags they keep in the car.

Once they got to the waiting room and sat down, her husband put his arm around her.

She asked a nurse whether she could hold off on the CT-scan because she was worried she wouldn't be able to keep down the contrast dye.

"Today is a rough day," he said, worry in his eyes. He asked whether they could test her blood calcium levels and give her something to manage the nausea.

He teared up when they recalled how they first met when he was stationed at K.I. Sawyer Air Force Base in Marquette in the late 1980s, and what it was that drew him to her.

"You know, it was one of those things where you look at somebody and you just feel comfortable, you know?" he said. "Like it's somebody you've known."

She teared up, too.

Kimberlie said she'd initially been set up on a date with his roommate, but was immediately drawn to Jason instead.

"When you asked me to dance, and we started talking, it was just instant," she said. "It sure was meant to be. I'm glad I didn't end up with your roommate."

They both laughed.

She managed the tests that day. Together, the Newtons manage a lot of things.

Her new immunotherapy treatment, which combines an FDA-approved drug called Keytruda with another experimental medication, started March 19.

She gets infusions every 21 days.

Newton has had two treatments so far, and says she's feeling OK. Her first scans to look for cancer changes are to be scheduled in mid-May.

"I'm hoping that this is successful, and that other breast cancer patients that have this same scenario, this same mutation that I have, that it gives them hope that there is something coming down the pipeline to help patients," Newton said.

That's the promise of clinical trials.

They give patients more options. Sometimes, as a first-line treatment, or when all other FDA-approved treatments no longer work.

They offer hope for a new way forward, especially given that now, nearly 15 million Americans count themselves as cancer patients or survivors.

The American Society of Clinical Oncology's 2018 annual report suggests that number is growing steadily as the rate of deaths from cancer fall and people live longer than ever with the disease. The report showed that 65% of cancer patients diagnosed in 2005 have lived 10 or more years after diagnosis.

"In the past, when we've told patients that they have stage 4 disease, it implies that the disease is terminal," Weise said. "It will, ultimately, take their life. With some of the newer treatments, that is changing, dramatically.

"Some of the newer treatments will end up resulting in prolonged stable disease or disease control. It ends up being a chronic disease that never goes away but may have slowed down enough to the point that at least the end of life is delayed -- sometimes by years.

"Sometimes, there's a cure, though we're always hesitant to use the word cure because cure means never going to come back in the future and we can't be sure of that. ... But it is becoming more like diabetes or high blood pressure in that regard."

Jason squeezed Kimberlie Newton's hand.

"Maybe that's the goal," Kimberlie Newton said. "If you can't cure it, having it where it's considered a chronic disease. It's not going away, but you're able to control it and stop progression."

Contact Kristen Jordan Shamus: 313-222-5997 or kshamus@freepress.com. Follow her on Twitter @kristenshamus.

How to go to Pink out the Park

Tickets are still available to watch Kimberlie Newton throw the ceremonial first pitch during the Tigers/Mariners game at 1:10 p.m.May 13 at Comerica Park.

A special on-field pregame ceremony begins at 12:40 p.m. with ceremonial first pitches by Newton and two other breast cancer survivors, and a full ballpark tribute in the fifth inning with Pink Out the Park cheer cards.

The other women who will throw out ceremonial first pitches at the game are Sue Shomsky, 54, of Livonia, and Shelly Rathbun, 44, of Perry, Mich., who also is the winner of the MLB's/Detroit Tigers 2018 Honorary Bat Girl contest.

Pink Out the Park ticket packages at various price ranges are available now at www.tigers.com/pinkout and will include a limited-edition Pink Out the Park T-shirt and a $5 donation to support breast cancer research at Karmanos.

The event, which honors and remembers those whose lives have been impacted and changed by breast cancer, also pays tribute to moms because the game falls on Mother's Day.

The first 10,000 fans to arrive that day will get a pink Tigers hat, courtesy of Kroger.

How to learn more about Karmanos clinical trials

The Barbara Ann Karmanos Cancer Institute is the largest cancer research and provider network in Michigan, and its trials program is among the biggest in the nation.

The Phase I Clinical Trials program at the Barbara Ann Karmanos Cancer Institute is focused on developing new treatments to fight cancer.

To learn more about clinical trials being done at Karmanos, go to https://www.karmanos.org/findtrials.

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