“I always dreamed of having a big family.”
For Kelly Spill, learning that she has rectal cancer didn’t just mean facing a potentially life-threatening disease.
The diagnosis also threatened many of the things she valued most in life.
Kelly was diagnosed at age 28, just months after giving birth to her son Jace. She and her husband, John Bonito, learned that the standard treatment for rectal cancer (usually a combination of surgery, radiation therapy, and chemotherapy) could make another pregnancy nearly impossible. , I felt heartbroken.
“The experts said we probably wouldn’t be able to have a second child,” Kelly recalls.
Hoping for the best, Kelly enrolled in a clinical trial conducted exclusively at Memorial Sloan Kettering Cancer Center (MSK).), guided by Medical Oncologist Dr. Andrea SelczekHead of Colorectal Cancer Division, Physician Scientist Luis Diaz Jr., MDDirector of Solid Tumor Oncology.
The goal of this trial was to help people like Kelly overcome rectal cancer while maintaining their quality of life using only immunotherapy.
That means avoiding surgery, radiation and chemotherapy, which can have life-altering consequences for rectal cancer patients. Instead, participants received immunotherapy injections every few weeks while closely monitoring their tumors.
The trial was small, enrolling 18 patients when results were announced in June 2022. Like Kelly, all participants were eligible because they had tumor-specific and extremely rare genetic mutations. This mutation (classified as mismatch repair defective, or MMR(d)) occurs in only about 5% to 10% of people diagnosed with rectal cancer.
The MSK team watched with excitement as patient after patient’s tumor shrank. The speed of the shrinkage surprised even the doctor in charge.
The results of the trial were so surprising that they made headlines around the world when they were announced in June. All 18 people in the trial, including Kelly, had their rectal cancer cleared. Experts say such results have never been seen in previous cancer clinical trials. James White, a statistician who works closely with MSK researchers, calculated the odds of such an outcome occurring at 1 in a trillion.
The trial continues to enroll patients, and its success reached new heights when Kelly and John announced the birth of their daughter Mya Grace in July 2023.
“She’s my miracle baby,” said Kelly, who welcomed Dr. Cercek to her southern New Jersey home four days after Maia Grace’s birth. “She’s who she is because of you,” Kelly told Dr. Circek.
Dr. Cercek visited Kelly and her family with a video crew. Let’s fight cancerperson who created Video about Kelly and clinical trials Participated in a nationally televised broadcast to raise funds for innovative cancer research. Stand Up To Cancer funded this groundbreaking clinical trial.
“Holding my beautiful little girl was an indescribable experience,” says Dr. Cercek. “We cried happy tears knowing that this trial helped people in exactly the way we had hoped.”
Using immunotherapy alone to treat rectal cancer
Dr. Andrea Selk of MSK holds newborn Maia Grace, daughter of Kelly Spill and John Bonito (Photo credit: James Mendoza)
“Standard treatments for rectal cancer work well,” explains Dr. Selczek. “But surgery, radiation, and chemotherapy can be particularly burdensome for patients with this cancer because of the location of their tumors. They can suffer from life-altering bowel and bladder dysfunction, incontinence, and sexual dysfunction. , may suffer from infertility.”
To avoid these terrible side effects, Drs. Cercek and Diaz are investigating whether the body can deploy its own immune system to attack cancer cells using a type of immunotherapy called checkpoint inhibitors. A clinical trial was planned.
Dr. Diaz’s previous research showed that checkpoint inhibitors targeting rectal tumors that carry the genetic mutation MMR(d), which prevents tumor cells from repairing damaged DNA, are effective. Dr. Diaz explains: “Using immunotherapy alone, we are able to regress and ultimately eliminate tumors with MMR(d) mutations, sparing patients from these life-altering consequences of standard treatments. I wanted to see if it was possible.”
life changing results
Like Kelly, other patients in the trial had hoped their cancer could be treated with immunotherapy alone.
Avery Holmes, another trial patient, recalls: “Maybe we can get through this.” I can’t imagine what my life would be like without this clinical trial. ”
Video | 01:56
We would like to ask patients about the treatment they received. This approach helps a patient’s own immune system recognize and attack tumors that contain vulnerable genetic mutations. This treatment allows patients to be treated without surgery, radiation, or chemotherapy.
Video details
Sacha Ross was the first patient to participate in the clinical trial. “At her home hospital in Washington, D.C., the doctors wanted to start me on standard treatment, starting with chemotherapy,” she says. “But I also consulted experts at MSK. They told me that because I have Lynch syndrome (a genetic trait that often leads to colorectal cancer), standard treatments were not suitable for me. As it turned out, I was the perfect candidate for this trial.
More than two years after treatment at MSK, Sasha has no evidence of cancer. This is an important milestone in rectal cancer treatment. “My whole experience was like a dream,” she says. And she smoothly returned to her vibrant social life while running her family’s upholstery business.
The promise of this trial also energized MSK staff dedicated to research. This large team included clinical trial nurse Jenna Sinopoli, MSN; Jill Weiss, clinical research supervisor; medical oncologist Melissa Lumisch, M.D.; The colorectal surgical team closely monitored the tumor response. and the many people who examined patients, drew blood, performed tests, recorded results, and organized data.
“One day, a young woman introduced herself to me in the elevator,” Dr. Sarcek recalls. “She said, ‘I’m the person who transports the biopsies from the doctor’s office to the lab for testing. It’s really great to be a part of your research because the results come back and the tumor It’s very moving because everyone is so happy when it disappears.”
Expanding access to more rectal cancer patients
“The response to this trial has been overwhelming,” says Dr. Diaz. “In the two months since the study was published, patient enrollment has almost doubled. 29 patients with rectal cancer are currently participating in the trial, with more patients on the way. continuing.”
MSK also works with the Hartford HealthCare Cancer Institute in Connecticut, the Lehigh Valley Cancer Institute in Pennsylvania, the Miami Cancer Institute at Baptist Health in South Florida, and MSK’s partner company New York Cancer, among others. , is expanding the trial to hospitals that are members of the MSK Cancer Alliance. and a blood specialist.
In February 2023, an FDA advisory committee approved a large-scale clinical trial led by MSK involving multiple clinics. This is an important step in gaining full FDA approval, allowing the approach to be used for patients at other hospitals facing rectal cancer with MMR(d) mutations. .
Possibility of new approaches to solid tumors
Medical oncologist Luis Diaz Jr., MD, is co-leader of MSK’s rectal cancer clinical trial.
MSK is also leveraging the success of the rectal cancer trial to expand this new approach to more cancers.
Dr. Cercek explains: “The MMR(d) mutation we targeted in this study is found in only 5% to 10% of all rectal cancers. It’s also seen in solid tumors such as bladder cancer, esophageal cancer, prostate cancer, pancreatic cancer, and other cancers, which means we have the potential to help more people.”
Doctors. Cercek, his Diaz, and their colleagues at MSK have started a new clinical trial to investigate this approach in other cancers and are currently enrolling patients. These trials target people whose tumors have the MMR(d) mutation in all cancer subtypes, including colon, bladder, stomach, prostate, and liver.
Dr. Diaz, who was appointed by President Biden to the National Cancer Advisory Council, coined the term “immunodisruptive” therapy for this new method. This means using immunotherapy instead of surgery, chemotherapy, or radiation therapy to remove cancer.
The new approach also targets targets beyond MMR(d). HER2, a gene that can produce too many proteins that promote cancer growth. That clinical trial, led by Dr. Cercek, is also being conducted at MSK and is enrolling patients. “Clinical trials for rectal cancer are just the tip of the iceberg,” Dr. Diaz said.
Even people who understand that the new approach won’t help their loved ones are emailing Dr. Circek. “People are reaching out to me and saying, ‘My relative has an advanced disease and I know things aren’t going well.’ But it gives us hope that better things will happen in the future. Thank you for that.”
“A better version of me”
Many of the patients in this trial are now helping others. In addition to caring for her two young children, Kelly also dedicates her time to counseling others diagnosed with rectal cancer. She said she found a new perspective on her life. She said: “I’m not the same person I was before cancer. I love who I am and I love who I was. But this is a perfectly good version of me these days.”
Sasha says one of the key lessons from this experience is that MSK is really needed to make this kind of breakthrough. “MSK’s research and cancer care is years ahead of other hospitals (even really good ones).”