Faithanne Hill is not your typical Trinidadian. For one, she loves the beach, which may sound obvious considering she lives on an island, but that is not the case for everyone in Trinidad.
“The beach is always there—it never goes away—so most people only go on special occasions or when there’s a holiday,” explained Faith (as she likes to be called). “But I make it a point of going. It’s one of my happy places.”
With her wide smile and bubbly personality, it’s hard to think of Faith as anything but happy, which would not seem obvious considering her diagnosis of stage 4 alveolar soft part sarcoma (ASPS). This ultrarare soft tissue sarcoma, with a global incidence of less than 1 per 1,000,000, is another thing that sets Faith apart, not only among Trinidadians but around the world.
In 2013, Faith was 10 when she was presumptively diagnosed with rhabdomyosarcoma, a type of sarcoma typically seen in Trinidad. She underwent treatment with chemotherapy as they waited for results from a biopsy that was sent to Miami.
“When we realized that I was misdiagnosed, the doctors in Trinidad stopped treating me and said I basically just have to go home and try to live the best life that I could because there wasn’t anything they could do for me,” Faith explained. “They only gave me three months to live.”
Her parents, undeterred, started researching ways they could help, eventually getting in touch with John W. Glod, MD, PhD, and Brigitte C. Widemann, MD, at the National Cancer Institute (NCI) within the National Institutes of Health (NIH). This would start Faith on a journey that truly makes her unique among Trinidadians.
In 2020, she became the first-ever patient to have an investigational agent administered in Trinidad and Tobago for an oncology clinical trial.
Making Clinical Trial History in Trinidad
Faith, now 22, has been participating in clinical research for half her life, starting with trials for cediranib and sunitinib (Sutent). But in each of those cases, she had to travel to the United States to receive treatment.
The same was true when she started on a phase II trial for the immunotherapy atezolizumab (Tecentriq) in late 2019. But when the COVID-19 pandemic forced the closure of Trinidad’s borders in March 2020, traveling to another country to get her treatment was no longer an option.
“The trial was actually going quite well,” explained Elad Sharon, MD, MPH, who at the time was working within the Cancer Therapy Evaluation Program (CTEP) at NCI. “We had seen responses in patients and the idea that an individual who was potentially benefiting from the therapy would not be able to get access to the therapy was of great concern to us.”
Faith had just completed a cycle of therapy prior to the enactment of travel restrictions, which meant the researchers had a little over a month to work out a way for her to continue to get her treatments in a country that had never been involved in an oncology clinical trial before. In order for that to happen, a laboratory facility, health center, pharmacy, radiologist, and oncologist all had to be accredited by both the NIH and the ethics review process of Trinidad and Tobago’s Ministry of Health. Further, the Ministry of Health had to liaise with the Customs and Excise Department to ensure treatments could be shipped into the country.
“The COVID situation allowed for the freedom to think outside of the box so this patient could continue treatment,” said Alice Chen, MD, the head of the Early Clinical Trials Development Program at NCI and the principal investigator of the trial, who added the fact that this trial was for a single agent with a known toxicity made it more feasible to pull off in another country in a short time span.
“It also helped that the patient had a very dedicated oncologist in Trinidad who really went above and beyond to push things through from the Trinidad side,” Chen said.
That oncologist was Kellie R. Alleyne-Mike, MD, now the medical director of the St. James Medical Complex and Cancer Centre of Trinidad and Tobago.
“I didn’t think that I would be able to continue treatment, but I was … and Dr. Mike was really nice. She always made me feel like she had it under control,” Faith said.
Alleyne-Mike credits the “amazing buy-in” from the various government bodies involved in Trinidad that understood the urgency of the situation and acted quickly to complete the needed assessments and made any necessary adjustments along the way.
“We have a lot of presumed challenges in developing countries in terms of our capabilities of being able to do something on the magnitude of this trial,” said Alleyne-Mike. “But the proof is in the pudding with how quickly we acted to make this happen during a circumstance of great need.”
Faith was able to continue with her treatments of atezolizumab until her disease progressed, which as Chen explained, is not uncommon for a cancer treatment to work for a period of time before the cancer finds a way to get around the drug.
Still, the data collected from Faith’s participation in the trial was ultimately included in the submission sent to the U.S. Food and Drug Administration (FDA) that led to the approval of atezolizumab in December 2022 to treat ASPS in both adults and children.
“I think this trial has already had a significant impact for patients with this rare disease, and now other countries are looking to get approval for atezolizumab in ASPS,” Chen said. “It also shows that having participation globally for rare tumor types is extremely important, especially in underdeveloped countries because if they only have three patients with a certain disease, those patients potentially would not have options to join a clinical trial. We really need to start thinking about clinical research in a very global fashion.”
Turning This Example Into One of Many
Following the success of this trial, several of the researchers involved—including Glod, Chen, Sharon, and Alleyne-Mike—wrote a commentary that asked why other trials can’t follow a similar model to this more often to increase patient participation from developing and middle-income countries.
“We were able to show that middle-income countries—countries that have not necessarily been involved with the treatment of cancer patients to date—could contribute and make a difference globally for everyone,” said Sharon, who is now a medical oncologist at Dana-Farber Cancer Institute. “This type of access to other countries can assist us in having more rapid trial activation and accrual, while also helping to reduce disparities between wealthier countries and middle-income countries.”
In addition to this trial, Alleyne-Mike has experience working on multinational research collaborations as a member of the African Caribbean Cancer Consortium Team (AC3), which was the 2023 recipient of the American Association of Cancer Research (AACR) Team Science Award. This group is dedicated to addressing cancer disparities for all populations of African ancestry with Alleyne-Mike serving a role within the head and neck working group that is trying to establish data repositories on the genetic makeup of different patients in marginalized groups, as well as increase access to clinical trials.
“Facilitating a single patient on a clinical trial is one thing, but facilitating multiple patients will require a greater investment,” said Alleyne-Mike. “We need to make sure we have more systems in place within developing nations so that we can possibly do this on a larger level.”
Alleyne-Mike said such systems could include more direct interactions between clinicians in developing countries and the external institutions running trials, so clinicians can be aware of opportunities for their patients. Certain entities within the AC3 are working on a way to achieve this.
According to Alleyne-Mike, Trinadad and Tobago is one of the more fortunate islands within the Caribbean community (CARICOM) in terms of the percentage of physicians specialized in oncology. But other nations within CARICOM may need additional government support to fund training for more specialists and lab technicians who can collaborate with those running the trials.
“Support should be fueled by the realization that if we were to make this happen, the gains for our countries and the gains from a knowledge standpoint would be significant,” Alleyne-Mike said.
Bringing Innovation to the Patients
As Faith knows firsthand, the gains would also be significant from the patient perspective. Throughout her childhood, she had to miss many milestones her peers experienced from field trips to graduation because of constant travel to the United States for treatment. Even though she still had friends and her parents made sure she had as normal a childhood as possible, she couldn’t help but feel isolated at times.
“If I am being honest, I didn’t understand the significance of this trial when it was happening,” Faith said. “But now I understand that I opened a door and maybe another person who is 11 doesn’t have to go through that process of isolation and they could be here and be a part of the newest development of oncology care.”
Faith wants to help address that feeling of isolation by establishing the Faith Foundation, which would provide a community for other young adults and kids with cancer.
She also stressed the importance of researchers building more personal relationships with their patients.
“One of the big things that has impacted my journey is the amount of trust I have in my doctors and their ability to just see me as a person,” she explained.
These days, Faith is focused on living her life and doing things that fascinate her, like studying obstetrics, dancing with her family, or just taking a trip to her happy place—the beach. It also means that Faith doesn’t spend too much time focusing on her prognosis, even as her cancer has continued to spread. Currently, she is participating in another trial, this one for cabozantinib (Cabometyx)—with the medication once again being shipped to Trinidad.
“We are just seeing where it goes,” Faith said.
“I don’t want to close myself off to the opportunity because I see it as giving up, and I’m not ready to give up yet.”
