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71-Year-Old Cancer Patient Broke Trial Age Limits for a Chance at a Cure

71-Year-Old Cancer Patient Broke Trial Age Limits for a Chance at a Cure

After Mikhail Rubin learned his lethal blood disease had progressed, he decided that he wanted a stem-cell transplant through a clinical trial. But there was an obstacle: his age.

Mr. Rubin, who is now 72, was too old to participate. Many cancer trials cap enrollment at age 65. Even when trials for older people are available, oncologists are reluctant to enroll elderly patients because frailties might make them less resilient against side effects from toxic treatments, according to a 2020 study in an American Cancer Society journal. People over 70 represent a growing share of the cancer-patient population but are vastly underrepresented in clinical trials, the study said.

“How can we make decisions for people over 70 if people over 70 are not included in the trials that we use to base our decision making?” said Dr. Mina Sedrak, deputy director of the Center for Cancer and Aging at City of Hope, a cancer center near Los Angeles and an author of the paper.

Mr. Rubin wanted to join a clinical trial testing stem and immune cells engineered by Orca Bio, a Menlo Park, Calif.-based biotech. Nathaniel Fernhoff, an Orca Bio founder, is Mr. Rubin’s son-in-law. Dr. Fernhoff asked a transplant physician at Stanford University, who is the trial’s principal investigator, to treat his father-in-law and to consider lifting the trial’s age limit so Mr. Rubin could enroll.

The personal connection helped, but Mr. Rubin’s enrollment was also part of a broader push to open more trials to older cancer patients. The Food and Drug Administration guidelines recommend “adequate representation” of the elderly in cancer trials, including people over age 75. The Journal of the National Cancer Institute in December 2022 published a series of papers presented at a workshop focused on how to improve trial enrollment of older people.

Researchers have developed geriatric assessment tools that try to predict patients’ survival chances based on more than age alone. Professional groups are also working to try to address gaps. Despite these efforts, enrollment of older patients still lags behind, cancer doctors said.

Mr. Rubin’s doctors told him the standard of care for his blood cancer involved a stem-cell transplant with chemotherapy so aggressive that older people often receive a less-intense version. But receiving the less-intense version raises the chances of relapse, the doctors warned.

To participate in many trials involving transplants, patients would have to undergo the more intense chemotherapy whether randomly assigned to receive an experimental treatment or the standard of care. That makes it harder to incorporate older patients into randomized trials, cancer doctors said.

Trial enrollment is often cut off at 65 because of risks for older patients, said Miguel-Angel Perales, chief of the adult bone marrow transplantation service at Memorial Sloan Kettering Cancer Center in New York City. Dr. Perales is also an adviser to Orca Bio but wasn’t involved in determining Mr. Rubin’s care.

Clinical trials frequently fail. Patients in a trial examining a stem-cell engineering approach that Dr. Perales helped develop didn’t live as long as those getting a standard transplant, according to a February 2022 study in the Journal of Clinical Oncology.

“It was a moment of reckoning for all of us,” Dr. Perales said.

Researchers have changed the chemotherapy regimen and started a new trial open to people over 65, Dr. Perales said.

Before his diagnosis, Mr. Rubin played tennis regularly. On most days, he rode his prized Gary Fisher mountain bike to his job as an engineer, nearly 12 miles round trip on San Francisco’s hilly streets.

“People age differently,” said Everett Meyer, Mr. Rubin’s transplant doctor at Stanford University. He said Mr. Rubin’s age gave him pause despite the man’s robust fitness. 

“You always worry about the unexplainable things,” said Dr. Meyer, an associate professor of blood and marrow transplantation and cellular therapy and director of the Stanford Cellular Immune Tolerance Program. “You see elderly patients who after a transplant fail to thrive and you don’t know exactly what is wrong.”

Mr. Rubin spends every Sunday with his daughter, Yuliya, and Dr. Fernhoff. Dr. Fernhoff raised with them the idea that Mr. Rubin consider the Orca Bio trial.

Dr. Fernhoff hoped the engineered cells could reduce the toxicity associated with transplants. That might give Mr. Rubin a better chance of withstanding the intense chemotherapy regimen that in combination with a transplant offers the best long-term survival, he said.

The family tapped Dr. Fernhoff’s network of transplant doctors to understand the risks. “It was frightening to think that my dad might not make it out alive from the treatment alone, but that the harsh treatment was likely his only chance at long-term survival,” said Ms. Rubin.

Dr. Meyer, the principal investigator in the Orca Bio trial at Stanford and a larger multiple-site Orca Bio trial, had presented Orca Bio data in over 50 patients. The data involved people 65 or younger, but suggested they experienced fewer complications and the potential for better one-year survival compared with patients who had received standard transplants at Stanford. He discussed the results with Mr. Rubin and the family. Eventually, they started to coalesce around Dr. Fernhoff’s suggestion.

“Sometimes it takes a patient coming into your room to help push the boundaries,” Dr. Meyer said.

Dr. Meyer proposed raising the age of enrollment to 72 to the doctors in Stanford’s transplantation and cell therapy department, two Stanford review boards, and the FDA. They all signed off, Dr. Meyer said. Two more patients over 65 received transplants in the trial after Mr. Rubin, Dr. Meyer said.

Mr. Rubin knew any transplant is risky. But he often reminded himself that doctors had been encouraged by his fitness besides the cancer. “Otherwise healthy,” Mr. Rubin said. “I liked that.”

The day of Mr. Rubin’s transplant in April 2021, Dr. Fernhoff went to the hospital to review the manufacturing records and testing on the engineered cells. Then he joined Mr. Rubin in the patient wing. The two men sat together as the stem cells were infused.

“I wanted to be there. He expected me to be there,” Dr. Fernhoff said. “It is family.”

Three months after the transplant, Mr. Rubin’s doctors told him he could start riding his bike again. By his calculation, he biked around 3,000 miles last year.

Write to Amy Dockser Marcus at