Dosage Study Improves Patients' Quality of Life

Sometimes less is more when it comes to cancer treatment. That’s the idea behind a study led by Qamar Khan, MD, breast medical oncologist.

Capecitabine is a chemotherapy drug used to treat certain types of cancer and is the only FDA-approved chemotherapy pill used to treat metastatic breast cancer. While effective at limiting the spread of cancer, it can come with rough side effects that include hand-foot syndrome, a condition that causes burning pain in the hands and feet, as well as severe diarrhea. 

“Like many physicians, when I started treating breast cancer early in my career, I followed the recommended dose of capecitabine,” Dr. Khan says. “We soon realized it is very difficult for patients to remain on the treatment because of the side effects.” 

Some of Dr. Khan’s patients would opt to skip taking the drug altogether. After observing these side effects in his patients for years, Dr. Khan wondered if adjusting the dosing schedule might make capecitabine more tolerable and improve his patients’ quality of life. 

A Practice-Changing Study

The standard FDA-approved dose is 1,250 mg/m2 two times a day for 14 days on and 7 days off. With pilot funding from The University of Kansas Cancer Center, Dr. Khan launched a phase 4 randomized trial comparing the effectiveness and side effects of the standard dose and schedule versus 1,500 milligrams (fixed dose) twice a day for 7 days on and 7 days off. It was the first randomized trial to investigate the new regimen against the standard approved treatment.

Compared to those who received the standard approved regimen, participants who received fixed-dose capecitabine on a 7-days-on/7-days-off schedule showed similar rates of progression-free and overall survival. They were, however, much less likely to develop severe cases of hand-foot syndrome and diarrhea, and they were far more likely to stick with treatment.

Dr. Khan presented his findings at the American Society of Clinical Oncology’s 2023 annual meeting - the biggest cancer conference in the world, which convenes 45,000 professionals from across the globe. His podium presentation was met with enthusiastic feedback, with experts hailing the study as “practice-changing.” 

“These findings will transform how people with metastatic breast cancer are treated,” Dr. Khan says.

An Assist From the Masonic Cancer Alliance

Since up to 85% of clinical trials fail to recruit enough participants, Dr. Khan leaned on community partners to recruit participants to his study. As the cancer center’s outreach network, the Masonic Cancer Alliance (MCA) partners with healthcare professionals and brings clinical trials to rural communities throughout Kansas and western Missouri. MCA partners helped recruit about 10% of the patients to Dr. Khan’s trial.

“A lot of the people we treat come from rural communities,” Dr. Khan says. “We have a strong network that allows us to bring leading-edge clinical trials to rural communities, which is an important component of our comprehensive designation from the National Cancer Institute.”

Dr. Khan adds that many other team members were integral to the study’s success, including the investigators who accrued patients, biostatisticians Holly Smith and Milind Phadnis, who analyzed the data, and pharmacists Taylor Monson and Colleen Bohnenkamp, who assisted with data organization.

Focusing on the Patient

As an oncologist who conducts research, Dr. Khan is in the unique position of identifying opportunities for improvement. This includes listening to the needs of those he treats. Dr. Khan has designed and led eight of his own clinical trials throughout his career, and all have been inspired by interactions with patients.
“It isn’t just about treating the cancer,” Dr. Khan says. “It’s about an individual’s well-being and quality of life.”