Trials, Targeted Agents Often Lead to Financial Toxicity From CCA

Clinical trials and targeted agents do not appear to affect health care–related quality of life, however.

People with cholangiocarcinoma (CCA) who enroll in a clinical trial or receive targeted therapy suffer a significant financial burden, but their health care–related quality of life (QOL) is unaffected, according to a new report published in Journal of Surgical Oncology.

The report highlights the burdens faced by people with CCA and the ways in which those burdens extend beyond the physical symptoms of the disease.

The study authors note that a diagnosis of CCA brings with it a dim prognosis. Most patients will not discover their cancers early enough to undergo surgical resection, even though surgery is the only treatment considered curative. Even when resection occurs, recurrence rates are high.

Patients who undergo resection typically are given adjuvant capecitabine, while cisplatin plus gemcitabine is the first-line option in advanced cases, the authors noted.

The lack of curative options leads many patients to seek out clinical trials or targeted therapies. The authors noted that the FOLFIRINOX (folinic acid, fluorouracil, irinotecan hydrochloride, oxaliplatin) and FOLFOX (folinic acid, fluorouracil, and oxaliplatin) chemotherapy regimens have shown promise in clinical trials of patients with advanced biliary cancers, and targeted molecular agents have also raised hopes.

“The application of these therapies continues to evolve and expand into the first-line setting,” the authors noted. “However, our understanding of the long-term patient-specific outcomes beyond toxicity and disease survival is limited.”

They decided to explore patient-specific outcomes by asking patients who were engaged with the Cholangiocarcinoma Foundation to complete surveys for 2 QOL instruments: Functional Assessment of Cancer Therapy (FACT)-Hepatobiliary and Comprehensive Score for Financial Toxicity (COST). The 208 patients who agreed to participate and were included in the analysis had a wide range of situations.

Most of the patients (75%) had intrahepatic CCA, 57% of whom were able to undergo resection; nearly half of those patients (48%) experienced recurrence. One in 5 patients (22%) was enrolled in a clinical trial, and these patients tended to be at a higher stage of disease and were more likely to have previously received targeted therapy.

Eighty percent of enrollees underwent molecular profiling, the authors said; however, just 29% of this group received targeted therapy. Most of these patients had advanced or metastatic disease.


In terms of QOL, the investigators said patients in clinical trials or who were receiving targeted care had similar outcomes to other patients in terms of their physical, emotional, social, or functional well-being. Yet, the same was not true when it came to financial well-being. Patients in clinical trials and those receiving targeted therapy were significantly more likely to report financial toxicity.

The study authors said deciding whether to enroll in a clinical trial is often based on issues such as a provider’s attitude toward trials or concerns about detrimental adverse effects. Less attention is paid, however, to issues such as the patient’s employment or insurance status or his or her household income.

“Financial toxicity related to cancer care is a critical component of patient quality of life that is not routinely examined and thus often overlooked,” the investigators wrote.

Even though participation in clinical trials usually does not result in direct costs for the consumer, the authors noted that other costs, such as transportation, meals, and urgent care visits, are often overlooked. They concluded that although it was an important finding that trials and targeted therapies do not compromise patient health care–related QOL, it is equally important to understand that such treatment avenues bring considerable financial stress.

“To limit deficits in comprehensive cancer care, it is vital to incorporate discussions of financial toxicity when counseling patients on goals of care,” they wrote.

In addition, they said it will be important to expand opportunities to participate in clinical trials and to find ways to eliminate the financial burdens associated with doing so.

Reference

Keilson JM, Lindsey S, Bachini M, et al. Patient reported outcomes: financial toxicity is a barrier to clinical trials and personalized therapy in cholangiocarcinoma. J Surg Oncol. Published online July 15, 2022. doi:10.1002/jso.27012