A recent clinical trial has identified cetuximab as a more effective second-line treatment option compared to durvalumab for patients with head and neck cancers who are unable to tolerate cisplatin. The study, published in The Lancet Oncology, found that cetuximab demonstrated superior outcomes in this patient population, leading to the early termination of the trial so that all participants could benefit from the treatment.
Study Details and Findings
The multi-center trial involved 186 patients with advanced squamous cell carcinomas of the head and neck who were cisplatin-intolerant. Participants were treated with either cetuximab or durvalumab in combination with radiotherapy. The primary endpoint was the probability of being alive and free of disease at two years.
The results indicated that cetuximab was significantly more effective, with approximately 64% of patients being alive and disease-free at two years, compared to 51% in the durvalumab arm. According to Dr. Loren Mell, professor at University of California San Diego School of Medicine and lead author of the study, there was "no evidence of a benefit of durvalumab over cetuximab." He added, "We had a lot of reasons to be optimistic about durvalumab, but it turned out to be potentially worse than the standard."
Implications for Clinical Practice
Cisplatin has long been the standard chemotherapy for head and neck cancers; however, roughly 30% of patients cannot tolerate its side effects. Cetuximab has been considered a viable alternative, but durvalumab has recently emerged as another potential option, leading many oncologists to believe it might be safer and more effective.
These findings reinforce the role of cetuximab as a robust alternative for patients who cannot receive cisplatin. "Our study helps reinforce that radiation with cetuximab is a very good alternative for patients who cannot get standard cisplatin," Dr. Mell stated.
Mechanism of Action and Potential Subgroups
Cetuximab functions by binding to proteins on the surface of cancer cells, thereby inhibiting their growth. In contrast, durvalumab blocks a different protein, rendering the cancer cells more susceptible to immune system destruction. While cetuximab showed overall superiority, researchers suggest that durvalumab may still hold promise for a specific subset of patients with highly immunoreactive tumors.
Addressing an Unmet Need
The study addresses a critical need for effective treatments for patients who cannot tolerate cisplatin, often due to advanced age or other health issues. "Historically, this has been an underserved group, so our trial sought to establish an evidence base for this rather unique population," Dr. Mell explained. The trial's findings could lead to increased utilization of cetuximab as a second-line therapy in this patient population.
