Shortened Immunotherapy Treatment for Advanced Melanoma Shows Positive Outcomes

A recent clinical trial has revealed that reducing the duration of immunotherapy for advanced melanoma does not significantly impact disease control compared to longer treatment periods. The study, conducted by researchers from the Universities of Sheffield and Leeds, along with the Sheffield Teaching Hospitals NHS Foundation Trust, highlights a potential shift in treatment protocols for patients with this challenging form of skin cancer.

The findings of the UK DANTE phase III trial were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. This trial is noted as the largest prospective study to evaluate the optimal treatment duration for inoperable late-stage melanoma using immunotherapy.

During the five-year study, which took place from September 2018 to March 2023, 80.2% of participants who stopped immunotherapy after 12 months maintained disease control after an additional year. This outcome is comparable to the 87.6% of those who continued treatment for two years or more, when accounting for a pre-established threshold for disease progression.

Additionally, evaluations of secondary endpoints demonstrated minimal differences in the quality of life for patients across varying treatment durations. Further investigations are planned to assess the cost-effectiveness of this shortened treatment protocol.

Melanoma stands as the fifth most prevalent skin cancer, and advancements in immunotherapy have significantly improved the prognosis for patients grappling with advanced stages of the disease, which was once deemed untreatable a decade ago. The current standard involves administering immunotherapy drugs like pembrolizumab and nivolumab for a minimum of two years, or as long as they remain effective. While this approach has led to enhanced survival rates, there is insufficient evidence to confirm that two years is the ideal duration for tumor management in patients with inoperable stage 3 and stage 4 metastatic melanoma. Furthermore, patients often endure severe side effects that necessitate increased medical attention, hospital visits, and sometimes inpatient care.

In the trial, 415 patients from 36 hospitals across the UK were recruited during their initial year of treatment. After reaching the one-year mark, 166 patients whose disease had not advanced were randomly assigned to either cease immunotherapy or continue for an additional year or longer, contingent on manageable treatment and toxicity levels.

Despite the significant insights gained regarding future strategies for treating metastatic melanoma, the trial faced recruitment challenges due to the COVID-19 pandemic, resulting in its premature closure before reaching the planned sample size. As a result, the study was underpowered, and the recommendation for a minimum of two years of immunotherapy should continue to be upheld as the standard approach.

The Chief Investigator of the DANTE trial, a Professor of Medical Oncology, emphasized the difficulty of reducing treatment duration, as there are common concerns among patients and healthcare providers that 'more treatment is better.' However, prolonged treatment can lead to increased side effects, which can be burdensome for patients. The trial has provided valuable insights and evidence regarding the management of advanced melanoma, prompting further research to identify if specific patient groups may benefit more from reduced treatment durations.

One participant in the trial, a 77-year-old patient diagnosed with inoperable stage 3 melanoma, reported a significant reduction in tumor size after participating in the trial. Initially informed that she would undergo immunotherapy for two years, she opted to join the DANTE trial after her first year of treatment. She expressed gratitude for the opportunity to contribute to ongoing cancer research, believing in the importance of supporting future patients through clinical trials.

The findings from the DANTE trial, particularly the comparative study of one year versus a minimum of two years of anti-PD1 immunotherapy, will be included in the upcoming 2025 Best of ASCO program, an educational meeting scheduled for the summer following the ASCO meeting. The researchers extend their appreciation to all participants who contributed to the trial, recognizing their role in advancing cancer treatment.