Adjuvant Immunotherapy Produced Survival Benefit for Patients With High-Risk Stage II Melanoma

Patients with resected high-risk stage II cutaneous melanoma saw a significant overall survival advantage when treated with adjuvant immunotherapy, according to data from a trial presented at the Society of Surgical Oncology 2021 International Conference on Surgical Cancer Care.

The research team concluded that adjuvant immunotherapy should be considered as a postoperative treatment option for patients with stage IIB and IIC melanoma.

“This is our first study to use the National Cancer Database [NCDB] to analyze postoperative immunotherapy specifically in patients with high-risk stage II cutaneous melanoma,” explained William Wong, DO, of the Penn State Health Milton S. Hershey Medical Center, in his presentation of the data. “We demonstrated a significant survival advantage with adjuvant immunotherapy and recommend that it should continue to be considered in postoperative treatment of stage IIB and stage IIC melanoma.”

The main analysis included a total of 10,592 patients with high-risk stage II cutaneous melanoma. Of this cohort, 419 patients (4%) received postoperative immunotherapy, while 10,173 (96%) did not.

For patients with stage IIB disease who received adjuvant immunotherapy, the 3-year overall survival rate was 86% compared with 77% for patients who did not receive immunotherapy (P = .0012). Looking at patients with stage IIC disease who received adjuvant immunotherapy, the 3-year overall survival rate was 79% compared with 61% for those who did not receive immunotherapy (P < .0001).

More, a Cox proportional hazard model found that the benefit in patients with stage II disease who received immunotherapy was statistically significant (HR, 0.663; 95% CI, 0.514-0.854; P = 0.002). Factors that were associated with poorer survival outcomes included patients aged 66 years or older, those on Medicare/Medicaid versus private insurance, and multiple comorbidities among other factors.

The research team collected data from the NCDB between 2013 and 2017 to find patients with stage IIB and IIC melanoma who underwent resection. Chi-square tests and a multivariable logistic regression model were used to examine the associations between adjuvant immunotherapy and characteristics of the patient population.

“The paradigm for treating advanced cutaneous melanoma has shifted with the approval of new immunotherapy agents since 2011,” explained Wong. “The use of immunotherapy agents is well accepted for stage II and stage IV disease. However, because of limited evidence of overall survival benefits, there continues to be a lack of consensus on adjuvant immunotherapy in high-risk stage 2 melanoma, which includes stage IIB and stage IIC disease.”

The primary end point for this research was the examination of neoadjuvant immunotherapy’s impact on overall survival. Secondary outcomes focused on factors associated with adjuvant immunotherapy use.

The NCDB does not provide information on what specific type of immunotherapy a patient received, limiting further specific data on the treatment option for this cohort of patients. Since immune checkpoint inhibitors were introduced as treatment in 2011, the research team restricted the study period to 2013 through 2017 to better allow for the assumption that patients received immune checkpoint inhibitors.

After mentioning an ongoing clinical trial to confirm the data that has an estimated primary completion date of October 2022, Wong concluded, “In the interim, utilization of postoperative immunotherapy for high-risk stage II melanoma will be left to the discretion of the patients and their multidisciplinary team.”

Reference:

Wong W, Holguin RP, Stahl K, et al. Utilization and Survival Benefit of Adjuvant Immunotherapy in Resected High-Risk Stage II Melanoma: A National Cancer Database Analysis. Presented at: Society of Surgical Oncology 2021 International Conference on Surgical Cancer Care. Virtual. Abstract 58.