{
  "abstract": "Background Based on improved RFS compared with observation, adjuvant immunotherapy was FDA approved for stage IIB/IIC melanoma on Dec 3, 2021 in the US. 1 2 Questions remain whether potential lifelong toxicities and costs justify a year of therapy given the lack of demonstrated survival benefit. Additionally, given high response rates in advanced disease (III-IV), watchful waiting has also been proposed, reserving treatment for recurrence and potentially avoiding unnecessary therapy in those cured by surgery alone.Methods The NCDB was queried for patients with stage IIB/IIC melanoma from 2018-2022, with 2018-2021 defining pre-approval and 2022 post-approval timepoints. Comparisons of clinical characteristics associated with adjuvant immunotherapy were evaluated using Chi-square, Kruskal Wallis, or Cochran Armitage trend tests where appropriate. Multivariable logistic regression models were utilized to assess predictors of adjuvant immunotherapy. We also report the rate of administration of adjuvant immunotherapy from our tertiary healthcare system.Results 11,756 IIB/IIC patients were identified from 2018-2022 in NCDB. Prior to FDA approval, 366/5989(6.1%) with stage IIB and 269/3363(8.0%) with stage IIC underwent adjuvant immunotherapy. In the first year following FDA approval 426/1556(27.4%) and 336/848(39.6%) received immunotherapy, respectively ( figure 1). On multivariable analysis, predictors of adjuvant immunotherapy included younger age and post approval timing. Younger age remained significant for both IIB and IIC patients when limiting to the post-approval period. When limiting to post-approval among patients with IIC disease, Medicare and uninsured compared to privately insured were less likely to receive immunotherapy along with those at academic research centers compared to community centers.This compares with 18/84(21%) patients within our tertiary healthcare system who received adjuvant immunotherapy in 2022 for stage IIB/C disease.Conclusions In the first year following FDA approval, 32% of patients in the US received adjuvant immunotherapy for stage IIB/C melanoma and 21% within our healthcare system. The limited dissemination of anti-PD1 therapy with a new indication within the first year of FDA approval is not unexpected; however, lower administration at academic centers argues there are additional barriers to uptake, such as lack of patient and/or provider buy-in. The cost/benefit ratio of treatment is also a factor when looking at RFS as the primary goal of treatment. The high surgical cure rate suggests a need for an improved strategy for patient selection for adjuvant immunotherapy, potentially through biomarker driven detection of molecularly recurrent disease, or through neoadjuvant approaches with shorter durations of immunotherapy exposure and the potential to guide adjuvant decision making based on immunologic response.Acknowledgements We would like to thank Todd Pletz and Sarah Holton from the Mayo Clinic Cancer RegistryReferences Kirkwood JM, et al. Adjuvant nivolumab in resected stage IIB/C melanoma: primary results from the randomized, phase 3 CheckMate 76K trial. Nat Med. Nov. 2023;29(11):2835–2843. doi: 10.1038/s41591-023-02583-2.Luke JJ, et al, Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial. The Lancet. Apr. 2022;399(10336):1718–1729. doi: 10.1016/S0140-6736(22)00562-1.Abstract 485 Figure 1Pre FDA approval and post approval administration of adjuvant immunotherapy for stage IIB/C melanoma",
  "authors": [
    {
      "affiliations": [
        "Mayo Clinic, Jacksonville, FL, USA"
      ],
      "name": "James W Jakub"
    },
    {
      "affiliations": [
        "Mayo Clinic, Rochester, MN, USA"
      ],
      "name": "Courtney Day"
    },
    {
      "affiliations": [
        "Mayo Clinic, Jacksonville, FL, USA"
      ],
      "name": "Bently Doonan"
    },
    {
      "affiliations": [
        "Mayo Clinic, Phoenix, AZ, USA"
      ],
      "name": "Mahesh Seetharam"
    },
    {
      "affiliations": [
        "H. Lee Moffitt Cancer Center and Research Institute, Inc, Rochester, MN, USA"
      ],
      "name": "Jeffrey Johnson"
    },
    {
      "affiliations": [
        "Mayo Clinic, Jacksonville, FL, USA"
      ],
      "name": "Ahmed Yahya"
    },
    {
      "affiliations": [
        "Mayo Clinic, Jacksonville, FL, USA"
      ],
      "name": "Roxana S Dronca"
    }
  ],
  "title": "485 Utilization of adjuvant immunotherapy for stage IIB-IIC melanoma in US in the first year following FDA approval",
  "uid": "1d10c0e9-932c-5874-aa64-a1172c4940b2"
}