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Tumor Discovery Adjuvant immunotherapy in high-risk melanoma

Table 1. Patient eligibility criteria
Inclusion criteria Exclusion criteria
• Male or female aged 18 years or older. • History of autoimmune diseases within 1 year or known active autoimmune
disease, except for diabetes mellitus and autoimmune thyroiditis causing
hypothyroidism that only requires replacement of thyroxine hormone.
• Eastern Cooperative Oncology Group performance status of 0 – 2. • Evidence or history of other serious physical or mental illness, alcoholism,
drug dependence, laboratory abnormalities, or other factors that may render
the patient at high risk.
• Histologically confirmed malignant melanoma with metastases • Two or more active malignancies within the last 2 years.
to regional lymph nodes or distant metastasis that had been
surgically resected.
• Treated with at least one dose of adjuvant pembrolizumab or • Diseases requiring immunosuppressant therapy, or requiring prednisolone
nivolumab. >10 mg/day or an equivalent dose of similar drugs during the treatment.

whereas eight patients received an intravenous infusion date of data collection, which was set at June 1, 2021. The
of pembrolizumab 200 mg every 3 weeks for up to 18 analysis of survival was carried out using the Kaplan–Meier
doses (or 400 mg every 6 weeks for up to nine doses). test, allowing for a comprehensive examination of the
The treatments were continued until disease recurrence, temporal aspects of these crucial endpoints.
unacceptable toxicity, or withdrawal of treatment, with any
toxicity managed according to local protocols. To conduct these statistical analyses and generate the
Kaplan–Meier curves, we employed GraphPad Prism
Regular computed tomography, magnetic resonance version 8.0.2 (California, USA).
imaging, and/or positron emission tomography scans
were performed at regular time intervals (12 – 24 weeks) 3. Results
and when clinically indicated by the treating clinician. 3.1. Patients
Melanoma recurrence was diagnosed based on a clinical
assessment by the treating physician or confirmed through Between January 1, 2019, and June 1, 2021, a total
histological and/or radiological evidence of new metastatic of 95 patients were included in the study. Patient
lesions. demographics and characteristics are detailed in Table 2.
Adverse events were documented throughout the The population had a mean age of 67 years, with 65 (68%)
treatment phase and until the end of the study period. patients being males. Nearly half of the patients (n = 47;
The grading and recording of these adverse events were 49.5%) were diagnosed with Stage IIIC malignant
conducted according to the common terminology criteria melanoma. A minority of patients (n = 27; 28.4%) were
for adverse events application, version 5.0. BRAF V600E mutants. In addition, the majority of patients
(n = 87, 91.5%) had primary cutaneous lesions.
2.2. Statistical analysis
3.2. Treatment
Patient and tumor characteristics were meticulously
delineated through the utilization of descriptive statistics Regarding the type of initial surgical treatment, 41 patients
in our study. A comprehensive comparison was drawn (43.1%) underwent wide local excision (WLE) and sentinel
between the features and outcomes within our cohort and lymph node biopsy, while 19 patients (20%) underwent
the data derived from historical trial records. WLE alone (Figure 1).
The evaluation of OS involved assessing the time from A total of 87 patients (91.6%) were treated with
the initiation of treatment to the eventual date of death. RFS, nivolumab alone, whereas only eight patients (8.4%)
on the other hand, was defined as the duration between were treated with pembrolizumab. The median time to
the initiation of treatment and the occurrence of the first start immunotherapy after surgery was 6.7 weeks. A total
recurrence, be it local, regional, or distant metastasis, or of 41 patients (43%) started treatment within 6 weeks
death from any cause. DMFS was specifically defined as the of surgery. A total of 38 patients (36.1%) completed the
interval from the commencement of treatment to the date treatment. Only 12 patients (13%) had to cease the treatment
of the first distant metastasis or death from any cause. early due to toxicity concerns, whereas 13 patients (12.3%)
For patients who remained alive and did not experience stopped earlier due to disease progression, as shown in
a recurrence of melanoma, RFS was censored at the cutoff Figure 2.

Volume 3 Issue 3 (2024) 3 doi: 10.36922/td.3143