Jesper A S Andersen1,2,3, Anders D Spatzek1,2,3, Mie H Vilstrup1, Peter Grupe1,4, Søren Hess5,6, Paw C Holdgaard7, Lars Bastholt8, Oke Gerke1,4, Malene G Hildebrandt9,10,11. 1. Department of Nuclear Medicine, Odense University Hospital, Odense, Denmark. 2. University of Southern Denmark, Odense, Denmark. 3. Open Patient Data Explorative Network, OPEN, Odense University Hospital, Odense, Denmark. 4. Department of Clinical Research, Research Unit of Clinical Physiology and Nuclear Medicine, University of Southern Denmark, Odense, Denmark. 5. Department of Radiology and Nuclear Medicine, Hospital South West Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark. 6. Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark. 7. Department of Nuclear Medicine, University Hospital Lillebaelt, Vejle, Denmark. 8. Department of Oncology, Odense University Hospital, Odense, Denmark. 9. Department of Nuclear Medicine, Odense University Hospital, Odense, Denmark. Malene.Grubbe.Hildebrandt@rsyd.dk. 10. Open Patient Data Explorative Network, OPEN, Odense University Hospital, Odense, Denmark. Malene.Grubbe.Hildebrandt@rsyd.dk. 11. Department of Clinical Research, Research Unit of Clinical Physiology and Nuclear Medicine, University of Southern Denmark, Odense, Denmark. Malene.Grubbe.Hildebrandt@rsyd.dk.
Abstract
OBJECTIVE: The benefit of FDG-PET/CT in follow-up of patients treated with adjuvant immunotherapy after resection of high-risk malignant melanoma (MM) is debated. This study evaluated the diagnostic accuracy and clinical impact of FDG-PET/CT for diagnosing MM recurrence during the first year after surgery. METHODS: We retrospectively included 124 patients with resected high-risk MM, who received adjuvant immunotherapy and follow-up FDG-PET/CT. Clinical information and AJCC-8 stage was obtained from patients' medical records. Recurrence was verified by biopsy/progression on a subsequent scan leading to change of treatment. Non-recurrence was assumed when no metastases were observed until the subsequent follow-up scan. Incidence of recurrence, sensitivity, specificity, positive and negative predictive values (PPV and NPV) were outcome measures. RESULTS: Incidence rate of MM recurrence was 0.27 [95% CI 0.17-0.37] per person-year during the first-year. Recurrence was detected in 13 patients (10%) at 3-month FDG-PET/CT, in 10 patients (8.1%) at 6 months, 1 patient (0.8%) at 9 months, 3 patients (2.4%) at 12 months. The overall sensitivity, specificity, PPV, and NPV were 97% [86-99], 82% [78-86], 39% [29-50], and 99% [98-99], respectively. The PPV trended towards higher values as disease stage increased. At the 3-month scan, the majority of actions derived from positive findings were surgery or earlier expedition of the subsequent follow-up scan. CONCLUSION: The high rate of recurrence in patients with high-risk MM treated with adjuvant immunotherapy emphasizes the need for follow-up. The potential harm by a moderately low specificity reflecting a high number of false-positive results must be weighed against the benefit of early detection of recurrence.
OBJECTIVE: The benefit of FDG-PET/CT in follow-up of patients treated with adjuvant immunotherapy after resection of high-risk malignant melanoma (MM) is debated. This study evaluated the diagnostic accuracy and clinical impact of FDG-PET/CT for diagnosing MM recurrence during the first year after surgery. METHODS: We retrospectively included 124 patients with resected high-risk MM, who received adjuvant immunotherapy and follow-up FDG-PET/CT. Clinical information and AJCC-8 stage was obtained from patients' medical records. Recurrence was verified by biopsy/progression on a subsequent scan leading to change of treatment. Non-recurrence was assumed when no metastases were observed until the subsequent follow-up scan. Incidence of recurrence, sensitivity, specificity, positive and negative predictive values (PPV and NPV) were outcome measures. RESULTS: Incidence rate of MM recurrence was 0.27 [95% CI 0.17-0.37] per person-year during the first-year. Recurrence was detected in 13 patients (10%) at 3-month FDG-PET/CT, in 10 patients (8.1%) at 6 months, 1 patient (0.8%) at 9 months, 3 patients (2.4%) at 12 months. The overall sensitivity, specificity, PPV, and NPV were 97% [86-99], 82% [78-86], 39% [29-50], and 99% [98-99], respectively. The PPV trended towards higher values as disease stage increased. At the 3-month scan, the majority of actions derived from positive findings were surgery or earlier expedition of the subsequent follow-up scan. CONCLUSION: The high rate of recurrence in patients with high-risk MM treated with adjuvant immunotherapy emphasizes the need for follow-up. The potential harm by a moderately low specificity reflecting a high number of false-positive results must be weighed against the benefit of early detection of recurrence.
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