Local Adjuvant Treatment with Low-Dose CpG-B Offers Durable Protection against Disease Recurrence in Clinical Stage I-II Melanoma: Data from Two Randomized Phase II Trials.

Purpose: Although risk of recurrence after surgical removal of clinical stage I-II melanoma is considerable, there is no adjuvant therapy with proven efficacy. Here, we provide clinical evidence that a local conditioning regimen, aimed at immunologic arming of the tumor-draining lymph nodes, may provide durable protection against disease recurrence (median follow-up, 88.8 months).Experimental Design: In two randomized phase II trials, patients, diagnosed with stage I-II melanoma after excision of the primary tumor, received local injections at the primary tumor excision site within 7 days preceding re-excision and sentinel lymph node (SLN) biopsy of either a saline placebo (n = 22) or low-dose CpG type B (CpG-B) with (n = 9) or without (n = 21) low-dose GM-CSF.Results: CpG-B treatment was shown to be safe, to boost locoregional and systemic immunity, to be associated with lower rates of tumor-involved SLN (10% vs. 36% in controls, P = 0.04), and, at a median follow-up of 88.8 months, to profoundly improve recurrence-free survival (P = 0.008), even for patients with histologically confirmed (i.e., pathologic) stage I-II disease (P = 0.02).Conclusions: Potentially offering durable protection, local low-dose CpG-B administration in early-stage melanoma provides an adjuvant treatment option for a large group of patients currently going untreated despite being at considerable risk for disease recurrence. Once validated in a larger randomized phase III trial, this nontoxic immunopotentiating regimen may prove clinically transformative. Clin Cancer Res; 23(19); 5679-86. ©2017 AACR.

[Fluorodeoxyglucose F18(FDG)-probe guided biopsy]. / De fluor-18-deoxyglucose(FDG)-probe: biopsie op geleide van FDG-activiteit.

Although positron emission tomography-computed tomography (PET-CT) has improved the diagnosis of malignant and inflammatory abnormalities, histopathological examination is often required to supplement imaging examination in order to make a definite diagnosis. In some cases a lesion is not visible using conventional imaging techniques but is visible on a PET scan with fluorodeoxyglucose F18 (FDG). In other cases a lesion cannot be approached percutanuously because of localisation or size of the lesion. In these cases the surgeon can now perform an FDG-probe guided biopsy or resection. Using this technique the surgeon can peroperatively detect lesions that have taken up radioactive FDG - so-called FDG-avid lesions - and excise these for histopathological examination. This technique reduces the inadvertent excision of non-representative tissue and can be of value for localising FDG-avid lesions for total resections. FDG-probe guided surgery can potentially increase the sensitivity of diagnostic resections.