In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. e21591-e21591
Abstract:
e21591 Background: Adjuvant therapy for melanoma patients (pts) is now available for pts from stage IIB onwards. Pts with cutaneous melanoma in early stages stage IB/IIA have low risk of relapse. However, this group still contributes to the most melanoma deaths in absolute numbers. Therefore, it is important to identify pts in stage IB/IIA that could benefit from adjuvant therapy. One promising biomarker is a proprietary 7-protein immunohistochemistry (7-P-IHC) signature (Immunoprint). Based on primary tumor tissue analysis, the 7-P-IHC has shown very high sensitivity and risk enhancement ability in previous prospective and retrospective validations. 1,2 The 7-P-IHC test result indicates a risk score predicting relapse-free and melanoma-free survival (RFS, MSS), thereby allocating most relapses to the high score risk group. To further validate its key parameters, the MelaRisk trial was started in 2022, aiming to analyze up to 500 tissue samples with Immunoprint. Here we present its interim analysis and a combined analysis of all available data for Immunoprint in stage IB/IIA. Methods: All pts with available formalin-fixed paraffin-embedded blocks of the Central German Melanoma Registry diagnosed from 2005-16 and AJCC v8 stage IB/IIA were screened. Tumor tissue samples from 119 pts (83/IB; 36/IIA) were available; the 7-P-IHC was used to determine a risk group. Results: 7-P-IHC assigned 68 pts to the low-risk (57%) and 51 (43%) to the high-risk group. Median follow-up was 76 months. 15/17 relapses after 5-years were detected, resulting in a sensitivity of 88%. 5-years RFS event rate of the cohort according to AJCC v8 was 12% and 19% for stages IB and IIA, respectively. This was enhanced to a risk of recurrence of 30% (stage IB) and 29% (stage IIA) in the respective high score group. 5y-RFS rate was 97% for pts with 7-P-IHC low score risk and 71% for pts with 7-P-IHC high score risk (p=0.0001). 7-P-IHC was the only significant factor in a multivariate Cox analysis for RFS (HR 10.78 (2.38-48.74), p=0.002) and could detect 4/5 MSS events. Combined analysis including these and previous Immunoprint results in stage IB/IIA are summarized in the table. Conclusions: 7-P-IHC could concentrate 88% of stage IB/IIA RFS events in a small high score risk group. This group entails 43% of pts of the total cohort, correctly identifying pts needing adjuvant therapy. Immunoprint should be used to select pts in future studies in the adjuvant setting if these promising interim results can be confirmed in the final analysis. 1. Meyer et al. (2023) EJC; 2. Reschke et al. (2021). [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2023.41.16_suppl.e21591
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2023
detail.hit.zdb_id:
2005181-5
