Multicenter phase 3 trial of whole-body imaging during follow-up after surgery for stage IIB-C and III cutaneous malignant melanoma

The multicenter randomized phase 3 TRIM study in Sweden evaluated addition of whole-body imaging CT or PET-CT to physical examination during follow-up after surgery for stage IIB-C and III cutaneous malignant melanoma in adult patients. Patients were randomized to 3 years of follow-up by physical examinations alone (standard group; n=498) or physcical examinations plus CT or PET-CT at baseline, 6, 12, 24, and 36 months (experimental group; n=485). Interim analysis at a median follow-up time of 33.6 months (IQR 16.3-49.8) found no statiscally significant differences between the groups in overall survival or distant-metastasis-free survival. The 3-year OS rate was 88.2% in the standard group versus 87.7% in the experimental group, and the 3-year DMFS rate was 81.6% versus 79.3%. The authors conclude that the interim analysis suggests that there is no benefit from imaging in the follow-up program for individuals with high-risk cutaneous malignant melanoma.