Survival update of neoadjuvant ipilimumab plus nivolumab in macroscopic stage III melanoma in the OpACIN and OpACIN-neo trials.
Abstract Background Neoadjuvant ipilimumab plus nivolumab has yielded high response rates in patients with macroscopic stage III melanoma. These response rates translated to high short-term survival rates. However, data on long-term survival and disease recurrence are lacking. Patients and methods In OpACIN, 20 patients with macroscopic stage III melanoma were randomized to ipilimumab 3 mg/kg plus nivolumab 1 mg/kg q3w four cycles of adjuvant or split two cycles of neoadjuvant and two adjuvant. In OpACIN-neo, 86 patients with macroscopic stage III melanoma were randomized to arm A (2× ipilimumab 3 mg/kg plus nivolumab 1 mg/kg q3w; n = 30), [...]
Neo-Adjuvant Immunotherapy emerges as best medical practice and will be the new standard of care for macroscopic stage III Melanoma.
Abstract Survival of macroscopic stage III melanoma is poor. Five-year overall survival and relapse-free survival rates for surgery alone range from 40 to 59% and 30 to–39%, respectively. The current standard of care is therapeutic lymph node dissection (TLND) followed by a year of adjuvant systemic therapy. Multiple phase 2 trials have shown that neo-adjuvant immunotherapy induces major pathologic response (MPR) rates (pathologic complete response (pCR): pCR, 0% viable tumour cells; near-pCR, <10% viable tumour cells), which translate into durable relapse free survival rates. Single agent anti-PD-1 achieves 20–30% MPR, the combination of ipilimumab and nivolumab doubles the MPR [...]
Alternatives and Reduced need for Sentinel Lymph Node Biopsy (SLNB) Staging for Melanoma
Abstract Sentinel lymph node biopsy (SLNB) has been introduced in the 1990s to identify patients who might benefit from completion lymph node dissection. Neither SLNB nor CLND improved survival, but SLNB staging did provide the best staging, above Breslow thickness and ulceration. The SLN status and SLN tumour burden were used in all trials until date looking at modern adjuvant systemic therapy with immune checkpoint inhibition (ICI) or targeted therapies (TT). Adjuvant ICI and TT are shifting towards stage II melanoma. The question is whether there is still role for SLNB in melanoma, in this day and age, and [...]
Tumor-Infiltrating Lymphocyte Therapy or Ipilimumab in Advanced Melanoma.
Abstract Background: Immune checkpoint inhibitors and targeted therapies have dramatically improved outcomes in patients with advanced melanoma, but approximately half these patients will not have a durable benefit. Phase 1-2 trials of adoptive cell therapy with tumor-infiltrating lymphocytes (TILs) have shown promising responses, but data from phase 3 trials are lacking to determine the role of TILs in treating advanced melanoma. Methods: In this phase 3, multicenter, open-label trial, we randomly assigned patients with unresectable stage IIIC or IV melanoma in a 1:1 ratio to receive TIL or anti-cytotoxic T-lymphocyte antigen 4 therapy (ipilimumab at 3 mg per kilogram of body [...]
Talimogene laherparepvec monotherapy for head and neck melanoma patients.
Abstract Talimogene laherparepvec (T-VEC) is a modified herpes simplex virus, type 1, intralesionally administered in patients with stage IIIB/C-IVM1a unresectable melanoma. When surgery is not a treatment option in the head and neck region, T-VEC can be an elegant alternative to systemic immunotherapy. Ten patients with metastatic melanoma in the head and neck region started treatment with T-VEC monotherapy at the Netherlands Cancer Institute. We collected data on response, adverse events (AEs), and baseline characteristics. For response evaluation, we used clinical evaluation with photography, 3-monthly PET/computed tomography (PET/CT) using 18F-fluoro-2-D-deoxyglucose, and histological biopsies. Median age at baseline was 78.2 [...]
ASO Visual Abstract: Predictors of Sentinel Lymph Node Metastasis in Patients with Thin Melanoma-An International Multi-institutional Collaboration.
Abstract In this international, multi-institutional, retrospective cohort study of 676 patients with thin melanoma undergoing sentinel lymph node biopsy, only 7.8% of patients had a positive sentinel lymph node. Mitotic rate and Breslow thickness were predictive of nodal metastasis. Read Full Paper
Is a History of Optimal Staging by Sentinel Lymph Node Biopsy in the Era Prior to Adjuvant Therapy Associated with Improved Outcome Once Melanoma Patients have Progressed to Advanced Disease?
Abstract Introduction: Sentinel lymph node biopsy (SLNB) is important for staging in patients with primary cutaneous melanoma. Did having previously undergone SLNB also affect outcomes in patients once they have progressed to metastatic melanoma in the era prior to adjuvant therapy? Methods: Data were retrieved from the Dutch Melanoma Treatment Registry, a prospectively collected, nationwide database of patients with unresectable stage IIIC or IV (advanced) melanoma between 2012 and 2018. Melanoma-specific survival (MSS) was compared between patients with advanced cutaneous melanoma, previously treated with a wide local excision (WLE) or WLE combined with SLNB as initial treatment of their primary tumor. [...]