Study of cutaneous melanoma recurrences after sentinel node biopsy: Patterns of dissemination and use of complementary test in follow-up.

OBJECTIVES: To investigate the patterns of melanoma recurrence in the local population, including factors that may influence in this event and timing of relapse, and to determine the mode of detection of them. METHODS: This is a retrospective cohort study of patients with melanoma who underwent sentinel lymph node biopsy at the Complejo Hospitalario de Navarra (Spain) from 2002 to 2012. The following data were collected of each patient: age, gender, date of diagnosis, location of melanoma, histological subtype, Breslow thickness, ulceration, mitosis, sentinel node status, AJCC 8th edition stage, site of first diagnosed metastasis, mode of relapse, date of first relapse and time of death. RESULTS: Of 308 patients, 30% people suffered metastasis. The mean follow-up time was 68.63 months. 51.1% of relapses were locoregional and 48.9% haemato-visceral. Sentinel node status was the only variable associated with higher risk of haemato-visceral metastasis (p < 0.001). The mean time between diagnosis of melanoma and recurrence was 2.7 years. Most recurrences were detected by the patient himself or had any type of symptoms and were consequently selected for a complementary test. CONCLUSION: It is important to follow-up all patients with diagnosis of cutaneous melanoma, essentially during the first 5 years after diagnosis.

Dabrafenib plus trametinib for compassionate use in metastatic melanoma: A STROBE-compliant retrospective observational postauthorization study.

The main objective of the study was to evaluate the efficacy and safety of dabrafenib alone or combined with trametinib for compassionate use in patients with metastatic melanoma.This retrospective, observational study involved 135 patients with unresectable stage IIIC or stage IV melanoma from an expanded-access program at 30 Spanish centers.Forty-eight patients received dabrafenib monotherapy and 87 received combination dabrafenib and trametinib; 4.4% and 95.6% of the patients had stage IIIC and IV melanoma, respectively. All patients showed BRAF mutations in their primary or metastatic lesions; 3 were positive for V600K while the remainder had V600E or V600+. A positive response to treatment was reported in 89.3% of the patients. Overall survival rates at 12 and 24 months were 59.6% (95% confidence interval [CI], 52.5-68.9%) and 36.4% (95% CI, 27.8-45%), respectively. Progression-free survival rates at 12 and 24 months were 39.3% (95% CI, 31.1-47.5%) and 21.6% (95% CI, 14.5-28.7%), respectively. Fifty-seven patients (42.2%) reported cutaneous toxicity of any type, mainly hyperkeratosis (14.8%) and rash (11.9%). The most frequent adverse events were pyrexia (27.4%), asthenia (19.3%), arthralgia (16.9%), and diarrhoea (13.2%).Our results suggest that both dabrafenib alone or in combination with trametinib are effective for compassionate use in terms of response and/or survival rates. However, differences in patients' prognostic features ought to be considered. No new findings were revealed regarding the safety profiles of either regimen. This is the first study to evaluate the efficacy of these 2 selective BRAF and mitogen-activated extracellular signal-regulated kinase inhibitors in a real-world setting in Spain.