Safety of combining dabrafenib plus trametinib in elderly BRAF V600 mutation-positive advanced melanoma patients: real-world data analysis of Spanish patients (ELDERLYMEL).

Efficacy and safety of dabrafenib and trametinib in metastatic melanoma have been demonstrated in two-phase III and one-phase I/II clinical trials. However, patients at least 75 years old (y.o.) were largely underrepresented. Additionally, the safety profile of dabrafenib and trametinib based on age is unknown. ELDERLYMEL is a retrospective noninterventional multicenter study, describing the effectiveness and safety of at least 75 y.o. patients compared with less than 75 y.o. patients with advanced BRAF V600-mutated melanoma treated with dabrafenib plus trametinib or dabrafenib monotherapy. A total of 159 patients were included, 130 less than 75 y.o. and 29 at least 75 y.o. Clinical features were similar between the groups, except in the number of comorbidities, number of metastatic sites, Eastern Cooperative Oncology Group (ECOG) performance status, and BRAF V600-mutation type. Five patients per group received dabrafenib monotherapy. There were no differences in adverse events (AEs) rate or grade between the groups. However, AE profiles were different between the groups, being pyrexia infrequent in patients at least 75 y.o. (13.8% vs. 42.3%; P = 0.005). Dabrafenib and trametinib dose intensities were lower in at least 75 y.o. patients ( P = 0.018 and P = 0.020), but there were no differences in effectiveness between the groups. Finally, in a multivariate analysis, sex (female) was the only variable independently associated with an increased risk of AE grade ≥3. Data from the ELDERLYMEL study demonstrate that dabrafenib plus trametinib is safe and effective in at least 75 y.o. patients with advanced BRAF V600-mutated melanoma without increasing toxicity. Additionally, we describe a different safety profile depending on age and sex.

Disease-Free Survival for Patients with Thin Melanomas according to the American Joint Committee on Cancer 8th Edition.

BACKGROUND: The recently implemented AJCC 8th edition TNM staging system for malignant melanoma (MM) changed the definition for T1a and T1b tumours. OBJECTIVES: To analyse differences in disease-free survival (DFS) among patients with thin MM staged according to both AJCC 7th and 8th editions. METHODS: An observational study including 285 patients with cutaneous thin MM (thickness ≤1 mm). Cases were staged as T1a and T1b using both 7th and 8th editions. Neither regional nor visceral diseases were present at diagnosis. DFS curves were generated according to the Kaplan-Meier method. RESULTS: An 8% shift of patients from a T1a towards a T1b stage group was observed after applying the AJCC 8th edition. According to this 8th edition, DFS for T1a patients was significantly longer than for T1b patients (log-rank test; p = 0.005); 5-year DFS for T1a and T1b was 100 and 95%, respectively (Wilcoxon test; p = 0.002). According to the AJCC 7th edition, DFS did not significantly differ for T1a and T1b patients; 5-year DFS for T1a and T1b was 99 and 97%, respectively (p > 0.05). CONCLUSIONS: The AJCC 8th edition seems to be a better tool for staging thin melanomas.

Hypoglycemic coma secondary to big insulin-like growth factor II secretion by a giant phyllodes tumor of the breast.

Nonislet cell tumor hypoglycemia (NICTH) is uncommon, and has been related to the production of insulin-like growth factor II or its high-molecular-weight precursor (big IGF-II) by the tumor. Cases of NICTH have been related to different tumors, mainly sarcomas. However, only three cases secondary to a phyllodes tumor of the breast (PTB) have been previously reported. We present the clinical course of a woman with a giant PTB, who developed an irreversible hypoglycemic coma secondary to big IGF-II production by the tumor. A brief review of the literature and possible mechanisms of this infrequent condition are also commented.

Angiosarcoma of the abdominal wall after dermolipectomy in a morbidly obese man. A rare form of presentation of Stewart-Treves syndrome.

Angiosarcoma is a rare malignant tumor, with a predilection for skin in the head and neck region, although it has been described in many other locations. Its association with chronic lymphedema is well known, mainly in the setting of postmastectomy lymphedema of the arm in breast cancer patients (termed Stewart-Treves syndrome). However, angiosarcoma can appear in lower limbs with chronic lymphedema and rarely in other locations such as the abdominal wall. Herein, we present a unique case of angiosarcoma developing in the abdominal wall of a morbidly obese patient after extensive dermolipectomy.

Epirubicin, cyclophosphamide and weekly paclitaxel as neoadjuvant chemotherapy for stage II and III breast cancer.

PURPOSE: To assess the efficacy and the toxicity of a new combination of epirubicin, cyclophosphamide and paclitaxel as neoadjuvant chemotherapy for breast cancer. METHODS: Patients with stage II and III breast cancer received 3-4 cycles of epirubicin 75 mg/m(2) plus cyclophosphamide 600 mg/m(2) on day 1, and paclitaxel at a dose of 100 mg on days 1, 8, 15 and 22 on a 28-day cycle. RESULTS: Forty-nine patients were enrolled in the study. Stage II was present in 16 patients (32.7%) and stage III in 33 patients (67.3%). Relevant toxicities were nausea/vomiting grades III-IV in 6 patients (12.2%) and neutropenia grade III-IV in 33 patients (67.3%). The overall clinical response rate was 83.7%. Partial response was observed in 25 patients (51%), complete response in 16 patients (32.7%), stable disease in 7 patients (14.3%) and progression in 1 patient. Thirty-three non-inflammatory breast cancer patients underwent surgery, 29 with breast-conserving surgery (87.9%). Pathological complete response was found in 5 patients (15.1%). CONCLUSIONS: The combination of epirubicin, cyclophosphamide and weekly paclitaxel as given in this study is safe and shows good activity in the neoadjuvant setting of stage II and III breast cancer patients.