Background: A clinical phase II study with a topical formulation of hexadecylphosphocholine (Miltefosine solution 6%) was performed in patients with skin-metas-tasized or locally recurrent breast cancer. Material and Methods: 76 patients had entered the study. At study entry, skin metas-tases or local recurrences were progressive, newly diagnosed or recurrent in most cases and stable in a few. All patients were pretreated with up to 4 different standard treatment modalities (surgery, radio-, chemo- and endocrine therapy). 24/76 patients had to be excluded from response analysis due to changes in the systemic anticancer therapy prior to study entry or during the study period (12/24), due to early systemic tumor progression (5/24), refusal of treatment (2/24), insufficient documentation (3/24), male breast cancer (1/24), or performance status of WHO grade 3 at study entry (1/24). Results: Within the scheduled time for response assessment (2 months) remissions were achieved in a total of 12 out of 52 patients (1 CR, 11 PR). In patients with concomitant systemic antitumor therapy the response rate was 24% (7/29), while it was 22% (5/23) in patients without concomitant systemic antitumor treatment. In 52% of the patients (27/52) a stabilization of the skin infiltration (no change) was observed. The treatment was well tolerated by the majority of patients. In 2/74 patients treatment was discontinued due to pruritus. In 46/74 patients local adverse reactions were observed, presenting as pruritus, rash, dry skin, bleeding at ulcer/lesion and skin atrophy. Systemic adverse reactions (anorexia, nausea/vomiting, alopecia, stomatitis) were only seen in patients with systemic antineoplastic comedication. Conclusion: This phase II trial confirms results of a phase I trial showing that topically applied Miltefosine solution causes objective tumor response in skin-metastasized and/or locally recurrent breast cancer.

Background: The use of novel immune checkpoint inhibitors (CPIs) has changed the face of management for cutaneous malignancies since their introduction. While these agents are associated with exciting outcomes, they are also associated with unique toxicities, referred to as immune-related adverse events (irAEs). Early recognition and management of these adverse reactions is important to prevent morbidity and mortality associated with these agents. At our institution, patients who receive every two-week CPIs are eligible for enrollment into the telephone toxicity monitoring program led by the skin center clinical pharmacists. Our intention for this study is to review the departmental experience and impact to patient care with the implementation of pharmacist telephone follow-up calls.Methods: This is a retrospective, observational cohort study of all adult skin center clinic patients who received every two-week dosing of nivolumab and avelumab with a documented telephone follow-up encounter from June 1, 2015 to September 30, 2019. Patients were identified via the skin center telephone call patient database.Results: A total of 726 follow up calls were conducted among 177 patients. There were 278 (38.3%) calls with at least one intervention. Of these interventions, 59.4% were considered clinically non-significant and 40.6% were clinically significant which are considered irAE-related. The most commonly identified irAEs were gastrointestinal, dermatologic, and endocrine, and most irAEs were low grade. The median time to complete a toxicity assessment for both clinically non-significant and significant was 30 minutes.Conclusions: Our data show that a pharmacist-driven telephone toxicity assessment program in a skin center clinic over a four-year time span can lead to the identification of clinically significant irAEs and beneficial interventions to patients. However, this process is time consuming and will need further evaluation in order to determine pharmacist full-time equivalents needed to carry out this program.