Systemic Therapy in Advanced Cutaneous Squamous Cell Carcinoma (CSCC): The Roswell Park Experience and a Review of the Literature.

OBJECTIVES: Treatment of locally advanced unresectable or metastatic cutaneous squamous cell carcinoma (mCSCC) is suboptimal with a paucity of robust data on systemic therapy. This retrospective study aimed to evaluate the efficacy and outcomes of patients with locally advanced unresectable or mCSCC treated with systemic therapy. METHODS: Records of patients with CSCC treated with systemic therapy from January 2001 to January 2011 were reviewed. Response was assessed using WHO criteria. Descriptive results were assessed using Wilcoxon rank-sum test for ordinal responses and Pearson χ test for categorical responses. Survival was calculated by the Kaplan-Meier method. RESULTS: Of 28 patients identified, 25 patients (M:F=18:7), median age 66 years (range, 39 to 85 y), had the required data for final analysis. Partial response was 44% and stable disease (SD) was 24%. The median progression-free survival (PFS) and overall survival (OS) were 5.5 months (2.3, 13.2) and 10.9 months (5.3, 21.3) respectively; 3-year OS was 22%. Patients with WHO response had improved PFS (20.8 mo; 4.4, NR) and OS (37.5 mo; 10.3, NR) compared with patients with SD/PD (PFS 2.7 mo; OS 5.9 mo). Use of platinum-based therapy significantly improved PFS and OS, whereas taxanes and cetuximab had no impact in this small cohort. There was no difference in PFS or OS with multiagent versus single-agent therapy. CONCLUSIONS: Platinum-based therapy remains as one of the standard options in advanced CSCC management. Agents to improve response rates are needed and future trials should address the use of novel targeted and new chemotherapy combinations in CSCC.

Dose rounding of ipilimumab in adult metastatic melanoma patients results in significant cost savings.

PURPOSE: To assess cost savings incurred with a dose rounding process that was implemented for ipilimumab. Secondarily, to assess response rates, patient tolerance, and adverse effects associated with ipilimumab upon implementation of dose rounding. METHODS: All patients with a diagnosis of metastatic melanoma and who received at least one dose ipilimumab were included for analysis. Doses of ipilimumab were calculated based upon the actual body weight (in kg) of the patient at the FDA approved regimen of 3 mg/kg every 21 days × 4 doses. The exact total mg dose was then rounded to the nearest 50 mg vial size. The potential effect on cost was calculated in US dollars for both the calculated and rounded doses. Waste, in mg, was defined as the amount of drug that may have been discarded if the calculated dose was used for therapy. The acquisition cost applied was US$120 per mg. RESULTS: 22 patients have received at least one dose of ipilimumab. 11 patients have completed therapy and received all four induction doses. 9 patients discontinued therapy early and 2 patients were still actively receiving induction at the time of this analysis. A total of 63 doses were given. The maximum potential cost savings by giving ipilimumab to the nearest 50 mg over the period was 155,400. CONCLUSIONS: Dose rounding of ipilimumab to the nearest 50 mg has the potential to result in a significant cost savings by eliminating drug waste.