Safety of antiemetic prophylaxis with HTX-019 as a 30-min infusion in patients with cancer: a retrospective study.

Aim: The NK-1 receptor antagonist HTX-019 (CINVANTI® [aprepitant injectable emulsion]) was approved for preventing chemotherapy-induced nausea and vomiting based on bioequivalence studies in healthy volunteers. The objective of this study was to evaluate HTX-019 safety in cancer patients. Patients & methods: This retrospective analysis evaluated the safety of HTX-019 130 mg 30-min intravenous infusion, as part of a three-drug antiemetic regimen. Results: No treatment-emergent adverse events (TEAEs) were deemed related to HTX-019. During treatment cycles, three of 100 patients developed five reversible TEAEs: dyspnea, hot flash, pain, nausea and visual disturbance. Between cycles, six patients had TEAEs of dizziness (three patients), infusion-site events (two patients) and headache (two patients). Conclusion: HTX-019 is safe in cancer patients receiving chemotherapy.

Phase II study of biweekly pemetrexed and gemcitabine in patients with previously untreated advanced non-small cell lung cancer.

INTRODUCTION: Pemetrexed and gemcitabine are safe and active non-small cell lung cancer (NSCLC) therapies when administered every 3 weeks. Biweekly scheduling was studied in this phase II trial. METHODS: The primary objective was to assess the overall response rate in chemotherapy-naive patients with unresectable stage III/IV NSCLC. Patients received 500 mg/m(2) of pemetrexed intravenously and 1500 mg/m(2) of gemcitabine intravenously every 2 weeks for 8 to 12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy. Entry criteria included the following: all non-small cell histologies, measurable disease, Eastern Cooperative Oncology Group 0 to 2, and informed consent. RESULTS: Seventy-two patients were enrolled. Baseline characteristics included the following: median age: 66 years (41-85 years); male/female: 65%/35%; Eastern Cooperative Oncology Group 0/1/2: 19%/67%/14%; and histology: adenocarcinoma (36%), large cell (18%), squamous (13%), and mixed or not specified (34%). The median number of cycles was 7 (range, 1-12). The most common (> or =5%) grade 3/4 toxicities were as follows: neutropenia (47%), leukopenia (31%), fatigue (25%), dyspnea (18%), pain (11%), and anemia (8%). Complete/partial responses for all patients: 1 patient/18 patients, respectively, for an overall response rate of 26% (95% confidence interval, 17-38%). Thirty-nine percentage of patients had stable disease, and 21% had disease progression (10 patients were not evaluable). Median progression-free survival was 6.2 months. One-year overall survival was 37.5%. CONCLUSION: Biweekly administration of pemetrexed and gemcitabine seems to be well tolerated with activity comparable with other first-line NSCLC regimens. Further study addressing whether biweekly scheduling could be an effective strategy to shorten overall treatment duration will require a randomized design.

A retrospective cohort study to assess the impact of therapeutic substitution of darbepoetin alfa for epoetin alfa in anemic patients with myelodysplastic syndrome.

Darbepoetin alfa and epoetin alfa are used to treat anemia in the undertreated population of patients with myelodysplastic syndrome (MDS). We implemented guidelines to switch anemic patients with MDS from epoetin alfa 40,000 U weekly to darbepoetin alfa 200 microg every 2 weeks and then conducted a retrospective cohort study of the initial 263 treated patients. Patients (> or = 18 years old, MDS diagnosis) were either previously treated with epoetin alfa (received 16 weeks of prior epoetin alfa and either switched to darbepoetin alfa or remained on epoetin alfa) or treatment-naive (no previous erythropoietin therapy and received only 1 agent for 16 weeks). Both major response and minor response based on the International Working Group criteria were calculated. The study was not powered to statistically compare treatment groups; values presented are for descriptive purposes only. Data from 244 patient records were included: 142 previous epoetin alfa patients (80 switched to darbepoetin alfa, 62 remained on epoetin alfa) and 102 naive patients (56 darbepoetin alfa, 46 epoetin alfa). Major response rates were similar between treatment groups in both the naive (46% for darbepoetin alfa, 35% for epoetin alfa) and previous epoetin alfa groups (26% for darbepoetin alfa, 17% for epoetin alfa). Overall response rates were 42%-76% across treatment groups. No differences in transfusions across groups were observed. Treatment of anemic patients with MDS with either darbepoetin alfa or epoetin alfa appeared to be effective. Whereas epoetin alfa was most frequently administered on a weekly basis, darbepoetin alfa was most frequently administered every 2 weeks, which may offer the benefit of convenience with its less frequent dosing.