[Influence of the Use of a Closed System Drug Transfer Device on the Preparation Time of Anticancer Drugs].

A closed system drug transfer device (CSTD) helps to minimize unnecessary exposure of healthcare workers such as pharmacists to hazardous drugs. One of the concerns in using CSTDs to prepare anticancer drugs is their influence on preparation time. Therefore, we compared the time needed to prepare anticancer drugs with the CSTDs NEOSHIELD® and BD PhaSeal® system and with an injection needle. In the comparison of NEOSHIELD® and an injection needle, the preparation time of the liquid formulations of the cytotoxic drugs irinotecan, eribulin, cisplatin, docetaxel, and paclitaxel was significantly shorter with the injection needle and that of gemcitabine was significantly shorter with NEOSHIELD®, but that of oxaliplatin, carboplatin, and doxorubicin was not significantly different between the two methods; the preparation time of the liquid formulations of the molecular-targeted drugs atezolizumab, obinutuzumab, cetuximab, daratumumab and vorhyaluronidase alfa, nivolumab, ramucirumab, and rituximab was significantly shorter with NEOSHIELD® and that of bevacizumab and pembrolizumab was significantly shorter with the injection needle; and the preparation time of the lyophilized formulation of cytotoxic and molecular-targeted drugs was not significantly different between the two methods. In the comparison of NEOSHIELD® and BD PhaSeal® system, the preparation time of cyclophosphamide and ifosfamide was significantly shorter with NEOSHIELD®, but that of bendamustine was not significantly different between the two CSTDs. In conclusion, these results suggest that the preparation time with CSTDs may be similar to or shorter than that with an injection needle, depending on the type of CSTD and the drug formulation and type.

Feasibility of olanzapine, multi acting receptor targeted antipsychotic agent, for the prevention of emesis caused by continuous cisplatin- or ifosfamide-based chemotherapy.

Background To determine the feasibility and efficacy of olanzapine, which is approved by the Pharmaceuticals and Medical Devices Agency as multi acting receptor targeted antipsychotic agent of the thienobenzodiazepine class, for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients undergoing continuous five-day chemotherapy. Patients and methods This study was a prospective dose escalation study at a single center (UMIN ID: UMIN000015386). Patients received a combination of adriamycin and ifosfamide (AI) or a combination of bleomycin, etoposide, and cisplatin (BEP). On days 1-5, all patients received intravenous granisetron (1 mg) and intravenous dexamethasone sodium phosphate (24 mg). Olanzapine was administrated on day-1 to day5 at bedtime. The dose of olanzapine followed a dose-escalation scheme, with monitoring of safety and tolerability at each dose. A 3 + 3 cohort design was used, with three to six patients per cohort. Results Nine patients were enrolled (three for each cohort). No patients experienced dose-limiting toxicity (DLT). The most frequent adverse events were dry mouth and constipation. In each cohort, the maximum severity of nausea was Grade 2, and no patients experienced a vomiting episode. Conclusion A 2.5 mg/day dosage of olanzapine is sufficient to prevent from CINV in Japanese patients receiving continuous five-day chemotherapy. A dose of 10 mg/day, which is recommended by international CINV guidelines, is also tolerated. If CINV is not controlled by an initial dose of 2.5 mg/day of olanzapine, dosage escalation is encouraged. Future studies should compare olanzapine with aprepitant.

[Retrospective study on intravenous compound injection of cancer pain patients with oxycodone and hydrocotarnine preparation in comparison with subcutaneous administration].

In Japan, although oral oxycodone is widely used for cancer pain treatment, there is no injection preparation of oxycodone used as a single ingredient. Only the compound injection of oxycodone and hydrocotarnine has received approval. Subcutaneous administration of the drug is approved, but there are few efficacy and safety reports about its intravenous administration. We compared 245 patients(187 intravenous administration patients and, 58 subcutaneous administration patients)to whom the compound injection of oxycodone and hydrocotarnine was administered from April, 2008 to September, 2011, in order to investigate the drug's efficacy and safety. The reasons for injection were the impossibility of oral administration in 105 patients, a need for dose adjustment in 56 patients, and that other drugs were not as effective in 37 patients, and side effect reduction in 33 patients. The average change in the numeric rating scale(0-10)was 3. 7→1. 8 in intravenous administration, and 3. 4→1. 2 in subcutaneous administration. The incidence of main adverse events(intravenous administration/subcutaneous administration)were constipation(37%/28%), vomiting(31%/34%), and somnolence(52%/50%). There was no significant difference in efficacy and safety. The conversion ratio differed in a case due to a change, and about 20 to 40% of addition was needed within four days after the start. It is considered that compound injection of oxycodone and hydrocotarnine is effective for cancer pain treatment.