Weinberg, R.S., Grecco, M.O., Ferro, G.S., Seigelshifer, D.J., Perroni, N.V., Terrier, F.J., . . . Alonso, D.F. (2015). A phase II dose-escalation trial of perioperative desmopressin (1-desamino-8-d-arginine vasopressin) in breast cancer patients. SpringerPLUS, 4, 428-015-1217-y. 

To determine safety and tolerability of increased doses of desmopressin (DDAVP) as well as what dose is most effective for cancer surgery, and to monitor the surgical bleeding, the plasma levels of the von Willebrand factor (VWF), and the circulating tumor cells (CTC).

Patients were divided into five groups of four. The patients received two IV infusions, first 30–60 minutes before surgery and again 24 hours later; if there were no dose-limiting toxicities noted, then the next group of patients had increased dosages. Desmopressin was diluted into 100 ml of normal saline. If no dose-limiting toxicity was reported, then the next cohort of patients were given higher doses of medication with the endpoint of a total dose at 2.0.

• N = 20  
• AGE RANGE = 36–62 years
• MEDIAN AGE = 47 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients with breast carcinoma stage 0-II
• OTHER KEY SAMPLE CHARACTERISTICS: Treatment included mastectomy or lumpectomy as primary treatment including sentinel lymph node biopsy.

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: Argentina

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

• Open-label phase II trial concentrating on dose escalation of perioperative DDAVP and looking at surgical bleeding, plasma levels in VWF, and circulating tumors

• The measurement included biochemical analysis and real-time quantitative reverse transcription-PCR looking at CTC and immunhistochemical detection of breast tumor samples
• PRISM 6 6.0.1 was used for statistical analysis.

Of the 20 patients that were enrolled the study, two patients had reversible adverse events. One patient experienced hyponatremia, nausea, and grade 1 dyspnea one hour after the first dose of DDAVP. The second patient experienced grade 2 hypersensitivity reaction, and the medication was interrupted. The rate of the administration was slowed down in additional cohorts to prevent further reactions. A 50% reduction of intraoperative bleeding was noted with the increasing doses of DDAVP, measured by the number/weight of pads used during the procedure. There was also a higher VWF plasma levels and a noted postoperative decrease in CTC counts.

Using 2.0 (mcg/kg) dose of DDVAP was deemed as safe with two slow IV infusions before and after surgical procedures. Using higher doses of DDVAP showed a reduction in intraoperative bleeding, higher circulating VWF levels, and a decrease in CTC counts after the procedure.

• Small sample (less than 30)

Nurses administering DDVAP need to be aware of the potential reactions that may occur with the use of this medication.