Evaluation of the Effects of Pasireotide LAR Administration on Lymphocele Prevention after Axillary Node Dissection for Breast Cancer: Results of a Randomized Non-Comparative Phase 2 Study

Abstract

ObjectiveThe aim of this study was to assess the efficacy (response rate centered on 80%) of a somatostatin analog with high affinity for 4 somatostatin receptors in reducing the postoperative incidence of symptomatic lymphocele formation following total mastectomy with axillary lymph node dissection.SettingThis prospective, double-blind, randomised, placebo-controlled, phase 2 trial was conducted in two secondary care centres.ParticipantsAll female patients for whom mastectomy and axillary lymph node dissection were indicated were eligible for the study, including patients who had received neo-adjuvant chemotherapy. Main exclusion criteria were related to diabetes, cardiac insufficiency, disorder of cardiac conduction or hepatic failure.InterventionsPatients were randomised to receive one injection of either prolonged-release pasireotide 60 mg or placebo (physiological serum), which were administered intramuscularly 7 to 10 days before the scheduled surgery. The study was conducted in a double-blind manner.Primary and Secondary Outcome MeasuresThe primary outcome measure was the percentage of patients who did not develop post-operative axillary symptomatic lymphoceles during the 2 postoperative months. Secondary endpoints were the total quantity of lymph drained, duration and daily volume of drainage and aspirated volumes of lymph.ResultsNinety-one patients were randomised. Ninety patients were evaluable: 42 patients received pasireotide, and 48 patients received placebo. The mean estimated response rate were 62.4% (95% Credibility Interval [CrI]: 48.6%-75.3%) in the treatment group and 50.2% (95% CrI: 37.6%-62.8%) in the placebo group. Overall safety was comparable across groups, and one serious adverse event occurred. In the treatment group, one patient with known insulin-depe*ndent diabetes required hospitalization for hyperglycaemia.ConclusionsWith this phase 2 preliminary study, even if our results indicate a trend towards a reduction in symptomatic lymphocele, pre-operative injection of pasireotide failed to achieve a response rate centered on 80%. Pharmacokinetics analysis suggests that effect of pasireotide could be optimised.Trial RegistrationClinicalTrials.gov NCT01356862

The Efficacy and Safety of Somatostatin Analog after Axillary Node Dissection in Breast Cancer: A Systematic Review and Meta-analysis

“…The following nine studies were then excluded: seven studies with duplicate records, one comparative study of the long- versus short-term use of octreotide (15) , and one protocol without results (16) . Ultimately, seven studies with 738 participants were considered eligible for inclusion (17) , (18) , (19) , (20) , (21) , (22) , (23) . No additional articles that met the inclusion criteria were identified from the reference lists of studies.…”

Prevention of lymphocele or seroma after mastectomy and axillary lymphadenectomy for breast cancer: systematic review and meta-analysis

“…Study characteristics are described in Table 1 . Two of the 15 studies concerned lymphoceles 20 , 31 , while all of the other studies concerned seromas. Six studies did not specify their definition of seroma, 9 studies reported a clinical definition of seroma or lymphocele (palpation, clinical examination, needle aspiration) and one study used an ultrasound definition.…”

Impact of Topical Epinephrine with Xylocaine on Drainage After Axillary Lymph Node Dissection: A Randomized Controlled Trial

“…Tranexamic acid and tissue adhesives like fibrin glue and cyanoacrylate have been tried; however, apart from an occasional study showing reduced drainage and earlier removal of the drain, meta-analyses have failed to show their advantage [3,[23][24][25][26][27]. Other techniques like use of compression dressing, somatostatin analog, newer energy devices and hemostatic patch have been tried for seroma formation following ALND; but have shown limited or no benefit [5,18,19,[28][29][30][31].…”