Lanreotide autogel 90 mg and lymphorrhea prevention after axillary node dissection in breast cancer: A phase III double blind, randomized, placebo-controlled trial

Gauthier, Tristan; Garuchet-Bigot, A.; Marin, Benoît; Mollard, J.; Loum, O.; Fermeaux, V.; Jammet, I.; Kanoun, Dorra; Maubon, A.; Aubard, Y.

doi:10.1016/j.ejso.2012.05.009

Cited by 14 publications

(13 citation statements)

References 19 publications

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“…The use of systemic somatostatin analog treatments has also been evaluated, again with mixed results. A study evaluating octreotide demonstrated a decrease in drain output [37], while a study evaluating lanreotide did not [38]. The significant methodological, sample size and clinical diversity between all these studies make it difficult to generate an overall conclusion.…”

Section: Discussionmentioning

confidence: 99%

Effect of topical microporous polysaccharide hemospheres on the duration and amount of fluid drainage following mastectomy: a prospective randomized clinical trial

et al. 2019

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BackgroundSeroma formation is the most common complication after mastectomy and places patients at risk of associated morbidities. Microporous polysaccharide hemospheres (MPH) consists of hydrophilic, plant based, polysaccharide particles and is currently used as an absorbable hemostatic agent. An animal model evaluating MPH and seroma formation after mastectomy with axillary lymph node dissection showed a significant decrease in seroma volume. Study aim was to evaluate topical MPH on the risk of post-mastectomy seroma formation as measured by total drain output and total drain days.MethodsProspective randomized single-blinded clinical trial of patients undergoing mastectomy for the treatment of breast cancer. MPH was applied to the surgical site in the study group and no application in the control group.ResultsFifty patients were enrolled; eight were excluded due to missing data. Forty-two patients were evaluated, control (n = 21) vs. MPH (n = 21). No difference was identified between the two groups regarding demographics, tumor stage, total drain days, total drain output, number of clinic visits, or complication rates. On a subset analysis, body mass index (BMI) greater than 30 was identified as an independent risk factor for high drain output. Post hoc analyses of MPH controlling for BMI also revealed no statistical difference.ConclusionsUnlike the data presented in an animal model, no difference was demonstrated in the duration and quantity of serosanguinous drainage related to the use of MPH in patients undergoing mastectomy for the treatment of breast cancer. BMI greater than 30 was identified as an independent risk factor for high drain output and this risk was not affected by MPH use. NCT03647930, retrospectively registered 08/2018.

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Section: Discussionmentioning

confidence: 99%

Effect of topical microporous polysaccharide hemospheres on the duration and amount of fluid drainage following mastectomy: a prospective randomized clinical trial

et al. 2019

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“…Two recent studies have demonstrated its value in reducing lymphoceles following ALNDs performed as part of breast cancer surgery [ 10 , 11 ]. However, one recent study, published during our study, did not identify any significant reduction of lymphorrhea using lanreotide, another somatostatin analogue [ 12 ].…”

Section: Introductionmentioning

confidence: 56%

“…More recently, Gauthier et al . [ 12 ] have reported the results of a phase 3, double-blind, randomized study using Lanreotide Autogel 90 mg LAR to reduce lymphorrhea volumes in the axillary drain during the first 4 postoperative days. They showed a non-significant tendency towards a reduction of the lymphorrhea volume in the lanreotide group (median 292 ml, range 1–965 ml) compared to the placebo group (median 337 ml, range 0–1230 ml).…”

Section: Discussionmentioning

confidence: 99%

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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

et al. 2016

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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

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“…The most common method to reduce the incidence of the lymphocele is the use of postoperative drainage. Several randomized trials have aimed to replace the drains by reducing seroma formation in different ways, but with inconsistent results [ 6 , 42 , 43 , 44 ]. Advanced hemostasis was also proposed as a lymphocele prevention tool after ALND in breast cancer patients [ 45 ].…”

Section: Discussionmentioning

confidence: 99%

Fibrin Sealants and Axillary Lymphatic Morbidity: A Systematic Review and Meta-Analysis of 23 Clinical Randomized Trials

Gasparri

Kuehn

Ruscito

et al. 2021

Cancers

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Background: use of fibrin sealants following pelvic, paraaortic, and inguinal lymphadenectomy may reduce lymphatic morbidity. The aim of this meta-analysis is to evaluate if this finding applies to the axillary lymphadenectomy. Methods: randomized trials evaluating the efficacy of fibrin sealants in reducing axillary lymphatic complications were included. Lymphocele, drainage output, surgical-site complications, and hospital stay were considered as outcomes. Results: twenty-three randomized studies, including patients undergoing axillary lymphadenectomy for breast cancer, melanoma, and Hodgkin’s disease, were included. Fibrin sealants did not affect axillary lymphocele incidence nor the surgical site complications. Drainage output, days with drainage, and hospital stay were reduced when fibrin sealants were applied (p < 0.0001, p < 0.005, p = 0.008). Conclusion: fibrin sealants after axillary dissection reduce the total axillary drainage output, the duration of drainage, and the hospital stay. No effects on the incidence of postoperative lymphocele and surgical site complications rate are found.

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Lanreotide autogel 90 mg and lymphorrhea prevention after axillary node dissection in breast cancer: A phase III double blind, randomized, placebo-controlled trial

Cited by 14 publications

References 19 publications

Effect of topical microporous polysaccharide hemospheres on the duration and amount of fluid drainage following mastectomy: a prospective randomized clinical trial

Effect of topical microporous polysaccharide hemospheres on the duration and amount of fluid drainage following mastectomy: a prospective randomized clinical trial

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

Fibrin Sealants and Axillary Lymphatic Morbidity: A Systematic Review and Meta-Analysis of 23 Clinical Randomized Trials

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