Abstract P3-14-04: Prevention of lymphedema in patients undergoing axillary dissection for breast cancer by benzathine penicillin: A non-inferiority randomised controlled trial

Abstract

Abstract Background: Axillary lymph node dissection (ALND) is performed for axillary lymph nodal metastasis. Major complication of ALND is lymphedema. Lymphedema is a morbid condition associated with impaired activities of daily life and deterioration in quality of life (QOL). Olszewski et al (Lymphology. 2005 Jun;38(2):66–80) have shown that low-grade staphylococcal infection is a risk factor for lymphedema. Hence, we embarked upon a randomised controlled trial with non-inferiority hypothesis to evaluate efficacy of injection Benzathine penicillin in preventing breast cancer related lymphedema. Methods: In this 2 group, open label, parallel design randomized controlled trial; patients undergoing ALND for breast cancer were included. Patients were randomized using block randomization to either injection Benzathine penicillin group or in control group. Patients in the penicillin group received injection Benzathine penicillin 1.2 million units as deep intramuscular injection after antibiotic sensitivity testing at intervals of 3 weeks. Primary endpoint was development of lymphedema at 6 months follow up. Analyses were done on an intention to treat basis. Lymphedema was defined as increase in >200ml of volume on water displacement method and or increase in arm circumference of >2cm from pre surgery values (Lancet Oncol. 2013 May 1;14(6):500–15). Findings: Between July 2016 and December 2017, 83 ladies were randomly allocated, 40 in the penicillin group and 43 in control group. At 6 months follow up; a total of 15 (18.07%) patients had lymphedema. Out of them 5 patients were in penicillin group and 10 in the control group. Cellulitis was seen in 2/3rd of patients (10 out of 15) having lymphedema. The relative risk of cellulitis in penicillin group was 0.119 with 95% CI of (0.016-0.901) and prevented fraction of 0.881. Other factors like radiotherapy, type of surgery for primary tumor, extent of axillary dissection and type of chemotherapy were comparable in both groups. None of the patients receiving penicillin have any adverse effect or allergic reaction to the drug during the study period. Comparison of lymphedema and cellulitis in two groupsOutcome Penicillin groupControl groupRR ( 95% CI)PFLymphedemaPresent05100.538 (0.201-1.437)0.462 Absent3533 CellulitisPresent01090.119 (0.016-0.901)0.881 Absent3934 RR: Relative risk, PF: Prevented fraction, CI: Confidence interval Conclusion: Penicillin administration in patients undergoing axillary lymph node dissection is safe and significantly reduces risk of lymphedema and cellulitis. Novelty: This is the first randomised trial demonstrating the benefit of long term administration of penicillin in reducing lymphedema and cellulitis. Citation Format: Singh K, Dhar A, Srivastava A, Ranjan P, Kataria K, Gour KS. Prevention of lymphedema in patients undergoing axillary dissection for breast cancer by benzathine penicillin: A non-inferiority randomised controlled trial [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P3-14-04.