Abstract P3-03-25: Quality of life and cost-effectiveness in patients undergoing level I versus level II and III axillary lymph node dissection for breast cancer: A double blind randomised controlled trial with non-inferiority hypothesis
Authors: Gour KS , Kataria K , Ranjan P , Dhar A , Srivastava A , Singh K 
Published: May 2019

Abstract
Background: Asian patients present with advanced breast cancer, necessitating full, level III axillary lymph node dissection (ALND). Full axillary dissection is associated with complications like seroma, surgical site infection, shoulder dysmobility and lymphedema. These complications lead to impaired activities of daily life and poor quality of life (QOL). Management of these morbidities escalates the cost of care. We designed this trial to ascertain and compare the quality of life and cumulative incidence and severity of complications of patients undergoing a level I vs level III axillary dissection.
Methods: In this two-group parallel design randomized trial with non-inferiority hypothesis, 70 patients were randomized. Patients were scheduled for level I axillary clearance. Those with no palpable nodes in the remaining axilla after level I clearance were randomized in OR to receive either complete ALND(level II,III clearance) or limit to level I only. Patients were followed for 3 months postoperatively(week 1,2,3,12). Baseline and postoperative quality of life scores calculated by EORTC-QLQ-C30 and BR23 module were compared between the two groups. Indirect cost for patients in each group was calculated based on the duration of OR time consumed and direct costs included the expenditure in the treatment of complications following surgery. Number of successfully managed patients was identified in each group(those patients not associated with incidence of seroma requiring aspiration and SSI). Cost effectiveness was calculated for each group by dividing the total cost of patient care in each group by the number of successfully managed patients.
Findings: There was a significant difference in the duration of procedure between the two groups[level I: 18.57 min vs level III: 32.48 min, p value = 0.000]. Significant differences with worse trend was found in level III patients for QOL[ Global Health Status/QOL- Level I: 77.25(8.92) vs Level III: 71.71(6.89), p value= 0.005; Physical functioning- Level I: 96.21(3.34) vs Level III: 92.92(2.32), p value= 0.000; Role functioning- Level I:91.44(8.44) vs Level III:78.78(11.23), p value= 0.000]. Significant differences were also found in symptom scales of fatigue, pain and arm symptoms. 72.9 % and 54.5 % of patients were successful in level I and level III groups, respectively(p value= 0.137), which yielded a cost-effectiveness ratio of Rs 2,240.46 for level I group and Rs 5.299.12 for level III group.
Comparison of different domains of QOL between 2 groupsOutcomeLevel ILevel IIIp valueGlobal Health Status77.25 (8.92)71.71 (6.89)0.005Physical Functioning96.21 (3.34)92.92 (2.32)0.000Role Functioning91.44 (8.44)78.78 (11.23)0.000Fatigue11.11 (0-33.33)22.22 (0-44.44)0.000Pain0 (0-33.33)33.33 (0-33.33)0.000Arm Symptoms0 (0-22.22)33.33 (11.11-44.44)0.000
Conclusion: Level I dissection was associated with significantly better quality of life and was more cost-effective method of ALND as compared to level III ALND.
Citation Format: Gour KS, Kataria K, Ranjan P, Dhar A, Srivastava A, Singh K. Quality of life and cost-effectiveness in patients undergoing level I versus level II and III axillary lymph node dissection for breast cancer: A double blind randomised controlled trial with non-inferiority hypothesis [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 P3-03-25.