At a follow-up of 18 months, addition of a sleeve compression/exercise intervention to standard education focused on lymphedema risk reduction did not significantly decrease the incidence of lymphedema following surgery in women with early-stage breast cancer, according to results of a randomized clinical trial published in Cancer.
Lymphedema, an accumulation of lymphatic fluid in the soft tissues, is a complication of breast cancer treatments that have the potential to damage lymph nodes and vessels. In the setting of breast cancer, lymphedema typically results in a swollen arm and/or hand, and often develops gradually in the months following breast cancer treatment. It has been consistently associated with detriments in quality of life and limitations in range-of-motion (ROM) of the affected limb.
In this multicenter, phase 3 study (Cancer and Leukemia Group B [CALGB] 70305; ClinicalTrials.gov Identifier: NCT00376597), patients with newly diagnosed stage I to III breast cancer were evaluated at a preoperative visit then randomly assigned to lymphedema education (EO) or lymphedema education and prevention program (LEAP) within 6 weeks following breast surgery plus lymph node dissection. Participants in the EO group received standard lymphedema education that included self-care preventive practices from a trained lymphedema educator, with or without individualized assessment and instruction for a daily exercise regimen from a physical therapist. The LEAP group also received a 2-pound hand weight to be used each day and an elastic compression sleeve and gauntlet for use during exercise or air travel.
The primary endpoint was the lymphedema-free rate at 18 months, with secondary study endpoints including change in arm circumference between preoperative and 12- or 18- month postoperative visits, self-reported ROM, and adherence to use of the sleeve/gauntlet and exercises in those assigned to that study arm.
Of 554 evaluable study participants, 242 were assigned to the EO arm and 312 were assigned to the LEAP arm. At baseline, the median age of the overall group was 58 years, and more than 90% had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0. Approximately two-thirds of patients underwent partial mastectomy/lumpectomy/excisional biopsy, and one-third underwent mastectomy. Regarding lymph node surgery, 41.3% of patients underwent sentinel-lymph node dissection only, 26.4% of patients were treated with axillary lymph node dissection only, and the remainder underwent both types of lymph node surgery.
No difference in lymphedema-free rates was observed between the EO group (58%) and the LEAP group (55%; P =.73) at 18 months follow-up. Furthermore, an analysis of these results according to type of lymph node surgery also did not show any improvements in the lymphedema-free rate with EO compared with LEAP. The respective rates were 69% and 70% for those treated with sentinel lymph node dissection only, 47% and 33% for those treated with axillary lymph node dissection alone, and 54% and 47% for those who underwent both sentinel and axillary lymph node dissections.
Although no significant differences were found in the arm circumferences of patients in the 2 study arms at the 12- and 18-month assessment points, a significant improvement in the percentage of patients reporting full ROM was observed in the LEAP arm compared with the EO arm at both assessment points (P <.0001 for both study arms).
Of note, at 18-month assessment, only 31% of patients assigned to the LEAP arm were found to have followed instructions at least 75% of the time regarding use of the compression garments, and only approximately half of participants in this study group reported performing the recommended exercises at least once weekly.
In their concluding remarks, the study authors noted that the results of this study revealed a need to perform assessments of adherence to interventions focused on preventing lymphedema. “Future research could test adherence-enhancing strategies and assisted activities among women at risk for developing breast cancer-related lymphedema,” commented the study authors.
Paskett ED, Le-Radmacher J, Oliveri JM, et al. A randomized study to prevent lymphedema in women treated for breast cancer: CALGB 70305 (Alliance).Cancer. Published online October 20, 2020. doi:10.1002/cncr.33183