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Sentinel lymph node biopsy (SLNB) and SLNB with axillary lymph node dissection (ALND) negatively affected some quality of life (QOL) measures among patients with early-stage breast cancer, according to an analysis of the INSEMA trial presented at the 2021 San Antonio Breast Cancer Symposium (SABCS).
“INSEMA is one of the first randomized trials investigating the omission of SLNB in clinically node-negative patients and the first to report QOL data,” Bernd Gerber, MD, Ph.D., of University of Rostock in Germany, and lead author of the study, said.
The INSEMA trial included 5230 patients with cN0/iN0, iT1, or iT2 breast cancer who were scheduled to undergo breast-conserving surgery and postoperative irradiation. Patients were randomly assigned 1:4 to undergo no SLNB or SLNB. Of the patients assigned to SLNB, those with positive sentinel lymph nodes (n=485) were randomly assigned 1:1 to undergo SLNB alone or with completion ALND.
The primary objective was noninferiority of invasive disease-free survival (iDFS) after breast-conserving surgery between no SLNB and SLNB alone. The secondary objective was iDFS after breast-conserving surgery between SLNB alone and with completion ALND. Another secondary objective was QOL, as presented in this analysis.
QOL was measured at baseline and at months 1, 3, 6, 12, and 18 using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLC-C30) and its breast cancer module (BR23).
The baseline characteristics between each arm were similar, with the majority of patients having grade 1-2, invasive carcinoma of no special type, estrogen receptor-and/or progesterone receptor-positive, and HER2-negative disease.
Global health status; body image; and physical, role, emotional, cognitive, and social functioning were similar between the no SLNB and the SLNB arms, and between the SLNB alone and the ALND arms. “Because of the high case number, some small differences reached statistical significance, but these differences were clinically not meaningful,” Dr. Gerber said.
The cohort from the first randomization demonstrated significant differences in breast (P <.001) and arm symptoms (P <.001), with improvement in the no SLNB group. However, only arm symptoms were clinically significant.
Among patients who underwent SLNB, arm symptoms, but not breast symptoms (P =.295), were both statistically (P <.001) and clinically significant, with improvement demonstrated in the SLNB only arm compared with the ALND arm.
More specifically, pain in the arm or shoulder, swelling in the arm or hand, and limited arm mobility was better in the no SLNB vs the SLNB arm and the SLNB alone vs the SLNB with ALND arm. The biggest differences in these scores occurred within the first month after surgery, but persisted for most of the scores throughout the 18-month duration of follow-up, Dr. Gerber said.
Follow-up of the INSEMA trial is ongoing, and the primary outcome data of iDFS is expected by the end of 2024.