Introduction: Although autologous fat grafting has been widely adopted globally to improve poor cosmetic outcomes following breast cancer surgery, oncologic concerns persist regarding the potential risk of cancer recurrence associated with fat transfer performed near the tumor bed. We sought to prospectively evaluate the oncologic safety and clinical benefits for breast cancer women undergoing breast-conserving surgery (BCS) with immediate autologous fat grafting (IAFG). Methods: This multicenter, prospective, randomized controlled clinical trial enrolled 360 women diagnosed with breast cancer between 3 March 2017 and 31 May 2021. Participants were randomly assigned in a 1:1 ratio to either the BCS with IAFG (IAFG group) or the BCS without IAFG (control group). The primary outcomes were the cumulative incidence rates of locoregional and systemic recurrence. The secondary outcomes included adverse events, patient’s satisfaction, and psychosocial well-being. Results: The average volume resected and volume grafted were 45.5 g and 66.5 mL, respectively, in the IAFG group. At a median follow-up period of 62.8 months (range: 4.3–86 months), the proportions of local relapse were 0.6% and 2.4% in the IAFG group and the control group, respectively ( P = 0.65). There was no increased risk of distant recurrence (3.6% vs. 3.5%) or breast cancer-specific mortality (0.6% vs. 0.6%) in the IAFG group. Among the secondary outcomes, the occurrence rates of complications were similar; however, the IAFG group showed significantly higher scores of satisfaction with breast appearance, psychosocial well-being, and sexual well-being than the controls (78 vs. 65, P < 0.001; 83 vs. 71, P < 0.001; 74 vs. 66, P < 0.001, respectively). Conclusion: Our results provide clear evidence that IAFG is a safe and effective surgical technique that does not increase the risk of local or distant recurrence in breast cancer patients and yields higher satisfaction with postoperative breast appearance and psychosocial outcomes.
Li et al. (Wed,) studied this question.