Evaluation of oncologic safety and clinical effectiveness of immediate autologous fat grafting in breast-conserving surgery: a multicenter, prospective, randomized controlled clinical trial for breast cancer.

Summary

In 360 randomized patients undergoing BCS, immediate autologous fat grafting did not increase locoregional (0.6% vs 2.4%; P=0.65) or distant recurrence (3.6% vs 3.5%) nor disease-specific mortality (0.6% vs 0.6%). Patient-reported satisfaction with breast appearance, psychosocial, and sexual well-being were significantly higher with IAFG.

Key Findings

• No increase in local relapse with IAFG vs control (0.6% vs 2.4%; P=0.65).
• No difference in distant recurrence (3.6% vs 3.5%) or breast cancer-specific mortality (0.6% vs 0.6%).
• Higher patient-reported satisfaction (78 vs 65; P<0.001), psychosocial well-being (83 vs 71; P<0.001), and sexual well-being (74 vs 66; P<0.001) with IAFG.

Clinical Implications

IAFG can be offered at the time of BCS to optimize cosmetic outcomes without compromising oncologic safety, with counseling on expected improvements in satisfaction and well-being.

Limitations

• Blinding to surgical intervention is not feasible, potentially influencing subjective outcomes.
• Technique and graft volume variability may affect generalizability; very long-term safety beyond ~7 years remains to be established.

Future Directions

Standardize grafting protocols and imaging surveillance; extend follow-up; compare IAFG with alternative oncoplastic techniques in diverse populations.