In the PRADA study—reported by Thiruchelvam et al in The Lancet Oncology—researchers found that a strategy of preoperative radiotherapy and deep inferior epigastric perforator (DIEP) flap reconstruction was feasible and safe in women requiring mastectomy for breast cancer.
As stated by the investigators, “Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy. However, evidence for this treatment sequence is sparse. We aimed to explore the feasibility of preoperative radiotherapy followed by skin-sparing mastectomy and DIEP flap reconstruction in patients with breast cancer requiring mastectomy.”
Study Details
The study enrolled 33 patients predicted to require postmastectomy radiotherapy from two National Health Service trusts between January 2016 and December 2017. Preoperative radiotherapy was started 3 to 4 weeks after neoadjuvant chemotherapy and was delivered to the breast, plus regional nodes as required, at 40 Gy in 15 fractions over 3 weeks or 42.72 Gy in 16 fractions over 3.2 weeks. Skin-sparing mastectomy and DIEP flap reconstruction were planned for 2 to 6 weeks after completion of radiotherapy. The primary endpoint was proportion of open breast wounds > 1 cm in width requiring dressing at 4 weeks after surgery.
Key Findings
Four weeks after surgery, four patients (12.1%, 95% confidence interval [CI] = 3.4%–28.2%) had an open wound > 1 cm requiring dressing. All four patients had mastectomy skin envelope necrosis. The wounds were managed with dressings and antibiotics in three patients (9%) patients, and one patient (3%) required reoperative intervention for debridement and skin graft. The only other unplanned return to surgery was within 24 hours after surgery to assess a congested flap that required no intervention.
After a median follow-up of 23.6 months, no DIEP flap failures were observed.
Radiotherapy skin toxicity consisted of grade 1 events in 22 patients (67%), grade 2 events in 9 (27%), and grade 3 events in 1 (confluent moist desquamation). No serious treatment-related adverse events and no treatment-related deaths were observed.
The investigators concluded, “Preoperative radiotherapy followed by skin-sparing mastectomy and immediate DIEP flap reconstruction is feasible and technically safe, with rates of breast open wounds similar to those reported with postmastectomy radiotherapy. A randomized trial comparing preoperative radiotherapy with postmastectomy radiotherapy is required to precisely determine and compare surgical, oncological, and breast reconstruction outcomes, including quality of life.”
Paul T.R. Thiruchelvam, FRCS, of the Department of Breast Surgery, Imperial College Healthcare NHS Trust, London, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by Cancer Research UK and National Institute for Health Research. For full disclosures of the study authors, visit thelancet.com.
