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Radiotherapy followed by skin-sparing mastectomy and deep inferior epigastric perforator (DIEP) flap reconstruction is feasible and safe, with low rates of postoperative complications and good aesthetic results, results of the PRADA study suggested.

In the prospective multicenter trial of 33 patients, just four (12%) had an open breast wound of greater than 1 cm requiring dressing or packing (the study's primary outcome), a rate similar to that with post-mastectomy radiotherapy, reported Paul Thiruchelvam, FRCS, MBBS, PhD, of Imperial College Healthcare NHS Trust in London, and colleagues.

"Given the longstanding concerns regarding wound healing following radiotherapy, open wound rate is an important safety outcome," the authors observed in . "Open wounds delay adjuvant therapy, might require secondary surgical intervention, prolong treatment, and affects the breast aesthetic."

The authors noted that the wounds were minor and managed conservatively with dressings and antibiotics in three patients, while one required a repeat intervention for debridement and skin graft.

Regarding secondary outcomes, Thiruchelvam and colleagues found the following:

• Four of 33 patients had an open breast wound >1 cm requiring a dressing at 8 weeks after surgery
• None had an open breast wound >1 cm requiring a dressing at 12 weeks
• After a median follow-up of 23.6 months, there were no DIEP flap failures
• Mastectomy skin envelope necrosis was reported in four patients at 4 weeks
• Fat necrosis was reported in one patient at 4 weeks after surgery, and in five patients at 8 weeks

"This study shows that autologous free-flap surgery is feasible and technically safe if performed within 6 weeks of completion of preoperative radiotherapy," the authors wrote. "In addition, preoperative radiotherapy can reduce treatment pathway delays that occur with post-mastectomy radiotherapy due to wound healing issues."

"PRADA provides a new treatment approach of administering radiotherapy to the intact breast and regional lymphatics before surgery, similar to what is done at several other tumor sites including in rectal, esophageal, sarcoma, and other tumors," wrote Orit Kaidar-Person, MD, of Tel-Aviv University in Israel, and Philip Poortmans, MD, PhD, of the University of Antwerp in Belgium, in a accompanying the study.

"The study shows the feasibility of performing a delicate autologous breast reconstruction with microvascular anastomosis without a significant increase in postoperative complications or implant loss," the duo added.

Eligible patients in the PRADA study were adult women with a laboratory diagnosis of primary breast cancer requiring mastectomy and post-mastectomy radiotherapy, who were suitable for DIEP flap reconstruction.

Preoperative radiotherapy was performed starting 3 to 4 weeks after neoadjuvant chemotherapy and was delivered to the breast plus regional nodes as required, at 40 Gy (15 fractions over 3 weeks) or 42.72 Gy (16 fractions over 3.2 weeks). Skin-sparing mastectomy and DIEP flap reconstruction were planned for 2 to 6 weeks after completion of radiotherapy.

As for reports of radiotherapy skin toxicity, one of the 33 patients had a grade 0 adverse event (AE), two-thirds had grade 1 AEs, and nine had grade 2 AEs. One patient had grade 3 confluent moist desquamation.

"Importantly, patients reported high satisfaction with the breast reconstruction 12 months after surgery and aesthetic outcomes were favorable upon panel assessment," Thiruchelvam's group wrote.

Of 14 patients who participated in aesthetic assessments, the median satisfaction score on the BREAST-Q questionnaire was 48 at baseline (with 100 being the best possible score), 73 at 3 months after surgery (13 patients), and 77 a year after surgery (12 patients). Median 3D-SI global panel assessment score for breast reconstruction aesthetics (where 1 is very poor and 5 is excellent) was 3.9 at baseline, 5.0 at 3 months after surgery, and 4.3 at 12 months after surgery.

"A randomized trial comparing preoperative radiotherapy with post-mastectomy radiotherapy is required to precisely determine and compare surgical, oncological, and breast reconstruction outcomes, including quality of life," the study authors concluded.

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