Patient-Reported Outcomes With Vitamin E and Pentoxifylline after Post-Mastectomy Radiation (PMRT) and Reconstruction; Initial Results From a Prospective Pilot Trial

Abstract

Purpose/Objective(s): Oral vitamin E and pentoxifylline have been used to decrease fibrosis after breast-conserving surgery and radiation therapy. The hypothesis was that this regimen would improve patient-reported outcomes and implant failure rates. Materials/Methods: Women who underwent PMRT after implant-based reconstruction were eligible. Subjects were given oral vitamin E 400 IU daily and pentoxifylline 400 mg twice daily for 1 week and if tolerated were increased to 400 mg thrice daily. Vitamin E and pentoxifylline were started 1 week after completion of radiation and continued for 6 months. Breast-Q surveys were administered at enrollment prior to starting radiation and at 1-, 6-, and 18-months post-radiation therapy. Patients were monitored for implant retention at the same time intervals. Subjects were asked to keep medication diaries to evaluate toxicity and compliance. Surveys and implant failure rates were compared to a cohort of women who underwent PMRT after implantbased reconstruction in the 2 years prior to initiation of this trial. Results: Patients were enrolled from February 2018 to January 2020. A total of 27 women were enrolled; 8 were excluded from analysis. Six of the 8 women did not want to participate after completion of radiation prior to starting medications. Another patient developed cellulitis of a VP drain shunt 1 month after radiation requiring removal of breast implant and declined further participation. One patient discontinued medications after a week due to nausea and declined further participation. Of the remaining 19 patients, 2 stopped medications after 1 month due to nausea, 1 stopped after 4 months due to implant failure and another stopped after 4 months due to travel. Fifteen patients completed the 6 months of therapy. All 19 women received standard fractionation of 50 Gy in 2-Gy fractions and 3 had additional 10 Gy in 5 fractions boost to the chest wall. At time of this analysis 3 of the 19 women underwent implant removal with subsequent autologous flap reconstruction. Of these 3, one had her implants removed prior to starting radiation due to postoperative infection. There were 22 women who were enrolled in the control cohort. Of these, 3 were lost to follow-up and 19 women were available for analysis. Radiation therapy consistent of 50-50.4 Gy using standard fractionation; 11 had a chest wall boost ranging from 4-16Gy. There were 4 implant failures. In the trial group, the Breast-Q scores improved at 6 months compared to baseline (t = 3.08, P = 0.006), but there was no difference in scores between the control and trial groups. Conclusion:Oral vitamin E and pentoxifylline did not improve either implant failure rate or patient-reported outcomes compared to historical control. Limitations to this study are small patient population and differences in radiation therapy that could have impacted implant failure rate.