Single preoperative radiation therapy with delayed surgery for low-risk breast cancer: Oncologic outcome, toxicity and cosmesis of the SPORT-DS phase I trial.

BACKGROUND: A novel approach using single-fraction preoperative partial breast irradiation (PBI) for low-risk breast cancer is under study. We sought to investigate the rate of pathologic response (pR), toxicities and cosmetic results related to this new treatment strategy. METHODS: Women of 65 years or older with stage I unifocal luminal A breast cancer were eligible for inclusion in this phase I prospective trial. Patients received a single 20 Gy dose of PBI followed by breast-conserving surgery (BCS) 3 months later. The primary endpoint was the pR rate, and the secondary endpoints were radiation therapy-related toxicity and cosmetic results. RESULTS: Thirteen patients were treated, with a median age of 71. Eleven patients (84.6 %) had pR with a median residual cellularity of 1 % (range: 0-10 %). At median follow-up of 48.5 months, no recurrences or cancer-related deaths were recorded. Acute radiation therapy-related toxicity were limited to grade 1 dermatitis and breast pain. At the 1-year follow-up, there were one grade 2 fat necrosis and two grade 3 toxicities (wound infection and hematoma). Only grade 1 toxicities remained at 2 years, but one grade 2 toxicity (fibrosis/induration) developed by the 3-year follow-up. Three-year patient-reported cosmetic outcomes were good or excellent in 60 % of patients. CONCLUSIONS: Single-fraction preoperative PBI preceding BCS for low-risk breast cancer is feasible, relatively well tolerated and leads to a high level of pR. The 3-month interval after PBI seems to place surgery in a post-radiation inflammatory phase. Further delay between PBI and surgery could improve pR and cosmetic outcome. NCT03917498.

Single pre-operative radiation therapy (SPORT-CK) trial for low-risk breast cancer: Early results of a phase 2 study.

BACKGROUND AND PURPOSE: Preoperative partial breast irradiation (PBI) is a novel technique that can be used in patients with early-stage breast cancer with the goal of limiting the irradiated breast volume, toxicity and number of fractions. The aim of this trial is to assess the toxicity, surgical, oncologic and cosmetic outcomes of preoperative PBI. MATERIALS AND METHODS: In this single-arm phase II trial, we enrolled women ≥ 60 years, with unifocal low-risk breast invasive ductal carcinoma (cT1N0, grade 1-2, ER+, Her2-). Patients were treated with a single fraction of 20 Gy of preoperative PBI using volumetric modulated arc therapy (VMAT). Patients then underwent breast-conserving surgery (BCS) +/- sentinel lymph node biopsy within 72 h of radiation. Primary outcomes were rate of surgical complications and early toxicity. Secondary outcomes were cosmesis at 12 months, chronic toxicity and ipsilateral breast tumor recurrence. RESULTS: Twenty-five patients were recruited with a median age of 67 years, and a median follow-up of 60 months. Sentinel biopsy was positive in 1 out of 24 patients (4 %). Two patients received adjuvant RT for close margins or positive lymph nodes. Within the first 90 days, none of the patients had surgical complications; almost all had grade 0 to 1 acute and late RTOG skin toxicity. The cosmetic outcome was rated between good and excellent in all cases by physicians and patients, except for one patient who self-rated her cosmesis as fair as of the third year. There were no recurrences. CONCLUSION: Preoperative single-fraction PBI is a safe and feasible treatment for elderly patients with low-risk early-stage breast cancer, with no surgical complications, very low rates of acute and late radiation toxicity, and excellent cosmetic outcomes. Randomized controlled trials are needed to compare preoperative to adjuvant PBI in this patient population.

Radiation-Induced Fibrosis in Patients with Head and Neck Cancer: A Review of Pathogenesis and Clinical Outcomes.

Radiotherapy-related fibrosis remains one of the most challenging treatment related side effects encountered by patients with head and neck cancer. Several established and ongoing novel therapies have been studied with paucity of data in how to best treat these patients. This review aims to provide researchers and health care providers with a comprehensive review on the presentation, etiology, and therapeutic options for this serious condition.

Incidence and Predictors of Surgical Site Infection Complications in Diabetic Patients Undergoing Lower Limb Amputation.

BACKGROUND: Surgical site infections (SSIs) following lower extremity amputations (LEAs) are a major cause of patient morbidity and mortality. The objectives of this study are to investigate the annual incidence of SSI and risk factors associated with SSI after LEA in diabetic patients. METHODS: LEAs performed on diabetic patients between 2005 and 2017 were retrospectively analyzed from the American College of Surgeons National Surgical Quality Improvement Program database. Incidence rates were calculated and analyzed for temporal change. Multivariable logistic regression was conducted to identify the independent predictors of SSIs in LEA. RESULTS: In 21,449 diabetic patients, the incidence of SSIs was 6.8% after LEA, with an overall decreasing annual trend (P = 0.013). Amputation location (below-knee in reference to above-knee) [OR (95% CI): 1.35 (1.20 - 1.53), P <0.001], smoking [OR (95% CI): 1.25 (1.11 - 1.41), P <0.001)], female sex [OR (95% CI): 1.16 (1.03 - 1.30)], preoperative sepsis [OR (95% CI): 1.24 (1.10 - 1.40), P <0.001], P = 0.013], emergency status [OR (95% CI): 1.38 (1.17 - 1.63), P <0.001], and obesity [OR (95% CI): 1.59 (1.12 - 2.27), P = 0.009] emerged as independent predictors of SSIs, while moderate/severe anemia emerged as a risk-adjusted protective factor [OR (95% CI): 0.75 (0.62 - 0.91), P = 0.003]. Sensitivity analysis found that moderate/severe anemia, not body mass index (BMI) class, remained a significant risk factor in the development of SSIs in below-the-knee amputations; in contrast, higher BMI, not preoperative hematocrit, was significantly associated with an increased risk for SSI in above-the-knee amputations. CONCLUSIONS: The incidence of SSIs after LEA in diabetic patients is decreasing. Overall, below-knee amputation, smoking, emergency status, and preoperative sepsis appeared to be associated with SSIs. Obesity increased SSIs in above-the-knee amputations, while moderate/severe preoperative anemia appears to protect against below-the-knee SSIs. Surgeons should take predictors of SSI into consideration while optimizing care for their patients, and future studies should investigate the role of preoperative hematocrit correction and how it may influence outcomes positively or negatively.