Purpose: To study those factors that influence the occurrence of surgical complications and local relapse in patients intervened for breast cancer and receiving intraoperative radiotherapy. Methods: Observational study on patients intervened for breast cancer with conservative surgery and intraoperative radiotherapy with low-voltage X-ray energy source (INTRABEAM), from 2015 to 2017 with 24 months minimum followup. Variables possibly associated to the occurrence of postoperative complications were analyzed with the Student t-test and the Fisher exact test; P < 0.05 considered significant. Subsequently, the construction of multiple multivariate analysis models began, thus building a logistic regression analysis using the IBM SPSS Statistics ver. 23 software. Local relapse was described. Results: The study included 102 patients, mean age of 61.2 years; mean global size of tumor, 12.2 mm. Complications occurred in 29.4%. Fibrosis was the most frequently observed complication, followed by postoperative seroma. Using a 45 mm or larger applicator were significantly associated with the occurrence of complications. Tumor size 2 cm or larger and reintervention showed borderline significant association. Only one case of local relapse was observed. Conclusion Certain factors may increase the risk of complication after the use of intraoperative radiotherapy. Using external complementary radiotherapy does not seem to increase the rate of complications. Select patients and the involvement of a multidisciplinary team are essential for achieving good results.

Objective: The prognostic impact of surgical paraaortic staging remains unclear in patients with locally advanced cervical cancer (LACC). The objective of our study was to evaluate the results of the surgical technique of preoperative aortic lymphadenectomy in LACC related to tumor burden and disease spread to assess its influence on survival. Methods: Data of 1,072 patients with cervical cancer were taken from 11 Spanish hospitals (Spain-Gynecologic Oncology Group [GOG] working group). Complete aortic lymphadenectomy surgery (CALS) was considered when the lymph nodes (LNs) were excised up to the left renal vein. The extent of the disease was performed evaluating the LNs by calculating the geometric means and quantifying the log odds between positive LNs and negative LNs. The Kaplan-Meier method was used to estimate the survival distribution. A Cox proportional hazards model was used to account for the influence of multiple variables. Results: A total of 394 patients were included. Pathological analysis revealed positive aortic LNs in 119 patients (30%). LODDS cut-off value of −2 was established as a prognostic indicator. CALS and LODDS <−2 were associated with better disease free survival and overall survival than suboptimal aortic lymphadenectomy surgery and LODDS ≥−2. In a multivariate model analysis, CALS is revealed as an independent prognostic factor in LACC. Conclusion When performing preoperative surgical staging in LACC, it is not advisable to take simple samples from the regional nodes. Radical dissection of the aortic and pelvic regions offers a more reliable staging of the LNs and has a favorable influence on survival.

Purpose: The surgical management of deep infiltrative endometriosis (DE) involving the rectum remains a challenge. The objective of this study was to assess the outcomes from a single tertiary center over a decade with an emphasis on the role of a protective loop ileostomy (PI). Methods: A retrospective review of outcomes for 168 patients managed between 2008 and 2018 is presented including 57 rectal shaves, 23 discoid excisions, and 88 segmental rectal resections. Results: The nodule size (mean±standard deviation) in the segmental resection group was 32.7±11.2 mm, 23.4±10.5 mm for discoid excision, and 18.8±6.0 mm for rectal shaves. A PI was performed in 19 elective cases (11.3%) usually for an ultra-low anastomosis <5 cm from the anal verge. All Clavien-Dindo grade III/IV complications occurred after segmental resections and included 5 anastomotic leaks, 6 rectovaginal fistulas, 2 ureteric fistulas, and 1 ureteric stenosis. Of 26 stomas (15.5%), there were 19 PIs, 3 secondary ileostomies (after complications), and 4 end colostomies. The median time to PI closure was 5.8 months (range, 0.4–16.7 months) in uncomplicated disease compared with 9.2 months (range, 4.7–18.4 months) when initial postoperative complications were recorded (P=0.019). Only 1 patient with a recurrent rectovaginal fistula had a permanent colostomy. Conclusion In patients with DE and rectal involvement a PI is selectively used for low anastomoses and complex pelvic reconstructions. Protective stomas and those used in the definitive management of a major postoperative complication can usually be reversed.

BACKGROUND: Mesenchymal stromal cells (MSCs) have potent immunomodulatory and neuroprotective properties, and have been tested in neurodegenerative diseases resulting in meaningful clinical improvements. Regulatory guidelines specify the need to perform preclinical studies prior any clinical trial, including biodistribution assays and tumourigenesis exclusion. We conducted a preclinical study of human bone marrow MSCs (hBM-MSCs) injected by intrathecal route in Non-Obese Diabetic Severe Combined Immunodeficiency mice, to explore cellular biodistribution and toxicity as a privileged administration method for cell therapy in Friedreich's Ataxia. METHODS: For this purpose, 3 × 10⁵ cells were injected by intrathecal route in 12 animals (experimental group) and the same volume of culture media in 6 animals (control group). Blood samples were collected at 24 h (n = 9) or 4 months (n = 9) to assess toxicity, and nine organs were harvested for histology and safety studies. Genomic DNA was isolated from all tissues, and mouse GAPDH and human β2M and β-actin genes were amplified by qPCR to analyze hBM-MSCs biodistribution. RESULTS: There were no deaths nor acute or chronic toxicity. Hematology, biochemistry and body weight were in the range of normal values in all groups. At 24 h hBM-MSCs were detected in 4/6 spinal cords and 1/6 hearts, and at 4 months in 3/6 hearts and 1/6 brains of transplanted mice. No tumours were found. CONCLUSION: This study demonstrated that intrathecal injection of hBM-MSCs is safe, non toxic and do not produce tumors. These results provide further evidence that hBM-MSCs might be used in a clinical trial in patients with FRDA.
Animals ; Biochemistry ; Body Weight ; Bone Marrow ; Brain ; Cell- and Tissue-Based Therapy ; Culture Media ; DNA ; Friedreich Ataxia ; Heart ; Hematology ; Humans ; Injections, Spinal ; Mesenchymal Stromal Cells ; Methods ; Mice ; Neurodegenerative Diseases ; Neuroprotection ; Reference Values ; Severe Combined Immunodeficiency ; Spinal Cord

Objective: We sought to evaluate the impact on survival of tumor burden and surgical complexity in relation to the number of cycles of neoadjuvant chemotherapy (NACT) in patients with advanced ovarian cancer (OC) with minimal (CC-1) or no residual disease (CC-0). Methods: This retrospective study included patients with International Federation of Gynaecology and Obstetrics IIIC–IV stage OC who underwent debulking surgery at 4 high-volume institutions between January 2008 and December 2015. We assessed the overall survival (OS) of primary debulking surgery (PDS group), early interval debulking surgery after 3–4 cycles of NACT (early IDS group) and delayed debulking surgery after 6 cycles (DDS group) with CC-0 or CC-1 according to peritoneal cancer index (PCI) and Aletti score. Results: Five hundred forty-nine women were included: 175 (31.9%) had PDS, 224 (40.8%) early IDS and 150 (27.3%) DDS. Regardless of Aletti score, median OS after PDS was significantly higher than after early IDS or DDS, but the survival difference was higher in women with an Aletti score <8. Among patients with PCI ≤10, median OS after PDS was significantly higher than after early IDS or DDS. In women with PCI >10, there were no differences between PDS and early IDS, but DDS was associated with decreased OS. Conclusion The benefit of complete PDS compared with NACT was maximal in patients with a low complexity score. In patients with low tumor burden, there was a survival benefit of PDS over early IDS or DDS. In women with high tumor load, DDS impaired the oncological outcome.