Cropsi study: Efficacy and safety of cryotherapy and cryocompression in the prevention of chemotherapy-induced peripheral neuropathy in patients with breast and gynecological cancer-A prospective, randomized trial.

OBJECTIVE: This study aimed to demonstrate the superiority of cryocompression over cryotherapy alone in the prevention of chemotherapy-induced peripheral neuropathy (CIPN) grade 2 or above. METHODS: This prospective randomized study was conducted between May 2020 and January 2023 in Innsbruck. Eligible patients had a diagnosis of gynecological cancer and received a minimum of 3 cycles of taxane-based CT (neoadjuvant, adjuvant or palliative therapy). Patients were randomized 1:1 to receive either cryotherapy or cryocompression on their upper extremities during chemotherapy (CT). We performed temperature measurements, two QoL questionnaires and neurological tests during CT and at follow-up 3 and 6-9 months after the completion of CT. CIPN was assessed using the CTCAE score. RESULTS: Of 200 patients recruited, both groups showed a lower prevalence of CIPN in this study compared to recent literature. In the group receiving cryotherapy, the prevalence of grade 1 CIPN was 30.1 %, and that of grade 2 CIPN or above was 13.7 %; in the group treated with cryocompression, the prevalence of grade 1 CIPN was 32.8 %, and that of grade 2 or above CIPN was 17.2 %. We found a significant reduction in temperature in the cryotherapy and cryocompression groups. Regarding the two QOL questionnaires as well as the neurological tests no significant differences were found between the two groups. CONCLUSION: Our study suggests that cryotherapy as well as cryocompression is a safe and effective way to cool patients' extremities to lower the prevalence of CIPN. Cryocompression was not more effective than cryotherapy alone in the prevention of CIPN.

PRO Hair Safe Study: The Patient's Perspective on the Effects of Scalp Cooling on Hair Preservation.

Purpose: Alopecia has been reported a distressing side-effect of chemotherapy for breast cancer patients (BCP) that is highly relevant for quality of life during treatment. For the prevention of chemotherapy-induced alopecia, scalp cooling (SC) has been reported to be an effective and safe intervention. However, data on the patient's perspective on effectiveness and applicability of SC in a clinical routine setting are scarce. In this comparative study, we aimed at a longitudinal assessment of patient-reported outcome (PRO) data on the effect of SC on alopecia and its effect on symptoms and functional health when applied in clinical routine in BCP receiving taxane or anthracycline-based chemotherapy. Patients and Methods: Study participants were allocated either to the intervention group receiving SC or to the control group based on patient preference (non-randomized study). All patients completed PRO-measures on hair preservation (EORTC Item Library items on hair loss), symptom and functional health measures (EORTC QLQ-C30 and -BR23) and the Body Image Scale (BIS). Outcomes were assessed at chemotherapy start (baseline), mid-chemotherapy, last chemotherapy cycle, 3 months follow-up and 6-9 months follow-up. Results: Overall, we included 113 patients: 75 patients underwent SC (mean age = 51.3 years, 52.7% premenopausal); 38 patients standard care (mean age = 55.6 years, 39.5% premenopausal). A total of 53 patients (70.7%) discontinued SC, with 39 patients (73.5%) stating alopecia as the primary reason. On average, BCP stayed on treatment with the cooling cap for 40.2% of the duration of their chemotherapy (SD 25.3%). In an intention-to-treat analysis, we found no difference between the SC group and the control group with regard to their patient-reported hair loss (p=0.831) across the observation period, overall QOL (p=0.627), emotional functioning (p=0.737), social functioning (p=0.635) and body image (p=0.463) did not differ between groups. Conclusion: We found a high rate of SC-decliners and no beneficial effects of SC for patient-reported hair loss, symptoms and functional health. The efficacy and tolerability of SC applied in a clinical routine setting hence appeared to be limited. The further determination and up-front definition of criteria prognostic for effectiveness of SC may be helpful to identify patient subgroups that may experience a treatment benefit.

Long-Term Results after Autologous Breast Reconstruction with DIEP versus PAP Flaps Based on Quality of Life and Aesthetic Outcome Analysis.

(1) Background: This work aimed to conduct a comparative study, providing long-term data about patient-reported outcome measures and donor site scar assessments, as well as an aesthetic evaluation of the reconstructed breasts in patients with DIEP versus PAP flap breast reconstruction. (2) Methods: This prospective, single-center, matched cohort study included a total of 36 patients after DIEP and PAP flap breast reconstruction. The evaluation was carried out using the Breast-Q and POSAS questionnaire, as well as the Breast Aesthetic Scale for cosmetic analysis, by four plastic surgeons. (3) Results: The postoperative Breast-Q evaluation revealed no significant differences between both patient groups for the categories of the physical well-being of the donor site, the physical well-being of the breast, and satisfaction with the breast. A scar evaluation of the donor site region showed equivalent results for the thigh and abdomen regions, concerning the overall opinion of the patients and the observers. There was no significant difference between both methods of reconstruction for all aspects of breast aesthetics. (4) Conclusions: Similar results for donor site morbidity, scar quality, and the aesthetic outcome of the breasts in both the DIEP and PAP patient groups have been demonstrated. Hence, in those cases suitable for both types of reconstruction, the decision can be based on factors such as patients' lifestyles, leisure activities, and preferences.

Postvoid residual bladder volume after uncomplicated vaginal delivery.

OBJECTIVE: To create a reference curve for postvoid residual volume (PVRV) in asymptomatic postpartum women who are at low risk of developing postpartum urinary retention (PUR), a well-known complication in the immediate postpartum period. METHODS: This is a prospective observational study measuring PVRV after uncomplicated vaginal delivery. PVRV was assessed by transabdominal ultrasound using a portable ultrasound scanner within the first 26 h after delivery (PVRV 1) and on the day of discharge (day 2 or 3 postpartum) (PVRV 2). A PVRV of 150 mL or more was defined as the cut-off value for covert PUR. RESULTS: The prevalence of covert PUR was 7.1%. Primiparity, duration of second stage, and obstetric injury were correlated with higher PVRV 1. The median PVRV 1 was 21 mL and PVRV 2 was 11 mL. The subgroup of nulliparous women had a significantly higher PVRV 1 compared with multiparous women. At discharge, the majority (99.1%) of women had a PVRV of less than 150 mL. CONCLUSION: Asymptomatic women were at low risk of developing PUR. However, women with a prolonged second stage may benefit from a routine postpartum assessment. Our results allow for a better understanding of PVRV in the early postpartum period.

Does the number of 6-monthly adjuvant zoledronate infusions received affect treatment efficacy for early breast cancer? A sub-study of ABCSG-12.

BACKGROUND: The widespread adoption of adjuvant bisphosphonate therapy for postmenopausal early breast cancer (EBC) patients was based on results of the Early Breast Cancer Trialist Group (EBCTCG) meta-analysis. Despite multiple regimens evaluated, there was no signal of varying efficacy with type, dose/dose intensity of bisphosphonate administration. We evaluated the effect of early treatment cessation using long-term outcome data from the ABCSG-12 trial. PATIENTS AND METHODS: ABCSG-12 randomized 1803 hormone-receptor positive EBC patients on ovarian suppression between 1999 and 2006 to receive 4 mg zoledronic acid 6-monthly or not (and tamoxifen or anastrozole, 2:2 factorial design). In the current study, we evaluated whether the number of zoledronate infusions had an impact on breast cancer-specific outcomes. We hypothesized that amongst patients who received at least one zoledronate infusion, the number of infusions had no effect on outcomes. Time-to-event endpoints were analysed with Cox models and Kaplan Meier curves starting from a 3-year landmark. BMD analysis was restricted to patients who participated in the BMD sub-study. RESULTS: 725 patients who received at least one zoledronate infusion were included in the time-to-event analysis. There was no statistically significant difference in disease-free or overall survival in the patients who received ≤6 zoledronate infusions (n = 170) compared to those who received ≥7 zoledronate infusions (n = 555). CONCLUSIONS: Comparable to efforts to de-escalate treatment duration in metastatic bone disease, there was no evidence to indicate that a reduced number of zoledronate infusions is associated with reduced adjuvant efficacy. Further studies to define optimal regimens of adjuvant bone-targeted therapies are required.

Donor-Site Morbidity and Quality of Life after Autologous Breast Reconstruction with PAP versus TMG Flap.

The transverse myocutaneous gracilis (TMG) and the profunda artery perforator (PAP) flap are both safe choices for autologous breast reconstruction originating from the same donor region in the upper thigh. We aimed to compare the post-operative outcome regarding donor-site morbidity and quality of life. We included 18 patients who had undergone autologous breast reconstruction with a PAP flap (n = 27 flaps). Prospective evaluation of donor-site morbidity was performed by applying the same questionnaire that had already been established in a previous study evaluating TMG flap (n = 25 flaps) outcome, and results were compared. Comparison of the two patient groups showed equivalent results concerning patient-reported visibility of the donor-site scar and thigh symmetry. Still, the TMG group was significantly more satisfied with the scar (p = 0.015) and its position (p = 0.001). No difference was found regarding the ability to sit for prolonged periods. Donor-site wound complications were seen more frequently in the PAP group (29.6%) than in the TMG group (4.0%). Both groups expressed rather high satisfaction with their quality of life. Both flaps show minimal functional donor-site morbidity and high patient satisfaction. To minimize wound healing problems in PAP patients, thorough planning of the skin paddle is necessary.

Long-Term Outcomes of Adjuvant Denosumab in Breast Cancer.

BACKGROUND: Adjuvant aromatase inhibitors increase osteoporosis and fractures in patients with hormone receptor­positive breast cancer. We have previously reported outcomes of the ABCSG-18 (study 18 from the Austrian Breast & Colorectal Cancer Study Group) trial showing that adjuvant anti­receptor activator of nuclear factor-κB ligand denosumab treatment counteracts these adverse effects and may improve outcomes. We report here the final long-term outcomes. METHODS: ABCSG-18 is a prospective, double-blind, placebo-controlled, phase 3 trial in which 3425 postmenopausal patients with early hormone receptor­positive breast cancer receiving aromatase inhibitor therapy were randomly assigned in 58 trial centers to receive either denosumab 60 mg or placebo administered subcutaneously every 6 months. The primary end point was the time to first clinical fracture after randomization. Secondary disease outcome­related end points were disease-free survival (DFS), bone metastasis­free survival (BMFS), and overall survival (OS). RESULTS: For this final protocol-defined analysis, median follow-up is 8 years (interquartile range, 6 to 9.6 years). There were 309 versus 368 DFS events (hazard ratio, 0.83; 95% confidence interval [CI], 0.71 to 0.97) in the denosumab versus the placebo group, respectively, resulting in an absolute 9-year DFS benefit of 3.5 percentage points (79.4 vs. 75.9%). Adjuvant denosumab improved BMFS by 2.5 percentage points (88.9 vs. 86.4%; hazard ratio, 0.81; 95% CI, 0.65 to 1.00) and OS by 1.0 percentage point (90.9 vs. 89.9%; hazard ratio, 0.80; 95% CI, 0.64 to 1.01). No new toxicities for this dose of adjuvant denosumab were observed. CONCLUSIONS: DFS, BMFS, and OS continued to show benefit in this final long-term analysis of ABCSG-18. There were no new toxicities. (Funded by Amgen; ClinicalTrials.gov number, NCT00556374.)

The effectiveness of surgical procedures to prevent post-hysterectomy pelvic organ prolapse: a systematic review of the literature.

INTRODUCTION AND HYPOTHESIS: Hysterectomy is one of the most commonly performed gynecological surgical procedures. One of the long-term risks associated with hysterectomy is the occurrence of pelvic organ prolapse (POP). To prevent post-hysterectomy POP, several suspension procedures are routinely performed at the time of hysterectomy. We performed a systematic review of published data in order to define the most effective surgical procedures for the prevention of post-hysterectomy POP. METHODS: We performed a systematic review of the literature by searching PubMed, the Cochrane Library, EMBASE, Ovid MEDLINE, and clinicaltrials.gov up to 24 May 2020. The search strategy included the keywords hysterectomy, post-hysterectomy, prolapse, colposuspension, culdoplasty, McCall, and combinations thereof. The inclusion criterion was a surgical procedure at the time of hysterectomy to prevent de novo POP. The outcome was incidence of post-hysterectomy POP. RESULTS: Six out of 553 retrieved studies met the methodological criteria for complete analysis. In this review, 719 women aged over 18 years were included. Only 2 studies were designed as prospective trials; however, only 1 compared women undergoing a procedure at the time of hysterectomy with controls. The prevalence of post-hysterectomy prolapse varied from 0% to 39%. CONCLUSION: A systematic review of published literature suggests that performing variations of McCall culdoplasty at the time of hysterectomy might be the most effective prophylactic surgical procedure for preventing post-hysterectomy pelvic organ prolapse.

Minimally Invasive Laparoscopic Transabdominal Cerclage with a "Needle-Free" Technique: A Single-Center Experience.

BACKGROUND: In high-risk patients with cervical incompetence, laparoscopic cerclage is a promising treatment option. However, the procedure exhibits relevant surgical risks. AIMS: The purpose of this study was to evaluate a surgical "needle-free" technique for minimally invasive, laparoscopically placed cervico-isthmic cerclage in high-risk patients. METHODS: This was a retrospective observational study over a 10-year period of pre- and postconceptional cerclage placement. The included patients either experienced previous transvaginal cerclage (TVC) failure or were not eligible for TVC. Laparoscopic transabdominal cerclage using a needle-less mersilene tape was performed via a broad ligament window lateral to the uterine vessels. RESULTS: Laparoscopic transabdominal cerclage was successfully performed in all included women with a median operation time of 62 min. We did not observe any intra- or postoperative complications, particularly no bleeding complications. Nine of 11 women became pregnant and/or carried out a successful pregnancy, respectively. Importantly, we did not observe any cases of miscarriage or mid-trimester loss. Two patients did not conceive; however, their medical histories did include Asherman's syndrome and advanced maternal age. CONCLUSION: Transabdominal laparoscopic "needle-free" cerclage is a safe and effective treatment option for a well-selected group of women at high risk of cervical incompetence. It provides good obstetric results without increasing perioperative morbidity.

Conservative management of abnormally invasive placenta: four case reports.

Prenatal diagnosis of placenta increta and percreta is essential to avoid potentially life-threatening hemorrhage by optimizing peripartal management. Invasive placentation presents significant challenges at cesarean section even for highly skilled surgeons. In the four cases of placenta increta/percreta presented here we tried to avoid hysterectomy by leaving the placenta behind and tried to accelerate regression of placental tissue by administering methotrexate. The outcome in each of the four women was different, but no major bleeding occurred in any of the cases. Close follow-up for many weeks is mandatory.