Historical Control Group Research Articles

Multimodal Prehabilitation in Patients Undergoing Complex Colorectal Surgery, Liver Resection, and Hyperthermic Intraperitoneal Chemotherapy (HIPEC): A Pilot Study on Feasibility and Potential Efficacy.

Surgery for complex primary and metastatic colorectal cancer (CRC), such as liver resection and hyperthermic intraperitoneal chemotherapy (HIPEC), in academic settings has led to improved survival but is associated with complications up to 75%. Prehabilitation has been shown to prevent complications in non-academic hospitals. This pilot study aimed to determine the feasibility and potential efficacy of a multimodal prehabilitation program in patients undergoing surgery in an academic hospital for complex primary and metastatic CRC. All patients awaiting complex colorectal surgery, liver resection, or HIPEC from July 2019 until January 2020 were considered potentially eligible. Feasibility was measured by accrual rate, completion rate, adherence to the program, satisfaction, and safety. To determine potential efficacy, postoperative outcomes were compared with a historical control group. Sixteen out of twenty-five eligible patients (64%) commenced prehabilitation, and fourteen patients fully completed the intervention (88%). The adherence rate was 69%, as 11 patients completed >80% of prescribed supervised trainings. No adverse events occurred, and all patients expressed satisfaction with the program. The complication rate was significantly lower in the prehabilitation group (37.5%) than the control group (70.2%, p = 0.020). There was no difference in the type of complications. This pilot study illustrates that multimodal prehabilitation is feasible in the majority of patients undergoing complex colorectal cancer, liver resection, and HIPEC in an academic setting.

Trends of Trauma Admissions in a Rural Trauma Center During Coronavirus Disease 2019 Pandemic

IntroductionThe spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to implementing strict social distancing mandates nationwide. This study evaluates the trauma trends during the pandemic at a rural level II trauma center in Pennsylvania. MethodsA retrospective review of all trauma registries between 2018 and 2021 was performed overall and on a 6-month basis. Injury severity score, injury types–blunt versus penetrating, and mechanisms of injury were compared across the years. ResultsA total of 3056 patients in 2018-2019 and 2506 patients in 2020-2021 were evaluated as the historic control and study group, respectively. The median age of the patients was 63 and 62 years in the control and the study group, respectively (P = 0.616). There was an overall significant decline in blunt injuries and an increase in penetrating injuries (Blunt: 2945 versus 2329, Penetrating: 89 versus 159, P < 0.001). Injury severity score was not different across the eras. Falls, motorcycle accidents, motor vehicle accidents, and all-terrain vehicles comprised most of the blunt traumas. Penetrating injuries secondary to assault with firearms and sharp weapons had an increasing trend. ConclusionsThere was no association between trauma numbers and the beginning of the pandemic. Overall, there was a decline in trauma numbers during the second 6 mo of the pandemic. There was an increase in injuries involving firearms and stabbing. Rural trauma centers have a unique demographic and admission trend that should be considered while advising regulatory changes during pandemics.

The use of a diversion tube to reduce blood culture contamination: A “real-life” quality improvement intervention study

BackgroundBlood culture contamination is associated with health care costs and potential patient harm. Diversion of the initial blood specimen reduces blood culture contamination. We report results of the "real-life" clinical implementation of this technique. MethodsFollowing an educational campaign, use of a dedicated diversion tube was recommended prior to all blood cultures. Blood culture sets taken from adults using a diversion tube were defined as "diversion sets," those without, "non-diversion" sets. Blood culture contamination and true positive rates were compared for diversion and nondiversion sets and to nondiversion historical controls. A secondary analysis investigated efficacy of diversion by patient age. ResultsOut of 20,107 blood culture sets drawn, the diversion group included 12,774 (60.5%) and the nondiversion group 8,333 (39.5%) sets. The historical control group included 32,472 sets. Comparing nondiversion to diversion, contamination decreased by 31% (5.5% [461/8333] to 3.8% [489/12744], P < .0001]. Contamination was also 12% lower in diversion than historical controls [3.8% (489/12744) vs 4.3% (1,396/33,174) P = .02)]. The rate of true bacteremia was similar. In older patients, contamination rate was higher, and the relative reduction associated with diversion decreased (54.3% amongst 20-40-year-olds vs 14.5% amongst >80-year-olds). ConclusionsUse of a diversion tube in the ED reduced blood culture contamination in this large real life observational study. Efficacy decreased with increasing age, which requires further investigation.

Long-term gastrointestinal outcomes of COVID-19

A comprehensive evaluation of the risks and 1-year burdens of gastrointestinal disorders in the post-acute phase of COVID-19 is needed but is not yet available. Here we use the US Department of Veterans Affairs national health care databases to build a cohort of 154,068 people with COVID-19, 5,638,795 contemporary controls, and 5,859,621 historical controls to estimate the risks and 1-year burdens of a set of pre-specified incident gastrointestinal outcomes. We show that beyond the first 30 days of infection, people with COVID-19 exhibited increased risks and 1-year burdens of incident gastrointestinal disorders spanning several disease categories including motility disorders, acid related disorders (dyspepsia, gastroesophageal reflux disease, peptic ulcer disease), functional intestinal disorders, acute pancreatitis, hepatic and biliary disease. The risks were evident in people who were not hospitalized during the acute phase of COVID-19 and increased in a graded fashion across the severity spectrum of the acute phase of COVID-19 (non-hospitalized, hospitalized, and admitted to intensive care). The risks were consistent in comparisons including the COVID-19 vs the contemporary control group and COVID-19 vs the historical control group as the referent category. Altogether, our results show that people with SARS-CoV-2 infection are at increased risk of gastrointestinal disorders in the post-acute phase of COVID-19. Post-covid care should involve attention to gastrointestinal health and disease.

Effect of Immuno-Nutrition on Malnutrition, Inflammatory Response and Clinical Course of Semi-Critically Ill COVID-19 Patients: A Pilot Perspective Study.

The SARS-COV 2 pandemic has hit on our lives since early 2020. During different contagion waves, both malnutrition and overweight significantly correlated with patient mortality. Immune-nutrition (IN) has shown promising results in the clinical course of pediatric inflammatory bowel disease (IBD) and in both the rate of extubation and mortality of patients admitted to an intensive care unit (ICU). Thus, we wanted to assess the effects of IN on a clinical course of patients admitted to a semi-intensive COVID-19 Unit during the fourth wave of contagion that occurred at the end of 2021. we prospectively enrolled patients admitted to the semi-intensive COVID-19 Unit of San Benedetto General hospital. All patients had a biochemical, anthropometric, high-resolution tomography chest scan (HRCT) and complete nutritional assessments at the time of admission, after oral administration of immune-nutrition (IN) formula, and at 15 days interval follow-up. we enrolled 34 consecutive patients (age 70.3 ± 5.4 years, 6 F, BMI 27.0 ± 0.5 kg/m2). Main comorbidities were diabetes (20%, type 2 90 %), hyperuricemia (15%), hypertension (38%), chronic ischemic heart disease (8 %), COPD (8%), anxiety syndrome (5%), and depression (5%). 58% of patients were affected as moderately-to-severely overweight; mini nutritional assessment (MNA) score (4.8 ± 0.7) and phase angle (PA) values (3.8 ± 0.5) suggestive of malnutrition were present in 15% of patients, mainly with a history of cancer. After 15 days upon admission, we recorded 3 deaths (mean age 75.7 ± 5.1 years, BMI 26.3 ± 0.7 kg/m2) and 4 patients were admitted to the ICU. Following IN formula administration, inflammatory markers significantly decreased (p < 0.05) while BMI and PA did not worsen. These latter findings were not observed in a historical control group that did not receive IN. Only one patient needed protein-rich formula administration. in this overweight COVID-19 population immune-nutrition prevented malnutrition development with a significant decrease of inflammatory markers.

Telehealth Rapid Access Chest Pain Clinic: Initial Experience During COVID-19 Pandemic.

Objectives: Rapid Access Chest Pain Clinics (RACPCs) provide safe and efficient follow-up for outpatients presenting with new-onset chest pain. RACPC delivery by telehealth has not been reported. We sought to evaluate a telehealth RACPC established during the coronavirus disease 2019 (COVID-19) pandemic. There was a need to reduce the frequency of additional testing arranged by the RACPC during this time, and the safety of this approach was also explored. Methods: This was a prospective evaluation of a cohort of RACPC patients reviewed by telehealth during the COVID-19 pandemic compared with a historical control group of face-to-face consultations. The main outcomes included emergency department re-presentation at 30 days and 12 months, major adverse cardiovascular events at 12 months, and patient satisfaction scores. Results: One hundred forty patients seen in the telehealth clinic were compared with 1,479 in-person RACPC controls. Baseline demographics were similar; however, telehealth patients were less likely to have a normal prereferral electrocardiogram than RACPC controls (81.4% vs. 88.1%, p = 0.03). Additional testing was ordered less often for telehealth patients (35.0% vs. 80.7%, p < 0.001). Rates of adverse cardiovascular events were low in both groups. One hundred twenty (85.7%) patients reported being satisfied or highly satisfied with the telehealth clinic service. Conclusions: In the setting of COVID-19, a telehealth RACPC model with reduced use of additional testing facilitated social distancing and achieved clinical outcomes equivalent to a face-to-face RACPC control. Telehealth may have an ongoing role beyond the pandemic, supporting specialist chest pain assessment for rural and remote communities. Pending further study, it may be safe to reduce the frequency of additional testing following RACPC review.

Patterns of Failure Outcomes for Combination of Stereotactic Radiosurgery and Immunotherapy for Melanoma Brain Metastases

BACKGROUND: Previous series have demonstrated central nervous system activity for immune checkpoint inhibitors (ICIs) and shown improved local control between stereotactic radiosurgery (SRS) and ICI for lung cancer brain metastases. OBJECTIVE: To assess whether the addition of ICI to SRS for melanoma brain metastasis improves outcomes when compared with historical control group treated in the era before ICI availability. METHODS: In this single institution retrospective series, outcomes of 24 patients with melanoma receiving concurrent ICI and SRS were compared with 111 historical controls treated before ICI era. Overall survival (OS) was estimated using the Kaplan-Meier method. Cumulative incidence of local and distant failures was estimated using a competing risk model that accounted for baseline differences using propensity score adjustments. RESULTS: The median OS time was improved in patients receiving ICI compared with the historical control group (17.6 vs 6.6 months, hazard ratio [HR] = 0.056, P = .0005). Cumulative incidence at 1 year for local failure in the historical control and ICI groups was approximately 12.5% and 6.5%, respectively (HR = 0.25, P = .19), while cumulative incidence of distant brain failure in the historical control and ICI groups was approximately 48% and 28%, respectively (HR = 0.326, P = .015) CONCLUSION: Distant brain failure and OS were improved in patients receiving concurrent ICI with SRS compared with historical controls. Local failure trended in the same direction; however, owing to small sample size, this did not reach statistical significance. While these data remain to be validated, they suggest that patients with brain metastasis may benefit from concurrent use of ICI with SRS.

Efficacy of indocyanine green systemic administration for bile leak detection after hepatectomy: a protocol for a prospective single-arm clinical trial with a historical control group

IntroductionBile leakage (BL) after hepatectomy cannot always be detected with conventional methods; moreover, BL cannot be completely prevented. Recently, navigation procedures with indocyanine green (ICG) have been reported. Furthermore, we...

Supplementing transcranial direct current stimulation to local infiltration series for refractory neuropathic craniocephalic pain: A randomized controlled pilot trial.

Some patients with neuralgia of cranial nerves with otherwise therapy-refractory pain respond to invasive therapy with local anesthetics. Unfortunately, pain regularly relapses despite multimodal pain management. Transcranial direct current stimulation (tDCS) may prolong pain response due to neuro-modulatory effects. This controlled clinical pilot trial randomized patients to receive anodal, cathodal or sham-tDCS stimulation prior to local anesthetic infiltration. Pain attenuation, quality-of-life and side effects were assessed and compared with historic controls to estimate effects of tDCS stimulation setting. Altogether, 17 patients were randomized into three groups with different stimulation protocols. Relative reduction of pain intensity in per protocol treated patients were median 73%, 50% and 69% in anodal, cathodal and sham group, respectively (p = 0.726). Compared with a historic control group, a lower rate of responders with 50% reduction of pain intensity indicates probable placebo effects (OR 3.41 stimulation vs. non-stimulation setting, NNT 3.63). 76.9% (n = 10) of tDCS patients reported mild side-effects. Of all initially included 17 patients, 23.5% (n = 4) withdrew their study participation with highest proportion in the cathodal group (n = 3). A sample size calculation for a confirmatory trial revealed 120 patients using conservative estimations. This pilot trial does not support series of anodal tDCS as neuro-modulatory treatment to enhance pain alleviation of local anesthetic infiltration series. Notably, results may indicate placebo effects of tDCS settings. Feasibility of studies in this population was limited due to relevant drop-out rates. Anodal tDCS warrants further confirmation as neuro-modulatory pain treatment option.

Multidisciplinary Limb Salvage Service Reduces Major Amputations in Diabetic Foot Infections.

Diabetic foot infections (DFIs) can lead to limb loss and mortality. To improve patient care at a safety-net teaching hospital, we created a multidisciplinary limb salvage service (LSS). We recruited a cohort prospectively and compared it to a historical control group. Adults admitted to the newly established LSS for DFI during a 6-month period from 2016 to 2017 were included prospectively. Patients admitted to the LSS had routine endocrine and infectious diseases consultations according to a standardized protocol. A retrospective analysis of patients admitted to the acute care surgical service for DFI before creation of the LSS during an 8-month period from 2014 to 2015 was performed. A total of 250 patients were divided into two groups: the pre-LSS (n = 92) and the LSS (n = 158) groups. There were no significant differences in baseline characteristics. Although all patients were ultimately diagnosed with diabetes, more patients in the LSS group had hypertension (71% versus 56%; P = .01) and a prior diagnosis of diabetes mellitus (92% versus 63%; P < .001) compared to the pre-LSS group. Significantly, with the LSS, fewer patients underwent a below-the-knee amputation (3.6% versus 13%; P = .001). There was no difference in the length of hospital stay or 30-day readmission rate between the groups. Further broken down into Hispanic versus non-Hispanic, we noted that Hispanics had significantly lower rates of below-the-knee amputations (3.6% versus 13.0%; P = .02) in the LSS cohort. The initiation of a multidisciplinary LSS decreased the below-the-knee amputation rate in patients with DFIs. Length of stay was not increased, nor was the 30-day readmission rate affected. These results suggest that a robust multidisciplinary LSS dedicated to the management of DFIs is both feasible and effective, even in safety-net hospitals.

Abstract GS4-09: Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsIVE breast cancer: Primary Results from the POSITIVE Trial (IBCSG 48-14/BIG 8-13)

Abstract Background: Pregnancy after breast cancer (BC) is of substantial importance for many young women at diagnosis and during follow-up. BC treatment including standard endocrine therapy (ET) (5-10 years) may reduce ovarian reserve and the chances of subsequent successful pregnancy, given conception is contraindicated during ET. A temporary interruption of ET to attempt and carry a pregnancy in this population has never been prospectively studied. Methods: POSITIVE is a single-arm, prospective, investigator-initiated, international trial evaluating the safety and pregnancy outcomes of interrupting ET for young women with early-stage hormone-receptor-positive (HR+) BC who desire pregnancy. The primary objective is to assess the risk of BC relapse associated with ET interruption for ~2 years to achieve pregnancy. Women ≤42 years with stage I-III HR+ BC who received adjuvant ET (SERM alone, GnRH analogue plus SERM or AI) for 18 to 30 months and wished to interrupt ET to attempt pregnancy were eligible. The primary endpoint is breast cancer free interval (BCFI) defined as the time from enrollment to the first BC event (local, regional, distant recurrence or a new invasive contralateral BC). Planned sample size was 500 patients. Three interim analyses of BCFI were reviewed by the Data Safety Monitoring Committee (DSMC) to assure a 95% chance of stopping the trial early if the annual BCFI event rate exceeded 4%; with primary analysis triggered after 1600 patient years of follow-up (pyfu) and no more than 46 BCFI events defined as the safety threshold. The DSMC recommended continuing the study following each interim analysis. We now report the primary results. Results: From 12/2014 to 12/2019, 518 women were enrolled. At enrollment, the median age of participants was 37 years (27-43 years); 75.0% were nulliparous, 93.4% had stage I/II disease, 66.3% node-negative. Median time from BC diagnosis to enrollment was 29 months (IQR: 25-32). Tamoxifen alone was the most prescribed ET (41.7%), followed by tamoxifen+ovarian function suppression (35.7%). 62.0% of participants had received neo/adjuvant chemotherapy. At a median follow-up of 41 months (1638 pyfu), 44 participants had experienced a BCFI event, not exceeding the pre-specified safety threshold of 46 events. The 3-year BCFI failure percent was 8.9% (95% CI: 6.3 to 11.6%), similar to the 9.2% (95% CI: 7.6 to 10.8%) calculated in the comparative external control cohort from the SOFT/TEXT trials (Sun et al, Breast 2020). Of 497 women followed for pregnancy status, 368 (74.0%) had at least one pregnancy, 317 (63.8%) had at least one live birth, with a total of 365 babies born. Based on competing risk analysis, 76.3% of patients resumed ET (half within 26 months), 8.3% had BCFI event/death before ET resumption, and 15.4% had not resumed ET yet. Conclusions: The POSITIVE trial demonstrates that for young women with early HR+ BC desiring pregnancy, temporary interruption of ET to attempt pregnancy does not confer a greater short-term risk of recurrence than that observed in a modern historical control group that did not interrupt ET. Most participants have had a live birth. Further follow-up is planned to confirm long-term safety. These results should be considered in counselling BC patients desiring future pregnancy. Citation Format: Ann Partridge, Olivia Pagani, Samuel M. Niman, Monica Ruggeri, Fedro Alessandro A. Peccatori, Hatem A. Azim, Marco Colleoni, Cristina Saura, Chikako Shimizu, Anna Saetersdal, Judith Kroep, Audrey Mailliez, Ellen Warner, Virginia F. Borges, Frédéric Amant, Andrea Gombos, Akemi Kataoka, Christine Rousset-Jablonski, Simona Borstnar, Junko Takei, Jeong Eon Lee, Janice Walshe, Manuel Ruiz Borrego, Halle Moore, Christobel Saunders, Vesna Bjelic-Radisic, Snezana Susnjar, Fatima Cardoso, Karen L. Smith, Teresa Ferreiro Vilarino, Karin Ribi, Kathryn Ruddy, Sarra El-Abed, Martine Piccart, Larissa A. Korde, Aron Goldhirsch, Richard D. Gelber. Pregnancy Outcome and Safety of Interrupting Therapy for women with endocrine responsIVE breast cancer: Primary Results from the POSITIVE Trial (IBCSG 48-14/BIG 8-13) [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr GS4-09.

Patient selection for urgent endoscopic retrograde cholangio-pancreatography by endoscopic ultrasound in predicted severe acute biliary pancreatitis (APEC-2): a multicentre prospective study

ObjectiveRoutine urgent endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic biliary sphincterotomy (ES) does not improve outcome in patients with predicted severe acute biliary pancreatitis. Improved patient selection for ERCP by means...

Effects of a small-baby protocol on early and long-term outcomes in extremely preterm infants: A quality improvement study

BackgroundExtremely preterm (EPT) infants (≤28 weeks) remain at risk for poor outcomes. Small baby protocols (SBPs) may improve outcomes, but optimal strategies are unknown. MethodsThis study evaluated whether EPT infants managed using an SBP would have better outcomes compared to a historical control (HC) group. The study compared a HC group of EPT infants 23 0/7 weeks to 28 0/7 weeks GA (2006–2007), to a similar SBP group (2007–2008). Survivors were followed until 13 years of life. The SBP emphasized antenatal steroids, delayed cord clamping, respiratory and hemodynamic minimalism, prophylactic indomethacin, early empiric caffeine, and control of sound and light. ResultsThere were 35 HC subjects and 35 SBP subjects. The SBP group had less severe IVH-PVH (9 % vs. 40 %, risk ratio 0.7, 95 % CI 0.5–0.9, P = 0.002) mortality (17 % vs. 46 %, risk ratio 0.6, 95 % CI 0.5–0.9, P = 0.004), and acute pulmonary hemorrhage (6 % vs. 23 %, risk ratio 0.8, 95 % CI 0.7–1.0, P = 0.04). Compliance with the SBP protocol was excellent. For the SBP group in the first 72 h, no subjects received inotropes, hydrocortisone, or sodium bicarbonate. Intubation, mechanical ventilation, fluid boluses, sedation, red blood cell transfusions, and insulin use decreased. At 10–13 years, more SBP subjects had survived without NDI (51 % vs. 23 %, risk ratio = 1.6, 95 % CI = 1.1–2.4, P = 0.01). More SBP subjects also survived without NDI and with a Vineland Adaptive Behavior Composite score > 85 (44 % vs. 11 %, risk ratio = 2.0, 95 % CI = 1.2–3.2, P ≤0.001). The SBP group had less visual impairment. ConclusionAn SBP was associated with improved outcomes, including normal neurologic survival after 10 years.

Extreme bipolar androgen therapy with darolutamide and testosterone cypionate in patients with metastatic castration-resistant prostate cancer: ExBAT (LACOG 0620) trial.

TPS276 Background: Prostate cancer has an intrinsic dependence on androgens and androgen receptor (AR) regulation. Suppression of gonadal androgen synthesis known as androgen deprivation therapy (ADT), either by orchiectomy or by pharmacological modulation, represents the treatment backbone of metastatic disease. Unfortunately, almost invariably, patients develop resistance to ADT, progressing to a state called castration-resistant prostate cancer (CRPC), defined as disease progression at serum testosterone levels in the castrate range. Bipolar Androgen Therapy (BAT), consisting of exogenous supraphysiological doses of testosterone followed by castrate levels, has shown clinical activity in multiple early phase clinical trials, in addition to improvement of quality of life (QoL) in CRPC patients. Alternated administration of BAT and novel AR-targeted therapies, a strategy entitled by our group as Extreme Bipolar Androgen Therapy (ExBAT), has never been tested in patients with CRPC. The objective of our study is to assess the ExBAT approach in metastatic CRPC. Methods: ExBAT (NCT04558866) is a phase 2, single-arm, multicenter trial assessing patients with mCRPC who progressed to abiraterone by PCWG3 criteria. Prior docetaxel for metastatic hormone-sensitive disease is allowed if ≥ 12 months elapsed from last dose of docetaxel. Included patients receive testosterone cypionate 400 mg IM on day 1 followed by darolutamide 1,200 mg/day orally for 4 weeks (starting on day 29 through day 56) on 63-day cycles. The primary endpoint is radiographic progression-free survival (rPFS) at 12 months. Secondary endpoints include PSA decline rates, overall survival, toxicity, quality of life, and predictive biomarkers of response/survival. Tumor assessments are performed every 9 weeks, for the first 2 cycles and every 18 weeks thereafter up to 12 months. Patients with disease progression with clinical benefit are allowed to continue treatment. Patients without disease progression after 12 months are allowed to receive study treatment on Extension Phase. The sample size of 47 patients (considering 5% drop-out) was calculated based on the primary endpoint using a two-sided 5% significance level Chi-square Test for One Proportion and achieves 80% power to detect the difference between a 50% rPFS at 12 months comparing with 30% in the historic control group. NCT04558866. From June2021 to September2022, 31 of planned 47 patients have been enrolled in 8 Brazilian centers. Results are not available at the time of submission. Clinical trial information: NCT04558866 .

Assessing the Effects of a Perioperative Nutritional Support and Counseling in Gastrointestinal Cancer Patients: A Retrospective Comparative Study with Historical Controls.

The aim of this study was to investigate the effects of perioperative nutritional therapy care in gastrointestinal (esophageal, gastric, gastroesophageal) cancer patients on nutritional status and disease progression (complications, hospitalization, mortality). We considered 62 gastrointestinal cancer patients treated at the Center for Integrated Oncology (CIO), University Hospital Bonn, Germany (August 2017-July 2019). Of these, 42 patients (as intervention group: IG) received pre- and postoperative nutritional support with counseling, while 20 patients (as historical control group CG) received only postoperative nutritional therapy. Several clinical parameters, such as Body Mass Index (BMI), nutritional risk screening (NRS), phase angle, postoperative complications, length of hospital stay, and mortality, were determined. There were significantly fewer patients with gastric cancer/CDH1 gene mutation and more with esophageal cancer in IG (p = 0.001). Significantly more patients received neoadjuvant therapy in IG (p = 0.036). No significant differences were found between the groups regarding BMI, NRS, complications, length of hospital stay, and mortality. However, the comparison of post- and preoperative parameters in IG showed a tendency to lose 1.74 kg of weight (p = 0.046), a decrease in phase angle by 0.59° (p = 0.004), and an increase in NRS of 1.34 points (p < 0.001). Contrary to prior reports, we found no significant effect of perioperative nutritional therapy care in gastrointestinal cancer patients; however, the small cohort size and infrequent standardization in nutritional status may possibly account for the variance. Considering that oncological pathways and metabolic nutritional pathways are interrelated, dividing patients into subgroups to provide a personalized nutritional approach may help in improving their treatment.

The treatment of relapsed/refractory anaplastic large cell lymphoma expressing the anaplastic lymphoma kinase: a single-center experience

The treatment of relapsed/refractory anaplastic large cell lymphoma expressing the anaplastic lymphoma kinase: a single-center experience

Comparison of four-year toxicities and local control of ultra-hypofractionated vs moderate-hypofractionated image guided prostate radiation with HDR brachytherapy boost: A phase I-II single institution trial

Purpose/Objective(s)To analyze the long term efficacy and safety of an ultra-hypofractionated (UHF) radiation therapy prostate treatment regimen with HDR brachytherapy boost (BB) and compare it to moderate-hypofractionated regimens (MHF). Materials/MethodsIn this single arm, prospective monocentric study, 28 patients with intermediate risk prostate cancer were recruited in an experimental treatment arm of 25 Gy in 5 fractions plus a 15 Gy HDR BB. They were then compared to two historical control groups, treated with either 36 Gy in 12 fractions or 37.5 Gy in 15 fractions with a similar HDR BB. The control groups included 151 and 311 patients respectively. Patient outcomes were reported using the International Prostate Symptom Score (IPSS) and Expanded Prostate Index Composite (EPIC-26) questionnaires at baseline and at each follow-up visit. ResultsMedian follow-up for the experimental arm was 48.5 months compared to 47 months and 60 months compared to the 36/12 and 37,5/15 groups respectively.The IPSS and EPIC scores did not demonstrate any significant differences in the gastrointestinal or genitourinary domains between the three groups over time. No biochemical recurrence occurred in the UHF arm as defined by the Phoenix criterion. ConclusionThe UHF treatment scheme with HDR BB seems equivalent to standard treatment arms in terms of toxicities and local control. Randomized control trials with larger cohorts are ongoing and needed to further confirm our findings.

Risk of Acute Kidney Injury and Fracture-Related Infection After Antibiotic Prophylaxis With Piperacillin-Tazobactam in Open Fractures.

To evaluate the effects of prophylactic piperacillin-tazobactam (PT) on inpatient acute kidney injury (AKI) and fracture-related infection (FRI) in patients with open fractures. The study was conducted at a Level 1 trauma center. We reviewed 358 Gustilo-Anderson type II and III open fractures at our institution from January 2013 to December 2017. Administration of PT (the PT group) or antibiotics other than PT (the historical control group) during the first 48 hours of arrival for open fracture antibiotic prophylaxis. The main outcome measurements were rates of inpatient AKI and FRI within six months after definitive fixation. There were 176 patients in the PT group and 182 patients in the historical control group. The PT group had worse American Society of Anesthesiologists class ( P = 0.004) and injury severity scores ( P < 0.001), a higher average number of debridements before closure/coverage ( P = 0.043), and higher rates of gross soil contamination ( P = 0.049) and staged procedures ( P = 0.008) compared with the historical control group.There was no difference in the rate of AKI between the PT and historical control groups (5.7% vs. 2.7%, P = 0.166) nor when stratified by Gustilo-Anderson fracture classification (type II: 5.8% vs. 3.6%, P = 0.702; type III: 5.6% vs. 2.0%, P = 0.283). There was no significant difference in the rate of FRI between the PT and historical control groups (23.6% vs. 19.6%, P = 0.469). The use of PT in prophylactic antimicrobial treatment in patients with Gustilo-Anderson type II and III open fractures does not increase the rate of AKI or FRI. We believe PT can be used as an effective monotherapy in these patients without an increased risk of renal injury, but future investigations are necessary. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

SG-APSIC1203: Detection of carbapenemase genes in donor lungs at the point of care before transplantation reduces the risk of carbapenem-resistant Enterobacteriaceae–associated donor-derived infection in lung-transplant recipients

Objectives: The number of lung transplants is increasing year by year in China and globally. With the widespread use of donation after brainstem death (DBD) donor lungs and donation after circulatory death (DCD) donor lungs, donor-derived infection (DDI) poses a major challenge in lung transplantation. Using donor lungs infected or colonized with carbapenem-resistant Enterobacteriaceae (CRE) may have serious implications in lung-transplant recipients. Currently, traditional microbial culture along with antimicrobial susceptibility testing cannot fully meet the need for rapid and accurate diagnosis of CRE infection in a donor before organ harvest. Methods: The Xpert Carba-R device (Cepheid, Sunnyvale, CA) was used to detect and differentiate Klebsiella pneumoniae carbapenemase (KPC), New Delhi metallo-β-lactamase (NDM), Verona integron-encoded metallo-β-lactamase (VIM), active-on-imipenem (IMP), and OXA-48 carbapenemase genotypes in bronchial lavage fluid from donor lungs before organ harvest. Positive detection of 1 or more of these genotypes indicated a potentially CRE-infected donor lung, and these organs were removed from the lung transplantation cohort. Donor lungs negative for all KPC, NDM, VIM, IMP, and OXA-48 genotypes determined by the Xpert Carba-R device were used for lung transplantation. The incidence of CRE-associated DDI and infection-related complications were compared in the Xpert Carba-R screening group and an historic control group. Results: In this study, 21 donor lungs were tested with the Xpert Carba-R device to detect and differentiate carbapenemase genotypes. Among them, 4 were positive for 1 or more carbapenemase genotypes and were discarded, and the remaining 17 donor lungs showing no carbapenemase gene presence were used for lung transplantation. No CRE-associated DDI occurred in these 17 lung-transplant recipients. Conclusions: Rapid and accurate detection of the carbapenemase gene in donor lungs at the point of care before transplantation using the Xpert Carba-R device reduced the risk of CRE-associated DDI in lung-transplant recipients.

Intermediate-dose cyclophosphamide and bortezomib for PBSC mobilization in multiple myeloma

Although the incorporation of bortezomib into induction regimens has improved response rates in patients with multiple myeloma (MM), the role of bortezomib in the peripheral blood stem cell (PBSC) mobilization remains unclear. We assessed the PBSC mobilization efficacy, safety, and disease response of intermediate-dose cyclophosphamide and bortezomib in the PBSC mobilization. Twenty-one patients with newly diagnosed MM were enrolled in a phase II, non-randomized study that used bortezomib (1.3 mg/m2/day on days 1, 4, 8, and 11) and intermediate-dose cyclophosphamide (2 g/m2/day on days 2, 3) (Bor-ID-CY). The data from 15 patients who received intermediate-dose cyclophosphamide (ID-CY) were used as a historical control group. The total CD34 + cell yield of Bor-ID-CY and ID-CY groups were not significantly different (median 6.3 ×106/kg vs. 6.5 ×106/kg, p = 0.26). All three patients with mobilization failure of two groups had t(11;14). Six patients in Bor-ID-CY group were upgraded from a status that was less than a very good partial response (VGPR) at the time of PBSC mobilization to a VGPR or better after PBSC mobilization (p = 0.014). Four patients in Bor-ID-CY group developed sepsis. The time to engraftment was similar in the two groups. The addition of bortezomib to ID-CY did not impact the stem cell yield or quality.