Comparable Groups Research Articles

Are women with endometriosis more likely to experience reduced physical performance compared to women without the condition?

Endometriosis is a condition of the female reproductive system associated with pelvic pain. Chronic pain can affect physical performance by limiting the functional activities, thus, it is hypothesized that women with endometriosis may also present decreased functional capacity, decreased strength, and mobility. The objective of this study is to compare physical performance in women with and without endometriosis. This is a cross-sectional study composed of 115 women equally divided into two groups: the endometriosis group (EG), composed of women with a confirmed diagnosis of the disease by magnetic resonance imaging, and the comparator group (CG), consisting of women without suspicion of the disease. Physical performance (dependent variable) was assessed using hand dynamometry, the 6-min walk test (6MWT), gait speed, and the chair stands test. CG participants performed the tests during the luteal phase of the menstrual cycle. Descriptive statistics, unpaired t-tests, and chi-square tests were used to describe and compare the groups. Multiple linear regression tested the associations adjusted for covariates (age, income, education, age at menarche, and body mass index). The EG had worse gait speed (mean difference: -0.11; 95% CI: [-0.18 to -0.04]), weaker grip strength (mean difference: -3.32; 95% CI: [-5.30 to -1.33]), shorter distance covered in the 6MWT (mean difference: -83.46; 95% CI: [-121.38 to -45.53]), and a lower number of repetitions in the chair stands test (mean difference: -8.44; 95% CI: [-10.64 to -6.25]) than the CG, even after adjusting for covariates. Grip strength, lower limb strength, mobility, and functional capacity were worse in women diagnosed with endometriosis. Women with endometriosis should be encouraged to engage in physical exercise, adopt healthy lifestyle habits, and participate in rehabilitation activities to control pain, with the aim of reducing functional impairments.

Early Mobilization Dose Reporting in Randomized Clinical Trials With Patients Who Were Mechanically Ventilated: A Scoping Review.

The aim of this scoping review was to investigate the mobilization dose reporting in the randomized clinical trials (RCTs) of patients receiving mechanical ventilation in the intensive care unit. In this scoping review, RCTs published from inception to December 2022 were searched in relevant electronic databases. Trials that involved adults receiving mechanical ventilation (>48hours) and any early mobilization modality were analyzed. Two independent authors screened, selected, and extracted data. The mobilization doses of the intervention groups (IGs) and the comparator groups (CGs) were assessed as the proportion of reported items/total applicable from the main items of the Consensus on Exercise Reporting Template (CERT). Twenty-three RCTs comprising 2707 patients (1358 from IG and 1349 from CG) were included, involving studies on neuromuscular electrical stimulation (n = 7), progressive mobility (n = 6), leg cycling (n = 3), tilt table (n = 1), and multicomponent (n = 6) mobilization. The pooled reporting of CERT items was 68% (86% for IG and 50% for CG). The most reported CERT items were type of exercise (100%) and weekly frequency (100%) for IG, whereas the least reported were intensity (4%) and individualization (22%) for CG. Regardless of the group, individualization, progression, and intensity of mobilization were the least reported items. Eight IGs (35%) reported all CERT items, whereas no CGs reported all of them. Deficits in mobilization dose reporting of intensive care unit RCTs were identified, especially for exercise intensity in adults receiving mechanical ventilation. One-third of IG reported all exercise dosing items, whereas no CG reported all of them. Future studies should investigate the details of optimal dosage reporting, particularly for CG. The lack of dose reporting may partially explain the inconsistency in the meta-analysis results of early mobilization trials, thus limiting the interpretation for clinical practice in the intensive care unit.

Effectiveness of an Intensive, Functional, and Gamified Rehabilitation Program on Upper Limb Function in People With Stroke (EnteRtain): A Multicenter Randomized Clinical Trial

Background1 Despite a growing interest in gaming rehabilitation for upper limb (UL) recovery post-stroke, studies investigating the effects of game-based rehabilitation incorporating functional games are lacking. Objective To investigate the efficacy of an intensive, functional, gamified rehabilitation program compared to task-based training on UL motor function in acute/sub-acute stroke survivors. Methods This randomized, multicenter, single-blind, clinical trial comprises 120 participants with unilateral stroke who were randomized to receive either gamified training (n = 64) using the ArmAble™ [experimental group (EG)] or task-based training (n = 56) in conjunction with conventional therapy for 2 hours per day, 6 days per week for 2 weeks, followed by UL rehabilitation for another 4 weeks at home. Primary outcomes evaluated by a blinded assessor included the Fugl-Meyer Assessment-Upper Extremity (FM-UE), and Action Research Arm Test (ARAT). Data were analyzed using a linear mixed-effect regression model. Results The mean (standard deviation) age of the participants was 54.4 ± 11.7 years (78.1% men) in the EG and 57.7 ± 10.9 years (73.2% men) in the comparator group (CG). The median (interquartile range) time since stroke was 30.0 (54.0) days in the EG and 22.5 (45.0) days in the CG. Following the 2-week intervention, a statistically significant improvement was observed in the EG for the FM-UE [between-group mean differences (95% confidence interval): −3.9 (−6.5, −1.3); P = .003]; but not for the ARAT [−2.9 (−5.8, 0.0); P = .051]. Gains at 6 weeks were significantly greater in the EG for both FM-UE [−3.9 (−6.5, −1.3); P = .003]; and ARAT [−3.0 (−5.9, −0.0); P = .046]. Conclusion Gamified rehabilitation using the ArmAble™ device has shown immediate and short-term improvement in UL function after acute/sub-acute stroke. Clinical Trials Registry Number: CTRI/2020/09/027651

Immune profile of patients with peritoneal carcinomatosis selected for CRS-HIPEC therapy.

Cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) is a treatment option for peritoneal carcinomatosis (PC) from colorectal cancer (CRC), which is otherwise a terminal stage of disease. Nevertheless, survival outcomes are only marginally superior to other treatments. This fact highlights the need for better strategies to control intra-abdominal disease recurrence after CRS-HIPEC, including the complementary use of immunotherapies. The aim of this study was therefore to investigate the immune phenotype of T cells in patients with PC. Fifty three patients with CRC (34 patients with PC and 19 patients without PC) were enrolled in a prospective study (clinicaltrials.gov: NCT04108936). Peripheral blood and omental fat were collected to isolate peripheral blood mononuclear cells (PBMCs) and adipose tissue mononuclear cells (ATMCs). These cells were analysed by flow cytometry using a panel focused upon T cell memory differentiation and exhaustion markers. We found a more naïve profile for CD8+ T cells in peripheral blood and intra-abdominal fat of PC patients compared to comparator group (CG) patients. Furthermore, there was an over-representation of CD4+ T cells expressing inhibitory receptors in adipose tissue of PC patients, but not in blood. Our description of intraperitoneal T cell subsets gives us a better understanding of how peritoneal carcinomatosis shapes local immune responses.

Evaluation of a training program to support the implementation of a community pharmacist-led support service for people living with severe and persistent mental illness

BackgroundWith appropriate training, community pharmacists can support people living with severe and persistent mental illness (SPMI) by identifying and managing medication-related issues and physical health concerns. The Bridging the Gap between Physical and Mental Illness in Community Pharmacy (PharMIbridge) randomized controlled trial (RCT) tested the impact of an individualized, pharmacist-led support service for people living with SPMI. Objective(s)To evaluate the impact of the PharMIbridge training program on pharmacy participants’ knowledge and confidence, as well as stigma and attitudes, in relation to supporting, and providing services to, people living with SPMI; compared to Mental Health First Aid (MHFA) training alone. MethodsPharmacy staff (n = 140) from 55 community pharmacies across 4 RCT regions attended face-to-face training. Both intervention group (IG) and comparator group (CG) participants received MHFA training while IG participants received additional PharMIbridge training, involving role-plays and mental health consumer educators (MHCEs). A questionnaire including validated instruments was administered at baseline, after training and after 12 months. Comparative analyses included paired t tests and mixed between/within analysis of variance (ANOVA). ResultsPre and post-training surveys were completed by 136 participants, most of which were pharmacists. Both IG and CG participants had significant reductions in stigma (P < 0.001) post-training. IG participants’ confidence and knowledge regarding metabolic monitoring significantly improved compared to CG (P < 0.001). IG participants were significantly more confident and comfortable in providing medication counseling, compared to CG participants (P < 0.05). ConclusionMHFA training reduced participants’ stigma toward mental health. However, the purpose-designed PharMIbridge training program provided pharmacists with additional knowledge and skills to confidently support the physical health care needs of people living with SPMI. The inclusion of role-plays and MHCEs allowed pharmacists to self-reflect and practice skills in safe, supportive environments. Future studies should continue to involve MHCEs in pharmacy training and explore whether these improvements are sustainable.

Protein supplementation during an energy-restricted diet induces visceral fat loss and gut microbiota amino acid metabolism activation: a randomized trial

Interactions between diet and gut microbiota are critical regulators of energy metabolism. The effects of fibre intake have been deeply studied but little is known about the impact of proteins. Here, we investigated the effects of high protein supplementation (Investigational Product, IP) in a double blind, randomised placebo-controled intervention study (NCT01755104) where 107 participants received the IP or an isocaloric normoproteic comparator (CP) alongside a mild caloric restriction. Gut microbiota profiles were explored in a patient subset (n = 53) using shotgun metagenomic sequencing. Visceral fat decreased in both groups (IP group: − 20.8 ± 23.2 cm2; CP group: − 14.5 ± 24.3 cm2) with a greater reduction (p < 0.05) with the IP supplementation in the Per Protocol population. Microbial diversity increased in individuals with a baseline low gene count (p < 0.05). The decrease in weight, fat mass and visceral fat mass significantly correlated with the increase in microbial diversity (p < 0.05). Protein supplementation had little effects on bacteria composition but major differences were seen at functional level. Protein supplementation stimulated bacterial amino acid metabolism (90% amino-acid synthesis functions enriched with IP versus 13% in CP group (p < 0.01)). Protein supplementation alongside a mild energy restriction induces visceral fat mass loss and an activation of gut microbiota amino-acid metabolism.Clinical trial registration: NCT01755104 (24/12/2012). https://clinicaltrials.gov/ct2/show/record/NCT01755104?term=NCT01755104&draw=2&rank=1.

Gait parameters and functional performance following multi-factorial treatment among degenerative joint disease patients

Introduction and Aim: Degenerative Joint Disease (DJD) poses a challenge to manage and restore functional capabilities among patients. Incorporation of structured exercises, manual therapy and patient education had a significant impact on clinical and functional status of patients. Past research hasexplored benefits of therapy on functions and gait. Although, such studies did not address the functional restoration. Hence, present study was aimedto address the lacunae.&#x0D; &#x0D; Materials and Methods: 100 patients with mean age and SD; 51.61(5.4) were included. Participants had knee Degenerative Joint Disease (DJD); grade 2 or 3 on Kellgren and Lawrence scale, were allocated to Experimental Group (EG) and Comparative Group (CG). EG received joint mobilization and Muscle Energy Technique (MET). CG received Interferential therapy (carrier frequency 4 kHz; beat frequency 100 Hz; and sweep frequency 150 Hz). Strengthening exercises and patient education were common for both groups. Intervention lasted two weeks, the post-intervention metrics included; stride length, step length, and cadence for gait and knee injury and osteoarthritis outcome score.&#x0D; &#x0D; Results: Data obtained was subjected to statistical analysis. Frequency and percentage were used for categorical variables; mean andstandard deviation (SD) were used for continuous variables. Post-intervention, there was a significant improvement of gait parameters and Knee Injury and Osteoarthritis Outcome Score (KOOS) in both groups. CG had a better improvement in STL, SL, CAD with mean of 39.84(5.68), 20.22(2.84), 97.16(3.75) and EG with mean of 44.36(4.48), 22.30(3.75), 92.82(3.75) and p &lt; .0005. However, it was evident that the proportion of functional improvement among CG was lesser.&#x0D; &#x0D; Conclusion: Inclusion of structured exercises, manual therapy and patient education in intervention would be effective and improve the functional status of DJD patients.&#x0D;

98. Clinical and Pharmacoeconomic Impact of Rapid Diagnostic Pneumonia Panel in Critically Ill Patients Admitted with Nosocomial Pneumonia

BackgroundRapid identification of causative organisms and tailored antibiotic therapy is essential to improving patient outcomes in critically ill patients with nosocomial pneumonia (NP). The BioFire ® FilmArray ® Pneumonia Panel (BFPP) can identify and semi-quantify the causative organisms via PCR. However, there is limited evidence of its implementation and utility within antimicrobial stewardship program (ASP) in managing NP.MethodsThis was an IRB-approved retrospective pre- and post-interventional study at an acute care hospital. Critically ill patients were included in the intervention group (IG) with a confirmed diagnosis of NP and had BFPP performed. Patients in IG were matched on a 2:1 ratio to a comparator group (CG) who did not receive BFPP. The primary endpoint was clinical cure (CC), defined as: 1) resolution of symptoms and/or leukocytosis; or 2) radiographic improvement; or 3) expression of CC noted by infectious disease physician. Secondary endpoints include time to escalation, de-escalation, or discontinuation of antibiotics, and inpatient mortality (IM). In addition, a pharmaco-economic analysis of the utilization of this panel was conducted.ResultsThere were 52 patients evaluated, of which 26 were included in IG and 13 were matched to be included in CG. Demographics were similar between the two groups. No difference in CC was observed between IG and CG (38.5% vs 38.5%, p = 1). However, when evaluating ASP interventions, more patients in IG had de-escalation (53.8% vs 15.4%, p = 0.01) and discontinuation (50% vs 7.7%, p = 0.003) performed compared to CG. No difference was seen in escalation of therapy (34.6% vs 30.8%, NS) and IM (26.9% vs 46.2%, p = 0.27). Time to ASP intervention was quicker by 24 hours in IG vs CG (24 vs 48 hours, p = 0.01). No difference was seen in total cost of therapy between the two groups ($289,500 vs $243,705, p = 0.6). However, cost savings of $31,000 was seen in total cost of ICU care in IG vs CG ($144,000 vs $175,000, p = 0.032).Figure 1: ASP Intervention ConclusionThere was no observed impact of BFPP on CC and IM in critically ill patients. However, utilization of BFPP led to faster time to ASP interventions and higher rates of de-escalation and discontinuation of antibiotics. When utilized as part of ASP, BFPP can serve to be a cost-effective option for critically ill patients.Disclosures All Authors: No reported disclosures

Bridging the gap between physical and mental illness in community pharmacy (PharMIbridge): protocol for an Australian cluster randomised controlled trial

IntroductionThere is a significant life expectancy gap attributable to physical comorbidities for people living with severe and persistent mental illness (SPMI) compared with the general population. Medications are a major...

Methods of Hydrokinesis Therapy for Children 3-5 Years with Cerebral Palsy of Spastic Form

Today there is a need to develop a method of hydrokinesis therapy as a means of gradual formation of motor skills in children with spastic diplegia of cerebral palsy of the chronic-residual stage of the disease in a comprehensive program of physical rehabilitation. The purpose of the study is to develop a method of hydrokinesis therapy for children 3-5 years with cerebral palsy of spastic form. The main novelties of the developed technique of hydrokinesis therapy: development of application of complexes of exercises in hydrokinesis therapy, which differs in structure from the generally accepted methods for patients with cerebral palsy of spastic form in the chronic-residual stage of the disease; combination of means of physical rehabilitation with the technique of hydrokinesis therapy during the annual cycle. The study involved 24 children 3-5 years of age with a diagnosis of "cerebral palsy, spastic diplegia" of the chronic-residual stage of the disease of moderate severity. To achieve this goal, theoretical analysis and generalization of data from scientific and methodological literature were used; pedagogical experiment and observation; medical and biological methods (used anthropometry and Pinier index; goniometry, assessment of basic motor functions (ABMF) on the Likert scale, muscle tone on the Ashfort scale, muscle strength on the Lovett scale; assessment of manipulative activity and speed response of the hands on trapping- the test made it possible to determine the level of development of fine motor skills); sociological methods (surveys of parents on questionnaires of social and emotional state and level of children's play activities); methods of mathematical statistics were used to process the actual experimental material, assess the reliability of the data. There were significant (p &lt;0.01) changes in the indicators of social and emotional state in children with main group (MG) by 15.5%, in comparative group (CG) - by 11.7%, and there was a slight improvement in play activity in children with MG by 9.6%, in CG - by 5.75%. The developed method of hydrokinesiotherapy is effective and helps to improve the functions of general and fine motor skills, socio-emotional state and the level of activity of play activities of children 3-5 years with cerebral palsy of spastic form.

A psychological study of male, female related and unexplained infertility in Indian urban couples

Objective: The study intended to see the impact of infertility on experience of emotional trauma, belief pattern and formation of psychopathology and also to explore the psychopathology with respect to degree of infertility related stress impact among male, female and unexplained factor infertility in couples suffering from primary infertility.Design: This was a clinic-based, cross-sectional comparative study based on a consecutive sampling method.Subjects: Sixty couples were studied of whom 10 couples had male-related infertility (MF), 10 had female-related infertility (FF) and 10 unexplained infertility (UF). Another 30 fertile couples were also included as comparative group (CG) after matching on certain sociodemographic variables with the clinical groups.Measures: Impact of Event Scale, Symptom Checklist-90 Revised and Irrational Belief Scale were used.Results: The impact of emotional trauma and irrational belief was greatest in the male-related infertility couples, and somatisation in the unexplained group, whereas depression and interpersonal sensitivity were higher in the female-related infertility couples. An impact of moderate to severe infertility-related stress on depression and irrational beliefs was also observed. Gender difference was evident with respect to psychopathology and types of infertility.Conclusion: The impact of infertility is evident with respect to psychopathology with differential impact of various types of infertility groups among Indian couples.

Assessment of the Possibilities of B-Mode Ultrasonography in the Diagnosis of Atlanto-Axial Rotary Subluxation in Children

Assessment of the Possibilities of B-Mode Ultrasonography in the Diagnosis of Atlanto-Axial Rotary Subluxation in Children

The usefulness of soluble transferrin receptor (sTfR) in differentiating anemia occurring in young children

We evaluated the usefulness of soluble transferrin receptor (sTfR) and of the sTfR/log ferritin index(sTfR/logF) in the differentiation of anemia in young children. 96 children, aged 6-36 months, were examined.From these, four groups were distinguished: 1 - (IDA): 33 children with anemia due to iron deficiency; 2 -(IA): 19 children with infectious anemia without iron deficiency; 3 - (IA + ID): 16 children with infectious anemia and iron deficiency; and 4 - a comparator group (CG): 28 healthy children without iron deficiency. The soluble transferrin receptor, hematological indices and iron balance were evaluated and the sTfR/logF was calculated for each examined child. It was proved that the mean values of sTfR and sTfR/logF were substantially higher in children with anemia due to iron deficiency, and in those with infectious anemia and iron deficiency,vs. those with infectious anemia or in healthy children. This suggests that both sTfR and the sTfR/logF are good indicators of iron deficiency and could be useful in the differential diagnostics of anemia, especially in young children.

Phase 3 Trial of Pixantrone Dimaleate Compared with Other Agents as Third-Line, Single-Agent Treatment of Relapsed Aggressive Non-Hodgkin Lymphoma (EXTEND): End of Study Results.

AbstractAbstract 2833 Introduction:No therapy with reliable, durable efficacy exists for patients with aggressive non-Hodgkin lymphoma (aNHL) who relapse following at least two lines of therapy. Pixantrone dimaleate (PIX) is a novel aza-anthracenedione, structurally similar to anthracyclines and mitoxantrone, and forms stable DNA adducts. Unlike anthracyclines and mitoxantrone, PIX does not bind iron, minimally promotes reactive oxygen species formation, and is substantially less cardiotoxic in preclinical models. On the basis of promising early clinical activity and acceptable safety, we conducted a phase 3 trial with PIX in patients with aNHL and ≥2 relapses. Patients and Methods:This randomized, multicenter, controlled, open-label study enrolled patients with aNHL (de novo or transformed) with ≥1 prior anthracycline-containing regimen and ≥2 relapses. Patients were randomized to PIX 85 mg/m2 on days 1, 8, and 15 of a 28-day cycle, for up to 6 cycles, or to investigator's choice of single-agent comparator (COMP): vinorelbine, oxaliplatin, ifosfamide, etoposide, mitoxantrone, or, in the US only, gemcitabine or rituximab. Both groups were followed for 18 months after last treatment. The primary endpoint, CR/CRu rate in ITT population, was assessed by an independent assessment panel. Other efficacy endpoints were overall response rate (ORR), duration of response, progression-free survival (PFS), and overall survival (OS). Final end-of-study results are reported here. Results:Planned enrollment was set at 320 patients; however, due to slow accrual, a total of 140 patients were randomized (n=70 per group) to this study. Median number of treatment cycles for PIX group was 4 vs 3 for COMP. Median duration of treatment for patients in the PIX group was about one month longer than in the COMP group (3.8 vs 2.6 months). The end-of-study CR/CRu rate was 24% (16% CR, 8%CRu) for PIX vs 7% (no CRs, 7% CRu only) for COMP (P = 0.009); ORR (CR/CRu/PR) was 40% vs 14% (P = 0.001). After treatment ended, 3 patients in the PIX group achieved CR with no subsequent therapy. Two of the 3 patients converted from SD to CR and 1 from PR to CRu. Median CR/CRu duration was 9.6 months for PIX vs 4.0 months for COMP (P = 0.081). For survival endpoints, there was a 40% improvement in PFS with a median of 5.3 months vs 2.6 months (HR = 0.60, log-rank P = 0.005) and a 21% improvement in OS with a median of 10.2 months for PIX vs 7.6 months for COMP (HR = 0.79, log-rank P = 0.251). Exploratory subgroup analyses of CR/CRu and ORR were consistently higher for PIX patients and suggest stronger efficacy with the subgroups sex (female), <3 prior regimens, no prior rituximab, and ≥1 yr from 1st to 2nd line therapy. During treatment, neutropenia and leukopenia were the most common (≥10%) grade 3/4 adverse events and the incidence of febrile neutropenia was 7.4% for PIX vs 3% for COMP. Percentage of patients with cardiac disorder SAEs was 8.8% for PIX vs 4.5% for COMP. There were 11 grade 1/2 and 2 grade 3 LVEF events for PIX vs 7 grade 1/2 for COMP. Conclusions:In this phase 3 study, patients treated with PIX achieved superior efficacy when compared with other agents, as assessed by CR/CRu rate, ORR, and PFS, and had a positive trend in OS. Pixantrone had a tolerable safety profile in heavily pretreated patients with relapsed aggressive NHL. Disclosures:Pettengell:Cell Therapeutics, Inc: Honoraria. Coiffier:Cell Therapeutics, Inc: Advisory Board. Schiller:Sunesis: Consultancy; Celgene, Genzyme, Millenium, CTI, Antisoma, Novartis: Research Funding. Rizzieri:Cell Therapeutics, Inc: Membership on an entity's Board of Directors or advisory committees. Cernohous:Cell Therapeutics, Inc: Employment. Wang:Cell Therapeutics, Inc: Employment. Singer:Cell Therapeutics, Inc: Employment, Membership on an entity's Board of Directors or advisory committees; DiaKine Therapeutics, Inc: Membership on an entity's Board of Directors or advisory committees.

Pixantrone Dimaleate (PIX) and Comparators In the Treatment of Relapsed Aggressive Non-Hodgkin Lymphoma (aNHL): An Analysis of Response and Survival by Gender and Age

AbstractAbstract 4883 Introduction:Survival after treatment for aNHL is higher in women than men (Leuk Lymph 48:736-745, 2007) and may be worse in elderly patients. We conducted an exploratory demographic subgroup analysis of a phase 3 study that compared PIX, a novel aza-anthracenedione, to single agents in the treatment of patients with multiply relapsed aNHL. Overall, PIX was efficacious on the basis of primary and secondary endpoints. The results from these exploratory analyses suggest that PIX potentially is most efficacious in women and elderly patients even though there are no significant gender- or age-dependent differences in PIX pharmacokinetics. Patients and Methods:This phase 3, randomized, multicenter, controlled, open-label study enrolled patients who had ≥1 prior anthracycline-containing regimen and failed 2 prior treatment regimens for relapsed aNHL (de novo or transformed). Patients (N=140) were randomized to either PIX 85 mg/m2 on days 1, 8, and 15 of a 28-day cycle, for up to 6 cycles, or to investigator's choice of a single-agent comparator (COMP): vinorelbine, oxaliplatin, ifosfamide, etoposide, mitoxantrone, or, in the US only, gemcitabine or rituximab. The primary endpoint was the complete response/complete response unconfirmed (CR/CRu) rate in the intent-to-treat population. Other efficacy endpoints were overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Response was assessed by an independent radiologic panel. Results:A total of 140 patients were randomized (n=70 per group). The results of the analysis of efficacy by gender and age are shown in the table below. There were no important demographic differences between the study groups or between patients in these exploratory analyses. The differences in CR/CRu rate and ORR between the study groups appeared greater in women than in men and also in patients ≥65 years than in younger patients. PFS and OS were significantly better for women in the PIX group than in the COMP group. During the treatment period, neutropenia and leukopenia were the most common (≥10%) grade 3/4 adverse events and were similar by gender and age. Conclusions:In this phase 3 study, an exploratory subgroup analysis suggests that treatment with PIX appears to provide particular benefit in women and elderly patients and was not accompanied by a meaningful increase in toxicities. These results are limited by small sample sizes and would need to be validated with an additional prospective study. [Display omitted] Disclosures:Singer: Cell Therapeutics, Inc: Employment, Membership on an entity's Board of Directors or advisory committees; DiaKine Therapeutics, Inc: Membership on an entity's Board of Directors or advisory committees. Cernohous: Cell Therapeutics, Inc: Employment. Jurida: Cell Therapeutics, Inc: Employment. Wang: Cell Therapeutics, Inc: Employment. Kuepfer: Cell Therapeutics, Inc: Consultancy, Equity Ownership. Pettengell: Cell Therapeutics, Inc: Honoraria.

Hematological and Lipid Profile Changes in Sea-Level Natives after Exposure to 3550-m Altitude for 8 Months

The aim of this epidemiological study was to determinate the effects on hematological and lipid profile in a young group of newcomers to altitude after being exposed chronically for 8 months to 3550 m (n = 50), age 17.8 +/- 0.7; and not overweight, BMI 22.9 +/- 0.5). Readings taken at altitude on day 1 and on month 8 were hematocrit (Hct, %), hemoglobin (Hb, g/dL), Sa(O(2)), total leukocyte and subset count (mm(3), %), and lipid profile (mg/dL). The same measurements were taken in a comparative group (CG) at sea level (SL). At altitude, elevations of Hct (44.6 +/- 0.4; 51.2 +/- 0.4) and Hb (15.5 +/- 0.1; 17.3 +/- 0.1) were seen (p < 0.001) and none with Hb >/= 21 g/dL. No correlation was observed between Hb and Sa(O(2)), r = 0.11, p > 0.05. Total leukocyte count showed no changes (6037 +/- 74; 6002 +/- 43), but a relative neutropenia (55.2 + -1.5; 50.6 + -1.3) and lymphocytosis (34.2 + 1; 42.4 + 1, p < 0.001) between periods were found and also when compared to SL. Also, an inverse relationship between Sa(O(2)) and total leukocytes on month 8 (r = 0.46; r(2) = 0.204), suggesting a probable representation of a hypoxia effect. Total cholesterol (153.8 +/- 4.5; 157.3 +/- 5.1; p, ns) showed no changes, but a mild decrease of LDL-cholesterol (88.4 +/- 3.3; 81.0 +/- 3.9; p < 0.05), and a rise in triglycerides (121.6 +/- 10.9; 178.8 +/- 11.7; p < 0.001) was found. Changes observed in leukocytes subset count and triglycerides could suggest a contributory role of hypoxic conditions, raising some future epidemiological concerns regarding immune system and fatty acid behaviour at altitude.