Incidence Of Peripheral Neuropathy Research Articles

Effect of gradient pressure therapy on the prevention of chemotherapy-induced peripheral neuropathy in patients with breast cancer.

To investigate the effect of gradient pressure therapy on the prevention of chemotherapy-induced peripheral neuropathy (CIPN) and improvement in activities of daily living (ADL) in patients with breast cancer. Eighty female patients with breast cancer treated at Tangshan People's Hospital between October 2022 and July 2023 were selected as research participants and divided into control and intervention, with 40 patients in each group. The control group received routine treatment and care, whereas the intervention group received gradient pressure therapy based on routine treatment and care. Incidence of peripheral neuropathy and the degree of impact on ADL between the two groups were compared after the intervention for cycles 2, 4, and 6. There was no significant difference in the general information between the two groups (P > 0.05). After two intervention cycles, there was no significant difference in the incidence of CIPN, various dimensions of Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT), and total scores between the two groups (P > 0.05). After four intervention cycles, the two groups had a statistically significant difference in the incidence of CIPN, sensory dimension, general activity dimension, and total CIPNAT score (P < 0.05). After six intervention cycles, there was a significant difference in the incidence of CIPN, sensory dimension, fine activity dimension, general activity dimension, and total CIPNAT score between the two groups (P < 0.05), while there was no significant difference in the other dimensions (P > 0.05). Gradient pressure therapy can effectively prevent or alleviate peripheral neuropathy in patients with breast cancer undergoing chemotherapy and improve their ability to perform ADL. Thus, it is safe, effective, and worthy of clinical application. RMYY-LLKS-2022-054.

Association Between First-time Neurologic Events and Metronidazole Treatment: A Case-time Control Study

PurposeMetronidazole, a widely used antimicrobial medication, has been linked to neurologic adverse drug reactions. This study investigates the association between metronidazole use and first-time neurologic events. MethodsWe conducted a case-time-control study using data from the Danish National Patient Register and the National Prescription Register in years 2013 to 2021. Patients with a first-time diagnosis of encephalopathy, cerebellar dysfunction, or peripheral neuropathy were included. Conditional logistic regression analyses were performed to estimate the risk of neurologic events associated with metronidazole use. FindingsOut of 476,066 first-time metronidazole prescriptions, the 100-day cumulative incidence of peripheral neuropathy was 0.016%, and 0.002% for cerebellar dysfunction or encephalopathy. In the case-time control study, we identified 17,667 persons with a first-time neurologic event and were included for the analysis. The estimated odds ratio for the combined neurologic events was 0.98 (95% CI, 0.59–1.64, P = 0.95) with no statistically significant association across different subgroups and time windows. ImplicationsOur findings suggest that metronidazole-induced neurologic events may be rarer than previously described, and we did not find any consistent or statistically significant association between metronidazole exposure. Nonetheless, clinicians should remain vigilant to potential neurologic risks in patients receiving metronidazole, to ensure its safe and effective use.

A retrospective analysis of the efficacy and safety of capecitabine plus oxaliplatin (CapeOX) and docetaxel plus S-1 (DS) as adjuvant chemotherapy for pathological stage III (p stage III) gastric cancer (GC).

342 Background: Adjuvant chemotherapy following surgical resection is the standard treatment for patients with p stage III GC in Japan. Although CapeOX and DS are available for adjuvant chemotherapy for stage III GC, there is limited data on which treatment is more effective. We aim to compare the efficacy and safety of CapeOX and DS as adjuvant chemotherapy in patients with p stage III GC. Methods: We extracted data of patients with p stage III GC who received either CapeOX (capecitabine on days 1–14 plus oxaliplatin on day1 for 8 cycles [q 3week]) or DS (S-1 on days 1–14 at 1st cycle [q 3 week], docetaxel on day 1 plus S-1 on days 1–14 during 2–7 cycles [q 3 week], and S-1 on days 1–28 up to 1 year [q 6 week]) as adjuvant chemotherapy after surgical resection at our institution from February 2016 to May 2022. Three-year relapse-free survival (RFS) and adverse events (AEs) were assessed. Cox proportional hazard model was used in multivariable analysis to assess the effect of independent variables on RFS. Results: A total of 74 patients were included in this study (CapeOX 31/ DS 43). Patient characteristics (CapeOX/DS) were as follows: median age, 60/64 years; male, 77/65 %; ECOG-PS 0/1, 45%/44%, 55%/56 %; p stage IIIA/IIIB/IIIC, 10%/30%, 48%/51 %, 42%/19 %. The 3-year RFS was 37% in the (hazard ratio [HR] = 0.81, P=0.48). For p stage IIIA, IIIB, and IIIC, the 3-year RFS in the CapeOX group and the DS group was 67% vs. 75% (HR = 0.56, P =0.52), 43% vs. 42% (HR = 1.11, P =0.81), and 23% vs. 0% (HR = 1.59, P =0.39), respectively. Multivariable analysis adjusted for p stage showed no significant differences in RFS between the CapeOX group and the DS group (HR=1.06, P=0.85). Compared to DS, CapeOX was associated with lower incidences of febrile neutropenia (0% vs 7%) and alopecia (6% vs 74%), and a higher incidence of peripheral neuropathy (80% vs 23%). Conclusions: This analysis indicates that CapeOX and DS have comparable efficacy as adjuvant chemotherapy for p stage III GC in terms of RFS, albeit with different profiles of AEs.

Correlation of nerve damage and peripheral neuropathy incidence using the MNSI and MDNS instrument approaches

The World Health Organization (WHO) reported that by 2030, diabetes mellitus would become the 7th leading cause of death. Diabetes mellitus is a chronic disease that causes various complications, one of which is peripheral neuropathy. Preventive efforts for peripheral neuropathy involve conducting detection examinations. The purpose of this study was to analyze nerve damage in peripheral neuropathy cases using the MNSI (Michigan Neuropathy Screening Instrument) and MDNS (Michigan Diabetic Neuropathy Score) instruments. The study employed a cross-sectional study approach with a sample of 50 people, using total sampling as the sampling technique. The independent variable in this study was nerve damage, and the dependent variable was peripheral neuropathy. Data collection in the study was carried out using the MNSI and MDNS instruments to link the dependent and independent variables. Hypothesis analysis in this study was conducted using the Spearman's rho correlation test. The study found that autonomic, sensory, and motor damage correlated with peripheral neuropathy, with a P-value of &lt; 0.05. Examinations in the feet of diabetics were significantly related to the level of peripheral neuropathy. However, there was no evidence of a correlation between the characteristics of the respondents and the incidence of peripheral neuropathy. The results of the nerve damage examination demonstrated a correlation between different types of damage, and the MNSI and MDNS instruments proved effective in detecting peripheral neuropathy damage. Future research should focus on more in-depth studies to explore the correlation of nerve damage in patients with diabetes mellitus detected at a young age and consider other variables, such as HbA1c levels, as potential risk factors for peripheral neuropathy.

Prevalence and incidence of peripheral neuropathy, peripheral artery disease, foot disease, and lower extremity amputation in people with diabetes in Ireland; a systematic review protocol.

Introduction Internationally, the prevalence of diabetes is increasing, and with this comes an increase in diabetes related complications. Diabetic foot disease is the most common lower extremity complication in people with diabetes, and is associated with major morbidity, mortality, and costs to health services. Despite this burden, the incidence and prevalence of diabetic foot disease is unknown in Ireland. This paper presents a protocol for a systematic review to examine the incidence and prevalence of diabetic foot disease in the Irish population. Methods A systematic review will be performed using the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. Pubmed, EMBASE, and Lenus, the Irish Health Research repository, will be searched for publications in any language and without restrictions to date. Title, abstract, and full text screening will be carried out independently by two investigators. Publications reporting on the incidence or prevalence of peripheral neuropathy, peripheral artery disease, ulceration, or amputation in people with diabetes in Ireland, from a defined geographical catchment area of Ireland, will be included. Joanna Briggs Institute (JBI) Critical Appraisal tool will be used to assess included studies methodological quality. Results will be reported in line with the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. Conclusion The results of this systematic review can be used to inform appropriate stakeholders on the incidence and prevalence of diabetic foot disease in Irish populations, enabling decision making around appropriate use of resources to help prevent, and improve management of this disease. Systematic review registration CRD42023472904

Preliminary Insights into JWH182: a Synthetic Cannabinoid’s Neuroprotective Role Against Paclitaxel-Induced Neuronal Toxicity

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN), a frequently encountered consequence of neurotoxic chemotherapy, affects approximately 30 to 40% of patients. Taxanes are associated with an exceptionally high incidence of peripheral neuropathy, with Paclitaxel (PTX) accounting for approximately 70,8% of CIPN cases. Patient’s symptoms are severe, compelling oncologists to consider dosage reduction or even complete abandonment of the treatment plan. Several recent studies have shown the potential efficacy of either synthetic, endogenous or phytocannabinoids in alleviating CIPN symptoms. In case of in vitro studies, neural protection can be assessed by measuring the axon length of the cultured neurons. Therefore, our study aimed to investigate whether the synthetic cannabinoid JWH182 could emerge as a promising new candidate for managing Paclitaxel-induced peripheral neuropathy, in case of an in vitro neural model. METHODS: Primary neuronal cultures were obtained from mouse-derived dorsal root ganglia (DRG) explants. The harvested ganglia were subjected to a series of enzymatic and mechanical dissociating processes, followed by a density-gradient centrifugation to isolate neurons, which were then seeded in Poly-D-Lysine coated 6-well plates and incubated for 24h. Thereafter, cells were exposed to an equal parts solution of 20 uM JWH182 and 1uM PTX. As a means of comparison, the neurons from the positive control group were exclusively exposed to a 1uM PTX solution, whereas the negative control group was left untreated. Photographs of the neurons were taken before the treatment and subsequently at 6, 24, 48 and 72 hours, with a particular focus on observing changes in axon length and cell viability. RESULTS: Unlike our positive control group, which displayed noticeable adverse effects on axon length, the sample treated with both PTX and JWH182 presented more promising outcomes. To be precise, there was a less important reduction in axon length at all time points following drug administration. In the meantime, the negative control exhibited no changes, maintaining a typical morphology and rate of axonal growth. CONCLUSION: These findings suggest that the synthetic cannabinoid JWH182 confers a protective effect on DRG neurons treated with Paclitaxel. As a result, this compound holds the potential to emerge as a novel treatment option for managing Paclitaxel-induced peripheral neuropathy. This could lead to the alleviation of symptoms in oncological patients, thereby enhancing their quality of life and their overall disease prognosis. Ultimately, these initial results lay the foundation for subsequent in vitro and in vivo experiments, aimed at validating our hypothesis.

Effect of Aerobic Exercise with and without Strengthening Exercises on Neuropathic Symptoms in People with Diabetic Peripheral Neuropathy

Background: The incidence of peripheral neuropathy among chronic diabetic patients is escalating, with a notable rise observed in Pakistan. This trend has been partly attributed to the predominant reliance on pharmacotherapy, while the role of physical exercise in management remains underutilized. Aerobic exercise is widely recommended in clinical guidelines for the treatment and prevention of diabetic complications, and it is hypothesized that the addition of strength training could yield even more benefits. Objective: This study aimed to evaluate the effects of combined aerobic and strength training exercises on neuropathic symptoms in patients with diabetic peripheral neuropathy. Methods: In this randomized clinical trial, 40 patients with diabetic peripheral neuropathy were equally divided into two groups: Group A underwent a combined regimen of aerobic and strength training exercises, whereas Group B engaged in aerobic exercises alone. The effectiveness of these interventions was assessed using the Michigan Neuropathy Screening Instrument (MNSI), Numeric Pain Rating Scale (NPRS), and Clinical Global Impression of Change (CGIC). Data were analyzed using SPSS version 20.0, employing independent t-tests, repeated measures ANOVA, and descriptive statistics for in-depth analysis. Results: Group A demonstrated a significant reduction in MNSI scores with a mean difference of 1.700 and a p-value &lt; 0.001, indicating a substantial improvement in neuropathic symptoms compared to Group B. While both groups showed significant improvements in NPRS and CGIC scores, the differences were not statistically significant, with p-values of 0.599 and 0.330, respectively, and mean differences of 0.1500 and 0.2500 for NPRS and CGIC. The overall statistical analysis revealed a high significance level (p &lt; 0.001) within both groups in all measured outcomes, suggesting considerable improvements post-intervention. Conclusion: The addition of strength training to aerobic exercises significantly enhances the reduction of neuropathic symptoms in diabetic patients. However, for pain relief and overall clinical improvement, both treatment approaches—combined aerobic and strength training or aerobic exercise alone—were equally effective.

Brentuximab Vedotin in the Treatment of Cutaneuous T Cell Lymphomas: A Multicenter, Retrospective, Case-Control Study from Italy

Brentuximab Vedotin (BV) is an anti-CD30 monoclonal antibody approved for relapsed/refractory CD30+ cutaneous T-cell lymphomas. The posology recommends its use until disease progression, unbearable toxicity, or completion of 16 cycles. A common side effect of BV is peripheral neuropathy (PN), which may lead to chronic complications and often leads to early treatment interruption. To reduce long-term side effects, clinicians often choose to interrupt BV early when the patient shows an adequate response. However, it remains uncertain whether this approach effectively reduces the incidence of PN. Furthermore, it is unknown whether this reduction in cumulative dose negatively impacts the relapse-free interval (RFI) or the time to next treatment (TTNT). This study aims to investigate whether a reduced BV treatment schedule is beneficial in terms of severe side effects compared to the standard schedule and to compare RFI and TTNT between the two schedules. The study was conducted retrospectively as a multicenter, observational case-control study. Clinical and pathological data from 71 patients (44 males, median age 66 yeas) were analyzed. Various CTCLs subtypes were represented in the study population (43 had MF, 7 had folliculotropic MF, 10 had pc ALCL, 3 had PTCL-NOS, and 8 had SS). The median follow-up duration was 525 days. Of the patients, 11 (15.4%) completed 16 cycles of BV, 21 (29.6%) stopped treatment due to disease progression (PD), 12(16.9%) experienced severe adverse events, 20 (28.1%) stopped treatment due to an adequate response based on the clinician's decision, the remaining patients were still under treatment at the time of data cut-off. Out of the 71 patients, 20 developed PN, with 6 of them experiencing severe (G3) symptoms. At the last follow-up, 7 (35%) cases of PN had resolved, 8 were mild (G1), and 5 remained moderate (G2). No differences were observed in PN incidence or the number of infusions between patients who achieved an adequate clinical response and those who developed PN. No significant differences were observed in the median number of BV infusions between the groups. Age at the time of the first infusion was the only variable associated with an increased risk of toxicity. However, no significant correlation was found between any variable and the incidence of PN. The median RFI for patients receiving all 16 cycles was 882 days (95% CI 461, NA), compared to 357 days (95%CI 313, NA) for those who stopped BV after an adequate response, but this difference was not statistically significant (Pv=0.25). Similarly, the median TTNT in patients receiving all 16 cycles was 814 days (lower 95% CI = 458, upper NA), compared to 502 days in patients who stopped BV after achieving an adequate response (324, NA; pV=0.6). In conclusion, based on the data analyzed, early interruption of BV after achieving an adequate response did not significantly reduce the incidence of severe adverse events or PN. Further data are required to determine if early interruption of BV negatively impacts patients' RFI or TTNT.

Efficacy and Safety of Daratumumab, Pomalidomide, and Dexamethasone (DPd) Compared to Daratumumab, Bortezomib, and Dexamethasone (DVd) in Daratumumab-Naïve Relapsed Multiple Myeloma.

Daratumumab-based combinations with pomalidomide/dexamethasone (DPd), or bortezomib/dexamethasone (DVd), have shown activity in relapsed/refractory multiple myeloma (RRMM) patients. However, no direct comparisons of safety or efficacy of the two regimens have been published to date. We conducted a retrospective study to compare the safety and efficacy of DPd and DVd in daratumumab-naïve RRMM patients. We included 140 daratumumab-naïve patients who had received DPd or DVd for RRMM. Overall, the DPd group had a greater number of patients who had high-risk disease characteristics. Although response was deeper in the DPd group, the median progression-free survival (PFS) and overall survival (OS) were similar between the two groups. The DPd group exhibited a higher incidence of hematologic toxicities, whereas the DVd group had a higher incidence of peripheral neuropathy. The study results showed that while DPd may provide a deeper response, there was no significant difference in PFS or OS compared to DVd. For the high proportion of difficult-to-treat patients, duration of treatment may have contributed to these results, indicating that patient and disease characteristics should be considered when selecting salvage treatments.

Nonlinear relationship between dietary calcium and magnesium intake and peripheral neuropathy in the general population of the United States.

Calcium and magnesium are essential minerals that have significant roles in nerve function and regulation. There may be a correlation between dietary calcium and magnesium intake and peripheral neuropathy. However, this relationship remains unclear and requires further study. Data from 7,726 participants in the National Health and Nutrition Examination Survey (NHANES) from 1999 to 2004 were analyzed in this study. The relationship between total dietary calcium and magnesium intake, as well as each quantile, and peripheral neuropathy was analyzed using a multifactor logistic regression model. To illustrate the dose-response relationship between calcium and magnesium intake and peripheral neuropathy, we utilized a restricted cubic spline (RCS) plot. Our analysis found a positive correlation between dietary intake of calcium and magnesium and peripheral neuropathy (calcium: OR 1.000, 95% CI 1.000-1.000; magnesium: OR 1.001, 95% CI 1.00-1.002). Participants in the first and third quantiles of dietary calcium intake had a significantly higher incidence of peripheral neuropathy than those in the second quantile (OR 1.333, 95% CI 1.034-1.719, OR 1.497, 95% CI 1.155-1.941). Those in the first and third quantiles of dietary magnesium intake also had a significantly higher incidence of peripheral neuropathy than those in the second quantile (OR 1.275, 95% CI 1.064-1.528, OR 1.525, 95% CI 1.231-1.890). The restricted cubic spline analysis revealed a U-shaped nonlinear relationship between dietary intake of calcium and magnesium and peripheral neuropathy. The study found a U-shaped non-linear relationship between dietary calcium and magnesium intake levels and peripheral neuropathy, indicating that both excessive and insufficient intake of calcium and magnesium can increase the incidence of peripheral neuropathy.

Real-world data on induction therapy in patients with transplant-ineligible newly diagnosed multiple myeloma: retrospective analysis of 598 cases from Kansai Myeloma Forum.

To investigate the real-world clinical outcomes and management of novel drug-containing therapies for newly diagnosed multiple myeloma (MM) patients, we retrospectively analyzed data on the first-line treatment for newly diagnosed transplant-ineligible MM patients from Kansai Myeloma Forum, a registry network in Japan. A total of 598 patients treated with novel drugs between March 2007 and February 2018 were analyzed. Regimens used were VD (n = 305), Rd (n = 103), VMP (n = 97), VCD (n = 71), and VRd (n = 22). Younger patients tended to receive VRd or VCD, whereas the regimen with the highest median patient age was Rd. More than three-quarters of patients in the Rd group received a reduced dose of lenalidomide. The Rd and VRd groups had a relatively high incidence of infection and skin complications, and the VMP group had the highest incidence of peripheral neuropathy. Overall response rate did not differ significantly between regimens. Multivariate analysis in all patients revealed several poor prognostic factors, such as poor performance status. Novel drug-containing regimens for newly diagnosed MM showed a durable response with manageable AEs in the real-world setting.

Brentuximab vedotin plus AVD for Hodgkin lymphoma: incidence and management of peripheral neuropathy in a multisite cohort

AbstractBrentuximab vedotin (BV) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) is increasingly used for frontline treatment of stage III/IV classical Hodgkin lymphoma (cHL). Peripheral neuropathy (PN) was the most common and treatment-limiting side effect seen in clinical trials but has not been studied in a nontrial setting, in which clinicians may have different strategies for managing it. We conducted a multisite retrospective study to characterize PN in patients who received BV + AVD for newly diagnosed cHL. One hundred fifty-three patients from 10 US institutions were eligible. Thirty-four patients (22%) had at least 1 ineligibility criteria for ECHELON-1, including stage, performance status, and comorbidities. PN was reported by 80% of patients during treatment; 39% experienced grade (G) 1, 31% G2, and 10% G3. In total, BV was modified in 44% of patients because of PN leading to BV discontinuation in 23%, dose reduction in 17%, and temporary hold in 4%. With a median follow-up of 24 months, PN resolution was documented in 36% and improvement in 33% at the last follow-up. Two-year progression-free survival (PFS) for the advanced-stage patients was 82.7% (95% confidence interval [CI], 0.76-0.90) and overall survival was 97.4% (95% CI, 0.94-1.00). Patients who discontinued BV because of PN did not have inferior PFS. In the nontrial setting, BV + AVD was associated with a high incidence of PN. In our cohort, which includes patients who would not have been eligible for the pivotal ECHELON-1 trial, BV discontinuation rates were higher than previously reported, but 2-year outcomes remain comparable.

Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE) in Locally Advanced or Metastatic Breast Cancer: Prospective Cohort Study.

Eribulin, a halichondrin-class microtubule dynamics inhibitor, is a preferred treatment option for patients with advanced breast cancer who have been pretreated with an anthracycline and a taxane. Peripheral neuropathy (PN) is a common side effect of chemotherapies for breast cancer and other tumors. The Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE) noninterventional postauthorization safety study assessed the incidence and severity of PN in patients with breast cancer treated with eribulin. IRENE is an ongoing observational, single-arm, prospective, multicenter, cohort study. Adult patients (≥18 years of age) with locally advanced or metastatic breast cancer and disease progression after 1-2 prior chemotherapeutic regimen(s) for advanced disease were treated with eribulin. Patients with eribulin-induced PN (new-onset PN or worsening of preexisting PN) were monitored until death or resolution of PN. Primary endpoints included the incidence, severity, and time to resolution of eribulin-induced PN. Secondary endpoints included time to disease progression and safety. In this interim analysis (data cutoff date: July 1, 2019), 67 (32.4%) patients experienced any grade eribulin-induced PN, and 12 (5.8%) patients experienced grade ≥3 eribulin-induced PN. Median time to resolution of eribulin-induced PN was not reached. Median time to disease progression was 4.6 months (95% CI, 4.0-6.5). Treatment-emergent adverse events (TEAEs) occurred in 195 (93.8%) patients and serious TEAEs occurred in 107 (51.4%) patients. The rates of any grade and grade ≥3 eribulin-induced PN observed in this real-world study were consistent with those observed in phase III randomized clinical trials. No new safety findings were observed.

Safety outcomes of rapid- versus standard-infusion rate oxaliplatin.

The National Comprehensive Cancer Network guidelines state that the oxaliplatin dose of 85 mg/m2 used in various gastrointestinal cancer regimens may be infused over a rapid rate of 85 min instead of the standard time of 120 min. We evaluated the safety outcomes of rapid administration of oxaliplatin compared to standard infusion. We performed a retrospective, cohort study by chart review. Adult patients who received oxaliplatin as part of a FOLFOX, FOLFOXIRI, or FOLRINOX chemotherapy regimen from January 1, 2018, through June 30, 2021, were included. Primary outcomes were the incidence of hypersensitivity reaction (HSR) and treatment modification of oxaliplatin due to adverse drug events. Secondary outcomes included peripheral neuropathy (PN), myelosuppressive signs, and oxaliplatin-related emergency department visit and/or hospital admission. A total of 178 patients were included (90 and 88 in the rapid-rate and standard-rate groups, respectively). Rapid-rate oxaliplatin was not associated with increased HSR or difference in toxicity requiring dose reduction, delayed dose, or slowed infusion rate, but was associated with increased rate of permanent discontinuation of oxaliplatin, 7.8% and 1.1% in the rapid-rate group and standard-rate groups, respectively (p = 0.032). Peripheral neuropathy occurred in 72.2% and 42% of patients in the rapid-rate group and standard-rate groups, respectively (relative risk for PN, 2.09; 95%, CI: 1.43-3.04; p < .001). There were no differences in any other adverse drug event measured. Rapid-rate oxaliplatin was associated with minimal treatment modifications; however, there was an increase in PN incidence. A faster rate of oxaliplatin administration may not be worth the increased risk of PN.

Brentuximab vedotin + AVD for newly diagnosed classic Hodgkin lymphoma (cHL): Incidence and management of peripheral neuropathy in a multi-institution cohort.

7542 Background: Brentuximab vedotin (BV) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) is the new standard of care for newly diagnosed stage III/IV cHL. In the pivotal ECHELON-1 trial, peripheral neuropathy (PN) was the most common toxicity, seen in 67% of patients (pts) and leading to discontinuation of BV in 6.6%. However, PN from BV+AVD in cHL has not been studied in a non-trial setting, where clinicians may have different strategies for managing it. Methods: We conducted a multi-site, retrospective study to characterize PN in pts who were planned to receive 6 cycles of BV+AVD for newly diagnosed cHL before 9/2022. Data was obtained from medical records and PN was graded retrospectively using CTCAE v5.0 criteria. Multivariable logistic regression was used to assess factors associated with PN. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan Meier method. A Cox proportional hazards model was used to test the effect of discontinuation on PFS. Results: 153 pts from 10 US institutions were eligible. Median age was 35 years (range 18-76) with 22% of pts over 60 years old. Thirty-four pts (22%) had at least 1 ineligibility criteria for ECHELON-1, including stage (8% stage I/II), performance status (3% ECOG 3+), preexisting PN (6%), or other comorbidities including HIV and other malignancies (10%). Of advanced stage pts, 41% had IPS 4-7. Median no. BV+AVD cycles was 6 (range 1-6). PN was reported by 80% of pts during treatment; 39% experienced grade (G) 1, 31% G2, and 10% G3. In total, BV was modified in 44% of pts due to PN leading to BV discontinuation in 23% with median no. of doses omitted of 4 (range 1-10), dose reduction in 17% and temporary dose hold in 4%. Vinblastine was modified in 17% of pts due to PN including discontinuation or temporary hold in 10% and dose-reduction in 7%; in 35% of pts with vinblastine modification, BV was continued. None of the factors assessed (age, sex, baseline PN, diabetes mellitus) predicted development of any grade PN. However, higher initial dose of BV in mg (based on weight) was associated with increased risk of grade 2+ PN (OR 1.03, 95% CI 1.01-1.05, p = 0.002). With median follow up of 24 months (range 0.33-87), PN resolution was documented in 36% and improvement in 33% at last follow up. Ongoing G2+ PN was present in 13% of pts at last follow up. 2-year PFS for the advanced stage patients was 82.7% (95% CI 0.76-0.90) and OS was 97.4% (95% CI 0.944-1). Discontinuation of BV due to neuropathy did not affect PFS (HR 1.1, 95% CI 0.45-2.5). Conclusions: In the non-trial setting, BV+AVD was associated with a high incidence of PN. In our cohort, which includes pts who would not have been eligible for the pivotal ECHELON-1 trial, BV discontinuation rates were higher than previously reported, but 2-year outcomes remain comparable; discontinuation of BV was not associated with inferior PFS.

Assessment of the risk factors determining the prognosis of major and minor limb amputations in patients with diabetic foot ulcers.

Diabetes mellitus (DM) is a major global health problem, and its incidence is growing. Depending on this increase, the number of diabetes-related complications will also rise. This study aimed to determine the risk factors associated with major and minor amputations resulting from diabetes. Patients diagnosed with diabetic foot complications (n = 371) and hospitalized between January 2019 and March 2020 were retrospectively evaluated using information obtained from the database of Diabetic Foot Wound Clinic. Examination of the data identified 165 patients for inclusion in the study, who were stratified into major amputation (group 1, n = 32), minor amputation (group 2, n = 66) and non-amputation (group 3, n = 67) groups. Of the 32 patients who underwent major amputations, 84% had a below-knee amputation, 13% had an above-knee amputation and 3% had knee disarticulation. At the same time, 73% of 66 patients who underwent minor amputation had a single-finger amputation, 17% had a multiple-finger amputation, 8% had a transmetatarsal amputation, and 2% had Lisfranc amputation. Laboratory results showed high acute phase protein and low albumin (ALB) levels in patients from group 1 (p < 0.05). Although Staphylococcus aureus was found to be the most common infectious agent, Gram-negative pathogens were dominant (p < 0.05). Also, there was a significant cost difference between the groups (p < 0.05). Furthermore, those aged over 65 had a high Wagner score, high Charlson Comorbidity Index (CCI), long diabetic foot ulcer (DFU) duration, and high white blood cell (WBC) count, all of which were risk factors for major amputation (p < 0.05). This study demonstrated an increased Wagner staging and incidence of peripheral neuropathy (PN) and peripheral arterial disease (PAD) in major amputation patients. In addition, the rate of distal vessel involvement was high in major amputation patients, with elevated acute phase proteins and low ALB levels crucial in laboratory findings.

Real-world effectiveness and safety of multiple myeloma treatments based on thalidomide and bortezomib: A retrospective cohort study from 2009 to 2020 in a Brazilian metropolis

BackgroundMultiple myeloma (MM) is an incurable cancer of plasma cells; the survival of which has improved over the years with the emergence of new treatments. In Brazil, the availability of treatment-regimens is different from developed countries. Real-world evidence with Brazilian patients is lacking. ObjectivesOur aim was to evaluate the effectiveness and the safety of MM treatments in a Brazilian metropolis. MethodsThis was a retrospective cohort study with MM patients, beginning MM treatment from 2009 to 2020 (i.e., before bortezomib became available in public health services). Patients’ medical records were revised to obtain clinical variables. The primary outcomes were Overall Survival (OS) and Progression Free Survival (PFS, measured as time to next treatment), and the secondary outcomes were Adverse Events (AE). Kaplan-Meier curves were obtained and the Cox proportional hazards model was performed for univariate and multivariate analyses. The incidence of AE was estimated and the chi-squared test was performed to evaluate the association between AE and MM regimens. ResultsIn total, 278 patients participated in the study with median age of 64 years; 50.4 % were females, 55.8 % attended a private clinic, 34.9 % received autologous stem cell transplantation (ASCT) and 32.4 % were on polypharmacy. Most patients from public services used thalidomide-based regimens (40.3 %) and at private clinics used bortezomib-based regimens (38.1 %) as first-line treatment. Patients had a median OS of 99 months. Patients had median PFS of 28 months in first-line treatment, which was significantly different for age (p = 0.0055), polypharmacy (p = 0.0094) and ASCT (p < 0.0001). PFS was independently associated to polypharmacy and ASCT. The incidence of peripheral neuropathy (39.6 %) was high. In contrast, the incidence of severe AE was low. We found significant difference between first-line T + B-based regimens and leukopenia (p = 0.012). ConclusionOur study showed that patients on polypharmacy and who did not receive ASCT had worse PFS. Similar to other Latin countries, most patients used thalidomide- and bortezomib-based regimens as first-line treatments having similar OS and PFS. Treatments were considered relatively safe, especially regarding serious AE.

Evaluation of Peripheral Arterial Disease in Patients Presenting with Diabetic Foot Ulcer to Endocrine Clinic

Background and Aim: Diabetes mellitus is an increase in blood glucose levels results in altered fat, protein metabolism, and carbohydrate which leads to cardiac, eye, nervous system dysfunction, and kidney. The major cause of hospitalizations in patients with diabetes mellitus (DM) is diabetic foot ulcers (DFU). The purpose of the present study was to evaluate the peripheral arterial disease in diabetic foot ulcer patients presented to endocrine clinic. Patients and Methods: This descriptive cross-sectional study was carried out on 206 diabetic foot ulcers patients presented to the endocrine clinic in Peshawar from January 2021 to December 2022. Patients were enrolled after taking written informed consent from each individual. Patient’s details such as gender, age, peripheral artery disease (PAD), diabetes types, heart failure, wound size, diabetes duration, end-stage renal disease, DFU history, prior history of amputation, and peripheral neuropathy were recorded. Angiography and revascularization may be required if arterial Doppler ultrasound confirmed PAD. Additionally, wound debridement and topical dressings were applied. In the treatment of wound ischemia, pentoxifylline, and calcium blockers were recommended along with diabetes control procedures and appropriate antibiotics. SPSS version 27 was used for data analysis. Results: Of the total 206 DFU patients, there were 142 (68.9%) male and 64 (31.1%) females. The prevalence of peripheral artery disease (PAD) was 58.3% (n=120). Age-wise distribution of patients were as follows: 31 (15%) in 25-45 years, 107 (52%) in 46-65 years, 60 (29.1%) in 66-85 years, and 8 (3.9%) &gt;85 years. Out of 206 DFU patients, the prevalence of type-I diabetes mellitus and type-II diabetes mellitus was 8 (3.9%) and 198 (96.1%) respectively. PAD prevalence was significantly associated with Type 2 diabetes. The incidence of PAD in plantar foot, non-plantar foot, and heel was 66 (55%), 42 (35%), and 12 (10%) respectively among 120 cases. Out of 206 DFU cases, the incidence of peripheral neuropathy, DFU history, amputation history, heart failure, and chronic renal failure was 142 (68.9%), 104 (50.5%), 54 (26.2%), 46 (22.3%), and 42 (20.4%) respectively. Conclusion: The present study concluded that the prevalence of peripheral artery disease (PAD) was 58.3% among diabetic foot ulcers. Results indicate that DFU and PAD are significantly related. It has been found that male patients with DFU were more likely to suffer from PAD as compared to women with statistically insignificant association. Keywords: Peripheral artery disease, diabetic foot ulcers, type-II diabetes mellitus

Somatosensory evoked potentials in spinocerebellar ataxias type 3 and 10: Preliminary data (P8-11.012)

<h3>Objective:</h3> To report the electrophysiological findings presented in somatosensory evoked potentials in a cohort of patients with spinocerebellar ataxias type 3 and 10, comparing them. <h3>Background:</h3> Although spinocerebellar ataxias (SCA) are heterogeneous diseases, the Brazilian patients with SCA 10 tend to have a low incidence of peripheral neuropathy. Electrophysiological testing might uncover subclinical abnormalities, and somatosensory evoked potentials (SSEPs) can provide further insights by evaluating the dorsal column-medial lemniscus pathway. <h3>Design/Methods:</h3> This is a cross-sectional study evaluating the somatosensory evoked potentials in a cohort of patients with SCA 3 (n = 15) and SCA 10 (n = 8). The patients underwent a clinical evaluation in which demographic and clinical data, such as sex, age, duration of disease, and SARA scores, were registered. After the clinical evaluation, all patients were submitted to somatosensory evoked potentials following the American College of Neurophysiology guidelines. We evaluated amplitudes, latencies, and interpeak latencies for the N9, N20, N21, and P40 potentials. <h3>Results:</h3> The groups did not differ regarding demographic and clinical data. In the cohort of patients with SCA 3, 86% of the sample (n = 13) presented SSEP abnormalities, while only 12.5% (n = 1) of the SCA 10 sample presented abnormalities, and this difference was statistically significant (<i>p</i> = 0.001). Correlations of SSEP abnormalities to SARA scores (SCA 3: Rho = 0.11, <i>p</i> = 0.6866; SCA 10: Rho = − 0.41, <i>p</i> = 0.31) and duration of disease (SCA 3: Rho = − 0.13, <i>p</i> = 0.626; SCA 10: Rho = − 0.58, <i>p</i> = 0.136) did not present statistical significance. <h3>Conclusions:</h3> Our preliminary data indicate that the Brazilian patients with SCA 10 present a low incidence of SSEP abnormalities, suggesting that the dorsal column-medial lemniscus pathway. Our findings are following most of the descriptions of clinical phenotypes for Brazilian patients with SCA 10. <b>Disclosure:</b> Dr. Coutinho has nothing to disclose. Dr. Hernandez Fustes has nothing to disclose. Miss Nunes has nothing to disclose. Patricia Bonilha has nothing to disclose. Miss Cassarotti has nothing to disclose. Dr. Bayer has nothing to disclose. Dr. Filpo has nothing to disclose. Dr. Cassou has nothing to disclose. Dr. Teive has nothing to disclose.

Lower Extremity Nerve Conduction Abnormalities in Vietnamese Patients with Type 2 Diabetes: A Cross-Sectional Study on Peripheral Neuropathy and Its Correlation with Glycemic Control and Renal Function.

Peripheral neuropathy is a common complication of type 2 diabetes mellitus (T2DM) that results in nerve conduction abnormalities. This study aimed to investigate the parameters of nerve conduction in lower extremities among T2DM patients in Vietnam. A cross-sectional study was conducted on 61 T2DM patients aged 18 years and older, diagnosed according to the American Diabetes Association's criteria. Data on demographic characteristics, duration of diabetes, hypertension, dyslipidemia, neuropathy symptoms, and biochemical parameters were collected. Nerve conduction parameters were measured in the tibial and peroneal nerves, including peripheral motor potential time, response amplitude M, and motor conduction speed, as well as sensory conduction in the shallow nerve. The study found a high rate of peripheral neuropathy among T2DM patients in Vietnam, with decreased conduction rate, motor response amplitude, and nerve sensation. The incidence of nerve damage was highest in the right peroneal nerve and left peroneal nerve (86.7% for both), followed by the right tibial nerve and left tibial nerve (67.2% and 68.9%, respectively). No significant differences were found in the rate of nerve defects between different age groups, body mass index (BMI) groups, or groups with hypertension or dyslipidemia. However, a statistically significant association was found between the rate of clinical neurological abnormalities and the duration of diabetes (p < 0.05). Patients with poor glucose control and/or decreased renal function also had a higher incidence of nerve defects. The study highlights the high incidence of peripheral neuropathy among T2DM patients in Vietnam and the association between nerve conduction abnormalities and poor glucose control and/or decreased renal function. The findings underscore the importance of early diagnosis and management of neuropathy in T2DM patients to prevent serious complications.