Effective Treatment For Elderly Patients Research Articles

Retrospective multicenter study of elderly patients with platinum-sensitive relapsed ovarian cancer treated with trabectedin and pegylated liposomal doxorubicin (pld) in a real-world setting: a geico study

BackgroundTrabectedin in combination with pegylated liposomal doxorubicin (PLD) is approved for the treatment of patients with platinum-sensitive relapsed ovarian cancer. Nevertheless, there is currently limited information regarding this treatment in elderly patients with ovarian cancer in a real-world setting.MethodsThis observational and multicentric study retrospectively evaluated trabectedin plus PLD in a real-world setting treatment of elderly patients diagnosed with platinum-sensitive relapsed ovarian cancer, treated according to the Summary of Product Characteristics (SmPC) from 15 GEICO-associated hospitals. Patients ≥ 70 years old at the time of treatment initiation and platinum-free intervals ≥ 6 months were considered eligible.ResultsForty-three patients with a median age of 74.0 years were treated between January 1st, 2015, and December 31st, 2019 in 15 Spanish centers. Four patients achieved complete response (9.3%), 14 (32.6%) partial response, and 13 (30.2%) stable disease as the best radiological response. In the analysis of biological overall response according to CA125 serum levels (i.e., Rustin criteria), 14 responded to the treatment (32.6%), 11 responded and normalized (25.6%), three patients stabilized (7.0%) and three progressed (7.0%). Median progression-free survival (PFS) and overall survival (OS) in the study population were 7.7 and 19.5 months, respectively. The most common grade 3/4 adverse events were neutropenia (n = 8, 18.7%) and asthenia (n = 5, 11.6%).ConclusionsThis analysis demonstrated that trabectedin combined with PLD is a feasible and effective treatment in elderly patients with platinum-sensitive relapsed ovarian cancer, showing an acceptable safety profile, which is crucial in the palliative treatment of these patients.

The effects of dietary intervention combined with comprehensive exercise instruction on somatic function and quality of life in elderly patients with diabetes mellitus.

To assess the effects of dietary intervention combined with comprehensive exercise instruction on somatic function and quality of life in elderly patients with diabetes mellitus (DM). This was application research. A total of 120 elderly patients with type-2 diabetes mellitus (T2DM) admitted to The No.2 Hospital of Baoding from March 10, 2022 to March 10, 2023 were included and randomly divided into the control group and the experimental group(n=60). Patients in the control group received conventional treatment and nursing regimen, while those in the experimental group were given dietary intervention combined with comprehensive exercise instruction based on the control group. The differences before and after treatment between the two groups were compared and analyzed. After the intervention, the experimental group had remarkably lower levels of fasting blood glucose (FBG), 2h postprandial blood glucose(2hPG) and glycated hemoglobin (HbA1c) than the control group (p=0.00), while significantly improved somatic function, psychological function, social function and material life status compared to the control group (p=0.00). The levels of SAS and SDS in the experimental group were significantly decreased compared with those in the control group (p=0.00). The levels of SOD, MDA and CAT in the experimental group were obviously superior to those in the control group, with statistically significant differences (p=0.00). Dietary intervention combined with comprehensive exercise instruction is an effective treatment for elderly patients with DM, boasting a variety of benefits such as regulating patients' blood glucose levels, improving patient satisfaction, and ameliorating the level of oxidative stress in the body, which is worthy of clinical promotion.

Outcomes of R-Mini-CHOP Therapy for Elderly Patients with Diffused Large B Cell Lymphoma (DLBCL) and High-Grade Follicular Lymphoma (FL)

Introduction: DLBCL represents the most common lymphoma of the elderly, with R-CHOP remaining the standard of care. For elderly patients survival and outcomes data remains limited. Reduced dose R-mini-CHOP was demonstrated to be safe and effective treatment for elderly patients with overall survival of 58%. Defining predictor factors of response and identifying patients that benefit from R-CHOP remains essential.Methods: Retrospective analysis of elderly patients (pts) with frontline DLBCL and high-grade FL treated with R-mini-CHOP and R-CHOP between April 2014 and June 2021. Adult pts 75 years and older were included in the analysis. We performed a chart review to obtain treatment responses and analyze correlations between clinical, molecular characteristics and outcomes. A comparative study with outcomes of standard R-CHOP treatment was conducted. Primary objective was to determine safety and efficacy of R-mini-CHOP in elderly pts. Secondary objectives include overall response rates (ORR), overall survival (OS), and progression-free survival (PFS) after R-mini-CHOP compared with standard R-CHOP.Results: A total of 22 frontline elderly pts 75 years and older were included. Twenty pts (91%) were >80 years, with a median age of 83 years. Most patients had a diagnosis of DLBCL (86%), with stage III-IV in 61%. LDH was increased in 54% of pts. Fifteen pts had a high-risk IPI score (68%). Baseline characteristics are listed in Table 1.Sixteen pts (73%) completed at least 3 cycles of therapy, with a median of 4 cycles (range 1-6). Nineteen pts were evaluable for response. With a median follow-up of 16 months, the overall response rate (ORR) was 79%, including 53% complete response and 26% partial response. Figure 1.The overall survival (OS) was 36 months with a progression-free survival of 22 months and event-free survival of 16 months. With a 2-year OS and PFS of 63% and 44%, respectably, with a median duration of response of 44 months. A total of 7 pts died (32%), 3 pts from disease progression (14%), 3 pts from infection (14%), and 1 pt from bleeding (4%); and the 4-week mortality rate was 18%.Response rates were compared with a contemporary group treated with standard R-CHOP therapy. Significant differences were observed between both subgroups with an increased performance status (PS>2) (P=<0.001), LDH (P=0.015), and high-risk IPI score (P=0.002) among R-mini-CHOP pts compared to R-CHOP pts. With a significantly younger median age of 78 years for R-CHOP vs 83 years for R-mini-CHOP pts (P=<0.001). Table 1. Univariate analysis for predictors of response revealed a PS equal to 2 or higher to be significantly associated with decreased response rates. (Odds ratio 0.1, P=0.007)Among R-CHOP treated pts, the ORR was 96% with 76% complete responses, while the OS, PFS, and EFS were not reached. Figure 2.Conclusions: Dose-reduced R-mini-CHOP is an effective and safe therapy for elderly patients with a diagnosis of DLBCL and high-grade FL. Response rates compared favorably with previously reported 2-year OS 58% and PFS 47% by the GELA study. Compared with contemporary subgroup treated with R-CHOP therapy showed higher response rates with significantly improved OS and PFS. However, pts in this group were younger with a significantly lower IPI and PS. Further comparison analysis with historical R-CHOP and R-CVP therapy is undergoing [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Challenges and Opportunities in the Management of Diffuse Large B-Cell Lymphoma in Older Patients.

Most patients with diffuse large B-cell lymphoma (DLBCL) are diagnosed at age 60 years or older. Challenges to effective therapy among older individuals include unfavorable biologic features of DLBCL, geriatric vulnerabilities, suboptimal treatment selection, and toxicities of cytotoxic chemotherapy. Wider application of geriatric assessments may help identify fit older patients who benefit from standard immunochemotherapy without unnecessary dose reductions. Conversely, attenuated regimens may provide a better balance of risk and benefit for selected unfit or frail patients. Supportive care with the use of corticosteroid-based prephase, prophylactic growth factors, and early institution of supportive and palliative care can help maximize treatment tolerance. Several novel or emerging therapies have demonstrated favorable toxicity profiles, thus facilitating effective treatment for elderly patients. In the relapsed or refractory setting, patients who are not candidates for stem cell transplantation can benefit from newly approved options including polatuzumab vedotin-based combinations or tafasitamab plus lenalidomide, which may have higher efficacy and/or lower toxicity than historical chemotherapy regimens. Chimeric antigen receptor T-cell therapy has been successfully applied to older patients outside of clinical trials. In the first-line setting, emerging immunotherapy options (bispecific antibodies) and targeted therapies (anti-CD20 antibodies combined with lenalidomide and/or B-cell receptor inhibitors) may provide chemotherapy-free approaches for DLBCL. Enrolling older patients in clinical trials will be paramount to fully examine potential efficacy and toxicity of these strategies. In this review, we discuss recent advances in fitness stratification and therapy that have expanded curative options for older patients, as well as future opportunities to improve outcomes in this population. IMPLICATIONS FOR PRACTICE: Management of diffuse large B-cell lymphoma in older patients poses challenges due to aggressive disease biology and geriatric vulnerability. Although R-CHOP remains standard first-line treatment, geriatric assessment may help evaluate patients' fitness for immunochemotherapy. Corticosteroid prephase, prophylactic growth factors, and early palliative care can improve tolerance of treatment. Novel salvage options (polatuzumab vedotin-based combinations, tafasitamab plus lenalidomide) or chimeric antigen receptor T-cell therapy should be considered in the relapsed or refractory setting for patients ineligible for stem cell transplantation. Emerging immunotherapies (bispecific antibodies) and targeted therapies provide potential first-line chemotherapy-free approaches, which need to be rigorously assessed in clinical trials that involve geriatric patients.

The therapeutic effect of repetitive transcranial magnetic stimulation in elderly depression patients.

Background:Depression, a common psychiatric disorder in elderly, serves as a remarkable precipitating factor for suicide among the elderly people. Here, a randomized double-blinded study was performed to investigate the efficacy of repetitive transcranial magnetic stimulation (rTMS) on improving the clinical symptoms and reducing suicidal ideation in elderly patients with depression.Methods:In this study, 103 elderly patients with depression and suicidal ideation were randomly divided into 2 groups, 48 cases in the rTMS group and 55 cases in the control group (sham rTMS). Both groups received routine drug therapy with rTMS or sham rTMS. The patients received evaluation by Hamilton depression scale and self-rating idea of suicide scale before treatment and after 2 and 4 weeks of treatment, respectively.Results:The measurement from the present study demonstrated that Hamilton depression scale and self-rating idea of suicide scale scores decreased to varying degrees in the 2 groups after treatment, and the decrease was more significant in rTMS group. The rate of marked effectiveness was much higher in rTMS group after 2 weeks of treatment compared with the control group. Furthermore, the rate of moderate effectiveness at 4 weeks after treatment was significantly higher in rTMS group compared with the control group.Conclusion:Together, the present study shows that rTMS with routine drug therapy exhibited effect with quick onset to improve the clinical symptoms and reduce suicidal ideation in elderly patients with depression.

Proton beam therapy is a safe and effective treatment in elderly patients with esophageal squamous cell carcinoma.

BackgroundThere are many elderly patients with esophageal squamous cell carcinoma (ESCC). However, there are currently few articles regarding the clinical outcome following proton beam therapy in these patients. The purpose of this study was to evaluate the clinical results of proton beam therapy in elderly patients with ESCC.MethodsBetween January 2009 and December 2013, patients aged ≥75 years who underwent proton beam therapy were examined using multi‐institutional data from Japan.ResultsThere were 38 inoperable patients (70.4%) and 16 operable patients (29.6%). More than 40% of patients had stage III/IV ESCC. The five‐year overall and cancer‐specific survival rates were 56.2% and 71.7%, respectively. Performance status was the only factor that significantly influenced overall survival during the multivariate analysis. The five‐year local control rate was 61.8%, and local recurrence occurred within 13 months in 82.4% of patients,. There was no grade 3 or higher toxicity, excluding three patients with grade 3 esophageal ulcers.ConclusionsIn conclusion, proton beam therapy may become an alternative treatment with lower toxicity in elderly patients with ESCC, compared to surgery or conventional X‐ray radiotherapy. This includes inoperable patients.Key pointsSignificant findings of the studyProton beam therapy was a safe and effective treatment for elderly patients with esophageal squamous cell carcinoma (ESCC) including inoperable patients.What this study addsProton beam therapy may be a safer treatment choice for elderly patients with ESCC compared to conventional X‐ray radiotherapy.

Real-life efficacy and safety of secukinumab in elderly patients with psoriasis over a 2-year period.

The prevalence of psoriasis is increasing among older people. Elderly patients with psoriasis represent a challenge for dermatologists owing to multiple comorbidities, polypharmacy and immune senescence, which lead to an increased possibility of adverse events (AEs), drug interactions and susceptibility to cancers and infections. Therefore, conventional systemic therapies are often contraindicated, with biologics appearing as the mainstay for moderate-to-severe disease. However, the data on efficacy and safety of biologics in older people are scant. To evaluate the efficacy and safety of secukinumab in elderly patients with psoriasis over a 2-year period. A real-life retrospective observational study was performed on patients aged ≥65years with moderate-to-severe plaque psoriasis who were treated with secukinumab at the Psoriasis Care Unit of the University of Naples Federico II, Italy from June 2016 to June 2019. Mean Psoriasis Area Severity Index (PASI) reduced from 11.4±6.3 at baseline to 2.1±1.7 at week 24 and 1.7±1.9 at week 96 (P<0.001 for all follow-up visits), with a final mean PASI reduction of 85.1%. A similar trend was noted for body surface area (BSA), with baseline value of 27.5±15.7 decreasing to 6.8±5.0 at week 24, and to 3.3±2.5 at week 96 (P<0.001 at all follow-up visits), with a final mean BSA score reduction of 88.0%. Registered AEs did not lead to secukinumab discontinuation, except in one patient (3.4%). Secukinumab seems to be a safe and effective treatment for elderly patients with psoriasis, who frequently have multiple comorbidities, polypharmacy and multiple failures with previous systemic treatments including biologics.

ECT FOR THE TREATMENT OF SOMATIC SYMPTOM DISORDER AND UNINTENTIONAL WEIGHT LOSS IN OLDER ADULTS: 2 CASE REPORTS

Introduction Somatoform disorders occur in up to 13% of those over age 65 and symptoms often cause significant impairment and disability (Hilderink et al. 2013; Leong et al. 2015). Unintentional weight loss in the elderly is also common and associated with increased morbidity and mortality (Hajek et al. 2017; McMinn et al. 2011). Studies show that depression is often comorbid with both somatoform disorders and unintentional weight loss in the elderly (Leong et al. 2015; Thompson and Morris 1991). Electroconvulsive therapy (ECT) is an effective treatment for severe depression, especially in older adults. However, there is limited of evidence regarding the use of ECT in elderly patients for the treatment of somatic symptom disorders (with predominant GI symptoms) or unintentional weight loss. Three case reports have been documented of women in their seventh decade of life with functional GI symptoms that responded to ECT (Cooper 2016; Cybulska 1997; Dols et al. 2012). Leong et?al reported a case series of 28 patients with somatic symptoms disorder who were successfully treated with ECT, examining the primary endpoint of improvement in somatic symptoms. However, only 2 of these cases included functional GI symptoms, and neither of the patients were over the age of 50 (Leong et al. 2015). Methods We report 2 cases of patients over age 65 who were psychiatrically hospitalized for co-morbid depressive symptoms, somatic symptom disorder (with predominant GI symptoms), and unintentional weight loss. Due to inability to tolerate medications and severity of depressive and somatic symptoms, both received an acute course of ECT. Results Both patients had gastrointestinal medical history (dumping syndrome, gastroparesis, irritable bowel syndrome), but extensive medical workup did not account for the severity of somatic symptoms, most notably nausea, or weight loss at the time of psychiatric admission. Both patients had diagnoses of major depressive episodes with PHQ-9 scores in the moderate range on admission (14 and 15). Both patients completed a full acute course of bitemporal ECT and reported subjective improvement in their somatic symptoms, appetite, and depressive symptoms (PQH-9 scores 0 and 1 respectively) following the course of ECT. Both also objectively gained a weight from time of admission to long-term follow-up without subsequent ECT treatment. Patient A's BMI on admission was 17.1 and increased to 23.81 at 8 month follow-up. Patient B's BMI on admission was 25.6 and increased to 29.17 at 7 month follow-up. In these two cases, ECT was well tolerated with reported side effects of mild headache, body aches, and mild to moderate memory loss. Of note, both patients had a rapid and robust response to ECT with remission of depressive symptoms and significant improvement in gastrointestinal symptoms after 5 bitemporal treatments. Conclusions Due to the higher rate of co-morbid medical conditions that could potentially contribute to somatic symptoms, it can be more challenging to diagnose somatic symptoms disorder in older adults (Wijeratne et al. 2003). When older adults present with somatic symptoms that are not fully explained by medical pathology, somatic symptom disorder should be considered and appropriate treatment initiated. Given the adverse outcomes and higher mortality in elderly individuals with unexplained weight loss, timely treatment is imperative. This case report suggests that ECT may be a well-tolerated and highly effective treatment for elderly patients with medically unexplained gastrointestinal disorders/somatic symptom disorder and significant weight loss with comorbid depression. This research was funded by: Not Applicable

Laparoscopic common bile duct exploration for elderly patients with choledocholithiasis: a systematic review and meta-analysis.

Laparoscopic common bile duct exploration (LCBDE) has been becoming more and more popular in patients with symptomatic choledocholithiasis. However, the safety and effectiveness of LCBDE in elderly patients with choledocholithiasis is still uncertain. This meta-analysis is aimed to appraise the safety and feasibility of LCBDE for elderly patients with choledocholithiasis. Studies comparing elderly patients and younger patients who underwent LCBDE for common bile duct stone were reviewed and collected from the PubMed, Medline, EMBASE, and Cochrane Library. Primary outcomes were stone clearance rate, overall complication rate, and mortality rate. Secondary outcomes were operative time, conversion rate, pulmonary complication, bile leakage, reoperation, residual stone rate, and recurrent stone rate. Nine studies, including two prospective studies and seven retrospective studies, met the inclusion criteria. There were 2004 patients in this meta-analysis, including 693 elderly patients and 1311 younger patients. There was no statistically significant difference between elderly patients and younger patients regarding stone clearance rate (OR 0.73; 95% CI 0.42-1.26; p = 0.25), overall complication rate (OR 1.31; 95% CI 0.94-1.82; p = 0.12), and mortality rate (OR 2.80; 95% CI 0.82-9.53; p = 0.10). Similarly, the operative time, conversion rate, bile leakage, reoperation, residual stone rate, and recurrent stone rate showed no significant difference between two groups (p > 0.05). While elderly patients showed high risk for pulmonary complication (OR 4.41; 95% CI 1.78-10.93; p = 0.001) compared with younger patients. Although there is associated with higher pulmonary complication, LCBDE is still considered as a safe and effective treatment for elderly patients with choledocholithiasis.

Typical trigeminal neuralgia in patients older than 65: Safety and efficacy of microvascular decompression by the retrosigmoid approach

AbstractOBJECT: Incidence of typical trigeminal neuralgia (TN) increases with age and neurologists and neurosurgeons frequently observe patients with this disorder at the age of 65 or more. Microvascular decompression (MVD) of the trigeminal root entry zone in posterior cranial fossa is the only etiological therapy for typical TN with the highest efficacy and durability of all treatments. This procedure is associated with possible risks (cerebellar hematoma, cranial nerve injury, stroke, and death) not seen with the alternative ablative procedures. Thus, the safety of MVD in the elderly remains non definitively demonstrated. This study was conducted to determine whether MVD is a safe and effective treatment in elderly patients with TN in comparison to younger patients.METHODS: In this retrospective study, 25 patients older than 65 (mean age 70.1 ± 3.7 years) and 32 aging &lt;65 (mean age 51.1 ± 6.2 years) underwent MVD by key-hole retrosigmoid approach for Type 1 TN (typical) or Type 2a TN (typical chronicized) from November 2011 to November 2016. A 75 y-o patient had Type 2b TN (atypical) versus 3 nonelderly patients were excluded. Elderly and younger groups were compared in relation to outcome and complication data.RESULTS: At a mean follow-up 23.0 ± 5.5 months, 22 old patients (88%) reported a very good outcome without necessity of any medication for pain, versus 28 (87,5%) of the younger group. Twenty elderly patients with Type 1 TN were compared with 24 younger patients with Type 1 TN, and no significant difference in outcomes was found (p &gt; 0.05). Five elderly patients with Type 2a TN were compared with 8 younger patients with Type 2a TN, and no significant difference in outcomes was noted (p &gt; 0.05). There was one case of CSF leak and one case of cerebellar hematoma both in the younger cohort. Mortality was zero in both groups.CONCLUSIONS: On the basis of our experience and of the international literature, age itself seems not to represent a major contraindication against MVD for TN. Keywords: Elderly, Microvascular Decompression, Retrosigmoid approach, Trigeminal neuralgia, Tic douloureux

Clinical Characteristics and Efficacy of Radiofrequency Catheter Ablation in the Treatment of Elderly Patients with Atrial Fibrillation

ObjectiveThis study aims to investigate the clinical characteristics and therapeutic effect of radiofrequency catheter ablation (RFCA) in elderly patients with atrial fibrillation (AF). Materials and MethodsThis retrospective study included 668 patients with AF who underwent RFCA in our hospital from June 2010 to June 2015. Patients were divided into 2 groups according to age: group E (≥60 years old, n = 308) and group N (<60 years old, n = 360). Ablation endpoints included the following 3 points: (1) all preset ablation lines were completed; (2) all pulmonary veins were electrically isolated; and (3) negative evoked results were achieved. The success of follow-up was defined as patients who did not have an atrial arrhythmia attack for at least 3 months without the administration of antiarrhythmia drugs. ResultsClinical characteristics of elderly patients with AF: the proportion accounted for by female patients with AF, patients with hypertension, and patients with a CHADS2 score ≥2 points was significantly higher than that in group N (P < 0.001). RFCA procedure and safety: differences in the success rate of the first operation and severe complications were not statistically significant (P > 0.05). Postoperative follow-up: the follow-up period was between 6 and 12 months after operation. Differences in the proportion of patients with repeated ablation and total success rate were not statistically significant (P > 0.05). ConclusionsAlthough elderly patients with AF had more clinical complications, no differences in the success rate of RFCA and postoperative complications between the 2 groups were found. RFCA is a safe and effective treatment for elderly patients with AF.

A Case Report of Sibak-tang Effectiveness in an Elderly Patient with Sputum and Dysphagia after Conventional Treatment for Pneumonia

Objectives We conducted this study to report the clinical effects of Sibak-tang (Saiboku-to) in an elderly patient suffering from sputum and dysphagia after conventional treatment for pneumonia. Methods The Sibak-tang was administered to the patient to treat sputum and dysphagia. The results were assessed by measuring the frequency of the sputum and conducting a videofluoroscopic swallowing study. Results After about three weeks of herbal medicine treatments, the patient’s symptoms of respiratory problems improved. The results of the videofluoroscopic swallowing study were also improved. Conclusion Sibak-tang could be an effective treatment for elderly patients suffering from sputum and dysphagia after conventional treatment for pneumonia. Keywords: pneumonia, sputum, dysphagia, Sibak-tang (Saiboku-to), herbal medicine

Debridement, interbody graft using titanium mesh cages, posterior instrumentation and fusion in the surgical treatment of multilevel noncontiguous spinal tuberculosis in elderly patients via a posterior-only

PurposeTo analyse the efficacy and feasibility of surgical management for elderly patients with multilevel non-contiguous spinal tuberculosis(MNSTB)by using one-stage posterior focus debridement, interbody graft using titanium mesh cages, posterior instrumentation and fusion. MethodsFrom September 2009 to October 2013, 15 elderly patients with MNSTB were treated with one-stage posterior focus debridement, interbody graft using titanium mesh cages, posterior instrumentation and fusion. There were 10 males and 5 females with a mean age of 63.2 years (range: 60–68 years) at the time of surgery. The mean follow-up time was 40 months(range 26–68 months). Patients were evaluated before and after surgery in terms of erythrocyte sedimentation rate(ESR), neurological status, pain and kyphotic angle. ResultsThe spinal tuberculosis was completely cured, and the grafted bones were fused in all 15 patients. There were no recurrent tuberculous infections. The ESR reached a normal level within 3 months in all patients. The ASIA neurological classification improved in all cases, and pain relief was reported by all patients. The average preoperative kyphosis was 20.1° (range 8–38°) and decreased to 7.6° (range 1–18°) postoperatively. There was no significant loss of the correction at the latest follow-up. ConclusionsOur results showed that one-stage posterior focus debridement, interbody graft using titanium mesh cages, posterior instrumentation and fusion was an effective treatment for elderly patients with MNSTB. It is characterized by minimum surgical trauma, good neurological recovery, and good correction of kyphosis.

Rituximab, bendamustine, and low-dose cytarabine as induction therapy in elderly patients with mantle cell lymphoma: a multicentre, phase 2 trial from Fondazione Italiana Linfomi

The combination of rituximab, bendamustine, and cytarabine (R-BAC) was highly active in a pilot trial of mantle cell lymphoma, but its use was restricted by high haematological toxicity. We aimed to assess the efficacy and safety of an R-BAC regimen with low-dose cytarabine (RBAC500). In this multicentre, phase 2 trial, we recruited previously untreated patients with an established histological diagnosis of mantle cell lymphoma from 29 Fondazione Italiana Linfomi centres in Italy. Patients had to be older than 65 years and fit according to the comprehensive geriatric assessment, or aged 60-65 years if they were ineligible for high-dose chemotherapy plus autologous stem-cell transplantation and were fit or unfit. All patients received RBAC500 (rituximab 375 mg/m2 on day 1, bendamustine 70 mg/m2 on days 2 and 3, and cytarabine 500 mg/m2 on days 2-4; all administered intravenously) every 4 weeks for up to six cycles. Primary endpoints were the proportion of patients achieving complete response at the end of treatment and toxicity, defined as the occurrence of any of the stop treatment criteria or of any episode of relevant toxicity. All patients who started at least one cycle of RBAC500 were included in the primary and safety analyses. Using efficacy and toxicity as a composite primary endpoint, we considered the final conclusion positive if more than 28 of 57 patients achieve complete response and fewer than 18 of 57 patients report toxicities. This study is registered with EudraCT, number 2011-005739-23, and ClinicalTrials.gov, number NCT01662050, and is completed. Between May 2, 2012, and Feb 25, 2014, we enrolled 57 patients (median age 71 years, IQR 67-75). 54 (95%) patients received at least four RBAC500 cycles (three discontinued because of toxicity), and 38 (67%) completed six cycles. Two (4%) had disease progression (one after the fourth cycle and one after the sixth cycle). All 52 (91%, lower limit of one-sided 95% CI 85%) remaining patients achieved complete response at the end of treatment. 23 (40%, upper limit of one-sided 95% CI 53%) of 57 patients had at least one episode of relevant toxicity. The most frequent grade 3-4 haematological toxicities were neutropenia (149 [49%] of 304 cycles) and thrombocytopenia (158 [52%]). Most treatment-related non-haematological adverse events were of grade 1-2, with the most frequent ones being fatigue (14 [25%] patients), nausea or vomiting (12 [21%]), and infusion-related reactions or tumour lysis syndrome (12 [21%]). 41 (72%) patients required a dose reduction. 12 patients died during the study, but no deaths were related to treatment. RBAC500 is an effective treatment for elderly patients with mantle cell lymphoma and, despite not meeting our prespecified safety boundary, haematological toxicity was manageable with appropriate supportive care and dose reduction. Since maintenance therapy is not required, RBAC500 could be considered an option and should be studied in phase 3 trials. Fondazione Italiana Linfomi and Mundipharma.

POSTEROLATERAL FUSION AND PEDICLE SCREW FIXATION FOR TREATING OLD THORACOLUMBAR FRACTURE COMBINED WITH KYPHOSIS IN ELDERLY PATIENTS

To investigate the clinical efficacy and the indications of posterolateral fusion and pedicle screw short-segment fixation via injured vertebra for treating old thoracolumbar fracture combined with kyphosis in elderly patients. Between January 2012 and December 2014, 24 patients with old thoracolumbar fracture and kyphosis received posterolateral fusion and pedicle screw short-segment fixation via injured vertebra. Of 24 cases, 8 were male and 16 were female with an average age of 66.3 years (range, 56-79 years). The mean disease course was 17.5 months (range, 5-36 months). There were 13 cases of osteoporosis, 9 cases of osteopenia, and 2 cases of normal bone. The visual analogue scale (VAS) was 6.53±0.95, and Oswestry disability index (ODI) was 52.63%±5.74% preoperatively. The thoracolumbar kyphosis located at T10 to L2, and the kyphotic Cobb angle was (28.79±5.04)° before operation. The operation was completed successfully without related complications. The operative time was 1.2-2.3 hours (mean, 1.6 hours), and intraoperative blood loss was 80-210 mL (mean, 158 mL). No nerve injury occurred. Poor healing of incision was observed in 1 patient with diabetes, and primary healing of incision was obtained in the other patients. Nineteen patients were followed up 6-30 months (mean, 14.4 months), and there were 2 deaths. Pain relief and function recovery were obtained in 19 patients after operation. The VAS score and ODI were significantly decreased to 2.4±0.7 and 32.14%±5.12% at last follow-up (t=8.542, P=0.000; t=9.826, P=0.000). The kyphotic Cobb angle was significantly decreased to (21.23±4.30)° at immediate after operation (P<0.05) and to (23.68±4.35)° at last follow-up (P<0.05), but no significant difference was found between at immediate and last follow-up (P>0.05). No loosening or breakage of internal fixation was observed during follow-up. Posterolateral fusion and pedicle screw short-segment fixation via injured vertebra is a safe and effective treatment for elderly patients with old thoracolumbar fracture combined with kyphosis (Cobb angle less than 40°).

Outcomes of Elderly Patients Who Receive Combined Modality Therapy for Locally Advanced Non–Small-Cell Lung Cancer

BackgroundThe objective of this study was to review our institution's experience among patients with locally advanced non–small-cell lung cancer (LA-NSCLC) treated with chemotherapy and radiation and to determine the prognostic significance of age. Patients and MethodsPatients were included if they underwent sequential or concurrent chemoradiotherapy from 2006 to 2014 for LA-NSCLC. Patients were stratified according to age ≤70 and >70 years. Kaplan–Meier and Cox regression methods were performed to evaluate overall survival (OS) and progression-free survival (PFS). ResultsOne hundred twenty-three patients were identified. Ninety-eight patients were 70 years of age or younger and 25 patients were older than 70 years of age. The median radiotherapy dose was 6660 cGy (range, 3780-7600 cGy). A greater percentage of elderly patients were men, 72% (18 patients) versus 39% (38 patients) (P = .006) and received carboplatin/paclitaxel-based chemotherapy, 60% (15 patients) versus 21% (20 patients) (P < .001). Median follow-up for OS was 25.9 (95% confidence interval [CI], 21.3-33.9) months. There was no difference in the PFS of older patients versus younger patients (hazard ratio [HR], 1.15; P = .64), adjusted for significant covariates. The 1-year PFS rate for patients 70 years of age or younger was 51% (95% CI, 42%-63%) versus 45% (95% CI, 28%-71%) in patients older than 70 years. After adjusting for significant covariates, there was no difference in the OS of older patients compared with younger patients (HR, 1.18; P = .65). The 1-year OS rate for patients 70 years of age or younger was 77% (95% CI, 68%-86%) versus 56% (95% CI, 39%-81%) in patients younger than 70 years. ConclusionChemoradiotherapy is an effective treatment in elderly patients with LA-NSCLC, with outcomes similar to that in younger patients. Appropriately selected elderly patients should be considered for chemoradiation.

Treating chronic lymphocytic leukemia with obinutuzumab: safety and efficacy considerations

ABSTRACTIntroduction: Obinutuzumab is a novel glycoengineered type II anti-CD20 monoclonal antibody (MoAb) with a higher affinity for CD20 epitope. It was approved by the United States Food and Drug Administration (FDA) in November 2013 for use in combination with chlorambucil for previously untreated chronic lymphocytic leukemia (CLL).Areas covered: This article evaluates the safety of obinutuzumab in CLL patients, also addressing pharmacokinetics/pharmacodynamics (PK/PD), clinical use and efficacy. Moreover, a comparison with other anti-CD20 MoAb is performed. The principal available studies on obinutuzumab are reviewed, focusing on CLL.A PubMed literature search (August 2002 to September 2015) was conducted using the terms obinutuzumab, GA101, anti-CD20 antibody, and CLL.Expert opinion: Obinutuzumab, a third-generation anti-CD20 MoAb, is a safe and effective treatment for elderly patients who are un-fit for fludarabine-based regimen. Its use, proven in the CLL11 study and the results of many ongoing trials evaluating other obinutuzumab-based regimen can lead obinutuzumab to be a candidate to replace rituximab as the first-line treatment option.

Minimally Invasive Spinal Decompression in Patients Older Than 75 Years of Age: Perioperative Risks, Complications, and Clinical Outcomes Compared with Patients Younger Than 45 Years of Age

Minimally invasive spinal decompression for the treatment of spinal stenosis or disk herniation is often indicated if conservative management fails. However, the influence of old age on the risk of postoperative complications and clinical outcome is not well understood. We therefore sought to compare complication rates and outcomes after minimally invasive surgery decompression and discectomy in elderly patients with a cohort of younger patients undergoing similar procedures. We evaluated medical records of 61 patients older than 75 years and 69 patients younger than 45 years that underwent minimally invasive lumbar decompression between April 2009 and July 2013 at our institute. Medical history, American Society of Anesthesiologists score, perioperative mortality, complications, and revision surgery rates were analyzed. Patient outcomes included visual analog scale and EuroQol-5 Dimension scores. The average age was 78.66 ± 4.42 years in the elderly group and 33.59 ± 6.7 years in the younger group. No major postoperative complications were recorded in either group, and all recruited patients were still alive at the time of the last follow-up. No statistically significant difference existed in the surgical revision rate between the groups. Both groups showed significant improvement in their outcome scores after surgery. Our results indicate that minimally invasive decompressive surgery is a safe and effective treatment for elderly patients and does not pose an increased risk of complications. Future prospective studies are necessary to validate the specific advantages of the minimally invasive techniques in the elderly population.

Rituximab is an effective and safe treatment of relapse in elderly patients with resistant warm AIHA.

We evaluated the efficacy and safety of rituximab for the treatment of 23 elderly patients (median age 78 years) with warm autoimmune haemolytic anaemia (AIHA). The median follow-up was 31 months. Patients had received one to five previous treatments. Rituximab was administered by intravenous infusion at a dose of 375 mg/m(2) once weekly for 4 weeks. The OR rate was 86.9 % (CR = 39.1 %, PR = 47.8 %). Median OS was 87 months. The median OS of patients who reached CR could not be calculated, and that of patients with PR was 67 months. At last follow-up, eight of the 20 responding patients, including one patient in CR and seven in PR, had relapsed after a median of 6 months. Failure to achieve CR was a risk factor for relapse (p = 0.028). We did not identify any pretreatment characteristics predictive of response to rituximab. In conclusion, rituximab is an effective treatment for elderly patients with refractory warm AIHA.

Clinical Outcomes of Patients over 75 Years of Age with Degenerative Spondylolisthesis Following Bilateral Decompression via Unilateral Approach.

To investigate the clinical outcomes of bilateral decompression via unilateral approach (BDUA) on degenerative spondylolisthesis with spinal stenosis in patients over 75 years of age. Elderly patients (n=41; average age=79.3±2.5 years) who underwent BDUA under spinal anaesthesia between April 2011 and May 2014 were enrolled. Visual Analogue Scale (VAS) scores and Oswestry Disability Index (ODI) values of the patients were evaluated preoperatively and at the last visit postoperatively (Mean follow-up period=27 month). All parameters were analysed using Student paired-sample t test with p < 0.05 considered statistically significant. All 41 patients experienced significant postoperative improvement in VAS leg (p < 0.01) and back pain (p < 0.05) scores. Average ODIs were 52±4.1% preoperatively and 39±3.5% postoperatively. All changes were statistically significant. BDUA is a safe and very effective treatment in elderly patients with degenerative spondylolisthesis with spinal stenosis. This procedure has a very low complication rate and can be performed successfully under spinal anaesthesia.