Anlotinib Alone or in Combination With Temozolomide in the Treatment of Recurrent High-Grade Glioma: A Retrospective Analysis

Background: Anlotinib is a multi-target anti-angiogenic agent. This retrospective study aimed to evaluate the efficacy and safety of anlotinib alone or in combination with temozolomide for the treatment of recurrent high-grade glioma.Materials and Methods: The clinical data of patients with recurrent high-grade glioma treated with anlotinib alone or in combination with temozolomide in our cancer center were collected and analyzed. Treatment response was evaluated according to the response assessment for neuro-oncology criteria. Progression-free survival, progression-free survival at 6 months, overall survival, and overall survival at 12 months were evaluated by Kaplan–Meier method and compared by log-rank test.Results: Between August 2019 and December 2020, 31 patients with recurrent high-grade glioma (21 of grade 4 and 10 of grade 3) were enrolled in this study. Seventeen patients received anlotinib alone and 14 received anlotinib plus temozolomide. All patients were heavily treated, the median lines of previous treatments were 2, and the median Karnofsky score was 60. At the data cutoff date, the median progression-free survival was 4.5 months and the progression-free survival at 6 months was 43.5%. The median overall survival was 7.7 months, and the overall survival at 12 months was 26.7%. The progression-free survival at 6 months and the overall survival at 12 months for 21 patients with grade 4 glioma was 40.2 and 27.9%, respectively. The tumor objective response rate was 41.9% in all patients and 33.3% in patients with grade 4 glioma. No grade 3 or worse treatment-related adverse events were recorded during the treatment.Conclusion: Anlotinib alone or in combination with temozolomide showed encouraging efficacy and favorable tolerability in patients with recurrent high-grade glioma who had been heavily treated.

Trans-oral Trans-Sheath Forceps Biopsy For Patients With Severe Esophageal Obstruction Under Fluoroscopy

Background: To investigate the safety and effectiveness of trans-oral trans-sheath forceps biopsy (TTFB) for patients with severe esophageal obstruction under fluoroscopy.Methods: From November 2016 to November 2019, 35 patients with level Ⅲ or Ⅳ dysphagia and a Karnofsky score of less than 60 were enrolled to undergo TTFB and esophageal nutrition tube insertion or stenting simultaneously. Data on diagnostic performance, early complications, and radiation dose were collected, and Karnofsky scores before and after the procedures were compared.Results: The technical success of TTFB was 100%. The sensitivity, specificity and accuracy were 92.3% (24/26), 77.8% (7/9), and 88.6% (31/35), respectively. Complications occurred in two cases (5.7%). The mean procedure duration and irradiation dose were 23.2 min and 7.2 mSv, respectively. The Karnofsky scores significantly increased after 2-4 weeks (t = -8.9, P < 0.01).Conclusions: TTFB is a safe and effective method for patients with severe esophageal obstruction under fluoroscopy, especially in those who cannot undergo or refuse endoscopy.

Determination of Significant Pretreatment Factors that Predict Survival in Indonesian Subjects with Breast Cancer

BACKGROUND: The determination of the pre-treatment’s survival predictive factors is very important as a basis for clinicians to educate and determine appropriate management for patients. AIM: This study aimed to determine the pre-treatment risk factors that predict survival in Indonesian subjects with breast cancer. METHODS: This was a cohort retrospective study conducted on breast cancer subjects visiting Sanglah General Hospital from 2016 to 2020. Data were collected from Indonesian Cancer Registry medical records such as age, tumor size, lymph nodes, metastasis, Karnofsky score, serum CA15-3 level, hormonal receptor status (ER/PR), HER2, Ki-67, LVI, tumor-infiltrating lymphocytes, cell type, histological grade, and survival status until December 2020. Data were tabulated and analyzed statistically using SPSS 25.0. RESULTS: The median survival of breast cancer in this study was 47 months (SD 4.851). Majority of breast cancer subjects with mortality outcome were those who had Karnofsky score less than 70, tumor size ≥5 cm with infiltration, presence of contralateral lymph node, with metastasis, serum CA15-3 level >25 IU/mL, negative hormonal receptor, negative HER2 receptor, Ki67 higher than 14, negative lymphovascular invasion, negative tumor-infiltrating lymphocytes, and histological Grade 3. Age and pathological type were not significantly differed the breast cancer outcome. CONCLUSION: There were significant effects of tumor size, KGB status, metastasis, serum CA15-3 levels, hormone receptor, HER2 receptor, Karnofsky score, lymphovascular invasion, tumor-infiltrating lymphocytes, and histological grade on breast cancer subjects’ survival.

Potential Benefits of a 6-Week Exercise and Mindfulness-Based Telehealth Training for HCT Survivors to Meet the Challenges of the COVID-19 Pandemic - a Feasibility Study

Background: Impairment of quality of life (QOL) such as reduced physical fitness and psycho-social dysfunction, is a recognized late effect of HCT, a life-saving procedure. Guided exercise and mindfulness-based stress management (MBSM) programs, delivered alone or in combination, have shown promise in improving patient's QOL mainly in the inpatient setting. Delivery of equitable and effective interventions in outpatient settings is challenging but may be addressed via telecommunication technology, reducing clinic visits and infection transmission. The aim of this study is to examine the feasibility and efficacy of a virtual and home-based program of combined exercise and MBSM via videoconference. Methods: Patients attending our post-HCT outpatient clinic were invited to participate (SVH HREC approval 12/175). Eligibility criteria included aged 18-75 years, &gt;6 months post allogeneic HCT and the basic skills to access the online training and assessment packages. Patients with severe medical and psychological problems were excluded by their clinicians. Consented participants attended an initial in-person introductory session and were provided materials including booklet and audio recordings for skill practice. This was followed by once weekly exercise and MBSM training for 6 weeks via videoconferencing. Assessments were performed pre, and then virtually post training, and at 3, 6 and 12 months. Assessment session included: 6-minute walk test (6-MWT), Modified Bruce Test (MBT), sit-to-stand (STS), hand grip strength (HGS). Subjective measures were Goal Attainment Scale, Karnofsky Score, FACT-BMT, Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Scale, and Godin-Shephard Leisure Time Index. Linear mixed-effects model was used for outcome comparisons. This maximum likelihood approach utilizes all acquired data points and manages missing data points by missing at random (MAR) assumption. P values were adjusted using Holm-Sidak method for multiple comparisons. Results: Twenty-four eligible patients responded to the invitation and completed the program (54% male, median age 53 years (33 - 73), median time post-HCT of 37 months (13 - 68), 38% rural/remote). Based on participant feedback surveys at 6 months, this combined modality telehealth program was found to be well-accepted and safe. The 6-MWT scores were significantly higher at 3 and 12 months (M=646.5m, SD=53.34 and M=615.33m, SD= 94.95, respectively; both p &lt; 0.01) compared to baseline (M=566.94, SD=145.22). The MBT, the only test that required participants to attend the clinic was ceased after 3 months as changes in 6-MWT paralleled changes in MBT. STS Test was significantly higher at 3 and 12 months (M=19.53, SD=6.93, p&lt;0.01 and M=19.07 SD= 8.0; both p &lt; 0.05) compared to baseline (M=15.14, SD=6.44). For the upper limb assessment, dominant hand grip was significantly stronger at 3, and 12 months (M=35.09, SD=9.83; p&lt; 0.01) compared to baseline (M=29.07, SD=9.79). A significantly higher FACT-BMT total and FACT-G scores were found at 3 months (M=123.37, SD=15.12 and M=91.23, SD=11.76; p&lt; 0.01) compared to baseline (M=116.44, SD=14.16 and M=88.25, SD=12.52 respectively), and a trend non-significant at 12 months. Conclusion: A 6-week internet and home-based exercise and MBSM programme was an acceptable, safe, and potentially effective intervention for sustained improvement of some QOL outcomes in HCT survivors. The positive findings of this feasibility study provided valuable data for the design of a multicentre RCT that is underway . Disclosures No relevant conflicts of interest to declare.

Integration of Oncology and Palliation Benefits Patients with Advanced Cancer and Unmet Needs: A Prospective Observational Study

Background: Patients with advanced cancer and bone metastases may have unmet palliative care needs that go unnoticed during clinical oncological practice. This observational study describes palliative care needs and interventions identified because of participation in a clinical study. Methods: Patients with advanced cancer and painful bone metastases included in the Palliative Radiotherapy and Inflammation Study (PRAIS) aiming to predict the response of radiotherapy (RT) were eligible. All patients met with the palliative care (PC) study team prior to start of RT, after they had completed patient reported outcome measures (PROMs). Symptoms prompting interventions by the study team were documented in the patient charts and reviewed.Results: One hundred-and thirty-three patients were reviewed; 63% males, mean age 65 and mean Karnofsky score (KPS) 73. Interventions were initiated in 50% (n=67) of the patients. Most common were changed opioid management (69%), treatment of constipation (43%) and nausea (24%) and nutritional advices (21%). Patients receiving interventions had lower mean KPS (70 vs 77 p <0.001), shorter survival time after study inclusion (median 28 vs. 57.5 weeks p = 0.005) and were more often opioid naïve (12% vs 39% p <.001) compared with the non-intervention group. Conclusions: Adverse symptoms are often not identified in routine oncological consultations prior to RT for cancer pain. Special attention should be directed to frail patients. These findings call for an early and systematic integration of palliative care in patients with advanced cancer.Trial registration: ClinicalTrials.gov NCT02107664

Comparison of profile and treatment outcomes between elderly and non-elderly tuberculosis patients in Puducherry and Tamil Nadu, South India

The rising geriatric population and the increased susceptibility of this age group to tuberculosis (TB), the deadliest single infectious agent, is bothersome for India. This study tried to explore the demographic and treatment outcome differences between the elderly (aged 60 years and above) and non-elderly TB (<60 years) patients from South India. This study was part of a large ongoing cohort study under the RePORT India consortium. Newly diagnosed TB patients recruited into the cohort between 2014 and 2018 were included in this study. Pretested and standardized questionnaire and tools were used to collect data and were stored securely for the entire cohort. Required demographic, anthropometric and treatment related variables were extracted from this database and analyzed using Stata version 14.0. Prevalence of elderly TB was summarized as percentage with 95% confidence interval (CI). Generalized linear modelling was attempted to find the factors associated with elderly TB. A total of 1,259 eligible TB patients were included into this present study. Mean (SD) of the participants in the elderly and non-elderly group was 65.8 (6.2) and 40.2 (12.0) respectively. Prevalence of elderly TB was 15.6% (95%CI: 13.6%-17.6%) with nearly 71% belonging to 60–69 age category. Male sex, OBC caste, poor education, unemployment, marriage, alcohol consumption and unable to work as per Karnofsky score were found to be significantly associated with an increased prevalence of elderly TB. Unfavorable outcomes (12% vs 6.5%, p value: 0.018), including death (9.3% vs 3.4%, p value: 0.001) were significantly higher among the elderly group when compared to their non-elderly counterparts. The current TB programme should have strategies to maintain follow up with due attention to adverse effects, social support and outcomes. Additional research should focus on predictors for unfavorable outcomes among the elderly TB group and explore ways to handle the same. Rendering adequate social support from the health system side and family side would be a good start.

Is Neuropathic Pain a Good Marker of Peripheral Neuropathy in Hospice Patients with Advanced Cancer? The Single Center Pilot Study

Neuropathic pain (NP) affects approximately 30% of patients with advanced cancer. The prevalence of neuropathic pain related to peripheral neuropathy (NP-RPN) in these patients is not known. The aim of the study was to evaluate NP-RPN prevalence in hospice patients and to find out whether the absence of this pain is sufficient to rule out peripheral neuropathy. The study included a total of 76 patients with advanced cancer who were cared for at inpatient hospices. All patients were asked about shooting or burning pain (of the feet and hands), were examined systematically for sensory deficits and had a nerve conduction study performed. NP-RPN was found in 29% of the patients. Electrophysiologically-diagnosed peripheral neuropathy was found in 79% of patients, and the diagnostic electrophysiological criteria for neuropathy were met by one half of the patients without NP-RPN. The severity of NP-RPN was correlated with the clinically assessed severity of sensory neuropathy and the Karnofsky score, but was not correlated with the intensity of the clinical signs of motor neuropathy. The presence of NP-RPN did not reflect greater prevalence of motor and sensory abnormalities in neurological and electrophysiological examinations. The absence of NP-RPN did not rule out polyneuropathy in hospice patients.

Clinical Performance Status and Technical Factors Affecting Outcomes from Percutaneous Transhepatic Biliary Interventions; A Multicentre, Prospective, Observational Cohort Study

Purpose The purpose of this study was to evaluate the predictive value of a ‘Modified Karnofsky Scoring System’ on outcomes and provide real-world data regarding the UK practice of biliary interventions. Materials and Methods A prospective multi-centred cohort study was performed. The pre-procedure modified Karnofsky score, the incidence of sepsis, complications, biochemical improvement and mortality were recorded out to 30 days post procedure. Results A total of 292 patients (248 with malignant lesions) were suitable for inclusion in the study. The overall 7 and 30 day mortality was 3.1% and 16.1%, respectively. The 30 day sepsis rate was 10.3%. In the modified Karnofsky ‘high risk’ group the 7 day mortality was 9.7% versus 0% for the ‘low risk’ group (p = 0.002), whereas the 30 day mortality was 28.8% versus 13.3% (p = 0.003). The incidence of sepsis at 30 days was 19% in the high risk group versus 3.3% at the low risk group (p = 0.001) Conclusion Percutaneous biliary interventions in the UK are safe and effective. Scoring systems such as the Karnofsky or the modified Karnofsky score hold promise in allowing us to identify high risk groups that will need more careful consideration and enhanced patient informed consent but further research with larger studies is warranted in order to identify their true impact on patient selection and outcomes post biliary interventions.

Five-year survival in patients with Glioblastoma is overestimated in registry data - A nationwide population-based Swedish survey during 1958 - 1999

Background Some glioblastoma (GBM) patients survive more than five years with hitherto no clearly established epidemiological or molecular causes. Since varying rates of GBM five-year survival have been reported our aim was to assess the true prevalence of five-year survivors in Sweden from 1958 to 1999, before the introduction of concomitant temozolomide treatment.Methods After screening the Swedish Cancer Registry and the Cause of Death Register 736 out of 12765 patients with high-grade glioma were defined as five-year survivors. The full text pathology report was reviewed in 585 patients. Data on epidemiology and treatment were retrieved from the medical records of 556 patients.Results 77 five-year survivors with primary GBM were identified which corresponded to 0.60 % of the initial population. During 1990 to 1999 GBM five-year survival was 0. 90%. Younger age, Karnofsky score > 70 and non-eloquent tumour location were found in most but not all five-year survivors.Conclusion GBM five-year survival was exceedingly rare in Sweden until 2004, comprising less than 1 % of registered HGGs. Relying on registry data without reviewing the pathology report will overestimate the accurate number of five-year survivors. To our knowledge, this is the only nationwide population-based study of five-year survival in GBM patients.

Factors influencing length of survival in ambulatory palliative care - a cross sectional study based on secondary data

Background Quality of life and patient self-determination are key elements in successful palliative care. To achieve these goals, a robust prediction of the remaining survival time is useful as it can provide patients and their relatives with information for individual goal setting including appropriate priorities. The Aim of our study was to assess factors that influence survival after enrollment into ambulatory palliative care. Methods In this cross-sectional, multicenter study (n = 14 study centers) clinical records of all palliative care patients who were treated in 2017 were extracted and underwent statistical analysis. The main outcome criterion was the association of survival time with clinical characteristics such as age, type of disease, symptoms and performance status. Results A total of 6282 cases were evaluated. Median time of survival was 26 days (95 % CI: 25–27 days). The strongest association for an increased hazard ratio was found for the following characteristics: moderate/severe weakness (aHR: 1.91; 95 % CI: 1.27–2.86) Karnofsky score 10–30 (aHR: 1.80; 95 % CI: 1.67–1.95), and age > 85 (aHR: 1.50; 95 % CI: 1.37–1.64). Surprisingly, type of disease (cancer vs. non-cancer) was not associated with a change in survival time (aHR: 1.03; 95 % CI: 0.96–1.10). Conclusions In this cross-sectional study, the most relevant predictor for a short survival time in specialized ambulatory palliative care was the performance status while type of disease was irrelevant to survival.