Karnofsky Performance Status Scale Score Research Articles

A Comparative Analysis of Vitamin D Status among Tuberculosis Patients and Healthy Household Contacts: A Case–Control Study from Central India

Background and Objectives: When it comes to the nature of the relationship between tuberculosis (TB) and Vitamin D, the available literature offers contradictory findings. The purpose of this study was to assess the relationship between Vitamin D and TB, as well as the relationship between Vitamin D and functional capacity in TB patients from Central India. Materials and Methods: This case–control study comprised 400 participants divided into two equal groups: cases (200 TB patients) and controls (200 healthy household contacts). The study involved subjecting participants to standard laboratory tests in accordance with the management guidelines implemented by the institute. Abbott Architect i1000SR PLUS was used to test the Vitamin D levels while the Karnofsky Performance Status Scale score was used for the functional capacity of cases. Vitamin D levels were categorized into deficient, insufficient, and sufficient for every participant. Information related to the study was noted down on a structured pro forma. Results: The difference in Vitamin D values between the two groups was statistically significant, with 62.5% of deficient patients in the case group compared to 15% in the control group (confidence interval = 95%, χ 2 = 173.97, P = 0.001). The relationship between Vitamin D concentration and Karnofsky scale categories was statistically significant ( r = 0.752, P = 0.01). Interpretation and Conclusions: Vitamin D deficiency is associated with TB and a decrease in functional capacity in the region of Bundelkhand, highlighting the vital role of Vitamin D for TB patients.

Minimally invasive interventions on celiac plexus in patients with persistent abdominal pain caused by pancreatic cancer

Background. Chronic abdominal pain is common in 50 % of patients with intra-abdominal malignancies and has a huge impact on quality of their lives. As the number and doses of systemic analgesics increase, so does the frequency of side effects that can further worsen functional status, which is important for this cohort of patients who have a five-year survival rate of only 8 %. The purpose of the study: to assess the efficacy and safety of computed tomography-guided celiac plexus neurolysis as a method of reducing persistent, severe pain in patients with pancreatic cancer that affects their functional status. Materials and methods. The analysis of the results of 17 interventional procedures on the celiac plexus in 16 participants was conducted, sympatholysis was performed twice in one patient. Inclusion criteria: pancreatic cancer with persistent pharmacoresistant neuropathic abdominal pain for ≥ 3 months, which did not respond to medications, including opioids, anti-inflammatory drugs, and other conservative methods of treatment. Age of patients was 39 to 72 years (mean of 62.6 ± 8.2 years), 10 (62.5 %) research participants were male and 6 (37.5 %) were female. Results. Interventions were successfully performed for all patients on the first attempt. There were no cases of perforations of hollow organs, damage to blood vessels, pleural sinuses, or other structures of the abdominal and thoracic cavities. No neurological complications were recorded, and no one required blood transfusion. All study patients had a significant reduction in pain on the visual analogue scale compared to baseline, both one week after the procedure, from 9.7 ± 0.6 to 4.7 ± 1.4 (P < 0.001), and in six months, from 9.7 ± 0.6 to 4.1 ± 1.4 (P < 0.001). The average Karnofsky Performance Status Scale score compared to the data before the procedure, one week after increased from 64.7 ± 7.9 to 78.2 ± 6.4 (P < 0.001). A significant improvement in functional status was maintained up to three months — 71.2 ± 6.9 (P < 0.001). However, in six months, this indicator was 63.5 ± 6.0 (Р = 0.668), which may be related not only to the intensity of the pain syndrome, but also to other complications of the underlying disease (ascites, cachexia, tumor growth, palliative surgical interventions, etc.). Conclusions. Computed tomography-guided celiac plexus neurolysis is a safe and effective procedure for patients with abdominal pain caused by inoperable pancreatic cancer. Sympatholysis provides a long-term significant reduction in pain syndrome according to the visual analogue scale after 1, 3, 6 months (Р < 0.001) and increases the functional status of patients according to the Karnofsky Performance Status Scale in 1 (Р < 0.001), 3 months (Р = 0.023). Celiac plexus neurolysis should be considered as part of a multidisciplinary approach to the comprehensive treatment of upper abdominal pain associated with cancer in the early stages of the disease.

Outcomes and influencing factors of dental implants in fibula, iliac crest, and scapula free flaps: a retrospective case–control study

PurposeReconstruction with vascularized bone grafts after ablative surgery and subsequent dental rehabilitation with implants is often challenging; however, it helps improve the patient’s quality of life. This retrospective case–control study aimed to determine the implant survival/success rates in different vascularized bone grafts and potential risk factors.MethodsOnly patients who received implants in free vascularized bone grafts between 2012 and 2020 were included. The free flap donor sites were the fibula, iliac crest, and scapula. The prosthetic restoration had to be completed, and the observation period had to be over one year after implantation. Implant success was defined according to the Health Scale for Dental Implants criteria.ResultsSixty-two patients with 227 implants were included. The implant survival rate was 86.3% after an average of 48.7 months. The causes of implant loss were peri-implantitis (n = 24), insufficient osseointegration (n = 1), removal due to tumor recurrence (n = 1), and osteoradionecrosis (n = 5). Of all implants, 52.4% were classified as successful, 19.8% as compromised, and 27.8% as failed. Removal of osteosynthesis material prior to or concurrent with implant placement resulted in significantly better implant success than material not removed (p = 0.035). Localization of the graft in the mandibular region was associated with a significantly better implant survival (p = 0.034) and success (p = 0.002), also a higher Karnofsky Performance Status Scale score with better implant survival (p = 0.014).ConclusionImplants placed in vascularized grafts showed acceptable survival rates despite the potential risk factors often present in these patient groups. However, peri-implantitis remains a challenge.Graphical abstract

Application of traditional Chinese medicine acupoint needle embedding combined with emotional nursing in patients with gynecological malignant tumors.

Few relevant literature reports on applying acupoint press-needle embedding combined with emotional nursing in patients with a gynecological malignant tumor. To explore the effect of traditional Chinese medicine acupoint needle embedding combined with emotional nursing on chemotherapy-related nausea and vomiting (CINV), cancer-related fatigue (CRF) and psychological state in patients with gynecological malignant tumors. Retrospective analysis of the clinical information of 84 patients with gynecological malignant tumors treated in our hospital from August 2020 to December 2022 Led to the development of an observation group (n = 42) and a control group (n = 42) based on various nursing approaches. Ondansetron hydrochloride injection was administered to the individuals in the control group. However, the observation group received emotional nursing based on the control group and acupoint press-needle embedding of traditional Chinese medicine. Patients in both groups received the chemotherapy regimen of paclitaxel liposome + carbo-platin/ cisplatin. For four weeks, both groups intervened. The CINV grade, quality of life, CRF, psychological status and sleep quality scores of the two groups before and after intervention were compared. After intervention, the degree of CINV in the observation group was significantly better than that in the control group. After intervention, the scores of each dimension and total score of FLIE scale were significantly higher than those in the control group. After intervention, the scores of each dimension and total score of Piper Fatigue Scale were significantly lower than those in the control group (P < 0.05). After intervention, the scores of avoidance and yield dimensions in the observation group were significantly lower than those in the control group, and the scores of confrontation dimension were significantly higher than those in the control group (P < 0.05). After intervention, the sleep quality score of the observation group was significantly lower than that of the control group, and the Karnofsky Performance Status scale score was significantly higher than that of the control group (P < 0.05). The acupuncture point needle embedding of traditional Chinese medicine combined with emotional nursing can further reduce the incidence of chemotherapy-related nausea and vomiting in patients with gynecological malignant tumors, improve the quality of life and the degree of CRF, alleviate the bad psychological state, adopt a positive way to face the disease and treatment, and improve the quality of sleep and quality of life.

Exploring the influencing factors of unmet palliative care needs in Chinese patients with end-stage renal disease undergoing maintenance hemodialysis: a cross-sectional study

BackgroundThe role of palliative care for end-stage renal disease (ESRD) patients have been proven in some developed countries, but it is still unclear in the mainland of China. In fact, patients with ESRD experience many unmet palliative care needs, such as physical, psychological, social and spiritual needs, but the factors influencing these needs have not investigated.MethodsA cross-sectional study was conducted at two hemodialysis centers in the mainland of China from January to September 2022. Convenience sampling was used to collect data on the participants' socio-demographics, clinical characteristics, the Palliative Care Outcome Scale (POS), the Dialysis Symptom Index (DSI), the Karnofsky Performance Status Scale (KPS), the Patient Health Questionnaire-9 item (PHQ-9), and the Social Support Rate Scale (SSRS). Data were analyzed using latent profile analysis, Kruskal–Wallis test, one-way analysis of variance (ANOVA), the chi-square test and multinomial logistic regression analysis.ResultsThree hundred five participants were included in this study, and divided palliative care needs into three categories: Class 1, mild palliative care needs (n = 154, 50.5%); Class 2, moderate palliative care needs (n = 89, 29.2%); Class 3, severe palliative care needs (n = 62, 20.3%). Based on the analysis of three profiles, the influencing factors of unmet needs were further analyzed. Compared with Class 3, senior high school education, the household per capita monthly income < 2,000, low KPS scores, high PHQ-9 scores, and low SSRS scores were less likely to be in Class 1 (OR = 0.03, P = 0.012; OR = 0.003, P < 0.001; OR = 1.15, P < 0.001; OR = 0.55, P < 0.001; OR = 1.35, P = 0.002; respectively) and Class 2 (OR = 0.03, P = 0.007; OR = 0.05, P = 0.011; OR = 1.10, P = 0.001; OR = 0.60, P = 0.001; OR = 1.32, P = 0.003; respectively), and high symptom severity were less likely to be in Class 1 (OR = 0.82, P = 0.001). Moreover, compared with Class 1, the household per capita monthly income < 2,000 (OR = 16.41, P < 0.001), high symptom severity scores (OR = 1.12, P = 0.002) and low KPS scores (OR = 0.95, P = 0.002) were more likely to be in Class 2.ConclusionsThis study showed that almost half of ESRD patients receiving MHD presented moderate to severe palliative care needs, and the unmet needs were mainly affected by education level, financial pressure, functional status, symptom burden and social support. In the future, it is important to identify the populations with the greatest need for palliative care and consider the influencing factors of unmet needs from a comprehensive perspective, so as to help them improve health-related quality of life.

Nonconvulsive status epilepticus characteristics in glioma patients: a retrospective study

PurposeEpilepsy is a common complication of gliomas. The diagnosis of nonconvulsive status epilepticus (NCSE) is challenging because it causes impaired consciousness and mimics glioma progression. NCSE complication rate in the general brain tumor patient population is approximately 2%. However, there are no reports focusing on NCSE in glioma patient population. This study aimed to reveal the epidemiology and features of NCSE in glioma patients to enable appropriate diagnosis.MethodsWe enrolled 108 consecutive glioma patients (45 female, 63 male) who underwent their first surgery between April 2013 and May 2019 at our institution. We retrospectively investigated glioma patients diagnosed with tumor-related epilepsy (TRE) or NCSE to explore disease frequency of TRE/NCSE and patient background. NCSE treatment approaches and Karnofsky Performance Status Scale (KPS) changes following NCSE were surveyed. NCSE diagnosis was confirmed using the modified Salzburg Consensus Criteria (mSCC).ResultsSixty-one out of 108 glioma patients experienced TRE (56%), and five (4.6%) were diagnosed with NCSE (2 female, 3 male; mean age, 57 years old; WHO grade II 1, grade III 2, grade IV 2). All NCSE cases were controlled by stage 2 status epilepticus treatment as recommended in the Clinical Practice Guidelines for Epilepsy by the Japan Epilepsy Society. The KPS score significantly decreased after NCSE.ConclusionHigher prevalence of NCSE in glioma patients was observed. The KPS score significantly decreased after NCSE. Actively taking electroencephalograms analyzed by mSCC may facilitate accurate NCSE diagnosis and improve the activities of daily living in glioma patients.

Influence of humanized nursing on patients with intracranial aneurysm subarachnoid hemorrhage undergoing interventional embolization

ObjectiveTo investigate the effect of nursing intervention on patients with intracranial aneurysm subarachnoid hemorrhage who underwent interventional embolization. MethodsAccording to the random number table method, 80 patients with subarachnoid hemorrhage caused by intracranial aneurysm who received interventional embolization in our hospital from September 2018 to May 2021 were randomly divided into a control group of 40 cases and an observation group of 40 cases. 40 cases, the two groups were implemented routine nursing and humanized nursing. ResultsCompared with before nursing, the anxiety score, depression score, compliance rate, complication rate and PSQI score of the observation group were significantly lower than those of the control group after nursing (P < 0.05); Karnofsky Performance Status Scale score, Activity of daily living scale of the observation group and quality of life scores were significantly higher than those in the control group (P < 0.05). ConclusionHumanized nursing can effectively improve the psychological state of patients with subarachnoid hemorrhage caused by intracranial aneurysm during the perioperative period of interventional embolization, enhance their compliance with treatment, reduce complications, and make patients more satisfied with nursing services.

Association between Karnofsky performance status and outcomes in cancer patients on home parenteral nutrition

The selection of appropriate criteria is essential to accurately identify cancer patients eligible for home parenteral nutrition (HPN). In this study, the association between Karnofsky Performance Status (KPS) Scale scores and outcomes in cancer patients on HPN was evaluated. Retrospective-observational-longitudinal-analytical study of a database of adult cancer patients on HPN. The variables analyzed were sex, age, cancer diagnosis, cancer location (digestive tract and genitourinary), nutritional status, including initial weight (IW), at the start of HPN), usual weight (UW) and IW/UW ratio, and body mass index (BMI) at the start of HPN. Performance status was assessed with the KPS scale. Type of catheter used, number of days on HPN and clinical progression of cancer patients were also studied. Data of 41 cancer patients (60.8% female) were evaluated. Mean age at the start of HPN was 60.45 years. Cancer location was digestive tract (n=36; 87.8%); gynecologic (n=4; 9.7%), urinary tract (n=1; 2.4%). Median IW was 55kg (45; 64) and BMI was 20 (17.58; 22.84). The IW/UW ratio was-15kg (-20;-10). The catheters used were peripherally inserted central catheter (n=30; 73.2%), tunneled (n=9; 22%) and port (n=2; 4.8%). The median duration of HPN was 72 days (30; 159). The KPS results showed that 16 cancer patients (39%) had KPS scores ≤50, 17 (41.5%) requiring HPN were discharged and 24 (58.5%) died. The association between disease progression and KPS scores ≤50 was significant (p=0.025; OR (95% CI): 5.28 (1.07; 36.18). The KPS scale is a reliable tool to identify cancer patients eligible for HPN. Cancer patients with ≤50 scores had a five-fold increased risk of death than patients with >50 scores.

Efficacy and safety of total lymphoid irradiation in different chronic lung allograft dysfunction phenotypes.

Total lymphoid irradiation (TLI) is an alternative treatment for chronic lung allograft dysfunction (CLAD). However, data regarding its efficacy and tolerance are scarce. This study included patients with CLAD treated with TLI at our center between 2011 and 2018. Clinical characteristics before and after TLI and related complications were analyzed. Forty patients with CLAD (twenty-nine bronchiolitis obliterans syndrome [BOS], nine restrictive allograft syndrome [RAS], and two mixed) were included. Significant attenuation of the forced expiratory volume in 1-sec (FEV1 ) decline slope was observed in all phenotypes, in both the BOS and RAS. The median FEV1 12, 6, and 3 months pre-TLI were as follows: 1980 (IQR 1720-2560), 1665 (IQR 1300-2340) and 1300 (IQR 1040-1740) ml (p<.001), while the median FEV1 at 3, 6, and 12 months post-TLI was 1110 (IQR 810-1440), 1130 (IQR 860-1470), and 1115 (IQR 865-1490) ml (p=.769). No dropouts due to radiation toxicity were observed. The mean survival according to the Karnofsky Performance Status Scale (KPS) >70 or ≤70 at baseline was 1837 (IQR 259-2522) versus 298 (IQR 128-554) days (p<.0001), respectively. In conclusion, TLI may stop FEV1 decline in both BOS and RAS. Moreover, a good KPS score may be an important prognostic factor.

Orthopedic therapeutic surgery for bone metastasis of liver cancer: Clinical efficacy and prognostic factors.

In this study, the objectives were to investigate the clinical efficacy of orthopedic therapeutic surgery (OTS) in patients with bone metastasis of liver cancer and explore the prognostic factors. The electronic medical records of patients with bone metastasis of liver cancer in the Third Affiliated Hospital of Naval Medical University from September 2016 to August 2021 were retrospectively collected. A total of 53 patients were included. Patients were assigned to the OTS (n = 35) or the control group (n = 18) based on receiving orthopedic therapeutic surgery or conservative treatment. The pre/posttreatment Karnofsky Performance Status scale (KPS) and numeric rating scale (NRS) scores were compared. Univariate and multivariate Cox regression analyses were used to explore the prognostic factors affecting survival after bone metastasis. Logistic regression analyses were adopted to discover potential factors that contributed to greater KPS score improvement. The axial bone accounted for 69.8% of all bone metastases. The proportion of multiple bone metastases was 52.8%. After surgery, the median KPS score of the OTS group increased from 60 to 80 (p < 0.001), and the median increase in the OTS group was higher than that of the control group (p = 0.033). The median NRS score of the OTS group declined from 6 to 2 after surgery (p < 0.001), and the median decline in the OTS group was higher (p = 0.001). The median survival was 10 months in the OTS group vs. 6 months in the control group (p < 0.001). Higher pretreatment KPS scores, undergoing liver primary lesion surgery, and undergoing orthopedic therapeutic surgery were protective factors of survival. Undergoing orthopedic therapeutic surgery greatly improved the KPS score. Orthopedic therapeutic surgery for bone metastasis of liver cancer provides benefits to the quality of life. Patients who have their primary liver lesions removed, undergo orthopedic therapeutic surgery, and have a better physical condition before treatment tend to have longer survival.

Karnofsky performance status and visual analogue scale scores are simple indicators for quality of life in long-term AYA survivors who received allogeneic hematopoietic stem cells transplantation in childhood

The purpose of this study was to investigate Karnofsky performance status (KPS) scores and visual analogue scale (VAS) scores to explain which domains in the standardized self-reported quality of life (QOL) are instrumental for long-term hematopoietic stem cell transplantation (HSCT) survivors. We conducted a nationwide cross-sectional questionnaire study on 221 survivors with allogeneic-HSCT in 28 pediatric centers. Patient-reported QOL was assessed at a single time point using the 36-item Short-Form Survey (SF-36), the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT), and VAS scores. KPS scores were significantly correlated with both physical and role component summary scores of the SF-36, while the VAS provided by the patient (VASpt) was significantly correlated with the mental component summary score of the SF-36 and many subscales of the FACT-BMT. The VAS provided by the participants' attending physician (VASdoc) was correlated well with KPS scores. A VASpt score more than 40% lower than KPS scores suggested mental health problems. In conclusion, KPS scores might be considered as an indicator for physical and role/social components and VASpt score as an indicator for mental components and HSCT-specific QOL.

Meaning in life and its relationship with family cohesion: A survey of patients with palliative care in China

ObjectiveMeaning in life (MIL) and family cohesion are important concerns for the palliative care population; however, evidence of the relationship between MIL and family cohesion is scarce. Therefore, this study aimed to examine the relationship between MIL and family cohesion and explore the factors that influence MIL among the palliative care population. MethodsIn this cross-sectional study, 205 patients with advanced cancer were recruited from two palliative care units in China. Data were collected using the meaning in life scale (MiLS), the family cohesion subscale of the Family Adaptability and Cohesion Scale, second edition, Chinese version, and the Karnofsky Performance Status Scale (KPS). Multivariate linear regression models were used to examine the relationship between family cohesion and perceived MIL and identify the potential factors of participants’ MiLS score. ResultsThe mean MiLS score was 100.90 (SD ​= ​9.17). The results showed that family cohesion (r ​= ​0.313, P ​< ​0.001) and KPS scores (r ​= ​0.311, P ​< ​0.001) were positively correlated with MiLS scores. Multivariate linear regression revealed that MIL was significantly influenced by family cohesion, KPS score, sex, religiosity, whether participants lived alone, and their medical insurance payment method (Adjust R2 ​= ​28.4%, F ​= ​6.281, P ​= ​0.013). ConclusionsOur findings indicate a positive relationship between family cohesion and MIL, suggesting that clinicians should consider increasing patients’ family cohesion as an approach to enhance perceived MIL.

Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): Analysis of progression after first subsequent therapy in KEYNOTE-426.

4513 Background: The randomized, open-label, phase 3 KEYNOTE-426 study (NCT02853331) met its primary and key secondary end points of improved OS, PFS, and ORR with pembro + axi versus sunitinib as first-line treatment for patients with advanced ccRCC. Extended follow-up (42.8-mo median follow-up) continued to show the superior efficacy of pembro + axi versus sunitinib in this patient population. We describe the results of PFS2 for all randomly assigned patients and across IMDC risk categories. Methods: Treatment-naive patients with advanced ccRCC, Karnofsky Performance Status Scale score ≥70% and measurable disease per RECIST v1.1 were randomly assigned 1:1 to receive pembro 200 mg IV every 3 weeks for up to 35 doses (̃2 y) + axi 5 mg orally twice daily or sunitinib 50 mg orally once daily on a 4-wk on/2-wk off schedule. The end point of this exploratory analysis was PFS2, defined as time from randomization to progression after first subsequent therapy or any-cause death. The Kaplan-Meier method was used to estimate PFS2 and hazard ratios were estimated using a Cox regression model. Results: Of 861 patients, 432 were assigned to receive pembro + axi; 429, to sunitinib. Median time from randomization to the database cutoff date (January 11, 2021) was 42.8 mo (range, 35.6-50.6). Overall, 47.2% of patients (204/432) in the pembro + axi arm and 65.5% of patients (281/429) in the sunitinib arm received ≥1 line of subsequent anticancer therapy. For patients who received subsequent therapy, anti–PD-1/PD-L1 agents were the first subsequent treatment for 11.3% of patients (23/204) in the pembro + axi arm and 54.8% of patients (154/281) in the sunitinib arm. In the pembro + axi arm, 82.8% of patients (169/204) received a VEGF/VEGFR inhibitor as first subsequent therapy, as did 43.4% (122/281) in the sunitinib arm. PFS2 results are displayed in the Table. Conclusions: In this exploratory analysis, PFS2 was longer for patients randomized to pembro + axi compared to sunitinib. Results were consistent across IMDC risk groups. These data support use of pembro + axi for the first-line treatment of patients with advanced ccRCC. Clinical trial information: NCT02853331. [Table: see text]

The Effect of Race in the Palliative Treatment of Bone Metastases

PurposePrior studies demonstrated that single and multiple-fraction radiation therapy (RT) provide comparable pain relief in palliative-care patients. In addition, unconscious racial biases may affect practice patterns in oncology. In this study, we examined the effect of race on the duration of RT for palliative treatment of bone metastases. Methods and MaterialsThis is a retrospective study of 707 patients treated for bone metastases between 2013 and 2020 (1348 treatments). Patient race, demographics, RT dose, number of fractions, use of stereotactic radiosurgery (SRS), and performance score were collected. A short-course was defined as a single fraction, whereas a long-course was defined as more than one fraction. SRS cases were analyzed separately. ResultsOf all nonradiosurgery RT treatments delivered, 28.9% were single fraction and 71.1% were multiple fraction. In total, 76% of the patients were White and 24% were non-White. With regard to race, the number of White patients receiving short- and long-course RT was 256 (27.9%) and 663 (72.1%), respectively. The number of non-White patients receiving short- and long-course RT was 97 (31.9%) and 207 (68.1%), respectively. There was no difference in treatment duration based on patient race (P = .20). The use of SRS did not vary based on race (P = .79). There was no statistically significant difference in Karnofsky Performance Status Scale score between White and non-White patients (P = .44). ConclusionsAnalysis of patient and physician characteristics revealed that race did not influence treatment decisions such as duration of palliative RT regimen or use of SRS. Although palliative-care regimens must be individualized for each patient, such investigations can identify potential biases in treatment decisions.

Efficacy of Aidi Injection Combined With Radiotherapy for the Treatment of Nasopharyngeal Carcinoma: A Systematic Review and Meta-Analysis

Objective: Radiotherapy (RT) is the first choice in the treatment of nasopharyngeal carcinoma (NPC) but there are many adverse reactions. There is evidence that Aidi injection can improve the effect of RT and reduce the occurrence of adverse reactions after RT, but there is still a lack of evidence-based study. The objective of this study was to evaluate the efficacy and safety of Aidi injection combined with RT in the treatment of NPC. Methods: The PubMed, Cochrane Library, CNKI, EMBASE, Web of Science, CBM, Wanfang, and VIP data were thoroughly searched for randomized controlled trials (RCTs) on Aidi injection combined with RT against NPC until February 2021. The literature was screened, extracted, and evaluated by 2 investigators independently. Meta-analysis was performed by RevMan5.3 and Stata 14.0, and the quality of evidence was evaluated by Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Results: In this study, we included 9 RCT studies involving 422 patients. The results showed significant between-group differences in complete remission rate (CRR) [relative risk (RR) = 1.17, 95% CI (1.04, 1.31), P = .009], Karnofsky Performance Status Scale (KPS) score [RR = 1.30, 95% CI (1.19, 1.42), P &lt; .00001], leukopenia [RR = 0.65, 95% CI (0.54, 0.78), P &lt; .00001], hemoglobin reduction [RR = 0.60, 95% CI (0.43, 0.84), P = .003], nausea and vomiting [RR = 0.60, 95% CI (0.45, 0.80), P = .0004], oropharyngeal mucosa injury (OMI) [RR = 0.25, 95% CI (0.15, 0.44), P &lt; .00001], but the differences were not statistically significant in total effective rate (TER) [RR = 1.03, 95% CI (0.98, 1.08), P = .20 &gt; 0.05], thrombocytopenia [RR = 0.78, 95%CI (0.52,1.16), P = .22 &gt; .05], and skin injury [RR = 0.81, 95% CI (0.64, 1.04), P = .1 &gt; .05]. Conclusion: Aidi injection combined with RT can improve patients’ quality of life (KPS score) and reduce the adverse reactions caused by RT (such as leukopenia, hemoglobin reductio，OMI，nausea, and vomiting). However, limited by the quality and quantity of the included trials，more high-quality studies should be performed to verify our conclusions.

416 An open-label phase 2 study of 2 doses of the hypoxia-inducible factor (HIF)–2α inhibitor belzutifan for the treatment of advanced clear cell renal cell carcinoma after progression on systemic therapy

BackgroundAccumulation and aberrant stabilization of transcription factor HIF-2α drives the expression of genes associated with progression of clear cell renal cell carcinoma (ccRCC). Belzutifan, a first-in-class HIF-2α inhibitor, has demonstrated promising antitumor activity with a favorable safety profile in patients with heavily pretreated ccRCC. The efficacy and safety of 2 doses of belzutifan in patients with advanced ccRCC who experienced progression after systemic therapy will be evaluated in this randomized, open-label, multicenter, phase 2 trial (NCT04489771).MethodsApproximately 150 adults will be randomly assigned 1:1 to receive oral belzutifan 120 mg once daily or 200 mg once daily. Patients with locally advanced or metastatic ccRCC (per RECIST v1.1) who experienced progression on or after 1 line of anti–PD-1/PD-L1 therapy as monotherapy or combined with other agents, with the immediately preceding line of treatment an anti–PD-1/PD-L1 therapy, will be enrolled. Progression is defined as received ≥2 doses of an anti–PD-1/PD-L1 agent and having demonstrated radiographic disease progression (per investigator). Other key eligibility criteria: ≤3 prior systemic regimens and a Karnofsky Performance Status Scale score ≥70%. Patients who previously received belzutifan or another HIF-2α inhibitor; require supplemental oxygen; have a baseline hemoglobin level &lt;10 g/dL; have a history of HIV, hepatitis B, or hepatitis C infection; or have active central nervous system metastases are excluded. Patients will be stratified by International mRCC Database Consortium prognostic scores (0, 1 or 2, or 3–6) and by number of prior tyrosine kinase inhibitor–containing therapies (0, 1, or 2 or 3). Treatment will continue until progression, unacceptable toxicity, or withdrawal of consent. Computed tomography or magnetic resonance imaging will be performed at baseline, every 8 weeks through week 49, and every 12 weeks thereafter. Adverse events will be monitored throughout the study and for 30 days after treatment (90 days for serious adverse events). The primary end point is objective response rate per RECIST v1.1 by blinded independent central review (BICR). Secondary end points are progression-free survival, duration of response, and clinical benefit rate per RECIST v1.1 by BICR, overall survival, pharmacokinetics, and safety. The study will enroll patients in at least 9 countries (Australia, Belgium, Greece, Ireland, Israel, Netherlands, Russia, the United Kingdom, and the United States) and is recruiting.AcknowledgementsMedical writing and/or editorial assistance was provided by Matthew Grzywacz, PhD of ApotheCom (Yardley, PA, USA). This assistance was funded by Merck Sharp &amp; Dohme Corp., a subsidiary of Merck &amp; Co., Inc., Kenilworth, NJ, USA. Funding for this research was provided by Merck Sharp &amp; Dohme Corp., a subsidiary of Merck &amp; Co., Inc., Kenilworth, NJ, USA.Trial RegistrationClinicaltrials.gov, NCT04489771Ethics ApprovalThe study and the protocol were approved by the Institutional Review Board or ethics committee at each site.

417 Phase 3 study of pembrolizumab + belzutifan + lenvatinib or pembrolizumab/quavonlimab + lenvatinib versus pembrolizumab + lenvatinib as first-line treatment for advanced renal cell carcinoma

BackgroundPembrolizumab + vascular endothelial growth factor (VEGF) inhibitor lenvatinib demonstrated antitumor activity as first-line treatment for advanced clear cell renal cell carcinoma (ccRCC) in phase 3 trial KEYNOTE-581/CLEAR (NCT02811861). Hypoxia-inducible factor 2α (HIF-2α) inhibitor belzutifan (MK-6482) showed antitumor activity in ccRCC, and a coformulation of pembrolizumab and CTLA-4 inhibitor quavonlimab (MK-1308A) showed antitumor activity in non–small cell lung cancer. HIF-2α or CTLA-4 inhibition with PD-1 and VEGF inhibition backbone combination may provide additional benefit as first-line treatment in ccRCC. This open-label, randomized, phase 3 study (NCT04736706) will be conducted to compare novel combination therapies pembrolizumab + belzutifan + lenvatinib (arm A) and MK-1308A + lenvatinib (arm B) with pembrolizumab + lenvatinib (arm C).MethodsApproximately 1431 adults with metastatic ccRCC, measurable disease per RECIST v1.1, and Karnofsky Performance Status Scale score ≥70% who had not previously undergone systemic therapy for advanced ccRCC will be enrolled. Patients will be randomly assigned 1:1:1 to arm A (belzutifan 120 mg + lenvatinib 20 mg oral once daily + pembrolizumab 400 mg IV every 6 weeks), arm B (MK-1308A [quavonlimab 25 mg + pembrolizumab 400 mg] IV every 6 weeks and lenvatinib 20 mg oral once daily), or arm C (pembrolizumab 400 mg IV every 6 weeks + lenvatinib 20 mg oral once daily). Treatment will continue until documented disease progression, withdrawal of consent, or other discontinuation event; patients will receive pembrolizumab and MK-1308A for up to 18 cycles (approximately 2 years). Patients will be stratified by International mRCC Database Consortium (IMDC) score (favorable vs intermediate vs poor), region of the world (North America vs Western Europe vs rest of the world), and sarcomatoid features (yes vs no). Response will be assessed by CT or MRI per RECIST v1.1 by blinded independent central review (BICR) at week 12 from randomization, every 6 weeks through week 78, and every 12 weeks thereafter. Adverse events and serious adverse events will be monitored throughout the study and for 90 days after treatment. Dual primary end points are progression-free survival per RECIST v1.1 by BICR and overall survival. Primary end points will be assessed in arm A compared with arm C and in arm B compared with arm C for patients with IMDC intermediate/poor status and in all patients regardless of IMDC status. Secondary end points are objective response rate and duration of response per RECIST v1.1 by BICR, patient-reported outcomes, and safety.AcknowledgementsMedical writing and/or editorial assistance was provided by Matthew Grzywacz, PhD, of ApotheCom (Yardley, PA, USA). This assistance was funded by Merck Sharp &amp; Dohme Corp., a subsidiary of Merck &amp; Co., Inc., Kenilworth, NJ, USA, and Eisai Inc., Woodcliff Lake, NJ, USA. Funding for this research was provided by Merck Sharp &amp; Dohme Corp., a subsidiary of Merck &amp; Co., Inc., Kenilworth, NJ, USA,Eisai Inc., Woodcliff Lake, NJ, USA.Trial RegistrationClinicaltrials.gov, NCT04736706Ethics ApprovalThe study and the protocol were approved by the Institutional Review Board or ethics committee at each site.

Spinal Manifestation of Malignant Primary (PLB) and Secondary Bone Lymphoma (SLB).

Manifestation of malignant lymphoma in the spine is rare; there have only been a few cases reported in the literature. Due to its rarity, there is no gold standard for the management of patients suffering from spinal lymphoma manifestations. Methods: We retrospectively reviewed the data for 37 patients (14 female, 23 male) with malignant lymphoma in the spine receiving intervention in our center from March 2006 until June 2020. Neurological impairment, pain, diagnostics, and/or surgical instability were the criteria for surgery in this patient cohort. Otherwise, only CT-guided biopsies were conducted. Analysis of the patient cohort was based on the Karnofsky performance status scale (KPSS), location of the lesion, spinal levels involved, spinal instability neoplastic score (SINS), surgical treatment, histopathological workup, adjuvant therapy, and overall survival. The following surgical procedures were performed: posterior stabilization and decompression in nine patients; decompression and/or tumor debulking in 18 patients; a two-staged procedure with dorsal stabilization and vertebral body replacement in four patients; decompression and biopsy in one patient; a two-stage procedure with kyphoplasty and posterior stabilization for one patient; posterior stabilization without decompression for one patient; a vertebroplasty and cement-augmented posterior stabilization for one patient; and a CT-guided biopsy alone for two patients. Twenty-one patients (56.78%) had ≥1 lesion in the thoracic spine, 10 patients (27.03%) had lesions in the lumbar spine, two patients had lesions in the cervicothoracic junction, two patients had lesions in the thoracolumbar junction, one patient had a lesion in the lumbosacral junction, and one patient had a lesion in the sacrum. The diagnoses of the histopathological workup were diffuse large B-cell lymphoma in 23 (62.16%) cases, indolent lymphoma in 11 (29.74%) cases, anaplastic T-cell lymphoma in one case (2.70%), T-cell lymphoma in one case (2.70%), and Burkitt lymphoma in one (2.70%) case. The median overall survival was 7.2 months (range 0.1–266.7 months). Pre- and postoperative KPSS scores were 70% (IQR 60–80%). Manifestation of malignant lymphomas in the spine is rare. Similar to the approach taken for spine metastases, a surgical intervention in cases of neurological impairment or manifest or potential instability is indicated, followed by chemoimmunotherapy and radiotherapy.

Cement-Augmented Carbon Fiber–Reinforced Pedicle Screw Instrumentation for Spinal Metastases: Safety and Efficacy

To investigate the complication rates and long-term implant failure rates in a monocentric study of a consecutive cohort of patients with thoracolumbar spinal metastases after posterior instrumentation with a fenestrated carbon fiber-reinforced poly-ether-ether-ketone (CFRP) pedicle screw system. We retrospectively reviewed demographics, Karnofsky Performance Status Scale scores, complications, and implant failure rates. Between June 2016 and November 2019, 51 consecutive patients underwent cement-augmented CFRP pedicle screw instrumentation at our institution. Mean age was 68 years (standard deviation 10.5), the median preoperative Karnofsky Performance Status Scale of 80 increased to 90 postoperatively (P= 0.471). Most common primary entities were breast (25.5%), lung (15.7%), and prostate (13.7%) cancers. Of 428 placed screws, 293 (68.5%) were augmented with polymethylmethacrylate, a mean 6 per patient (standard deviation ±2). Screws were inserted via a minimally invasive system technique in 54.9% of cases. In total, 11.8% of patients had immediate postoperative sequelae related to the cement. Pulmonary cement embolisms were noted in 3 patients, 2 had paravertebral extravasation, and 1 had an embolism into a segmental artery. Of these 6, 2 patients with pulmonary embolisms reported related symptoms. Follow-up was available for 80.4%. After a mean 9.8 months, screw loosening was noted in 11.8% of cases on computed tomography, although it was asymptomatic in all but 1 patient. Screw pull-out did not occur. Neither cement-related (P= 0.353) nor general complication rates (P= 0.507) differed significantly between open and minimally invasive system techniques. Percutaneous cement-augmented CFRP pedicle screw instrumentation facilitates artifact-reduced postoperative imaging, while maintaining a risk profile and implant failure rates comparable to conventional metallic instrumentation.

Post-Transplantation Cyclophosphamide and Short-Term Methotrexate for Tolerance Induction in HLA-Haploidentical Transplantation for Severe Aplastic Anemia

Background. Haploidentical related donors (HIDs) are attractive donors for patients with severe aplastic anemia (SAA) because they are readily available for nearly all the patients. Bone marrow transplant (BMT) using post-transplant cyclophosphamide (PTCy) has been shown effective to cross the immune barriers between the recipients and their HIDs. Short-term low dose of methotrexate (ST-MTX) has long been adopted either alone or combined with calcineurin inhibitors to get across the immune barrier in hematopoietic stem cell transplant (HSCT).Aim of the study. We presented the outcome of 15 patients with SAA who underwent haploidentical transplant (HIT) using T-cell-replete peripheral graft and combination of PTCy with ST-MTX.Patients and grafts. We analyzed the medical records of 15 patients with SAA between Jan 2015 and July 2017. The transplants were either upfront (8/15) or rescue treatment (7/15). The median age of the patients was 16 (range 5-39) years and 66.7% (10/15) were male. All the patients received granulocyte colony-stimulating factor (G-CSF) mobilized peripheral graft from haploidentical related donors. The median mononuclear cells (MNCs) was 12.4 × 108 cells/kg recipient ideal body weight (IBW) with the range of (7.0-22.0) × 108 cells/kg, the CD34+ cell was 7.5 × 106 cells/kg with the range of (5-23) × 106 cells/kg and the CD3+ cells was 2.7 × 108 cells/kg with the range of (1.8-5.0) × 108 cells/kg.Conditioning regimen and GvHD prophylaxis. We used a TBI-free transplantation platform named FBC+PTCy/ST-MTX. Fludarabine was administered at 40 mg/m2 IV daily for 5 days. Busulfan was delivered in a total dose of 6.4mg/kg. Cyclophosphamide was given 14.5 mg/kg daily for 2 days. PTCy was administered at 60mg/kg/day IV on days +3 and +4 post-transplant. Low doses of MTX were delivered on days +1, +2 and +5 post-transplant at 15mg/m2, 10mg/m2 and 10mg/m2. Cyclosporine was given from day +6 through day +180 with the target through level 150~180ng/ml and then was tapered until 12 months post transplant. Mycophenolate mofetil (MMF) was given from day +6 to +35 days for the first 3 patients and then was eliminated for the following patients.Results.Neither primary nor secondary graft failure (GF) was seen in this study. Neutrophil engrafted at 15 days (range, 13-18 days). Platelets engrafted at 19 days (range, 14-36 days) and recovered over 100 × 109/L at 38 days (range, 14-77 days). The time to total lymphocytes recovery over 0.5 × 109/L for 3 consecutive days was 34 days (range, 25-72 days). The accumulated engraftment of neutrophil and platelets were both 100% at +40 days. (Figure 1-A, B.)The cumulative incidence of aGvHD at 100 days was 20.0%(3/15). Two patients had grade I skin aGvHD and the other one had grade II skin aGvHD. No grade III-IV aGvHD was seen. 12 patients were evaluable for the incidence of cGvHD and none of them developed moderate or sever cGvHD with a median of 150 (102-806) days post transplant. (Figure 1-C, D.) During the follow-up, one patients had skin cGvHD and received systemic therapy with corticoid. The treatment was discontinued after 8 months post transplant. All 3 patients, who survived beyond 12 months post transplant at the end of our follow-up, were off immunosuppress.With a median follow-up of 230 days (range 41-806 days), all the patients are alive. They are transfusion independent with karnofsky performance status scale (KPS) scores 100.Conclusion.This study shows that haploidentical related transplant can be successfully applied using T-cell-repleted peripheral grafts. ST-MTX may facilitate PTCy to achieve a stable engraftment with a minimal risk of GvHD in HIT for patients with SAA. Our approach should expand the donor pool for patients with SAA. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.