Karnofsky Performance Score Score Research Articles

Patient Characteristics Following Surgery for Spinal Metastases: A Multicenter Retrospective Study.

ObjectivesTo summarize the epidemiological characteristics of patients following surgery for spinal metastases retrospectively and make a univariate analysis to identify independent variables that could affect the operation decision making.MethodsThis was a multicenter retrospective review of patients with spinal metastasis who were treated with surgery from 1 January 2007 to 31 July 2019. Basic clinical data were analyzed retrospectively by univariate analysis to identify independent variables that could affect the decision of operation modalities, including gender, age, spinal metastatic site, Frankel score, Karnofsky performance score (KPS), spinal instability neoplastic score (SINS), visual analogue scale (VAS), Tokuhashi score, urinary and fecal incontinence, spinal pathological fracture, primary tumor, extraspinal metastasis, visceral metastasis, and bone lesion (osteolytic, osteoblastic or mixed).ResultsA total of 580 patients including 332 males and 248 females were enrolled in the study with an average age of 58.26 years old (range, 13–86 years old). The most common spinal metastatic level was the thoracic vertebra (190 [32.76%]), followed by the lumbar vertebra (146 [25.17%]), cervical vertebra (47 [8.10%]), and sacral vertebra (35 [6.03%]). Metastases involving more than two sites of the cervical, thoracic, lumbar, and sacral vertebrae arose in 162 (27.93%) patients. For primary tumor, there were 198 (34.14%) cases of lung cancer, 41 (7.07%) cases of kidney cancer, 39 (6.72%) cases of breast cancer, 38 (6.55%) cases of gastrointestinal cancer, 35 (6.03%) cases of lymphoma and myeloma, 25 (4.31%) cases of prostate cancer, 24 (4.14%) cases of liver cancer, 23 (3.97%) cases of mesenchymal tissue sarcoma, 20 (3.45%) cases of thyroid cancer, and 84 (14.48%) cases were tumor with unknown origin. Sixty‐three (10.86%) patients received minimally invasive surgery, 460 (79.31%) patients received palliative surgery, and the remaining 57 (9.83%) received tumor resection. According to the univariate analysis, the KPS score, SINS score, VAS score, Tokuhashi score, urinary and fecal incontinence, spinal pathological fracture, and bone lesion (osteolytic, osteoblastic or mixed) were independent and favorable factors affecting the surgery modalities.ConclusionsSurgical treatment for spinal metastases was mainly to relieve pain, rebuild spinal stability, improve nerve function, control local tumors, and improve the quality of life of patients. For middle‐aged and elderly patients with good general conditions, severe pain, spinal pathological fracture, spine instability and without urinary and fecal incontinence, early surgical treatment should be actively carried out.

Disease Risk Index (DRI) and Age but Not HCT Comorbidity Index (HCT-CI) Are Predictive of Overall Survival after Cord Blood Transplantation Supported By Haplo-CD34+ progenitor Cells

Introduction: Predictors routinely used to assess long-term survival after allogeneic hematopoietic cell transplantation (alloHCT) have not been specifically validated for pre-transplant risk assessment of patients getting cord blood transplantation supported by Haplo-CD34+ Progenitor cells as a myeloid bridge (haplo-cord). Methods: All consecutive adult patients with hematological malignancies who received an alternative donor alloHCT with a haplo-cord at Weill Cornell Medicine were included. Data was collected from an ongoing haplo-cord protocol (clinicaltrials.gov identifier 01810588). Plasma cell disorders were excluded. Age, CIBMTR Disease Risk Index (DRI), Karnofsky performance score (KPS), and HCT comorbidity index (HCT-CI) (routinely calculated since 06/2014), were assessed before alloHCT. The Kaplan-Meier method was used to estimate OS probabilities. Comparisons of OS were evaluated by the log-rank test. Significant predictors were considered in a Cox proportional hazards regression model using forward stepwise selection. A cumulative incidence function (CI) for relapse was calculated using a competing risk model for non-relapse mortality (NRM). We further validated our findings in the subgroup of patients with AML. Results: Between 06/2012 and 12/2018, 217 patients underwent haplo-cord transplantation. Indications for alloHCT included: 66% leukemia, 19% MDS/MPN, 15% Lymphoma. Median age was 58 yr (22% ≤ 40yrs, 33% between 41-59yrs, and 45% ≥ 60 yrs). 43% of patients were women. KPS score was ≥ 90 in 56%. DRI was high/very-high in 43% and low/intermediate in 56%. HCT-CI for 154 patients was 0 in 14%, 1-2 in 21%, 3-5 in 45% and ≥ 6 in 20%. Conditioning regimens included fludarabine with melphalan 45%, plus TBI 51%, other 4%. Median follow-up was 30 months. 2yr OS was 38% (95%CI 31-44%). 2yr CI of NRM was 35% and relapse 36%. Age (p=0.001), DRI (p<0.001), and KPS (p=0.003) were associated with OS in univariate analysis(Figure 1). HCT-CI did not correlate with OS (p=0.53). In a multivariable model, only age ≥60 (HR 1.86, p=0.01) and high/very high DRI (HR 1.86, p<0.001) remained predictive of OS. (Figure 2). Age ≥ 60 was associated with increased NRM at 2 yrs (45% vs 27%, p=0.01). High/very high DRI was associated with relapse at 2 years (51% vs 24%, p<0.001). A subgroup analysis of 123 patients with AML showed consistent findings; age ≥ 60 (HR 2.11, p=0.04) and high/very high DRI (HR 2.51, p<0.001) remained predictive for OS in multivariable analysis. Conclusion: DRI and age are highly predictive of OS for patients undergoing haplo-cord transplantation. Our finding that HCT-CI is not predictive of OS when applied to haplo-cord alloHCT is supported by previous findings investigating the role of HCT-CI in cohorts with cord blood donors (Adachi Y et al BBMT 2018 and Majhail N et al BBMT 2008). To this end, our findings demonstrate that a high HCT-CI score should not preclude patients from evaluation for alternative donor transplantation using cord blood supported by Haplo-CD34+ progenitor cells. Other prognostic tools to assess specific comorbidities impacting this transplant platform are needed for accurate pre-transplant risk assessment in order to improve decision making and clinical trial assignments. Disclosures Van Besien: Miltenyi Biotec: Research Funding.

OS3.4 Karnofsky and WHO performance scores of brain tumour patients may limit inclusion in protocols though they depend on clinician status

Abstract BACKGROUND Inclusion criteria for oncological protocols often use the Karnofsky performance score (KPS) >=70 or the WHO performance score (PS) 0–2 as a cut-off value. Inclusion of neuro-oncology patients may be hampered, when general condition is preserved, while performance is decreased due to physical handicap. The goal of this study is to compare the KPS and PS assessments according to the status of the clinician. MATERIAL AND METHODS A cross-sectional survey was conducted through ANOCEF and EANO networks. Clinicians evaluated KPS and PS in 6 clinical situations concerning neuro oncology patients (from youngest and fittest to oldest, crippled with comorbidities). RESULTS The rate of PS <70 or PS> 2 increased significantly from case 1 to 6. Sex or nationality of the clinicians had no impact when adjusting on clinician characteristics. Conversely, speciality (residents/general practitioner vs neurosurgeons vs neurologists vs oncologists), impacted KPS or PS evaluations (p<.0001 and p=0.0046, respectively). Residents or general practitioner estimate KPS much lower than the others specialities. Neurosurgeons estimate PS more severely. Clinicians who were not used to including patients in clinical trials proposed lower KPS scores (p = 0.0008). This tendancy was not shown on PS. Eldest physicians significantly rated more severely than the youngest (p = 0.0459 and p <.0001 for KPS and PS, respectively). In a multivariate analysis, age and speciality were correlated with KPS and PS rating even if adjusted on cases. Discordant decision for protocol inclusion (i:e: (KPS) >=70 vs PS 0–2) showed little discrepancy in case 1 (2.3%), while discrepancy increased to respectively 16, 46, 39, 33 and 43% for cases 2 to 6: in nearly all cases, the KPS would have denied access to a trial, while WHO Ps would have allowed CONCLUSION Rating of KP and PS is subjective in neuro oncology patients: influenced by speciality, age and inclusion habit (for KPS) of clinicians, PS 0–2 allows usually more inclusion than KPS>=70 in more severely disabled patients. A Neuro oncology specific KPS and/or PS definition is warranted to allow more widely inclusion of patients with exclusive neurologic handicap.

Dual Modality Radiation With External Beam Radiation Therapy and Transarterial Radioembolization for Hepatocellular Carcinoma With Gross Vascular Invasion.

Patients with hepatocellular carcinoma (HCC) and gross vascular invasion (GVI) have poor outcomes with systemic therapy such as sorafenib. Both external beam radiation therapy (EBRT) and transarterial radioembolization (TARE) have been utilized for this patient population. We sought to compare outcomes using dual modality radiation (EBRT+TARE) versus EBRT alone in patients with HCC and GVI. Between 2011 and 2017, 45 patients with HCC and GVI were treated with EBRT±TARE at our institution. Progression-free survival (PFS) and overall survival (OS) were assessed and compared using Kaplan-Meier method and log-rank test. Univariable and multivariable Cox proportional hazards regression was used to assess the impact of the variables stage, etiology of cirrhosis, Child-Pugh (CP) score, and Karnofsky Performance Score (KPS) on PFS and OS. Patient characteristics were well-balanced except for KPS (80 vs. 90) and CP score. Median OS for patients receiving EBRT+TARE was 263 days (95% confidence interval [CI]: 167, -) versus 193 days (95% CI: 51, 262) for EBRT alone (P=0.049). However, this did not hold up on MVA. When EBRT and TARE were delivered within 2 months as planned (n=12), median PFS was 218 days (95% CI: 44, -) for dual modality radiation versus 63 days (95% CI: 38, 137) for EBRT alone (P=0.048). When EBRT and TARE were delivered within 6 months, the difference in PFS was no longer seen (P=NS), because some patients received TARE as a salvage therapy. Dual modality radiation with EBRT and TARE may be associated with improved OS in patients with HCC and GVI. Dual modality radiation may be associated with improved PFS in patients with HCC and GVI compared with EBRT alone when EBRT and TARE are delivered within 2 months of each other as part of a planned dual modality treatment strategy. However, since this is a retrospective study with inherent selection bias, these findings need further validation in a prospective clinical trial for patients with HCC and GVI.

Clinical efficacy and safety of hypofractionated three-dimensional conformal radiotherapy in the treatment of recurrent nasopharyngeal carcinoma

Objective To evaluate the clinical efficacy and safety of the hypofractionated three-dimensional conformal radiotherapy in the treatment of recurrent nasopharyngeal carcinoma. Methods Clinical data of 153 patients with recurrent nasopharyngeal carcinoma admitted to our hospital from 2008 to 2013 undergoing hypofractionated three-dimensional conformal radiotherapy (3 Gy for each time, 5 times a week, a total dose of 51-60 Gy, 17-20 times/4 weeks) were retrospectively analyzed. The short-and long-term radiation-induced injury, Karnofsky performance score (KPS), short-and long-term clinical efficacy were evaluated. Results For the short-term radiation-induced injury, the incidence of oral mucosa and fatigue significantly differed before and after treatment (both P<0.05). Regarding the long-term radiation-induced injury, the incidence of dry mouth (95.4%) and deafness (51.0%), difficulty in opening mouth (79.1%), maxillofacial fibrosis (33.3%) and radiation-induced encephalopathy (15.0%) significantly differed before and following treatment (all P<0.05). The actual long-term radiation-induced injury included dry mouth (91.5%), deafness (50.9%), difficulty in opening mouth (76.5%), maxillofacial fibrosis (32.0%) and radiation-induced encephalopathy (14.4%). The number of patients with changes in the KPS scores significantly differed between the end of treatment and 3 months after treatment (P<0.05). The local control rates were 29.4%, 68.6%, 79.1%, 83.7% and 86.9% at 1-, 3-, 6-, 9-and 12-month after corresponding treatment, respectively. The local control rate significantly differed between 1 and 3 months, and between 3 and 6 months after treatment (both P<0.05). The 1-, 2-, 3-, 4-and 5-year survival rates were calculated as 96.1%, 80.4%, 68.5%, 57.9% and 51.1%, respectively. Conclusions Hypofractionated three-dimensional conformal radiotherapy is an efficacious and safe treatment of recurrent nasopharyngeal nasopharyngeal carcinoma, which yields relatively high short-and long-term clinical efficacy, high local control rate and well tolerance by the patients. Key words: Nasopharyngeal neoplasm recurrence/three-dimensional conformal radiotherapy; Radiotherapy, hypofractionated; Radiation-induced injury; Treatment outcome

Clinician versus patient: Who gets it right when assessing function in palliative care?

40 Background: The Karnofsky Performance Score (KPS) is an important prognostic indicator in cancer care. Additionally, patient-reported outcomes are increasingly incorporated into clinical care and are validated in cancer patients with the NIH’s Patient-Reported Outcomes Measurement Information System (PROMIS). However, little is known about the concordance of the provider-rated KPS and patient-rated PROMIS measures. Methods: Retrospective review of patients with advanced cancer who underwent implantation of an intrathecal pump for refractory pain. We compared KPS and PROMIS scores recorded within 1 week of each other. PROMIS scores included an average score and 3 domains: physical function, fatigue, and pain interference. We divided each measure into 3 previously-described categories (Functionally Independent, Needs Limited Assistance, and Functionally Dependent) and assessed categorical concordance within each measure. The association of patient-related demographic and clinical characteristics were analyzed with KPS–PROMIS concordance using chi-square and Mann-Whitney U tests. Results: 47 patients were included. The provider-rated KPS score consistently indicated a higher functional status compared to the patient-rated PROMIS average score and across all PROMIS domain scores. 40% of patients were rated “Functionally Dependent” using the average PROMIS score, compared to just 19.1% using the KPS, a statistically significant difference (p=0.042). We noted categorical concordance of 55.3% for PROMIS average score, 57.5% for physical function, 44.7% for fatigue and 42.7% for pain interference compared to KPS. We found no statistically significant associations between concordance and patient demographics or characteristics. Conclusions: Our results revealed a notably low concordance in functional status in advanced cancer patients between provider-rated KPS and patient-rated PROMIS measures. Provider-rated scores consistently indicated a higher overall performance status, in particular with measures of the lowest functional status. Additional work is needed to better understand the reasons for this lack of concordance and its implications for ongoing clinical decision-making.

Chest X ray score (Timika score): an useful adjunct to predict treatment outcome in tuberculosis.

Chest X-ray (CXR) has been used since long as an aid in the diagnosis of pulmonary tuberculosis (PTB) and also to determine the extent of the disease. The present study was conducted to evaluate the correlation of disease extent on CXR basing on the Timika CXR score with clinical and microbiological parameters at baseline, in sputum positive cases of pulmonary tuberculosis. The study was conducted at a tertiary referral centre for chest diseases in Bangalore, Karnataka from January 2017 to January 2018. This is a prospective study of new sputum smear positive pulmonary tuberculosis cases diagnosed in the department of Pulmonary Medicine. At baseline, patients' symptoms and signs on chest auscultation were recorded. The clinical scoring was done by the Karfosky performance score (KPS) and TB score I (Bandim TB score) and II. Baseline CXR- PA view of each patient was assessed independently by two chest physicians and evaluated by the Timika CXR scoring method. Routine blood investigations and sputum smear for acid fast bacilli were done. The correlation between the CXR score and other disease severity parameters was analysed. Clinical scores such as the KPS and TB score I (Bandim TB score) and II, did not correlate with the presence of cavitary disease on CXR (p > 0.05). 48.6% of patients with cavitary disease had higher baseline AFB density in sputum (i.e. sputum smear microscopy grade 3+) as compared to 40% of patients with non cavitary disease, which was not statistically significant. CXR score > 71 was significantly associated with longer duration of symptoms, higher clinical scores (KPS and TB score I, II) and lower Body Mass Index (BMI) at diagnosis of PTB (p < 0.05). 65.2% of the patients with CXR score ≤ 71 had significantly higher baseline AFB density as compared to only 32.4% with CXR result > 71 (p 0.04). CXR score > 71 also had significant association with higher ESR. Cavitary disease on CXR is associated with a higher mycobacterial load at baseline. The Timika CXR score is a simple, standard scoring system which can be used by a chest physician in a clinical setting. The CXR score significantly correlates with a broad range of clinical and microbiological measures of disease severity in PTB patients. Thus, it has a role in risk stratification, especially in patients not producing sputum or sputum negative PTB at diagnosis.

Therapeutical effect of intrapleural perfusion with hyperthermic chemotherapy on malignant pleural effusion under video-assisted thoracoscopic surgery

Background: Patients with malignant pleural effusions (MPEs) have limited life expectancy. This study aims to investigate the feasibility of intrapleural perfusion with hyperthermic chemotherapy (IPHC) under video-assisted thoracoscopic surgery on MPE patients.Methods: MPE patients were enrolled in the study and treated with IPHC. The treatment response was classified as complete response (CR, no re-accumulation of pleural fluid for 4 weeks), partial response (PR, re-accumulation above the post-IPHC level but below the pre-IPHC level for four weeks), no response (NR; re-accumulation or above the pre-IPHC level). The change of Karnofsky performance score (KPS) and tumour markers were also recorded. Follow-up was done every two weeks during first month and monthly thereafter until death.Results: Eighty patients included 46 males and 34 females were included in the study. The total response rate was 100%, with 71.3% of CR and 28.7% of PR. The KPS scores were significantly elevated and the level of tumour markers in pleural effusion were dramatically decreased after IPHC. The median survival was 16.8 months ranged from 2.1 to 67.4 months. One-year and two-year survival rates were 82.5% and 23.8%, respectively. There were no serious clinical compilations during IPHC treatment.Conclusions: IPHC is a safety, effective and promising approach for MPE patients. It provides well survival benefit and minor toxicities.

Early expression of serum neutrophil gelatinase-associated lipocalin (NGAL) is associated with neurological severity immediately after traumatic brain injury

PurposeIntracranial bleeding and inflammatory reactions are common consequences of traumatic brain injury (TBI). Neutrophil gelatinase-associated lipocalin (NGAL), an iron-handling and acute phase protein, may participate in the pathogenesis of TBI. Therefore, we hypothesize that NGAL may be of high diagnostic and therapeutic relevance in the prognosis of TBI. Methods74 subjects were recruited in this study. 30 TBI patients receiving emergent operation were designated as severe TBI group (sTBI), 24 TBI patients receiving conservative treatment as mild TBI group (mTBI), while 20 age-matched healthy volunteers as healthy controls (CNT). We detected the expression and localization of NGAL in brain tissue by Q-PCR, western blotting, and immunofluorescence. Serum NGAL was evaluated by ELISA. Clinical manifestations and outcomes were measured by Glasgow Score (GCS), Trauma score (TS), Revised Trauma score (RTS), APACHEII, Sequential Organ Failure Assessment (SOFA), and Abbreviated Injury Scale (AIS) 85 at admission. Glasgow outcome score (GOS) and Karnofsky Performance Score (KPS) were documented at discharge. ResultsNGAL mRNA and protein levels in brain tissue from sTBI group were profoundly higher than control tissue. Double labeled NGAL with GFAP, NeuN and Iba-1 by immunofluroscence demonstrated that increased NGAL was mainly located in neurons. Compared to CNT and mTBI groups, serum NGAL were significantly increased in sTBI group (sTBI: 532.6±71.77ng/ml vs. mTBI: 230.5±29.59ng/ml, p<0.01; sTBI: 532.6±71.77ng/ml vs. CNT 178.0±19.83ng/ml, p<0.01). Linear regression analysis indicated that there was a negative correlation between the NGAL levels and GCS (r=−0.427, p=0.033), TS (r=−0.429, p=0.032), RTS (r=−0.413, p=0.040) in sTBI group. However, NGAL levels did not correlated with GOS and KPS scores. The NAGL cut-off value of 244.13ng/ml yielded good sensitivity at 84% and specificity at 78.9%. ConclusionNGAL may be a novel biomarker reflecting TBI severity, which increased obviously and negatively correlated with GCS, TS, and RTS scores; additionally, this characteristic of NGAL may be helpful in guiding clinical TBI therapeutic strategies.

中药泡洗改善肿瘤患者生活质量临床观察

Objective: To evaluate the effects of the traditional Chinese medicine (TCM) soaking on the quality of life for advanced cancer patients. Methods: With a prospective, longitudinal cohort study, based on patient’s Compliance, 96 cancer patients admitted to Xiyuan Hospital were allocated in the study, 94 cases evaluated at last: the experiment group (65cases), the control group (29cases). Patients in the experiment group accepted TCM soaking, the patients in the control group just accepted the conventional treatment without any TCM soaking. A course of treatment was two weeks, with 35 minutes each day, 5 days a week. The Quality of Life (QOL)，Karnofsky performance score (KPS) and Levis of neurotoxicity were measured in the two groups pro-post treatment respectively. Results: There were no significant differences for some items in baseline at comparable scales in the two groups ( P > 0.05). There were significant differences in symptoms, KPS and Levis score in experiment group. Additionally, there were significant differences in symptoms and Levis score ( P 0.05). Conclusion: TCM socking has a curative effect in relieving symptoms for advanced cancer patients

Effects of Chinese medicine five-element music on the quality of life for advanced cancer patients: A randomized controlled trial

To evaluate the effects of the Chinese medicine (CM) five-element music on quality of life for senior and non-senior advanced cancer patients. With a randomized controlled trial, 170 advanced cancer patients were randomly assigned to three groups: the CM five-element music group (68 patients), the Western music therapy group (68 cases), and the no music therapy group (34 cases). All patients of 70 years old or older were considered seniors and the remaining patients younger than 70 years were considered nonseniors. Patients in the CM five-element music group listened to CM five-element music, the patients in the Western music group listened to Western music, and the patients in the no music group did not listen to music. A course of treatment was 3 weeks, with 30 min each day, 5 days a week. The Hospice Quality of Life Index-Revised (HQOLI-R) and Karnofsky performance score (KPS) were measured in the three groups before and after treatment. The symptom diary score was measured in the three groups every 3 days, 7 times in total. CM five-element music group showed a significant difference of HQOLI-R, KPS and symptom diary score with other groups (all P<0.01). There were significant differences of HQOLI-R, symptom diary score, and KPS after treatment in CM five-element music group and other groups in the non-senior subgroup (P<0.05). Additionally, there were significant differences in HQOLI-R and KPS after treatment among the three groups in the senior subgroup (P<0.05). CM five-element music therapy could improve the quality of life and KPS for senior and non senior advanced cancer patients, and it could improve subjective symptoms for non-senior advanced cancer patients.

MicroRNA-650 expression in glioma is associated with prognosis of patients

MicroRNAs are known as non-coding RNAs that regulate the expression of target mRNA. Accumulating evidence has indicated that microRNA expression in human malignancies can be utilized as a prognostic marker for patients. However, the prognostic value of miR-650 in human glioma has not been investigated yet. In the present investigation, we have recruited 168 cases glioma specimens and 21 normal control brain specimens. Quantitative real-time PCR was carried out to investigate the expression of miR-650. Kaplan-Meier analysis and Cox's proportional hazards model was used to evaluate the association of miR-650 with prognosis of glioma patients. Results showed that miR-650 expression was increased in glioma compared with normal control specimens (P < 0.001). It was also found that miR-650 expression was related to World Health Organization grade and Karnofsky performance score (KPS) for high expression was more frequently detected in glioma of high grade or low KPS score (P < 0.001). The prognosis of glioma with high miR-650 expression was significantly worse compared with that of glioma with low miR-650 expression. These results proved that miR-650 expression was a significant prognostic indicator in glioma, which may suggest new management of human glioma.

Multivariate comparison of B-ultrasound guided and laparoscopic continuous circulatory hyperthermic intraperitoneal perfusion chemotherapy for malignant ascites

Clinical efficacy of B-ultrasound-guided and laparoscopy-assisted continuous hyperthermic intraperitoneal perfusion chemotherapy (CHIPC) for treatment of malignant ascites was investigated. Sixty-two patients with malignant ascites induced by ovarian or gastrointestinal cancers were randomly treated with B-ultrasound-guided CHIPC (therapeutic group) or laparoscopy-assisted CHIPC (control group) performed at the same center. Hospitalization costs and surgical duration were evaluated. Follow-up was conducted for 21 months with B-ultrasound or computed tomography at least once per month for assessment of ascites amount and tumor progression. Clinical efficacy was assessed by modified World Health Organization criteria. Survival time, Karnofsky performance score (KPS) of quality of life (QOL), and complications were recorded for all patients. Overall condition, primary disease type, and ascites amounts were comparable between groups. Significantly shorter mean duration of perfusion catheter placement (35 vs. 85 min) and mean hospitalization cost (36,000 vs. 55,000 ¥/patient) were observed in the therapeutic group than the control group (P < 0.01). Significantly different KPS scores were not observed before or after CHIPC (23.13 vs. 22.64 %) in both groups (P > 0.05). No significant differences in objective remission rates of malignant ascites (93.75 vs. 93.34 %), median survival times (9 vs. 8 months), or stamp hole metastasis rates (18.75 vs. 18.15 %) were observed between groups (P > 0.05). B-ultrasound-guided and laparoscopy-assisted CHIPC have similar clinical efficacy for improving QOL and prolonging patient survival. B-ultrasound-guided CHIPC may, however, shorten operation times and reduce hospitalization costs, making the treatment available to a broader patient population, although port hole metastasis remains an issue.

The incidence and significance of multiple lesions in glioblastoma

The location and distribution of glioblastoma (GBM) within the brain parenchyma plays an important role in surgical and radiation planning. Prior studies have reported incidences of multiple lesions at the time of diagnosis ranging from 0.5 to 20 %. Multiple lesions can be further categorized as multifocal (multiple areas involved, but with a clear path of spread from one lesion to another) or multicentric (multiple lesions, no clear path of spread). In this retrospective study, we reviewed our experience with GBM and found the incidence of multiple lesions at time of diagnosis was 35 %, much higher than previously suggested in the literature. Patients with single lesions had an improved overall survival when compared to patients with multiple lesions (18 vs. 10 months). Patients with multicentric lesions fared the worst, with average survival of 3 months. However, the difference between single and multiple lesions (multifocal or multicentric) was no longer significant when taking into consideration age, Karnofsky performance score (KPS) and extent of resection by multivariate analysis. Age, KPS, gross total resection, and MGMT status were independent predictors of outcome. Multiple lesions did not independently confer a worse outcome, but were associated with lower KPS scores and inability to perform gross total resection. These findings suggest that single, multiple and multicentric imaging exams represent a spectrum of presentations of a single disease. The rate of multiple lesions reported here may be the result of improved imaging technology, suggesting that incidence of multiple lesions will continue to increase as imaging technology advances.

Extensive duraplasty with autologous graft in decompressive craniectomy and subsequent early cranioplasty for severe head trauma

Objective To compare the effect of extensive duraplasty and subsequent early cranioplasty on the recovery of neurological function in management of patients with severe traumatic brain injuries received decompressive craniectomy. Methods The computer-aided designation of titanium armor plate was used as a substitute for the repair of skull defect in all the patients. The patients were divided into three groups. Twenty-three patients were in early cranioplasty group who received extensive duraplasty in craniectomy and subsequent cranioplasty within 3 months after previous operation (Group I). Twenty-one patients whose cranioplasty was performed more than 3 months after the first operation were in the group without duraplasty (Group II); while the other 26 patients in the group with duraplasty in previous craniotomy (Group III). Both the Barthel index of activity of daily living (ADL) 3 months after craniotomy for brain injuries and 1 month after cranioplasty and Karnofsky Performance Score (KPS) at least 6 months after cranioplasty were assessed respectively. Results The occurrence of adverse events commonly seen in cranioplasty, such as incision healing disturbance, fluid collection below skin flap, infection and onset of postoperative epilepsy was not significantly higher than other 2 groups. The ADL scores at 3 months after craniotomy in Groups I-III were 58.9±26.7, 40.8±20.2 and 49.2±18.6. The ADL scores at 1 month after cranioplasty were 70.2±25.2, 50.8±24.8 and 61.2±21.5. The forward KPS scores were 75.4±19.0, 66.5±24.7 and 57.6±24.7 respectively. The ADL and KPS socres were significantly higher in group I than other 2 groups. Conclusion The early cranioplasty in those with extensive duraplasty in previous craniotomy is feasible and helpful to improving ADL and long-term quality of life in patients with severe traumatic brain injuries.

Cost-effectiveness of cetuximab for the first-line treatment of squamous cell carcinoma of the head and neck (SCCHN) in Canada

e17000 Background: Squamous cell carcinoma of the head and neck (SCCHN) is a disfiguring and potentially fatal condition. Cetuximab is a new therapeutic option which has been shown to improve locoregional control (LRC) and reduce mortality in the treatment of locally and regionally advanced disease. Objectives: To estimate the incremental cost-utility of cetuximab plus radiotherapy (CxRT) versus cisplatin plus radiotherapy (CsRT) among platinum eligible patients and versus RT alone in platinum ineligible patients in Canada. Methods: A lifetime transition model was developed with four health states: 1) acute treatment phase; 2) LRC; 3) disease progression and 4) death. Adverse events were accounted for in the first two states. Efficacy of treatment (LRC and overall survival) was obtained from the literature. Based on network meta-analyses, CsRT and CxRT were assumed to have equal efficacy. Resource use was obtained from published literature and clinical expert opinion. The perspective adopted was that of a provincial ministry of health or cancer agency. Utilities were obtained from a previous study of United Kingdom oncology nurses. Costs (2008 CDN$) and outcomes were discounted at 5% annually. Incremental cost-effectiveness ratios (ICERs) were reported with one-way and probabilistic sensitivity analyses performed to assess robustness of results. A priori sub-group analyses were carried out by baseline Karnofsky Performance Scores (KPS). Results: Among all patients (KPS 60–100), the ICERs comparing CxRT to RT were $19,740/QALY (95% CI: $11,122 to $695,295) among platinum ineligible patients and for CxRT vs. CsRT, $99,147/QALY (95% CI: $75,998 to $148,951) among platinum eligible patients. ICERs decreased with increasing KPS scores. At a willingness to pay of $50,000 among platinum-ineligible patients and $100,000 among platinum-eligible patients, the likelihood that CxRT is cost-effective is 90% and 45% respectively. Sensitivity analyses indicated that time horizon and assumptions about CsRT effectiveness had the largest impact on results. Conclusion: Cetuximab is an economically attractive option for SCCHN patients. [Table: see text]

Gemcitabine Plus Capecitabine Compared With Gemcitabine Alone in Advanced Pancreatic Cancer: A Randomized, Multicenter, Phase III Trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group

This phase III trial compared the efficacy and safety of gemcitabine (Gem) plus capecitabine (GemCap) versus single-agent Gem in advanced/metastatic pancreatic cancer. Patients were randomly assigned to receive GemCap (oral capecitabine 650 mg/m2 twice daily on days 1 to 14 plus Gem 1,000 mg/m2 by 30-minute infusion on days 1 and 8 every 3 weeks) or Gem (1,000 mg/m2 by 30-minute infusion weekly for 7 weeks, followed by a 1-week break, and then weekly for 3 weeks every 4 weeks). Patients were stratified according to center, Karnofsky performance score (KPS), presence of pain, and disease extent. A total of 319 patients were enrolled between June 2001 and June 2004. Median overall survival (OS) time, the primary end point, was 8.4 and 7.2 months in the GemCap and Gem arms, respectively (P = .234). Post hoc analysis in patients with good KPS (score of 90 to 100) showed a significant prolongation of median OS time in the GemCap arm compared with the Gem arm (10.1 v 7.4 months, respectively; P = .014). The overall frequency of grade 3 or 4 adverse events was similar in each arm. Neutropenia was the most frequent grade 3 or 4 adverse event in both arms. GemCap failed to improve OS at a statistically significant level compared with standard Gem treatment. The safety of GemCap and Gem was similar. In the subgroup of patients with good performance status, median OS was improved significantly. GemCap is a practical regimen that may be considered as an alternative to single-agent Gem for the treatment of advanced/metastatic pancreatic cancer patients with a good performance status.

Quality-adjusted survival analysis of malignant glioma. Patients treated with twice-daily radiation (RT) and carmustine: A report of radiation therapy oncology group (RTOG) 83-02

To quantify the quality of life of malignant glioma patients treated on a randomized Phase I/II trial of twice-daily radiation therapy (RT) and carmustine, using a modified quality adjusted survival (QAS) model, and to compare the QAS among assigned treatment arms. The Radiation Therapy Oncology Group (RTOG) accrued 786 malignant glioma patients to a Phase I/II randomized dose escalation trial of twice-daily RT with carmustine from 1983 to 1989. Patients were randomized to one of four arms of hyperfractionated RT in 1.2 Gy twice daily (BID) fractions (64.8 Gy, 72.0 Gy, 76.8 Gy, or 81.6 Gy) or to either of two accelerated hyperfractionated RT arms in 1.6 Gy BID fractions (48.0 or 54.4 Gy). Although preliminary toxicity and survival data have been published, little information is available regarding the quality of these patients' lives during and following such therapy. QAS is a refinement of the methodology for assessing survival quality among breast cancer patients receiving adjuvant chemotherapy. The QAS method allows for inclusion of both improvement and decline in neurologic functional status. Patients were scored by the presence or absence of 15 neurologic signs and symptoms at on-study and at every follow-up. Within each category were gradations of severity, with the quality survival time (Q-TIME) adjusted according to any changes in these neurologic findings. The summation of all changes in signs and symptoms were weighted by 1/15th and incorporated into the QAS model as QAS = Q-TIME-TOX-RRX. TOX was the time spent with treatment-related toxicities, and RRX was the time spent in recovery from subsequent therapy. Of 747 evaluable patients, the average QAS time was 18.5 months. The average QAS for the hyperfractionated arms of 64.8 Gy, 72.0 Gy, 76.8 Gy, and 81.6 Gy were 15.6, 20.8, 10.0, and 13.7 months, respectively. For the accelerated hyperfractionated RT arms of 48.0 and 54.4 Gy, the average QAS times were 13.1 and 13.4 months. The QAS time of the 72.0 Gy arm was significantly longer than that of all other groups, except the 64.8 Gy arm. As expected, the QAS times were strongly discriminated by both age and Karnofsky Performance Scores (KPS) (p < 0.001). Younger patients and patients with high KPS benefited most from assignment to the 72.0 Gy arm; QAS time was not significantly longer in any treatment arm among patients over age 50 or with KPS scores of 80 or less. This quality-adjusted survival methodology can be successfully applied to malignant glioma patients and permits a quantitative assessment of the influence of investigational therapies on patient quality of life. This analysis confirms the potential benefit of intermediate dose (72.0 Gy) hyperfractionated RT for selected malignant glioma patients.