Mean Karnofsky Performance Status Research Articles

Early Experience With Biologically Effective Dose-Comparable Short-Course Whole Brain Radiation Therapy for Metastatic Intracranial Disease.

For inpatients with metastatic intracranial disease burden exceeding established guidelines for stereotactic radiosurgery (SRS), the standard of care involves whole brain radiation therapy (WBRT), typically administered as a 2-week course of treatment with biologically effective dose (BED) of 60Gy. However, shorter course WBRT provides theoretical advantages in quality of life and decreasing systemic therapy delay. This retrospective study evaluates our early experience with BED-comparable short-course WBRT (23Gy in 5 fractions; BED=58.3Gy) for metastatic intracranial disease. Over a recent 2-month timeframe, 3 inpatients with intracranial disease burden exceeding SRS guidelines were administered BED-comparable short-course WBRT. Due to the high intracranial disease burden, 23Gy was chosen over 20Gy for 5-fraction WBRT due to the desire to optimally mimic the durability of the classic 30Gy in 10 fraction treatment regimen. The mean age at treatment was 65.7 years, the mean Karnofsky Performance Status (KPS) was 60, and the mean number of intracranial metastases was 20.3. The mean duration between inpatient Radiation Oncology consultation and the start of WBRT (following CT radiation therapy simulation) was 6.7 days. All patients completed WBRT no later than 2 weeks from the initial inpatient consultation. For inpatients with intracranial metastatic disease burden exceeding established SRS guidelines, BED-comparable short-course WBRT administered to 23Gy in 5 fractions (4.6Gy/fraction) is safe and efficacious. Given previous literature indicating that nearly half of the patients prescribed traditional 2-week WBRT die without completing treatment, BED-comparable WBRT represents an attractive and promising WBRT alternative in this patient population.

Surgical, functional, and oncological considerations regarding awake resection for giant diffuse lower-grade glioma of more than 100 cm3.

Surgery for giant diffuse lower-grade gliomas (LGGs) is challenging, and very few data have been reported on this topic in the literature. In this article, the authors investigated surgical, functional, and oncological aspects in patients who underwent awake resection for large LGGs with a volume > 100 cm3. The authors retrospectively reviewed a consecutive cohort of patients who underwent surgery in an awake condition for an LGG (WHO grade 2 with possible foci of grade 3 transformation) with a volume > 100 cm3. A total of 108 patients were included, with a mean age of 36.1 ± 8.5 years. The mean presurgical LGG volume was 136.7 ± 34.5 cm3. In all but 2 patients a disconnection resective surgery up to functional boundaries was possible thanks to active patient collaboration during the awake period. At 3 months of follow-up, all but 1 patient had a normal neurological examination, with a mean Karnofsky Performance Status (KPS) score of 89.8 ± 10.36. In all patients with preoperative epilepsy, there was postoperative control or significant reduction of seizure events. Moreover, 85.1% of patients returned to work. The mean extent of resection (EOR) was 88.9% ± 7.0%, with a mean residual tumor volume (RTV) of 16.3 ± 12.0 cm3 (median RTV 15 cm3). Pathological examination revealed 73 grade 2 gliomas (67.6%; 26 oligodendrogliomas and 47 astrocytomas) and 35 gliomas with foci of grade 3 (32.4%; 19 oligodendrogliomas and 16 astrocytomas). During the postoperative period, 93.6% of patients underwent adjuvant chemotherapy with a median interval between surgery and first chemotherapy of 14 months (IQR 2-26 months), and 55% of patients had radiotherapy with a median interval of 38.5 months (IQR 18-59.8 months). At the last follow-up, 69.7% of patients were still alive with a median follow-up of 62 months (IQR 36-99 months). Overall survival (OS) rates at 1, 5, and 10 years were 100% (95% CI 0.99-1), 80% (95% CI 0.72-0.9), and 58% (95% CI 0.45-0.73), respectively. The median OS was 138 months. In multivariable Cox regression analysis, RTV was established as the only independent prognostic factor for survival. With the application of rigorous surgical methodology based on functional-guided resection, resection of giant LGGs (volume > 100 cm3) can be reproducibly achieved during surgery with patients under awake mapping with both favorable functional results (< 1% permanent neurological worsening) and favorable long-term oncological outcomes (median OS > 11 years, with a more significant benefit when the RTV is < 15 cm3).

Optimizing maximum resection of glioblastoma: Raman spectroscopy versus 5-aminolevulinic acid.

The objective of this study was to assess and compare the potential of 5-aminolevulinic acid (5-ALA) and Raman spectroscopy (RS) in detecting tumor-infiltrated brain in patients with glioblastoma (GBM). Between July 2020 and October 2021, the authors conducted a prospective clinical trial with 15 patients who underwent neurosurgical treatment of newly diagnosed and histologically verified GBM. A solid contrast-enhancing tumor core and peritumoral tissue were investigated intraoperatively for cancer cells by using 5-ALA and RS to achieve pathology-tailored maximum resection. In each case, a minimum of 10 biopsies were sampled from navigation-guided areas. Two neuropathologists examined the biopsies for the presence of neoplastic cells. The detection performance of 5-ALA and RS alone and in combination was assessed. Pre- and postoperative MRI, Karnofsky Performance Status (KPS), and National Institutes of Health Stroke Scale (NIHSS) scores were compared, and median progression-free survival (PFS) was evaluated. A total of 185 biopsy samples were harvested from the contrast-enhancing tumor core (n = 19) and peritumoral tissue (n = 166). In the tumor core, 5-ALA and RS each showed a sensitivity of 100%. In the peritumoral tissue, 5-ALA was less sensitive than RS in detecting cancer (46% vs 69%) but showed higher specificity (81% vs 57%). When the two methods were combined, the accuracy of tumor detection was increased by about 10%. Pathology-tailored resection led to a 52% increase in resection volume comparing the volume of preoperative contrast enhancement with the postoperative resection cavity on MRI (p = 0.0123). Eloquent brain involvement prevented gross-total resection in 4 patients. Four weeks after surgery, mean KPS (p = 0.7637) and NIHSS scores (p = 0.3146) were not significantly different from preoperative values. Of the 13 patients who had received postoperative chemoradiotherapy, 4 did not show any progression after a median follow-up of 14 months. The remaining 9 patients had a median PFS of 8 months. According to the study data, RS is capable of detecting tumor-infiltrated brain with higher sensitivity but lower specificity than the current standard of 5-ALA. With further technological and workflow advancements, RS in combination with protoporphyrin IX fluorescence may contribute to pathology-tailored glioma resection in the future.

An Evaluation of the Multifactorial Model of Cancer-Related Cognitive Impairment.

Up to 45% of patients report cancer-related cognitive impairment (CRCI). A variety of characteristics are associated with the occurrence and/or severity of CRCI. However, an important gap in knowledge of risk factors for CRCI is the relative contribution of each factor. The multifactorial model of cancer-related cognitive impairment (MMCRCI) is a conceptual model of CRCI that can be used to evaluate the strength of relationships between various factors and CRCI. The purpose of this study was to use structural regression methods to evaluate the MMCRCI using data from a large sample of outpatients receiving chemotherapy ( n = 1,343). Specifically, the relationships between self-reported CRCI and four MMCRCI concepts (i.e., social determinants of health, patient-specific factors, treatment factors, and co-occurring symptoms) were examined. The goals were to determine how well the four concepts predicted CRCI and determine the relative contribution of each concept to deficits in perceived cognitive function. This study is part of a larger, longitudinal study that evaluated the symptom experience of oncology outpatients receiving chemotherapy. Adult patients were diagnosed with breast, gastrointestinal, gynecological, or lung cancer; had received chemotherapy within the preceding 4 weeks; were scheduled to receive at least two additional cycles of chemotherapy; were able to read, write, and understand English; and gave written informed consent. Self-reported CRCI was assessed using the attentional function index. Available study data were used to define the latent variables. On average, patients were 57 years of age, college educated, and with a mean Karnofsky Performance Status score of 80. Of the four concepts evaluated, whereas co-occurring symptoms explained the largest amount of variance in CRCI, treatment factors explained the smallest amount of variance. A simultaneous structural regression model that estimated the joint effect of the four exogenous latent variables on the CRCI latent variable was not significant. These findings suggest that testing individual components of the MMCRCI may provide useful information on the relationships among various risk factors, as well as refinements of the model. In terms of risk factors for CRCI, co-occurring symptoms may be more significant than treatment factors, patient-specific factors, and/or social determinants of health in patients receiving chemotherapy.

Long-Term Evolution of Activities of Daily Life (ADLs) in Critically Ill COVID-19 Patients, a Case Series

The most common long-term symptoms of critically ill COVID-19 patients are fatigue, dyspnea and mental confusion. Adequate monitoring of long-term morbidity, mainly analyzing the activities of daily life (ADLs), allows better patient management after hospital discharge. The aim was to report long-term ADL evolution in critically ill COVID-19 patients admitted to a COVID-19 center in Lugano (Switzerland). A retrospective analysis on consecutive patients discharged alive from ICU with COVID-19 ARDS was performed based on a follow-up one year after hospital discharge; ADLs were assessed through the Barthel index (BI) and the Karnofsky Performance Status (KPS) scale. The primary objective was to assess differences in ADLs at hospital discharge (acute ADLs) and one-year follow-up (chronic ADLs). The secondary objective was to explore any correlations between ADLs and multiple measures at admission and during the ICU stay. A total of 38 consecutive patients were admitted to the ICU; a t-test analysis between acute and chronic ADLs through BI showed a significant improvement at one year post discharge (t = -5.211, p < 0.0001); similarly, every single task of BI showed the same results (p < 0.0001 for each task of BI). The mean KPS was 86.47 (SD 20.9) at hospital discharge and 99.6 at 1 year post discharge (p = 0.02). Thirteen (34%) patients deceased during the first 28 days in the ICU; no patient died after hospital discharge. Based on BI and KPS, patients reached complete functional recovery of ADLs one year after critical COVID-19.

Long-term outcomes after a transcranial microsurgical approach to craniopharyngiomas: a 20-year clinical follow-up study

Craniopharyngioma (CP) is a mostly benign tumor that is nonetheless one of most formidable skull base lesions. CP tends to recur, and scarce clinical results are available regarding its long-term outcomes. From February 1996 to April 2002, craniopharyngiomas primarily resected by open surgery in a single-center and single-surgeon practice were screened. Medical information regarding patients' baseline, tumor parameters, endocrinological results, complications, and quality of life in those patients with a follow-up longer than 20years were reviewed. Nineteen out of 187 patients who met the inclusion criteria were eligible, and 78.9% of the patients were admitted due to visual deficits. The transcranial approach was mostly applied for the first attempt of opening resection, with 94.7% gross total resection. The size of the tumor ranged from 25 to 45mm with a mean maximal diameter of 34.7mm. Although 7 out of 19 patients received an extra procedure, 6 patients (31.5%) regained fertility, with 3 women bearing a total of 5 children and 3 men fathering a total of 4 children, during the 21.4-year follow-up (range: 20.0-23.3years). The mean Karnofsky Performance Status (KPS) score was 97.9 (range: 80-100) at the last follow-up, and the physical and mental 36-Item Short Form Health Survey (SF-36) scores were 88.0 and 80.5, respectively. The tumor sizes of the patients who regained fertility were not significantly different from those of the patients who remained infertile (t = 1.29, P > 0.2). The time interval from prior surgery to tumor resection for recurrent cases ranged from 0.3 to 17.4years (mean, 7.3years). There was no significant difference in the time until tumor recurrence in the patients who underwent a second surgery, a third surgery, or a fourth surgery. The satisfactory results in the present study revealed favorable long-term outcomes following the transcranial management of CPs, with acceptable endocrinological function and tumor-free survival. A decisive policy of open surgery with the objective of radical tumor removal remains a valid method for the primary treatment of CPs, aiming to avoid retreatment after tumor recurrence involving vital hypothalamic structures or hydrocephalus.

Benefits of Study Participation for Patients with Advanced Cancer Receiving Radiotherapy: A Prospective Observational Study.

Patients with advanced cancer and bone metastases may have unmet palliative care (PC) needs that go unnoticed during clinical oncological practice. This observational study describes interventions that were initiated as the patients participated in the Palliative Radiotherapy and Inflammation Study (PRAIS). It was hypothesized that the patients would benefit from study participation due to PC interventions initiated by the study team. A retrospective review of patients' electronic records. Patients with advanced cancer and painful bone metastases included in PRAIS were eligible. All patients met with the study team before start of radiotherapy, after completion of Patient Reported Outcome Measures. Interventions initiated by the study team were documented in the patients' electronic records. A total of 133 patients were reviewed: 63% males, mean (standard deviation [SD]) age 65 (9.6) and mean (SD) Karnofsky performance status (KPS) score 73.2 (9.1). Interventions were initiated in 50% (n = 67) of the patients. Changes in opioid management (69%), treatment of constipation (43%), and nausea (24%) and nutritional advice were most frequent (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 < 0.001) than those not receiving interventions by the study team. Patients with advanced cancer and painful bone metastasis benefited from study participation due to multiple PC interventions initiated by the study team. The findings call for a systematic integration of PC in patients with advanced cancer. ClinicalTrials.gov NCT02107664.

Efficacy and Safety of Pembrolizumab Monotherapy for Recurrent/Unresectable/Metastatic Oral Squamous Cell Carcinoma: A Single-Center Study in China.

Although pembrolizumab is recommended as a first-line treatment for advanced recurrent/unresectable/metastatic (R/U/M) head and neck squamous carcinoma, the differences in its efficacy among different populations need to be investigated. We reviewed 15 consecutive patients with R/U/M oral squamous cell carcinoma (OSCC) treated with pembrolizumab monotherapy at the Affiliated Hospital of Qingdao University between February 2021 and May 2022. All the 15 patients had known programmed death-ligand 1 expression and received multiple cycles of pembrolizumab monotherapy as first-line treatment. We evaluated and analyzed patients' basic characteristics, time to first remission, the clinical efficacy of pembrolizumab monotherapy, and treatment-related adverse reactions. The objective response rate of the 15 patients was 60%. Six patients (40.0%) achieved partial response, while three patients (20.0%) achieved complete response. In our study, the objective response status of the patients was observed in two to five cycles (mean, 3.6 cycles). For patients who responded well to immunotherapy, the mean Karnofsky Performance Status (KPS) score after treatment was significantly higher than that before treatment (P < 0.001). The progression-free survival rates were 66.9% and 50.1% at 6 months and 1 year, respectively. Eight adverse events were observed, comprising four cases of rash and one case each of hypothyroidism, interstitial pneumonia, cheilitis, and cerebral thrombosis. Our study suggests that pembrolizumab is beneficial to the most responsive patients with R/U/M OSCC in our single-center study and may shed light on the management of OSCC.

Assessment of safe and gross total resection of intra-axial brain tumors

Background Safe and gross total resection (GTR) of intra-axial brain-tumor surgery is associated with improving functional outcomes, reducing symptoms, and decreasing the incidence of postoperative complications. Intraoperative imaging helps in achieving the maximum extent of resection. Intraoperative evaluation of the neurological function provides safe tumor resection in eloquent areas.Aim This study aimed to assess the achievement of GTR of intra-axial brain tumors guided by neuronavigation and intraoperative ultrasound and to evaluate the safety of tumor resection in eloquent areas with the use of intraoperative neurophysiological monitoring or awake craniotomy.Patients and methods This study included 30 patients with intra-axial brain tumors in the period from September 2019 to February 2021. Neuronavigation and intraoperative ultrasound were used for all cases, while intraoperative neurophysiological monitoring or awake craniotomy was used for intra-axial brain tumor in eloquent area. Operative details, outcomes, and final results had been recorded and analyzed.Results The mean age was 42 years (4–75 years). GTR was achieved in 18/30 (60%) of all cases. GTR was achieved in 4/10 (40%) of tumors located in the eloquent area, while GTR increased to 14/20 (70%) in noneloquent areas. The mean Karnofsky performance status for all cases has improved from 80 preoperatively to 86.67 postoperatively.Conclusion Neuronavigation and intraoperative ultrasound provides maximization of the extent of resection of intra-axial brain tumors. Intraoperative neurophysiological monitoring or awake craniotomy provides safe tumor resection in eloquent areas.

Pulsed Reduced-Dose Rate Re-Irradiation With Intensity Modulated Radiation Therapy (IMRT) for Recurrent Primary Central Nervous System Malignancies

Pulsed Reduced-Dose Rate (PRDR) Re-irradiation with Intensity Modulated Radiation Therapy (IMRT) for recurrent primary Central Nervous System (CNS) malignancies was previously reported to be a feasible and well tolerated treatment option. We report our IMRT PRDR outcomes and toxicities for 55 patients with KPS ≥ 70 treated at our institution.We did a retrospective review of our database of 55 patients with recurrent primary CNS tumors treated at our institution treated with PRDR IMRT. Data collected included demographic information, initial diagnosis, prior surgery, radiation, and chemotherapy, toxicities for each treatment, PRDR IMRT plans, dates of progression, and date of death when available.The mean age of our patient population at diagnosis was 40.2 years. 31 patients were male and 24 patients were female. The initial diagnosis was WHO grade IV in 16 patients, 12 grade III, 21 Grade II, 1 Grade I glioma, and 5 patients had other primary CNS malignancies. All patients had at least 1 surgery (range 1-5) followed by initial radiation. The mean number of salvage treatments undergone by our cohort before PRDR IMRT was 2.83 treatments. The mean dose of prior radiation therapy was 57.75 Gy (Range 50.4 Gy to 75 Gy). Mean Karnofsky Performance Status (KPS) at PRDR IMRT was 80. 14 patients had an updated pathologic diagnosis before PRDR; 6 of those had grade III gliomas and 8 had grade IV. The average time from the first radiation treatment to the PRDR was 68.6 months. The dose of PRDR given ranged from 50.4 Gy to 60 Gy at 1.8-2 Gy/fraction (Median 54 Gy in 30 fractions, with one exception of a patient who stopped early). The mean progression free survival (PFS) after PRDR IMRT was 5.59 months. The median PFS was 4.8 months. Overall Survival (OS) from the time of initiation of PRDR was 10.98 months. The treatment was well tolerated with 86.6% of adverse events being grade 1-2. There were 3 grade 3 adverse events and 3 grade 4 side effects all attributed to concurrent chemotherapy. There was no radiation necrosis reported after PRDR IMRT.We report a large institutional series of patients who were treated with PRDR IMRT for recurrent primary CNS malignancies. Our series shows the feasibility, safety and efficacy of PRDR IMRT for re-irradiation for recurrent primary CNS malignancies in our heavily pretreated population with a good performance status. This warrants further prospective studies of PRDR IMRT in a randomized setting.A. Halima: None. S.T. Chao: Honoraria; Varian Medical Systems, Zeiss, AbbVie. Consultant; AbbVie. J.H. Suh: Consultant; Philips, Novocure. Met to discuss current indications for TTF; Novocure. Met during 1 day retreat to discuss future of radiation oncology; Philips. Scientific advisory board; Neutron Therapeutics. J.S. Yu: None. T.A. Chan: None. S.S. Kilic: None. D. Peereboom: None. G. Stevens: None. Y. Rauf: None. E.S. Murphy: None.

Surgical Outcome of Large Solid Posterior Fossa Hemangioblastoma without Preoperative Embolization.

Large solid hemangioblastoma in the posterior fossa has an abundant blood supply as an arteriovenous malformation. The presence of adjacent vital neurovascular structures makes them vulnerable and difficult to operate. Complete surgical resection is always a challenge to the neurosurgeon. We share the surgical difficulties and outcome in this case series of large solid hemangioblastomas without preoperative embolization as an adjunct. This study included five patients (three men and two women, with a mean age of 42.2 years). Preoperative embolization was attempted in one patient but was unsuccessful. All the patients have headache (100%) and ataxia (100%) as an initial symptom. A ventriculoperitoneal shunt was inserted in one case before definite surgery due to obstructive hydrocephalus. The surgical outcome was measured using the Karnofsky Performance Status (KPS) score. The tumor was excised completely in all the cases. No intra- and postoperative morbidity occurred in four patients; one patient developed transient lower cranial nerve palsy. Mean blood loss was 235 mL, and no intraoperative blood transfusion was needed in any case. The mean follow-up period was 14.2 months. The mean KPS score at last follow-up was 80.One patient had a KPS score of 60. Our treatment strategy is of circumferential dissection followed by en bloc excision, which is the optimal treatment of large solid hemangioblastoma. The use of adjuncts as color duplex sonography and indocyanine green video angiography may help complete tumor excision with a lesser risk of complication. Preoperative embolization may not be needed to resect large solid posterior fossa hemangioblastoma, including those at the cerebellopontine angle location.

Does COVID-19 Affect Survival and Functional Outcome in Emergency and Urgent Neurosurgical Procedures? A Single-Center Prospective Experience During the Pandemic

ObjectiveTo assess organizational and technical difficulties of neurosurgical procedures during the coronavirus disease 2019 (COVID-19) pandemic and their possible impact on survival and functional outcome and to evaluate virological exposure risk of medical personnel.MethodsData for all urgent surgical procedures performed in the COVID-19 operating room were prospectively collected. Preoperative and postoperative variables included demographics, pathology, Karnofsky performance status (KPS) and neurological status at admission, type and duration of surgical procedures, length of stay, postoperative KPS and functional outcome comparison, and destination at discharge. We defined 5 classes of pathologies (traumatic, oncological, vascular, infection, hydrocephalus) and 4 surgical categories (burr hole, craniotomy, cerebrospinal fluid shunting, spine surgery). Postoperative SARS-CoV-2 infection was checked in all the operators.ResultsWe identified 11 traumatic cases (44%), 4 infections (16%), 6 vascular events (24%), 2 hydrocephalus conditions (8%), and 2 oncological cases (8%). Surgical procedures included 11 burr holes (44%), 7 craniotomies (28%), 6 cerebrospinal fluid shunts (24%), and 1 spine surgery (4%). Mean patient age was 57.8 years. The most frequent clinical presentation was coma (44 cases). Mean KPS score at admission was 20 ± 10, mean surgery duration was 85 ± 63 minutes, and mean length of stay was 27 ± 12 days. Mean KPS score at discharge was 35 ± 25. Outcome comparison showed improvement in 16 patients. Four patients died. Mean follow-up was 6 ± 3 months. None of the operators developed postoperative SARS-CoV-2 infection.ConclusionsStandardized protocols are mandatory to guarantee a high standard of care for emergency and urgent surgeries during the COVID-19 pandemic. Personal protective equipment affects maneuverability, dexterity, and duration of interventions without affecting survival and functional outcome.

Oxycodone/Acetaminophen: The Tailoring Combination Treatment for Specific Clinical Profile of Opioid Well-Responsive Cancer Pain.

BackgroundInternational guidelines recommend moderate-to-severe cancer pain to be treated with strong opioids. However, pain management remains an unsolved matter, at least in the demanding oncology and palliative care setting. Although cancer pain consists of multiple components, which interact in complex ways where combination therapy can better intercept multiple pain characteristics, few studies have used a non-opioid/opioid association to exploit possible synergistic actions. Even the efforts of a recent approach emphasizing appropriate pain assessment and accurate classification to obtain personalized pain management have not produced a satisfactory analgesic strategy.ObjectiveThis analysis was intended to evaluate the effectiveness of the immediate release fixed combination of oxycodone/acetaminophen (OxyIR/Par) for the treatment of moderate-to-severe intensity background pain used alone or in combination with other strong opioids in cancer patients with breakthrough cancer pain (BTcP). This is a secondary analysis of a wider observational, prospective, multicenter study [Italian Oncologic Pain multiSetting Multicentric Survey (IOPS-MS)] performed on 179 patients treated with opioids for cancer pain who received the fixed combination of oxycodone/acetaminophen (OxyIR/Par) for the treatment of background pain (BGP).ResultsCancer patients with breakthrough cancer pain and controlled BGP (Background Pain) were classified according to the presence of analgesic therapy with tablets of fixed combination OxyIR/Par alone (group A, n=120) or tablets of fixed combination OxyIR/Par combined with other strong opioids (group B, n=59). Clinical features of group A were different to group B: higher mean Karnofsky Performance Status Index 70.3% (95% CI=67.2–73.5; median=70, CI=60–80) vs 58.3 (95% CI=53.4–63.2; median=50, CI=45–70) (P<0.001), and mainly group A patients were treated in an ambulatory setting (55.0% group A vs 33.9% group B) (p<0.001). Both groups had managed BGP with similar mean dosages (group A: 12.0, CI=10.5–13.4; group B: 13.1, CI=11.0–15.1) and frequencies of OxyIR/Par alone for group A and in association to other opioids for group B, but Breakthrough cancer Pain (BTcP) exhibited different characteristics in the two groups, showing a lower mean intensity numerical rating scale (NRS) of 7.5 (95% CI=7.2–7.7; median=7, CI=7–8 group A) vs 7.9 (95% CI=7.6, 8.2; median= 8, CI=7–9 group B) (P=0.04) and a higher percentage of patients had a faster onset, defined as the maximum intensity reached in less than 10 minutes, 81.7% (N=98) in group A vs 59.3% (n=35) in group B (P=0.002).ConclusionThis is the first analysis about the efficacy of an immediate-release fixed combination of OxyIR/Par in the real world for moderate-to-severe background cancer pain and breakthrough cancer pain. The oral fixed combination OxyIR/Par provided an adequate level of analgesia for moderate–severe background cancer pain, in a different cohort of cancer patients with different performance status, both in ambulatory and palliative settings. The low dosage of fixed combination OxyIR/Par was effective alone or in association with other opioids.

The short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer in a randomized, placebo-controlled, double-blind trial

PurposeAlthough corticosteroids are frequently used in patients with advanced cancer, few studies have examined the impact of these drugs on patient-reported sleep. We aimed to examine the short-term impact of methylprednisolone on patient-reported sleep in patients with advanced cancer.MethodsPatient-reported sleep was a predefined secondary outcome in a prospective, randomized, placebo-controlled, double-blind trial that evaluated the analgesic efficacy of corticosteroids in advanced cancer patients (18+), using opioids, and having pain ≥ 4 past 24 h (NRS 0–10). Patients were randomized to the methylprednisolone group with methylprednisolone 16 mg × 2/day or placebo for 7 days. The EORTC QLQ-C30 (0–100) and the Pittsburgh Sleep Quality Index questionnaire (PSQI) (0–21) were used to assess the impact of corticosteroids on sleep at baseline and at day 7.ResultsFifty patients were randomized of which 25 were analyzed in the intervention group and 22 in the control group. Mean age was 64 years, mean Karnofsky performance status was 67 (SD 13.3), 51% were female, and the mean oral daily morphine equivalent dose was 223 mg (SD 222.77). Mean QLQ-C30 sleep score at baseline was 29.0 (SD 36.7) in the methylprednisolone group and 24.2 (SD 27.6) in the placebo group. At day 7, there was no difference between the groups on QLQ-C30 sleep score (methylprednisolone 20.3 (SD 32.9); placebo 28.8 (SD 33.0), p = 0.173). PSQI showed similar results.ConclusionsMethylprednisolone 16 mg twice daily for 7 days had no impact on patient-reported sleep in this cohort of patients with advanced cancer.Trial registrationClinical trial information NCT00676936 (13.05.2008)

Correlation of Magnetic Resonance Spectroscopy Changes in Hippocampal and Perihippocampal Regions and Neuro-Psychologic Evaluation with Various Clinical Factors Following Whole Brain Radiotherapy in Brain Metastasis

Objectives: To study the correlation of magnetic resonance spectroscopy (MRS) changes in hippocampal and perihippocampal regions and neuro-psychologic evaluation with various clinical factors following whole brain radiotherapy in brain metastasis. Methods: A total of 33 patients with newly diagnosed brain metastasis, referred to our Department of Radiation Oncology were recruited after a prior informed written consent. All patients underwent baseline clinical/neurological evaluation, detailed MMSE examination, gadolinium enhanced MRI along with MRS (for ratio of Choline: NAA = CNI) from the bilateral hippocampal and perihippocampal areas. All patients then underwent WBRT by two opposing lateral portals on a linear accelerator to a dose of 30 gray in 10 fractions delivered over 2 weeks. Serial evaluations along with MRS and MMSE score were done at 1st, 3rd and 6 months after WBRT. The trends of CNI and MMSE scores at last follow-up were correlated with various clinical factors. Results: Our cohort had 33 patients, predominantly women (M:F, 12:21) with a median age of 47 years, median KPS (Karnofsky performance status) of 80, mean RPA (recursive partitioning analysis) class 2, primary histology (lung, breast, GI, Gy, GU, MUO (metastasis of unknown origin): 10, 11, 2, 4, 4, 2). Median survival of the cohort was 4 months. At the end of 14 months of follow-up 30% of the patients were alive with a mean KPS of 70. Trend in the CNI values with time showed that, KPS (P = 0.079), RPA class (P = 0.079), primary diagnosis site (P = 0.049), number of brain metastasis (P = 0.045) showed statistical significance in terms of change in mean value of CNI value at last follow-up. Site of primary (lung/breast vs. others, P = 0.02) and number of metastasis (solitary/oligo vs. multiple, P = 0.02) showed significant correlation with decline in CNI. The KPS at presentation (< 70 or > 70, P = 0.04); RPA class (class II or higher, P = 0.04); Site of primary (lung/breast vs. others, P = 0.01), presence of extracranial disease (yes or no, P = 0.045), number of metastasis (solitary/oligo vs. multiple, P = 0.06), Size of the largest metastatic lesion (< or > 4 cm, P = 0.02) showed significant correlation with decline in MMSE at last follow-up. Conclusions: Cognitive functioning after WBRT is influenced by a number of factors; patient related, systemic disease burden and local tumor load. Local disease control has significant impact on preservation of neurocognition. The trend in the CNI index and MMSE scores at last follow-up correlated with various factors and can be used as a guide to aid in patient selection for hippocampus- avoidance WBRT.

Intradural Transpetrosectomy for Petrous Apex Meningiomas.

ObjectiveThis study aimed to assess the surgical results of the intradural transpetrosectomy for petrous apex meningiomas (PAMs). In addition, we describe the methods and techniques used to expose and manage superior petrous vein and greater superficial petrosal nerve. MethodsThe authors conducted a retrospective study of 16 patients with PAMs operated by the senior author via the intradural transpetrosectomy between February 2012 to May 2017. We reviewed patient data regarding the general characteristics, surgical technique and surgery-related outcomes and adopted a combined follow-up strategy of clinic and telephone contacts to evaluate postoperative complications. ResultsSimpson grade I and II resection was performed in 10 out of 16 cases (62.5%), and grade III resection were reported in the remaining six cases (37.5%) with no resultant mortality. The mean Karnofsky Performance Status score was 85.6 preoperatively and improved to 91.9 postoperatively, with a mean follow-up period of 34.4 months (range, 6–66 months). Tumor recurrence was found in two patients and they underwent the second surgical operation. ConclusionPAMs could be completely resected by the intradural transpetrosectomy with an improved survival rate and postoperative life quality. Superior petrous vein and greater superficial petrosal nerve should be managed properly in avoidance of postoperative complications. Finally, most meningioma inside cavernous sinus or adhered to brainstem could be totally removed without postoperative complications.

WHO grade I meningiomas: classification-tree for prognostic factors of survival.

World Health Organization (WHO) grade I meningiomas are intracranial extracerebral tumors, in which microsurgery as a stand-alone therapy provides high rates of disease control and low recurrence rates. Our aim was to identify prognostic factors of overall survival and time-to-retreat (OS; TTR) in a cohort of patients with surgically managed WHO grade I meningioma. Patients with WHO grade I meningiomas from a retrospectively (1990 to 2002) and prospectively managed (2003 to 2010) databank of Oslo University Hospital, Norway, were included. The mean follow-up was 9.2 ± 5.7years, with a total of 11,414 patient-years. One thousand three hundred fifty-five patients were included. The mean age was 58 ± 13.2, mean Karnofsky Performance Status (KPS) 92.6 ± 26.1 and female-to-male ratio 2.5:1. The 1-year, 5-year, 10-year, 15-year, and 20-year probabilities were 0.98, 0.91, 0.87, 0.84, and 0.8 for TTR. Patient age (OR 0.92 [0.91, 0.94]), male sex (OR 0.59 [0.45, 0.76]), preoperative KPS ≥ 70 (OR 2.22 [1.59, 3.13]), skull base location (OR 0.77 [0.60, 1]), and the occurrence of a postoperative hematoma (OR 0.44 [0.26, 0.76]) were identified as independent prognostic factors of OS. Patient age (OR 1.02 [1.01, 1.03]) and skull base location (OR 0.30 [0.21, 0.45]) were independent predictors of decreased PFS. Using a recursive partitioning analysis, we suggest a classification tree for the prediction of 5-year PFS based on patient and tumor characteristics. The findings from this cohort of meningioma WHO I patients helps to identify patients at risk of recurrence and tailor the therapeutic management.

Lobectomy confers a survival benefit over gross-total resection without lobectomy in cases of primary glioblastoma in non-eloquent area: A retrospective study.

e13561 Background: Following resection, the microscopic remnants of glioblastomas in nearby tissue cause tumor recurrence more often than other tumors. Although surgical oncologists traditionally resect some of the surrounding normal tissue, whether further removal of nearby tissue may improve survival in cases of primary glioblastomas (pGBM) is unknown. In this single-center retrospective study, we assessed whether lobectomy confers a survival benefit over gross-total resection without lobectomy when treating pGBM in the non-eloquent area. Methods: We selected 28 patients who had complete resection of a histopathologically-diagnosed pGBM in the right frontal or temporal lobe, and divided them into two groups according to whether gross-total resection of the tumor involved lobectomy (SupTR group, n = 15) or did not (GTR group, n = 13). Progression-free survival (PFS), overall survival (OS), and Karnofsky Performance Status (KPS) scores were compared statistically between groups (p≤0.05 for significant differences). Results: Median post-operative PFS times (GTR, 9.7 months [95% CI 2.9-16.5]; SupTR, 35.0 months [95% CI 11.1–58.9]; p = 0.082) and mean KPS scores (GTR, 73.4; SupTR, 71.3; p = 0.586) were not significantly different; however, median post-operative OS times were (GTR, 14.4 months [95% CI 12.1–16.7]; SupTR, 35.0 months [95% CI 17.4–52.6]; p = 0.018). In multivariate analysis, the SupTR group was significantly better than the GTR group in terms of both OS (HR 0.249; 95% CI 0.085–0.730; p = 0.011) and PFS (HR 0.362; 95% CI 0.0134–0.982; p = 0.046). Conclusions: In cases of completely resectable, non-eloquent area pGBMs, including lobectomy improved overall survival without negatively impacting patient performance.

The Safety Profile of Concurrent Therapy for Multiple Myeloma in the Modern Era

PurposeThe management of multiple myeloma has evolved in the modern era, partially owing to the increasing number of biologic therapeutics. Nonetheless, radiation remains an important treatment in the management of painful lytic lesions from multiple myeloma. The goal of this study is to evaluate the side effect profile of radiation therapy (RT) while patients are concurrently treated with biologic agents. Methods and MaterialsWe conducted a retrospective study based on data collected from patients receiving RT at our institute from 2007 to 2017. A total of 130 patients (279 treatment sites) were included in this study with a median follow-up time of 14 months. Patients were required to be receiving a biological agent at least within 1 month before starting and up to 1 month after RT. Generalized estimating equations with a log link function and binomial distribution were used to estimate the prevalence ratio (PR) and corresponding 95% confidence interval (CI) and compare the side effects between patients with RT alone and RT + biologic agent. ResultsThe median age of all patients in our cohort was 64 years, with 53 men (58.9%) and 37 women (41.1%). The mean Karnofsky performance status score of all cohorts was 80. No significant difference in incidence of acute (PR: 1.33; 95% CI, 0.80-2.22; P = .2660) or subacute (PR: 0.90; 95% CI, 0.49-1.67; P = .7464) toxicities was found between patients with or without biologic agents who were treated concurrently with RT. No significant difference was found in reduction in laboratory values between patients with or without biologic agents treated concurrently with RT for white blood cells (P = .6916), platelets (P = .7779), or hematocrit (P = .0858). ConclusionsOur study did not detect any significant toxicity rates from palliative radiation while patients were concurrently treated with biologic agents.

Fractionated Gamma Knife Radiosurgery as Initial Treatment for Large Skull Base Meningioma.

We present our experience on the hypofractionated Gamma Knife radiosurgery (FGKS) for large skull base meningioma as an initial treatment. We retrospectively reviewed 23 patients with large skull base meningioma ≥10 cm3 who underwent FGKS as the initial treatment option. The mean volume of tumors prior to radiosurgery was 21.2±15.63 cm3 (range, 10.09~71.42). The median total margin dose and marginal dose per fraction were 18 Gy (range, 15~20) and 6 Gy (range, 5~6), respectively. Patients underwent three or four fractionations in consecutive days with the same Leksell® frame. The mean follow-up duration was 38 months (range, 17~78). There was no mortality. At the last follow-up, the tumor volume was stationary in 15 patients (65.2%) and had decreased in 8 patients (34.8%). Six patients who had cranial neuropathy at the time of FGKS showed improvement at the last clinical follow-up. Following FGKS, 4 patients (17%) had new cranial neuropathy. The trigeminal neuropathy was the most common and all were transient. The mean Karnofsky Performance Status score at pre-FGKS and the last clinical follow-up was 97.0±10.4 points (median, 100) and 98.6±6.9 (median, 100) points, respectively. FGKS has showed satisfactory tumor control with functional preservation for large skull base meningiomas. Further prospective studies of large cohorts with long term follow-up are required to clarify the efficacy in the tumor control and functional outcome as well as radiation toxicity.