Background
For high-risk classified patients, patients with superobesity and in cases of contraindication to abdominal surgery, traditional bariatric surgery might lead to potential morbidity and ...mortality. Endoscopic sleeve gastroplasty (ESG) is a novel and effective bariatric therapy for morbidly obese patients. Our research group initially evaluated the safety, feasibility, and efficacy of ESG for high-risk, high body mass index (BMI) patients, and patients contraindicated to abdominal surgeries.
Methods
Eligible patients characterized as high-risk for bariatric surgery due to high-BMI, severe comorbidities, or impenetrable abdomen were prospectively documented. ESG was performed by using Overstich® (Apollo Endosurgery, Austin, TX, USA). Primary outcomes included technical success, post-procedure adverse events and mortality, and the change of weight and BMI.
Results
ESG was successfully performed for all patients (
N
= 24, mean age was 55.6 (± 9.2) years old, 75% male). Baseline weight and BMI were 157.9 (± 49.1) kg and 49.9 (± 14.4) kg/m
2
. According to Edmonton Obesity Staging System (EOSS), 8 (33.3%), 14 (58.3%), and 2 (8.3%) patients were respectively classified as EOSS 2, 3, and 4. Mean operation time was 114.7 (± 26.0) min, without intraoperative complication. Weight loss, BMI reduction, %total weight loss (%TWL), and %excess weight loss (%EWL) were 17.5 (± 14.6) kg, 5.6 (± 4.6) kg/m
2
, 12.2% (± 8.9%), and 29.1% (± 17.9%) at post-ESG 12-month, respectively. One (4.2%) moderate post-procedure adverse event (gastric mucosal bleeding) was observed.
Conclusions
ESG can be used as a safe, feasible, and effective option for the therapy of patients with superobesity, high-risk patients, and patients contraindicated to abdominal surgery.
Graphical Abstract
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
Meningiomas are the most common primary tumors of the central nervous system. In patients with WHO grade I meningiomas no adjuvant therapy is recommended after resection. In case of anaplastic ...meningiomas (WHO grade III), adjuvant fractionated radiotherapy is generally recommended, regardless of the extent of surgical resection. For atypical meningiomas (WHO grade II) optimal postoperative management has not been clearly defined yet.
We conducted a retrospective analysis of patients treated for intracranial atypical meningioma at Charité Universitätsmedizin Berlin from March 1999 to October 2018. Considering the individual circumstances (risk of recurrence, anatomical location, etc.), patients were either advised to follow a wait-and-see approach or to undergo adjuvant radiotherapy. Primary endpoint was progression-free survival (PFS).
This analysis included 99 patients with atypical meningioma (WHO grade II). Nineteen patients received adjuvant RT after primary tumor resection (intervention group). The remaining 80 patients did not receive any further adjuvant therapy after surgical resection (control group). Median follow-up was 37 months. Median PFS after primary resection was significantly longer in the intervention group than in the control group (64 m vs. 37 m, p = 0.009, HR = 0.204, 95% CI = 0.062-0.668). The influence of adjuvant RT was confirmed in multivariable analysis (p = 0.041, HR = 0.192, 95% CI = 0.039-0.932).
Our study adds to the evidence that RT can improve PFS in patients with atypical meningioma.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Background and purpose
To evaluate the effect of changes in bladder volume during high-dose intensity-modulated-radiotherapy (IMRT) of prostate cancer on acute genitourinary (GU) toxicity and ...prospectively evaluate a simple biofeedback technique for reproducible bladder filling with the aim of reducing acute GU toxicity.
Methods
One hundred ninety-three patients were trained via a biofeedback mechanism to maintain a partially filled bladder with a reproducible volume of 200–300 cc at planning CT and subsequently at each fraction of radiotherapy. We prospectively analyzed whether and to what extent the patients’ ability to maintain a certain bladder filling influenced the degree of acute GU toxicity and whether cut-off values could be differentiated.
Results
We demonstrated that the ability to reach a reproducible bladder volume above a threshold volume of 180 cc and maintain that volume via biofeedback throughout treatment predicts for a decrease in acute GU toxicity during curative high-dose IMRT of the prostate. Patients who were not able to reach a partial bladder filling to that cut-off value and were not able to maintain a partially filled bladder throughout treatment had a significantly higher risk of developing ≥grade 2 GU acute toxicity.
Conclusion
Our results support the hypothesis that a biofeedback training for the patient is an easy-to-apply, useful, and cost-effective tool for reducing acute GU toxicity in high-dose IMRT of the prostate. Patients who are not able to reach and maintain a certain bladder volume during planning and treatment—two independent risk factors—might need special consideration.
To compare 4 Gy × 5 (1 week) to 3 Gy × 10 (2 weeks) in relieving pain and distress in patients with metastatic epidural spinal cord compression (MESCC).
The randomized SCORE-2 trial compared 4 Gy × 5 ...(n = 101) to 3 Gy × 10 (n = 102) for MESCC. In this additional analysis, these regimens were compared for their effect in relieving pain and distress. Distress was evaluated with the distress-thermometer (0 = no distress, 10 = extreme distress) and pain on a linear scale (0 = no pain, 10 = worst pain). Relief of distress was defined as decrease of ≥2 points; complete and partial pain relief were defined as achieving a score of 0 points and a decrease ≥2 points, respectively, without increase of analgesic use. This prospective secondary analysis of the SCORE-2 trial aimed to show that 4 Gy × 5 was not inferior to 3 Gy × 10 regarding distress and pain relief. Analyses were performed using the unconditional test of noninferiority for binomial differences based on restricted maximum likelihood estimates (noninferiority margin: -20%). Evaluations were performed before, directly after, and 1, 3, and 6 months after radiation therapy. (ClinicalTrials.gov: NCT02189473).
At baseline, median distress scores were 8 (2-10) points in the 4 Gy × 5 group and 8 (2-10) points in the 3 Gy × 10 group. At 1 month, distress relief rates were 58.1% (43/74) and 62.7% (47/75) (difference: -4.6%; 95% confidence interval, -20.0% to +11.1%; P = .025). At baseline, median pain scores were 7 (2-10) and 7 (2-10) points, respectively. At 1 month, complete pain relief rates were 23.5% (16/68) versus 20.0% (14/70) (difference, +3.5%; 95% confidence interval, -10.4% to +17.5%; P < .001), and overall pain relief rates were 52.9% (36/68) versus 57.1% (40/70) (difference, -4.2%; 95% confidence interval, -20.5% to +12.3%; P = .029). Distress and pain relief rates after 4 Gy × 5 were largely comparable to 3 Gy × 10 at all time points. Associated 95% confidence intervals did not point toward any relevant differences.
In patients with MESCC and poor to intermediate survival prognoses, 4 Gy × 5 appeared noninferior to 3 Gy × 10 regarding pain and distress relief.
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GEOZS, IJS, NUK, OILJ, UL, UM, UPUK
Background
Thymic epithelial tumors (TETs) are relatively rare malignant thoracic tumors. Tumor mutation burden (TMB) and immune infiltration play important roles in tumorigenesis.
Methods
Research ...data was obtained using the Cancer Genome Atlas (TCGA) database to evaluate the landscape of tumor mutations, related factors, and relationship of prognosis. The CIBERSORT algorithm was used to evaluate immune cell infiltration in TETs and its relationship with TMB. Immune‐related differentially expressed genes (irDEGs) were identified. Hub irDEGs independently related to prognosis were analyzed using univariate and multivariate Cox proportional hazard models. A survival signature was constructed from hub irDEGs.
Results
A total of 122 patients were included in this study. GTF2I was the most common gene mutation. Higher TMB was significantly associated with the later stage, more advanced pathological type, and older age. The overall survival (OS) of patients in the low‐TMB group was significantly better. There was no significant correlation between TMB levels and PD‐L1 expression. Enrichment analysis showed that DEGs were mainly involved in the P13K–Akt signaling pathway. There were significant differences in macrophage and other types of immune cell infiltration between the high‐ and low‐TMB groups. CCR5, FASLG, and CD79A independently relating to prognosis were screened from 391 irDEGs. The low‐risk group had a significantly better prognosis than the high‐risk group based on the signature, which has a good predictive effect on OS.
Conclusions
In this study, TETs patients with high TMB had a significantly poor prognosis and an immune‐related gene signature was found to effectively evaluate the long‐term prognosis.
Thymic epithelial tumors (TETs) patients with high tumor mutation burden (TMB) had a significantly poor prognosis. There was a significantly higher TMB in older patients, later stages, and thymic carcinoma. The study also revealed that there was no significant association between TMB and PD‐L1 expression.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SAZU, SBCE, SBMB, UL, UM, UPUK
To analyze the impact of weight loss before and during chemoradiation on survival outcomes in patients with locally advanced head and neck cancer.
From 07/1994-07/2000 a total of 224 patients with ...squamous cell carcinoma of the head and neck were randomized to either hyperfractionated radiation therapy alone or the same radiation therapy combined with two cycles of concomitant cisplatin. The primary endpoint was time to any treatment failure (TTF); secondary endpoints were locoregional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS) and overall survival (OS). Patient weight was measured 6 months before treatment, at treatment start and treatment end.
The proportion of patients with >5% weight loss was 32% before, and 51% during treatment, and the proportion of patients with >10% weight loss was 12% before, and 17% during treatment. After a median follow-up of 9.5 years (range, 0.1 - 15.4 years) weight loss before treatment was associated with decreased TTF, LRRFS, DMFS, cancer specific survival and OS in a multivariable analysis. However, weight loss during treatment was not associated with survival outcomes.
Weight loss before and during chemoradiation was commonly observed. Weight loss before but not during treatment was associated with worse survival.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
This retrospective German and Italian multicenter analysis aimed to compare the role of normofractionated stereotactic radiotherapy (nFSRT) to CyberKnife-based hypofractionated stereotactic ...radiotherapy (CK-hFSRT) for skull base meningiomas.
Overall, 341 patients across three centers were treated with either nFSRT or CK-hFSRT for skull base meningioma. Treatment planning was based on computed tomography (CT) and magnetic resonance imaging (MRI) following institutional guidelines. Most nFSRT patients received 33 × 1.8 Gy, and most CK-hFSRT patients received 5 × 5 Gy. The median follow-up time was 36 months (range: 1-232 months).
In the CK-hFSRT group, the 1-, 3-, and 10-year local control (LC) rates were 99.4, 96.8, and 80.3%, respectively. In the nFSRT group, the 1-, 3-, and 10-year LC rates were 100, 99, and 79.1%, respectively. There were no significant differences in LC rates between the nFSRT and CK-hFSRT groups (p = 0.56, hazard ratio = 0.76, 95% confidence interval, 0.3-1.9). In the CK-hFSRT group, only one case (0.49%) of severe toxicity (CTCAE 4.0 ≥ 3) was observed. In the nFSRT group, three cases (2.1%) of grade III toxicity were observed.
This analysis of pooled data from three centers showed excellent LC and low side effect rates for patients treated with CK-hFSRT or nFSRT. The efficacy, safety, and convenience of a shortened treatment period provide a compelling case for the use of CK-hFSRT in patients with moderate size skull base meningioma and provided that OAR constraints are met.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Malignant melanoma brain metastases (MBM) are the third most common cause for brain metastases (BM). Historically Whole-brain radiotherapy (WBRT) was considered the goldstandard of treatment even ...though melanoma cells are regarded as very radioresistant. Therapeutic possibilities have fundamentally changed since the availability of stereotactic radiotherapy (SRT), where it is possible to apply high ablative doses in a very precise manner. In this work we analyze prognostic factors of overall survival (OS) after SRT in patients with MBM and evaluate the applicability of popular prognostic indices that mainly stem from the WBRT-era.
This work is a retrospective analysis of OS of 80 malignant melanoma (MM) patients who received SRT for intracranial melanoma metastases between 2004 and 2014 who had not received prior treatment for MBM in terms of surgery or WBRT. Potential prognostic factors were analyzed using univariable and multivariable analysis. Existing prognostic scores Graded Prognostic Assessment (GPA), Diagnosis-Specific-GPA (DS-GPA), Golden Grading System (GGS) and RADES were calculated and tested using log-rank analysis.
Eighty patients, respectively 177 brain metastases, were irradiated. The median survival time from radiation was 7.06 months. Overall, GGS, GPA and DS-GPA were significant predictors of survival. The MM-specific index DS-GPA showed the best p-value but did not show adequate division when looking at the two intermediate risk subgroups. RADES did not show any statistically significant prognostic value. In univariable as well as in multivariable analyses a higher Karnofsky-Index, a single BM, and non nodular melanoma (NM) histology were positive predictors of survival.
The existing prognostic scores do not seem to ideally fit for this special group of patients. Our results indicate that the histologic subtype of MM could add to the prognostic value of specialized future indices.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
The dismal overall survival (OS) prognosis of glioblastoma, even after trimodal therapy, can be attributed mainly to the frequent incidence of intracranial relapse (ICR), which tends to present as an ...in-field recurrence after a radiation dose of 60 Gray (Gy). In this study, molecular marker-based prognostic indices were used to compare the outcomes of radiation with a standard dose versus a moderate dose escalation.
This retrospective analysis included 156 patients treated between 2009 and 2016. All patients were medically fit for postoperative chemoradiotherapy. In the dose-escalation cohort a simultaneous integrated boost of up to 66 Gy (66 Gy RT) within small high-risk volumes was applied. All other patients received daily radiation to a total dose of 60 Gy or twice daily to a total dose of 59.2 Gy (60 Gy RT).
A total of 133 patients received standard 60 Gy RT, while 23 received 66 Gy RT. Patients in the 66 Gy RT group were younger (p < 0.001), whereas concomitant temozolomide use was more frequent in the 60 Gy RT group (p < 0.001). Other intergroup differences in known prognostic factors were not observed. Notably, the median time to ICR was significantly prolonged in the 66 Gy RT arm versus the 60 Gy RT arm (12.2 versus 7.6 months, p = 0.011), and this translated to an improved OS (18.8 versus 15.3 months, p = 0.012). A multivariate analysis revealed a strong association of 66 Gy RT with a prolonged time to ICR (hazard ratio = 0.498, p = 0.01) and OS (hazard ratio = 0.451, p = 0.01). These differences remained significant after implementing molecular marker-based prognostic scores (ICR p = 0.008, OS p = 0.007) and propensity-scored matched pairing (ICR p = 0.099, OS p = 0.023).
Radiation dose escalation was found to correlate with an improved time to ICR and OS in this cohort of glioblastoma patients. However, further prospective validation of these results is warranted.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
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