Publications by authors named "Minesh Mehta"

455 Publications

Impact of MRI timing on tumor volume and anatomic displacement for brain metastases undergoing stereotactic radiosurgery.

Neurooncol Pract 2021 Dec 28;8(6):674-683. Epub 2021 Jul 28.

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, Florida, USA.

Background: The objective of this study was to evaluate the impact of the time interval between planning imaging and stereotactic radiosurgery (SRS) delivery on tumor volumes and spatial anatomic displacements of brain metastases (BM).

Methods: Consecutive patients diagnosed with BM treated with SRS over a 3-year period were evaluated. Only patients who underwent an institutionally standardized diagnostic MRI (MRI-1) and a treatment planning MRI (MRI-2) were included. The impact of histology, inter-scan time interval, lesion location, tumor volume, and diameter were evaluated on final lesion diameter, volume, anatomic displacement, and ultimate need for change in management (ie, expanding margins, rescanning).

Results: 101 patients (531 lesions) with a median inter-scan time interval of 8 days (range: 1-42 days) met the inclusion criteria. The median percentage increase in BM diameter and volume were 9.5% (IQR: 2.25%-24.0%) and 20% (IQR: 0.7%-66.7%). Overall, 147 lesions (27.7%) in 57 patients (56.4%) required a change in management. There was a statistically significant relationship between initial tumor diameter (cm) and change in management (OR: 2.69, 95% CI: 1.93-3.75; < .001). Each day between MRI-1 and MRI-2 was associated with a change in management with an OR of 1.05 (95% CI: 1.03-1.07; < .001).

Conclusions: Changes in tumor diameter, volume, and spatial position occur as a function of time. Planning imaging for SRS is recommended to occur in close temporal proximity to treatment; for those with delays, a larger setup margin may need to be used to ensure tumor coverage and account for positional changes.
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http://dx.doi.org/10.1093/nop/npab047DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8579090PMC
December 2021

Cross-sectional survey of patients, caregivers, and physicians on diagnosis and treatment of brain metastases.

Neurooncol Pract 2021 Dec 13;8(6):662-673. Epub 2021 Jul 13.

Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, Massachusetts, USA.

Background: The development of brain metastases (BM) is one of the most feared complications of cancer due to the substantial neurocognitive morbidity and a grim prognosis. In the past decade, targeted therapies and checkpoint inhibitors have demonstrated promising intracranial response rates for tumors of multiple histologies. As overall survival for these patients improves, there is a growing need to identify issues surrounding patient survivorship and to standardize physician practice patterns for these patients. To date, there has not been an adequate study to specifically explore these questions of survivorship and practice standardization for patients with advanced cancer and BM.

Methods: Here, we present results from a cross-sectional survey in which we analyze responses from 237 patients, 209 caregivers, and 239 physicians to identify areas of improvement in the clinical care of BM.

Results: In comparing physician and patient/caregiver responses, we found a disparity in the perceived discussion of topics pertaining to important aspects of BM clinical care. We identified variability in practice patterns for this patient population between private practice and academic physicians. Many physicians continue to have patients with BM excluded from clinical trials. Finally, we obtained patient/physician recommendations on high-yield areas for federal funding to improve patient quality of life.

Conclusion: By identifying potential areas of unmet need, we anticipate this wealth of actionable information will translate into tangible benefits for both patients and caregivers. Future studies are needed to validate our findings.
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http://dx.doi.org/10.1093/nop/npab042DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8579087PMC
December 2021

Factors associated with unplanned readmissions and costs following resection of brain metastases in the United States.

Sci Rep 2021 Nov 12;11(1):22152. Epub 2021 Nov 12.

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Office 1R203, Miami, FL, 33176, USA.

The purpose of this study was to critically analyze the risk of unplanned readmission following resection of brain metastasis and to identify key risk factors to allow for early intervention strategies in high-risk patients. We analyzed data from the Nationwide Readmissions Database (NRD) from 2010-2014, and included patients who underwent craniotomy for brain metastasis, identified using ICD-9-CM diagnosis (198.3) and procedure (01.59) codes. The primary outcome of the study was unplanned 30-day all-cause readmission rate. Secondary outcomes included reasons and costs of readmissions. Hierarchical logistic regression model was used to identify the factors associated with 30-day readmission following craniotomy for brain metastasis. During the study period, 44,846 index hospitalizations occurred for patients who underwent resection of brain metastasis. In this cohort, 17.8% (n = 7,965) had unplanned readmissions within the first 30 days after discharge from the index hospitalization. The readmission rate did not change significantly during the five-year study period (p-trend = 0.286). The median per-patient cost for 30-day unplanned readmission was $11,109 and this amounted to a total of $26.4 million per year, which extrapolates to a national expenditure of $269.6 million. Increasing age, male sex, insurance status, Elixhauser comorbidity index, length of stay, teaching status of the hospital, neurological complications and infectious complications were associated with 30-day readmission following discharge after an index admission for craniotomy for brain metastasis. Unplanned readmission rates after resection of brain metastasis remain high and involve substantial healthcare expenditures. Developing tools and interventions to prevent avoidable readmissions could focus on the high-risk patients as a future strategy to decrease substantial healthcare expense.
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http://dx.doi.org/10.1038/s41598-021-01641-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8589950PMC
November 2021

Independently validated sex-specific nomograms for predicting survival in patients with newly diagnosed glioblastoma: NRG Oncology RTOG 0525 and 0825.

J Neurooncol 2021 Nov 10. Epub 2021 Nov 10.

University Hospitals, Cleveland, OH, USA.

Background/purpose: Glioblastoma (GBM) is the most common primary malignant brain tumor. Sex has been shown to be an important prognostic factor for GBM. The purpose of this study was to develop and independently validate sex-specific nomograms for estimation of individualized GBM survival probabilities using data from 2 independent NRG Oncology clinical trials.

Methods: This analysis included information on 752 (NRG/RTOG 0525) and 599 (NRG/RTOG 0825) patients with newly diagnosed GBM. The Cox proportional hazard models by sex were developed using NRG/RTOG 0525 and significant variables were identified using a backward selection procedure. The final selected models by sex were then independently validated using NRG/RTOG 0825.

Results: Final nomograms were built by sex. Age at diagnosis, KPS, MGMT promoter methylation and location of tumor were common significant predictors of survival for both sexes. For both sexes, tumors in the frontal lobes had significantly better survival than tumors of multiple sites. Extent of resection, and use of corticosteroids were significant predictors of survival for males.

Conclusions: A sex specific nomogram that assesses individualized survival probabilities (6-, 12- and 24-months) for patients with GBM could be more useful than estimation of overall survival as there are factors that differ between males and females. A user friendly online application can be found here- https://npatilshinyappcalculator.shinyapps.io/SexDifferencesInGBM/ .
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http://dx.doi.org/10.1007/s11060-021-03886-5DOI Listing
November 2021

Systematic evaluation and plan quality assessment of the Leksell® gamma knife® lightning dose optimizer.

Med Dosim 2021 Oct 22. Epub 2021 Oct 22.

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL 33176 USA; Herbert Wertheim College of Medicine, Florida International University, Miami, FL 33199 USA. Electronic address:

To compare stereotactic radiosurgery (SRS) plan quality metrics of manual forward planning (MFP) and Elekta Fast Inverse Planning™ (FIP)-based inversely optimized plans for patients treated with Gamma Knife®. Clinically treated, MFP SRS plans for 100 consecutive patients (115 lesions; 67 metastatic and 48 benign) were replanned with the FIP dose optimizer based on a convex linear programming formulation. Comparative plans were generated to match or exceed the following metrics in order of importance: Target Coverage (TC), Paddick Conformity Index (PCI), beam-on time (BOT), and Gradient Index (GI). Plan quality metrics and delivery parameters between MFP and FIP were compared for all lesions and stratified into subgroups for further analysis. Additionally, performance of FIP for multiple punctate (<4 mm) metastatic lesions on a subset of cases was investigated. A Wilcoxon signed-rank test for non-normal distributions was used to assess the statistical differences between the MFP and FIP treatment plans. Overall, 76% (87/115) of FIP plans showed a statistically significant improvement in plan quality compared to MFP plans. As compared to MFP, FIP plans demonstrated an increase in the median PCI by 1.1% (p<0.01), a decrease in GI by 3.7% (p< 0.01), and an increase in median number of shots by 74% (p< 0.01). TC and BOT were not statistically significantly different between MFP and FIP plans (p>0.05). FIP plans showed a statistically significant increase in use of 16 mm (p< 0.01) and blocked shots (p< 0.01), with a corresponding decrease in 4 mm shots (p< 0.01). Use of multiple shots per coordinate was significantly higher in FIP plans (p<0.01). The FIP optimizer failed to generate a clinically acceptable plan in 4/115 (3.5%) lesions despite optimization parameter changes. The mean optimization time for FIP plans was 5.0 min (Range: 1.0 - 10.0 min). In the setting of multiple punctate lesions, PCI for FIP was significantly improved (p<0.01) by changing the default low-dose/BOT penalty optimization setting from a default of 50/50 to 75-85/40. FIP offers a significant reduction in manual effort for SRS treatment planning while achieving comparable plan quality to an expert planner-substantially improving overall planning efficiency. FIP plans employ a non-intuitive increased use of blocked sectors and shot-in-shot technique to achieve high quality plans. Several FIP plans failed to achieve clinically acceptable treatments and warrant further investigation.
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http://dx.doi.org/10.1016/j.meddos.2021.08.006DOI Listing
October 2021

A multi-center prospective study of re-irradiation with bevacizumab and temozolomide in patients with bevacizumab refractory recurrent high-grade gliomas.

J Neurooncol 2021 Oct 24. Epub 2021 Oct 24.

Division of Neuro-Oncology, Department of Neurology, Feinberg School of Medicine Northwestern University, Chicago, IL, 60611, USA.

Purpose: Survival is dismal for bevacizumab refractory high-grade glioma patients. We prospectively investigated the efficacy of re-irradiation, bevacizumab, and temozolomide in bevacizumab-naïve and bevacizumab-exposed recurrent high-grade glioma, without volume limitations, in a single arm trial.

Methods: Recurrent high-grade glioma patients were stratified based on WHO grade (4 vs. < 4) and prior exposure to bevacizumab (yes vs. no). Eligible patients received radiation using a simultaneous integrated boost technique (55 Gy to enhancing disease, 45 Gy to non-enhancing disease in 25 fractions) with bevacizumab 10 mg/kg every 2 weeks IV and temozolomide 75 mg/m daily followed by maintenance bevacizumab 10 mg/kg every 2 weeks and temozolomide 50 mg/m daily for 6 weeks then a 2 week holiday until progression. Primary endpoint was overall survival. Quality of life was studied using FACT-Br and FACT-fatigue scales.

Results: Fifty-four patients were enrolled. The majority (n = 36, 67%) were bevacizumab pre-exposed GBM. Median OS for all patients was 8.5 months and 7.9 months for the bevacizumab pre-exposed GBM group. Patients ≥ 36 months from initial radiation had a median OS of 13.3 months compared to 7.5 months for those irradiated < 36 months earlier (p < 0.01). FACT-Br and FACT-Fatigue scores initially declined during radiation but returned to pretreatment baseline. Treatment was well tolerated with 5 patients experiencing > grade 3 lymphopenia and 2 with > grade 3 thrombocytopenia. No radiographic or clinical radiation necrosis occurred.

Conclusions: Re-irradiation with bevacizumab and temozolomide is a safe and feasible salvage treatment for patients with large volume bevacizumab-refractory high-grade glioma. Patients further from their initial radiotherapy may derive greater benefit with this regimen.
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http://dx.doi.org/10.1007/s11060-021-03875-8DOI Listing
October 2021

Transrectal Endoscopic Ultrasound-Guided Drainage of a Tubo-Ovarian Abscess Via a Lumen-Apposing Metal Stent.

ACG Case Rep J 2020 Dec 7;7(12):e00486. Epub 2020 Dec 7.

Department of Gastroenterology, Geisinger Commonwealth School of Medicine, Danville, PA.

Tubo-ovarian abscess (TOA) is a potentially lethal condition, often requiring a combination of medical and surgical interventions. Endoscopic ultrasound (EUS)-guided drainage is a known modality for safe and effective management of pelvic fluid collections, but its role for the treatment of TOA is not well documented. We report the first known case of successful treatment of a large TOA with EUS-guided transrectal drainage using a lumen-apposing metal stent.
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http://dx.doi.org/10.14309/crj.0000000000000486DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8483819PMC
December 2020

Long-Term Report of a Comprehensive Molecular and Genomic Analysis in NRG Oncology/RTOG 0424: A Phase II Study of Radiation and Temozolomide in High-Risk Grade II Glioma.

JCO Precis Oncol 2021 1;5. Epub 2021 Sep 1.

Ohio State University Comprehensive Cancer Center, Columbus, OH.

Purpose: This study sought to determine the prognostic significance of the WHO-defined glioma molecular subgroups along with additional alterations, including promoter methylation and mutations in , , , , and , in NRG/RTOG 0424 using long-term follow-up data.

Methods: Mutations were determined using an Ion Torrent sequencing panel. 1p/19q co-deletion and promoter methylation were determined by Affymetrix OncoScan and Illumina 450K arrays. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method and tested using the log-rank test. Hazard ratios were calculated using the Cox proportional hazard model. Multivariable analyses (MVAs) included patient pretreatment characteristics.

Results: We obtained complete molecular data to categorize 80/129 eligible patients within the WHO subgroups. Of these, 26 (32.5%) were mutant/co-deleted, 28 (35%) were mutant/non-co-deleted, and 26 (32.5%) were wild-type. Upon single-marker MVA, both mutant subgroups were associated with significantly better OS and PFS ( values < .001), compared with the wild-type subgroup. promoter methylation was obtained on 76 patients, where 58 (76%) were methylated and 18 (24%) were unmethylated. Single-marker MVAs demonstrated that promoter methylation was statistically significant for OS ( value < .001) and PFS ( value = .003). In a multimarker MVA, one WHO subgroup comparison (mutant/co-deleted wild-type) was significant for OS ( value = .045), whereas methylation did not retain significance.

Conclusion: This study reports the long-term prognostic effect of the WHO molecular subgroups, promoter methylation, and other mutations in NRG/RTOG 0424. These results demonstrate that the WHO molecular classification and both serve as strong prognostic indicators, but that does not appear to add statistically significant prognostic value to the WHO subgrouping, above and beyond and 1p/19q status.
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http://dx.doi.org/10.1200/PO.21.00112DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8462570PMC
September 2021

Designing Clinical Trials for Combination Immunotherapy: A Framework for Glioblastoma.

Clin Cancer Res 2021 Sep 24. Epub 2021 Sep 24.

Duke University, Durham, North Carolina.

Immunotherapy has revolutionized treatment for many hard-to-treat cancers but has yet to produce significant improvement in outcomes for patients with glioblastoma. This reflects the multiple and unique mechanisms of immune evasion and escape in this highly heterogeneous tumor. Glioblastoma engenders profound local and systemic immunosuppression and is remarkably effective at inducing T-cell dysfunction, posing a challenge to any immunotherapy-based approach. To overcome these mechanisms, multiple disparate modes of immune-oriented therapy will be required. However, designing trials that can evaluate these combinatorial approaches requires careful consideration. In this review, we explore the immunotherapy resistance mechanisms that have been encountered to date and how combinatorial approaches may address these. We also describe the unique aspects of trial design in both preclinical and clinical settings and consider endpoints and markers of response best suited for an intervention involving multiple agents.
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http://dx.doi.org/10.1158/1078-0432.CCR-21-2681DOI Listing
September 2021

Glioblastoma Clinical Trials: Current Landscape and Opportunities for Improvement.

Clin Cancer Res 2021 Sep 24. Epub 2021 Sep 24.

Preston Robert Tisch Brain Tumor Center, Department of Neurosurgery, Duke University Medical Center, Durham, North Carolina.

Therapeutic advances for glioblastoma have been minimal over the past 2 decades. In light of the multitude of recent phase III trials that have failed to meet their primary endpoints following promising preclinical and early-phase programs, a Society for Neuro-Oncology Think Tank was held in November 2020 to prioritize areas for improvement in the conduct of glioblastoma clinical trials. Here, we review the literature, identify challenges related to clinical trial eligibility criteria and trial design in glioblastoma, and provide recommendations from the Think Tank. In addition, we provide a data-driven context with which to frame this discussion by analyzing key study design features of adult glioblastoma clinical trials listed on ClinicalTrials.gov as "recruiting" or "not yet recruiting" as of February 2021.
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http://dx.doi.org/10.1158/1078-0432.CCR-21-2750DOI Listing
September 2021

Effect of Postoperative Radiation Therapy Timing on Survival in Pediatric and Young Adult Ependymoma.

Adv Radiat Oncol 2021 Jul-Aug;6(4):100691. Epub 2021 Mar 26.

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, Florida.

Purpose: Postoperative radiation therapy (RT) is commonly used for World Health Organization grade II-III intracranial ependymoma. Clinicians generally aim to begin RT ≤5 weeks after surgery, but postoperative recovery and need for second look surgery can delay the initiation of adjuvant therapy. On ACNS 0831, patients were required to enroll ≤8 weeks after initial surgery and begin adjuvant therapy within 3 weeks after enrollment. The purpose of this study was to determine the optimal timing of RT after surgery.

Methods And Materials: The National Cancer Database was queried for patients (aged 1-39 years) with localized World Health Organization grade II-III intracranial ependymoma treated with surgery and postoperative RT. Overall survival (OS) curves were plotted based on RT timing (≤5 weeks, 5-8 weeks, and >8 weeks after surgery) and were compared by log-rank test. Factors associated with OS were identified by multivariate analysis. After 2009, complete data were available on whether patients underwent gross total resection or subtotal resection. Planned subset analysis was performed to examine the effect of RT timing on OS in patients with known extent of resection.

Results: In the final analytical data set of 1043 patients, no difference in 3-year OS was observed in patients who initiated RT ≤5 weeks, 5 to 8 weeks, and >8 weeks after surgery (89.8% vs 89.1% vs 88.4%;  = .796). On multivariate analysis, grade III tumors (hazard ratio, 2.752; 95% confidence interval, 1.969-3.846, < .001) and subtotal resection (hazard ratio, 2.253; 95% confidence interval, 1.405-3.611, < .001) were significantly associated with reduced OS. Timing of RT, total RT dose, age, and other factors were not significant. These findings were affirmed in the subset of patients treated between 2010 and 2016, when extent of resection was routinely recorded.

Conclusions: Delayed postoperative RT was not associated with inferior survival in patients with intracranial ependymoma. Delayed RT initiation may be acceptable in patients who require longer postoperative recovery or referral to an appropriate RT center, but should be minimized whenever practical.
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http://dx.doi.org/10.1016/j.adro.2021.100691DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8360936PMC
March 2021

Integration of Systemic Therapy and Stereotactic Radiosurgery for Brain Metastases.

Cancers (Basel) 2021 Jul 22;13(15). Epub 2021 Jul 22.

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL 33176, USA.

Brain metastasis (BM) represents a common complication of cancer, and in the modern era requires multi-modal management approaches and multi-disciplinary care. Traditionally, due to the limited efficacy of cytotoxic chemotherapy, treatment strategies are focused on local treatments alone, such as whole-brain radiotherapy (WBRT), stereotactic radiosurgery (SRS), and resection. However, the increased availability of molecular-based therapies with central nervous system (CNS) penetration now permits the individualized selection of tailored systemic therapies to be used alongside local treatments. Moreover, the introduction of immune checkpoint inhibitors (ICIs), with demonstrated CNS activity has further revolutionized the management of BM patients. The rapid introduction of these cancer therapeutics into clinical practice, however, has led to a significant dearth in the published literature about the optimal timing, sequencing, and combination of these systemic therapies along with SRS. This manuscript reviews the impact of tumor biology and molecular profiles on the management paradigm for BM patients and critically analyzes the current landscape of SRS, with a specific focus on integration with systemic therapy. We also discuss emerging treatment strategies combining SRS and ICIs, the impact of timing and the sequencing of these therapies around SRS, the effect of corticosteroids, and review post-treatment imaging findings, including pseudo-progression and radiation necrosis.
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http://dx.doi.org/10.3390/cancers13153682DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8345095PMC
July 2021

Systematic review of combinations of targeted or immunotherapy in advanced solid tumors.

J Immunother Cancer 2021 07;9(7)

Duke Cancer Institute, Duke University, Durham, North Carolina, USA

With rapid advances in our understanding of cancer, there is an expanding number of potential novel combination therapies, including novel-novel combinations. Identifying which combinations are appropriate and in which subpopulations are among the most difficult questions in medical research. We conducted a Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-guided systematic review of trials of novel-novel combination therapies involving immunotherapies or molecular targeted therapies in advanced solid tumors. A MEDLINE search was conducted using a modified Cochrane Highly Sensitive Search Strategy for published clinical trials between July 1, 2017, and June 30, 2020, in the top-ranked medical and oncology journals. Trials were evaluated according to a criterion adapted from previously published Food and Drug Administration guidance and other key considerations in designing trials of combinations. This included the presence of a strong biological rationale, the use of a new established or emerging predictive biomarker prospectively incorporated into the clinical trial design, appropriate comparator arms of monotherapy or supportive external data sources and a primary endpoint demonstrating a clinically meaningful benefit. Of 32 identified trials, there were 11 (34%) trials of the novel-novel combination of anti-programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) and anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) therapy, and 10 (31%) trials of anti-PD-1/PD-L1 and anti-vascular endothelial growth factor (VEGF) combination therapy. 20 (62.5%) trials were phase II trials, while 12 (37.5%) were phase III trials. Most (72%) trials lacked significant preclinical evidence supporting the development of the combination in the given indication. A majority of trials (69%) were conducted in biomarker unselected populations or used pre-existing biomarkers within the given indication for patient selection. Most studies (66%) were considered to have appropriate comparator arms or had supportive external data sources such as prior studies of monotherapy. All studies were evaluated as selecting a clinically meaningful primary endpoint. In conclusion, designing trials to evaluate novel-novel combination therapies presents numerous challenges to demonstrate efficacy in a comprehensive manner. A greater understanding of biological rationale for combinations and incorporating predictive biomarkers may improve effective evaluation of combination therapies. Innovative statistical methods and increasing use of external data to support combination approaches are potential strategies that may improve the efficiency of trial design. Designing trials to evaluate novel-novel combination therapies presents numerous challenges to demonstrate efficacy in a comprehensive manner. A greater understanding of biological rationale for combinations and incorporating predictive biomarkers may improve effective evaluation of combination therapies. Innovative statistical methods and increasing use of external data to support combination approaches are potential strategies that may improve the efficiency of trial design.
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http://dx.doi.org/10.1136/jitc-2021-002459DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8256733PMC
July 2021

Expanding the Utilization of Rectal Spacer Hydrogel for Larger Prostate Glands (>80 cc): Feasibility and Dosimetric Outcomes.

Adv Radiat Oncol 2021 May-Jun;6(3):100651. Epub 2021 Jan 16.

Radiation Oncology Department, Miami Cancer Institute, Miami, Florida.

Purpose: The Hydrogel Spacer Prospective Randomized Pivotal Trial achieved mean rectoprostatic spacing of 12.6 mm resulting in lowering of rectal V70 from 12.4% (without spacer) to 3.3% (with spacer) in patients with glands up to 80 cm. The value of this approach in patients with larger glands is inadequately established. This study assesses the feasibility and dosimetric outcomes of perirectal spacing in patients with prostate cancer with larger glands (>80 cm).

Methods And Materials: Between January 2017 and December 2019, 33 patients with prostate glands >80 cm (mean 108.1 cm; range, 81.1-186.6 cm) were treated, 15 with glands >80 to 100 cm and 18 >100 cm. Median follow-up was 10 months (range, 3-26). The median international prostate symptom score was 9 (range, 1-18). Hydrogel was placed under local anesthesia in all cases. Treatment modality included intensity modulated radiation therapy in 15 and proton therapy (PT) in 18 patients. Treatment targeted the prostate plus seminal vesicles in 21 patients and 12 also had elective nodal irradiation. Conventional fractionation (CF) to 78 Gy in 39 fractions was used in 16 and moderate hypofractionation (HF) to 70 Gy in 28 fractions in 17 patients.

Results: In the CF group, mean rectum (r) V75, 70, 60, 50 was 0.87%, 2.25%, 5.61%, and 10.5%, respectively. For glands >80 to 100 cm and >100 cm, rV70 was 2.55% and 2%, respectively. In HF patients, mean rV65, 63, 60, and 50 was 1.67%, 2.3%, 3.4%, and 8.6%. For glands >80 to 100 cm and >100 cm, rV63 was 2% and 2.56%, respectively. Overall, the mean midgland rectoprostatic hydrogel separation was 9.3 mm (range, 4.7-19.4 mm). All patients tolerated treatment well; no acute grade 2 or higher adverse gastrointestinal events were observed.

Conclusions: Hydrogel placement is feasible in prostate glands larger than 80 cm with favorable dosimetric outcomes.
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http://dx.doi.org/10.1016/j.adro.2021.100651DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8233470PMC
January 2021

Stereotactic MR-guided online adaptive radiotherapy reirradiation (SMART reRT) for locally recurrent pancreatic adenocarcinoma: A case report.

Med Dosim 2021 Winter;46(4):384-388. Epub 2021 Jun 11.

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL 33176, USA; Herbert Wertheim College of Medicine, Florida International University, Miami, FL 33199, USA. Electronic address:

Introduction: Stereotactic MR-guided online adaptive radiation therapy (SMART) has demonstrated a superior radiotherapeutic ratio for pancreatic patients, by enabling dose escalation while minimizing the dose to the proximal gastrointestinal organs at risk through online adaptive radiotherapy. The safe delivery of stereotactic body radiation therapy (SBRT) is of particular importance in the reirradiation setting and has been historically limited to CT-based nonadaptive modalities. Herein, we report the first use of online adaptive radiotherapy in the reirradiation setting, specifically for treatment of locally recurrent pancreatic adenocarcinoma through SMART reirradiation (SMART reRT).

Case Description: We describe the treatment of a 68-year-old male who was diagnosed with, unresectable locally advanced pancreatic adenocarcinoma. Initial treatment included FOLFIRINOX followed by 45 Gy in 25 fractions on a helical intensity-modulated radiotherapy (IMRT) device with concurrent capecitabine, followed by a boost of 14.4 Gy in 8 fractions to a on an MR-guided radiotherapy (MRgRT) linac. At approximately 12 months from initial radiotherapy, the patient experienced local progression of the pancreas body/tail and therefore SMART reRT of 50 Gy in 5 fractions was initiated. The technical considerations of cumulative dose for gastrointestinal organs across multiple courses, treatment planning principles, and adaptive radiotherapy details are outlined in this case study. The patient tolerated treatment well with minimal fatigue.

Conclusions: The therapeutic ratio of reirradiation may be improved using daily MR guidance with online adaptive replanning, especially for lesions in proximity to critical structures. Future studies are warranted to assess long-term outcomes of dose escalated MR-guided reRT, define OAR dose constraints for reRT, and assess cumulative dose across the adapted SMART reRT fractions and the original RT plan.
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http://dx.doi.org/10.1016/j.meddos.2021.04.006DOI Listing
November 2021

Meta-Analysis of Survival and Development of a Prognostic Nomogram for Malignant Pleural Mesothelioma Treated with Systemic Chemotherapy.

Cancers (Basel) 2021 May 2;13(9). Epub 2021 May 2.

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL 33176, USA.

(1) Purpose: Malignant pleural mesothelioma (MPM) is a rare cancer with an aggressive course. For patients who are medically inoperable or surgically unresectable, multi-agent systemic chemotherapy remains an accepted standard-of-care. The purpose of this meta-analysis is to provide baseline summative survival estimates as well as evaluate the influence of prognostic variables to provide comparative estimates for future trial designs. (2) Methods: Using PRISMA guidelines, a systematic review and meta-analysis was performed of MPM studies published from 2002-2019 obtained from the Medline database evaluating systemic therapy combinations for locally advanced or metastatic disease. Weighted random effects models were used to calculate survival estimates. The influence of proportions of known prognostic factors on overall survival (OS) were evaluated in the creation of a prognostic nomogram to estimate survival. The performance of this model was evaluated against data generated from one positive phase II study and two positive randomized trials. (3) Results: Twenty-four phase II studies and five phase III trials met the eligibility criteria; 2534 patients were treated on the included clinical studies. Ten trials included a platinum-pemetrexed-based treatment regimen, resulting in a pooled estimate of progression-free survival (PFS) of 6.7 months (95% CI: 6.2-7.2 months) and OS of 14.2 months (95% CI: 12.7-15.9 months). Fifteen experimental chemotherapy regimens have been tested in phase II or III studies, with a pooled median survival estimate of 13.5 months (95% CI: 12.6-14.6 months). Meta-regression analysis was used to estimate OS with platinum-pemetrexed using a variety of features, such as pathology (biphasic vs. epithelioid), disease extent (locally advanced vs. metastatic), ECOG performance status, age, and gender. The nomogram-predicted estimates and corresponding 95% CIs performed well when applied to recent randomized studies. (4) Conclusions: Given the rarity of MPM and the aggressive nature of the disease, innovative clinical trial designs with significantly greater randomization to experimental regimens can be performed using robust survival estimates from prior studies. This study provides baseline comparative values and also allows for accounting for differing proportions of known prognostic variables.
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http://dx.doi.org/10.3390/cancers13092186DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8124134PMC
May 2021

Regression of Intracranial Meningiomas Following Treatment with Cabozantinib.

Curr Oncol 2021 04 18;28(2):1537-1543. Epub 2021 Apr 18.

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL 33176, USA.

Recurrent meningiomas remain a substantial treatment challenge given the lack of effective therapeutic options aside from surgery and radiation therapy, which yield limited results in the retreatment situation. Systemic therapies have little effect, and responses are rare; the search for effective systemic therapeutics remains elusive. In this case report, we provide data regarding significant responses in two radiographically diagnosed intracranial meningiomas in a patient with concurrent thyroid carcinoma treated with cabozantinib, an oral multitarget tyrosine kinase inhibitor with potent activity against MET and VEGF receptor 2. Given the clinical experience supporting the role of VEGF agents as experimental therapeutics in meningioma and the current understanding of the biological pathways underlying meningioma growth, this may represent a new oral therapeutic alternative, warranting prospective evaluation.
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http://dx.doi.org/10.3390/curroncol28020145DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8167720PMC
April 2021

Systematic review and meta-analysis of breast cancer brain metastasis and primary tumor receptor expression discordance.

Neurooncol Adv 2021 Jan-Dec;3(1):vdab010. Epub 2021 Jan 16.

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, Florida, USA.

Background: Change in hormone receptor (estrogen [ER] and progesterone [PR]) and/or human epidermal growth factor receptor type 2 (HER2) status during the evolutionary course of metastatic breast cancer and the effect of tumor classification subtype switching remain understudied and underappreciated in brain metastasis patients.

Methods: Using preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, a systematic review of series published prior to April 2020 obtained from the Medline database of biopsied or resected breast cancer brain metastasis (BCBM) was performed. Weighted random effects models were used to calculate pooled estimates.

Results: 15 full-text articles were included with receptor expression analyses on 1373 patients who underwent biopsy or resection of at least one intracranial lesion to compare to the primary tumor. Primary tumor receptor expression immunophenotypes were 45.0% ER+, 41.0% ER-, 31.0% PR+, 51.0% PR-, 35% HER2+, and 47.0% HER2-. Corresponding BCBM immunophenotypes were 19.0% ER+, 31.0% ER-, 13.0% PR+, 40.0% PR-, 21.0% HER2+, and 26.0% HER2-. On primary/BCBM comparison, 540 patients (42.6%) exhibited discordance in any receptor with 17.0% (95% CI: 13.0%-23.0%) discordant on ER, 23.0% (95% CI: 18.0%-30.0%) discordant on PR, and 12.0% (95% CI: 8.0%-16.0%) discordant on HER2 status. The most common receptor conversions found in BCBM were ER loss 11.0% (95% CI: 8.0%-16.0%), PR loss 15.0% (95% CI: 11.0%-21.0%), and HER2 gain 9.0% (95% CI: 7.0%-11.0%).

Conclusions: BCBM exhibits significant receptor expression discordance in comparison to primary tumors in approximately 40% of patients. Classification patterns need to be analyzed to determine factors predictive of BCBM/primary tumor discordance. Overall, tumor subtype switching and its effect on clinical management remains underappreciated.
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http://dx.doi.org/10.1093/noajnl/vdab010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8055057PMC
January 2021

Hospitalization rates for complications due to systemic therapy in the United States.

Sci Rep 2021 04 1;11(1):7385. Epub 2021 Apr 1.

Florida International University, Miami, FL, USA.

The aim of this study was to estimate the trends and burdens associated with systemic therapy-related hospitalizations, using nationally representative data. National Inpatient Sample data from 2005 to 2016 was used to identify systemic therapy-related complications using ICD-9 and ICD-10 external causes-of-injury codes. The primary outcome was hospitalization rates, while secondary outcomes were cost and in-hospital mortality. Overall, there were 443,222,223 hospitalizations during the study period, of which 2,419,722 were due to complications of systemic therapy. The average annual percentage change of these hospitalizations was 8.1%, compared to - 0.5% for general hospitalizations. The three most common causes for hospitalization were anemia (12.8%), neutropenia (10.8%), and sepsis (7.8%). Hospitalization rates had the highest relative increases for sepsis (1.9-fold) and acute kidney injury (1.6-fold), and the highest relative decrease for dehydration (0.21-fold) and fever of unknown origin (0.35-fold). Complications with the highest total charges were anemia ($4.6 billion), neutropenia ($3.0 billion), and sepsis ($2.5 billion). The leading causes of in-hospital mortality associated with systemic therapy were sepsis (15.8%), pneumonia (7.6%), and acute kidney injury (7.0%). Promoting initiatives such as rule OP-35, improving access to and providing coordinated care, developing systems leading to early identification and management of symptoms, and expanding urgent care access, can decrease these hospitalizations and the burden they carry on the healthcare system.
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http://dx.doi.org/10.1038/s41598-021-86911-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8016938PMC
April 2021

Novel Radiation Approaches.

Neurosurg Clin N Am 2021 Apr;32(2):211-223

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL, USA; Herbert Wertheim College of Medicine, Florida International University, Miami, FL, USA.

The standard of care treatment for glioblastoma is surgical resection followed by radiotherapy to 60 Gy with concurrent and adjuvant temozolomide with or without tumor-treating fields. Advanced imaging techniques are under evaluation to better guide radiotherapy target volume delineation and allow for dose escalation. Particle therapy, in the form of protons, carbon ions, and boron neutron capture therapy, are being assessed as strategies to improve the radiotherapeutic ratio. Stereotactic, hypofractionated, pulsed-reduced dose-rate, and particle radiotherapy are re-irradiation techniques each uniquely suited for different clinical scenarios. Novel radiotherapy approaches, such as FLASH, represent promising advancements in radiotherapy for glioblastoma.
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http://dx.doi.org/10.1016/j.nec.2020.12.007DOI Listing
April 2021

Assessment of extracranial metastatic disease in patients with brain metastases: How much effort is needed in the context of evolving survival prediction models?

Radiother Oncol 2021 06 4;159:17-20. Epub 2021 Mar 4.

Department of Radiation Oncology (MAASTRO Clinic), Maastricht University Medical Center, GROW, The Netherlands.

Survival prediction models may serve as decision-support tools for clinicians who have to assign the right treatment to each patient, in a manner whereby harmful over- or undertreatment is avoided as much as possible. Current models differ regarding their components, the overall number of components and the weighting of individual components. Some of the components are easy to assess, such as age or primary tumor type. Others carry the risk of inter-assessor inconsistency and time-dependent variation. The present publication focuses on issues related to assessment of extracranial metastases and potential surrogates, e.g. blood biomarkers. It identifies areas of controversy and provides recommendations for future research projects, which may contribute to prognostic models with improved accuracy.
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http://dx.doi.org/10.1016/j.radonc.2021.02.038DOI Listing
June 2021

Case report of visual biofeedback-driven, magnetic resonance-guided single-fraction SABR in breath hold for early stage non-small-cell lung cancer.

Med Dosim 2021 Autumn;46(3):247-252. Epub 2021 Feb 26.

Department of Radiation Oncology, Miami Cancer Institute, Miami, FL 33176, USA; Herbert Wertheim College of Medicine, Florida International University, Miami, FL, USA.

Stereotactic ablative body radiation therapy (SABR) is a well-established alternative to surgery for early stage non-small-cell lung cancer (NSCLC). While SABR is typically delivered in 3 to 5 fractions, randomized trials have shown single-fraction SABR to be a reasonable alternative. We present the case of a 66-year-old male with history of cholangiocarcinoma who was subsequently diagnosed with peripheral early stage NSCLC and treated in mid-inspiration breath hold (BH) to 34 Gy in 1 fraction on a magnetic resonance (MR)-guided linear accelerator, with treatment delivery completed in 17 minutes. Visual biofeedback was utilized to maximize patient compliance with appropriate depth of inspiration BH and improve overall treatment delivery time efficiency. The benefits of single- vs multifraction SABR and unique advantages of MR guidance that are particularly well-suited for single-fraction SABR are reviewed.
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http://dx.doi.org/10.1016/j.meddos.2021.01.003DOI Listing
November 2021

Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients - a report of the PET/RANO group.

Neuro Oncol 2021 06;23(6):881-893

German Cancer Consortium (DKTK), Partner Site Munich, Munich, Germany.

The management of patients with glioma usually requires multimodality treatment including surgery, radiotherapy, and systemic therapy. Accurate neuroimaging plays a central role for radiotherapy planning and follow-up after radiotherapy completion. In order to maximize the radiation dose to the tumor and to minimize toxic effects on the surrounding brain parenchyma, reliable identification of tumor extent and target volume delineation is crucial. The use of positron emission tomography (PET) for radiotherapy planning and monitoring in gliomas has gained considerable interest over the last several years, but Class I data are not yet available. Furthermore, PET has been used after radiotherapy for response assessment and to distinguish tumor progression from pseudoprogression or radiation necrosis. Here, the Response Assessment in Neuro-Oncology (RANO) working group provides a summary of the literature and recommendations for the use of PET imaging for radiotherapy of patients with glioma based on published studies, constituting levels 1-3 evidence according to the Oxford Centre for Evidence-based Medicine.
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http://dx.doi.org/10.1093/neuonc/noab013DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8168815PMC
June 2021

Neurocognitive, symptom, and health-related quality of life outcomes of a randomized trial of bevacizumab for newly diagnosed glioblastoma (NRG/RTOG 0825).

Neuro Oncol 2021 07;23(7):1125-1138

Department of Radiation Oncology, University of Maryland, Baltimore, Maryland, USA.

Background: Results of NRG Oncology RTOG 0825 reported adding bevacizumab to standard chemoradiation did not significantly improve survival endpoints and resulted in greater decline in neurocognitive function (NCF) and patient-reported outcomes (PRO) over time in bevacizumab-treated patients. The present report provides additional results of patient-centered outcomes over time and their prognostic association with survival endpoints.

Methods: NCF tests, MD Anderson Symptom Inventory - Brain Tumor Module (MDASI-BT), and European Organization for Research and Treatment of Cancer (EORTC) quality of life (QOL) questionnaire with brain cancer module (QLQ-C30/BN20) were completed in a subset of progression-free patients at baseline and longitudinally. The prognostic value of baseline and early changes in NCF and PROs and differences between treatments from baseline to follow-up assessments were evaluated.

Results: A total of 508 randomized patients participated. Baseline/early changes in NCF and PROs were prognostic for OS and PFS. No between-arm differences in time to deterioration were found. At week 6, patients treated with bevacizumab evidenced greater improvement on NCF tests of executive function and the MDASI-BT Cognitive Function scale, but simultaneously reported greater decline on the EORTC Cognitive Function Scale. At later time points (weeks 22, 34, and 46), patients treated with bevacizumab had greater worsening on NCF tests as well as PRO measures of cognitive, communication, social function, motor symptoms, general symptoms, and interference.

Conclusion: The collection of patient-centered clinical outcome assessments in this phase III trial revealed greater deterioration in NCF, symptoms, and QOL in patients treated with bevacizumab. Baseline and early change in NCF and PROs were prognostic for survival endpoints.
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http://dx.doi.org/10.1093/neuonc/noab011DOI Listing
July 2021

Effect of a physician led education invention on colon cancer screening at underserved clinics in Georgia.

Patient Educ Couns 2021 06 1;104(6):1494-1496. Epub 2020 Dec 1.

Division of Gastroenterology & Hepatology, Medical College of Georgia at Augusta University, Augusta, USA. Electronic address:

Objective: Colorectal cancer (CRC) screening rates are much lower at federally qualified health centers (FQHC) than the rest of the nation. The study aim was to determine if a physician led, low cost intervention, can improve CRC screening rates at FQHCs for underserved patients.

Methods: A CRC quality improvement outreach program was conducted at 4 FQHCs. The program included direct provider education sessions, systems process improvements, patient education resources and low cost testing. We analyzed pre and post intervention screening rates for all eligible patients, defined as age 50-74 at average CRC risk.

Results: CRC screening rates significantly increased at all sites 3 months following intervention: Site 1: 41%-48.3%, p < .0001; site 2: 31.6%-37.8%, p < .0001; site 3: 30.5%-38.2%, p < .0001 and site 4: 43.9%-46.8%, p = .012.

Conclusion: The education program successfully increased CRC screening rates in the underserved by 2.9%-7.7% 3 months post-intervention.

Practice Implications: This approach of direct provider education sessions, systems process improvements, patient education resources and low cost testing improved underserved CRC screening. Implementation across Georgia would be expected to improve CRC related mortality and morbidity for the state's underserved.
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http://dx.doi.org/10.1016/j.pec.2020.11.040DOI Listing
June 2021

Can proton therapy reduce radiation-related lymphopenia in glioblastoma?

Neuro Oncol 2021 02;23(2):179-181

Miami Cancer Institute and Florida International University, Miami, Florida.

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http://dx.doi.org/10.1093/neuonc/noaa273DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7906054PMC
February 2021

Phase I/II study of sorafenib in combination with erlotinib for recurrent glioblastoma as part of a 3-arm sequential accrual clinical trial: NABTC 05-02.

Neurooncol Adv 2020 Jan-Dec;2(1):vdaa124. Epub 2020 Sep 17.

Neuro-Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Maryland, USA.

Background: Receptor tyrosine kinases such as epidermal growth factor receptors (EGFRs) and their downstream signaling pathways such as the Ras-Raf-mitogen-activated protein kinase (MAPK) pathway play important roles in glioblastoma (GBM). This study investigated the safety, pharmacokinetics, and efficacy of sorafenib (Ras/Raf/MAPK inhibitor) in combination with erlotinib (EGFR inhibitor) for treatment of recurrent GBMs.

Methods: Patients with recurrent GBM were eligible. A novel sequential accrual trial design was used, where patients were sequentially accrued into separate treatment arms in phase I and phase II investigations to optimize recruitment efficiency. In phase I, a standard 3 + 3 format was used to identify dose-limiting toxicities (DLTs), determine maximum tolerated dose (MTD), and investigate pharmacokinetics. Phase II followed a 2-stage design with the primary endpoint being 6-month progression-free survival (PFS6).

Results: Sixteen patients were recruited for phase I, and the MTD was determined to be sorafenib 200 mg twice daily and erlotinib 100 mg once daily. DLTs include Grade 3 hypertension, Grade 3 elevated liver transaminases, and Grade 4 elevated lipase. While erlotinib did not affect sorafenib levels, sorafenib reduced erlotinib levels. In phase II, 3 of 19 stage 1 participants were progression free at 6 months. This did not meet the predetermined efficacy endpoint, and the trial was terminated.

Conclusion: This study identified the MTD and DLTs for sorafenib and erlotinib combination therapy for recurrent GBMs; however, efficacy data did not meet the primary endpoint. This study also demonstrates the feasibility of a novel sequential accrual clinical trial design that optimizes patient recruitment for multiarm studies, which is particularly effective for multicenter clinical trials.
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http://dx.doi.org/10.1093/noajnl/vdaa124DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7668489PMC
September 2020

Radiation therapy alone versus radiation therapy plus radiofrequency ablation/vertebral augmentation for spine metastasis: study protocol for a randomized controlled trial.

Trials 2020 Nov 23;21(1):964. Epub 2020 Nov 23.

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Office 1R203, Miami, FL, 33176, USA.

Background: Spine metastasis is a common occurrence in cancer patients and results in pain, neurologic deficits, decline in performance status, disability, inferior quality of life (QOL), and reduction in ability to receive cancer-directed therapies. Conventional external beam radiation therapy (EBRT) is associated with modest rates of pain relief, high rates of disease recurrence, low response rates for those with radioresistant histologies, and limited improvement in neurologic deficits. The addition of radiofrequency ablation/percutaneous vertebral augmentation (RFA/PVA) to index sites together with EBRT may improve pain response rates and corresponding quality of life.

Methods/design: This is a single-center, prospective, randomized, controlled trial in patients with spine metastasis from T5-L5, stratified according to tumor type (radioresistant vs. radiosensitive) in which patients in each stratum will be randomized in a 2:1 ratio to either RFA/PVA and EBRT or EBRT alone. All patients will be treated with EBRT to a dose of 20-30 Gy in 5-10 fractions. The target parameters will be measured and recorded at the baseline clinic visit, and daily at home with collection of weekly measurements at 1, 2, and 3 weeks after treatment, and at 3, 6, 12, and 24 months following treatment with imaging and QOL assessments.

Discussion: The primary objective of this randomized trial is to determine whether RFA/PVA in addition to EBRT improves pain control compared to palliative EBRT alone for patients with spine metastasis, defined as complete or partial pain relief (measured using the Numerical Rating Pain Scale [NRPS]) at 3 months. Secondary objectives include determining whether combined modality treatment improves the rapidity of pain response, duration of pain response, patient reported pain impact, health utility, and overall QOL.

Trial Registration: ClinicalTrials.gov NCT04375891 . Registered on 5 May 2020.
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http://dx.doi.org/10.1186/s13063-020-04895-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7685662PMC
November 2020

A Comprehensive Analysis of a Prospective Multidisciplinary Peer Review Process Before Radiation Therapy Simulation.

Pract Radiat Oncol 2021 Jul-Aug;11(4):e366-e375. Epub 2020 Nov 13.

Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, Florida; Herbert Wertheim College of Medicine, Florida International University, Miami, Florida.

Purpose: Although peer review in radiation oncology (RO) has been recommended to improve quality of care, an analysis of modifications resulting from an RO multidisciplinary presimulation standardized review process has yet to be empirically demonstrated.

Methods And Materials: A standardized simulation directive was used for patients undergoing simulation for external beam radiation therapy at a single tertiary care institution. The simulation directives were presented, and all aspects were reviewed by representatives from key RO disciplines. Modifications to the original directives were prospectively captured in a quality improvement registry. Association between key variables and the incidence of modifications were performed using Fisher exact test and t test.

Results: A registry of 500 consecutive simulations for patients undergoing radiation therapy was reviewed. A median of 105 simulations occurred per month. All simulation directives were entered by a physician a median of 3 days before simulation (range, 1-76 days). The treatment intent was curative for 269 patients (53.8%), palliative for 203 patients (40.6%), and benign for 3 patients (0.6%). Twenty-five (5%) patients did not have a treatment intent selected. Based on RO multidisciplinary review, 105 directives (21%) were modified from the original intent, with 29 (5.8%) requiring more than 1 modification. A total of 149 modifications were made and categorized as changes to patient positioning and immobilization (n = 100, 20%), treatment site and care path (n = 34, 6.8%), simulation coordination activities (n = 6, 1.2%), and treatment technique and planning instructions (n = 9, 1.8%). A higher proportion of modifications occurred at the time of multidisciplinary review in patients receiving more complex treatments (intensity modulated radiation therapy/stereotactic radiosurgery/stereotactic body radiation therapy [IMRT/SRS/SBRT] vs 3-dimensional radiation therapy [3DCRT] radiation therapy, 25% vs 16%, P < .025).

Conclusions: Given the complexity of radiation therapy simulation, standardization of directives with prospective RO multidisciplinary presimulation peer review is critical to optimizing department processes and reducing errors. Approximately 1 in 5 patients benefits from this peer review process, especially patients treated with IMRT/SRS/SBRT.
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http://dx.doi.org/10.1016/j.prro.2020.10.012DOI Listing
September 2021
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