Resection and surgically targeted radiation therapy for locally recurrent GBM.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2054-2054
Author(s):  
David Brachman ◽  
Peter Nakaji ◽  
Kris Smith ◽  
Theresa Thomas ◽  
Christopher Dardis ◽  
...  
Keyword(s):  
Overall Survival ◽  
Radiation Therapy ◽  
Local Control ◽  
Local Treatment ◽  
Post Hoc Analysis ◽  
Locally Recurrent ◽  
Targeted Radiation Therapy ◽  
Post Hoc ◽  
Recurrent Gbm

2054 Background: Recurrent GBM (rGBM) is a diffuse disease, and resection (R) alone does not provide durable local control (LC) or prolong overall survival (OS). Hypothesizing R plus immediate radiation (RT) may achieve durable LC and secondarily improve OS by permitting time for subsequent potentially effective but biologically slower treatments to have an impact, we prospectively evaluated R combined with a novel surgically targeted radiation therapy (STaRT) device utilizing Cs-131 embedded in bioresorbable collagen tiles. Methods: From 2/13-2/18 patients (pts) with locally recurrent GBM were treated on a prospective single arm trial (ClinicalTrials.gov, NCT#03088579) of maximum safe resection and immediate RT (GammaTile, GT Medical Technologies, Tempe AZ). Upon resection the at-risk areas of the surgical bed were lined with the GammaTile (GT) device, delivering 60-80 Gy at 5 mm. Follow up treatments were not specified but captured; no pt. underwent additional local therapy without progression, and no pt. was lost to follow up. We present study specified endpoints of local control (LC), overall survival (OS), and adverse events (AE), and a post hoc, hypothesis-generating analysis of outcomes by receipt of systemic (Sys) therapy. Results: 28 locally recurrent GBM were treated, 20 at first progression (range 1-3). Median age was 58 years (yrs.) (range 21-80), KPS 80 (60-100), female: male ratio 10:18 (36/64%). MGMT was methylated in 11%, unmethylated in 18%, and unknown in 71%. For all pts., median OS was 10.7 months (mo.) (range.1-42.3), and radiographic LC was 8.8 mo. (range.01-34.5). LC (defined as < 15 mm from surgical bed) was maintained in 50% of pts., and no first failure was local. 12 mo. OS was 75% for pts. < 50 yrs. vs. 43% for > 50 yrs. (HR.46, p =.009). MGMT, KPS, and sex were non-predictive. After R+GT, 17 pts. received > 1 cycle of systemic therapy (Sys), either as adjuvant or salvage, alone or in combination . Sys was bevacizumab (BEV) in 15 pts., temozolomide (TMZ) in 12, and lomustine (CCNU) in 8 (N > 17 as some pts. received > 1 Sys). Post hoc analysis disclosed a 15.1 mo. OS for pts. receiving > 1 cycle of Sys (Sys+, N = 17) vs. 6.5 mo. for no Sys (Sys-, N = 11) (hazard ratio (HR).38, p =.017)). LC was 11.4 mo. for Sys+ and 2.1 mo. for Sys- (HR.44; p =.16)). Median OS (mo.) for BEV+ vs. BEV- was 16.7/4.5 (HR.38, p =.017), for TMZ+ vs. TMZ- 17.5/6.7 (HR.40, p =.025) and for CCNU+ vs. CCNU- 17.5/7.9 (HR.61, p =.25), respectively. Three attributed AE occurred, 1 dehiscence requiring surgery and 2 radiation brain effects, medically treated. 4 unrelated deaths occurred < 60 days post-op, all in the Sys- cohort, impacting their opportunity for subsequent treatment. Conclusions: In this study local treatment alone was insufficient to achieve prolonged OS. Post hoc analysis suggests R+GT coupled with Sys may have potential to impact OS in rGBM patients. GT was FDA cleared in 2020 for use in newly diagnosed malignant and all recurrent intracranial neoplasms. Clinical trial information: NCT#03088579.

CTNI-31. RESECTION AND SURGICALLY TARGETED RADIATION THERAPY FOR TREATMENT OF LOCALLY RECURRENT GBM IN 28 PROSPECTIVELY TREATED PATIENTS

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi66-vi66
Author(s):  
Kris Smith ◽  
Peter Nakaji ◽  
Theresa Thomas ◽  
Dilini Pinnaduwage ◽  
Garrick Wallstrom ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Post Hoc Analysis ◽  
Diffuse Disease ◽  
P 16 ◽  
Locally Recurrent ◽  
First Recurrence ◽  
Targeted Radiation Therapy ◽  
Immediate Implantation ◽  
Post Hoc ◽  
Recurrent Gbm

Abstract INTRODUCTION Recurrent GBM is a diffuse disease and resection (R) alone does not routinely provide durable local control (LC) or prolonged overall survival (OS). We hypothesized R plus immediate radiation (RT) utilizing a novel brachytherapy device might achieve more durable LC and thereby secondarily improve OS. METHODS From 2/2013-2/2018, locally recurrent GBM were treated in a single arm trial (ClinicalTrials.gov, NCT#03088579) of R plus immediate implantation of a surgically targeted radiation therapy (STaRT) device utilizing Cs-131 in bioresorbable collagen tiles (GammaTile, GT Medical Technologies, Tempe AZ USA). RESULTS 28 patients (pts) were treated, 20 at first recurrence (range 1-3). Median age 58 (range 21-80), KPS 80 (60-100), female:male ratio 10:18. Median OS was 10.7 mo., radiographic LC 8.8 mo., and no first failure was local. MGMT, KPS, and sex were non-predictive. Post hoc analysis disclosed after R+STaRT, 17 pts (54%) received &gt; 1 cycle of Sys (“Sys+”) and 13 (46%) did not (“Sys- “). Sys was given as adjuvant, salvage, or both, either alone or in combination. 15 pts received bevacizumab (BEV), 12 temozolomide (TMZ) and 8 lomustine (CCNU). Median OS (mo.) for Sys+ vs. Sys- was 15.1/6.5 (hazard ratio (HR) .38, p=.017); OS for BEV+ vs. BEV- was 16.7/4.5 (HR .38, p=.017), TMZ+ vs. TMZ- 17.5/6.7 (HR .40, p=.025) and for CCNU+ vs. CCNU- 17.5/7.9 (HR .61, p=.25), respectively. LC was 11.4 mo. for Sys+ vs. 2.1 mo. for Sys- (HR .44; p=.16). Three attributed AE occurred, 1 wound infection requiring surgery and 2 radiation brain effects, managed medically. CONCLUSION Post hoc analysis suggests R+STaRT+Sys may have the potential to impact OS in locally recurrent GBM, possibly by allowing sufficient time for effective but biologically slower treatments to have an impact. FDA clearance was received in 2018 for recurrent intracranial neoplasms and in 2020 for newly-diagnosed malignant brain tumors.

scholarly journals Baseline Interleukin-6 and -8 predict response and survival in patients with advanced hepatocellular carcinoma treated with sorafenib monotherapy: an exploratory post hoc analysis of the SORAMIC trial

2021 ◽  
Author(s):  
Osman Öcal ◽  
Kerstin Schütte ◽  
Juozas Kupčinskas ◽  
Egidijus Morkunas ◽  
Gabija Jurkeviciute ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Objective Response ◽  
Advanced Hepatocellular Carcinoma ◽  
Sorafenib Treatment ◽  
Post Hoc Analysis ◽  
Y90 Radioembolization ◽  
Baseline Values ◽  
Post Hoc

Abstract Purpose To explore the potential correlation between baseline interleukin (IL) values and overall survival or objective response in patients with hepatocellular carcinoma (HCC) receiving sorafenib. Methods A subset of patients with HCC undergoing sorafenib monotherapy within a prospective multicenter phase II trial (SORAMIC, sorafenib treatment alone vs. combined with Y90 radioembolization) underwent baseline IL-6 and IL-8 assessment before treatment initiation. In this exploratory post hoc analysis, the best cut-off points for baseline IL-6 and IL-8 values predicting overall survival (OS) were evaluated, as well as correlation with the objective response. Results Forty-seven patients (43 male) with a median OS of 13.8 months were analyzed. Cut-off values of 8.58 and 57.9 pg/mL most effectively predicted overall survival for IL-6 and IL-8, respectively. Patients with high IL-6 (HR, 4.1 [1.9–8.9], p < 0.001) and IL-8 (HR, 2.4 [1.2–4.7], p = 0.009) had significantly shorter overall survival than patients with low IL values. Multivariate analysis confirmed IL-6 (HR, 2.99 [1.22–7.3], p = 0.017) and IL-8 (HR, 2.19 [1.02–4.7], p = 0.044) as independent predictors of OS. Baseline IL-6 and IL-8 with respective cut-off values predicted objective response rates according to mRECIST in a subset of 42 patients with follow-up imaging available (IL-6, 46.6% vs. 19.2%, p = 0.007; IL-8, 50.0% vs. 17.4%, p = 0.011). Conclusion IL-6 and IL-8 baseline values predicted outcomes of sorafenib-treated patients in this well-characterized prospective cohort of the SORAMIC trial. We suggest that the respective cut-off values might serve for validation in larger cohorts, potentially offering guidance for improved patient selection.

Treatment of diatal rectal cancer with preoperative intensity-modulated radiation therapy (IMRT) combined with chemotherapy: Updated 5-year results of 42 patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14157-e14157
Author(s):  
Albert S. DeNittis ◽  
John Marks ◽  
Filip Troicki ◽  
Erik L. Zeger ◽  
George Nassif ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Local Control ◽  
Medical Center ◽  
Neoadjuvant Chemoradiotherapy ◽  
Intensity Modulated Radiation Therapy ◽  
Intensity Modulated ◽  
Distal Rectal Cancer

e14157 Background: Preoperative chemoradiotherapy is currently the standard of care for patients with distal rectal cancer. With Intensity Modulated Radiation Therapy (IMRT), more conformal doses of radiation can be delivered to tumor while sparing normal tissue. It is our intent to present updated data showing 5 year follow up on patients treated concurrently with chemotherapy and IMRT reporting on local control, overall survival, and toxicity. Methods: From April 2007 to February of 2012 a sequential retrospective study of 42 patients at Lankenau Medical Center were treated for distal rectal cancer using IMRT. Patients staged from T2N0M0 to T3N1M0 and all received 5580 cGy to the pelvis using a 9 field plan to tumor, involved and uninvolved lymph nodes. All but one patient received 5FU based chemotherapy and four patients also received oxaliplatin. All patients then went on to surgery 8 – 12 weeks following neoadjuvant therapy. Twenty six patients underwent transabdominal transanal mesorectal (TATA) resection, 9 patients underwent a transanal endoscopic microsurgery (TEM), and 1 patient had an open low anterior resection. 3 patients have yet to go to surgery. FOLFOX was given to 25 of 42 patients adjuvently. Patients were analyzed for local control (LC), median survival (MS), overall survival (OS), and toxicity. Results: The median follow-up was 35 months. Complete pathological response was achieved in 12 (30.7%) patients, partial response was achieved in 25 (64%) patients, and 2 had stable disease at the time of surgery. There were no patients with local failure and only six (14%) patients progressed with distant metastatic disease. OS at 5 years was 92.8% with a MS of 37 months. Toxicity was acceptable with eight patients with grade 1, 5 patients with grade 2, and 3 grade 3 diarrhea. There were 3 (7%) patients with grade 1 neutropenia. Three patients experienced disease related death. Conclusions: With 5 years of follow-up data, our experience has shown that neoadjuvant chemoradiotherapy using IMRT to treat advanced stage rectal cancer is well tolerated and effective. Still further follow-up and additional studies will be required to confirm our findings.

Does stereotactic body radiation therapy have a role in oligoprogressive metastatic colorectal cancer?

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 755-755
Author(s):  
Will Jin ◽  
Aidan M. Burke ◽  
Abdul Rashid ◽  
John Marshall ◽  
Keith Robert Unger
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Metastatic Colorectal Cancer ◽  
Local Control ◽  
Stereotactic Body Radiation Therapy ◽  
Primary Tumors ◽  
Progression Of Disease ◽  
Delay Progression

755 Background: Patients with metastatic colorectal cancer undergoing systemic therapy may enter an oligoprogressive state. Traditionally, local ablative therapy (LAT) has been limited to symptom palliation. We hypothesize that LAT for oligoprogressive lesions with stereotactic body radiation therapy (SBRT) is a feasible alternative to surgical interventions and may delay progression of disease. Methods: An IRB-approved retrospective review of patients with oligoprogressive, metastatic colorectal cancer who were treated with SBRT at Georgetown University Hospital from 2012-2016 was performed. Results: 40 patients with 41 metastatic lesions of the lung (n = 11), liver (n = 10), lymph nodes (n = 8), soft tissue (n = 6), and bone (n = 6) were reviewed. Median follow-up, overall survival, and freedom from distant progression were 10.6, 17.3, and 6.4 months, respectively. Crude one year local control and overall survival were 82.9% and 75%, respectively. First site of progression was distally in 63.4% of patients. Patients treated with SBRT in the liver were significantly more likely to locally progress than other treated sites (13.18 vs. 39.81 months, p = 0.007). On univariate analysis, non-lymph node treated tumors (p = 0.046), larger CEA change at 6 month follow-up (p = 0.048), and right sided primary tumors (p = 0.004) were associated with local failure within 1 year. On multivariate analysis, only right sided primary tumors were significantly more likely to locally progress (p = 0.009). Conclusions: Patients with oligoprogressive colorectal cancer can be effectively treated with SBRT to achieve acceptable rates of local control and potentially delay progression of disease.

scholarly journals Impacts of Faith-Based Lifestyle Interventions on Congregational-Level Nutrition and Physical Activity Environment and Policies

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 300-300
Author(s):  
Summer Wilmoth ◽  
Leah Carrillo ◽  
Elana Martinez ◽  
Raymundo Mendoza Mendoza ◽  
Lauren Correa ◽  
...  
Keyword(s):  
Physical Activity ◽  
Program Effectiveness ◽  
San Antonio ◽  
Macro Level ◽  
Policy Changes ◽  
Environment Policy ◽  
Post Hoc Analysis ◽  
Faith Based ◽  
Post Hoc

Abstract Objectives Hispanics are disproportionally affected by obesity, cancer, and other obesity-related chronic diseases. Building a Healthy Temple (BHT) was a multi-component, faith-based lifestyle intervention implemented in 27 low-income, predominately-Hispanic congregations in San Antonio, TX between 2012 and 2017. One aim of BHT was to assess program effectiveness at improving health-conducive church environment/policy and sustainability of these improvements at follow-up. Methods A key macro-level program component of BHT was the formation of a Health Ministry Committee to initiate church-wide health-conducive environment/policy changes. The Congregational Health Index (CHI) was used to assess church nutrition (17 items) and physical activity (PA, 5 items) environment/policy at baseline, end of program, and follow-up (6 months or more post-intervention). Data were expressed as % of the maximum scores. Friedman test and post hoc analysis were performed with Wilcoxon signed-rank tests and significance of pairwise comparisons, adjusted with Bonferroni correction. Results Eighteen churches completed all 3 CHI assessments. Percentage of total nutrition and PA environment/policy scores for baseline, end of program, and follow-up were 38% (35–45), 64% (53–75), and 69% (64–77), respectively. Post hoc analysis shows significant improvements in nutrition and PA environment/policy scores at end of program (Z = –3.73, P &lt; 0.001) and follow-up (Z = –3.73, P &lt; 0.001) as compared to baseline, as well as significantly higher scores at follow-up compared to end of program (Z = –3.18, P = 0.001). Conclusions Study findings reveal the importance of utilizing congregation-wide macro-level interventions to create health-conducive enviroment/policy changes to facilitate and sustain healthy lifestyle changes in predominately-Hispanic faith community settings. Funding Sources Baptist Health Foundation San Antonio & Cancer Prevention Research Institute of Texas.

scholarly journals RADT-47. A MULTICENTER OBSERVATIONAL STUDY OF SURGICALLY TARGETED RADIATION THERAPY (START) USING IMPLANTED CS-131 SEEDS IN A COLLAGEN-BASED CARRIER TILE IN INTRACRANIAL BRAIN NEOPLASMS - PROTOCOL IN PROGRESS

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii191-ii192
Author(s):  
Peter Nakaji ◽  
David Brachman ◽  
Lisa Misell
Keyword(s):  
Radiation Therapy ◽  
Brain Tumors ◽  
Clinical Outcomes ◽  
Local Control ◽  
Real World ◽  
Functional Decline ◽  
Registry Study ◽  
Multicenter Observational Study ◽  
Patient Reported ◽  
Targeted Radiation Therapy

Abstract INTRODUCTION Post-resection radiotherapy (RT) is the most effective adjuvant treatment for brain tumors. However, there is no current consensus as to the “best” type of post-resection RT, either at diagnosis or recurrence. The use of internally placed radiation (brachytherapy) allows immediate initiation of RT when residual tumor burden is minimal, which theoretically should lessen the risk of recurrence. Brachytherapy placement intraoperatively allows more precise identification of the tumor margins than by postoperative imaging. Traditional brachytherapy methods have several drawbacks, including uneven dose distribution, long operating room times, a need for expensive equipment, and/or frequent adverse events (AE). To address these issues, a device with Cs-131 radiation seeds in a resorbable collagen-based carrier tile (GammaTile, GT Medical Technologies, Tempe AZ) was developed and is described as Surgically Targeted Radiation Therapy or STaRT. The device has demonstrated excellent safety and local control in early commercial use. OBJECTIVE The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT. METHOD Patients (N=600) with surgically resected (R) brain tumors of any pathology who have undergone STaRT are eligible. Accrual to start at 20+ sites in Q3 2020. Data collected includes local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE’s. Data will be collected at 1, 3, 6, 9, and 12 months, then every 6 months through 5 years. RESULT Data will be used to benchmark clinical outcomes of STaRT therapy and allow for comparisons to existing standard-of-care treatments. CONCLUSION This will be the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting.

scholarly journals MBCL-14. A STUDY OF LOW-DOSE CRANIOSPINAL RADIATION THERAPY IN PATIENTS WITH NEWLY DIAGNOSED AVERAGE-RISK MEDULLOBLASTOMA

2020 ◽  
Vol 22 (Supplement_3) ◽  
pp. iii390-iii391
Author(s):  
Aaron Mochizuki ◽  
Anna Janss ◽  
Sonia Partap ◽  
Paul Fisher ◽  
Yimei Li ◽  
...  
Keyword(s):  
Overall Survival ◽  
Radiation Therapy ◽  
Treatment Modalities ◽  
Average Risk ◽  
Craniospinal Radiation ◽  
Grade 5 ◽  
Therapy Studies ◽  
Do So

Abstract INTRODUCTION Medulloblastoma is one of the most common malignant brain tumors in children. To date, the treatment of average-risk (non-metastatic, completely resected) medulloblastoma includes craniospinal radiation therapy and adjuvant chemotherapy. Modern treatment modalities and now risk stratification of subgroups have extended the survival of these patients, exposing the long-term morbidities associated with radiation therapy. METHODS We performed a single-arm, multi-institution study, seeking to reduce the late effects of treatment in patients with average-risk medulloblastoma prior to advances in molecular subgrouping. To do so, we reduced the dose of craniospinal irradiation by 25% to 18 gray with the goal of maintaining the therapeutic efficacy as described in CCG 9892 with maintenance chemotherapy. RESULTS 28 patients aged 3–30 years were enrolled across three institutions between April 2001 and December 2010. Median age at enrollment was 9 years with a median follow-up time of 11.7 years. The 3-year relapse-free (RFS) and overall survival (OS) were 78.6% (95% CI 58.4% to 89.8%) and 92.9% (95% CI 74.4% to 98.2%), respectively. The 5-year RFS and OS were 71.4% (95% CI 50.1% to 84.6%) and 85.7% (95% CI 66.3% to 94.4%), respectively. Toxicities were similar to those seen in other studies; there were no grade 5 toxicities. CONCLUSIONS Given the known neurocognitive adverse effects associated with cranial radiation therapy, studies to evaluate the feasibility of dose reduction are needed. In this study, we demonstrate that select patients with average-risk medulloblastoma may benefit from reduced craniospinal radiation dose of 18 gray without impacting relapse-free or overall survival.

Excessive Toxicity When Treating Central Tumors in a Phase II Study of Stereotactic Body Radiation Therapy for Medically Inoperable Early-Stage Lung Cancer

2006 ◽  
Vol 24 (30) ◽  
pp. 4833-4839 ◽  
Author(s):  
Robert Timmerman ◽  
Ronald McGarry ◽  
Constantin Yiannoutsos ◽  
Lech Papiez ◽  
Kathy Tudor ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Radiation Therapy ◽  
Phase Ii ◽  
Local Control ◽  
Stereotactic Body Radiation Therapy ◽  
Early Stage ◽  
Stage I ◽  
Severe Toxicity ◽  
Stereotactic Body Radiation

PurposeSurgical resection is standard therapy in stage I non–small-cell lung cancer (NSCLC); however, many patients are inoperable due to comorbid diseases. Building on a previously reported phase I trial, we carried out a prospective phase II trial using stereotactic body radiation therapy (SBRT) in this population.Patients and MethodsEligible patients included clinically staged T1 or T2 (≤ 7 cm), N0, M0, biopsy-confirmed NSCLC. All patients had comorbid medical problems that precluded lobectomy. SBRT treatment dose was 60 to 66 Gy total in three fractions during 1 to 2 weeks.ResultsAll 70 patients enrolled completed therapy as planned and median follow-up was 17.5 months. The 3-month major response rate was 60%. Kaplan-Meier local control at 2 years was 95%. Altogether, 28 patients have died as a result of cancer (n = 5), treatment (n = 6), or comorbid illnesses (n = 17). Median overall survival was 32.6 months and 2-year overall survival was 54.7%. Grade 3 to 5 toxicity occurred in a total of 14 patients. Among patients experiencing toxicity, the median time to observation was 10.5 months. Patients treated for tumors in the peripheral lung had 2-year freedom from severe toxicity of 83% compared with only 54% for patients with central tumors.ConclusionHigh rates of local control are achieved with this SBRT regimen in medically inoperable patients with stage I NSCLC. Both local recurrence and toxicity occur late after this treatment. This regimen should not be used for patients with tumors near the central airways due to excessive toxicity.

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