Supralesional Ablation Volumes Are Feasible in the Posterior Fossa and May Provide Enhanced Symptomatic Relief

2021 ◽  
Author(s):  
Evan Luther ◽  
Victor M Lu ◽  
Alexis A Morell ◽  
Turki Elarjani ◽  
Samuel Mansour ◽  
...  
Keyword(s):  
Posterior Fossa ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Symptomatic Relief ◽  
Lesion Volume ◽  
Steroid Dependence ◽  
Ablation Volume ◽  
Perilesional Edema ◽  
Local Progression

Abstract BACKGROUND Laser interstitial thermal therapy (LITT) for posterior fossa lesions remains rare as the small size of the infratentorial compartment, proximity to the brainstem, and thickness/angulation of the occipital bone creates barriers to procedural success. Furthermore, evaluation of the effect of ablation volume on outcomes is limited. OBJECTIVE To analyze our institutional experience with LITT in the posterior fossa stratifying perioperative and long-term outcomes by ablation volumes. METHODS Seventeen patients with posterior fossa lesions treated with LITT from 2013 to 2020 were identified. Local progression-free survival (PFS), overall survival, steroid dependence, and edema reduction were evaluated with Kaplan-Meier analysis grouped by ablation volume. Preoperative, postoperative, and last known Karnofsky Performance Status (KPS) were compared using a matched paired t test. RESULTS No differences in pathology, preoperative KPS, or preoperative lesion volume were found between patients with total (100%-200% increase in pre-LITT lesion volume) versus radical (>200% increase in pre-LITT lesion volume) ablations. Patients who underwent radical ablation had a higher postoperative KPS (93 vs 82, P = .02) and higher KPS (94 vs 87, P = .04) and greater reduction in perilesional edema at last follow-up (P = .01). Median follow-up was 80.8 wk. CONCLUSION Despite obvious anatomical challenges, our results demonstrate that radical ablations are both feasible and safe in the posterior fossa. Furthermore, radical ablations may lead to greater decreases in perilesional edema and improved functional status both immediately after surgery and at last follow-up. Thus, LITT should be considered for patients with otherwise unresectable or radioresistant posterior fossa lesions.

scholarly journals Robotic radiosurgery treatment in liver tumors: Early experience from an Indian center

2018 ◽  
Vol 07 (03) ◽  
pp. 175-182 ◽  
Author(s):  
Debnarayan Dutta ◽  
Sathiya Krishnamoorthy ◽  
H. Sudahar ◽  
M. Muthukumaran ◽  
T. Ramkumar ◽  
...  
Keyword(s):  
Liver Tumors ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Liver Lesion ◽  
Target Volume ◽  
Prior Treatment ◽  
Related Factors ◽  
Robotic Radiosurgery ◽  
Local Progression

Abstract Purpose: The purpose of this study is to report CyberKnife experience in hepatocellular carcinoma (HCC) and liver metastasis (LM). Materials and Methods: Fifty liver lesions in 31 consecutive patients with liver lesion [mean age 54.5 years (range 32-81 years), 77% were male patient, GTV <10cc in 5 patients, 11-90cc in 18 & >90cc in 8 patients respectively. Eighty percentage (25/31) had prior treatment (chemotherapy 18 patient & TACE in 7 patients). Dosage schedule was 21-45Gy/3# (mean PTV dose 33Gy, Prescription isodose 84%, target coverage 94%). Mean CI, nCI & HI were 1.19, 1.31 & 1.18 respectively. Mean liver dose was 5.4 Gy, 800 cc liver dose 11.1 Gy; Results: At mean follow-up of 12.5 months (range 1.9–44.6 months), 19 patients were expired and 12 were alive (nine patient with stable disease, two local progression, and one with metastasis). Median overall survival (OS) of all patients are 9 months (1.9–44.6 months), in HCC patients 10.5 months (2.1–44.6 months) and MT 6.5 months (1.9–24.6 months) respectively. Gr-I-II GI toxicities were in 11/50 (22%) patients. OS was influenced by PS (Karnofsky Performance Status 70–80 vs. 90–100: 9.9 vs. 16.4; P = 0.024), Child-Pugh (CP A/B vs. C: 23.6 vs. 6.5; P = 0.069), cirrhosis (only fatty liver vs. diffuse cirrhosis: 17.8 vs. 10.6; P = 0.003), prior treatment (no Rx vs. prior Rx: 30.1 vs. 8.2; P = 0.08), number of lesions (single vs. multiple: 16.4 vs. 6.9; P = 0.001), and target volume (<10 cc vs. >90 cc: 24.6 vs. 11.2; P = 0.03). Conclusion: Stereotactic body radiation therapy is a safe and effective treatment. Patient related factors such as performance status, Child-Pugh classification, cirrhosis status, prior treatment, number of liver lesion & target volume (GTV) influence the survival functions.

scholarly journals The effect of Gamma Knife radiosurgery on large posterior fossa metastases and the associated mass effect from peritumoral edema

2020 ◽  
pp. 1-9
Author(s):  
Baha’eddin A. Muhsen ◽  
Krishna C. Joshi ◽  
Bryan S. Lee ◽  
Bicky Thapa ◽  
Hamid Borghei-Razavi ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Posterior Fossa ◽  
Gamma Knife ◽  
Fourth Ventricle ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Gamma Knife Radiosurgery ◽  
Secondary Outcome ◽  
Peritumoral Edema

OBJECTIVEGamma Knife radiosurgery (GKRS) as monotherapy is an option for the treatment of large (≥ 2 cm) posterior fossa brain metastases (LPFMs). However, there is concern regarding possible posttreatment increase in peritumoral edema (PTE) and associated compression of the fourth ventricle. This study evaluated the effects and safety of GKRS on tumor and PTE control in LPFM.METHODSThe authors performed a single-center retrospective review of 49 patients with 51 LPFMs treated with GKRS. Patients with at least 1 clinical and radiological follow-up visit were included. Tumor, PTE, and fourth ventricle volumetric measurements were used to assess efficacy and safety. Overall survival was a secondary outcome.RESULTSFifty-one lesions in 49 consecutive patients were identified; 57.1% of patients were male. At the time of GKRS, the median age was 61.5 years, and the median Karnofsky Performance Status score was 90. The median number of LPFMs and overall brain metastases were 1 and 2, respectively. The median overall tumor, PTE, and fourth ventricle volumes at diagnosis were 4.96 cm3 (range 1.4–21.1 cm3), 14.98 cm3 (range 0.6–71.8 cm3), and 1.23 cm3 (range 0.3–3.2 cm3), respectively, and the median lesion diameter was 2.6 cm (range 2.0–5.07 cm). The median follow-up time was 7.3 months (range 1.6–57.2 months). At the first follow-up, 2 months posttreatment, the median tumor volume decreased by 58.66% (range −96.95% to +48.69%, p < 0.001), median PTE decreased by 78.10% (range −99.92% to +198.35%, p < 0.001), and the fourth ventricle increased by 24.97% (range −37.96% to +545.6%, p < 0.001). The local control rate at first follow-up was 98.1%. The median OS was 8.36 months. No patient required surgical intervention, external ventricular drainage, or shunting between treatment and first follow-up. However, 1 patient required a ventriculoperitoneal shunt at 23 months from treatment. Posttreatment, 65.30% received our general steroid taper, 6.12% received no steroids, and 28.58% required prolonged steroid treatment.CONCLUSIONSIn this retrospective analysis, patients with LPFMs treated with GKRS had a statistically significant posttreatment reduction in tumor size and PTE and marked opening of the fourth ventricle (all p < 0.001). This study demonstrates that GKRS is well tolerated and can be considered in the management of select cases of LPFMs, especially in patients who are poor surgical candidates.

Impact of the Karnofsky Performance Status on Survival and its Dynamics during the Terminal Year of Peritoneal Dialysis Patients

2018 ◽  
Vol 38 (1) ◽  
pp. 24-29 ◽  
Author(s):  
Ana Paula Modesto ◽  
Len Usvyat ◽  
Viviane Calice-Silva ◽  
Dandara Novakowski Spigolon ◽  
Ana Elizabeth Figueiredo ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Family Income ◽  
Independent Predictor ◽  
Karnofsky Performance Status ◽  
Low Cost ◽  
Performance Status ◽  
Multi Center Study ◽  
Complications And Mortality ◽  
First Time

Background Simple and low-cost tools to monitor the risk profile of patients on peritoneal dialysis (PD) at high risk of complications and mortality are scarce. One of the tools available to monitor the variation in vitality and dependence levels is the Karnofsky performance status (KPS). This study analyzed the average trends and variation of KPS during the 12 months before death and its independent value in predicting patients’ survival. Methods The data were compiled from the BRAZPD II multi-center study, performed in Brazil between 2004 and 2011. For the analysis of KPS dynamics, we included patients with at least 12 months of follow-up on PD and who had a fatal event during the follow-up. The following covariables were evaluated: age, gender, ethnicity, educational level, and presence of diabetes. We used the linear regression model to present the results: the log (time) before death was represented by the regression variable and KPS was the response. We also analyzed the independent impact of baseline KPS on patients’ survival. Results From the population of 9,905 patients enrolled in the BRAZPD study, 4,133 survived 12 months on PD and were included in the analysis. There was a gradual decline in the KPS scores, which accelerated in the last 2 months before death. These changes were similar irrespective of age, race, family income, gender, diabetes, PD modality, and education level. We observed 989 fatal events in this population during the observation period, and the KPS score was identified as an independent predictor for mortality in this cohort. Conclusions This study demonstrates for the first time the dynamics of KPS before death in PD patients, indicating a progressive and accelerated decline of KPS in the 12 months before patients died. In addition, KPS was an independent predictor of mortality in this population.

scholarly journals Functional Outcome Following Synthetic Vertebral Body Implantation in the Management of Spinal Disorders

2020 ◽  
Vol 8 (B) ◽  
pp. 76-80
Author(s):  
Moneer K. Faraj ◽  
Bassam Mahmood Flamerz  Arkawazi ◽  
Hazim Moojid Abbas ◽  
Zaid Al-Attar
Keyword(s):  
Functional Outcome ◽  
Vertebral Body ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Spinal Tuberculosis ◽  
Vertebral Body Replacement ◽  
Spinal Tumors ◽  
Karnofsky Performance Status Scale ◽  
Significant Change

OBJECTIVE: Synthetic vertebral body replacement has been widely used recently to treat different spinal conditions affecting the anterior column. They arrange from trauma, infections, and even tumor conditions. In this study, we assess the functional outcome of this modality in different spinal conditions. PATIENTS AND METHODS: Thirty-six cases operated from October 2010 to December 2017. Twelve patients had spinal type A3 fractures, 11 cases with spinal tuberculosis (TB), and 13 cases with spinal tumors. They were followed clinically for a mean period of 2.4 years. RESULTS: All the cases were approached anteriorly. Seven cases had a post-operative infection. No neurological worsening reported. We had dramatic neurological improvement in all spinal TB cases. Mortality recorded in only 4 cases with metastatic spinal tumor during the mean period of follow-up. Karnofsky performance status scale showed statistically significant change for spinal TB, and tumor cases during the follow-up period, but there was no significant change in cases of spinal type A3 fractures. CONCLUSION: The positive outcome of this surgery makes it recommended for properly selected patients, especially with spinal TB and tumors.

Radiosurgery for parasagittal and parafalcine meningiomas

2013 ◽  
Vol 119 (4) ◽  
pp. 871-877 ◽  
Author(s):  
Dale Ding ◽  
Zhiyuan Xu ◽  
Ian T. McNeill ◽  
Chun-Po Yen ◽  
Jason P. Sheehan
Keyword(s):  
Cox Regression ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Tumor Control ◽  
Who Grade ◽  
Tumor Control Rate ◽  
Karnofsky Performance Status Score ◽  
Status Score ◽  
Performance Status Score

Object Parasagittal and parafalcine (PSPF) meningiomas represent the second most common location for intracranial meningiomas. Involvement of the superior sagittal sinus or deep draining veins may prevent gross-total resection of these tumors without significant morbidity. The authors review their results for treatment of PSPF meningiomas with radiosurgery. Methods The authors retrospectively reviewed the institutional review board–approved University of Virginia Gamma Knife database and identified 65 patients with 90 WHO Grade I parasagittal (59%) and parafalcine (41%) meningiomas who had a mean MRI follow-up of 56.6 months. The patients' mean age was 57 years, the median preradiosurgery Karnofsky Performance Status score was 80, and the median initial tumor and treatment volumes were 3 and 3.7 cm3, respectively. The median prescription dose was 15 Gy, isodose line was 40%, and the number of isocenters was 5. Kaplan-Meier analysis was used to determine progression-free survival (PFS). Univariate and multivariate Cox regression analyses were used to identify factors associated with PFS. Results The median overall PFS was 75.6 months. The actuarial tumor control rate was 85% at 3 years and 70% at 5 years. Parasagittal location, no prior resection, and younger age were found to be independent predictors of tumor PFS. For the 49 patients with clinical follow-up (mean 70.8 months), the median postradiosurgery Karnofsky Performance Status score was 90. Symptomatic postradiosurgery peritumoral edema was observed in 4 patients (8.2%); this group comprised 3 patients (6.1%) with temporary and 1 patient (2%) with permanent clinical sequelae. Two patients (4.1%) died of tumor progression. Conclusions Radiosurgery offers a minimally invasive treatment option for PSPF meningiomas, with a good tumor control rate and an acceptable complication rate comparable to most surgical series.

Surgical Outcome of Large Solid Posterior Fossa Hemangioblastoma without Preoperative Embolization

2021 ◽  
Author(s):  
Prashant Raj Singh ◽  
Raghvendra Kumar Sharma ◽  
Jitender Chaturvedi ◽  
Nitish Nayak ◽  
Anil Kumar Sharma
Keyword(s):  
Posterior Fossa ◽  
Surgical Outcome ◽  
Karnofsky Performance Status ◽  
Obstructive Hydrocephalus ◽  
Case Series ◽  
Preoperative Embolization ◽  
Initial Symptom ◽  
Lower Cranial Nerve ◽  
The Mean

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

Equivalent Outcome Between Reduced Intensity Versus Conventional Myeloablative Conditioning Hematopoietic Stem Cell Transplantation for Patients Older Than 35 Years with Acute Myeloid Leukemia.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3103-3103
Author(s):  
Marie Sebert ◽  
Raphaël Porcher ◽  
Marie Robin ◽  
Lionel Ades ◽  
Emmanuel Raffoux ◽  
...  
Keyword(s):  
Myeloid Leukemia ◽  
Research Funding ◽  
Cox Regression ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Conditioning Regimen ◽  
Hematopoietic Stem ◽  
Treatment Related Mortality ◽  
Related Mortality

Abstract Abstract 3103 Introduction: Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) provides the best chance of long-term survival for patients with intermediate or high-risk acute myeloid leukemia (AML). The major limitation of this procedure is the risk of treatment related mortality (TRM). Use of reduced intensity conditioning (RIC) regimen has become standard practice among older candidates with comorbidities. Although RIC regimen have been used for over a decade in older patients, the benefit of this approach in younger patients with AML compared with the risk of toxicity of standard regimen (MAC) is still discussed. We compared the outcomes for patients with AML over 35 years using RIC or MAC HSCT. Patients, methods, and transplantation characteristics: From January 2000 to December 2010, 132 consecutive patients older than 35 years with AML (18 secondary AML) received HSCT in our center, either from siblings (n=87) or HLA 10/10 allele-matched donors (n=45). MAC (n=72) and RIC (n=60) regimens were defined as previously described (Bacigalupo, 2009). Seventy-three patients were in first complete remission (CR1); 30% of patients had poor risk cytogenetics (MRC classification). Karnofsky performance status was scored at time of HSCT. Engraftment, acute and chronic graft-versus-host disease (GvHD), transplantation-related mortality (TRM), relapse rate as well as overall survival (OS) at 4 years were compared according to the intensity of the conditioning regimen. First a classical multivariable Cox analysis was conducted. In a second step, baseline confounding factors were adjusted for using inverse probability-of-treatment weighting (IPTW). Results of the comparison: Patient characteristics according to the intensity of the conditioning regimen were similar for AML type (de novo versus secondary), gender, karnofsky performance status, CR#, donor type and number of CD34+ infused. Particularly, cytogenetic risks were comparable in both groups. Patients were younger in the MAC group (median age 44 years [range 35 to 56 years] vs 54[37 to 66] for RIC, p<0,0001), received mainly bone marrow as source of stem cells (54% versus 2% for RIC, p<0,0001) and GvHD prophylaxis using cyclosporine plus methotrexate (89% versus 5% for RIC, p<0,0001). Moreover, ATG in the conditioning regimen (more ATG in RIC: 51 vs. 14%, p<0.0001), donor age (older for RIC: 49 vs. 39 years, p=0.002) and number of nucleated cells infused (higher in RIC: 11 vs. 4 × 108/kg, p<0.0001) were also different. The median follow-up was 47 months (10 to 134), and 25% of patients had a follow-up of at least 74 months. During evolution, all patients engrafted. The cumulative incidence (CIf) of acute GVHD grade II-IV was 49% (35% after RIC vs 61% after MAC, p=0.001). The 5-year CIf of chronic GVHD was 37% (40% after RIC vs 30% after MAC, p=0.32). During FU, 71 patients died. The 5-year CIf of TRM was 21% (13% after RIC vs 28% after MAC, p=0.009). Adjusting for cytogenetic risk, gender donor/recipient mismatch and infused nucleated cells, no difference was observed between RIC and MAC (HR 0.9, p=0.16). The 5-year CIf of relapse was 42% (51% after RIC vs 35% after MAC (p=0.22)). Adjusting for gender donor/recipient mismatch, donor/recipient CMV serostatus and infused CD34+ cells, no marked difference was observed between RIC and MAC (HR 0.8, 95%CI 0.4–1.5, p=0.50). The 5-year OS was 39% (50% after RIC vs 34% after MAC, p=0.38). Using both Cox regression and IPTW to account for imbalance in patients characteristics, similar OS was found after RIC and MAC (Figure 1), with adjusted HRs for MAC vs RIC of 0.9 (95%CI 0.4–1.8, p=0.68) with Cox regression and 0.9 (95%CI 0.4–1.8, p=0.76) with IPTW. Conclusion: In patients with AML over 35 years, MAC regimen lead to a non significant higher rate of treatment related mortality with no benefit in terms of relapse when compared with RIC regimen. Until prospective trials are completed, this study supports the use of a RIC regimen for patients with AML older than 35 years who are transplanted either from siblings or matched unrelated donors. Disclosures: Fenaux: Amgen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Roche: Honoraria, Research Funding; GSK: Honoraria, Research Funding; Novartis: Honoraria, Research Funding.

scholarly journals Epidermoid cysts of the cavernous sinus: clinical features, surgical outcomes, and literature review

2018 ◽  
Vol 129 (4) ◽  
pp. 973-983 ◽  
Author(s):  
Feng Zhou ◽  
Zixiao Yang ◽  
Wei Zhu ◽  
Liang Chen ◽  
Jianping Song ◽  
...  
Keyword(s):  
Cavernous Sinus ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Case Series ◽  
Symptomatic Improvement ◽  
Subtotal Resection ◽  
Imaging Data ◽  
Epidermoid Cysts ◽  
The Past

OBJECTIVEEpidermoid cysts of the cavernous sinus (CS) are rare, and no large case series of these lesions has been reported. In this study, the authors retrospectively reviewed the outcomes of the surgical management of CS epidermoid cysts undertaken at their center and performed a review of any such cysts reported in the literature over the past 40 years.METHODSClinical data were obtained on 31 patients with CS epidermoid cysts that had been surgically treated at the authors’ hospital between 2001 and 2016. The patients’ medical records, imaging data, and follow-up outcomes were retrospectively analyzed. The related literature from the past 40 years (18 articles, 20 patients) was also evaluated.RESULTSThe most common chief complaints were facial numbness or hypesthesia (64.5%), absent corneal reflex (45.2%), and abducens or oculomotor nerve deficit (35.5%). On MRI, 51.6% of the epidermoid cysts showed low T1 signals and equal or high T2 signals. In the other lesions, the radiological findings varied considerably given differences in the composition of the cysts. Surgery was performed via the extradural approach (58.1%), intradural approach (32.3%), or a combined approach (9.7%). After the operation, symptoms remained similar or improved in 90.3% of patients and new oculomotor paralysis developed after the operation in 9.7% of patients. Seven patients (22.6%) developed meningitis postoperatively (5 aseptic and 2 septic), and all of them recovered. All patients achieved good recovery before discharge (Karnofsky Performance Status score ≥ 70). Over an average follow-up of 4.6 ± 3.0 years in 25 patients (80.6%), no recurrence or reoperation occurred, regardless of whether total or subtotal resection of the capsule had been achieved.CONCLUSIONSBoth the extradural and intradural approaches can enable satisfactory lesion resection. A favorable prognosis and symptomatic improvement can be expected after both total and subtotal capsule resections. Total capsule resection is encouraged to minimize the possibility of recurrence provided that the resection can be safely performed.

A phase II safety study of bevacizumab in patients with multiple recurrent or progressive malignant gliomas

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2079-2079 ◽  
Author(s):  
J. J. Raizer ◽  
L. Gallot ◽  
R. Cohn ◽  
J. Chandler ◽  
R. Levy ◽  
...  
Keyword(s):  
Karnofsky Performance Status ◽  
Performance Status ◽  
Treatment Options ◽  
Single Agent ◽  
Malignant Gliomas ◽  
Response Rates ◽  
Median Number ◽  
Mcdonald Criteria ◽  
Normal Urine

2079 Introduction: Available treatment options for patients with recurrent MG are few. Recent trends have used target specific agents but none has been effective to date. A single agent trial was designed to determine the safety and efficacy of bevacizumab in patients with recurrent MG. Recently, bevacizumab and CPT-11 in combination have shown response rates of approximately 60%. Patients and Methods: All patients (pts) had to sign an IRB informed consent. All pts had to have at least two relapses. Pts had to be > 18 year of age with Karnofsky performance status of > 60. Adequate bone marrow, liver and renal function was required, as well as normal urine protein and creatinine. Patients were required to be on a non-enzyme inducing anti-convulsants. An MRI with perfusion was done at baseline (if patient consented) and then every 6 weeks. Patients continued on trial as long as they did not have tumor progression. Patients received bevacizumab 15 mg/kg every 3 weeks as a 60–90 minute infusion. Results: To date, 16 pts with recurrent MG have been treated. 14 pts had a glioblastoma (GBM) and 2 had an anaplastic oligodendroglioma (AO). Median number of doses given was 3 (range 1–12). No patient had an intracranial hemorrhage and the only significant toxicity was a DVT in a patient with prior DVT. Best responses per McDonald criteria were: PR in 2 pts, SD in 4 pts, PD in 3 pts and non-evaluable in 7 pts: 4 follow up imaging not done, 1 each with stable MRI after 2 doses but WD for non-compliance, clinical decline and patient’s choice. Results: Bevacizumab as a single agent given every 3 weeks at 15 mg/kg is safe. Partial responses and stable disease were seen in about 30 % of patients with follow up imaging but many patients are early in treatment. Our response rates to date are lower then previous reports of patients treated with CPT-11 and bevacizumab; this maybe due to the increased number of prior therapies, a different schedule of bevacizumab or the omission of CPT-11. Updated response rates, time to progression and overall survival will be presented. [Table: see text] No significant financial relationships to disclose.

IMMU-26. SAFETY AND EFFICACY OF PVSRIPO IN RECURRENT GLIOBLASTOMA: LONG-TERM FOLLOW-UP AND INITIAL MULTICENTER RESULTS

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi97-vi97
Author(s):  
Annick Desjardins ◽  
Matthias Gromeier ◽  
Henry Friedman ◽  
Daniel Landi ◽  
Allan Friedman ◽  
...  
Keyword(s):  
Karnofsky Performance Status ◽  
Performance Status ◽  
Recurrent Glioblastoma ◽  
External Control ◽  
Published Data ◽  
Single Center ◽  
Term Survival ◽  
Long Term Survival

Abstract BACKGROUND Recurrent glioblastoma (rGBM) is rapidly fatal (median overall survival [mOS] of ~9 months; OS at 12 months [OS12] &lt; 35%) with approved therapies (lomustine±bevacizumab). PVSRIPO is an intratumoral immunotherapy targeting CD155 on antigen-presenting and malignant cells of solid tumors. Preclinically, PVSRIPO delivers a systemic, tumor antigen-specific, polyfunctional T-cell mediated anti-tumor response. Interim, single-center, phase (Ph) 1 results showed greater long-term survival with PVSRIPO vs. criteria-matched external control rGBM patients (Desjardins 2018). Updates to Ph1 safety (at the Ph2 dose) and efficacy and interim multicenter (Ph2) results are presented. METHODS Adults with histologically-confirmed rGBM, Karnofsky performance status ≥ 70, and an active, supratentorial, contrast-enhancing lesion (1-5.5cm) received PVSRIPO (5x107 TCID50) intratumorally via convection-enhanced delivery on Day 1, with a planned follow-up of 24 months. Safety (treatment-emergent adverse events [TEAEs]), efficacy (reported as OS12, OS24, mOS), and blood/tissue were assessed. RESULTS 149 patients (&gt;90% with 1-2 prior progressions, including failure of SOC and patients with prior bevacizumab failure) received the Ph2 dose of PVSRIPO (n=30 received other doses in Ph1 with safety summarized previously). Follow-up durations for surviving patients were 51-74 months (Ph1) and 10-44 months (Ph2). No dose-limiting toxicities occurred; up to 97% of patients experienced mostly grade 1-2 related TEAEs; ≤ 23% patients experienced grade ≥ 3 related events. Neurologic symptoms related to peritumoral edema were most common ( &gt; 90% patients) and were effectively managed with low-dose bevacizumab/corticosteroids. Survival estimates were: OS12: 54%, 50%; OS24: 18%, 17%; mOS: 12.3 (95% CI 10,15.3), 12 (10.6,13.7) months, for the Ph1 and Ph2 trials, respectively. Baseline correlates of longer survival included smaller lesions and methylated MGMT-promoter status. CONCLUSIONS The multicenter/Ph2 study replicated the single-center/Ph1 results. Relative to published data with approved therapies, PVSRIPO was associated with greater long-term survival and mOS in patients with rGBM and was generally well-tolerated.

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