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Effect of Vocimagene Amiretrorepvec in Combination With Flucytosine vs Standard of Care on Survival Following Tumor Resection in Patients With Recurrent High-Grade Glioma: A Randomized Clinical Trial

Cloughesy, Timothy F; Petrecca, Kevin; Walbert, Tobias; Butowski, Nicholas; Salacz, Michael; Perry, James; Damek, Denise; Bota, Daniela; Bettegowda, Chetan; Zhu, Jay-Jiguang; Iwamoto, Fabio; Placantonakis, Dimitris; Kim, Lyndon; Elder, Brad; Kaptain, George; Cachia, David; Moshel, Yaron; Brem, Steven; Piccioni, David; Landolfi, Joseph; Chen, Clark C; Gruber, Harry; Rao, Aliz R; Hogan, Daniel; Accomando, William; Ostertag, Derek; Montellano, Tiffany T; Kheoh, Thian; Kabbinavar, Fairooz; Vogelbaum, Michael A
Importance:New treatments are needed to improve the prognosis of patients with recurrent high-grade glioma. Objective:To compare overall survival for patients receiving tumor resection followed by vocimagene amiretrorepvec (Toca 511) with flucytosine (Toca FC) vs standard of care (SOC). Design, Setting, and Participants:A randomized, open-label phase 2/3 trial (TOCA 5) in 58 centers in the US, Canada, Israel, and South Korea, comparing posttumor resection treatment with Toca 511 followed by Toca FC vs a defined single choice of approved (SOC) therapies was conducted from November 30, 2015, to December 20, 2019. Patients received tumor resection for first or second recurrence of glioblastoma or anaplastic astrocytoma. Interventions:Patients were randomized 1:1 to receive Toca 511/FC (n = 201) or SOC control (n = 202). For the Toca 511/FC group, patients received Toca 511 injected into the resection cavity wall at the time of surgery, followed by cycles of oral Toca FC 6 weeks after surgery. For the SOC control group, patients received investigators' choice of single therapy: lomustine, temozolomide, or bevacizumab. Main Outcomes and Measures:The primary outcome was overall survival (OS) in time from randomization date to death due to any cause. Secondary outcomes reported in this study included safety, durable response rate (DRR), duration of DRR, durable clinical benefit rate, OS and DRR by IDH1 variant status, and 12-month OS. Results:All 403 randomized patients (median [SD] age: 56 [11.46] years; 62.5% [252] men) were included in the efficacy analysis, and 400 patients were included in the safety analysis (3 patients on the SOC group did not receive resection). Final analysis included 271 deaths (141 deaths in the Toca 511/FC group and 130 deaths in the SOC control group). The median follow-up was 22.8 months. The median OS was 11.10 months for the Toca 511/FC group and 12.22 months for the control group (hazard ratio, 1.06; 95% CI 0.83, 1.35; P = .62). The secondary end points did not demonstrate statistically significant differences. The rates of adverse events were similar in the Toca 511/FC group and the SOC control group. Conclusions and Relevance:Among patients who underwent tumor resection for first or second recurrence of glioblastoma or anaplastic astrocytoma, administration of Toca 511 and Toca FC, compared with SOC, did not improve overall survival or other efficacy end points. Trial Registration:ClinicalTrials.gov Identifier: NCT02414165.
PMCID:7596685
PMID: 33119048
ISSN: 2374-2445
CID: 4668492

Spontaneous Cerebrospinal Fluid Leak in a Transgender Man: Is Testosterone Therapy a Risk Factor?

Lin, Giant C; Paz, Melody; Porrmann, Jade Wells; Scharf, Richard; Benitez, Ronald P; Moshel, Yaron A
PMID: 32910142
ISSN: 2168-619x
CID: 4589412

Organized Hematoma of the Sphenoid Sinus With Acute Blindness: Insight Into Pathogenesis of Disease

Lin, Giant C; Wells Porrmann, Jade; Paz, Melody; Moshel, Yaron A; LeBenger, Jeffrey; Benitez, Ronald P
Sinonasal organized hematomas (OHs) are rare lesions that primarily localize to the maxillary sinus. The rate of growth of these masses has not been described in the literature. We present a case of a 59-year-old gentleman with polyostotic fibrous dysplasia who presented with acute loss of vision in the left eye from an expanding OH of the sphenoid sinusitis. After expanded endonasal, transpterygoid approach and debulking, patient experienced significant vision improvement. Close follow-up imaging preoperatively allowed radiologic documentation of the rate of OH growth and this is presented in detail.
PMID: 32692289
ISSN: 1942-7522
CID: 4532152

TOCA 511 & TOCA FC VERSUS STANDARD OF CARE IN PATIENTS WITH RECURRENT HIGH GRADE GLIOMA [Meeting Abstract]

Cloughesy, Timothy; Petrecca, Kevin; Walbert, Tobias; Butowski, Nicholas; Salacz, Michael; Perry, James; Damek, Denise; Bota, Daniela; Bettegowda, Chetan; Zhu, Jay-Jiguang; Iwamoto, Fabio; Placantonakis, Dimitris; Martinez, Nina; Elder, J. Bradley; Kaptain, George; Cachia, David; Moshel, Yaron; Brem, Steven; Picconi, David; Nam Tran; Nam, Do-Hyun; Park, Chul-Kee; Landolfi, Joseph; Tran, David; Ramakrishna, Rohan; Fink, Karen; Heros, Deborah; Zadeh, Gelareh; Nicholas, Garth; Mehta, Vivek; Robins, H. Ian; Chen, Clark; Pitz, Marshall; Heth, Jason; Nagpal, Seema; Pearlman, Michael; Ahluwalia, Manmeet; Mohile, Nimish; Merrell, Ryan; Schiff, David; Thompson, Reid; Davis, Raphael; Macdonald, David; Kheoh, Thian; Kabbinavar, Fairooz; Lossos, Alexander; Vogelbaum, Michael
ISI:000509478706204
ISSN: 1522-8517
CID: 4431942

Correction to: First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma [Correction]

Liau, Linda M; Ashkan, Keyoumars; Tran, David D; Campian, Jian L; Trusheim, John E; Cobbs, Charles S; Heth, Jason A; Salacz, Michael; Taylor, Sarah; D'Andre, Stacy D; Iwamoto, Fabio M; Dropcho, Edward J; Moshel, Yaron A; Walter, Kevin A; Pillainayagam, Clement P; Aiken, Robert; Chaudhary, Rekha; Goldlust, Samuel A; Bota, Daniela A; Duic, Paul; Grewal, Jai; Elinzano, Heinrich; Toms, Steven A; Lillehei, Kevin O; Mikkelsen, Tom; Walbert, Tobias; Abram, Steven R; Brenner, Andrew J; Brem, Steven; Ewend, Matthew G; Khagi, Simon; Portnow, Jana; Kim, Lyndon J; Loudon, William G; Thompson, Reid C; Avigan, David E; Fink, Karen L; Geoffroy, Francois J; Lindhorst, Scott; Lutzky, Jose; Sloan, Andrew E; Schackert, Gabriele; Krex, Dietmar; Meisel, Hans-Jorg; Wu, Julian; Davis, Raphael P; Duma, Christopher; Etame, Arnold B; Mathieu, David; Kesari, Santosh; Piccioni, David; Westphal, Manfred; Baskin, David S; New, Pamela Z; Lacroix, Michel; May, Sven-Axel; Pluard, Timothy J; Tse, Victor; Green, Richard M; Villano, John L; Pearlman, Michael; Petrecca, Kevin; Schulder, Michael; Taylor, Lynne P; Maida, Anthony E; Prins, Robert M; Cloughesy, Timothy F; Mulholland, Paul; Bosch, Marnix L
Following publication of the original article [1], the authors reported an error in the spelling of one of the author names. In this Correction the incorrect and correct author names are indicated and the author name has been updated in the original publication. The authors also reported an error in the Methods section of the original article. In this Correction the incorrect and correct versions of the affected sentence are indicated. The original article has not been updated with regards to the error in the Methods section.
PMCID:6026340
PMID: 29958537
ISSN: 1479-5876
CID: 3196472

First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma

Liau, Linda M; Ashkan, Keyoumars; Tran, David D; Campian, Jian L; Trusheim, John E; Cobbs, Charles S; Heth, Jason A; Salacz, Michael; Taylor, Sarah; D'Andre, Stacy D; Iwamoto, Fabio M; Dropcho, Edward J; Moshel, Yaron A; Walter, Kevin A; Pillainayagam, Clement P; Aiken, Robert; Chaudhary, Rekha; Goldlust, Samuel A; Bota, Daniela A; Duic, Paul; Grewal, Jai; Elinzano, Heinrich; Toms, Steven A; Lillehei, Kevin O; Mikkelsen, Tom; Walpert, Tobias; Abram, Steven R; Brenner, Andrew J; Brem, Steven; Ewend, Matthew G; Khagi, Simon; Portnow, Jana; Kim, Lyndon J; Loudon, William G; Thompson, Reid C; Avigan, David E; Fink, Karen L; Geoffroy, Francois J; Lindhorst, Scott; Lutzky, Jose; Sloan, Andrew E; Schackert, Gabriele; Krex, Dietmar; Meisel, Hans-Jorg; Wu, Julian; Davis, Raphael P; Duma, Christopher; Etame, Arnold B; Mathieu, David; Kesari, Santosh; Piccioni, David; Westphal, Manfred; Baskin, David S; New, Pamela Z; Lacroix, Michel; May, Sven-Axel; Pluard, Timothy J; Tse, Victor; Green, Richard M; Villano, John L; Pearlman, Michael; Petrecca, Kevin; Schulder, Michael; Taylor, Lynne P; Maida, Anthony E; Prins, Robert M; Cloughesy, Timothy F; Mulholland, Paul; Bosch, Marnix L
BACKGROUND:-L) to standard therapy for newly diagnosed glioblastoma. METHODS:After surgery and chemoradiotherapy, patients were randomized (2:1) to receive temozolomide plus DCVax-L (n = 232) or temozolomide and placebo (n = 99). Following recurrence, all patients were allowed to receive DCVax-L, without unblinding. The primary endpoint was progression free survival (PFS); the secondary endpoint was overall survival (OS). RESULTS:For the intent-to-treat (ITT) population (n = 331), median OS (mOS) was 23.1 months from surgery. Because of the cross-over trial design, nearly 90% of the ITT population received DCVax-L. For patients with methylated MGMT (n = 131), mOS was 34.7 months from surgery, with a 3-year survival of 46.4%. As of this analysis, 223 patients are ≥ 30 months past their surgery date; 67 of these (30.0%) have lived ≥ 30 months and have a Kaplan-Meier (KM)-derived mOS of 46.5 months. 182 patients are ≥ 36 months past surgery; 44 of these (24.2%) have lived ≥ 36 months and have a KM-derived mOS of 88.2 months. A population of extended survivors (n = 100) with mOS of 40.5 months, not explained by known prognostic factors, will be analyzed further. Only 2.1% of ITT patients (n = 7) had a grade 3 or 4 adverse event that was deemed at least possibly related to the vaccine. Overall adverse events with DCVax were comparable to standard therapy alone. CONCLUSIONS:Addition of DCVax-L to standard therapy is feasible and safe in glioblastoma patients, and may extend survival. Trial registration Funded by Northwest Biotherapeutics; Clinicaltrials.gov number: NCT00045968; https://clinicaltrials.gov/ct2/show/NCT00045968?term=NCT00045968&rank=1 ; initially registered 19 September 2002.
PMCID:5975654
PMID: 29843811
ISSN: 1479-5876
CID: 3156362

Diffuse midline gliomas with subclonal H3F3A K27M mutation and mosaic H3.3 K27M mutant protein expression [Letter]

Lopez, Giselle Y; Oberheim Bush, Nancy Ann; Phillips, Joanna J; Bouffard, John-Paul; Moshel, Yaron A; Jaeckle, Kurt; Kleinschmidt-DeMasters, B K; Rosenblum, Marc K; Perry, Arie; Solomon, David A
PMCID:6078201
PMID: 29063183
ISSN: 1432-0533
CID: 2757422

The transplanum transtuberculum approaches for suprasellar and sellar-suprasellar lesions. Avoidance of CSF leak and lessons learned

Mascarenhas, Lino; Moshel, Yaron A; Bayad, Fatema; Szentirmai, Oszkar; Salek, Al Amin; Leng, Lewis Z; Hofstetter, Christoph P; Placantonakis, Dimitris G; Tsiouris, Apostolos J; Anand, Vijay K; Schwartz, Theodore H
OBJECTIVE: To present a large series of patients and examine the learning curve of the endonasal endoscopic transplanum, transtuberculum approach for primarily suprasellar or sellar-suprasellar tumors.. METHODS: We identified 122 patients who underwent 126 surgeries using the transplanum, transtuberculum approach . Extent of resection was determined with volumetric analysis of MRI's. Results concerning vision, endocrine function and complications were noted. RESULTS: Average tumor volume was 14 cm3. The most frequent pathologies were pituitary macroadenoma (51.6%), craniopharyngioma (20.6%) and meningioma (15.9%). 73% presented with visual compromise. Rates of GTR and NTR for the group as a whole were 58.1% and 13.7%, and for the patients in whom GTR was intended (n=90), rates of GTR and NTR were 77.5% and 12.5% for a total of 90%. Extent of resection in this group was 97.6%. Vision improved in 52.4% and deteriorated in 4.8%. Favorable endocrine outcome occurred in 63.5%. CSF leak rate was 3.1% for the series as a whole. It improved from 6.3% in the first half of the series to 0% in the second half. Leak rates varied with technique from 11% (fat graft only) to 4.2% (gasket seal only) to 1.8% (fat plus nasoseptal flap) to 0% (gasket plus nasoseptal flap). The rate of other complications was 14.3% in the first half of the series and 1.6% in the second half. There was one infection (0.8%). CONCLUSION: The endonasal endoscopic transtuberculum transplanum approach is a safe and effective minimal access approach to midline pathology in the suprasellar cistern.
PMID: 23403355
ISSN: 1878-8750
CID: 240312

Efficacy of gamma knife radiosurgery for small-volume recurrent malignant gliomas after initial radical resection

Elliott, Robert E; Parker, Erik C; Rush, Stephen C; Kalhorn, Stephen P; Moshel, Yaron A; Narayana, Ashwatha; Donahue, Bernadine; Golfinos, John G
OBJECTIVE: To review the authors' experience with Gamma Knife radiosurgery (GKR) for small recurrent high-grade gliomas (HGGs) following prior radical resection, external-beam radiation therapy (EBRT), and chemotherapy with temozolomide (TMZ). METHODS: The authors retrospectively analyzed 26 consecutive adults (9 women and 17 men; median age 60.4 years; Karnofsky Performance Status [KPS] >/=70) who underwent GKR for recurrent HGGs from 2004-2009. Median lesion volume was 1.22 cc, and median treatment dose was 15 Gy. Pathology included glioblastoma multiforme (GBM; n = 16), anaplastic astrocytoma (AA; n = 5), and anaplastic mixed oligoastrocytoma (AMOA; n = 5). Two patients lost to follow-up were excluded from radiographic outcome analyses. RESULTS: Median overall survival (OS) for the entire cohort from the time of GKR was 13.5 months. Values for 12-month actuarial survival from time of GKR for GBM, AMOA, and AA were 37%, 20% and 80%. Local failure occurred in 9 patients (37.5%) at a median time of 5.8 months, and 18 patients (75%) experienced distant progression at a median of 4.8 months. Complications included radiation necrosis in two patients and transient worsening of hemiparesis in one patient. Multivariate hazard ratio (HR) analysis showed KPS 90 or greater, smaller tumor volumes, and increased time to recurrence after resection to be associated with longer OS following GKR. CONCLUSIONS: GKR provided good local tumor control in this group of clinically stable and predominantly high-functioning patients with small recurrent HGGs after radical resection. Meaningful survival times after GKR were seen. GKR can be considered for selected patients with recurrent HGGs
PMID: 21839964
ISSN: 1878-8750
CID: 136644

Bilateral invasive electroencephalography in patients with tuberous sclerosis complex: a path to surgery?

Carlson, Chad; Teutonico, Federica; Elliott, Robert E; Moshel, Yaron A; LaJoie, Josiane; Miles, Daniel; Devinsky, Orrin; Weiner, Howard L
OBJECT: Many children with epilepsy and tuberous sclerosis complex (TSC) have multiple tubers on MR imaging and poorly localized/lateralized video electroencephalography (EEG) findings. Given the long-term risks associated with frequent seizures and multiple antiepileptic drugs, along with improved success in identifying focal epileptogenic zones in patients with multifocal lesions, the authors used bilateral intracranial EEG to lateralize the epileptogenic zone in patients with nonlateralizable noninvasive preoperative evaluations. METHODS: A retrospective analysis from January 1, 1998, to June 30, 2008, identified 62 children with TSC who were presented at a surgical conference. Of the 52 patients undergoing diagnostic or therapeutic procedures during the study period, 20 underwent bilateral intracranial EEG. The presurgical testing results, intracranial EEG findings, surgical interventions, and outcomes were reviewed. RESULTS: Fourteen of 20 patients had intracranial EEG findings consistent with a resectable epileptogenic zone. One patient is awaiting further resection. Five patients had findings consistent with a nonresectable epileptogenic zone, and 1 of these patients underwent a callosotomy. Seven patients had Engel Class I outcomes, 1 was Class II, 3 were Class III, and 3 were Class IV (mean follow-up 25 months). CONCLUSIONS: Bilateral intracranial EEG can identify potential resectable seizure foci in nonlateralizable epilepsy in TSC. Although 6 of 20 patients did not undergo resection (1 patient is pending future resection), significant improvements in seizures (Engel Class I or II) were noted in 8 patients. In the authors' experience, this invasive monitoring provided a safe method for identifying the ictal onset zone
PMID: 21456917
ISSN: 1933-0715
CID: 132575