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Clinton J. Baird, Alia Hdeib, Ian Suk, Howard W. Francis, Michael J. Holliday, Rafael J. Tamargo, Henry Brem and Donlin M. Long

Object

Cerebrospinal fluid (CSF) rhinorrhea remains a significant cause of morbidity after resection of vestibular schwannomas (VSs), with rates of rhinorrhea after this procedure reported to range between 0 and 27%. The authors investigated whether reconstruction of the drilled posterior wall of the porus acusticus with hydroxyapatite cement (HAC) would decrease the incidence of postoperative CSF rhinorrhea.

Methods

A prospective observational study of 130 consecutive patients who underwent surgery for reconstruction of the posterior wall of the drilled porus acusticus with HAC was conducted between October 2002 and September 2005. All patients underwent a retrosigmoid transmeatal approach for VS resection and were followed up to document cases of CSF rhinorrhea, incisional CSF leak, meningitis, or rhinorrhea-associated meningitis. A cohort of 150 patients with VSs who were treated with the same surgical approach but without HAC reconstruction served as a control group.

Results

The authors found that HAC reconstruction of the porus acusticus wall significantly reduced the rate of postoperative CSF rhinorrhea in their patients. In the patients treated with HAC, rhinorrhea developed in only three patients (2.3%) compared with 18 patients (12%) in the control group. This was a statistically significant finding (p = 0.002, odds ratio = 5.8).

Conclusions

The use of HAC in the reconstruction of the drilled posterior wall of the porus acusticus, occluding exposed air cells, greatly reduces the risk of CSF rhinorrhea.

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Oral Presentations

2010 AANS Annual Meeting Philadelphia, Pennsylvania May 1–5, 2010

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Betty Tyler, Kirk D. Fowers, Khan W. Li, Violette Renard Recinos, Justin M. Caplan, Alia Hdeib, Rachel Grossman, Luca Basaldella, Kimon Bekelis, Gustavo Pradilla, Federico Legnani and Henry Brem

Object

Paclitaxel, a cellular proliferation inhibitor/radiation sensitizer, while effective against gliomas in vitro, has poor CNS penetration and dose-limiting toxicities when administered systemically. OncoGel (paclitaxel in Re-Gel) provides controlled local paclitaxel release when placed into the CNS. The authors evaluated the safety and efficacy of OncoGel in rats with intracranial 9L gliosarcoma.

Methods

Safety studies included intracranial delivery of increasing volumes of ReGel and OncoGel containing 1.5 (OncoGel 1.5) or 6.3 (OncoGel 6.3) mg/ml paclitaxel. An in vivo radiolabeled biodistribution study was performed in 18 Fischer-344 rats to determine intracerebral distribution. Efficacy studies compared overall survival for controls, ReGel only, radiation therapy only, OncoGel 6.3, or OncoGel 6.3 in combination with radiation therapy. ReGel and OncoGel 6.3 were delivered either simultaneously with tumor implantation (Day 0) or 5 days later (Day 5). Radiation therapy was given on Day 5.

Results

Control and ReGel animals died of tumor within 17 days. Survival significantly increased in the Onco-Gel 6.3 group on Day 0 (median 31 days; p = 0.0001), in the OncoGel 6.3 group on Day 5 (median 17 days; p = 0.02), and in the radiation therapy–only group (median 26 days; p = 0.0001) compared with controls. Animals receiving both OncoGel and radiation therapy had the longest median survival: 83 days in the group with radiation therapy combined with OncoGel 6.3 on Day 0, and 32 days in the group combined with OncoGel 6.3 on Day 5 (p = 0.0001 vs controls). After 120 days, 37.5% of the animals in the OncoGel Day 0 group, 37.5% of animals in the OncoGel 6.3 Day 0 in combination with radiation therapy group, and 12.5% of the animals in the OncoGel 6.3 on Day 5 in combination with radiation therapy group were alive. In the biodistribution study, measurable radioactivity was observed throughout the ipsilateral hemisphere up to 3 weeks after the OncoGel injection, with the most radioactivity detected 3 hours after injection. The highest dose of radioactivity observed in the contralateral hemisphere was at the Day 3 time point.

Conclusions

OncoGel containing 6.3 mg/ml of paclitaxel is safe for intracranial injection in rats and effective when administered on Day 0. When combined with radiation therapy, the combination was more effective than either therapy alone and should be studied clinically for the treatment of malignant glioma.

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Betty M. Tyler, Alia Hdeib, Justin Caplan, Federico G. Legnani, Kirk D. Fowers, Henry Brem, George Jallo and Gustavo Pradilla

Object

Treatment options for anaplastic or malignant intramedullary spinal cord tumors (IMSCTs) remain limited. Paclitaxel has potent cytotoxicity against experimental intracranial gliomas and could be beneficial in the treatment of IMSCTs, but poor CNS penetration and significant toxicity limit its use. Such limitations could be overcome with local intratumoral delivery. Paclitaxel has been previously incorporated into a biodegradable gel depot delivery system (OncoGel) and in this study the authors evaluated the safety of intramedullary injections of OncoGel in rats and its efficacy against an intramedullary rat gliosarcoma.

Methods

Safety of intramedullary OncoGel was tested in 12 Fischer-344 rats using OncoGel concentrations of 1.5 and 6.0 mg/ml (5 μl); median survival and functional motor scores (Basso-Beattie-Bresnahan [BBB] scale) were compared with those obtained with placebo (ReGel) and medium-only injections. Efficacy of OncoGel was tested in 61 Fischer-344 rats implanted with an intramedullary injection of 9L gliosarcoma containing 100,000 cells in 5 μl of medium, and randomized to receive OncoGel administered on the same day (in 32 rats) or 5 days after tumor implantation (in 29 rats) using either 1.5 mg/ml or 3.0 mg/ml doses of paclitaxel. Median survival and BBB scores were compared with those of ReGel-treated and tumor-only rats. Animals were killed after the onset of deficits for histopathological analysis.

Results

OncoGel was safe for intramedullary injection in rats in doses up to 5 μl of 3.0 mg/ml of paclitaxel; a dose of 5 μl of 6.0 mg/ml caused rapid deterioration in BBB scores. OncoGel at concentrations of 1.5 mg/ml and 3.0 mg/ml paclitaxel given on both Day 0 and Day 5 prolonged median survival and preserved BBB scores compared with controls. OncoGel 1.5 mg/ml produced 62.5% long-term survivors when delivered on Day 0. A comparison between the 1.5 mg/ml and the 3.0 mg/ml doses showed higher median survival with the 1.5 mg/ml dose on Day 0, and no differences in median survival or BBB scores after treatment on Day 5.

Conclusions

OncoGel is safe for intramedullary injection in rats in doses up to 5 μl of 3.0 mg/ml, prolongs median survival, and increases functional motor scores in rats challenged with an intramedullary gliosarcoma at the doses tested. This study suggests that locally delivered chemotherapeutic agents could be of temporary benefit in the treatment of malignant IMSCTs under experimental settings.

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James Wright, Jessey Chugh, Christina Huang Wright, Fernando Alonso, Alia Hdeib, Haley Gittleman, Jill Barnholtz-Sloan and Andrew E. Sloan

OBJECTIVE

Laser interstitial thermal therapy (LITT), sometimes referred to as “stereotactic laser ablation,” has demonstrated utility in a subset of high-risk surgical patients with difficult to access (DTA) intracranial neoplasms. However, the treatment of tumors larger than 10 cm3 is associated with suboptimal outcomes and morbidity. This may limit the utility of LITT in dealing with precisely those large or deep tumors that are most difficult to treat with conventional approaches. Recently, several groups have reported on minimally invasive transsulcal approaches utilizing tubular retracting systems. However, these approaches have been primarily used for intraventricular or paraventricular lesions, and subtotal resections have been reported for intraparenchymal lesions. Here, the authors describe a combined approach of LITT followed by minimally invasive transsulcal resection for large and DTA tumors.

METHODS

The authors retrospectively reviewed the results of LITT immediately followed by minimally invasive, transsulcal, transportal resection in 10 consecutive patients with unilateral, DTA malignant tumors > 10 cm3. The patients, 5 males and 5 females, had a median age of 65 years. Eight patients had glioblastoma multiforme (GBM), 1 had a previously treated GBM with radiation necrosis, and 1 had a melanoma brain metastasis. The median tumor volume treated was 38.0 cm3.

RESULTS

The median tumor volume treated to the yellow thermal dose threshold (TDT) line was 83% (range 76%–92%), the median tumor volume treated to the blue TDT line was 73% (range 60%–87%), and the median extent of resection was 93% (range 84%–100%). Two patients suffered mild postoperative neurological deficits, one transiently. Four patients have died since this analysis and 6 remain alive. Median progression-free survival was 280 days, and median overall survival was 482 days.

CONCLUSIONS

Laser interstitial thermal therapy followed by minimally invasive transsulcal resection, reported here for the first time, is a novel option for patients with large, DTA, malignant brain neoplasms. There were no unexpected neurological complications in this series, and operative characteristics improved as surgeon experience increased. Further studies are needed to elucidate any differences in survival or quality of life metrics.

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Christina Huang Wright, James Wright, Gino Cioffi, Alia Hdeib, Manish K. Kasliwal, Carol Kruchko, Jill S. Barnholtz-Sloan and Andrew E. Sloan

OBJECTIVE

Chordomas of the spine and sacrum are a rare but debilitating cancer and require complex multidisciplinary care. Studies of other such rare cancers have demonstrated an association of high-volume and/or multidisciplinary centers with improved outcomes and survival. Such an association has been proposed for chordomas, but evidence to support this claim is lacking. The authors performed a study to investigate if treatment facility type is associated with patterns of care and survival for patients with spinal and sacral chordomas by assessing records from a US-based cancer database.

METHODS

In this observational retrospective cohort study, the authors identified 1266 patients from the National Cancer Database with vertebral column or sacral chordomas diagnosed between 2004 and 2015. The primary study outcome was overall survival, and secondary outcomes included odds of receiving treatment and time to treatment, defined as radiation therapy, surgery, and/or any treatment, including surgery, radiation therapy, chemotherapy, or participation in clinical trials. The results were adjusted for age, sex, race/ethnicity, level of education, income, and Charlson/Deyo score.

RESULTS

Of the 1266 patients identified, the mean age at diagnosis was 59.70 years (SD 16.2 years), and the patients were predominantly male (n = 791 [62.50%]). Patients treated at community cancer programs demonstrated an increased risk of death (HR 1.98, 95% CI 1.13–3.47, p = 0.018) when compared to patients treated at academic/research programs (ARPs). The median survival was longest for those treated at ARPs (131.45 months) compared to community cancer programs (79.34 months, 95% CI 48.99–123.17) and comprehensive community cancer programs (CCCPs) (109.34 months, 95% CI 84.76–131.45); 5-year survival rates were 76.08%, 52.71%, and 61.57%, respectively. Patients treated at community cancer programs and CCCPs were less likely to receive any treatment compared to those treated at ARPs (OR 6.05, 95% CI 2.62–13.95, p < 0.0001; OR 3.74, 95% CI 2.23–6.28, p < 0.0001, respectively). Patients treated at CCCPs and community cancer programs were less likely to receive surgery than those treated at ARPs (OR 2.69, 95% CI 1.82–3.97, p = 0.010; OR = 2.64, 95% CI 1.22–5.71, p = 0.014, respectively). Patients were more likely to receive any treatment (OR 0.59, 95% CI 0.40–0.87, p = 0.007) and surgery (OR 0.58, 95% CI 0.38–0.88, p < 0.0001) within 30 days at a CCCP compared to an ARP. There were no differences in odds of receiving radiation therapy or time to radiation by facility type.

CONCLUSIONS

Clinical care at an ARP is associated with increased odds of receiving treatment that is associated with improved overall survival for patients with spinal and sacral chordomas, suggesting that ARPs provide the most comprehensive specialized care for patients with this rare and devastating oncological disease.