The aim of the present study was to examine the causes of death, the mortality attributable to liver failure, and the impact of hepatitis virus infections on the survival of a cohort of HIV-infected patients before and after the extensive use of highly active antiretroviral therapy (HAART). Liver disease associated with hepatitis C virus (HCV) seems to be accelerated in patients infected with the human immunodeficiency virus (HIV). On the other hand, the effect of HCV on HIV progression was controversial before the introduction of HAART. However, the last study to report changes in mortality due to liver failure was published in 1997, and the impact of HCV carriage on the survival of HIV-infected patients receiving HAART needs to be clarified. In this investigation, 492 patients who were prescribed antiretroviral drugs between April 1989 and September 2000 were included in the study cohort. The median duration of follow-up of the cohort was 1,392 days. HCV infection was present in 323 (68%). Mortality attributable to AIDS decreased from 4.5 to 1.8 per 100 persons per year. Mortality due to liver failure increased from 0.3 to 0.5 per 100 persons per year ( P<0.01). The survival of patients with and without HCV infection was similar ( P=0.8). Although liver failure is an increasing cause of death among HIV-infected patients receiving HAART, HCV infection has still no impact on the survival of HIV-infected patients.
Guillain-Barré syndrome (GBS) is defined as an acute demyelinating peripheral neuropathy. We describe a case of GBS in a patient with glioblastoma undergoing chemotherapy treatment. A 57 year old woman diagnosed with glioblastoma developed a subacute progressive history of bilateral symmetric numbness of her fingers and toes, belt-type neuropathic pain, a left facial droop and upper and lower extremity muscle weakness. There was no evidence of a tumor mass or leptomeningeal disease in the spine. Electrophysiological studies confirmed the diagnosis. Although rare, GBS should be considered in primary brain tumor patients with generalized acute-subacute progressive weakness that is inconsistent with the location of their tumor, particularly if they are also on chemotherapy contributing to their immunosuppressive state.
TPS2106 Background: Treatment for GBM is an area of unmet need. Despite optimal therapy, survival is poor and 2nd line therapies are scarce. There is an urgent need to find better treatments for recurrence, but also more effective 1st line therapies. Dose-dense temozolomide (ddTMZ) using the 7/14-day regimen has shown promising preliminary results in combination with cytostatic agents. Memantine (MEM) is a glutamate receptor (NMDA) blocker with antiproliferation properties and possibly neuroprotective effect. Mefloquine (MFQ) induces autophagy and apoptosis. Metformin (MFM) has mTOR inhibitor properties. Methods: Trial Design: Phase I/II trial to evaluate adjuvant ddTMZ with MEM MFQ and MFM. Primary objective Phase I: MTDs of ddTMZ with MEM/MFQ/MFM, 3+3 design. MTDs will be the recommended Phase II doses for a subsequent randomized factorial Phase II trial (ddTMZ alone and single, double and triple combinations). Accrual of about 55 eligible patients was calculated for Phase I (48-144). Clinical trial registry number is NCT01430351. Treatment planned: Patients accrued sequentially to ddTMZ with 1, 2, or 3 drugs. Arm 1 (ddTMZ alone) will be enrolled in Phase II only. Patients were first accrued to 1-drug Arms 2-4. Once MTDs were determined, accrual started to 2-drug Arms 5-7. Once completed, accrual to Arm 8 will start. Arms 2-4 were started at a predetermined target dose, and deescalated if excessive toxicity. Treatment in Arms 5-8 will be escalated for each drug to reach MTDs of Arms 2-4. Major eligibility criteria: Adults (≥ 18) with supratentorial GBM, KPS ≥60, adequate bone marrow and organ function. Post chemoradiation MRI ≤14 days before enrollment on stable/decreasing steroids and no progression; registration ≤5 weeks of chemoradiation. Patients on MFQ: no EIAED, EKG without prolonged QTc or arrhythmia. Pregnancy not allowed; adequate contraception required. Informed consent in keeping with IRB policies. Current enrollment: To date, 49 patients started treatment and 18 are still active. Enrollment to Arms 2-4 and 6 is completed and MTDs determined. Accrual is ongoing in Arms 5 and 7, and pending in Arm 8. Clinical trial information: NCT01430351.
Pseudoprogression (psPD) refers to an increase in size or appearance of new areas of MRI contrast enhancement soon after completing chemoradiation, timely diagnosis of which has been a challenge. Given that tissue sampling of the MRI changes would be expected to accurately distinguish psPD from true progression when MRI changes are first seen, we examined the utility of surgery in diagnosing psPD and influencing patient outcome. We retrospectively reviewed data from adults with GBM who had MRI changes suggestive of progression within 3 months of chemoRT; of these, 34 underwent surgical resection. Three subsets-tumor, psPD or mixed-were identified based on histology and immunohistochemistry in the surgical group and by imaging characteristics in the nonsurgical group. A cohort of patients with stable disease post-chemoRT served as control. PFS and OS were determined using the Kaplan-Meier method and log rank analysis. Concordance for psPD between radiological interpretation and subsequent histological diagnosis was seen in only 32 % of cases (11/34) 95 %CI 19-49 %. A large proportion of patients had a histologically "mixed" pattern with tumor and treatment effect. No significant differences in PFS or OS were seen among the three subtypes. Surgical sampling and histologic review of MRI changes after chemoRT may not serve as a gold standard to distinguish psPD from true progression in GBM patients. Refinement of the histological criteria, careful intraoperative selection of regions of interest and advanced imaging modalities are needed for early differentiation of PsPD from progression to guide clinical management.
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