A Phase III comparison of BCNU, hydroxyurea, and radiation therapy to BCNU and radiation therapy for treatment of primary malignant gliomas

1979 ◽  
Vol 51 (4) ◽  
pp. 526-532 ◽  
Author(s):  
Victor A. Levin ◽  
Charles B. Wilson ◽  
Richard Davis ◽  
William M. Wara ◽  
Tana L. Pischer ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Tumor Progression ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Malignant Gliomas ◽  
Tumor Resection ◽  
Phase Iii ◽  
Tumor Type ◽  
Content Type ◽  
Fine Print

✓ This Phase III clinical trial compared the effectiveness of the combination of 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU), radiation therapy, and hydroxyurea (BHR group) to the combination of BCNU and radiation therapy (BR group) for the treatment of malignant gliomas. In both arms of the study, BCNU was administered intravenously for 3 consecutive days before the initiation of radiation therapy, and at 8-week intervals thereafter until unequivocal tumor progression. In the BHR arm of the study, hydroxyurea was administered orally on alternate days during radiation therapy. Patients in each arm were stratified almost equally by tumor type (glioblastoma multiforme (GM) or other nonglioblastoma multiforme malignant gliomas (NGM)) and extent of surgical resection of tumor. Patients were also evaluated with the Karnofsky Performance Status (KPS) scale. Time to progression was determined by comparing the results of sequential neurological examinations and radionuclide and computerized tomographic scans. Of the 130 patients entered into the study, 99 constitute the valid study group. Data were analyzed with Kaplan-Meier representations and the statistical methods of Gehan and Cox. The NGM patients with KPS ratings of ≥60 did better on both arms of the study, with median times to tumor progression (MTP's) of 50 and 72 weeks for BHR and BR, respectively. However, GM patients showed statistically significant differences (p = 0.03) between the two arms of the study, with MTP's of 41 and 31 weeks for BHR and BR, respectively. The GM patients with subtotal tumor resection did slightly better on BHR than on BR, with MTP's of 49 weeks (p = 0.03) and 31 weeks for the respective groups.

Resection, biopsy, and survival in malignant glial neoplasms

1993 ◽  
Vol 78 (5) ◽  
pp. 767-775 ◽  
Author(s):  
Bertrand C. Devaux ◽  
Judith R. O'Fallon ◽  
Patrick J. Kelly
Keyword(s):  
Radiation Therapy ◽  
Survival Time ◽  
Median Survival ◽  
Median Survival Time ◽  
Tumor Resection ◽  
External Beam Radiation ◽  
Newly Diagnosed ◽  
Content Type ◽  
Grade Iii ◽  
Fine Print

✓ Between July, 1984, and October, 1988, 263 patients (163 male, 100 female), aged from 4 to 83 years (mean 52 years), with malignant brain gliomas underwent surgical procedures: stereotactic biopsy in 160 and resection in 103 patients. There were 170 grade IV astrocytomas, 17 grade IV mixed oligoastrocytomas, 44 grade III astrocytomas, 22 grade III mixed oligoastrocytomas, and 10 malignant oligodendrogliomas. Overall median survival time was 30.1 weeks for grade IV gliomas, 87.7 weeks for grade III gliomas, and 171.3 weeks for malignant oligodendrogliomas. Multivariate analysis in 218 newly diagnosed cases revealed that the variables most strongly correlated with survival time were: tumor grade, patient age, seizures as a first symptom, a Karnofsky Performance Scale score of less than 70%, tumor resection, and a radiation therapy dose greater than 50 Gy. The proportions of patients receiving tumor resection versus biopsy in each of these prognosis factor groups were similar. Since most of the 22 patients with midline and brain-stem tumors were treated with biopsy alone, these were excluded. Considering 196 newly diagnosed patients with cortical and subcortical tumors, grade IV glioma patients undergoing resection of the contrast-enhancing mass (as evidenced on computerized tomography and magnetic resonance imaging) and postoperative external beam radiation therapy lived longer than those undergoing biopsy only and radiation therapy (median survival time 50.6 weeks and 33.0 weeks, respectively; Smirnov test, p = 0.0380). However, survival in patients with resected grade III gliomas was no better than in those with biopsied grade III lesions (p = 0.746). The authors conclude that, in selected grade IV gliomas, resection of the contrast-enhancing mass followed by radiation therapy is associated with longer survival times than radiation therapy after biopsy alone.

Survival following surgery and prognostic factors for recently diagnosed malignant glioma: data from the Glioma Outcomes Project

2003 ◽  
Vol 99 (3) ◽  
pp. 467-473 ◽  
Author(s):  
Edward R. Laws ◽  
Ian F. Parney ◽  
Wei Huang ◽  
Fred Anderson ◽  
Angel M. Morris ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Survival Data ◽  
Performance Status ◽  
Malignant Gliomas ◽  
Karnofsky Performance Scale ◽  
Median Length ◽  
Content Type ◽  
The Impact ◽  
Grade Iii ◽  
Fine Print

Object. The Glioma Outcomes Project represents a contemporary analysis of the management of malignant (Grade III and Grade IV/GBM) gliomas in North America. This observational database was used to evaluate the influence of resection, as opposed to biopsy, on patient outcome as measured by the length of survival. Attempts were made to reduce the impact of selection bias by repeating the data analysis after omitting patients with major negative prognostic factors. Methods. Outcome data from 788 patients accrued from multiple sites over a 4-year period (1997–2001) were analyzed with the primary outcome measure being length of survival. Of these, 565 patients with recent diagnoses formed the basis of the present analysis. Patients were systematically followed up until death or up to 24 months after enrollment in the study, and survival data were correlated with the histopathological grade and location of the tumor, the extent of surgery, the patient's performance status, and demographic factors. The median length of survival was 40.9 weeks for patients with recently diagnosed GBMs. The true median length of survival for patients with Grade III gliomas was not reached, although there was a 58% survival rate at 104 weeks. In multivariate analysis, resection rather than biopsy (p < 0.0001), age 60 years or younger (p < 0.0001), and a Karnofsky Performance Scale (KPS) score of 70 or greater (p = 0.0004) were associated with a prolonged survival time for patients with Grade III or IV gliomas. The prognostic value of resection compared with biopsy was maintained (p < 0.0001), even after eliminating patients considered to be “poor risk” (those with age > 60 years, KPS score < 70, or presence of multifocal tumors), who may have been overrepresented in the biopsy group. Survival “tails” at 24 months were 58% for Grade III gliomas and 11% for GBMs. Conclusions. These data provide Class II evidence to support tumor grade, patient's age, and patient's functional status as prognostic factors for survival in individuals with recently diagnosed malignant gliomas. Resection (compared with biopsy) is also a strong prognostic factor; however, no quantitative attempt was made to assess the true extent of the resection.

GliaSite Brachytherapy for Treatment of Recurrent Malignant Gliomas:A Retrospective Multi-institutional Analysis

Neurosurgery ◽  
2006 ◽  
Vol 58 (4) ◽  
pp. 701-709 ◽  
Author(s):  
Arash J. Gabayan ◽  
Sylvan B. Green ◽  
Abhay Sanan ◽  
Joseph Jenrette ◽  
Christopher Schultz ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Glioblastoma Multiforme ◽  
Median Survival ◽  
Karnofsky Performance Status ◽  
External Beam Radiotherapy ◽  
Performance Status ◽  
Malignant Gliomas ◽  
Balloon Catheter ◽  
Median Dose ◽  
Karnofsky Performance Status Score

Abstract OBJECTIVE: To review the cumulative experience of 10 institutions in treating recurrent malignant gliomas with the brachytherapy device, GliaSite Radiation Therapy System. METHODS: The patient population consisted of 95 patients with recurrent grade 3 or 4 gliomas, a median age of 51 years, and a median Karnofsky performance status score of 80. All patients had previously undergone resection and had received external beam radiotherapy as part of their initial treatment. After recurrence, each patient underwent maximal surgical debulking of their recurrent lesion and placement of an expandable balloon catheter (GliaSite) in the tumor cavity. The balloon was afterloaded with liquid 125I (Iotrex) to deliver a median dose of 60 Gy to an average depth of 1 cm with a median dose rate of 52.3 Gy/hr. Patients were carefully followed with serial magnetic resonance imaging and monthly examinations for tumor progression, side effects, and survival. RESULTS: The median survival for all patients, measured from date of GliaSite placement, was 36.3 weeks with an estimated 1 year survival of 31.1%. The median survival was 35.9 weeks for patients with an initial diagnosis of glioblastoma multiforme and 43.6 weeks for those with non- glioblastoma multiforme malignant gliomas. Analysis of the influence of various individual prognostic factors on patient survival demonstrated that only Karnofsky performance status significantly predicted for improved survival. There were three cases of pathologically documented radiation necrosis. CONCLUSION: Reirradiation of malignant gliomas with the GliaSite Radiation Therapy System after reresection seems to provide a modest survival benefit above what would be expected from surgery alone. This report not only confirms the initial results of the feasibility study but provides evidence that similar outcomes can be obtained outside of a clinical trial.

Supratentorial malignant gliomas of childhood

1984 ◽  
Vol 60 (3) ◽  
pp. 495-499 ◽  
Author(s):  
Surasak Phuphanich ◽  
Michael S. B. Edwards ◽  
Victor A. Levin ◽  
Pamela S. Vestnys ◽  
William M. Wara ◽  
...  
Keyword(s):  
Tumor Progression ◽  
Malignant Gliomas ◽  
Subtotal Resection ◽  
Significant Prognostic Factor ◽  
Postoperative Radiation Therapy ◽  
Content Type ◽  
Initial Procedure ◽  
First Recurrence ◽  
Fine Print ◽  
Time To Tumor Progression

✓ Twenty-seven patients aged 1 to 18 years harboring supratentorial (20 in the cerebrum and seven in the thalamus) malignant gliomas were treated between 1975 and 1982. There were four glioblastomas multiforme, 14 anaplastic astrocytomas, and nine malignant gliomas. All patients had a subtotal resection or biopsy as the initial procedure and received postoperative radiation therapy (RT). Fifteen of 27 patients were treated by RT alone; 14 had tumor progression with a median time to tumor progression (MTP) of 65 weeks. Twelve patients were treated with chemotherapy as an adjuvant to RT; only seven had tumor recurrence, with an MTP of 130 weeks. Of the 21 patients with recurrent tumors in both groups, 18 were treated with chemotherapy alone, or chemotherapy with a second surgical procedure or second course of RT. For all histological grades of tumor, the MTP for first recurrence was 75 weeks and the median survival time was 180 weeks. Age at initial diagnosis was found to be a statistically significant prognostic factor, with patients younger than 10 years of age surviving longer than patients aged over 10 years (p = 0.02).

Phase III comparison of BCNU and the combination of procarbazine, CCNU, and vincristine administered after radiotherapy with hydroxyurea for malignant gliomas

1985 ◽  
Vol 63 (2) ◽  
pp. 218-223 ◽  
Author(s):  
Victor A. Levin ◽  
William M. Wara ◽  
Richard L. Davis ◽  
Pamela Vestnys ◽  
Kenneth J. Resser ◽  
...  
Keyword(s):  
Glioblastoma Multiforme ◽  
Tumor Progression ◽  
Randomized Study ◽  
Malignant Gliomas ◽  
Phase Iii ◽  
Content Type ◽  
Anaplastic Gliomas ◽  
Risk Patients ◽  
Extent Of Surgical Resection ◽  
Time To Tumor Progression

✓ The authors report the results of a randomized study conducted to evaluate the relative benefit of treatment with 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) or the combination of procarbazine, 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea, and vincristine (PCV) administered after radiation therapy with hydroxyurea to 76 evaluable patients with glioblastoma multiforme and 72 patients with other anaplastic gliomas. The primary end-point of the study was time to tumor progression. For better-risk patients with Karnofsky performance scores of 70 to 100, results suggest that PCV was of greater benefit than BCNU (p = 0.15 for glioblastoma multiforme; p = 0.13 for other anaplastic gliomas). Median times to tumor progression were 31 and 32 weeks for patients with glioblastoma multiforme; 25th percentile times to progression were 70 and 40 weeks for patients treated with PCV and BCNU, respectively. For patients with other anaplastic gliomas treated with PCV and BCNU, median times to progression were 123 and 77 weeks, respectively. Multivariate analysis showed that the prognostic variables of age and Karnofsky scores were important for patients with glioblastoma multiforme and other anaplastic gliomas, and that the extent of surgical resection was important for those with other anaplastic gliomas.

scholarly journals Survival of patients treated with radiation therapy for anaplastic astrocytoma

2014 ◽  
Vol 48 (4) ◽  
pp. 381-386 ◽  
Author(s):  
Christopher A. Barker ◽  
Maria Chang, Kathryn Beal ◽  
Timothy A. Chan
Keyword(s):  
Radiation Therapy ◽  
Anaplastic Astrocytoma ◽  
Cox Regression ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Recursive Partitioning ◽  
Radiation Therapy Oncology Group ◽  
Tumor Resection ◽  
Related Factors ◽  
Duration Of Symptoms

Abstract Background. Anaplastic astrocytoma (AA) represents 7% of primary brain tumors in adults. Patient-, tumor-, and treatment-related factors are thought to be predictive of survival. We retrospectively assessed the association of patient-, tumor-, and treatment-related factors with survival in AA treated with radiotherapy (RT) at our institution. Patients and methods. Medical records of patients with AA treated with RT between 1987 and 2007 were reviewed. Patient-, tumor-, and treatment-related variables were recorded and used to assign patients to a Radiation Therapy Oncology Group recursive partitioning analysis (RTOG RPA) classification. First use of chemotherapy was recorded. Log-rank tests and Cox regression models were used to assess for an association of patient-, tumor- and treatment-related factors with survival. Results. One-hundred twenty-six patients were eligible for study. Median age, Karnofsky performance status, and duration of symptoms were 43 years, 90, and 8 weeks. Median radiation dose was 59.4 Gy; 61% of patients underwent tumor resection, and 17% and 41% of patients received temozolomide during and after RT. Median survival was 31 months, and 2-year survival was 58%. RTOG RPA class was associated with survival (p < 0.001), but use of temozolomide during or after RT was not (p > 0.05). Conclusions. In this retrospective study with inherent limitations, RTOG RPA classification was associated with survival. Further studies are necessary to confirm or refute this finding

An inflatable balloon catheter and liquid 125I radiation source (GliaSite Radiation Therapy System) for treatment of recurrent malignant glioma: multicenter safety and feasibility trial

2003 ◽  
Vol 99 (2) ◽  
pp. 297-303 ◽  
Author(s):  
Stephen B. Tatter ◽  
Edward G. Shaw ◽  
Mark L. Rosenblum ◽  
Kastytis C. Karvelis ◽  
Lawrence Kleinberg ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Malignant Glioma ◽  
Tumor Resection ◽  
Balloon Catheter ◽  
Target Volume ◽  
Feasibility Trial ◽  
Recurrent Malignant Glioma ◽  
Content Type ◽  
And Performance ◽  
Fine Print

Object. In this study the authors evaluated the safety and performance of the GliaSite Radiation Therapy System (RTS) in patients with recurrent malignant brain tumors who were undergoing tumor resection. Methods. The GliaSite is an inflatable balloon catheter that is placed in the resection cavity at the time of tumor debulking. Low-dose-rate radiation is delivered with an aqueous solution of organically bound iodine-125 (Iotrex [sodium 3-(125I)-iodo-4-hydroxybenzenesulfonate]), which are temporarily introduced into the balloon portion of the device via a subcutaneous port. Adults with recurrent malignant glioma underwent resection and GliaSite implantation. One to 2 weeks later, the device was filled with Iotrex for 3 to 6 days, following which the device was explanted. Twenty-one patients with recurrent high-grade astrocytomas were enrolled in the study and received radiation therapy. There were two end points: 1) successful implantation and delivery of brachytherapy; and 2) safety of the device. Implantation of the device, delivery of radiation, and the explantation procedure were well tolerated. At least 40 to 60 Gy was delivered to all tissues within the target volume. There were no serious adverse device-related events during brachytherapy. One patient had a pseudomeningocele, one patient had a wound infection, and three patients had meningitis (one bacterial, one chemical, and one aseptic). No symptomatic radiation necrosis was identified during 21.8 patient-years of follow up. The median survival of previously treated patients was 12.7 months (95% confidence interval 6.9–15.3 months). Conclusions. The GliaSite RTS performs safely and efficiently. It delivers a readily quantifiable dose of radiation to tissue at the highest risk for tumor recurrence.

Effects of ACNU and radiotherapy on malignant glioma

1986 ◽  
Vol 64 (1) ◽  
pp. 53-57 ◽  
Author(s):  
Kintomo Takakura ◽  
Hiroshi Abe ◽  
Ryuichi Tanaka ◽  
Koichi Kitamura ◽  
Tetsuro Miwa ◽  
...  
Keyword(s):  
Tumor Size ◽  
Performance Status ◽  
Malignant Gliomas ◽  
Hematological Toxicity ◽  
Survival Times ◽  
Chemotherapeutic Regimen ◽  
Content Type ◽  
Randomized Clinical Study ◽  
Radiotherapy Alone ◽  
Fine Print

✓ A randomized clinical study of irradiation and irradiation combined with ACNU in the treatment of malignant gliomas was performed in order to determine if there was an enhancing therapeutic effect of ACNU given in addition to radiotherapy. An effect was defined as a reduction in tumor size, changes in neurological signs and performance status within 1 month after the completion of radiotherapy, or statistically improved survival times. Seventy-seven patients from 14 neurosurgical clinics were included in this validated study group. Radiotherapy with a total dose of 5000 to 6000 rads, given in 25 to 30 subdoses, was applied to the whole brain and to a generous field surrounding the tumor. Patients who were assigned to receive chemotherapy were given ACNU intravenously once or twice during radiotherapy at a dose of 100 mg/sq m of body surface area. The response rate (more than 50% reduction of the tumor size) was 13.5% in the group treated by radiotherapy alone and 47.5% in the group with radiotherapy and ACNU. The hematological toxicity was more severe in the group treated with radiotherapy and ACNU. Other toxicity was mild and acceptable. The survival rates of patients with astrocytoma grade III and glioblastoma multiforme at 36 months after the surgery were 48.9% and 0% for radiotherapy alone and 59.0% and 16.3% for radiotherapy plus ACNU, respectively. The differences between the survival curves were not significant at the p = 0.05 level. This study has demonstrated that, although the use of ACNU during radiotherapy suppressed malignant gliomas more than radiotherapy alone, the survival time was not extended significantly. It is necessary to continue to search for an effective chemotherapeutic regimen to prolong survival of patients with malignant gliomas.

Papillary craniopharyngioma: a clinicopathological study of 48 cases

1995 ◽  
Vol 83 (2) ◽  
pp. 206-214 ◽  
Author(s):  
Thomas B. Crotty ◽  
Bernd W. Scheithauer ◽  
William F. Young ◽  
Dudley H. Davis ◽  
Edward G. Shaw ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Mr Imaging ◽  
Third Ventricle ◽  
Tumor Resection ◽  
Subtotal Resection ◽  
Pituitary Insufficiency ◽  
Free Survival ◽  
Content Type ◽  
Initial Surgery ◽  
Fine Print

✓ Two distinct clinicopathological variants of craniopharyngioma exist: the classic adamantinomatous type and a recently described papillary form that predominates in adults and reportedly behaves in a less aggressive manner. The present study describes the clinicopathological features of 48 patients with papillary craniopharyngioma treated at the Mayo Clinic between 1910 and 1994. An additional four tumors were found to have histological features of both adamantinomatous and papillary craniopharyngioma. Whereas adamantinomatous tumors typically occur in adolescent patients, the mean age of the 48 patients (23 males and 25 females) with papillary craniopharyngioma was 44.7 years (range 10 to 74 years). Presenting clinical features included visual impairment (84%), headache (68%), and pituitary insufficiency (anterior 42%; posterior 27%). Preoperative computerized tomography (CT) and magnetic resonance (MR) imaging in 17 patients typically revealed a noncalcified, partially cystic mass that enhanced peripherally and contained mural nodules (67%). Many (41%) of the lesions involved or extended into the third ventricle on imaging. At first surgery, gross total tumor removal was achieved in 17 patients (36%) and subtotal resection in 30 patients (64%) in whom tumor resection was attempted. Tumor recurrence was noted in two patients who underwent gross total removal. Tumor-free survival rates of 100% and 78% were obtained in patients who underwent gross total and subtotal resection at initial surgery, respectively. Postoperative radiation therapy was beneficial to patients having undergone a subtotal resection, with an increase in tumor-free survival from 26% to 86%. Aside from well-documented morphological distinctions, papillary craniopharyngiomas differ from adamantinomatous tumors in several important respects. These include the almost exclusive occurrence of papillary tumors in adulthood and their more uniform appearance on both CT and MR imaging. However, a preliminary analysis of our data suggests there are no significant differences between the two lesions with respect to resectability, efficacy of radiation therapy, and overall survival.

Convection-enhanced delivery of paclitaxel for the treatment of recurrent malignant glioma: a Phase I/II clinical study

2004 ◽  
Vol 100 (3) ◽  
pp. 472-479 ◽  
Author(s):  
Zvi Lidar ◽  
Yael Mardor ◽  
Tali Jonas ◽  
Raphael Pfeffer ◽  
Meir Faibel ◽  
...  
Keyword(s):  
Mr Imaging ◽  
Tumor Response ◽  
Response Rate ◽  
Malignant Gliomas ◽  
Tumor Resection ◽  
Mr Images ◽  
Convection Enhanced Delivery ◽  
Content Type ◽  
Diffusion Weighted ◽  
Fine Print

Object. A minority of patients with recurrent glioblastomas multiforme (GBMs) responds to systemic chemotherapy. The authors investigated the safety and efficacy of intratumoral convection-enhanced delivery (CED) of paclitaxel in patients harboring histologically confirmed recurrent GBMs and anaplastic astrocytomas. Methods. Fifteen patients received a total of 20 cycles of intratumoral CED of paclitaxel. The patients were observed daily by performing diffusion-weighted (DW) magnetic resonance (MR) imaging to assess the convective process and routine diagnostic MR imaging to identify the tumor response. Effective convection was determined by the progression of the hyperintense signal within the tumor on DW MR images, which corresponded to a subsequent lytic tumor response displayed on conventional MR images. Of the 15 patients, five complete responses and six partial responses were observed, giving a response rate of 73%. The antitumor effect was confirmed by one biopsy and three en bloc resections of tumors, which showed a complete response, and by one tumor resection, which demonstrated a partial response. Lack of convection and a poor tumor response was associated with leakage of the convected drug into the subarachnoid space, ventricles, and cavities formed by previous resections, and was seen in tumors containing widespread necrosis. Complications included transient chemical meningitis in six patients, infectious complications in three patients, and transient neurological deterioration in four patients (presumably due to increased peritumoral edema). Conclusions. On the basis of our data we suggest that CED of paclitaxel in patients with recurrent malignant gliomas is associated with a high antitumor response rate, although it is associated with a significant incidence of treatment-associated complications. Diffusion-weighted MR images may be used to predict a response by demonstrating the extent of convection during treatment. Optimization of this therapeutic approach to enhance its efficacy and reduce its toxicity should be explored further.

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