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Roy A Patchell

Publications and source records attributed to Roy A Patchell.

16 recordsLinked to original sources
PubMed2006

Cost-effectiveness of surgery plus radiotherapy versus radiotherapy alone for metastatic epidural spinal cord compression.

PURPOSE: A recent randomized clinical trial has demonstrated that direct decompressive surgery plus radiotherapy was superior to radiotherapy alone for the treatment of metastatic epidural spinal cord compression. The current study compared the cost-effectiveness of the two approaches. METHODS AND MATERIALS: In the original clinical trial, clinical effectiveness was measured by ambulation and survival time until death. In this study, an incremental cost-effectiveness analysis was performed from a societal perspective. Costs related to treatment and posttreatment care were estimated and extended to the lifetime of the cohort. Weibull regression was applied to extrapolate outcomes in the presence of censored clinical effectiveness data. RESULTS: From a societal perspective, the baseline incremental cost-effectiveness ratio (ICER) was found to be $60 per additional day of ambulation (all costs in 2003 Canadian dollars). Using probabilistic sensitivity analysis, 50% of all generated ICERs were lower than $57, and 95% were lower than $242 per additional day of ambulation. This analysis had a 95% CI of -$72.74 to 309.44, meaning that this intervention ranged from a financial savings of $72.74 to a cost of $309.44 per additional day of ambulation. Using survival as the measure of effectiveness resulted in an ICER of $30,940 per life-year gained. CONCLUSIONS: We found strong evidence that treatment of metastatic epidural spinal cord compression with surgery in addition to radiotherapy is cost-effective both in terms of cost per additional day of ambulation, and cost per life-year gained.

Canada↗
PubMed2006

Clinical approach to metastatic epidural spinal cord compression.

Metastatic epidural spinal cord compression (MESCC) is a devastating complication of cancer that occurs when cancer metastasizes to the spine and then secondarily compresses the spinal cord. It is a relatively common complication of cancer and. in the United States, more than 20,000 cases of MESCC are diagnosed annually. If left untreated, virtually 100% of these patients would become paraplegic; therefore, it is considered a true medical emergency and immediate intervention is required. Even with aggressive therapy, results can often be unsatisfactory. Although most patients with MESCC have limited survival, up to one third will survive beyond one year. Thus. it is essential to consider aggressive therapy to preserve or improve the quality of life and prevent paraplegia.

Clinical Trials as Topic↗
PubMed2004

Stereotatic radiosurgery of 468 brain metastases < or =2 cm: implications for SRS dose and whole brain radiation therapy.

PURPOSE: The national standard stereostatic radiosurgery (SRS) dose for brain metastases < or =2 cm is 24 Gy as established by the Radiation Therapy Oncology Group study 90-05, in which planned whole brain radiotherapy (WBRT) was not used. On the basis of our institutional experience, the goal of this study was to determine the optimal SRS dose and influence of WBRT on local tumor control among 468 < or =2-cm metastases. METHODS AND MATERIALS: Between October 1992 and May 2001, 468 newly diagnosed or recurrent < or =2-cm brain metastases, among 160 patients, were treated with SRS (dose range, 7-30 Gy; median, 20). A total of 240 metastases received planned WBRT (range, 6.75-50.4 Gy; median, 40.5) vs. 228 metastases that did not. The variables tested by multivariate analysis for their potential effect on tumor control included histologic type, site of metastasis, primary diagnosis, tumor volume, SRS dose, newly diagnosed vs. recurrent metastasis, and planned WBRT vs. no planned WBRT. RESULTS: Follow-up ranged from 1 to 82 months (median 7). On multivariate analysis, the addition of WBRT was the most significant predictor of local tumor control. Overall, patients who received WBRT had superior local tumor control rates (97% vs. 87% in those who did not receive WBRT; p = 0.0001). Patients receiving WBRT and SRS > or =20 Gy achieved local control rates of 99% compared with 91% control rates when treated with WBRT and SRS <20 Gy (p = 0.0029). Increasing the SRS dose to >20 Gy resulted in no improvement in local tumor control and a higher rate of Grade 3 and 4 neurotoxicity, approaching statistical significance (5.9% vs. 1.9%, p = 0.078). CONCLUSION: First, optimal control of brain metastasis < or =2 cm was seen with 20-Gy SRS combined with planned WBRT. Second, SRS doses >20 Gy resulted in no obvious improvement in local control and appeared to be associated with a greater rate of complications.

Adolescent↗
PubMed2004

Feasibility of neurocognitive outcome evaluations in patients with brain metastases in a multi-institutional cooperative group setting: results of Radiation Therapy Oncology Group trial BR-0018.

PURPOSE: A multi-institutional trial was conducted by the Radiation Therapy Oncology Group (RTOG) to test the feasibility of performing a test battery consisting of five neurocognitive measures and a quality-of-life instrument in patients with brain metastases. METHODS AND MATERIALS: The major eligibility requirements included histologic proof of a primary malignancy, measurable single or multiple brain metastases, Zubrod performance status of 0-1, neurologic function status of 0-2, and "certification" for administration of neurocognitive assessments. This certification process required either attendance at an RTOG neurocognitive assessment training workshop or review of an instructional video, followed by submission of an audiotape of mock/simulated test sessions for central review. The test battery included the following measures: the Mini-Mental Status Examination, Hopkins Verbal Learning Test, Verbal Fluency/Controlled Word Association Test, Ruff 2 and 7 test, Trailmaking Test, and Profile of Mood States-Short Form. The primary objective of this trial was to establish whether patients were able to complete this test battery. Compliance was defined as successful completion of a test measure. The test battery was to be administered just before, at completion of, and 1 month after whole brain radiotherapy to 37.5 Gy at 2.5 Gy/fraction once daily. Fifty-nine patients were enrolled in the trial. RESULTS: The patient characteristics included 32% > or =65 years; 44% with Zubrod performance status of 0; and 81% with multiple brain metastases. The overall compliance rate for administration and completion of the five neurocognitive measures and a quality-of-life instrument before treatment, at treatment completion, and 1 month after treatment was > or =95%, > or =84%, and > or =70%. The most common causes of noncompliance were patient-related factors (e.g., performance status or inability to understand test instructions) and not institutional error. CONCLUSION: Neurocognitive evaluation of patients with brain metastases in a multi-institutional and cooperative group setting is feasible using the test battery and certification process used in this study. This battery and certification process will be incorporated into future RTOG brain tumor trials.

Affect↗
PubMed2004

Recursive partitioning analysis classifications I and II: applicability evaluated in a randomized trial for resected single brain metastases.

PURPOSE: Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) prognostic classes I and II for patients with brain metastases is derived from a database made up primarily of patients with unresected and multiple metastases. An analysis of a previously published randomized trial was performed to determine the applicability of these RPA prognostic classes in the setting of resection of single metastases to the brain. PATIENTS AND METHODS: Ninety-five patients with single metastases to the brain that were treated with complete surgical resection entered this study. Patients were randomly assigned to treatment with postoperative whole brain radiotherapy (WBRT) (n = 49 patients) or no further brain treatment (n = 46 patients). All patients entered on this study had a Karnofsky performance status of > or =70. Therefore, although the RTOG RPA has 3 classes, only patients with RPA classes I (n = 26) or II (n = 69) were eligible for this study analysis. RESULTS: For RPA class I, the median survival was 10.9 months versus 9.8 months for class II patients (P = 0.45). Multivariate analysis showed that only postoperative WBRT, independent of RPA class I or II, lessened the risk of brain tumor recurrence (P < 0.0001). CONCLUSION: This analysis of a randomized trial evaluating postoperative WBRT in the treatment of single metastases to the brain showed no difference in survival between RPA class I or II patients. In addition, the use of postoperative WBRT after complete surgical resection of single brain metastases results in substantially better control of disease in the brain independent of RPA classes I or II.

Adult↗
PubMed2003

Neurologic complications of bladder carcinoma: a review of 359 cases.

BACKGROUND: Carcinoma of the urinary bladder accounts for approximately 2% of all malignant tumors and usually spreads through both local invasion and hematogenous dissemination. In the current study, the authors reviewed a large series of patients to determine the nature and frequency of neurologic complications. METHODS: In the current study, the authors reviewed the records of 359 patients with bladder carcinoma who were treated at the study institution between 1962-2001. RESULTS: Fifty-two patients (14%) were reported to have neurologic complications. Complications resulting from neurologic metastases were relatively infrequent (5%). Seven patients (2%) had lumbosacral plexopathies and 6 patients (2%) had metastatic epidural spinal cord compression. Brain metastases were present in only 4 patients (1%). Nonmetastatic complications were more common than metastatic complications and were comprised of metabolic encephalopathies in 24 patients (7%), peripheral neuropathies in 9 patients (2.5%), cerebral infarctions in 6 patients (2%), and seizures in 5 patients (1%). No cases of neurologic infection or carcinomatous meningitis were reported. CONCLUSIONS: The results of the current study demonstrate that neurologic complications are relatively uncommon in patients with bladder carcinoma and that local extension into peripheral nerves or bone, rather than hematogenous dissemination, is the most common cause of neurologic complications resulting from bladder carcinoma.

Adenocarcinoma↗
PubMed2003

The management of brain metastases.

Brain metastases are neoplasms that originate in tissues outside the brain and then spread secondarily to the brain. Metastases to the brain are the most common intracranial tumours in adults. Substantial progress has been made in the treatment of these tumours, and radiotherapy, surgery, and stereotactic radiosurgery are now established treatments. With aggressive treatment, most patients experience meaningful symptom reduction and extension of life.

Brain Neoplasms↗
PubMed2003

The rationale for adjuvant whole brain radiation therapy with radiosurgery in the treatment of single brain metastases.

Randomized trials have established the efficacy of focal treatment (either stereotactic radiosurgery or conventional surgery) for single brain metastases. In the past, adjuvant whole brain radiation therapy (WBRT) was routinely given with focal therapy. Recently, the utility of adjuvant WBRT has been called into question. This paper examines the scientific evidence and the arguments, pro and con, concerning the use of adjuvant WBRT in association with stereotactic radiosurgery or conventional surgery.

Brain Neoplasms↗
PubMed2002

Lead-in phase to randomized trial of motexafin gadolinium and whole-brain radiation for patients with brain metastases: centralized assessment of magnetic resonance imaging, neurocognitive, and neurologic end points.

PURPOSE: Motexafin gadolinium is a redox mediator that selectively targets tumor cells, is detectable by magnetic resonance imaging (MRI), and enhances the effect of radiation therapy. This lead-in phase to a randomized trial served to evaluate radiologic, neurocognitive, and neurologic progression end points and to evaluate the safety and radiologic response of motexafin gadolinium administered concurrently with 30 Gy in 10-fraction whole-brain radiation therapy for the treatment of brain metastases. PATIENTS AND METHODS: Motexafin gadolinium (5.0 mg/kg/d for 10 days) was administered before each radiation treatment in this prospective international trial. Patients were evaluated by MRI, neurologic examinations, and neurocognitive tests. Prospective criteria and centralized review procedures were established for radiologic, neurocognitive, and neurologic progression end points. RESULTS: Twenty-five patients with brain metastases from lung (52%) and breast (24%) cancer, recursive partitioning analysis class 2 (96%), and an average of 11 brain metastases were enrolled. Neurocognitive function was highly impaired at presentation. Motexafin gadolinium was well tolerated. Freedom from neurologic progression was 77% at 1 year. Median survival was 5.0 months. In 29% of patients, the cause of death was brain metastasis progression. The radiologic response rate was 68%. Motexafin gadolinium's tumor selectivity was established with MRI. CONCLUSION: (1) Centralized neurologic progression scoring that incorporated neurocognitive tests was implemented successfully. (2) Motexafin gadolinium was well tolerated. (3) Local control, measured by radiologic response rate, neurologic progression, and death caused by progression of brain metastasis, seemed to be improved compared with historical results. A randomized phase III trial using these methods for evaluation of efficacy has just been completed.

Adult↗
PubMed2002

Risk of symptomatic brain tumor recurrence and neurologic deficit after radiosurgery alone in patients with newly diagnosed brain metastases: results and implications.

PURPOSE: A single-institution experience using primary stereotactic radiosurgery (SRS) alone in the management of newly diagnosed brain metastases was analyzed to identify the risk of symptomatic brain tumor recurrence (BTR) and neurologic deficit associated with such a treatment strategy. METHODS AND MATERIALS: Thirty-six patients were treated for newly diagnosed single/multiple brain metastases using SRS alone followed by planned observation. SRS minimum tumor dose ranged from 8 to 25 Gy (median: 20 Gy). Factors evaluated in analysis of treatment outcome included number of metastases, site of metastasis, primary tumor site, histology, extent of intracranial and extracranial disease, and interval to diagnosis of brain metastasis. RESULTS: Median and 1-year survival for the entire group was 9 months and 36%, respectively. BTR anywhere in the brain occurred in 47% (17/36) of patients. Forty-seven percent of BTR (8/17) recurred at the site of original metastasis; 35% (6/17) recurred at both original [corrected] and distant sites in the brain, and 18% (3/17) recurred at distant only [corrected] brain sites. Seventy-one percent (12/17) of the patients were symptomatic at the time of recurrence, and 59% (10/17) had an associated neurologic deficit. Multivariate analysis found that only the extent of disease was a predictor of BTR. Patients who had disease limited to the brain only had a BTR rate of 80% (8/10) vs. 35% (9/26) who had disease involving the brain, primary site, and/or other extracranial metastatic sites (p = 0.03). CONCLUSIONS: Use of primary SRS alone in this setting is associated with an increasingly significant risk of BTR with increasing survival time. In addition, the majority of such recurrences are symptomatic and associated with a neurologic deficit, a finding not analyzed in recently reported experiences withholding whole brain radiation therapy as part of the primary treatment of brain metastasis.

Adult↗
PubMed2002

A phase I trial of continuously infused intratumoral bleomycin for the treatment of recurrent glioblastoma multiforme.

Intratumoral (IT) chemotherapy has theoretical advantages in the treatment of brain tumors. The blood-brain barrier is not a factor in drug delivery, and large concentrations of drug can be instilled in the tumor with little systemic toxicity. Bleomycin has activity against gliomas and is a cell cycle selective agent whose efficacy should be enhanced by continuous infusion. We performed a phase I trial to test the feasibility of IT chemotherapy using a refillable, sustained release device, and to determine the maximum tolerable dose of IT bleomycin. The study was an open-ended dose escalation study. A modified Ommaya reservoir (containing a semipermeable membrane) was implanted with the delivery tube in the center of the tumor. Groups of three patients with recurrent glioblastoma multiforme were entered at progressively higher dose levels of bleomycin. The study closed when all patients at a given starting dose level developed toxicity. Nine patients received doses ranging from 5 to 34 U/wk; the median total cumulative dose was 195 U. No dose limiting systemic toxicity was detected. Neurologic toxicity occurred only at doses above 16 U/wk. We conclude that continuously infused IT bleomycin is well tolerated; the MTD (and recommended dose for a phase II efficacy trial) of IT bleomycin is 16 U/wk.

Aged↗
PubMedDate not supplied

Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomised trial.

BACKGROUND: The standard treatment for spinal cord compression caused by metastatic cancer is corticosteroids and radiotherapy. The role of surgery has not been established. We assessed the efficacy of direct decompressive surgery. METHODS: In this randomised, multi-institutional, non-blinded trial, we randomly assigned patients with spinal cord compression caused by metastatic cancer to either surgery followed by radiotherapy (n=50) or radiotherapy alone (n=51). Radiotherapy for both treatment groups was given in ten 3 Gy fractions. The primary endpoint was the ability to walk. Secondary endpoints were urinary continence, muscle strength and functional status, the need for corticosteroids and opioid analgesics, and survival time. All analyses were by intention to treat. FINDINGS: After an interim analysis the study was stopped because the criterion of a predetermined early stopping rule was met. Thus, 123 patients were assessed for eligibility before the study closed and 101 were randomised. Significantly more patients in the surgery group (42/50, 84%) than in the radiotherapy group (29/51, 57%) were able to walk after treatment (odds ratio 6.2 [95% CI 2.0-19.8] p=0.001). Patients treated with surgery also retained the ability to walk significantly longer than did those with radiotherapy alone (median 122 days vs 13 days, p=0.003). 32 patients entered the study unable to walk; significantly more patients in the surgery group regained the ability to walk than patients in the radiation group (10/16 [62%] vs 3/16 [19%], p=0.01). The need for corticosteroids and opioid analgesics was significantly reduced in the surgical group. INTERPRETATION: Direct decompressive surgery plus postoperative radiotherapy is superior to treatment with radiotherapy alone for patients with spinal cord compression caused by metastatic cancer.

Combined Modality Therapy↗