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Eastern Cooperative Oncology Group (eastern + cooperative_oncology_group)
Terms modified by Eastern Cooperative Oncology Group Selected AbstractsMedium-term results of percutaneous vertebroplasty in multiple myelomaEUROPEAN JOURNAL OF HAEMATOLOGY, Issue 1 2006Luis Ramos Abstract:, Vertebral compression fractures (VCFs) are common in multiple myeloma (MM). Percutaneous vertebroplasty (PVP) is used to stabilize vertebral collapse and treat the pain. Few studies have been carried out on PVP in MM and follow-up has tended to be short. We have prospectively evaluated the safety and efficacy of PVP in the VCFs resulting from MM or plasmacytomas. Nineteen PVP were performed in 12 consecutive patients. We monitored their pain and functional status using visual analog (VAS) and Eastern Cooperative Oncology Group (ECOG) scale, respectively. For a subjective assessment, every patient was asked about his/her degree of satisfaction. The mean age of the participants was 66 yr. Significant improvement occurred 1 d after PVP according to the VAS score (7.5 pre-PVP to 3.7, P < 0.0001) and ECOG assessment (3.1 to 2.5, P = 0.002). This significant improvement was maintained after 3.2 yr of follow-up. Sixty-three percent of patients were highly satisfied with the result of the PVP and 37% were satisfied. The peri-operative mortality was 0%. Leakage of the cement outside of the vertebral body was noted in 16 of 19 injected vertebrae (84%) but none of the patients developed any clinical or neurological symptoms. At the last follow-up, no further collapse in the treated or neighboring vertebrae was noted. VCFs caused by MM or plasmacytomas can be effectively treated by vertebroplasty. PVP is associated with early clinical improvement of pain and function and can be maintained after a long follow-up without major procedure-related complications. [source] Phase II trial of taxol in salivary gland malignancies (E1394): A trial of the Eastern Cooperative Oncology GroupHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 3 2006Jill Gilbert MD Abstract Background. Malignant tumors of the salivary glands make up approximately 5% of head and neck cancers. The Eastern Cooperative Oncology Group (ECOG) initiated a phase II evaluation of paclitaxel in patients with locally recurrent or metastatic salivary gland malignancies. Methods. Chemo-naive patients with histologically confirmed recurrent or metastatic carcinoma of salivary gland origin (mucoepidermoid, adenocarcinoma, or adenoid cystic) were eligible. Patients were treated with paclitaxel, 200 mg/m2 IV, every 21 days for a minimum of four cycles. Results. Forty-five patients were treated. Eight partial responses were seen among the 31 patients with mucoepidermoid or adenocarcinoma histologic findings for a response rate of 26%. No responses were seen in the adenoid cystic carcinoma group. No significant difference in overall survival was found among these three histologic subgroups. Conclusion. Paclitaxel demonstrates moderate activity in salivary gland tumors of mucoepidermoid and adenocarcinoma histology. The poor response rate in adenoid cystic carcinoma is consistent with prior reports in this chemoresistant histologic subtype. © 2006 Wiley Periodicals, Inc. Head Neck28: 197,204, 2006 [source] Prognostic index to identify patients who may not benefit from whole brain radiotherapy for multiple brain metastases from lung cancerJOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY, Issue 1 2010P Sundaresan Summary Palliative whole brain radiotherapy (WBRT) is often recommended in the management of multiple brain metastases. Allowing for WBRT waiting time, duration of the WBRT course and time to clinical response, it may take 6 weeks from the point of initial assessment for a benefit from WBRT to manifest. Patients who die within 6 weeks (,early death') may not benefit from WBRT and may instead experience a decline in quality of life. This study aimed to develop a prognostic index (PI) that identifies the subset of patients with lung cancer with multiple brain metastases who may not benefit from WBRT because of ,early death'. The medical records of patients with lung cancer who had WBRT recommended for multiple brain metastases over a 10-year period were retrospectively reviewed. Patients were classified as either having died within 6 weeks or having lived beyond 6 weeks. Potential prognostic indicators were evaluated for correlation with ,early death'. A PI was constructed by modelling the survival classification to determine the contribution of these factors towards shortened survival. Of the 275 patients recommended WBRT, 64 (23.22%) died within 6 weeks. The main prognostic factor predicting early death was Eastern Cooperative Oncology Group (ECOG) status >2. Patients with a high PI score (>13) were at higher risk of ,early death'. Twenty-three per cent of patients died prior to benefit from WBRT. ECOG status was the most predictive for ,early death'. Other factors may also contribute towards a poor outcome. With further refinement and validation, the PI could be a valuable clinical decision tool. [source] Bayesian cure rate models for malignant melanoma: a case-study of Eastern Cooperative Oncology Group trial E1690JOURNAL OF THE ROYAL STATISTICAL SOCIETY: SERIES C (APPLIED STATISTICS), Issue 2 2002Ming-Hui Chen We propose several Bayesian models for modelling time-to-event data. We consider a piecewise exponential model, a fully parametric cure rate model and a semiparametric cure rate model. For each model, we derive the likelihood function and examine some of its properties for carrying out Bayesian inference with non-informative priors. We also examine model identifiability issues and give conditions which guarantee identifiability. Also, for each model, we construct a class of informative prior distributions based on historical data, i.e. data from similar previous studies. These priors, called power priors, prove to be quite useful in this context. We examine the properties of the power priors for Bayesian inference and, in particular, we study their effect on the current analysis. Tools for model comparison and model assessment are also proposed. A detailed case-study of a recently completed melanoma clinical trial conducted by the Eastern Cooperative Oncology Group is presented and the methodology proposed is demonstrated in detail. [source] Maximum Likelihood Methods for Nonignorable Missing Responses and Covariates in Random Effects ModelsBIOMETRICS, Issue 4 2003Amy L. Stubbendick Summary. This article analyzes quality of life (QOL) data from an Eastern Cooperative Oncology Group (ECOG) melanoma trial that compared treatment with ganglioside vaccination to treatment with high-dose interferon. The analysis of this data set is challenging due to several difficulties, namely, nonignorable missing longitudinal responses and baseline covariates. Hence, we propose a selection model for estimating parameters in the normal random effects model with nonignorable missing responses and covariates. Parameters are estimated via maximum likelihood using the Gibbs sampler and a Monte Carlo expectation maximization (EM) algorithm. Standard errors are calculated using the bootstrap. The method allows for nonmonotone patterns of missing data in both the response variable and the covariates. We model the missing data mechanism and the missing covariate distribution via a sequence of one-dimensional conditional distributions, allowing the missing covariates to be either categorical or continuous, as well as time-varying. We apply the proposed approach to the ECOG quality-of-life data and conduct a small simulation study evaluating the performance of the maximum likelihood estimates. Our results indicate that a patient treated with the vaccine has a higher QOL score on average at a given time point than a patient treated with high-dose interferon. [source] Intracranial tumor surgery in patients >70 years of age: is clinical practice worthwhile or futile?ACTA NEUROLOGICA SCANDINAVICA, Issue 5 2009S. G. Rogne Objectives,,, To study survival and functional outcome after intracranial tumor surgery in elderly patients. Materials and methods,,, This is a retrospective study of 289 consecutive patients of age ,70 years, who underwent primary surgery (resection or biopsy) in the time period 2003,2007 for an intracranial tumor (87 astrocytomas, 79 meningiomas, 62 brain metastases, 33 pituitary adenomas and 28 other tumors). Results,,, The surgical mortality was 2.8%. Overall survival at 6 months, 1, 2 and 5 years was 73%, 57%, 46% and 38% respectively. Histology, pre-operative Eastern Cooperative Oncology Group (ECOG) performance score and resection, as opposed to biopsy, were significantly associated with survival. Gender, age and American Association of Anaesthetists (ASA) score were not significantly related to survival. One-year survival after surgery for astrocytoma, meningioma, brain metastases and pituitary adenoma were 24%, 94%, 31% and 96% respectively. More than 85% of the patients who were alive 6 months after surgery had a stable or improved ECOG score compared with their pre-operative score. Conclusions,,, Surgery for intracranial tumors in selected elderly patients is worthwhile, not futile. Age alone should not be used as a selection criterion for treatment. [source] Prognostic model to predict outcomes in nonsmall cell lung cancer patients treated with gefitinib as a salvage treatmentCANCER, Issue 7 2009Min Jae Park MD Abstract BACKGROUND: A prognostic model based on clinical parameters for nonsmall cell lung cancer (NSCLC) patients treated with gefitinib (250 mg/day) as a salvage therapy was devised. METHODS: Clinical data regarding a total of 316 metastatic or recurrent NSCLC patients who were treated with gefitinib were analyzed. RESULTS: Poor prognostic factors for overall survival (OS) by multivariate analysis were an Eastern Cooperative Oncology Group (ECOG) performance status of 2 to 3 (hazards ratio [HR] of 2.07; 95% confidence interval [CI], 1.57-2.73 [P < .001]), the presence of intra-abdominal metastasis (HR of 1.76; 95% CI, 1.33-2.34 [P < .001]), elevated serum alkaline phosphatase (HR of 1.50; 95% CI, 1.13-2.00 [P = .005]), time interval from diagnosis to gefitinib therapy of ,12 months (HR of 1.48; 95% CI, 1.12-1.95 [P = .005]), low serum albumin (HR of 1.45; 95% CI, 1.09-1.92 [P = .009]), progression-free interval for previous chemotherapy of ,12 weeks (HR of 1.40; 95% CI, 1.0-1.84 [P = .015]), white blood cell >10,000/,L (HR of 1.38; 95% CI, 1.02-1.85 [P = .032]), and ever-smoker (HR of 1.33; 95% CI, 1.02-1.75 [P = .033]). Of the 272 patients applicable to this prognostic model, 41 patients (15%) were categorized as a good prognosis group (0-1 risk factors), 100 patients (37%) as an intermediate prognosis group (2-3 risk factors), 81 patients (30%) as a poor prognosis group (4-5 risk factors), and 50 patients (16%) as a very poor prognosis group (,6 risk factors). The median OS from the time of gefitinib treatment for the good, intermediate, poor, and very poor prognosis groups were 18.0 months, 11.2 months, 4.0 months, and 1.3 months, respectively (P < .001). CONCLUSIONS: This prognostic model based on easily available clinical variables would be useful to identify patients who might derive more benefit from gefitinib treatment and to make decisions in clinical practice. Cancer 2009. © 2009 American Cancer Society. [source] Prognostic factors for functional outcome and survival after reirradiation for in-field recurrences of metastatic spinal cord compression,CANCER, Issue 5 2008Dirk Rades MD Abstract BACKGROUND. The purpose of the current study was to retrospectively investigate clinical outcome and potential prognostic factors after reirradiation (Re-RT) for in-field recurrence of metastatic spinal cord compression (MSCC). METHODS. Re-RT with 1 × 8 Gy (n = 48), 5 × 3 Gy (n = 29), 5 × 4 Gy (n = 30), 7 × 3 Gy (n = 3), 10-12 × 2 Gy (n = 11), or 17 × 1.8 Gy (n = 3) was administered to 124 patients. Cumulative biologically effective dose (BED) (first course of RT plus re-RT) ranged from 77.5 Gy2 to 142.6 Gy2, and was ,120 Gy2 in 114 (92%) patients. Twelve potential prognostic factors were investigated for associations with motor function and survival. RESULTS. Motor function improved in 45 (36%) patients, was stable in another 62 (50%) patients, and deteriorated in 17 (14%) patients. Upon multivariate analyses, the effect of Re-RT on motor function was significantly associated with the effect of the first course of RT (P = .048), Eastern Cooperative Oncology Group (ECOG) performance status (P = .020), time to development of motor deficits before Re-RT (P = .002), and visceral metastases (P < .001). Survival was associated with ECOG performance status (P < .001), ambulatory status before Re-RT (P < .001), time to development of motor deficits (P = .018), and visceral metastases (P <.001). Re-RT dose schedule or cumulative BED had no significant impact on functional outcome or survival. Acute toxicity was mild, and late toxicity, such as radiation myelopathy, was not observed. CONCLUSIONS. Given the limitations of a retrospective study and the relatively short follow up after Re-RT, spinal reirradiation appeared to be effective and safe when the cumulative BED is ,120 Gy2. Motor function after Re-RT was associated with the effect of first irradiation, performance status, time to development of motor deficits, and visceral metastases, whereas the Re-RT schedule had no significant impact. Cancer 2008. © 2008 American Cancer Society. [source] Adenosine triphosphate-based chemotherapy response assay (ATP-CRA)-guided platinum-based 2-drug chemotherapy for unresectable nonsmall-cell lung cancer,CANCER, Issue 9 2007Yong Wha Moon MD Abstract BACKGROUND. The study investigated correlations between adenosine triphosphate / chemotherapy response assay (ATP-CRA) and clinical outcomes after ATP-CRA-guided platinum-based chemotherapy for unresectable nonsmall-cell lung cancer (NSCLC). METHODS. The authors performed an in vitro chemosensitivity test, ATP-CRA, to evaluate the chemosensitivities of anticancer drugs such as cisplatin, carboplatin, paclitaxel, docetaxel, gemcitabine, and vinorelbine for chemonaive, unresectable NSCLC. The cell death rate was determined by measuring the intracellular ATP levels of drug-exposed cells compared with untreated controls. A sensitive drug was defined as a drug producing 30% or more reduction in ATP compared with untreated controls. Assay-guided platinum-based 2-drug chemotherapy was given to patients with pathologically confirmed NSCLC. RESULTS. Thirty-four patients were enrolled. Thirty tumor specimens were obtained by bronchoscopic biopsies and 4 obtained surgically. The median age was 61 years and 27 patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0,1. The response rate was 43.8%. At a median follow-up period of 16.9 months, the median progression-free and overall survivals were 3.6 and 11.2 months, respectively. Patients were dichotomized into the platinum-sensitive (S; 20 patients) and resistant (R; 14 patients) groups. The positive/negative predictive values were 61.1% and 78.6% with a predictive accuracy of 68.8%. Although without significant differences in pretreatment parameters, the S-group showed better clinical response (P = .036), longer progression-free survival (P = .060), and longer overall survival (P = .025). CONCLUSIONS. Despite using bronchoscopic biopsied specimens, ATP-CRA and clinical outcomes correlated well after assay-guided platinum-based 2-drug chemotherapy for unresectable NSCLC. There was a favorable response and survival in the platinum-sensitive vs resistant groups. Cancer 2007. © 2007 American Cancer Society. [source] A Phase II study of gemcitabine and cisplatin in advanced biliary tract cancerCANCER, Issue 6 2006Seung Tai Kim M.D. Abstract BACKGROUND The authors performed a Phase II study of combination chemotherapy with gemcitabine and cisplatin in patients with inoperable biliary tract cancer to evaluate efficacy and toxicity of this combination. In addition, the correlation between the CA 19-9 response and clinical outcome was analyzed. METHODS The eligibility criteria for this study were 1) histologically or cytologically confirmed inoperable biliary tract cancer in patients with metastatic or recurrent disease; 2) age between 18 and 70 years; 3) at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria; 4) an Eastern Cooperative Oncology Group (ECOG) performance status , 2; 5) a life expectancy of at least 3 mos; and 6) adequate bone marrow, hepatic, and renal function. The patients received gemcitabine (1250 mg/m2, Days 1 and 8) and cisplatin (60 mg/m2, Day 1) every 3 weeks. Tumor response was assessed by RECIST criteria every 2 cycles of chemotherapy. Treatment was continued until progression of disease was documented. RESULTS Twenty-nine patients were enrolled. The median age of these patients was 52 years (range, 37 to 69 yrs), and the median ECOG performance status was 1. No complete response was observed, and 10 of 29 patients had partial responses. The overall response rate was 34.5% (95% confidence interval [CI], 17.9,54.3) for the intent-to-treat analysis. Stable disease was observed in 4 (13.8%) patients and progressive disease in 13 (44.8%) patients. The median follow-up time was 10.0 months (95% CI, 7.2,12.8). The median time to progression (TTP) was 3.0 months (95% CI, 2.12,3.88), and the median overall survival was 11 months (95% CI, 5.49,16.5). Although these results showed a better response rate (57.1 % vs. 27.3%) and survival (12 vs. 10 mos) in patients with a decline in CA 19-9 of at least 25%, these data were statistically not significant. In addition, there was a significant positive correlation between the increment in CA 19-9 values and tumor progression as determined with RECIST criteria (r = 0.96, P < 0.01). However, there was no definite correlation between the CA 19-9 response and the response according to RECIST criteria (P = 0.087). National Cancer Institute (NCI) common toxicity criteria (CTC) Grade 3 or 4 hematologic toxicities included neutropenia in 4 (14%) patients and anemia in 1 (3%) patient. Two of 4 patients with Grade 3 or 4 neutropenia had febrile episodes (7%) and required hospital admissions. NCI-CTC Grade 3 or 4 nonhematologic toxicity included nausea in 1 (3%) patient. There were no treatment-related deaths. CONCLUSION The combination chemotherapy with gemcitabine and cisplatin in inoperable biliary tract cancer was tolerable for most patients and showed modest response rates. The role of CA 19-9 monitoring as a surrogate biomarker in patients with BTC treated with gemcitabine chemotherapy should be further investigated. Cancer 2006. © 2006 American Cancer Society. [source] Mature results of a phase III randomized trial of bacillus Calmette,Guerin (BCG) versus observation and BCG plus dacarbazine versus BCG in the adjuvant therapy of American Joint Committee on Cancer Stage I,III melanoma (E1673),,CANCER, Issue 8 2004A trial of the Eastern Cooperative Oncology Group Abstract BACKGROUND The local and systemic effects of bacillus Calmette,Guerin (BCG) have been known for decades. To investigate the adjuvant effect of BCG on resected American Joint Committee on Cancer (AJCC) Stage I,III melanoma, the Eastern Cooperative Oncology Group conducted a large trial to study the use of BCG alone or a combination of BCG and dacarbazine between 1974 and 1978. METHODS A total of 734 patients were randomized to 4 clinical groups consolidated into 2 cohorts. Cohort I compared BCG with observation and Cohort II compared BCG with a combination of BCG and dacarbazine. The primary end points were survival time and time to disease progression. RESULTS Within Cohort I, no statistically significant difference in disease-free survival (DFS) (P = 0.84) or overall survival (OS) (5-year survival 67% vs. 62%; P = 0.40) was observed between BCG treatment and observation. Within Cohort II, the addition of dacarbazine to BCG did not improve DFS (P = 0.74) or OS (P = 0.81) compared with BCG alone. Toxicity was mild to moderate in both cohorts. Although toxicity with this agent is mild, the use of BCG is associated with the development of punctate abscesses in greater than two-thirds of patients treated. CONCLUSIONS In what to our knowledge is the largest ever trial to test the role of BCG as adjuvant therapy for melanoma, no benefit for BCG was observed for patients with AJCC Stage I,III disease. The mature results of the current trial projected to 30 years confirmed the negative results of previous smaller studies utilizing this agent. Cancer 2004. © 2004 American Cancer Society. [source] | |||||||||||||