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Rodrigues G.,University of Western Ontario | MacBeth F.,National Institute for Health and Clinical Excellence | Burmeister B.,Princess Alexandra Hospital | Kelly K.-L.,Kootenai Cancer Center | And 4 more authors.
Clinical Lung Cancer | Year: 2012

The purpose of this work is to disseminate a consensus statement on palliative radiotherapy (RT) of lung cancer created in conjunction with the Third International Lung Cancer Consensus Workshop. The palliative lung RT workshop committee agreed on 5 questions relating to (1) patient selection, (2) thoracic external-beam radiation therapy (XRT) fractionation, (3) endobronchial brachytherapy (EBB), (4) concurrent chemotherapy (CC), and (5) palliative endpoint definitions. A PubMed search for primary/cross-referenced practice guidelines, consensus statements, meta-analyses, and/or systematic reviews was conducted. Final consensus statements were created after review and discussion of the available evidence. The following summary statements reflect the consensus of the international working group. 1. Key factors involved in the decision to deliver palliative RT include performance status, tumor stage, pulmonary function, XRT volume, symptomatology, weight loss, and patient preference. 2. Palliative thoracic XRT is generally indicated for patients with stage IV disease with current/impending symptoms and for patients with stage III disease treated for palliative intent. 3. There is no evidence to routinely recommend EBB alone or in conjunction with other palliative maneuvers in the initial palliative management of endobronchial obstruction resulting from lung cancer. 4. There is currently no evidence to routinely recommend CC with palliative-intent RT. 5. Standard assessment of symptoms and health-related quality of life (QOL) using validated questionnaires should be carried out in palliative RT lung cancer trials. Despite an expanding literature, continued prospective randomized investigations to better define the role of XRT, EBB, and CC in the context of thoracic palliation of patients with lung cancer is needed. © 2012 Elsevier Inc. All Rights Reserved. Source

Chugh R.,University of Michigan | Wathen J.K.,University of Texas M. D. Anderson Cancer Center | Patel S.R.,University of Texas M. D. Anderson Cancer Center | Maki R.G.,Sloan Kettering Cancer Center | And 8 more authors.
Clinical Cancer Research | Year: 2010

Purpose: Aggressive fibromatoses (AF; desmoid tumors) are rare clonal neoplastic proliferations of connective tissues that can be locally aggressive despite wide surgical resection and/or radiation therapy. The Sarcoma Alliance for Research through Collaboration (SARC) initiated a prospective phase II trial to investigate the outcome of patients treated with imatinib, a multiple tyrosine kinase inhibitor, in patients with AF, or 1 of 10 sarcoma subtypes. Here, we report specifically on the outcome of patients with AF as well as evaluations undertaken to examine the mechanism of imatinib. Experimental Design: Patients ≥10 years old with desmoid tumors that were not curable by surgical management or in whom curative surgery would lead to undesirable functional impairment were eligible. Imatinib was prescribed at 300 mg twice daily [body surface area (BSA) = 1.5 m2], 200 mg twice daily (BSA = 1.0-1.49 m2), or 100 mg twice daily (BSA < 1.0 m2). Response outcomes at 2 and 4 months were assessed. Tissue specimens were analyzed by immunohistochemistry for expression of cKIT, plateletderived growth factor receptor α (PDGFRα), PDGFRβ, AKT, PTEN, FKHR, and β-catenin. Tumor DNA was analyzed for PDGFRα exon 18 and APC mutations by allelic discrimination PCR. Results: Fifty-one patients were enrolled. The median number of prior regimens was 1. Kaplan-Meier estimates of 2- and 4-month progression-free survival rates were 94% and 88%, respectively, and 1-year progression-free survival was 66%. Objective response rate was 6% (3 of 51). Expression and polymorphisms of target proteins were identified in tissue samples, but no significant correlation with outcome was observed using the samples available. Conclusion: Imatinib may have a role in the management of unresectable or difficult to resect desmoid tumors. ©2010 AACR. Source

Bendell J.C.,Sarah Cannon Research Institute | Bekaii-Saab T.S.,Ohio State University | Cohn A.L.,Rocky Mountain Cancer Center | Hurwitz H.I.,Duke University | And 8 more authors.
Oncologist | Year: 2012

Background. The Avastin® Registry: Investigation of Effectiveness and Safety (ARIES) study is a prospective, community- based observational cohort study that evaluated the effectiveness and safety of first-line treatment patterns, assessing the impact of chemotherapy choice and treatment duration. Methods. The ARIES study enrolled patients with metastatic colorectal cancer (mCRC) receiving first-line chemotherapy with bevacizumab and followed them longitudinally. The protocol did not specify treatment regimens or assessments. Analyses included all patients who initiated bevacizumab in combination with either first-line oxaliplatin with infusional 5-fluorouracil and leucovorin (FOLFOX) or irinotecan with infusional 5-fluorouracil and leucovorin (FOLFIRI). Progression-free survival (PFS) and overall survival (OS) times were estimated using Kaplan-Meier methods. Hazard ratios (HRs) were estimated with multivariate Cox regression analysis, adjusting for potential confounding factors. Results. In total, 1,550 patients with first-line mCRC were enrolled (median follow-up, 21 months) and most received FOLFOX-bevacizumab (n = 968) or FOLFIRI- bevacizumab (n = 243) as first-line therapy. The baseline characteristics and median treatment duration were generally similar between subgroups. There were no significant differences in the median PFS (10.3 months vs. 10.2 months) or OS (23.7 months vs. 25.5 months) time between the FOLFOX-bevacizumab and FOLFIRI-bevacizumab subgroups, respectively, by unadjusted analyses. Multivariate analyses showed FOLFIRI-bevacizumab resulted in a similar PFS (HR, 1.03; 95% confidence interval [CI], 0.88 -1.21) and OS (HR, 0.95; 95% CI, 0.78 -1.16) outcome as with FOLFOX-bevacizumab. The incidence proportions of bevacizumab-associated adverse events were similar for FOLFOX- and FOLFIRI-based therapies. Conclusions. In first-linemCRCpatients, the FOLFOX- bevacizumab and FOLFIRI-bevacizumab regimens were associated with similar treatment patterns and clinical outcomes. © AlphaMed Press. Source

Samuels B.L.,Kootenai Cancer Center | Chawla S.,Sarcoma Oncology Center | Patel S.,University of Houston | von Mehren M.,Chase Medical | And 5 more authors.
Annals of Oncology | Year: 2013

Background: This expanded access program (EAP) was designed to provide trabectedin access for patients with incurable soft tissue sarcoma (STS) following progression of disease with standard therapy. The outcomes of trial participants accrued over approximately 5 years are reported. Patients and methods: Adult patients with advanced STS of multiple histologies, including leiomyosarcoma and liposarcoma (L-sarcomas), following relapse or disease progression following standard-of-care chemotherapy, were enrolled. Trabectedin treatment cycles (1.5 mg/m2, intravenously over 24 h) were repeated q21 days. Objective response, overall survival (OS), and safety were evaluated. Results: Of 1895 patients enrolled, 807 (43%) had evaluable objective response data, with stable disease reported in 343 (43%) as best response. L-sarcoma patients exhibited longer, OS compared with other histologies [16.2 months (95% confidence interval (CI) 14.1-19.5) versus 8.4 months (95% CI 7.1-10.7)], and a slightly higher objective response rate [6.9% (95% CI 4.8-9.6) versus 4.0% (95% CI 2.1-6.8)]. The median treatment duration was 70 days representing a median of three treatment cycles; 30% of patients received ≥6 cycles. Safety and tolerability in this EAP were consistent with prior clinical trial data. Conclusion: Results of this EAP are consistent with previous reports of trabectedin, demonstrating disease control despite a low incidence of objective responses in advanced STS patients after failure of standard chemotherapy. ClinicalTrials.gov: NCT00210665. © The Author 2013. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Source

Rodrigues G.,University of Western Ontario | Macbeth F.,National Institute for Health and Clinical Excellence | Burmeister B.,Princess Alexandra Hospital | Kelly K.-L.,Kootenai Cancer Center | And 5 more authors.
Clinical Lung Cancer | Year: 2012

Background: The purpose of this work was to disseminate international practice survey results created in conjunction with the Third International Lung Cancer Consensus Workshop.Patients and Methods: In conjunction with the American Society for Radiation Oncology (ASTRO) Guideline for Palliative Lung Cancer Care and International Workshop Consensus statements, an online international practice survey was conducted during the summer of 2010. The survey included demographic, educational, and clinical questions as well as 5 cases exploring the role of external beam radiotherapy, endobronchial brachytherapy, and concurrent chemoradiation. Results: A total of 279 individuals responded to the survey over a 3-month period. Most respondents were hospital-based, academic, or government-funded radiation oncologists. Factors that consistently related to use and choice of external beam dose fractionation included estimated treatment benefit to patient, performance status (PS), symptom severity, patient choice, estimated prognosis, and previous radiation to the same site. Factors consistently not related to use and dose fractionation included requirement for future radiation therapy, department policy, and waiting lists. A significant range of dose fractionation schedules existed for external beam (n = 35) and endobronchial brachytherapy treatment (n = 10). The integration of concurrent chemotherapy was recorded by a significant minority of respondents despite lack of level I evidence to support its use. Geographic differences in the use of external beam dose fractionation and of concurrent chemotherapy were seen. Conclusions: Various patient, tumor, treatment, and logistic factors are associated with the variable use and external beam dose fractionation of palliative lung treatments. The copublication of the ASTRO Guideline for Palliative Lung Cancer Care and International Workshop Consensus statements should assist clinicians by providing evidence-based care. © 2012 Elsevier Inc. Source

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