23 research outputs found
Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial.
BACKGROUND: Achievement of durable responses in patients with relapsed/refractory peripheral T cell lymphoma (PTCL) is challenging with current therapies, and there are few data regarding the potential benefits of continuing treatment in patients with the best response of stable disease (SD). Histone deacetylase inhibitors are a novel class of drugs with activity in T cell malignancies. Romidepsin was approved by the US Food and Drug Administration for the treatment of relapsed/refractory PTCL based on a pivotal trial demonstrating an objective response rate of 25 % (33/130), including 15 % with confirmed/unconfirmed complete response and a median duration of response of 28 months. Our objective was to further study the clinical benefits of romidepsin in patients that had the best response of SD.
METHODS: Patients with PTCL relapsed/refractory to ≥1 prior therapy were treated with the approved dose of 14 mg/m(2) romidepsin on days 1, 8, and 15 of six 28-day cycles; patients with SD or response after cycle 6 were allowed to continue on study until progression. By protocol amendment, patients treated for ≥12 cycles could receive maintenance dosing twice per cycle; after cycle 24, dosing could be further reduced to once per cycle in those who had received maintenance dosing for ≥6 months.
RESULTS: Of the 32 patients (25 %) with the best response of SD, 22 had SD for ≥90 days (SD90; cycle 4 response assessment). The longest SD was \u3e3 years in a patient who received maintenance dosing of 14 mg/m(2) on days 1 and 15 beginning in cycle 13. Patients with the best response of SD90 or partial response achieved similar overall and progression-free survival. Prolonged dosing of romidepsin was well tolerated.
CONCLUSIONS: We concluded that patients who achieve SD may consider continuing treatment because the clinical benefits of romidepsin may extend beyond objective responses.
TRIAL REGISTRATION: NCT00426764
Erratum to: Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial
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Integrating microbial ecology into ecosystem models: challenges and priorities
Microbial communities can potentially mediate feedbacks between global change and ecosystem function, owing to their sensitivity to environmental change and their control over critical biogeochemical processes. Numerous ecosystem models have been developed to predict global change effects, but most do not consider microbial mechanisms in detail. In this idea paper, we examine the extent to which incorporation of microbial ecology into ecosystem models improves predictions of carbon (C) dynamics under warming, changes in precipitation regime, and anthropogenic nitrogen (N) enrichment. We focus on three cases in which this approach might be especially valuable: temporal dynamics in microbial responses to environmental change, variation in ecological function within microbial communities, and N effects on microbial activity. Four microbially-based models have addressed these scenarios. In each case, predictions of the microbial-based models differ—sometimes substantially—from comparable conventional models. However, validation and parameterization of model performance is challenging. We recommend that the development of microbial-based models must occur in conjunction with the development of theoretical frameworks that predict the temporal responses of microbial communities, the phylogenetic distribution of microbial functions, and the response of microbes to N enrichment
Results From a Pivotal, Open-Label, Phase II Study of Romidepsin in Relapsed or Refractory Peripheral T-Cell Lymphoma After Prior Systemic Therapy
Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials
Comparative Assessments of Benzene, Toluene, and Xylene Natural Attenuation by Quantitative Polymerase Chain Reaction Analysis of a Catabolic Gene, Signature Metabolites, and Compound-Specific Isotope Analysis
Romidepsin induces durable responses in patients with relapsed or refractory angioimmunoblastic T-cell lymphoma
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Ibrutinib in Early Stage CLL: Preliminary Safety Results of a Placebo-Controlled Phase III Study
Serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) in early stage patients with CLL treated with ibrutinib or placebo: safety results of the ongoing randomized CLL12 phase III-trial
Money Value Art : State Funding, Free Markets, Big Pictures
The essays and artists’ projects in this collection explore the issue of arts funding in Canada, particularly in light of cuts in government funding. Twenty-two authors address a diverse range of topics in a variety of styles, from humorous personal anecdotes to sociological analysis. The editors intend to mark a moment of flux in Canadian culture, when global capitalism is the dominant model. Includes a timeline of arts funding in Canada from 1941 to 2001. Notes on contributors. Bibliography 2 p. Circa 200 bibl. ref