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New Oncology Research Study Results from National Cancer Institute Described

February 26, 2014

By a News Reporter-Staff News Editor at Biotech Week -- A new study on Oncology is now available. According to news reporting from Bethesda, Maryland, by NewsRx journalists, research stated, "No standard treatment exists for refractory or relapsed advanced thymic epithelial tumours. We investigated the efficacy of cixutumumab, a fully human IgG1 monoclonal antibody targeting the insulin-like growth factor 1 receptor in thymic epithelial tumours after failure of previous chemotherapy."

The news correspondents obtained a quote from the research from National Cancer Institute, "Between Aug 25, 2009, and March 27, 2012, we did a multicentre, open-label, phase 2 trial in patients aged 18 years or older with histologically confirmed recurrent or refractory thymic epithelial tumours. We enrolled individuals who had progressed after at least one previous regimen of platinum-containing chemotherapy, had an Eastern Cooperative Oncology Group performance status of 0 or 1, and had measurable disease and adequate organ function. Eligible patients received intravenous cixutumumab (20 mg/kg) every 3 weeks until disease progression or development of intolerable toxic effects. The primary endpoint was the frequency of response, analysed on an intention-to-treat basis. We also did pharmacodynamic studies. This trial is registered with, number NCT00965250. Findings 49 patients were enrolled (37 with thymomas and 12 with thymic carcinomas) who received a median of eight cycles of cixutumumab (range 1-46). At the final actuarial analysis when follow-up data were updated (Nov 30, 2012), median potential follow-up (from on-study date to most current follow-up date) was 24.0 months (IQR 17.3-36.9). In the thymoma cohort, five (14%) of 37 patients (95% CI 5-29) achieved a partial response, 28 had stable disease, and four had progressive disease. In the thymic carcinoma cohort, none of 12 patients (95% CI 0-26) had a partial response, five had stable disease, and seven had progressive disease. The most common grade 3-4 adverse events in both cohorts combined were hyperglycaemia (five [10%]), lipase elevation (three [6%]), and weight loss, tumour pain, and hyperuricaemia (two each [4%]). Nine (24%) of 37 patients with thymoma developed autoimmune conditions during treatment (five were new-onset disorders), the most common of which was pure red-cell aplasia. Two (4%) patients died; one was attributed to disease progression and the other to disease-related complications (respiratory failure, myositis, and an acute coronary event), which could have been precipitated by treatment with cixutumumab. Cixutumumab monotherapy is well-tolerated and active in relapsed thymoma."

According to the news reporters, the research concluded: "Development of autoimmunity during treatment needs further investigation."

For more information on this research see: Cixutumumab for patients with recurrent or refractory advanced thymic epithelial tumours: a multicentre, open-label, phase 2 trial. Lancet Oncology, 2014;15(2):191-200. Lancet Oncology can be contacted at: Elsevier Science Inc, 360 Park Ave South, New York, NY 10010-1710, USA. (Elsevier -; Lancet Oncology -

Our news journalists report that additional information may be obtained by contacting A. Rajan, National Cancer Institute, Biostat & Data Management Sect, Off Clin Director, Center Canc ResNIH, Bethesda, MD 20892, United States. Additional authors for this research include C.A. Carter, A. Berman, L. Cao, R.J. Kelly, A. Thomas, S. Khozin, A.L. Chavez, I. Bergagnini, B. Scepura, E. Szabo, M.J. Lee, J.B. Trepel, S.K. Browne, L.B. Rosen, Y.K. Yu, S.M. Steinberg, H.X. Chen, G.J. Riely and G. Giaccone (see also Oncology).

Keywords for this news article include: Bethesda, Maryland, Oncology, Treatment, Chemotherapy, United States, Adverse Drug Reaction, North and Central America

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Source: Biotech Week

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