16 research outputs found
HOLOGRAPHIC RECORDING MEDIA BASED ON ELECTRONS DONOR OLIGOMERS
Information properties of recording media based on electrons donor oligomer of different structure for thermoplastic technique are investigated
Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial
Background: Previous trials have shown that anti-EGFR monoclonal antibodies can improve clinical outcomes of patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SCCHN). We assessed the efficacy and safety of panitumumab combined with cisplatin and fluorouracil as first-line treatment for these patients.
Methods: This open-label phase 3 randomised trial was done at 126 sites in 26 countries. Eligible patients were aged at least 18 years; had histologically or cytologically confi rmed SCCHN; had distant metastatic or locoregionally recurrent disease, or both, that was deemed to be incurable by surgery or radiotherapy; had an Eastern Cooperative Oncology Group performance status of 1 or less; and had adequate haematological, renal, hepatic, and cardiac function. Patients were randomly assigned according to a computer-generated randomisation sequence (1:1; stratifi ed by previous treatment, primary tumour site, and performance status) to one of two groups. Patients in both groups received up to six 3-week cycles of intravenous cisplatin (100 mg/m(2) on day 1 of each cycle) and fl uorouracil (1000 mg/m(2) on days 1-4 of each cycle); those in the experimental group also received intravenous panitumumab (9 mg/kg on day 1 of each cycle). Patients in the experimental group could choose to continue maintenance panitumumab every 3 weeks. The primary endpoint was overall survival and was analysed by intention to treat. In a prospectively defi ned retrospective analysis, we assessed tumour human papillomavirus (HPV) status as a potential predictive biomarker of outcomes with a validated p16-INK4A (henceforth, p16) immunohistochemical assay. Patients and investigators were aware of group assignment; study statisticians were masked until primary analysis; and the central laboratory assessing p16 status was masked to identifi cation of patients and treatment. This trial is registered with ClinicalTrials. gov, number NCT00460265.
Findings: Between May 15, 2007, and March 10, 2009, we randomly assigned 657 patients: 327 to the panitumumab group and 330 to the control group. Median overall survival was 11.1 months (95% CI 9.8-12.2) in the panitumumab group and 9.0 months (8.1-11.2) in the control group (hazard ratio [HR] 0.873, 95% CI 0.729-1.046; p = 0.1403). Median progression-free survival was 5.8 months (95% CI 5.6-6.6) in the panitumumab group and 4.6 months (4.1-5.4) in the control group (HR 0.780, 95% CI 0.659-0.922; p = 0.0036). Several grade 3 or 4 adverse events were more frequent in the panitumumab group than in the control group: skin or eye toxicity (62 [19%] of 325 included in safety analyses vs six [2%] of 325), diarrhoea (15 [5%] vs four [1%]), hypomagnesaemia (40 [12%] vs 12 [4%]), hypokalaemia (33 [10%] vs 23 [7%]), and dehydration (16 [5%] vs seven [2%]). Treatment-related deaths occurred in 14 patients (4%) in the panitumumab group and eight (2%) in the control group. Five (2%) of the fatal adverse events in the panitumumab group were attributed to the experimental agent. We had appropriate samples to assess p16 status for 443 (67%) patients, of whom 99 (22%) were p16 positive. Median overall survival in patients with p16-negative tumours was longer in the panitumumab group than in the control group (11.7 months [95% CI 9.7-13.7] vs 8.6 months [6.9-11.1]; HR 0.73 [95% CI 0.58-0.93]; p = 0.0115), but this difference was not shown for p16-positive patients (11.0 months [7.3-12.9] vs 12.6 months [7.7-17.4]; 1.00 [0.62-1.61]; p = 0.998). In the control group, p16-positive patients had numerically, but not statistically, longer overall survival than did p16-negative patients (HR 0.70 [95% CI 0.47-1.04]).
Interpretation: Although the addition of panitumumab to chemotherapy did not improve overall survival in an unselected population of patients with recurrent or metastatic SCCHN, it improved progression-free survival and had an acceptable toxicity profile. p16 status could be a prognostic and predictive marker in patients treated with panitumumab and chemotherapy. Prospective assessment will be necessary to validate our biomarker findings
Randomized Phase Ib/II Trial of Rilotumumab or Ganitumab with Panitumumab versus Panitumumab Alone in Patients with Wild-type KRAS
Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM): an open-label phase 3 randomised trial
HOLOGRAPHIC INFORMATION MEDIA BASED ON AZO-POLYMERS WITH DIFFERENT STRUCTURES
Polarization sensitive holographic recording was accomplished in new synthesized azobenzene polymer composites with Co metallic polycomplexes of different structure
Thermodynamic evaluation of the stabilization indicators of milk quality as influenced by a complex protector
In the present article the authors discuss the possibility of increasing of the suitability of milk as a raw material for cheese production through preservation of native properties of milk proteins, in the first place biologically complete whey proteins as well as the weight ratio of total and ionic calcium. For thermodynamic evaluation of the biosystem we used activation energy (Ea), chemical, physical and organoleptic characteristics. As a result: a methodology has been developed for determination of foodstuffs activation energy; it was determined that with increase in the proportion of the pectin introduced the activation energy and structuredness of the biosystem also increases, when the proportion of pectin is 0.5% the activation energy is 1.788 kJ/mol, when the proportion of pectin is 3% the activation energy is 2.241 kJ/mol, which means the increase by 25%; in the studied pasteurization standard, the maximum content of calcium is observed at 85oC and is equal to 133.8 mg%., in the control sample of milk the content of calcium is 130 mg%; addition of a complex food additive as a protector makes it possible to preserve native properties of the biosystem and guarantees formation of a denser protein coagulum which allows producing high-quality fermented milk products and cheeses
PHOTOELECTRIC PROPERTIES OF HETEROSTRUCTURES BASED ON PEPC AND MEH-PPV FILMS DOPED WITH ZINC OCTABUTYLPHTHALOCYANINE
Planar organic heterostructures were prepared using poly-N- epoxypropylcarbazole films and poly[2-methoxy-5-(2’-ethylhexyloxy)-1,4-phenylenevinylene] by the method of successive deposition adding 2,3,9,10,16,17,23,24-zinc octabutylphthalocyanine. Photoelectric, photodielectric and photovoltaic properties of the heterostructures were studied
Cisplatin and fluorouracil with or without panitumumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (SPECTRUM) : an open-label phase 3 randomised trial
Influence of Softening Temperature of Azobenzene Polymers and External Electric Field on Diffraction Efficiency of Polarization Holograms
Growth of the diffraction efficiency and recording velocity was found in the films of copolymers 4-((2- nitrophenyl) diazeniyl)phenylmethacrylate) with octylmethacrylate at room temperature holographic recording for copolymer with less softening temperature. Effect of strengthening of the diffraction efficiency was observed when charging surface of the films with recorded hologram in crown discharge