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Posted by Wimberly on 29.11.2016 20:54:57: erlotinib cns

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ТЕМА: Posted by Wimberly on 29.11.2016 20:54:57: erlotinib cns

Posted by Wimberly on 29.11.2016 20:54:57: erlotinib cns 7 года 5 мес. назад #929

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Simultaneous Determination of Celecoxib, Erlotinib, and its Metabolite Desmethyl-Erlotinib (OSI-420) in Rat Plasma by Liquid chromatography/Tandem Mass Spectrometry with Positive/Negative Ion-Switching Electrospray Ionisation.
It's not known whether Tarceva passes into breast milk. Don't breastfeed while taking this drug.
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Walleser S, Ray J, Bischoff H, Vergnenègre A, Rosery H, Chouaid C, et al . Maintenance erlotinib in advanced nonsmall cell lung cancer: Cost-effectiveness in EGFR wild-type across Europe. Clinicoecon Outcomes Res 2012;4:269-75.
There have been infrequent reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Tarceva for treatment of NSCLC, pancreatic cancer or other advanced solid tumors. In the pancreatic cancer trial, other serious adverse events associated with Tarceva plus gemcitabine and which may have included fatalities, were myocardial infarction/ischemia, cerebrovascular accident and microangiopathic hemolytic anemia with thrombocytopenia. When receiving Tarceva therapy, women should be advised against becoming pregnant or breastfeeding. Tarceva is pregnancy category D. The most common side effects in patients with NSCLC receiving Tarceva monotherapy 150 mg were rash and diarrhea. The most common side effects in patients with pancreatic cancer receiving Tarceva 100 mg plus gemcitabine were fatigue, rash, nausea, anorexia and diarrhea.
Tarceva is a once-daily, oral, non-chemotherapy treatment for the treatment of advanced or metastatic NSCLC. It has been shown to potently inhibit EGFR, a protein involved in the growth and development of cancers. Tarceva is a trademark of OSI Pharmaceuticals, LLC, a wholly owned subsidiary of Astellas Holding US Inc. a holding company owned by Astellas Pharma Inc.
If you experience any of the following serious side effects from erlotinib, contact your doctor immediately:
Erlotinib 100 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m^2 intravenous every 7 days during RT) and continuing daily through radiation
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Tarceva (erlotinib) Cancer de l'intestin
Side effects of Tarceva therapy for pancreatic cancer
Pulmonary toxicities have been infrequently reported in patients receiving erlotinib for the treatment of advanced solid tumours (8 ,10 –15 ). A double-blind, multicentre, randomized trial that was performed by National Cancer Institute of Canada Clinical Trials Group compared orally administered erlotinib (150 mg daily) with placebo. Patients with locally advanced or metastatic NSCLC after failure of at least one previous chemotherapy regimen were enrolled in this study. Overall, the incidence of ILD in this study was approximately 0.8%. Patients in the placebo group had a similar incidence of ILD. In this report, included cases were described in nonspecific terms, such as interstitial pneumonia, alveolitis, pneumonitis and pulmonary fibrosis (3 ). In a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced NSCLC (TRIBUTE), patients were randomly assigned to receive either a daily dose of 150 mg of erlotinib or a placebo concurrently with chemotherapy. There were five severe ILD cases in the erlotinib arm (1.0%), versus one ILD case in the placebo arm (0.2%). All six cases of ILD were fatal. The clinical presentation and the nature of these ILDs were not reported (12 ). Erlotinib treatment in the management of previously treated stage IIIB or IV NSCLC was evaluated in another randomized, placebo-controlled, double-blind trial (13 ). Patients were enrolled in the trial at least 21 days after chemotherapy and one week after radiotherapy. The patients were randomly assigned to the erlotinib arm (150 mg of erlotinib daily) or placebo arm. Three cases of pneumonitis were reported in each of the two groups (13 ). Risk factors for EGFR tyrosine kinase inhibitor-associated ILD are not well defined. Gefitinib is another EGFR tyrosine kinase inhibitor that has been used in the treatment of advanced NSCLC. A high incidence of ILD has been reported in Japan. In a study by Takano et al (14 ), pre-existing pulmonary fibrosis was a significant risk factor for gefitinib-associated ILD. It is not known whether this observation is also true for erlotinib-associated lung toxicity.
As for Avastin, I was referring to the ECOG 4599 trial, which randomized NSCLC patients (not EGFR mutants) to chemo with or without Avastin first-line, but also continued Avastin as maintenance therapy after finishing the chemo part. No one has even shown that Avastin maintenance is better than no Avastin maintenance, but it is part of the FDA label so it is commonly used for that purpose. I am not convinced that the maintenance portion has much benefit, but if it did then it could dilute any benefit from the Tarceva when the two are combined.
Now, to address the Tarceva sales question: There are approximately 100,000 non-small cell lung cancer patients in the U.S. who would conceivably be eligible for Tarceva therapy, based on this study. Banc of America Securities biotech analyst Mike King puts a $30,000 price tag on the drug and assumes that these patients survive about six months, which puts Tarceva peak sales around $1.5 billion. This, of course, assumes that every patient gets the drug, which never happens. It also assumes that Tarceva is priced at a healthy premium to AstraZeneca's ( AZN ) lung cancer drug, Iressa, its primary competitor.
According to the Mayo Clinic website, regarding Tarceva,if you miss a dose, take it as soon as possible HOWEVER, if it is almost time for the next dose, wait until it is time for the next dose. DO NOT double up doses. That is standard advice for most medications, in my experience. I doubt if missing a dose is serious. When filling a prescription, or when receiving medication from any source, ask for a monograph for that medication. (My pharmacy, CVS, attaches one to the package.) A monograph is a sheet(s) of paper with all the pertinent information about that medication, including the trade name, the generic name, (if available as a generic), what it is, what it does, and how to take it, as well as other information. It is a good idea to save and file all monographs that you receive, so that you have a reference file, especially in situation like the one in which you find yourself now. In cancer treatment, it is always a good idea to have hard copies of information/instructions on file. It sometimes becomes impossible to remember everything about the information you are receiving.
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3.5 Effects of erlotinib plus nicotine on signaling pathways in tumor tissues
5. Erlotinib Clinical applications
Inhibition of CIP2A determines erlotinib-induced apoptosis in hepatocellular carcinoma
18. ^ J Clin Invest. 2009 October 1; 119(10). Tang, Dual MET EGFR combinatorial inhibition against T790M-EGFR-mediated erlotinib-resistant lung cancer, Br J Cancer. 2008 September 16; 99(6)
you are allergic to any ingredient in erlotinib
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Iyer R, Bharthuar A. A review of erlotinib--an oral, selective epidermal growth factor receptor tyrosine kinase inhibitor. Expert Opin Pharmacother . 2010 Feb;11(2):311-20.
RAD001 (everolimus) was provided by The Novartis Institutes for BioMedical Research Basel, Oncology, Switzerland. Erlotinib was dissolved in DMSO and provided by Professor Thomas Grunt (Department of Medicine I, Institute of Cancer Research, Medical University of Vienna, Austria). Controls were treated with appropriate concentrations of DMSO.
Many clinical trial designs using one or more of these selectors as entry criteria are possible, and they are all valid because it is impossible to predict which combinations of selectors would be optimal in accurately identifying the population that would derive meaningful clinical benefit from front-line erlotinib. A very restrictive approach might result in a positive study, but at the price of excluding many patients that still could derive clinically relevant benefit. On the other hand, a less restrictive approach increases the risk of a negative study because patients that do not derive any benefit are included. Several studies that use positive or negative selection in front-line or adjuvant therapy using some of these selectors are being implemented: CALGB 30406 (nonsmokers), Spanish Lung Cancer Study Group (EGFR mutations; ref. 6 ), and the RADIANT adjuvant study (EGFR-positive status by IHC and FISH), among others.
In these circumstances, the PBAC determined the equi-effective doses as being erlotinib 150 mg daily, gefitinib 250 mg daily and afatinib 40 mg daily on the basis of the doses determined for their respective key trials without adjusting for any variations in dose intensity or treatment duration.
Poly-crystal L of erlotinib hydrochloride, preparation method and application thereof
The 2.23-month longer median time to BM in the patients administrating erlotinib failed to transfer into survival benefit in our study. Although BM occurrence largely shortened the survival of patients, subsequent treatments, including radiotherapy, systemic chemotherapy, and anti-EGFR treatment, succeeded in controlling BM to a certain extent. Disease progression in local disease and distant metastases other than brain also account for the balanced survival between two groups. Additionally, several randomized studies 13 ,22 –24 demonstrated that the first-line EGFR TKI resulted significant improvement in both disease response to treatment and progression-free survival than conventional platinum-based combined chemotherapy, but not in OS. The rather high proportion of patients in the chemotherapy arm crossing over to the EGFR TKI arm during disease progression provided the interpretation. Similarly in our study, 79 patients from the chemotherapy group took EGFR TKI orally after BM occurrence. The crossing over to erlotinib treatments makes the survival benefit not significant enough to be analyzed in statistics. Furthermore, for some patients in our study who died without BM occurrence, the 6.0-month time interval between median time to BM and median OS was shorter than the survival time after BM occurrence.
On June 1, 2016, the U. S. Food and Drug Administration approved cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.) using plasma specimens as a companion diagnostic test for the detection of exon 19 deletions or exon 21 (L858R) substitution mutations in the epidermal growth factor recptor (EGFR) gene to identify patients with metastatic non-small cell lung cancer (NSCLC) eligible for treatment with Tarceva® (erlotinib). The cobas EGFR Mutation Test v2 is already approved for this indication using formalin-fixed paraffin-embedded (FFPE) tissue specimens. The new use is for detection of these specific mutations in circulating-free tumor DNA (cfDNA) isolated from plasma specimens, also called liquid biopsy specimens, to aid physicians in identifying patients who may be treated first with TARCEVA (erlotinib). This is the first “liquid biopsy test” approved for use by FDA. This new test may benefit patients who may be too ill or are otherwise unable to provide a tumor specimen for EGFR testing. Patients positive by cobas EGFR Mutation Test v2 using plasma specimens for the presence of EGFR exon 19 deletions or L858R mutations are candidates for treatment with Tarceva (erlotinib). Patients who are negative by this test should undergo routine biopsy and testing for EGFR mutations with the FFPE tissue sample type.
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Over the past decade, the overwhelming majority of studies focused on elucidating the role of AXL in lung cancer have focused on the development of acquired resistance to TKI therapy. Recently, our laboratory along with two independent groups have shown that AXL inhibition can overcome acquired resistance to EGFR-targeted therapies in EGFR mutant lung cancer. In our study, we established multiple in vitro and in vivo erlotinib-resistant EGFR mutant lung cancer models and identified upregulation of AXL and an EMT phenotype to be associated with acquired resistance. Genetic and pharmacological inhibition of AXL restored sensitivity to erlotinib in TKI-resistant HCC827 lung adenocarcinoma cells. Consistent with our preclinical data, we revealed that 20% of EGFR mutant patient-derived tumors expressed higher levels of AXL upon acquiring resistance to erlotinib as compared to paired pretreatment samples. 35 Recently, independent evaluation of 26 additional paired pretreatment EGFR mutant tumors that initially responded to gefitinib and subsequently acquired resistance in the Korean population revealed an increase in AXL expression in 19% (5/26) of patients. 36
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Abb. 4 Overall Survival ab Erlotinib-Therapie, nach Rash, nur Drittlinientherapie. Auch bei Reduktion auf die Patienten, die Erlotinib in der dritten Therapielinie erhielten, haben Patienten mit mittelgradigem Rash die beste Prognose. n = Anzahl, verst. = verstorben.
The serum concentration of Erlotinib can be decreased when it is combined with Dabrafenib.
PK profile of erlotinib [ Time Frame: Predose and postdose on Days 1 and 15 ] [ Designated as safety issue: No ]
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erlotinib has not had very much success in ovarian cancer. most cancers do not carry the EGFR mutation. Also if you have a bowel obstruction, an oral agent is unlikely to be well absorbed however, alot of our therapy for women with ovarian cancer is empirical. We try something and see if it helps commonly even if there is not alot of biological information. This is one of the ways we fight for our patients.
Takeda M, Okamoto I, Fukuoka M, Nakagawa K: Successful Treatment With Erlotinib After Gefitinib-Related Severe Hepatotoxicity. J Clin Oncol. 2010, 28 (17): E273-E274. 10.1200/JCO.2009.26.5496. View Article PubMed Google Scholar
Tarceva (erlotinib): "My mother was diagnosed with lung Cancer May 2012. Due to her cancer she got a disability in her left leg she had one dose of radiation and since November she has been on the Tarceva tablet, since then she has been doing really well. Her reports have shown that the cancer has reduced and apart from rash she doesn't get any other side effects. Hope all you cancer suffers get well and God give you the power to fight it."
Since the MTT assay results can not be used as a direct evidence of MRP7-mediated drug transport, we determined the effect of lapatinib and erlotinib on the accumulation and efflux of [ 3 H]-paclitaxel, a known chemotherapeutic substrate of MRP7 transporter, in HEK293-pcDNA3.1 and HEK-MRP7-2 cells [31 ]. In our experiments, both lapatinib and erlotinib at 2.5 μM significantly increased the intracellular concentration of [ 3 H]-paclitaxel, and decreased the intracellular [ 3 H]-paclitaxel efflux from the HEK-MRP7-2 cells but not in parental HEK293-pcDNA3.1 cells. The reversal effect of lapatinib was similar to a known MRP7 inhibitor cepharanthine [33 ]. This suggests that lapatinib and erlotinib modulate MRP7-mediated MDR by increasing intracellular drug accumulation through inhibiting drug efflux function of MRP7.
During the Phase II portion of the study, half of the participants will not start receiving erlotinib hydrochloride until Day 8 of Cycle 1 (+/- 1 day). Every odd-numbered participant (1, 3, 5, and so on) enrolled in Phase II will receive this delayed schedule for erlotinib hydrochloride.
Erlotinib/Gemcitabine for First-Line Treatment of Locally Advanced or Metastatic Adenocarcinoma of the Pancreas