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Posted by Roderickon 28.11.2016 16:35:48: tarceva low dose

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ТЕМА: Posted by Roderickon 28.11.2016 16:35:48: tarceva low dose

Posted by Roderickon 28.11.2016 16:35:48: tarceva low dose 8 года 4 мес. назад #892

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Nineteen patients received erlotinib during the extended treatment phase. The only grade 3 or 4 erlotinib-related event during this period was dermatitis acneiform in a patient receiving 350 mg. Erlotinib was temporarily withheld and restarted at a reduced dose. In addition, a patient on 300 mg discontinued due to grade 1 nausea deemed related to erlotinib (in conjunction with unrelated dizziness). Otherwise the most frequent cause of discontinuation was disease progression (14 of 22; 64%). One patient remained on treatment at 300 mg at the time of data cutoff.
Overall survival in the SATURN study was significantly longer with erlotinib than with placebo in the intent-to-treat population, in patients with EGFR immunohistochemistry-positive tumors, and in patients with wild-type EGFR tumors. Median overall survival had not yet been reached in patients with tumors bearing EGFR-activating mutations.
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Table 6: Tarceva, Liver Cancer, The US, Estimated Sales ($m), 2013-2020
Trastornos oculares: Se han registrado frecuentemente queratitis en los ensayos clínicos de TARCEVA. La conjuntivitis ha sido frecuente en los estudios de cáncer de páncreas.
Hepatic failure and hepatorenal syndrome, including fatal cases, can occur with Tarceva treatment in patients with normal hepatic function; the risk of hepatic toxicity is increased in patients with baseline hepatic impairment [see Warnings and Precautions (5.3 ), Adverse Reactions (6.1. 6.2 ), and Dosage and Administration (2.4 )] .
Level 1. erlotinib 100 mg/day from day -7 to the time of completion of 10 fractions of cranial irradiation, followed by 150 mg/day until disease progression or toxicity
Il trattamento con Tarceva deve essere effettuato sotto la supervisione di un medico esperto nell’impiego di terapie antineoplastiche. Pazienti con carcinoma Polmonare Non a Piccole Cellule . Prima di inziare la terapia con Tarceva in pazienti chemio–naive con NSCLC avanzato o metestatico deve essere effettuato il test della mutazione EGFR. La dose giornaliera raccomandata di Tarceva è di 150 mg da assumere almeno un’ora prima o due ore dopo l’assunzione di cibo. Pazienti con carcinoma pancreatico . La dose giornaliera raccomandata di Tarceva è di 100 mg da assumere almeno un’ora prima o due ore dopo l’assunzione di cibo, in associazione con gemcitabina (vedere il Riassunto delle Caratteristiche del Prodotto della gemcitabina nell’indicazione del carcinoma pancreatico). In pazienti in cui non si sviluppa un rash cutaneo nelle prime 4–8 settimane di terapia deve essere rivalutato se continuare il trattamento con Tarceva (vedere paragrafo 5.1). Qualora fosse necessario modificare la dose, deve essere ridotta di 50 mg per volta (vedere paragrafo 4.4). Tarceva è disponibile nei dosaggi da 25 mg, 100 mg e 150 mg. L’uso concomitante di substrati e modulatori del CYP3A4 può rendere necessaria una modifica della posologia (vedere paragrafo 4.5). Pazienti con insufficienza epatica . l’eliminazione di erlotinib avviene attraverso il metabolismo epatico e l’escrezione biliare. Sebbene l’esposizione a erlotinib sia risultata simile in pazienti con moderata compromissione della funzione epatica (punteggio di Child–Pugh di 7–9) e in pazienti con funzione epatica adeguata, si deve procedere con cautela nel somministrare Tarceva a pazienti con insufficienza epatica. Se si verificano reazioni avverse gravi, si deve considerare una riduzione del dosaggio o l’interruzione del trattamento con Tarceva. La sicurezza e l’efficacia di erlotinib non sono state studiate in pazienti con disfunzione epatica grave (AST/SGOT e ALT/SGPT > 5 x ULN). Non è raccomandato l’impiego di Tarceva in pazienti affetti da grave disfunzione epatica (vedere paragrafo 5.2). Pazienti con insufficienza renale . la sicurezza e l’efficacia di erlotinib non sono state studiate in pazienti con insufficienza renale (creatininemia >1,5 volte il limite superiore del valore normale). Sulla base dei dati di farmacocinetica, nei pazienti con insufficienza renale lieve o moderata non è necessario modificare la posologia (vedere paragrafo 5.2). Non è raccomandato l’impiego di Tarceva in pazienti affetti da grave insufficienza renale. Popolazione pediatrica . la sicurezza e l’efficacia di erlotinib in pazienti di età inferiore a 18 anni non sono state stabilite. Non è raccomandato l’impiego di Tarceva in pazienti pediatrici. Fumatori . è stato dimostrato che il fumo di sigaretta riduce l’esposizione a erlotinib del 50–60 %. La dose massima tollerata di Tarceva nei pazienti con NSCLC che fumano sigarette è risultata pari a 300 mg. L’efficacia e la sicurezza a lungo termine di una dose più elevata rispetto a quelle iniziali raccomandate, non sono state determinate nei pazienti che continuano a fumare (vedere paragrafi 4.5 e 5.2). Pertanto, ai fumatori si deve raccomandare di smettere di fumare, perché le concentrazioni plasmatiche di erlotinib nei fumatori sono ridotte rispetto a quelle dei non fumatori.
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Age of people who have Fatigue when taking Tarceva *:
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ERLOTINIB HYDROCHLORIDE ERLOTINIB HYDROCHLORIDE Also known as Tarceva, CP-358774, OSI-774, NSC-718781 is a HCL salt with IC50 of 2 nM for HER1/EGFR TK. Unit: Each (500mg) This listing is for Each (500mg)
Erlotinib is a drug used in the treatment of cancer diseases, in particular for lung and pancreatic cancer. Erlotinib is an inhibitor of the tyrosine kinase receptor, acting in particular by inhibiting the EGF receptor, the epidermal growth factor receptor; in cancer there is the over-expression of growth factor receptors and related ligands. These are, in fact, some of the factors involved in processes of cancer etiopathogenesis. The stimulation of the growth factors leads to an increase of the cell proliferation with the consequent starting of the disease. The receptors, once bound the ligand, self-phosphorylate so generating a cascade of intracellular reactions that lead to the activation of transcription factors involved in the cell proliferation. Erlotinib binds itself to the intracellular catalytic portion of the receptor miming the ATP structure, but being more stable than that, they bind to the receptor and inhibit it. Therefore the activation of the cell reactions is not allowed, so blocking the cell expansion.
Erlotinib in advanced non-small cell lung cancer: efficacy and safety findings of the global phase IV Tarceva Lung Cancer Survival Treatment study. www.ncbi.nlm.nih.gov/pubmed/20736854 .
45. The process as claimed in claim 44, wherein the erlotinib hydrochloride crystalline particles having mean particle size (D 50 ) ranging from about 4.6 μm to 9.5 μm and 90 volume-% of the particles (D 90 ) ranging from about 14.6 μm to 24.5 μm.
The most common adverse reactions in patients receiving single-agent erlotinib 150 mg were rash and diarrhea. Grade 3/4 rash and diarrhea occurred in 6.0% and 1.8%, respectively, in erlotinib-treated patients. Rash and diarrhea resulted in study discontinuation in 1.2% and 0.5% of erlotinib-treated patients, respectively. Dose reduction or interruption for rash and diarrhea was needed in 5.1% and 2.8% of patients, respectively. In erlotinib-treated patients who developed rash, the onset was within two weeks in 66% and within one month in 81%.
Although both agents have similar structures and exemplify similar efficacy, there is a paucity of comparative data on the efficacy and safety of gefitinib and erlotinib in advanced NSCLC patients with EGFR mutation. Previously, we have reported that two agents showed similar outcomes in terms of response rate, disease control rate, PFS, and overall survival (OS) in unselected patients with advanced NSCLC in whom prior platinum-based chemotherapy was failed. 11 Another prospective, randomized phase II study demonstrated that both TKIs were effective in antitumor activity with similar tolerable toxicity profiles as second-line treatment for a clinically selected population of NSCLC. 12
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13. Erlotinib maleate monohydrate of Formula II.
Experimental: A: Erlotinib
Effect of erlotinib and pertuzumab on growth of a human NSCLC tumor xenograft model. Calu-3 cells were suspended in PBS and implanted s.c. (right flank) on anesthetized BALB/c nu/nu mice. Tumors were allowed to establish growth after implantation before initiation of treatment. Vehicle, erlotinib (50 mg/kg/d, orally), pertuzumab (12 mg/kg loading dose, then 6 mg/kg i.p. once weekly), or erlotinib with pertuzumab was administered for the duration of the study. Points, mean tumor volume (mm 3 ); bars, SE ( n = 12 mice per group).
To determine if Axl-dependent ER might be clinically relevant, the authors asked if Axl overexpression could be detected in NSCLC patients with acquired ER. 7 Axl expression was assessed by immunohistochemistry in 35 EGF R-mutant NSCLC specimens from individuals before treatment with erlotinib or gefitinib. another TKI, and then after acquisition of TKI resistance. Axl expression levels were at least two-fold higher in seven out of 35 TKI-resistant specimens compared to pre-treatment specimens. This suggested that overexpression of Axl may be important for ER acquisition in some NSCLC patients.
erlotinib versus standard chemotherapy as first-line treatment for european patients with advanced egfr mutation-positive non-small-cell lung cancer (eurtac) a multicentre, open-label, randomised phase 3 trial
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AZD9291 Versus Gefitinib or Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA)
Adverse events or serious adverse events after afatinib/erlotinib
Dose interruptions and reductions were allowed for erlotinib. Specifically, for grade 2 skin rashes, the dose was held until the rash resolved to grade 0 to 1; a dose reduction was not automatically mandated for the first grade 2 rash. Recurrent or intolerable grade 2 rashes required dose reduction by one level. Grade 3 rashes required dose reduction by one level, and the dose was held until resolution to grade 0 to 1. The first reduction was to 100 mg/d for adverse events, and a second reduction to 50 mg/d was allowed. If patients experienced additional toxicity at 50 mg/d, therapy was discontinued and the patient was taken off study.
In recent years, EGFR inhibitors and rapamycin analogues have been extensively tested against human solid tumors. Each class of agent has been found to be well tolerated and to produce clinical benefit in a wide range of tumor types. However, responses are typically seen only in a minority of patients and are often of short duration. Given the known interactions between signaling pathways downstream from EGFR and mTOR, we hypothesized that the combination of rapamycin plus erlotinib would show additive or synergistic effects in vivo and tested this in a series of human cervical squamous cell carcinoma cell lines. All three cell lines responded to rapamycin and erlotinib treatment in vitro with reduced phosphorylated S6 and phosphorylated ERK, respectively. SiHa and Me180 xenografts both showed enhanced tumor growth delay with the drug combination, associated with effects on signaling pathways that are consistent with our hypothesis.
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Phase I/II Study of HSP90 Inhibitor AUY922 and Erlotinib for EGFR -Mutant Lung Cancer With Acquired Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors
Consistent with the microarray data, we found increased levels of AXL and phosphorylated (p) AXL proteins in representative resistant HCC827 tumor xenografts at each dose of erlotinib compared with vehicle-treated tumors ( Figure 2a ). We did not find alterations in the levels of IGF-1R . pIGF-1R, or Ras in the erlotinib resistant tumors ( Figure 2a ). In contrast, we observed decreased levels of pEGFR, pErbB3, and pMET in response to erlotinib treatment both in sensitive tumors harvested at 48h of treatment ( Figure 2b ) and in resistant tumors at each dose of erlotinib compared to vehicle treated tumors ( Figure 2a ). Erlotinib treatment for 48h decreased pAKT, pERK, and pRelA and increased Parp cleavage in sensitive tumors (a marker of apoptosis) ( Figure 2b ) but pAKT, pERK, pRelA levels were maintained in each tumor with acquired erlotinib resistance ( Figure 2a ). Furthermore, we observed increased expression of the EMT marker vimentin in several erlotinib-resistant tumors ( Figure 2a ). These data suggest that AXL upregulation may activate AKT, MAPK or NF-kB signaling to promote resistance to erlotinib treatment in EGFR -mutant NSCLCs perhaps in association with an EMT.
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Tarceva™—Forging the Way Many of these novel anti-cancer drugs are designed to target growth-regulating genes that can cause cancer when they are either over-expressed or mutated in cancer cells. One of the most important of these oncogenes is the epidermal growth factor receptor (HER1/EGFR). HER1/EGFR is mutated or over-expressed in a variety of tumor types that impact a significant number of the approximately 1.3 million patients newly diagnosed with cancer in the United States each year.
References 1) Michaud DS. 2004. Epidemiology of pancreatic cancer Minerva Chir. Apr; 59(2):99-111 2) Moore MJ, Goldstein D, Hamm J, et al. Erlotinib plus gemcitabine compared to gemcitabine alone in patients with advanced pancreatic cancer. A Phase III trial of the National Cancer Institute of Canada Clinical Trials Group [NCIC-CTG]. (Abstract #1, ASCO 2005) 3) Ferlay J et al. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No. 5, Version 2.0, Lyon; IARC Press 2004
Dealing with Tarceva Side Effects: How to Treat a Scalp Rash
Trastornos respiratorios, torácicos y mediastínicos : Han sido infrecuentes los casos de episodios similares a la EPI (incluidos los mortales) en pacientes que recibían TARCEVA como tratamiento del cáncer pulmonar de células no pequeñas y otros tumores sólidos avanzados (ver Precauciones generales).
The international study was a multi-center, double-blind, placebo-controlled Phase III trial evaluating Tarceva in patients with locally advanced or metastatic pancreatic cancer. The study randomized 569 patients to receive either gemcitabine plus concurrent Tarceva or gemcitabine plus placebo.
Rare side effects are those that occur in 0.01–0.1% of people given Tarceva. These include:
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