T Ciuleanu

Iuliu Haţieganu University of Medicine and Pharmacy, Klausenburg, Cluj, Romania

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Publications (53)242.57 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Background:This phase II, open-label, randomised study evaluated whether patients with metastatic pancreatic cancer receiving erlotinib/gemcitabine derived survival benefits from increasing the erlotinib dose.Methods:After a 4-week run-in period (gemcitabine 1000 mg m(-2) once weekly plus erlotinib 100 mg per day), patients with metastatic pancreatic cancer who developed grade 0/1 rash were randomised to receive gemcitabine plus erlotinib dose escalation (150 mg, increasing by 50 mg every 2 weeks (maximum 250 mg); n=71) or gemcitabine plus standard-dose erlotinib (100 mg per day; n=75). The primary end point was to determine whether overall survival (OS) was improved by increasing the erlotinib dose. Secondary end points included progression-free survival (PFS), incidence of grade ⩾2 rash, and safety.Results:Erlotinib dose escalation induced grade ⩾2 rash in 29 out of 71 (41.4%) patients compared with 7 out of 75 (9.3%) patients on standard dose. Efficacy was not significantly different in the dose-escalation arm compared with the standard-dose arm (OS: median 7.0 vs 8.4 months, respectively, hazard ratio (HR), 1.26, 95% confidence interval (CI): 0.88-1.80; P=0.2026; PFS: median 3.5 vs 4.5 months, respectively, HR, 1.09, 95% CI: 0.77-1.54; P=0.6298). Incidence of adverse events was comparable between randomised arms.Conclusion:The erlotinib dose-escalation strategy induced rash in some patients; there was no evidence that the higher dose translated into increased benefit.British Journal of Cancer advance online publication, 23 September 2014. doi:10.1038/bjc.2014.494 www.bjcancer.com.
    British Journal of Cancer 09/2014; DOI:10.1038/bjc.2014.494 · 4.82 Impact Factor
  • 39th ESMO Congress (ESMO); 09/2014
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    ABSTRACT: Cancer of unknown primary origin (CUP) had a poor prognosis, determined by clinico-histological characteristics, partly due to the lack of insights on its biology. We screened tumour DNA from 87 patients with CUP for CTNNB1 (coding exons 2,3,4,5), MET (coding exon 18), PIK3CA (coding exons 9,20), KRAS (coding exons 1,2), BRAF (coding exon 15) gene mutations by using dd-sequencing and evaluated their impact on prognosis. Mutated gene incidences in the 87 CUP cases were: KRAS 11 (12.6 %), BRAF 5 (5.7 %), PIK3CA 8 (9 %), MET 6 (6.7 %) and CTNNB1 18 (20.7 %). Several mutations in the KRAS gene were not the commonly encountered mutations in other solid tumours. Activating mutations were observed in 10.2 % in KRAS, 4.5 % in BRAF, 6.6 % in PIK3CA, 4.5 % in MET, and 19.5 % in CTNNB1. Activating mutations in PIK3CA coding exon 9 were inversely correlated with MET coding exon 18 activating mutations (p = 0.036). MET activating mutations were prognostic for poor Progression-Free Survival (median PFS 5 vs 9 months, p = 0.009) and Overall Survival (median OS 7 vs 20 months, p = 0.005). The complex profile of either CTNNB1 or MET mutations also had an adverse prognostic significance (median OS 11 vs 21 months, p = 0.015). No other gene mutation exhibited prognostic significance. In multivariate analysis, poor performance status, male gender, visceral disease and adenocarcinoma histology, but not gene mutations, were independently associated with poor patient outcome. CTNNB1 gene mutations are frequent, and along with MET mutations have an adverse prognostic effect in patients with CUP.
    Clinical and Experimental Metastasis 07/2014; 31(7). DOI:10.1007/s10585-014-9666-1 · 3.73 Impact Factor
  • Annals of Oncology 06/2014; 25(suppl 2):ii5. DOI:10.1093/annonc/mdu164.2 · 6.58 Impact Factor
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    ABSTRACT: Background:Phase-IV, open-label, single-arm study (NCT01203917) to assess efficacy and safety/tolerability of first-line gefitinib in Caucasian patients with stage IIIA/B/IV, epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC).Methods:Treatment: gefitinib 250 mg day(-1) until progression. Primary endpoint: objective response rate (ORR). Secondary endpoints: disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety/tolerability. Pre-planned exploratory objective: EGFR mutation analysis in matched tumour and plasma samples.Results:Of 1060 screened patients with NSCLC (859 known mutation status; 118 positive, mutation frequency 14%), 106 with EGFR sensitising mutations were enrolled (female 70.8%; adenocarcinoma 97.2%; never-smoker 64.2%). At data cutoff: ORR 69.8% (95% confidence interval (CI) 60.5-77.7), DCR 90.6% (95% CI 83.5-94.8), median PFS 9.7 months (95% CI 8.5-11.0), median OS 19.2 months (95% CI 17.0-NC; 27% maturity). Most common adverse events (AEs; any grade): rash (44.9%), diarrhoea (30.8%); CTC (Common Toxicity Criteria) grade 3/4 AEs: 15%; SAEs: 19%. Baseline plasma 1 samples were available in 803 patients (784 known mutation status; 82 positive; mutation frequency 10%). Plasma 1 EGFR mutation test sensitivity: 65.7% (95% CI 55.8-74.7).Conclusion:First-line gefitinib was effective and well tolerated in Caucasian patients with EGFR mutation-positive NSCLC. Plasma samples could be considered for mutation analysis if tumour tissue is unavailable.British Journal of Cancer advance online publication, 21 November 2013; doi:10.1038/bjc.2013.721 www.bjcancer.com.
    British Journal of Cancer 11/2013; 110(1). DOI:10.1038/bjc.2013.721 · 4.82 Impact Factor
  • Value in Health 11/2013; 16(7):A411-A412. DOI:10.1016/j.jval.2013.08.509 · 2.89 Impact Factor
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    ABSTRACT: Molecularly targeted agents for non-small cell lung cancer (NSCLC) can provide similar efficacy to chemotherapy without chemotherapy-associated toxicities. Combining two agents with different modes of action could further increase the efficacy of these therapies. The TASK study evaluated the efficacy and safety of the epidermal growth factor receptor tyrosine kinase inhibitor erlotinib in combination with the anti-angiogenic agent bevacizumab as first-line therapy in unselected, advanced non-squamous NSCLC patients.
    Lung cancer (Amsterdam, Netherlands) 08/2013; 82(2). DOI:10.1016/j.lungcan.2013.08.002 · 3.74 Impact Factor
  • Lung Cancer 05/2013; 80:S31. DOI:10.1016/S0169-5002(13)70288-5 · 3.74 Impact Factor
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    ABSTRACT: Background: AGI004 is a controlled-release transdermal patch preparation of mecamylamine. We conducted a randomised placebo-controlled phase II study of two dose levels of AGI004 in chemotherapy-induced diarrhoea (CID). Methods: Adult patients receiving chemotherapy who had experienced diarrhoea (NCI grade 1–2) during previous cycles of chemotherapy were eligible. In all, 64 patients were randomised to receive AGI004 4 mg then 8 mg per 24 h transdermal patch or placebo for two sequential cycles of chemotherapy. Patients' severity of diarrhoea was physician-assessed using NCI grade of diarrhoea and patient-assessed using information recorded in daily diaries of bowel movements. Results: Overall AGI004 doubled the odds of a response to treatment on the first day of chemotherapy based on physician assessment of NCI grade of diarrhoea compared with placebo (odds ratio=2.0, 90% confidence interval: 0.9–4.5) and there was a trend to improved response rates for AGI004 for the full treatment cycle although these results were not statistically significant. There was also evidence of significantly improved response rates based on patient assessment of diarrhoea both overall (P=0.05) and at the 8-mg dose level (P=0.02) compared with placebo. Conclusion: AGI004 demonstrated effectiveness in reducing chemotherapy-associated diarrhoea, with results suggesting response across multiple measurements of diarrhoea. Treatment was well tolerated with no drug-related adverse events. Further evaluation of this agent in the management of CID is warranted.
    British Journal of Cancer 03/2013; 108(5). DOI:10.1038/bjc.2013.35 · 4.82 Impact Factor
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    ABSTRACT: Boala neoplazică reprezintă o problemă de sănătate publică mondială, fiind a doua cauză de deces, după bolile cardio-vasculare. În anul 2000 pe plan mondial s-au înregistrat 10 milioane de cazuri noi şi 6 milioane de decese prin cancer (1). Incidenţa cancerului arată o tendinţă de creştere continuă, astfel încât se prevede că, în anul 2020 numărul cazurilor nou diagnosticate în întreaga lume să crească cu 1,5 milioane, iar boala neoplazică să devină principala cauză de deces în ţările dezvoltate. În ultimele decenii s-a înregistrat îmbunătăţirea supravieţuirii la cinci ani a bolnavilor neoplazici, de la 40% în 1960, la 60% în anii 2000 (1), astfel încât se poate afirma că pentru o parte din bolnavi, cancerul a devenit o boală curabilă, iar pentru alţii o boală cronică, motiv pentru care atenţia se îndreaptă în zilele noastre spre cunoaşterea şi încercarea de a preveni efectele adverse ale tratamentelor antitumorale, mai ales a celor induse de chimioterapie.
    1 edited by Risoprint Cluj, 01/2013; Risoprint., ISBN: ISBN 978-973-53-1055-4
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    ABSTRACT: Background Hypothesising that cancer of unknown primary (CUP) may harbour unique characteristics, we present a translational study of the immunohistochemical expression and clinical correlation of key PTEN/AKT pathway molecules. Patients and methods We collected 100 paraffin-embedded CUP tissue blocks. We studied using tissue microarrays the expression of PTEN, phospho-AKT, Cyclin D1, p21, phospho-RPS6. From the percentage of staining tumour cells and the literature, we selected cut-offs to classify the expression of each biomolecule. We correlated IHC expression with clinical data. Results PTEN, pAKT, and pRPS6 showed frequent expression. At univariate analysis, high IHC expression of pAKT and pRPS6 displayed statistically significant association with worse survival. Prognosis was worse upon concurrent high IHC expression of pMAPK and pAKT {median overall survival = 8 months [95% confidence interval (CI) 5.3-10.7] versus 17 months [95% CI 13.1-20.9]}. In multivariate analysis, high p21 was associated with better survival (risk ratio [RR] = 0.34 [95% CI 0.16-0.73], P = 0.005). High expression of pAKT (RR = 2.39 [95% CI 1.23-4.66], P = 0.01) or pRPS6 (RR = 2.76 [95% CI 1.31-5.84], P = 0.008) was associated with worse survival. Conclusions p21 expression conferred favourable prognosis, while high pAKT or pRPS6 expression predicted worse prognosis. Concurrent MAPK and pAKT expression had a marked adverse impact on survival.
    Annals of Oncology 05/2012; 23(10):2725-30. DOI:10.1093/annonc/mds097 · 6.58 Impact Factor
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    ABSTRACT: Clinical results of a randomized phase III trial comparing pemetrexed-carboplatin (PC) with etoposide-carboplatin (EC) in chemonaive patients with extensive-stage disease small-cell lung cancer (ED-SCLC) resulted in trial closure for futility; biomarker analyses using immunohistochemistry (IHC) and single-nucleotide polymorphisms (SNPs) are described herein. Thymidylate synthase (TS), excision repair cross complementing-1 (ERCC1), glycinamide ribonucleotide formyltransferase (GARFT), and folylpolyglutamate synthetase (FPGS) were investigated using IHC (n=395). SNPs were genotyped for TS, FPGS, γ-glutamyl hydrolase (GGH), methylenetetrahydrofolate reductase (MTHFR), folate receptor-α FR-α, and solute carrier 19A1 (SLC19A1; n=611). None of the IHC biomarkers (folate pathway or ERCC1) were found to be predictive or prognostic in this setting. rs2838952 (adjacent to SLC19A1) had significant treatment-independent association with overall survival (OS; hazard ratio 0.590, P=0.01). Nine GGH-associated SNPs interacted with rs3788205 (SLC19A1) for OS on the PC arm. rs12379987 (FPGS) interacted with treatment for OS (interaction P=0.036). Potential ERCC1 and folate pathway IHC biomarkers failed to predict outcome in either study arm in ED-SCLC. SNPs in regions including FPGS and SLC19A1 and interacting SNPs in GGH and SLC19A1 were associated with differences in OS; however, none of these SNPs predicted for greater survival with PC over EC.
    Annals of Oncology 12/2011; 23(7):1723-9. DOI:10.1093/annonc/mdr563 · 6.58 Impact Factor
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    ABSTRACT: The current third consensus on the systemic treatment of non-small-cell lung cancer (NSCLC) builds upon and updates similar publications on the subject by the Central European Cooperative Oncology Group (CECOG), which has published such consensus statements in the years 2002 and 2005 (Zielinski CC, Beinert T, Crawford J et al. Consensus on medical treatment of non-small-cell lung cancer--update 2004. Lung Cancer 2005; 50: 129-137). The principle of all CECOG consensus is such that evidence-based recommendations for state-of-the-art treatment are given upon which all participants and authors of the manuscript have to agree (Beslija S, Bonneterre J, Burstein HJ et al. Third consensus on medical treatment of metastatic breast cancer. Ann Oncol 2009; 20 (11): 1771-1785). This is of particular importance in diseases in which treatment options depend on very particular clinical and biologic variables (Zielinski CC, Beinert T, Crawford J et al. Consensus on medical treatment of non-small-cell lung cancer--update 2004. Lung Cancer 2005; 50: 129-137; Beslija S, Bonneterre J, Burstein HJ et al. Third consensus on medical treatment of metastatic breast cancer. Ann Oncol 2009; 20 (11): 1771-1785). Since the publication of the last CECOG consensus on the medical treatment of NSCLC, a series of diagnostic tools for the characterization of biomarkers for personalized therapy for NSCLC as well as therapeutic options including adjuvant treatment, targeted therapy, and maintenance treatment have emerged and strongly influenced the field. Thus, the present third consensus was generated that not only readdresses previous disease-related issues but also expands toward recent developments in the management of NSCLC. It is the aim of the present consensus to summarize minimal quality-oriented requirements for individual patients with NSCLC in its various stages based upon levels of evidence in the light of a rapidly expanding array of individual therapeutic options.
    Annals of Oncology 09/2011; 23(5):1223-9. DOI:10.1093/annonc/mdr381 · 6.58 Impact Factor
  • European Journal of Cancer 09/2011; 47. DOI:10.1016/S0959-8049(11)70943-1 · 4.82 Impact Factor
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    ABSTRACT: In the placebo-controlled phase III SATURN study, maintenance erlotinib after first-line chemotherapy demonstrated significantly prolonged progression-free survival (PFS) and overall survival (OS) in the overall study population of patients with advanced non-small-cell lung cancer (NSCLC). After four cycles of platinum-based doublet chemotherapy, patients without progressive disease (PD) were randomised to erlotinib (150 mg/day) or placebo until PD or unacceptable toxicity. In this pre-planned analysis, data are assessed according to response to first-line chemotherapy (complete/partial response [CR/PR] or stable disease [SD]). Following first-line chemotherapy, 889 non-PD patients were included in the intention-to-treat population (55% SD; 44% CR/PR; <1% unknown response). Erlotinib maintenance therapy significantly prolonged PFS in both the SD (hazard ratio [HR] = 0.68; P < 0.0001) and CR/PR (HR = 0.74; P = 0.0059) groups, while OS was significantly prolonged in the SD group only (HR = 0.72; P = 0.0019). The erlotinib-related OS benefit in the SD group remained significant across subgroups, irrespective of tumour histology and/or EGFR mutation status. The incidence of adverse events was similar in the SD group and the overall population, and erlotinib treatment did not negatively impact quality of life. Patients with advanced NSCLC and SD following first-line platinum-based doublet chemotherapy derive a significant OS benefit from maintenance erlotinib therapy.
    Annals of Oncology 05/2011; 23(2):388-94. DOI:10.1093/annonc/mdr125 · 6.58 Impact Factor
  • Radiotherapy and Oncology 05/2011; 99. DOI:10.1016/S0167-8140(11)70400-5 · 4.86 Impact Factor
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    ABSTRACT: Concomitant administration of radiation therapy (RT) and chemotherapy with cisplatin (CCRT) is considered standard treatment in patients with locally advanced nasopharyngeal cancer (LA-NPC). The role of induction chemotherapy (IC) when followed by CCRT in improving locoregional control remains controversial. Totally, 141 eligible patients with LA-NPC were randomized to either three cycles of IC with cisplatin 75 mg/m(2), epirubicin 75 mg/m(2) and paclitaxel (Taxol) 175 mg/m(2) (CEP) every 3 weeks followed by definitive RT (70 Gy) and concomitant weekly infusion of cisplatin 40 mg/m(2) (investigational arm, 72 patients) or to the same CCRT regimen alone (control arm, 69 patients). Sixty-two patients (86%) received three cycles of IC. No difference between the arms was observed in the number of patients who completed RT (61 versus 64, P = 018). Overall and complete response rates were very similar in the two arms and so were 3-year progression-free and overall survival rates. Grade III or IV toxic effects from IC were infrequent, apart of alopecia. Mucositis, weight loss and leukopenia were the most prominent side-effects from CCRT. IC with three cycles of CEP when followed by CCRT did not significantly improve response rates and/or survival compared with that of CCRT alone.
    Annals of Oncology 04/2011; 23(2):427-35. DOI:10.1093/annonc/mdr116 · 6.58 Impact Factor
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    ABSTRACT: Background: Erlotinib, docetaxel and pemetrexed are all approved in the second-line setting for patients with advanced NSCLC who progress following first-line platinum doublet chemotherapy (PDC), but head-to-head data from large clinical trials are limited. The multicentre, international, open-label, phase III TITAN study investigated the efficacy and tolerability of erlotinib versus chemotherapy (docetaxel or pemetrexed) as second-line therapy for NSCLC after rapid progression on first-line PDC. Methods: A total of 2,590 chemonaïve patients with advanced NSCLC received up to 4 cycles of first-line PDC. Patients with controlled disease were offered entry into the SATURN phase III study of maintenance erlotinib; those with disease progression during or upon completion of PDC were offered entry into TITAN (n=424). Patients in TITAN were stratified by stage, Eastern Cooperative Oncology Group performance status, smoking history and region, and were randomised (1:1) to receive erlotinib 150mg/day or chemotherapy (either docetaxel or pemetrexed, investigators' choice; standard regimens), until toxicity or progression. Overall survival (OS) was the primary endpoint. Secondary endpoints included progression-free survival (PFS), overall response rate (ORR), biomarker analyses and safety. Results: Baseline characteristics were balanced between the two arms and the full analysis population comprised 203 patients for erlotinib and 221 for chemotherapy (116 for docetaxel and 105 for pemetrexed). No significant difference in OS was seen between arms: hazard ratio (HR)=0.96 (95% confidence interval [CI]: 0.78–1.19; log-rank p=0.73; median 5.3 months with erlotinib vs 5.5 months with chemotherapy). Similarly, no significant difference was seen in PFS: HR=1.19 (95% CI: 0.97–1.46; log-rank p=0.09; median 6.3 weeks with erlotinib vs 8.6 weeks with chemotherapy). Subgroup analyses will be presented. ORR was 7.9% with erlotinib vs 6.3% with chemotherapy. More treatment-related adverse events (AEs) were seen with erlotinib (AEs; 58.2% vs 40.8% with chemotherapy), mostly grade 1/2 rash or diarrhoea. Grade 5 AEs were rare with erlotinib (1.5% vs 5.2% of patients on chemotherapy). Serious treatment-related AEs were seen in 1% of patients in the erlotinib arm vs 6.6% of those in the chemotherapy arm; withdrawal due to AEs was required in 1% and 3.8% of patients, respectively. Conclusions: Erlotinib had similar efficacy to chemotherapy in second-line advanced NSCLC, even in patients who had progressed rapidly on first-line PDC. Erlotinib was well tolerated compared with chemotherapy in this population. Conclusions • This is the first prospective head-to-head study to specifically investigate erlotinib versus systemic chemotherapy in second-line NSCLC for patients who progressed during first-line platinum-doublet chemotherapy. • Similar OS was seen in both arms, with consistent results across subgroups, including the population with confirmed EGFR wild-type disease. • No new safety signals were observed and erlotinib was not associated with any of the haematological toxicity seen with chemotherapy. The most common AEs with erlotinib were skin rash and diarrhoea, most of which were grade 1 or 2.
    Lung Cancer 02/2011; 71. DOI:10.1016/S0169-5002(11)70225-2 · 3.74 Impact Factor
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    ABSTRACT: Hypertension (HTN), a recognized adverse effect of angiogenesis inhibitors, may be a potential biomarker of activity of these agents. We conducted a retrospective analysis to examine the incidence and predictors of the development of on-treatment HTN with the vascular endothelial growth factor receptor tyrosine kinase inhibitor cediranib, and the relationship of this adverse event with treatment outcomes. BR24 was a double-blind placebo-controlled phase II trial of carboplatin/paclitaxel chemotherapy with either daily oral cediranib or placebo in patients (n = 296) with advanced non-small-cell lung cancer (NSCLC). Exploratory analyses characterized relationships between HTN, baseline variables, and efficacy outcomes. New onset or worsening of preexisting HTN (treatment-emergent HTN) was more frequent in patients receiving cediranib (68 versus 45%, P < 0.0001). Factors associated with HTN in all randomized patients were good performance status and treatment with cediranib. In both arms, treatment-emergent HTN was associated with improved efficacy outcomes, but there was no evidence of a differential treatment effect, with nonsignificant interaction P values. In advanced NSCLC, HTN is frequent in patients receiving chemotherapy, with or without cediranib. The development of HTN was favorably prognostic in these patients, but not predictive of a differential outcome with cediranib.
    Annals of Oncology 11/2010; 21(11):2220-6. DOI:10.1093/annonc/mdq221 · 6.58 Impact Factor
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    ABSTRACT: AZD6244 (ARRY-142886) is a potent, selective MEK inhibitor. This study aimed to evaluate the efficacy and safety of AZD6244 versus pemetrexed as second- or third-line treatment in patients with advanced non-small cell lung cancer (NSCLC). In this randomized phase II study, patients received either 100 mg oral AZD6244 free-base suspension twice daily or 500 mg/m(2) intravenous pemetrexed once every 3 weeks after pretreatment with a corticosteroid, folic acid, and vitamin B12. The primary end point of the study was the disease progression event count. Eighty-four patients were randomized. Disease progression events were experienced by 28 (70%) and 26 (59%) patients in the AZD6244 and pemetrexed groups, respectively. Median progression-free survival was not statistically significantly different between the AZD6244 and pemetrexed groups (67 versus 90 days, respectively; hazard ratio 1.08, two-sided 80% confidence interval = 0.75-1.54; p = 0.79). Two patients in the AZD6244 group had a best response to treatment of partial response. In the pemetrexed group, one patient achieved a complete response and one patient a partial response. Dermatitis acneiform, diarrhea, nausea, and vomiting were the most frequently reported adverse events with AZD6244, compared with fatigue, anemia, nausea, anorexia, and dermatitis acneiform with pemetrexed. Oral AZD6244 showed clinical activity as second- or third-line therapy for patients with advanced NSCLC. In an unselected NSCLC population, there is no suggestion that AZD6244 monotherapy offers any advantage over standard treatment with pemetrexed. Based on preclinical data and recent clinical observations, further development of AZD6244 in NSCLC should focus on BRAF or RAS mutation-positive patients and/or AZD6244-based combination regimens.
    Journal of thoracic oncology: official publication of the International Association for the Study of Lung Cancer 10/2010; 5(10):1630-6. DOI:10.1097/JTO.0b013e3181e8b3a3 · 5.80 Impact Factor

Publication Stats

270 Citations
242.57 Total Impact Points

Institutions

  • 2013
    • Iuliu Haţieganu University of Medicine and Pharmacy
      Klausenburg, Cluj, Romania
  • 2007–2013
    • Institutul Oncologic Prof. Dr.I. Chiricuta
      Klausenburg, Cluj, Romania
  • 2010
    • Queens University of Charlotte
      New York, United States
  • 2008
    • Institutul Oncologic "Al. Trestioreanu"
      Bucureşti, Bucureşti, Romania