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Browsing by Author "Manojlovic, Nebojsa (7004217506)"

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    Publication
    Clamp-crushing vs. radiofrequency-assisted liver resection: Changes in liver function tests
    (2012)
    Palibrk, Ivan (6507415211)
    ;
    Milicic, Biljana (6603829143)
    ;
    Stojiljkovic, Ljuba (6508338499)
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    Manojlovic, Nebojsa (7004217506)
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    Dugalic, Vladimir (9433624700)
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    Bumbasirevic, Vesna (8915014500)
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    Kalezic, Nevena (6602526969)
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    Zuvela, Marinko (6602952252)
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    Milicevic, Miroslav (7005565664)
    Background/Aims: Liver resection is the gold standard in managing patients with metastatic or primary liver cancer. The aim of our study was to compare the traditional clamp-crushing technique to the radiofrequency-assisted liver resection technique in terms of postoperative liver function. Methodology: Liver function was evaluated preoperatively and on postoperative days 3 and 7. Liver synthetic function parameters (serum albumin level, prothrombin time and international normalized ratio), markers of hepatic injury and necrosis (serum alanine aminotransferase, aspartate aminotransferase and total bilirubin level) and microsomal activity (quantitative lidocaine test) were compared. Results: Forty three patients completed the study (14 had clamp-crushing and 29 had radiofrequency assisted liver resection). The groups did not differ in demographic characteristics, pre-operative liver function, operative time and perioperative transfusion rate. In postoperative period, there were similar changes in monitored parameters in both groups except albumin levels, that were higher in radiofrequency-assisted liver resection group (p=0.047). Conclusions: Both, traditional clamp-crushing technique and radiofrequency assisted liver resection technique, result in similar postoperative changes of most monitored liver function parameters. © H.G.E. Update Medical Publishing S.A.
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    Phase I/II trial of pimasertib plus gemcitabine in patients with metastatic pancreatic cancer
    (2018)
    Van Cutsem, Eric (7005959932)
    ;
    Hidalgo, Manuel (7101654996)
    ;
    Canon, Jean-Luc (7006124973)
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    Macarulla, Teresa (8702260000)
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    Bazin, Igor (6506333300)
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    Poddubskaya, Elena (56089215700)
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    Manojlovic, Nebojsa (7004217506)
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    Radenkovic, Dejan (6603592685)
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    Verslype, Chris (6701461460)
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    Raymond, Eric (55167320200)
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    Cubillo, Antonio (6603220099)
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    Schueler, Armin (24780773400)
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    Zhao, Charles (57191374469)
    ;
    Hammel, Pascal (55737656700)
    The selective MEK1/2 inhibitor pimasertib has shown anti-tumour activity in a pancreatic tumour model. This phase I/II, two-part trial was conducted in patients with metastatic pancreatic adenocarcinoma (mPaCa) (NCT01016483). In the phase I part, oral pimasertib was given once daily discontinuously (5 days on/2 days off treatment) or twice daily continuously (n = 53) combined with weekly gemcitabine (1,000 mg/m2) in 28-day cycles to identify the recommended phase II dose (RP2D) of pimasertib. In the phase II part, patients were randomised to pimasertib (RP2D) or placebo plus weekly gemcitabine (n = 88) to investigate progression-free survival (PFS), overall survival (OS) and safety. The RP2D was determined to be 60 mg BID. PFS and OS outcomes did not indicate any treatment benefit for pimasertib over placebo in combination with gemcitabine (median PFS 3.7 and 2.8 months, respectively, HR = 0.91, 95% CI: 0.58–1.42: median OS 7.3 vs. 7.6 months, respectively). KRAS status did not influence PFS or OS. The incidence of grade ≥3 adverse events was 91.1% and 85.7% for pimasertib/gemcitabine and placebo/gemcitabine respectively, but there was a higher incidence of ocular events with pimasertib/gemcitabine (28.9% vs. 4.8% for placebo/gemcitabine). In conclusion, no clinical benefit was observed with first-line pimasertib plus gemcitabine compared with gemcitabine alone in patients with mPaCa. © 2018 UICC
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    Publication
    Phase I/II trial of pimasertib plus gemcitabine in patients with metastatic pancreatic cancer
    (2018)
    Van Cutsem, Eric (7005959932)
    ;
    Hidalgo, Manuel (7101654996)
    ;
    Canon, Jean-Luc (7006124973)
    ;
    Macarulla, Teresa (8702260000)
    ;
    Bazin, Igor (6506333300)
    ;
    Poddubskaya, Elena (56089215700)
    ;
    Manojlovic, Nebojsa (7004217506)
    ;
    Radenkovic, Dejan (6603592685)
    ;
    Verslype, Chris (6701461460)
    ;
    Raymond, Eric (55167320200)
    ;
    Cubillo, Antonio (6603220099)
    ;
    Schueler, Armin (24780773400)
    ;
    Zhao, Charles (57191374469)
    ;
    Hammel, Pascal (55737656700)
    The selective MEK1/2 inhibitor pimasertib has shown anti-tumour activity in a pancreatic tumour model. This phase I/II, two-part trial was conducted in patients with metastatic pancreatic adenocarcinoma (mPaCa) (NCT01016483). In the phase I part, oral pimasertib was given once daily discontinuously (5 days on/2 days off treatment) or twice daily continuously (n = 53) combined with weekly gemcitabine (1,000 mg/m2) in 28-day cycles to identify the recommended phase II dose (RP2D) of pimasertib. In the phase II part, patients were randomised to pimasertib (RP2D) or placebo plus weekly gemcitabine (n = 88) to investigate progression-free survival (PFS), overall survival (OS) and safety. The RP2D was determined to be 60 mg BID. PFS and OS outcomes did not indicate any treatment benefit for pimasertib over placebo in combination with gemcitabine (median PFS 3.7 and 2.8 months, respectively, HR = 0.91, 95% CI: 0.58–1.42: median OS 7.3 vs. 7.6 months, respectively). KRAS status did not influence PFS or OS. The incidence of grade ≥3 adverse events was 91.1% and 85.7% for pimasertib/gemcitabine and placebo/gemcitabine respectively, but there was a higher incidence of ocular events with pimasertib/gemcitabine (28.9% vs. 4.8% for placebo/gemcitabine). In conclusion, no clinical benefit was observed with first-line pimasertib plus gemcitabine compared with gemcitabine alone in patients with mPaCa. © 2018 UICC

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