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Meinolf Karthaus, Ralf-Dieter Hofheinz, Laurent Mineur, Henry Letocha, Richard Greil, Josef Thaler, Eva Fernebro, Kelly S Oliner, Michael Boedigheimer, Brian Twomey, Ying Zhang, Gaston Demonty, Claus-Henning Köhne
BACKGROUND: To investigate tumour biomarker status and efficacy of first-line panitumumab+FOLFIRI for metastatic colorectal carcinoma (mCRC). METHODS: 154 patients received first-line panitumumab + FOLFIRI every 14 days. Primary end point was objective response rate (ORR). Data were analysed by tumour RAS (KRAS/NRAS) and BRAF status, and baseline amphiregulin (AREG) expression. RESULTS: Objective responses occurred more frequently in RAS wild type (WT) (59%) vs RAS mutant (MT) (41%) mCRC and in RAS WT/BRAF WT (68%) vs RAS or BRAF MT (37%) disease...
October 20, 2016: British Journal of Cancer
J Quidde, S Hegewisch-Becker, U Graeven, C A Lerchenmüller, B Killing, R Depenbusch, C-C Steffens, T Lange, G Dietrich, J Stoehlmacher, A Reinacher, A Tannapfel, T Trarbach, N Marschner, H-J Schmoll, A Hinke, S-E Al-Batran, D Arnold
BACKGROUND: First-line maintenance strategies are a current matter of debate in the management of mCRC. Their impact on patient's health-related quality of life (HRQOL) has not yet been evaluated. The objective of this study was to assess whether differences in HRQOL during any active maintenance treatment compared with no maintenance treatment exist. PATIENT AND METHODS: Eight hundred and thirty-seven patients were enrolled in the AIO KRK 0207 trial. Four hundred and seventy-two underwent randomization (after 24 weeks of induction treatment) into one of the maintenance arms: FP plus Bev (arm A), Bev alone (arm B), or no active treatment (arm C)...
October 17, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Carmine Pinto, Francesca Di Fabio, Gerardo Rosati, Ivan R Lolli, Enzo M Ruggeri, Libero Ciuffreda, Daris Ferrari, Giovanni Lo Re, Giovanni Rosti, Paolo Tralongo, Raimondo Ferrara, Oscar Alabiso, Silvana Chiara, Giovanni P Ianniello, Antonio Frassoldati, Domenico Bilancia, Giovanna A Campanella, Carlo Signorelli, Patrizia Racca, Elena Benincasa, Maria Elena Stroppolo, Francesco Di Costanzo
Cetuximab improves efficacy when added to chemotherapy for metastatic colorectal cancer (mCRC). Effective management of skin reactions from cetuximab improves quality of life (QoL), and treatment compliance in clinical trials. No data are available from real-world settings. The ObservEr observational, multicenter, prospective study evaluated QoL, the incidence of skin reactions, and management of chemotherapy plus cetuximab in first-line for mCRC. The primary endpoint was QoL measured with the Dermatology Life Quality Index (DLQI) and EORTC QLQ-C30...
October 17, 2016: Cancer Medicine
Rohan C Parikh, Xianglin L Du, Robert O Morgan, David R Lairson
BACKGROUND: Over the last decade, multiple chemotherapies/targeted biologics have been approved for metastatic colorectal cancer (mCRC). However, evidence is limited with regards to the array of treatments received by mCRC patients. OBJECTIVE: This study examines treatment sequences (first- to third-line chemotherapy/targeted biologics) and the factors associated with first-line targeted biologics and common treatment sequences for elderly mCRC patients treated in a community setting...
March 2016: Drugs—Real World Outcomes
Jun Gong, May Cho, Marwan Fakih
The treatment of metastatic colorectal cancer (mCRC) has been further refined with the development of monoclonal antibodies, cetuximab and panitumumab, towards the epidermal growth factor receptor (EGFR). Anti-EGFR therapy has afforded improved survival in those with wild-type RAS mCRC but provides no benefit and even harm in those with RAS-mutant tumors. BRAF mutations have also been shown to predict lack of clinically meaningful benefit to anti-EGFR therapy in mCRC. Mechanisms of resistance to EGFR blockade in wild-type RAS or BRAF metastatic colorectal tumors appear to converge on the mitogen-activated protein kinase (MAPK) signaling pathway...
October 2016: Journal of Gastrointestinal Oncology
Maria Thomsen, Christian Kersten, Halfdan Sorbye, Eva Skovlund, Bengt Glimelius, Per Pfeiffer, Julia S Johansen, Elin H Kure, Tone Ikdahl, Kjell Magne Tveit, Thoralf Christoffersen, Tormod Kyrre Guren
OBJECTIVES: The aim was to explore the prognostic significance of IL-6 and markers of systemic inflammatory response (SIR), in particular C-reactive protein (CRP), in metastatic colorectal cancer (mCRC) patients, in the total study population and according to RAS and BRAF mutation status. RESULTS: High levels of pretreatment serum IL-6 or CRP were associated with impaired outcome, in terms of reduced PFS and OS. Patients with low versus high serum IL-6 levels had median OS of 26...
October 12, 2016: Oncotarget
Tae Won Kim, Anneli Elme, Zvonko Kusic, Joon Oh Park, Anghel Adrian Udrea, Sun Young Kim, Joong Bae Ahn, Ricardo Villalobos Valencia, Srinivasan Krishnan, Ante Bilic, Nebojsa Manojlovic, Jun Dong, Xuesong Guan, Catherine Lofton-Day, A Scott Jung, Eduard Vrdoljak
BACKGROUND: We assessed the treatment effect of panitumumab plus best supportive care (BSC) vs BSC on overall survival (OS) in patients with chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer (mCRC) and report the first prospective extended RAS analysis in a phase 3 trial. METHODS: Patients with wild-type KRAS exon 2 mCRC were randomised 1 : 1 to panitumumab (6 mg kg(-1) Q2W) plus BSC or BSC. On-study crossover was prohibited. RAS mutation status was determined by central laboratory testing...
October 13, 2016: British Journal of Cancer
Nuh N Rahbari, Dmitriy Kedrin, Joao Incio, Hao Liu, William W Ho, Hadi T Nia, Christina M Edrich, Keehoon Jung, Julien Daubriac, Ivy Chen, Takahiro Heishi, John D Martin, Yuhui Huang, Nir Maimon, Christoph Reissfelder, Jurgen Weitz, Yves Boucher, Jeffrey W Clark, Alan J Grodzinsky, Dan G Duda, Rakesh K Jain, Dai Fukumura
The survival benefit of anti-vascular endothelial growth factor (VEGF) therapy in metastatic colorectal cancer (mCRC) patients is limited to a few months because of acquired resistance. We show that anti-VEGF therapy induced remodeling of the extracellular matrix with subsequent alteration of the physical properties of colorectal liver metastases. Preoperative treatment with bevacizumab in patients with colorectal liver metastases increased hyaluronic acid (HA) deposition within the tumors. Moreover, in two syngeneic mouse models of CRC metastasis in the liver, we show that anti-VEGF therapy markedly increased the expression of HA and sulfated glycosaminoglycans (sGAGs), without significantly changing collagen deposition...
October 12, 2016: Science Translational Medicine
David S Hong, Van K Morris, Badi El Osta, Alexey V Sorokin, Filip Janku, Siqing Fu, Michael J Overman, Sarina Piha-Paul, Vivek Subbiah, Bryan Kee, Apostolia Tsimberidou, David Fogelman, Jorge Bellido, Imad Shureiqi, Helen Huang, Johnique Atkins, Gabi Tarcic, Nicolas Sommer, Richard Lanman, Funda Meric-Bernstam, Scott Kopetz
In vitro, EGFR inhibition, combined with the BRAF inhibitor vemurafenib, causes synergistic cytotoxicity for BRAFV600E metastatic colorectal cancer (mCRC), further augmented by irinotecan. The safety and efficacy of vemurafenib, irinotecan, and cetuximab in BRAF-mutated malignancies are not defined. In this 3+3 phase I study, patients with BRAFV600E advanced solid cancers received cetuximab and irinotecan with escalating doses of vemurafenib. Nineteen patients (18 with mCRC, 1 with appendiceal cancer) were enrolled...
October 11, 2016: Cancer Discovery
Sabine Tejpar, Sebastian Stintzing, Fortunato Ciardiello, Josep Tabernero, Eric Van Cutsem, Frank Beier, Regina Esser, Heinz-Josef Lenz, Volker Heinemann
Importance: Metastatic colorectal cancer (mCRC) is heterogeneous, and primary tumors arising from different regions of the colon are clinically and molecularly distinct. Objective: To examine the prognostic and predictive value of primary tumor location in patients with RAS wild-type (wt) mCRC treated with first-line fluorouracil, leucovorin, and irinotecan (FOLFIRI) plus cetuximab in the Cetuximab Combined With Irinotecan in First-line Therapy for Metastatic Colorectal Cancer (CRYSTAL) trial and FOLFIRI Plus Cetuximab Versus FOLFIRI Plus Bevacizumab as First-Line Treatment For Patients With Metastatic Colorectal Cancer (FIRE-3) trial...
October 10, 2016: JAMA Oncology
J Feliu, I Díez de Corcuera, J L Manzano, M Valladares-Ayerbes, J Alcaide, T García García, R Vera, J Sastre
PURPOSE: In the VELOUR study, aflibercept + FOLFIRI regimen resulted in improved survival in metastatic colorectal cancer (mCRC) patients who progressed after oxaliplatin. The use of aflibercept outside the clinical trial framework needs to be further assessed in terms of effectiveness and tolerability. METHODS: Early access to aflibercept through a named patient programme (NPP) was provided to mCRC patients receiving FOLFIRI as second-line treatment in Spain...
October 7, 2016: Clinical & Translational Oncology
Timothy Price, Tae Won Kim, Jin Li, Stefano Cascinu, Paul Ruff, Attili Satya Suresh, Anne Thomas, Sergei Tjulandin, Xuesong Guan, Marc Peeters
PURPOSE: The primary analysis of the ASPECCT study demonstrated that panitumumab was non-inferior to cetuximab for overall survival (OS) in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (mCRC). Here, we report the final analysis results of ASPECCT. PATIENTS AND METHODS: Patients with wild-type KRAS exon 2 mCRC who progressed on or were intolerant to irinotecan- or oxaliplatin-based chemotherapy were randomised to receive panitumumab 6 mg/kg once every 2 weeks or cetuximab (400 mg/m(2)) followed by 250 mg/m(2) weekly...
October 4, 2016: European Journal of Cancer
Mehmet Artaç, Mükremin Uysal, Mustafa Karaağaç, Levent Korkmaz, Zehra Er, Tunç Güler, Melih Cem Börüban, Hakan Bozcuk
PURPOSE: Metastatic colorectal cancer (mCRC) is a lethal disease and fluorouracil-leucovorin-irinotecan (FOLFIRI) plus bevacizumab (bev) is a standard approach. Hence, there is a strong need for identifying new prognostic factors to show the efficacy of FOLFIRI-bev. METHODS: This is a retrospective study including patients (n = 90) with mCRC from two centers in Turkey. Neutrophil/lymphocyte (N/L) ratio, platelet count, albumin, and C-reactive protein (CRP) were recorded before FOLFIRI-bev therapy...
October 7, 2016: Journal of Gastrointestinal Cancer
Kohei Shitara, Kimio Yonesaka, Tadamichi Denda, Kentaro Yamazaki, Toshikazu Moriwaki, Masahiro Tsuda, Toshimi Takano, Hiroyuki Okuda, Tomohiro Nishina, Kazuko Sakai, Kazuto Nishio, Shoji Tokunaga, Takeharu Yamanaka, Narikazu Boku, Ichinosuke Hyodo, Kei Muro
This randomized phase II trial compared panitumumab plus fluorouracil, leucovorin, and irinotecan (FOLFIRI) with bevacizumab plus FOLFIRI as second-line chemotherapy for wild-type (WT) KRAS exon 2 metastatic colorectal cancer (mCRC) and to explore the values of oncogenes in circulating tumor DNA (ctDNA) and serum proteins as predictive biomarkers. Patients with WT KRAS exon 2 mCRC refractory to first-line chemotherapy containing oxaliplatin and bevacizumab were randomly assigned to panitumumab plus FOLFIRI or bevacizumab plus FOLFIRI...
October 6, 2016: Cancer Science
Chenxi Yin, Gang Ma, Yuming Rong, Pengfei Kong, Qiong Yang, Chang Jiang, Fangxin Liao, Bei Zhang, Wenzhuo He, Liangping Xia
Objective: To evaluate the effect of bevacizumab in different lines for Chinese patients with metastatic colorectal cancer (mCRC). Methods: Patients of mCRC treated with bevacizumab or not at Sun Yat-sen University Cancer Center from 2007 to 2013 were recruited as study and control group. Endpoints were overall survival (OS), progression free survival (PFS), objective response rate (ORR) and disease control rate (DCR). Corresponding survival rates of first- and second-line in study and control group were compared...
2016: Journal of Cancer
A Sebio, S Stintzing, V Heinemann, Y Sunakawa, W Zhang, W Ichikawa, A Tsuji, T Takahashi, A Parek, D Yang, S Cao, Y Ning, S Stremitzer, S Matsusaka, S Okazaki, A Barzi, M D Berger, H-J Lenz
The Hippo pathway is involved in colorectal cancer (CRC) development and progression. The Hippo regulator Rassf1a is also involved in the Ras signaling cascade. In this work, we tested single nucleotide polymorphisms within Hippo components and their association with outcome in CRC patients treated with cetuximab. Two cohorts treated with cetuximab plus chemotherapy were evaluated (198 RAS wild-type (WT) patients treated with first-line FOLFIRI plus Cetuximab within the FIRE-3 trial and 67 Ras WT patients treated either with first-line mFOLFOX6 or SOX plus Cetuximab)...
October 4, 2016: Pharmacogenomics Journal
Carmine Pinto, Lorenzo Antonuzzo, Luca Porcu, Giuseppe Aprile, Evaristo Maiello, Gianluca Masi, Fausto Petrelli, Mario Scartozzi, Valter Torri, Sandro Barni
BACKGROUND: Whether bevacizumab represents a feasible option for the first-line treatment of unfit and elderly patients with metastatic colorectal cancer (mCRC) remains controversial. The present systematic review and meta-analysis evaluated the efficacy and safety data of bevacizumab combined with first-line fluoropyrimidine monochemotherapy for these complex patients. PATIENTS AND METHODS: A systematic search of the published data was conducted through May 31, 2016...
August 31, 2016: Clinical Colorectal Cancer
Emily-Ruth Marriott, Guy van Hazel, Peter Gibbs, Anthony J Hatswell
AIMS: The primary aim of this study was to perform a mapping of the EORTC-QLQ-C30 scores to EQ-5D-3L for the SIRFLOX study; a large dataset of patients with previously untreated liver-only or liver-dominant metastatic colorectal cancer (mCRC). A secondary aim was to compare the predictive validity of existing mappings from EORTC-QLQ-C30 to EQ-5D-3L conducted in other cancers. METHODS AND MATERIALS: Questionnaires (completed within 529 patients) were used in a linear mixed regression to model EQ-5D-3L utility values (scored using the UK tariff) as a function of the five function scores, nine symptom scores, and the global score from the EORTC-QLQ-C30 questionnaire...
October 13, 2016: Journal of Medical Economics
Yoshihito Ohhara, Naoki Fukuda, Satoshi Takeuchi, Rio Honma, Yasushi Shimizu, Ichiro Kinoshita, Hirotoshi Dosaka-Akita
Colorectal cancer (CRC) is a significant cause of cancer-related morbidity and mortality all over the world. Improvements of cytotoxic and biologic agents have prolonged the survival in metastatic CRC (mCRC), with a median overall survival of approximately 2 years and more in the past two decades. The biologic agents that have proven clinical benefits in mCRC mainly target vascular endothelial growth factor (VEGF) and epidermal growth factor receptor (EGFR). In particular, bevacizumab targeting VEGF and cetuximab and panitumumab targeting EGFR have demonstrated significant survival benefits in combination with cytotoxic chemotherapy in the first-line, second-line, or salvage setting...
September 15, 2016: World Journal of Gastrointestinal Oncology
Carlo Garufi, Elisa Giacomini, Angela Torsello, Isabella Sperduti, Elisa Melucci, Marcella Mottolese, Massimo Zeuli, Giuseppe Maria Ettorre, Teresa Ricciardi, Francesco Cognetti, Mauro Magnani, Annamaria Ruzzo
The circadian system is composed of a set of clock-genes including PERIOD, CLOCK, BMAL1 and CRY. Disrupting this system promotes cancer development and progression. The expression levels of miR-206, miR-219, miR-192, miR-194 and miR-132 regulating clock-genes and three functional polymorphisms rs11133373 C/G, rs1801260 T/C, rs11133391 T/C in CLOCK sequence were associated with the survival of 83 mCRC patients (50 males and 33 females). Longer overall survival (OS) was observed in women compared to men, 50 versus 31 months...
September 26, 2016: Scientific Reports
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