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Feasibility of personalized treatment concepts in gastrointestinal malignancies： Sub-group results of prospective clinical phase Ⅱ trial EXACT

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Chinese Journal of Cancer Research 2018年第5期30卷 508-515页

作者： Matthias Unseld Robert Mader Lukas Baumann Clarence Veraar fritz wrba Fredrik Waneck Markus Kieler Daniela Bianconi Walter Berger Maria Sibilia Leonhard Miillauer Christoph Zielinski Gerald W. Prager Department of Medicine I Division of Oncology Medical University of Vienna Vienna 1090 Austria Comprehensive Cancer Center Medical University Vienna - General Hospital Vienna 1090 Austria Department of Medical Statistics Medical University of Vienna Vienna 1090 Austria Clinical Institute of Pathology Medical University of Vienna Vienna 1090 Austria Department of Interventional Radiology Medical University of Vienna Vienna 1090 Austria Department of Medicine I Institute of Cancer Research Medical University of Vienna Vienna 1090 Austria

Objective： Advances in high-throughput genomic profiling and the development of new targeted therapies improve patient＇s survival. In gastrointestinal （GI） malignancies, the concept of personalized medicine （PM） was not investigated so far. The aim of this prospective study was to evaluate the efficacy of a personalized treatment in GI patients who failed standard treatment. Methods： Out of the original prospective clinical phase II EXACT trial, 21 （38%） GI cancer patients who had no further treatment options were identified. A molecular profile （MP） via a 50 gene next generation sequencing （NGS） panel in combination with immunohistochemistry （IHC） was conducted using real-time biopsy tumor material. Results were discussed by a multidisciplinary team （MDT） to translate the individual MP in an experimental treatment. Results： Of the 55 patients originally included in the EXACT trial, 21 （38%） suffered from GI malignancies. The final analysis showed that 15 （71%） patients had experienced a longer progression-free survival （PFS） upon experimental targeted treatment （124 d, quartiles 70/193 d）, when compared with the PFS achieved by the previous conventional therapy （62 d, quartiles 55/83 d）（P=0.014）. Thirteen （62%） patients receiving targeted treatment experienced a disease control according to Response Evaluation Criteria in Solid Tumors （RECIST）. Median overall survival （OS） from the start of experimental therapy to time of censoring or death was 193 d （quartiles 115/374 d）. Conclusions： PM was not investigated in GI malignancies so far in a prospective trial. This study shows that treatment based on real-time molecular tumor profiling led to a superior clinical benefit, and survival as well as response was significantly improved when compared with previous standard medications.

关键词： Personalized medicine gastrointestinal malignancies prospective trial next generations sequencing

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Cetuximab plus FOLFOX6 or FOLFIRI in metastatic colorectal cancer: CECOG trial

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World Journal of Gastroenterology 2010年第25期16卷 3133-3143页

作者： Janja Ocvirk Thomas Brodowicz fritz wrba Tudor E Ciuleanu Galina Kurteva Semir Beslija Ivan Koza Zsuzsanna Pápai Diethelm Messinger Ugur Yilmaz Zsolt Faluhelyi Suayib Yalcin Demetris Papamichael Miklós Wenczl Zrinka Mrsic-Krmpotic Einat Shacham-Shmueli Damir Vrbanec Regina Esser Werner Scheithauer Christoph C Zie-linski Institute of Oncology 1000 Ljubljana Slovenia Clinical Division of Oncology Department of Medicine I Medical University of Vienna 1090 Vienna Austria Clinical Institute of Pathology Medical University of Vienna 1090 Vienna Austria Institutul Oncologic Cluj 400015 Cluj-Nap-oca Romania Department of Oncology National Specialized Hospital of Active Treatment in Oncology 1754 Sofi a Bulgaria Institute of Oncology Clinical Center of Sara-jevo University 71000 Sarajevo Bosnia-Herzegovina Department of Oncology National Cancer Institute 83310 Bratislava Slovak Republic AEK Onkologiai Osztaly 1122 Budapest Hungary Biometrics IST GmbH 68219 Mannheim Germany Department of Gastroenterology 9 Eylül Univer-sity Medical Faculty 35340 Izmir Turkey Oncology Department Veszprém County Hos-pital 8200 Veszprém Hungary Institute of Oncology Ankara Hacettepe Univer-sity 06100 Ankara Turkey Department of Medical Oncology Bank of Cyprus Oncology Center 2006 Nicosia Cyprus Department of Oncoradiology Markusovszky Teaching Hospital 9700 Szombathely Hungary Department of Medical Oncology Uni-versity Hospital for Tumors 10000 Zagreb Croatia Oncology Division Tel-Aviv Souraski Medical Center Tel Aviv 64239 Israel KBC Rebro Oncology Department 10000 Zagreb Croatia Merck KGaA D64293 Darmstadt Germany

AIM: To investigate efficacy and safety of cetuximab combined with two chemotherapy regimens in patients with unresectable metastatic colorectal cancer (mCRC). METHODS: Randomized patients received cetuximab with 5-fluorouracil (5-FU), folinic acid (FA) and oxaliplatin (FOLFOX) 6 (arm A, n = 74) or 5-FU, FA and irinotecan (FOLFIRI) (arm B, n = 77). KRAS mutation status was determined retrospectively in a subset of tumors (n = 117). RESULTS: No significant difference was found between treatment arms A and B in the progression-free survival (PFS) rate at 9 mo, 45% vs 34%; median PFS, 8.6 mo vs 8.3 mo [hazard ratio (HR) = 1.06]; overall response rate (ORR) 43% vs 45% [odds ratio (OR) = 0.93] and median overall survival (OS), 17.4 mo vs 18.9 mo (HR = 0.98). Patients with KRAS wild-type tumors demonstrated improved PFS (HR = 0.55, P = 0.0051), OS, (HR = 0.62, P = 0.0296) and ORR (53% vs 36%) and in arm A, improved PFS (HR = 0.49, P = 0.0196), OS (HR = 0.48, P = 0.0201) and ORR (56%vs 30%), compared with patients with KRAS mutated tumors. In arm B no significant differences were found in efficacy by KRAS mutation status. Treatment in arms A and B was generally well tolerated. CONCLUSION: This study confirms that combinations of cetuximab with FOLFOX6 or FOLFIRI are effective and significantly improve clinical outcome in KRAS wild-type compared with KRAS mutated mCRC.

关键词： Cetuximab 5-fluorouracil folinic acid and oxaliplatin 5-fluorouracil folinic acid and irinotecan KRAS Metastatic colorectal cancer

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