دورية أكاديمية
PICCA study: panitumumab in combination with cisplatin/gemcitabine chemotherapy in KRAS wild-type patients with biliary cancer—a randomised biomarker-driven clinical phase II AIO study
| العنوان: | PICCA study: panitumumab in combination with cisplatin/gemcitabine chemotherapy in KRAS wild-type patients with biliary cancer—a randomised biomarker-driven clinical phase II AIO study |
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| المؤلفون: | Vogel, Arndt, Kasper, Stefan, Bitzer, Michael, Block, Andreas, Sinn, Marianne, Schulze-Bergkamen, Henning, Moehler, Markus, Pfarr, Nicole, Endris, Volker, Goeppert, Benjamin, Merx, Kirsten, Schnoy, Elisabeth, Siveke, Jens T., Michl, Patrick, Waldschmidt, Dirk, Kuhlmann, Jan, Geissler, Michael, Kahl, Christoph, Evenkamp, Ralph, Schmidt, Torben, Kuhlmann, Alexander, Weichert, Wilko, Kubicka, Stefan |
| بيانات النشر: | ELSEVIER SCI LTD |
| سنة النشر: | 2018 |
| المجموعة: | University of Regensburg Publication Server |
| مصطلحات موضوعية: | 610 Medizin, ddc:610 |
| الوصف: | Background: Combination chemotherapy has shown benefit in the treatment of biliary cancer and further improvements might be achieved by the addition of a biological agent. We report here the effect of chemotherapy with the monoclonal EGFR antibody panitumumab as therapy for KRAS wild-type biliary cancer. Patients and methods: Patients with advanced biliary tract cancer were randomised (2:1) to receive cisplatin 25 mg/m(2) and gemcitabine 1000 mg/m(2) on day 1 and day 8/q3w with (arm A) or without panitumumab (arm B; 9 mg/kg BW, i.v q3w). The primary end-point was the evaluation of progression-free survival (PFS) at 6 months. Secondary end-points included objective response rate (ORR), overall survival (OS), and toxicity. In addition, a post hoc assessment of genetic alterations was performed. Finally, we performed a meta-analysis of trials with chemotherapy with and without EGFR antibodies. Results: Sixty-two patients were randomised in arm A and 28 patients in arm B. Patients received 7 treatment cycles in median (1-35) with a median treatment duration of 4.7 months (141 days, 8-765). PFS rate at 6 months was 54% in patients treated with cisplatin/gemcitabine and panitumumab but was 73% in patients treated with cisplatin/gemcitabine without antibody, respectively. Secondary end-points were an ORR of 45% in treatment arm A compared with 39% receiving treatment B and a median OS of 12.8 months (arm A) and of 20.1 months (arm B), respectively. In contrast to the p53-status, genetic alterations in IDH1/2 were linked to a high response after chemotherapy and prolonged survival. In accordance with our results, the meta-analysis of 12 trials did not reveal a survival advantage for patients treated with EGFR antibodies compared with chemotherapy alone. Conclusions: Panitumumab in combination with chemotherapy does not improve ORR, PFS and OS in patients with KRAS wild-type, advanced biliary cancer. Genetic profiling should be included in CCA trials to identify and validate predictive and prognostic biomarkers. (C) 2018 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | unknown |
| العلاقة: | Vogel, Arndt, Kasper, Stefan , Bitzer, Michael, Block, Andreas, Sinn, Marianne, Schulze-Bergkamen, Henning, Moehler, Markus, Pfarr, Nicole, Endris, Volker, Goeppert, Benjamin , Merx, Kirsten, Schnoy, Elisabeth, Siveke, Jens T., Michl, Patrick, Waldschmidt, Dirk, Kuhlmann, Jan, Geissler, Michael, Kahl, Christoph, Evenkamp, Ralph, Schmidt, Torben, Kuhlmann, Alexander, Weichert, Wilko und Kubicka, Stefan (2018) PICCA study: panitumumab in combination with cisplatin/gemcitabine chemotherapy in KRAS wild-type patients with biliary cancer—a randomised biomarker-driven clinical phase II AIO study. European Journal of Cancer 92, S. 11-19. |
| DOI: | 10.1016/j.ejca.2017.12.028 |
| الإتاحة: | https://doi.org/10.1016/j.ejca.2017.12.028Test https://epub.uni-regensburg.de/47439Test/ |
| رقم الانضمام: | edsbas.F85D2A3A |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.ejca.2017.12.028 |
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