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Modest, Dominik P.; Martens, Uwe M.; Riera-Knorrenschild, Jörge; Greeve, Jobst; Florschuetz, Axel; Wessendorf, Swen; Ettrich, Thomas; Kanzler, Stephan; Noerenberg, Dominik; Ricke, Jens; Seidensticker, Max; Held, Swantje; Buechner-Steudel, Petra; Atzpodien, Jens; Heinemann, Volker; Seufferlein, Thomas; Tannapfel, Andrea; Reinacher-Schick, Anke C. and Geissler, Michael (2019): FOLFOXIRI Plus Panitumumab As First-Line Treatment of RAS Wild-Type Metastatic Colorectal Cancer: The Randomized, Open-Label, Phase II VOLFI Study (AIO KRK0109). In: Journal of Clinical Oncology, Vol. 37, No. 35

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PURPOSE This trial investigated the addition of panitumumab to triplet chemotherapy with fluorouracil/folinic acid, oxaliplatin, and irinotecan (FOLFOXIRI) in a two-to-one randomized, controlled, open-label, phase II trial in patients with untreated RAS wild-type (WT) metastatic colorectal cancer. PATIENTS AND METHODS The primary end point was objective response rate (ORR) according to RECIST (version 1.1). The experimental arm (modified FOLFOXIRI [mFOLFOXIRI] plus panitumumab) was considered active if the ORR was >= 75%. The experimental ORR was compared with an estimated ORR of 60% based on historical data, verified by a randomized control group (FOLFOXIRI). The power of the trial was 80%, with a potential type I error of 0.05. Secondary end points included secondary resection rate, toxicity, progression-free survival, and overall survival. RESULTS A total of 63 patients were randomly assigned to the experimental arm and 33 patients to the control arm. The ORR of the mFOLFOXIRI plus panitumumab arm exceeded 75% and was higher when compared with that of FOLFOXIRI (87.3% v 60.6%;odds ratio, 4.469;95% CI, 1.61 to 12.38;P = .004). The secondary resection rate was improved with the addition of panitumumab (33.3% v 12.1%;P = .02). Progression-free survival was similar in the study arms, whereas overall survival showed a trend in favor of the panitumumab-containing arm (hazard ratio for death, 0.67;95% CI, 0.41 to 1.11;P = .12). CONCLUSION The addition of panitumumab to mFOLFOXIRI in patients with RAS WT metastatic colorectal cancer improved the ORR and rate of secondary resection of metastases and represents a treatment option in selected and fit patients in need of highly active first-line therapy. Future studies should determine whether the addition of panitumumab to mFOLFOXIRI prolongs survival.

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