FOLFOXIRI Plus Panitumumab As First-Line Treatment of RAS Wild-Type Metastatic Colorectal Cancer: The Randomized, Open-Label, Phase II VOLFI Study (AIO KRK0109)

Medientyp: E-Artikel
Titel: FOLFOXIRI Plus Panitumumab As First-Line Treatment of RAS Wild-Type Metastatic Colorectal Cancer: The Randomized, Open-Label, Phase II VOLFI Study (AIO KRK0109)
Beteiligte: Modest, Dominik P.; Martens, Uwe M.; Riera-Knorrenschild, Jorge; Greeve, Jobst; Florschütz, Axel; Wessendorf, Swen; Ettrich, Thomas; Kanzler, Stephan; Nörenberg, Dominik; Ricke, Jens; Seidensticker, Max; Held, Swantje; Buechner-Steudel, Petra; Atzpodien, Jens; Heinemann, Volker; Seufferlein, Thomas; Tannapfel, Andrea; Reinacher-Schick, Anke C.; Geissler, Michael
Erschienen: American Society of Clinical Oncology (ASCO), 2019
Erschienen in: Journal of Clinical Oncology
Sprache: Englisch
DOI: 10.1200/jco.19.01340
ISSN: 0732-183X; 1527-7755
Schlagwörter: Cancer Research ; Oncology
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Beschreibung: <jats:sec><jats:title>PURPOSE</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>PATIENTS AND METHODS</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> 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). </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> 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. </jats:p></jats:sec>
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