Tumor dynamics with fluorouracil/folinic acid, irinotecan, and oxaliplatin (FOLFOXIRI) plus panitumumab (pmab) or FOLFOXIRI alone as initial treatment of RAS wildtype metastatic colorectal cancer (mCRC): Central radiologic review of VOLFI—A randomized, open label, phase-2 study (AIO KRK0109).

Medientyp: E-Artikel

Titel: Tumor dynamics with fluorouracil/folinic acid, irinotecan, and oxaliplatin (FOLFOXIRI) plus panitumumab (pmab) or FOLFOXIRI alone as initial treatment of RAS wildtype metastatic colorectal cancer (mCRC): Central radiologic review of VOLFI—A randomized, open label, phase-2 study (AIO KRK0109)

Beteiligte: Modest, Dominik Paul; Noerenberg, Dominik; Seidensticker, Max; Ricke, Jens; Martens, Uwe Marc; Riera-Knorrenschild, Jorge; Greeve, Jobst; Florschütz, Axel; Wessendorf, Swen; Ettrich, Thomas Jens; Kanzler, Stephan; Held, Swantje; Buechner-Steudel, Petra; Atzpodien, Jens; Heinemann, Volker; Tannapfel, Andrea; Reinacher-Schick, Anke C.; Geissler, Michael

Erschienen: American Society of Clinical Oncology (ASCO), 2019

Sprache: Englisch

DOI: 10.1200/jco.2019.37.15_suppl.3530

ISSN: 0732-183X; 1527-7755

Schlagwörter: Cancer Research ; Oncology

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Beschreibung: 3530 Background: The VOLFI trial demonstrated improved objective response rate (ORR) with the addition of pmab to modified triplet chemotherapy with FOLFOXIRI in a 2:1 (63 patients FOLFOXIRI plus pmab; 33 patients FOLFOXIRI) randomized, controlled, phase II trial in patients with untreated RAS wildtype mCRC. Methods: Radiologic images from the study were centrally examined according to RECIST 1.1. We further assessed early tumor shrinkage (=ETS: 20% shrinkage of tumor diameter at first re-assessment) and depth of response (=DpR= maximum shrinkage of lesions defined as relation of smallest tumor diameter to baseline). Moreover, time to depth of response was calculated (randomisation to depth of response image). Results: Images were available for 88 of 96 patients (91.7%), 86 patients (89.6%) had at least one follow-up image and were included in the central review. According to central review, objective response rates were 89.2% vs 66.7% with FOLFOXIRI plus pmab vs FOLFOXIRI alone (P=0.02). ETS was also significantly more frequent (Fisher’s exact test; P=0.01)) and DPR (Wilcoxon test; P= 0.004) significantly greater with pmab as compared to chemotherapy alone. See table for details. Time to DpR was similar in the panitumumab- vs chemotherapy alone arm (3.9 (95% confidence interval 2.8-4.7) vs. 4.2 (95% CI 3.6-5.7) months, respectively. P=0.63). Conclusions: In this central review, pmab significantly improves ORR, the rate of ETS and also DpR when added to a mFOLFOXIRI regimen. Our findings underline the potential of this highly active regimen in patients with RAS wildtype mCRC that need to achieve early and profound shrinkage of the tumor. Additional analysis including molecular subgroups and tumor sidedness will be shown at the meeting. Clinical trial information: NCT01328171. [Table: see text]

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