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Early Findings Point To First-Line Metastatic CRC Response To Panitumumab Plus FOLFOXIRI

Combining panitumumab with FOLFOXIRI chemotherapy improved the objective response rate for patients with treatment-naïve RAS wild-type metastatic colorectal cancer
17 Oct 2019
Anticancer Agents;  Colon and Rectal Cancer
By Lynda Williams, Senior medwireNews Reporter

medwireNews: Phase II trial findings show an improvement in the objective response rate (ORR) for patients with metastatic colorectal cancer (CRC) with the addition of the epidermal growth factor receptor (EGFR)-directed monoclonal antibody (mAb) panitumumab to first-line FOLFOXIRI (irinotecan, oxaliplatin, folinic acid, 5-fluouruacil) chemotherapy.

The study population included 63 patients with untreated RAS wild-type metastatic CRC who were randomly assigned to receive open-label panitumumab 6 mg/kg plus FOLFOXIRI every 2 weeks and 33 patients who were instead given FOLFOXIRI only.

Patients in both the panitumumab and control arms received a median 11 cycles of treatment and were followed up for a median of 44.2 and 63.3 months, respectively, say Michael Geissler, from Klinikum Esslingen in Germany, and co-workers.

The primary endpoint of ORR was 87.3% for the combination arm versus 60.6% for the chemotherapy-only arm, giving a significant odds ratio of 4.47 in favour of panitumumab treatment, they report in the Journal of Clinical Oncology.

And efficacy analyses favoured the combination arm over FOLFOXIRI alone across patient subgroups, with significant benefits noted for those who had not undergone primary tumour resection (odds ratio [OR]=16.67), had left-sided primary tumours (OR=4.52), an age of less than 60 years (OR=12.82) and an ECOG performance status of 0 (OR=6.37).

Progression-free survival was a median of 9.7 months for both treatment arms, but there was a trend to improved overall survival with panitumumab use, at a median of 35.7 versus 29.8 months, although this did not reach significance.

Panitumumab plus chemotherapy was also associated with a significantly higher rate of secondary resection of metastases (33.3 vs 12.1%, odds ratio=3.63), which the researchers say “confirms that the addition of EGFR-targeted mAbs optimizes conversion therapies in [metastatic]CRC”.

Grade 3 and 4 adverse events were more common with panitumumab, occurring in 81.3% of the combination and 66.7% of the FOLFOXIRI arms, with the most common events including diarrhoea (25.0 vs 12.1%), dermatitis acneiform (14.1 vs 0.0%), mucositis/stomatitis (9.4 vs 0.0%), nausea (9.4 vs 0.0%), and vomiting (9.4 vs 3.0%).

“In clinical practice, this four-drug regimen might be best for younger patients with little or no comorbidity in the context of intended conversion therapy or clearly symptomatic disease”, the investigators suggest.

“Taking into account the unfavorable long-term survival in patients with right-sided [metastatic] CRC tumors receiving anti-EGFR mAbs, the regimen is ideally used in patients with left-sided primary tumors”, they add.

“Future studies are required to determine whether the addition of panitumumab to mFOLFOXIRI prolongs survival.” 



Modest DP, Martens UM, Riera-Knorrenschild J, et alFOLFOXIRI plus panitumumab as first-line treatment of RAS wild-type metastatic colorectal cancer: The randomized, open-label, phase II VOLFI study (AIO KRK0190)J Clin Oncol; Advance online publication 14 October 2019.DOI: 10.1200/JCO.19.01340 

Last update: 17 Oct 2019

medwireNews (www.medwireNews.com) is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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