Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display session 2

6111 - Quality of life during 1st-line FOLFOXIRI+/- panitumumab in RAS wild-type metastatic colorectal cancer: Results from the randomized VOLFI trial (AIO KRK-0109)


29 Sep 2019


Poster Display session 2


Tumour Site

Colon and Rectal Cancer


Michael Geissler


Annals of Oncology (2019) 30 (suppl_5): v198-v252. 10.1093/annonc/mdz246


M. Geissler1, T. Klingler2, D. Modest3, J. Riera Knorrenschild4, T.J. Ettrich5, S. Kanzler6, V. Heinemann7, S. Held8, U.M. Martens9

Author affiliations

  • 1 Gastroenterology, Oncology, Klinikum Esslingen, 73730 - Esslingen am Neckar/DE
  • 2 Oncology, Klinikum Esslingen, Esslingen/DE
  • 3 Oncology, Ludwig Maximilians University - Grosshadern, 81377 - Munich/DE
  • 4 Zentrum Für Innere Medizin, Uniklinikum Giessen und Marburg, 35043 - Marburg/DE
  • 5 Department Of Internal Medicine I, Ulm University Hospital, 89081 - Ulm/DE
  • 6 Gastroenterology, Oncology, Leopoldina Krankenhaus Medizinische Klinik II, 97422 - Schweinfurt/DE
  • 7 Department Of Medical Oncology And Hematology, Klinikum der Universtät München, Munich/DE
  • 8 Klinische Forschungs Gmbh, ClinAssess, 51379 - Leverkusen/DE
  • 9 Department Of Internal Medicine Iii, SLK-Kliniken Heilbronn GmbH, 74078 - Heilbronn/DE


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 6111


This trial evaluated activity and safety of mFOLFOXIRI + panitumumab (P) vs FOLFOXIRI in ECOG 0-1, primarily non-resectable mCRC patients. Here, we report the quality of life data.


Prospective 2:1 randomized, phase II trial comparing mFOLFOXIRI (Ox 85 mg/m2, Iri 150 mg/m2, 5FU 3000mg/m2 cont. 48h, LV 200 mg/m2) + P 6 mg/KG (arm A) with FOLFOXIRI (Ox 85 mg/m2, Iri 165 mg/m2, 5FU 3200mg/m2 cont. 48h, LV 200 mg/m2; arm B), both arms q2w. Cohort 1: irresectable mCRC; cohort 2: chance of secondary resection of metastatic lesions. Primary endpoint was ORR, secondary endpoints were secondary resection rate (cohort 2), toxicity, quality of life (QoL, QLQ-C30). Between-treatment differences in QoL were assessed from baseline to disease progression, and to discontinuation of 1st-line treatment, using analysis of covariance (ANCOVA).


A total of 96 patients were randomized (63 arm A, 33 arm B). There were significantly higher ORR (87.3% vs. 60.6%, p = 0.004), ETS (85.7% vs 60.0%, p = 0.01) and DpR (58.9% vs. 40.9%) in the P arm compared to FOLFOXIRI alone. QoL analyses was performed in 51 patients in arm A and 26 patients in arm B. There were no statistically significant differences between treatment arms from baseline to progression or to discontinuation. Although significantly more secondary resections of metastases were achieved in the P arm of cohort 2 (75.0% vs. 36.4%, p = 0.05), QoL was not different between cohorts 1 and 2 and the treatment arms, respectively. Toxicity or patient wish as the reason for end of therapy were not different between the treatment arms A and B (12.7% vs. 21.2% and 0% vs 6.1%, respectively). Grade III/IV toxicities were numerically higher in the P arm (81.3% vs. 66.7%). This increase was mainly due to toxicities such as diarrhea (25.0% vs 12.1%), mucositis (9.4 vs. 0%), rash (14.1% vs. 0%), and fatigue (7.8% vs. 0%).


mFOLFOXIRI plus P results in significantly higher response rates compared to FOLFOXIRI in RAS wild-type mCRC. Although toxicity was increased, QL reporting was similar in both arms. Therefore, intensive upfront therapy with modified FOLFIRINOX+P represents a valuable treatment option in patients with the need of a highly active 1st-line therapy.

Clinical trial identification


Editorial acknowledgement

Legal entity responsible for the study

Arbeitsgemeinschaft Internistische Onkologie (AIO).




M. Geissler: Honoraria (institution), Advisory / Consultancy: Amgen. D. Modest: Honoraria (institution), Advisory / Consultancy: Amgen. V. Heinemann: Honoraria (institution), Advisory / Consultancy: Amgen. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.