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Publications

Journal Article Clinical Trial, Phase II Randomized Controlled Trial Multicenter Study Comparative Study Ppublish

PubMed: 42743885 DOI: 10.1016/j.ejca.2026.117045

Quality of life in patients with RAS wild-type metastatic colorectal cancer treated mFOLFOXIRI + panitumumab versus FOLFOXIRI: A prespecified secondary analysis of the phase II VOLFI AIO-KRK 0109 trial.

Eur J Cancer 247:117045

Authors: Tshilidzi M Klingler, Uwe M Martens, Jorge Riera-Knorrenschild, Swen Wessendorf, Thomas Ettrich, Stephan Kanzler, Sophie Lugani, Elena Rohleder, Arndt Stahler, Alena A Hasenburg, Swantje Held, Petra Buechner-Steudel, Jens Atzpodien, Volker Heinemann, Michael Geissler, Dominik P Modest, Johannes Werner

Affiliations

  • Klinikum Esslingen, Esslingen, Germany.
  • SLK Kliniken Klinikum am Gesundbrunnen, Heilbronn, Germany.
  • Universitätsklinik Marburg, Marburg, Germany.
  • Universitätsklinikum Ulm, Ulm, Germany.
  • Leopoldina Krankenhaus, Schweinfurt, Germany.
  • Charité Comprehensive Cancer Center, Charité Universitätsmedizin Berlin, Berlin, Germany.
  • Medicine Department of Hematology, Oncology and Tumor Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany.
  • ClinAssess, Leverkusen, Germany.
  • Universitätsklinikum Halle (Saale), Halle, Germany.
  • Franziskus-Hospital Harderberg, Georgsmarienhütte, Germany.
  • Department of Medicine III and Comprehensive Cancer Center, University Hospital Munich (LMU), Munich, Germany.
  • Charité Comprehensive Cancer Center, Charité Universitätsmedizin Berlin, Berlin, Germany.

Abstract

BACKGROUND

The phase II, randomized VOLFI (AIO-KRK 0109) trial evaluated mFOLFOXIRI + panitumumab compared to FOLFOXIRI in untreated RAS wild type (WT) metastatic colorectal cancer (mCRC). Anti-EGFR antibodies like panitumumab are associated with a specific toxicity profile including skin toxicity, potentially compromising health-related quality of life (HRQoL).

METHODS

HRQoL of patients treated in the VOLFI trial was measured using EORTC QLQ-C30 questionnaires. We analyzed HRQoL of patients from the intention-to-treat (ITT) population who completed at least one EORTC QLQ-C30. HRQoL was assessed at baseline and after 6, 12, 18, 24 weeks and completion of treatment.

RESULTS

105 patients were randomized 2:1 to the mFOLFOXIRI + panitumumab and FOLFOXIRI arms. 63 and 33 patients were included in the ITT population, respectively. 77 patients (51 receiving mFOLFOXIRI + panitumumab, 26 receiving FOLFOXIRI) were available for HRQoL assessment. There were no statistically significant differences in overall HRQoL or specific HRQoL dimensions between treatment arms at baseline and after 12 weeks of treatment. Patients receiving mFOLFOXIRI + panitumumab had numerically worsened pain scores and improved social functioning during treatment. In patients receiving mFOLFOXIRI + panitumumab who experienced skin toxicity, overall HRQoL was not associated with the grade of skin toxicity.

CONCLUSION

The use of mFOLFOXIRI + panitumumab demonstrated efficacy in first line treatment of RAS WT mCRC compared to FOLFOXIRI without negatively affecting HRQoL. The option to use mFOLFOXIRI plus EGFR-antibodies should primarily be based on physical fitness to receive triplet chemotherapy and to a lesser extent on concerns regarding HRQoL.

TRIAL REGISTRATION

ClinicalTrials.gov NCT01328171.

MeSH

Skin, Quality Of Life, Antibodies, Neoplasms, Panitumumab, Therapeutics, Colorectal Neoplasms