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.

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.