Health-related quality of life in patients with RAS wild-type metastatic colorectal cancer treated with panitumumab-based first-line treatment strategy: A pre-specified secondary analysis of the Valentino study

Abstract Background: Quality of life (QoL) patient-reported outcomes (PROs) data from
pivotal first-line trials in metastatic colorectal cancer (mCRC) are poor. The Valentino study
showed that de-escalation to single-agent panitumumab after 4-month induction with
panitumumab-FOLFOX is inferior to panitumumab-5-FU/LV in patients with RAS wild type mCRC, although slightly reducing toxicity. We report QoL, a secondary end-point.
Methods: PROs were assessed by European Organisation for Research and Treatment of Can cer (EORTC) Quality of Life Questionnaire e Core 30 (QLQ-C30), EORTC QLQ-CR29,
EuroQol EQ-5D questionnaires, at baseline and every 8 weeks until disease progression. First
two evaluations correspond to induction treatment (identical in both arms), while subsequent
to maintenance. To describe QoL changes over time, mean changes from baseline at each time
point were calculated in overall population. To compare maintenance between two arms,
mean changes and proportion of improved/stable/worse patients versus baseline were
compared for each item.
Results: In arm A/B, 91.5%/92.0% of enrolled patients completed questionnaires at baseline.
No significant differences in the two arms were reported in compliance, baseline scores and
mean changes versus baseline for the three questionnaires during maintenance (24/32/40
weeks). Overall, mean changes versus baseline showed an early deterioration during induction
with partial recovering during maintenance for global QoL, functional scales and several
symptoms/items of QLQ-C30 (fatigue, nausea/vomiting, appetite loss, diarrhoea) and QLQ CR29 (body image, dry mouth, hair loss, taste, faecal incontinence, sore skin), and EQ-5D Vi sual Analogue Scale (VAS) score.
Conclusion: In patients with RAS wild-type mCRC, induction with oxaliplatin-containing
chemotherapy plus anti-EGFRs induces a transient significant QoL deterioration. After in duction phase, treatment deintensification determines an overall recovery of health-related
QoL, besides the expected prevention of oxaliplatin-related neurotoxicity