Abstract
Background and Objectives
We have previously showed that for patients with wild-type RAS metastatic colorectal
cancer (mCRC) progressing after bevacizumab plus chemotherapy, bevacizumab continuation
plus a switch of chemotherapy is the most appropriate option (PRODIGE 18 phase II
study). Here we aimed to determine treatment impact in patient's Health-Related Quality
Of Life (HRQoL) in PRODIGE18 study.
Methods
HRQoL was evaluated in 2 arms bevacizumab or cetuximab—combined with chemotherapy
(modified FOLFOX6 [mFOLFOX6] or FOLFIRI) using the European Organization for Research
and Treatment of Cancer (EORTC) QLQ-C30 at baseline, first and third tumor evaluation
and at the end of the study. The temporal evolution of quality of life scores was
investigated using longitudinal linear mixed models of variance. The time until definitive
deterioration (TUDD) was estimated using the Kaplan-Meier method and the long-rank
test. A univariate Cox model was used to calculate HR with 95% CI. A multivariate
Cox model was applied to determine association of TUDD with age and gender. Safety
was assessed by the National Cancer Institute Common Terminology Criteria for Adverse
Events.
Results
HRQoL QLQ-C30 questionnaire compliance was high at baseline (>90%) and declined over
time (∼70% in tumor evaluation 1 and ∼ 60% in tumor evaluation 3), but remained similar
in both treatment arms. Patient reported mean diarrhea QLQ-C30 score is significantly
higher in bevacizumab treatment arm. Clinician reported mild diarrhea was more frequently
declared in bevacizumab treatment arm. Cox multivariate analyses showed no statistically
significant differences in TUDD for all QLQ-C30 scales between treatments. TUDD of
appetite loss was significantly associated to age.
Conclusions
Our study shows that no relevant impairment of patients HRQoL between the 2 treatment
arms. So, the analysis of the HRQoL with equal effectiveness does not make it possible
to favor one treatment over another.
Keywords
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Article info
Publication history
Published online: October 03, 2021
Accepted:
September 9,
2021
Received in revised form:
April 20,
2021
Received:
January 14,
2021
Footnotes
ClinicalTrials.gov: NCT01442649; Clinicaltrialsregister.eu EUDRACT 2009-012942-22.
Identification
Copyright
© 2021 Published by Elsevier Inc.
