Highlights
- •Cetuximab alone could be a viable maintenance therapy option in metastatic colorectal cancer patients.
- •Progression-free survival (PFS) at 9 months was similar between cetuximab alone and FOLFOX+cetuximab.
- •PFS and overall survival were similar between cetuximab alone and FOLFOX+cetuximab.
- •Safety profile was similar between cetuximab alone and FOLFOX+cetuximab.
Abstract
Background
This multicentre, randomised, and phase II study evaluated mFOLFOX+cetuximab followed
by maintenance mFOLFOX+cetuximab or single-agent cetuximab in metastatic colorectal
cancer (mCRC) patients (NCT01161316).
Patients and methods
Previously, untreated mCRC patients (wild-type KRAS) were randomised to receive cetuximab+mFOLFOX-6 (8 cycles for 2 weeks) followed by
maintenance therapy: single-agent cetuximab (Arm-A) or mFOLFOX-6 + cetuximab (Arm-B)
until progression. Primary endpoint was progression-free survival (PFS) at 9 months.
Results
One hundred ninety-three patients (median [range] age 60 [33–74] years) were randomised
(2:1): 129 Arm-A versus 64 Arm-B. PFS at 9 months (95% confidence interval) showed
non-inferiority between arms (Arm-A/Arm-B: 60 [52, 69]%/72 [61, 83]%, p [non-inferiority]<0.1).
There were no statistically significant differences in the PFS (Arm-A/Arm-B: 9 [95%
CI 7, 10] months/10 [7,13] months, hazard ratio [HR] = 1.19 [0.80, 1.79]) or overall
survival (23 [19, 28] months/27 [18, 36] months, HR = 1.24 [0.85, 1.79]) between arms.
The objective response rate was also similar (48 [39, 57]%/39 [27, 52]%). The safety
profile was similar between arms, and all patients experienced at least one adverse
event (AE) (Arm-A/Arm-B grade ≥III AEs: 70%/68%). The most common grade ≥III AEs were
as follows: neutropenia (Arm-A/Arm-B: 28%/26%), rash acneiform (15%/24%) and sensory
neuropathy (2%/15%) in any group. Arm-A was associated with less grade ≥III rash and
sensory neuropathy and a lower rate of serious AEs (20%/27%).
Conclusion(s)
This phase II exploratory trial with a non-inferiority design suggests that maintenance
therapy with single-agent cetuximab following mFOLFOX+cetuximab induction could be
a valuable option compared with mFOLFOX+cetuximab treatment continuation. We await
phase III trials to confirm single-agent cetuximab as maintenance therapy in mCRC
patients.
Keywords
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Article info
Publication history
Published online: July 24, 2018
Accepted:
June 24,
2018
Received in revised form:
June 21,
2018
Received:
March 23,
2018
Identification
Copyright
© 2018 Elsevier Ltd. All rights reserved.
