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Treatment sequence with either irinotecan/cetuximab followed by FOLFOX-4 or the reverse strategy in metastatic colorectal cancer patients progressing after first-line FOLFIRI/bevacizumab: An Italian Group for the Study of Gastrointestinal Cancer phase III, randomised trial comparing two sequences of therapy in colorectal metastatic patients
Ist Teil von
European journal of cancer (1990), 2017-09, Vol.83, p.106-115
Ort / Verlag
England: Elsevier Ltd
Erscheinungsjahr
2017
Link zum Volltext
Quelle
ScienceDirect Journals (5 years ago - present)
Beschreibungen/Notizen
The optimal treatment strategy for RAS wild type (WT) mCRC is controversial. Our phase III study investigated the effect of introducing earlier (second-line) or later (third-line) cetuximab in patients progressed after FOLFIRI/bevacizumab first-line.
mCRC patients progressing after FOLFIRI/bevacizumab first-line were randomised to receive second-line irinotecan/cetuximab followed by third-line FOLFOX-4 (arm A) or the reverse sequence (arm B). Primary end-point was progression-free survival (PFS).
About 54 and 56 patients were randomised in arm A and in arm B, respectively. After a median follow-up of 37.5 months, 100 PFS events were recorded. Median PFS was 9.9 months in arm A and 11.3 months in arm B (Hazard ratio [HR] 1.04, 95% confidence interval [CI]: 0.69–1.56, p = 0.854), while median overall survival was 12.3 months in arm A and 18.6 months in arm B (HR 0.84, 95% CI: 0.55–1.28; p = 0.411). No overall difference in side-effects were observed between the two treatment arms.
This trial did not meet the primary end-point (PFS). Like other preclinical and clinical evidences, our study seems to suggest a reduced activity of cetuximab after a first-line bevacizumab-based therapy.
•The effect of introducing in second or third-line cetuximab after a progression to FOLFIRI/bevacizumab.•No difference in progression-free survival among the two sequences.•A trend for a better overall survival for cetuximab third-line.•An observed reduced activity of cetuximab after a first-line bevacizumab-based therapy.•This reduced activity may have relevant therapeutic consequences in patients with left tumours.