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Title
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Impact of early tumour shrinkage and resection on outcomes in patients with wild-type RAS metastatic colorectal cancer
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Author
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Abstract
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| Background: Tumour shrinkage (TS) increases the possibility of resection in metastatic colorectal cancer (mCRC) and may improve tumour-related symptoms. Here we report prespecified secondary response-related end-points and exploratory TS/resection outcomes for patients with RAS wild-type (WT) tumours (no mutations in KRAS/NRAS exons 2/3/4) from the PRIME study (NCT00364013). Methods: PRIME was a randomised phase 3 study comparing first-line panitumumab + FOLFOX4 versus FOLFOX4 in mCRC patients. Tumour response analyses were conducted to compare response rates and their impact on survival outcomes. Results: Overall, 505 patients had RAS WT mCRC. More patients receiving panitumumab + FOLFOX4 versus FOLFOX4 had >= 30% (59% versus 38%; P < 0.001) or >= 20% (72% versus 57%; P < 0.001) TS at week 8 (early TS); consistent TS benefits were observed over the first similar to 40 weeks of treatment. Objective response rate (P = 0.003), duration of response (P = 0.0027), depth of response (P = 0.0149), progression-free survival (PFS; P = 0.0015) and overall survival (OS; P = 0.0057) were improved in the panitumumab + FOLFOX4 group. Both early TS and resection were associated with improved PFS and OS. 2-year OS rates for patients who did (n = 64) versus did not (n = 441) undergo resection were 88% versus 40%; 2-year OS rates for patients who did (n = 45) versus did not (n = 460) undergo complete resection were 96% versus 41%. Conclusions: Morepatients receiving panitumumab + FOLFOX4 versus FOLFOX4 had >= 30% or >= 20% TS at week 8; PFS and OS were also improved with panitumumab + FOLFOX4. The clinical value of achieving early TS in mCRC warrants further investigation. (C) 2015 The Authors. Published by Elsevier Ltd. |
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Language
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English
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Source (journal)
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European journal of cancer. - Oxford, 1990, currens
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Publication
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Oxford
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2015
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ISSN
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0959-8049
[print]
1879-0852
[online]
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DOI
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10.1016/J.EJCA.2015.03.026
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Volume/pages
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51
:10
(2015)
, p. 1231-1242
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ISI
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000355332000004
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Pubmed ID
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25956209
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Full text (Publisher's DOI)
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Full text (publisher's version - intranet only)
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