A phase 3 trial evaluating panitumumab plus best supportive care vs best supportive care in chemorefractory wild-type KRAS or RAS metastatic colorectal cancer
TW Kim, A Elme, Z Kusic, JO Park, AA Udrea… - British journal of …, 2016 - nature.com
TW Kim, A Elme, Z Kusic, JO Park, AA Udrea, SY Kim, JB Ahn, RV Valencia, S Krishnan…
British journal of cancer, 2016•nature.comBackground: We assessed the treatment effect of panitumumab plus best supportive care
(BSC) vs BSC on overall survival (OS) in patients with chemorefractory wild-type KRAS exon
2 metastatic colorectal cancer (mCRC) and report the first prospective extended RAS
analysis in a phase 3 trial. Methods: Patients with wild-type KRAS exon 2 mCRC were
randomised 1: 1 to panitumumab (6 mg kg− 1 Q2W) plus BSC or BSC. On-study crossover
was prohibited. RAS mutation status was determined by central laboratory testing. The …
(BSC) vs BSC on overall survival (OS) in patients with chemorefractory wild-type KRAS exon
2 metastatic colorectal cancer (mCRC) and report the first prospective extended RAS
analysis in a phase 3 trial. Methods: Patients with wild-type KRAS exon 2 mCRC were
randomised 1: 1 to panitumumab (6 mg kg− 1 Q2W) plus BSC or BSC. On-study crossover
was prohibited. RAS mutation status was determined by central laboratory testing. The …
Abstract
Background:
We assessed the treatment effect of panitumumab plus best supportive care (BSC) vs BSC on overall survival (OS) in patients with chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer (mCRC) and report the first prospective extended RAS analysis in a phase 3 trial.
Methods:
Patients with wild-type KRAS exon 2 mCRC were randomised 1: 1 to panitumumab (6 mg kg− 1 Q2W) plus BSC or BSC. On-study crossover was prohibited. RAS mutation status was determined by central laboratory testing. The primary endpoint was OS in wild-type KRAS exon 2 mCRC; OS in wild-type RAS mCRC (KRAS and NRAS exons 2, 3, and 4) was a secondary endpoint.
Results:
Three hundred seventy seven patients with wild-type KRAS exon 2 mCRC were randomised. Median OS was 10.0 months with panitumumab plus BSC vs 7.4 months with BSC (HR= 0.73; 95% CI= 0.57–0.93; P= 0.0096). RAS ascertainment was 86%. In wild-type RAS mCRC, median OS for panitumumab plus BSC was 10.0 vs 6.9 months for BSC (HR= 0.70; 95% CI= 0.53–0.93; P= 0.0135). Patients with RAS mutations did not benefit from panitumumab (OS HR= 0.99; 95% CI= 0.49–2.00). No new safety signals were observed.
Conclusions:
Panitumumab significantly improved OS in wild-type KRAS exon 2 mCRC. The effect was more pronounced in wild-type RAS mCRC, validating previous retrospective analyses.
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