Final results and outcomes by prior bevacizumab exposure, skin toxicity,?and hypomagnesaemia from ASPECCT: randomized phase 3 non-inferiority study of panitumumab versus cetuximab in chemorefractory wild-type KRAS exon 2 metastatic colorectal cancer

Price, Timothy; Kim, Tae Won; Li, Jin; Cascinu, Stefano; Ruff, Paul; Suresh, Attili Satya; Thomas, Anne; Tjulandin, Sergei; Guan, Xuesong; Peeters, Marc
European journal of cancer (Oxford, England : 1990)
2016Nov ; 68 ( Pt A ) :51-59.
저자 상세정보
Price, Timothy -
Kim, Tae Won -
Li, Jin -
Cascinu, Stefano -
Ruff, Paul -
Suresh, Attili Satya -
Thomas, Anne -
Tjulandin, Sergei -
Guan, Xuesong -
Peeters, Marc -
ABSTRACT
PURPOSE: The primary analysis of the ASPECCT study demonstrated that panitumumab was non-inferior to cetuximab for overall survival (OS) in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (mCRC). Here, we report the final analysis results of ASPECCT. PATIENTS AND

METHODS: Patients with wild-type KRAS exon 2 mCRC who progressed on or were intolerant to irinotecan- or oxaliplatin-based chemotherapy were randomised to receive panitumumab 6?mg/kg once every 2 weeks or cetuximab (400?mg/m(2)) followed by 250?mg/m(2) weekly. The primary end-point was OS assessed for non-inferiority. Patients were followed for survival for 24 months after the last patient was randomised and a final analysis was conducted. No formal hypothesis testing was done. Post hoc analyses of outcomes by prior bevacizumab exposure, worst-grade skin toxicity (0-1 versus 2-4)?and worst-grade hypomagnesaemia (0 versus 1-4) were conducted.

RESULTS: Nine hundred ninety-nine patients were randomised and received ?? treatment dose (panitumumab, n?=?499; cetuximab, n?=?500). Median OS was 10.2 months with panitumumab versus 9.9 months with cetuximab (hazard ratio?=?0.94; 95% confidence interval?=?0.82-1.07). Median progression-free survival was 4.2 months with panitumumab and 4.4 months with cetuximab (hazard ratio?=?0.98; 95% confidence interval?=?0.87-1.12). Longer OS was observed for patients with increased skin toxicity and with hypomagnesaemia in both arms. Furthermore, OS was longer for patients with prior bevacizumab exposure treated with panitumumab than with cetuximab. The observed safety profiles were consistent with previous studies. CONCLUSION: Consistent with the primary analysis, the final analysis of ASPECCT showed panitumumab was non-inferior to cetuximab for OS for patients with chemotherapy-refractory, wild-type KRAS exon 2 mCRC. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01001377. CI - Copyright ??2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
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MESH
Adult, Aged, Aged, 80 and over, Angiogenesis Inhibitors/therapeutic use, Antibodies, Monoclonal/*therapeutic use, Antineoplastic Agents/*therapeutic use, Bevacizumab/therapeutic use, Carcinoma/*drug therapy/genetics/secondary, Cetuximab/*therapeutic use, Colorectal Neoplasms/*drug therapy/genetics/pathology, Disease-Free Survival, Drug Eruptions/epidemiology/etiology, Female, Humans, Liver Neoplasms/*drug therapy/genetics/secondary, Magnesium/blood, Male, Middle Aged, Multivariate Analysis, Neoplasm Metastasis, Proportional Hazards Models, Proto-Oncogene Proteins p21(ras)/genetics, Survival Rate, Water-Electrolyte Imbalance/blood/epidemiology, Young Adult
링크

주제코드
주제명(Target field)
연구대상(Population)
연구참여(Sample size)
대상성별(Gender)
질병특성(Condition Category)
연구환경(Setting)
연구설계(Study Design)
연구기간(Period)
중재방법(Intervention Type)
중재명칭(Intervention Name)
키워드(Keyword)
유효성결과(Recomendation)
Panitumumab remained non-inferior to cetuximab for overall survival (OS).
연구비지원(Fund Source)
근거수준평가(Evidence Hierarchy)
출판년도(Year)
참여저자수(Authors)
대표저자
DOI
10.1016/j.ejca.2016.08.010
KCD코드
ICD 03
건강보험코드