Phase III CORRECT trial of regorafenib in metastatic colorectal cancer (mCRC).

Gastrointestinal (Colorectal) Cancer
Session Type and Session Title: 
Oral Abstract Session, Gastrointestinal (Colorectal) Cancer
Abstract Number: 


J Clin Oncol 30, 2012 (suppl; abstr 3502)
Eric Van Cutsem, Alberto F. Sobrero, Salvatore Siena, Alfredo Falcone, Marc Ychou, Yves Humblet, Olivier Bouche, Laurent Mineur, Carlo Barone, Antoine Adenis, Josep Tabernero, Takayuki Yoshino, Heinz-Josef Lenz, Richard M. Goldberg, Daniel J. Sargent, Frank Cihon, Andrea Wagner, Dirk Laurent, Axel Grothey, on behalf of CORRECT Investigators; Digestive Oncology Unit, Leuven Cancer Institute, University Hospital Gasthuisberg, Leuven, Belgium; Ospedale San Martino, Medical Oncology, Genova, Italy; Ospedale Niguarda Ca' Granda, Milan, Italy; University of Pisa, Pisa, Italy; CRLC Val d'Aurelle, Montpellier, France; Cliniques Universitaires Saint-Luc, UCL, Brussels, Belgium; University Hospital Robert Debre, Reims, France; Radiology and Oncology Centre, Institut Sainte-Catherine, Avignon, France; Catholic University of Sacred Heart, Rome, Italy; Centre Oscar Lambret, Lille, France; Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain; National Cancer Center Hospital East, Kashiwa, Japan; University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA; Ohio State University Medical Center, Columbus, OH; Mayo Clinic, Rochester, MN; Bayer HealthCare Pharmaceuticals, Montville, NJ; Bayer HealthCare Pharmaceuticals, Berlin, Germany

Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).

Abstract Disclosures


Background: Regorafenib (REG) is an oral multi-kinase inhibitor. The CORRECT trial was conducted to evaluate REG in patients (pts) with mCRC who had progressed after all approved standard therapies. Methods: Enrollment criteria included documented mCRC and progression during or ≤3 months after last standard therapy. Pts were randomized 2:1 to receive best supportive care plus either REG (160 mg od po, 3 wks on/1 wk off) or placebo (PL). The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), overall response rate, disease control rate, safety and quality of life (QoL). Efficacy analyses across prespecified subgroups were evaluated using univariate Cox regression. Results: 760 pts were randomized (REG: 505; PL: 255). The OS primary endpoint was met at a preplanned interim analysis. OS and PFS were significantly improved in REG arm compared to PL arm: hazard ratio (HR) for OS 0.77 (95% CI 0.64-0.94, 1-sided p=0.0052), median OS 6.4 vs 5.0 mos; HR for PFS 0.49 (95% CI 0.42-0.58, 1-sided p<0.000001), median PFS 1.9 vs 1.7 mos. Comparable OS and PFS benefits were observed in exploratory subgroup analyses by region, age, time from diagnosis of mCRC to randomization, prior lines of treatment, and KRAS status (shown in table). The most common grade 3+ AEs related to REG were hand-foot skin reaction (16.6%), fatigue (9.6%), hypertension (7.2%), diarrhea (7.2%) and rash/desquamation (5.8%). QoL data will be presented. Conclusions: REG demonstrated statistically significant improvement in OS and PFS over PL, as well as comparable efficacy benefits across pt subgroups analyzed.
Subgroups N OS
HR 95% CI HR 95% CI
North America, Western EU,
Israel and Australia
632 0.77 0.62-0.95 0.50 0.42-0.60
Asia 104 0.79 0.43-1.46 0.43 0.28-0.68
< 65 yrs 475 0.72 0.56-0.91 0.42 0.34-0.51
≥ 65 yrs 285 0.86 0.61-1.19 0.65 0.50-0.86
Time from Dx of mCRC to randomization
< 18 mo 140 0.82 0.53-1.25 0.58 0.41-0.84
≥ 18 mo 620 0.76 0.61-0.95 0.48 0.40-0.58
No. of prior treatment lines on or after metastatic disease
≤ 3 395 0.79 0.60-1.04 0.53 0.43-0.67
> 3 365 0.75 0.56-0.99 0.47 0.37-0.59
WT 299 0.65 0.48-0.90 0.48 0.36-0.62
MUT 430 0.87 0.67-1.12 0.53 0.43-0.65

* 24 pts from other regions not shown. ^ Historical record.