Subgroup analysis of patients enrolled in the United States in the CORRECT phase 3 trial of the multikinase inhibitor regorafenib (REG) in metastatic colorectal cancer (mCRC).

Authors

null

Heinz-Josef Lenz

University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA

Heinz-Josef Lenz , Eric Van Cutsem , Udit N. Verma , Marc Saltzman , Jyotsna Fuloria , Ali Khojasteh , Martin Wiesenfeld , Frank Cihon , Andrea Wagner , Axel Grothey

Organizations

University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, University Hospitals Gasthuisberg/Leuven, Leuven, Belgium, The University of Texas Southwestern Medical Center, Dallas, TX, 20880 West Dixie Highway, Aventura, FL, Ochsner Medical Center, New Orleans, LA, Columbia Comprehensive Cancer Care Clinic, Jefferson City, MO, Oncology Associates of Cedar Rapids, Cedar Rapids, IA, Bayer HealthCare Pharmaceuticals, Montville, NJ, Bayer HealthCare Pharmaceuticals, Berlin, Germany, Mayo Clinic, Rochester, MN, Rochester, MN

Research Funding

Pharmaceutical/Biotech Company

Background: The CORRECT trial (NCT01103323) showed that REG improves overall survival (OS) vs placebo (PBO) in patients with mCRC who failed approved therapies (OS HR 0.77; 1-sided p=0.0052; Grothey 2013). A total of 760 patients were randomized to REG (n=505) or PBO (n=255) in more than 100 centers across North America, Europe, Asia, and Australia. We conducted a post-hoc exploratory subgroup analysis of the 83 (11%) patients from 18 US centers. Methods: Eligible patients had an ECOG PS ≤1 and had received approved therapies, including a fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab, and if KRAS wild-type cetuximab and/or panitumumab. Data from the overall cohort, including US patients, are provided for perspective. Descriptive statistics are shown. Results: Of the 83 US patients, 36 (43%) were randomized to PBO and 47 (57%) to REG. Baseline characteristics of the US group were consistent with the overall cohort: median age in the US was 58 yr (range, 34 – 85) vs 61 (22 – 85) overall, 49% of US patients were ECOG PS1 (vs 46%), and 46% received ≤ 3 treatments for mCRC (vs 52%). KRAS status mutant/wild-type was 57%/34% in the US vs 57%/39% overall. All patients in the trial had prior bevacizumab and 57% of US patients also had prior cetuximab and/or panitumumab (vs 51% overall). However, higher proportion of patients in the US were Black (11% vs 2%), KRAS status unknown (10% vs 4%), and had colon as the primary disease site (82% vs 65%). Mean percentages of planned REG dose were similar (76% US vs 79% overall) and mean REG treatment duration was 3.1 mos in US vs 2.8 mos overall. Rates of dose modifications REG/PBO were 87%/47% in the US vs 76%/38% overall and grade ≥3 adverse events REG/PBO were 74%/64% vs 78%/49%, respectively. Based on 44 total death events, the HR for OS in the US subgroup was 0.46 (95%CI 0.25 – 0.84) favoring REG; median OS was 4.7 mos for PBO, but could not be estimated for REG due to censored data. However, this analysis was based on a relatively small sample size and event count. Conclusions: Patients treated in the CORRECT study in the US appear similar to the overall cohort and results are generally consistent with the overall findings of the trial. Clinical trial information: NCT01103323

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Abstract Details

Meeting

2015 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session C: Cancers of the Colon, Rectum, and Anus

Track

Cancers of the Colon, Rectum, and Anus

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

NCT01103323

Citation

J Clin Oncol 33, 2015 (suppl 3; abstr 767)

DOI

10.1200/jco.2015.33.3_suppl.767

Abstract #

767

Poster Bd #

F5

Abstract Disclosures