• Explore /
  • Abstract
  • / Subgroup analyses results of the PETACC8 phase III trial comparing adjuvant FOLFOX4 with or without cetuximab (CTX) in resected stage III colon cancer (CC).

Subgroup analyses results of the PETACC8 phase III trial comparing adjuvant FOLFOX4 with or without cetuximab (CTX) in resected stage III colon cancer (CC).

Abstract Poster

Authors

null

Julien Taïeb

Georges Pompidou European Hospital, Paris, France

Julien Taïeb , Josep Tabernero , Enrico Mini , Fabien Subtil , Gunnar Folprecht , Jean-Luc Van Laethem , Joseph Thaler , John A. Bridgewater , Evaristo Sanches , Lone Petersen , Laurence Collette , Eric Van Cutsem , Karine Le Malicot , Philippe Rougier , Ramon Salazar , Laurent Bedenne , Jean Francois Emile , Pierre Laurent-Puig , Come Lepage

Organizations

Georges Pompidou European Hospital, Paris, France, Vall d'Hebron University Hospital, Barcelona, Spain, Unità di Chemioterapia, Dipartimento di Farmacologia, Università degli Studi di Firenze, Firenze, Italy, Fédération Francophone de la Cancérologie Digestive, Dijon, France, University Hospital Carl Gustav Carus, University Cancer Center / Medical Department I, Dresden, Germany, Erasme University Hospital, Brussels, Belgium, Department of Internal Medicine IV, Klinikum Kreuzschwestern Wels, Wels, Austria, University College London Cancer Institute, London, United Kingdom, Instituto Portugues de Oncologia, Porto, Portugal, Department of Oncology, Rigshospitalet, København, Denmark, EORTC Headquarters, Brussels, Belgium, University Hospital Gasthuisberg, Leuven, Belgium, Fédération Francophone de la Cancérologie Digestive Faculté de Médecine, Dijon, France, European Hospital George Pompidou, Paris, France, Translational Research Laboratory and Department of Medical Oncology, Institut Catala d'Oncologia-IDIBELL, Hospitalet de Llobregat, Spain, University Hospital, Dijon, France, Service d’Anatomie Pathologique Hôpital Ambroise Paré, Boulogne Billancourt, France, Hôpital Européen Georges Pompidou (HEGP), Assistance Publique Hôpitaux de Paris (APHP), Paris, France, Centre Hospitalier Universitaire Bocage, Dijon, France

Research Funding

Pharmaceutical/Biotech Company

Background: Potential benefit of adding CTX to the current standard treatment for stage III CC, was assessed. Subgroup analyses of demographic, clinical and molecular data may improve our understanding of this patient population. Methods: Patients (pts) were randomized 28-56 days following resection. They received 12 biweekly cycles of oxaliplatin 85 mg/m2 day (d) 1, with leucovorin 200 mg/m2, 5-FU 400 mg/m2 bolus IV, followed by 5-FU 600 mg/m2 22-hr IV on d1-2 (FOLFOX4), without (arm A) or with weekly CTX (arm B) 250 mg/m2 (initial dose 400 mg/m2). Primary endpoint was disease free survival time (DFS). Secondary endpoints included overall survival (OS), treatment compliance and safety. Enrolment was restricted to KRAS wt pts in 06/2008. Planned accrual of 1,407 KRAS wild-type (wt) pts provided 90% power to detect a hazard ratio (HR) of 0.75 with 2-sided α=0.05, with interim analyses after 65% of planned events. Preplanned subgroup analyses were performed. Results: 1,602 KRAS wt pts (811 arm A, 791 arm B) and 742 mutated (m) KRAS (prior to the amendment), were randomized. BRAF status was determined in 1134 (71%) KRAS wt pts. Median follow-up was 40 months. This interim analysis showed no difference between arms for DFS (HR 1.05, 95% CI 0.85-1.29; p=0.66) or OS (HR 1.09, 95% CI 0.81-1.47; p=0.55) in KRAS wt pts or for DFS (HR 0.99, 95% CI 0.75-1.28; p=0.91) or OS (HR 0.98, 95% CI 0.67-1.44; p=0.92) in KRAS/BRAF wt pts (n=984). Similar results were seen in KRAS mutant (mt) pts without any detrimental effect. In KRAS wt pts worse outcomes were seen with CTX in pts >70 years (n=149, DFS: HR 1.97, 95% CI 0.99-3.93; p=0.05), in females (n=666, HR 1.45, 95% CI 1.03-2.03; p=0.03) and in pts with right-sided CC (n=570, HR 1.40, 95% CI 1.01-1.94; p=0.04). Conversely, a better outcome was seen in pts with pT4pN2 CC (n=146, HR 0.55, 95% CI 0.35-0.89; p=0.01). Conclusions: Adding CTX to FOLFOX4 offered no benefit to pts with resected stage III KRAS wt, KRAS/BRAF wt and KRAS mt CC. Subgroup analyses suggest that KRAS wt pts with pT4pN2 tumors may derive benefit from CTX. MSI status determination is ongoing to explore its potential interaction with poor outcome in female and/or with right-sided tumors pts. Clinical trial information: NCT00265811.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2013 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Gastrointestinal (Colorectal) Cancer

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer

Clinical Trial Registration Number

NCT00265811

Citation

J Clin Oncol 31, 2013 (suppl; abstr 3525^)

DOI

10.1200/jco.2013.31.15_suppl.3525

Abstract #

3525^

Poster Bd #

17

Abstract Disclosures

Similar Abstracts

First Author: Naohiro Tomita

First Author: Takahiro Tsushima

First Author: Sreenivasa R Chandana

First Author: Sebastian Stintzing