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Attend this session at the
2017 ASCO Annual Meeting!


Session: Plenary Session Including the Science of Oncology Award and Lecture

Type: Plenary Session

Time: Sunday June 4, 1:00 PM to 4:00 PM

Location: Hall B1

Prospective pooled analysis of six phase III trials investigating duration of adjuvant (adjuv) oxaliplatin-based therapy (3 vs 6 months) for patients (pts) with stage III colon cancer (CC): The IDEA (International Duration Evaluation of Adjuvant chemotherapy) collaboration.

Sub-category:
Other

Category:
Gastrointestinal (Colorectal) Cancer

Meeting:
2017 ASCO Annual Meeting

Abstract No:
LBA1

Citation:
J Clin Oncol 35, 2017 (suppl; abstr LBA1)

Author(s): Qian Shi, Alberto F. Sobrero, Anthony Frank Shields, Takayuki Yoshino, James Paul, Julien Taieb, Ioannis Sougklakos, Rachel Kerr, Roberto Labianca, Jeffrey A. Meyerhardt, Franck Bonnetain, Toshiaki Watanabe, Ioannis Boukovinas, Lindsay A. Renfro, Axel Grothey, Donna Niedzwiecki, Valter Torri, Thierry Andre, Daniel J. Sargent, Timothy Iveson; Mayo Clinic Cancer Center, Rochester, MN; IRCCS San Martino - IST, Genoa, Italy; Wayne State University, Karmanos Cancer Institute, Detroit, MI; Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital, Chiba, Japan; University of Glasgow, Cancer Research UK Clinical Trials Unit, Glasgow, United Kingdom; Hopital Européen Georges Pompidou, Paris, France; University of Heraklion, Athens, Greece; University of Oxford, Oxford, United Kingdom; Ospedale Papa Giovanni XXIII, Bergamo, Italy; Dana-Farber Cancer Institute, Boston, MA; Methodology and Quality of Life Unit, Department of Oncology, INSERM UMR 1098, University Hospital of Besancon; French National Platform Quality of Life and Cancer, Besançon, France; Department of Surgical Oncology and Vascular Surgery, the University of Tokyo, Tokyo, Japan; Bioclinic Thessaloniki Medical Oncology Unit, Thessaloniki, Greece; Mayo Clinic, Rochester, MN; Duke University, Durham, NC; IRCCS - Mario Negri Institute for Pharmacological Research, Milan, Italy; Medical Oncology Department, Saint-Antoine Hospital, Paris, France; University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom

Abstract Disclosures

Abstract:

Background: Since 2004, 6 months (m) of oxaliplatin (oxali)-based treatment has been the standard of care as adjuvant therapy for stage III CC. Since oxali is associated with cumulative neurotoxicity, shorter duration of adjuv therapy could spare pts toxicity and lead to substantial saving in health expenditures. Methods: A prospective, pre-planned pooled analysis of 6 concurrently conducted randomized phase III trials (SCOT, TOSCA, Alliance/SWOG 80702, IDEA France (GERCOR/PRODIGE), ACHIEVE, HORG) was performed to evaluate the non-inferiority (NI) of 3m compared with 6m (ref) of adjuv FOLFOX/XELOX. The primary endpoint was disease-free survival (DFS), defined as time from enrolment to relapse, 2nd CRC, and death (all causes). NI was to be declared if the 2-sided 95% confidence interval (CI) for DFS hazard ratio (HR 3m v 6m) estimated by a stratified Cox model was below 1.12. NI was examined within regimen and stage subgroups as pre-planned. Results: The analysis included 12,834 pts from 12 countries, accrued from 6/07 to 12/15. Stage distribution: 13% T1-2, 66% T3, 21% T4; 28% N2; 40% received XELOX. G3+ neurotoxicity was higher in the 6m v 3m arm (16 v 3% FOLFOX, 9 v 3% XELOX, p<0.0001). With a median follow-up of 39 mos, 3263 DFS events were observed. Overall, the 3 year DFS rate was 74.6% (3m) and 75.5% (6m), with estimated DFS HR of 1.07 (95%CI, 1.00-1.15). The 3m v 6m DFS HRs were 1.16 (95%CI, 1.06-1.26) and 0.95 (95% CI, 0.85-1.06) for FOLFOX and XELOX treated pts, respectively. The 3m v 6m DFS HRs were 1.01 (95%CI, 0.90-1.12) in T1-3 N1, and 1.12 (95%CI, 1.03-1.23) for T4 or N2 pts. Conclusions: While NI was not established for the overall cohort, NI of 3m v 6m oxali-based adjuv therapy was supported for XELOX. As each IDEA trial treated varying proportions of pts with XELOX (0 to 75%), the regimen interaction likely produced the differential outcomes observed between individual studies. Certain substages (T1-3 N1) also showed NI for 3m v 6m. These data provide a framework for discussions on risks and benefits of individualized adjuv therapy approaches. Support: U10CA180821, U10CA180882, U10CA180888, U10CA180835, INCA, PHRC2009, EME 09/800/34, HTA 14/140/84, CRUK C1348/A15960, JFMC. Clinical trial information: NCT01150045

 
Other Abstracts in this Sub-Category:

 

1. FOLFOX4/XELOX in stage II–III colon cancer: Efficacy results of the Italian three or six colon adjuvant (TOSCA) trial.

Meeting: 2017 ASCO Annual Meeting Abstract No: 3501 First Author: Alberto F. Sobrero
Category: Gastrointestinal (Colorectal) Cancer - Other

 

2. Microbiota as a new indicator of colorectal cancer (CRC) heterogeneity.

Meeting: 2017 ASCO Annual Meeting Abstract No: 3615 First Author: Iradj Sobhani
Category: Gastrointestinal (Colorectal) Cancer - Other

 

3. Clonal evolution in locally advanced rectal cancers in response to neoadjuvant chemoradiotherapy.

Meeting: 2017 ASCO Annual Meeting Abstract No: 3616 First Author: Sinead Toomey
Category: Gastrointestinal (Colorectal) Cancer - Other

 

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