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2019 ASCO Annual Meeting!

Session: Gastrointestinal (Colorectal) Cancer

Type: Oral Abstract Session

Time: Saturday June 1, 3:00 PM to 6:00 PM

Location: Hall B1

FOxTROT: an international randomised controlled trial in 1052 patients (pts) evaluating neoadjuvant chemotherapy (NAC) for colon cancer.


Gastrointestinal (Colorectal) Cancer

2019 ASCO Annual Meeting

Abstract No:

J Clin Oncol 37, 2019 (suppl; abstr 3504)

Author(s): Matthew T. Seymour, Dion Morton, on behalf of the International FOxTROT Trial Investigators; National Institute for Health Research Clinical Research Network, Leeds, United Kingdom; The Queen Elizabeth Hospital, Birmingham, United Kingdom

Abstract Disclosures


Background: NAC is well established in many solid tumours but has not undergone large-scale evaluation in colon cancer. Methods: Pts had operable, non-obstructed colon cancer; CT-predicted stage T3-4, N0-2, M0, and were fit for FOLFOX and surgery. They were randomised 2:1 to the novel sequence (6 wk FOLFOX NAC, then surgery, then 18 wk FOLFOX) or control (surgery then 24 wk FOLFOX). RAS-wt pts allocated to the novel arm could optionally be sub-randomized 1:1 to ± panitumumab (pan) during the NAC phase. Two "dealer’s choices" allowed total chemo duration 12 wk instead of 24 (in older/low-risk pts) and OxCap in place of FOLFOX (except in pts randomized ± pan). Primary endpoint is freedom from recurrent or persistent disease after 2 yrs, by ITT. Secondary endpoints include safety, histological stage, completeness of resection, OS. Results: 1052 pts were randomised, Jun 2008-Dec 2016, at 85 centres in UK, Denmark and Sweden. Conclusions: NAC was well tolerated and safe, with no increase in perioperative morbidity and a trend toward fewer serious postoperative complications. Evidence of histological regression was seen in 59% pts after NAC, including some pCRs. This resulted in marked histological downstaging and a halving of the rate of incomplete resections. We observed an improvement in 2-yr failure rate (HR=0.77), but this fell short of statistical significance (p=0.11). NAC for colon cancer improves surgical outcomes and can now be considered as a treatment option; longer follow-up and further trials are required to confirm the long-term benefits, refine its use and optimise case selection. Clinical trial information: 87163246.

Received ≥1 cycle NAC674 (97%)-
Primary resection attempted684 (98%)349 (99%)
*Incomplete resection (R1, R2 or nil)33 (5%)35 (10%)p=0.001
*pCR25 (4%)0p<0.0001
*pT stage: ≤2;3;416;64;20%6;64;30%MH<0.0001
*pN stage: 0;1;260;25;15%48;25;27%MH<0.0001
*Complication prolonging postop stay79 (12%)48 (14%)p=0.29
*Anastomotic leak22 (3%)20 (6%)p=0.08
2-yr failure (relapse/persistent dis.)98 (14%)62 (18%)HR=0.77 p=0.11

(items marked * provisional pending final data checks)

Other Abstracts in this Sub-Category:


1. Three versus six months adjuvant FOLFOX or CAPOX for high risk stage II and stage III colon cancer patients: The efficacy results of Hellenic Oncology Research Group (HORG) participation to the International Duration Evaluation of Adjuvant chemotherapy (IDEA) project.

Meeting: 2019 ASCO Annual Meeting Abstract No: 3500 First Author: Ioannis Sougklakos
Category: Gastrointestinal (Colorectal) Cancer - Local-Regional


2. Prospective pooled analysis of four randomized trials investigating duration of adjuvant (adj) oxaliplatin-based therapy (3 vs 6 months {m}) for patients (pts) with high-risk stage II colorectal cancer (CC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 3501 First Author: Timothy Iveson
Category: Gastrointestinal (Colorectal) Cancer - Local-Regional


3. Re-evaluating disease-free survival (DFS) as an endpoint versus overall survival (OS) in adjuvant colon cancer (CC) trials with chemotherapy +/- biologics: An updated surrogacy analysis based on 18,886 patients (pts) from the Accent database.

Meeting: 2019 ASCO Annual Meeting Abstract No: 3502 First Author: Qian Shi
Category: Gastrointestinal (Colorectal) Cancer - Local-Regional