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
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
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 NAC||674 (97%)||-|
|Primary resection attempted||684 (98%)||349 (99%)|
|*Incomplete resection (R1, R2 or nil)||33 (5%)||35 (10%)||p=0.001|
|*pT stage: ≤2;3;4||16;64;20%||6;64;30%||MH<0.0001|
|*pN stage: 0;1;2||60;25;15%||48;25;27%||MH<0.0001|
|*Complication prolonging postop stay||79 (12%)||48 (14%)||p=0.29|
|*Anastomotic leak||22 (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)