398O - Effect of 5 years of imaging and CEA follow-up to detect recurrence of colorectal cancer (CRC) - PRODIGE 13 a FFCD phase III trial

Background

Intensive follow-up of patients (pts) after curative surgery for CRC is recommended by various scientific societies. These recommendations are mainly based on expert opinions and results of the few clinical trials performed are controversial. Moreover, no survival benefit has been demonstrated.

Methods

PRODIGE 13¹ is a prospective multicentre controlled trial evaluating by double randomisation the impact of i) intensive radiological monitoring (CT-scan/6m) versus a standard one (abdominal ultrasound/3m and thoracic radiography/6m) and ii) CEA assessment versus no, in the follow-up of resected stage II or III CRC with no evidence of residual disease on post-surgical investigation in France and Belgium. The primary endpoint was 5-year overall survival (OS).

Results

Between 09/2009 and 04/2015, 1995 pts were included (75.9%< 75 years old, 16% rectal, 44% left colon cancer (CC)). Among CC 52 % were Stage II (25% received adjuvant chemotherapy). With a median follow-up of 6.5 years, cancer recurrence was detected in 22% of the cases and second CRC in 1.7%. Among recurrences in CC, 8.4% were localized, 74.7% metastatic, and 15.7% both. These pts were treated with curative intent, respectively in 86.7%, 52.3% & 44.6%. Surgical treatment of recurrence with curative intent was 40.9% in the minimum follow-up group (No CEA & standard imaging), 66.3% in the CEA & standard imaging group, 50.7% in the No CEA & CT, and 59.5% in the maximum follow-up group (CEA & CT) (p=0.0035). Among recurrences in rectal cancer, 19.3% were localized, 65% metastatic, and 15.7% both. These pts were treated with curative intent, respectively in 50%, 53.7% & 38.5%. Surgical treatment of recurrence with curative intent was 42.9% in the minimum follow-up group, 57.9% in the CEA group & standard imaging, 55% in the No CEA & CT, and 47.8% in the maximum follow-up group (NS). None of the follow-up modalities resulted in a difference in OS (2^nd interim analysis - 455 events).

Conclusions

After curative surgery, the addition of CEA and/or CT does not provide any benefit in 5-year OS, but allows more curative intent secondary surgeries for patients with a more intensive follow-up. Final results of the study will be reported at the meeting. Ref: (1) Lepage Dig Liver Dis. 2015.

Clinical trial identification

NCT00995202.

Editorial acknowledgement

Legal entity responsible for the study

FFCD.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.