BGDO | Belgian Group of Digestive Oncology

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Pepita

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The PEPITA trial is Prospective Belgian multicenter non-interventional non-randomized phase II study studying PrEoperative chemosensitivity testing as PredIctor of Treatment benefit in Adjuvant stage III colon cancer :

Introduction

In Belgium, 7700 new cases of colorectal cancer are diagnosed each year, of which 50% will eventually die from disease recurrence or progression. Adjuvant FOLFOX improves the outcome of the stage III patients. Meanwhile, 70% of them will not benefit from chemotherapy either because the disease has already been cured by surgery or because cancer will recur anyhow.

No further drug regimen improvement is expected in the near future in that field as data from international trials become progressively available. The addition of bevacizumab or cetuximab to FOLFOX has shown no advantage.

PePiTA trial hypothesizes that preoperative assessment of metabolic response after one injection of FOLFOX will be able to predict the outcome of the complete adjuvant treatment course. Results could have a major impact in daily practice, avoiding useless toxicities in patients bearing resistant tumors and allowing tailorisation designs for future trials in adjuvant setting. 

National Health Authorities

PePiTA is a BGDO trial supported and monitored by the National Health Authorities through a grant from the National Cancer Plan-29th action. The authorities have decided during the last meeting at the Social Affairs Ministery on Friday 19th November 2010, to prolong their financial support for those projects.

Nevertheless, PePiTA’s current accrual rate remains slow. We hope, thanks to the investigators’commitment to achieve their purposed goals, to reach the target study population at the end of 2011. The study team thanks deeply the recruiting centers for the excellent quality of their work, and strongly encourage screening all possible patients. We express full support for the sites where no inclusion has been recorded so far. PePiTA needs all your efforts to become a successful story in adjuvant colorectal treatment for the benefit of our patients.

 

Study progress

26 patients have been included in the study so far, as shown in the figure hereunder. Since the last issue of newsletter on 29/06/2010: 15 new patients have been included and 4 new sites become active. Indeed Dr Van den Eynde, Dr Demolin, Prof Van Laethem and Dr Clausse included their first patients in the study. We particularly want to congratulate Dr. Van den Eynde and Dr Van Laethem and their entire site staff who included each 3 patients in 1 month.

 

Miscellaneous

The first course of FOLFOX is reimbursed for all stage II confirmed at surgery via an invoice

sent to Jules Bordet Institute. It is advised to give the course of preoperative FOLFOX during a short hospitalisation with a peripheral line in order to avoid technical problems linked with implantable devices.

Colon surgery is possible and safe during or after chemotherapy : Questions from surgeons

find their answer in the experiences of liver-first surgery in synchronous metastatic colon cancer (Mentha G et al., Dig Surg. 2008;25(6):430-5) and of secondary colonic continuity restablishment during adjuvant therapy. Use of neoadjuvant chemo- or radiochemotherapies, as far as clues exist in the literature, has proven its feasibility if not its relative inocuity for the patient. This point remains nevertheless under scrutiny, and Suspected Unexpected Serious Adverse Events will be reported to the investigators according to the legal prescriptions.