Preoperative chemosensitivity testing as Predictor of Treatment benefit in Adjuvant stage III colon cancer (PePiTA): Protocol of a prospective BGDO (Belgian Group for Digestive Oncology) multicentric study

Background: Surgery is a curative treatment for patients with locally advanced colon cancer, but recurrences are frequent for those with stage III disease. FOLFOX adjuvant chemotherapy has been shown to improve recurrence-free survival and overall survival by more than 20% and is nowadays considered a standard of care. However, the vast majority of patients will not benefit from receiving cytotoxic drugs because they have either already been cured by surgery or because their tumor cells are resistant to the chemotherapy, for which predictive factors are still not available.Identifying which pa... Mehr ...

Verfasser: Hendlisz, Alain
Golfinopoulos, Vassilis
Deleporte, Amélie
Paesmans, Marianne
Mansy, Hazem El
Garcia, Camilo
Peeters, Michel
Annemans, Lieven
Vandeputte, Caroline
Maetens, Marion M.
Borbath, Ivan
Dresse, Damien
Houbiers, Ghislain
Fried, Michael
Awada, Ahmad
Piccart-Gebhart, Martine
Van Laethem, Jean-Luc
Flamen, Patrick
Dokumenttyp: Artikel
Erscheinungsdatum: 2013
Schlagwörter: Cancérologie / Biologie / Adenocarcinoma -- drug therapy -- mortality -- pathology / Antineoplastic Combined Chemotherapy Protocols -- therapeutic use / Belgium / Chemotherapy / Adjuvant / Colonic Neoplasms -- drug therapy -- mortality -- pathology / Fluorouracil -- therapeutic use / Follow-Up Studies / Gene Rearrangement / Humans / Leucovorin -- therapeutic use / Lymphocytes / Tumor-Infiltrating / Neoplasm Staging / Neoplastic Cells / Circulating -- pathology / Organoplatinum Compounds -- therapeutic use / Polymorphism / Single Nucleotide -- genetics / Positron-Emission Tomography / Preoperative Care / Prognosis / Prospective Studies / Quality of Life / Survival Rate / Tomography / X-Ray Computed / Chemosensitivity / Colon cancer / Early assessment / FDG-PET / PET/CT
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-28877698
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : http://hdl.handle.net/2013/ULB-DIPOT:oai:dipot.ulb.ac.be:2013/178525

Background: Surgery is a curative treatment for patients with locally advanced colon cancer, but recurrences are frequent for those with stage III disease. FOLFOX adjuvant chemotherapy has been shown to improve recurrence-free survival and overall survival by more than 20% and is nowadays considered a standard of care. However, the vast majority of patients will not benefit from receiving cytotoxic drugs because they have either already been cured by surgery or because their tumor cells are resistant to the chemotherapy, for which predictive factors are still not available.Identifying which patients are unlikely to respond to adjuvant chemotherapy from among those who are eligible for such treatment would be a major step towards treatment personalization. It would spare such patients from unnecessary toxicities and would improve the allocation of societal healthcare resources.Methods/design: PePiTA is a prospective, multicenter, non-randomised trial built on the hypothesis that preoperative chemosensitivity testing using FDG-PET/CT before and after one course of FOLFOX can identify the patients who are unlikely to benefit from 6 months of adjuvant FOLFOX treatment for stage III colon cancer.The study's primary objective is to examine the ability of PET/CT-assessed tumor FDG uptake after one course of preoperative chemotherapy to predict the outcome of adjuvant therapy, as measured by 3-year disease-free survival.Secondary objectives are to examine the predictive value of changes in PET/CT-assessed tumor FDG uptake on overall survival, to define the best cut-off value of FDG uptake for predicting treatment outcome, and to analyse the cost-effectiveness of such preoperative chemo-sensitivity testing.At study planning, exploratory translational research objectives were 1) to assess the predictive value of circulating tumor cells for disease-free survival, 2) to examine the predictive value of single nucleotide polymorphisms for disease-free survival with respect to genes related either to toxicity or to drug ...