{Reference Type}: Journal Article
{Title}: Consensus statement on essential patient characteristics in systemic treatment trials for metastatic colorectal cancer: Supported by the ARCAD Group.
{Author}: Goey KKH;Sørbye H;Glimelius B;Adams RA;André T;Arnold D;Berlin JD;Bodoky G;de Gramont A;Díaz-Rubio E;Eng C;Falcone A;Grothey A;Heinemann V;Hochster HS;Kaplan RS;Kopetz S;Labianca R;Lieu CH;Meropol NJ;Price TJ;Schilsky RL;Schmoll HJ;Shacham-Shmueli E;Shi Q;Sobrero AF;Souglakos J;Van Cutsem E;Zalcberg J;van Oijen MGH;Punt CJA;Koopman M;
{Journal}: Eur J Cancer
{Volume}: 100
{Issue}: 0
{Year}: 09 2018
{Factor}: 10.002
{DOI}: 10.1016/j.ejca.2018.05.010
{Abstract}: Patient characteristics and stratification factors are key features influencing trial outcomes. However, there is substantial heterogeneity in reporting of patient characteristics and use of stratification factors in phase 3 trials investigating systemic treatment of metastatic colorectal cancer (mCRC). We aimed to develop a minimum set of essential baseline characteristics and stratification factors to include in such trials.<BR>We performed a modified, two-round Delphi survey among international experts with wide experience in the conduct and methodology of phase 3 trials of systemic treatment of mCRC.<BR>Thirty mCRC experts from 15 different countries completed both consensus rounds. A total of 14 patient characteristics were included in the recommended set: age, performance status, primary tumour location, primary tumour resection, prior chemotherapy, number of metastatic sites, liver-only disease, liver involvement, surgical resection of metastases, synchronous versus metachronous metastases, (K)RAS and BRAF mutation status, microsatellite instability/mismatch repair status and number of prior treatment lines. A total of five patient characteristics were considered the most relevant stratification factors: RAS/BRAF mutation status, performance status, primary tumour sidedness and liver-only disease.<BR>This survey provides a minimum set of essential baseline patient characteristics and stratification factors to include in phase 3 trials of systemic treatment of mCRC. Inclusion of these patient characteristics and strata in study protocols and final study reports will improve interpretation of trial results and facilitate cross-study comparisons.