Procedures
tumor, Tumor, Cancer
DISEASE PROGRESSION, TUMOR, TUMOR, DISEASE, BLOOD, CANCER
Patients received first-line induction with mFOLFOX6 consisting of an intravenous infusionClinical data were collected at the Department of Statistics of the Centre Georges-François Leclerc. Tumor assessments were based on investigator-reported measurements and were performed according to RECIST version 1.1 and repeated every 12 weeks. Safety was monitored continuously throughout the study. All AEs were recorded and classified according to CTCAE version 4.0, regardless of relation to the study drugs. An independent safety monitoring committee periodically reviewed the study safety data.Peripheral blood samples were collected in 10-ml cell preparation tubes (BD Biosciences) at baseline and at weeks 3, 9 and 23. All samples were processed within 4–6 h after collection.Blood samples for isolation of PBMCs were collected longitudinally at participating clinical sites, shipped overnight and processed at a central site (on the biomonitoring platform at Besançon) over a Ficoll gradient and cryopreserved. Serum was processed within 2 h of collection at each site and frozen immediately at −80 °C and then batch shipped to a central biorepository. Blood sampling for immune biomarkers occurred during screening, at cycle 1 days 1 and 15, at cycle 3 day 1 and at cycle 6 day 15 and at treatment discontinuation. These samples were shipped overnight and processed at a central site (on the Cancer Biology Transfer Platform at Dijon). If a patient began any new anti-cancer therapy before their end-of-treatment visit, samples were not collected. Baseline or archival as well as post-treatment tumor specimens were collected for biomarker analyses. Fresh tumor biopsies were immediately formalin-fixed and paraffin-embedded (FFPE). For patients who agreed, an on-treatment biopsy (at cycle 3) could be performed and were also FFPE. Additional biopsies were allowed for patients who had prolonged stable disease, defined as more than two consecutive disease assessments demonstrating response by RECIST version 1.1 as well as at the time of disease progression. Ad hoc biopsy collection was permitted with the approval of the medical monitor.