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Copyright ©The Author(s) 2016.
World J Gastroenterol. Dec 14, 2016; 22(46): 10124-10130
Published online Dec 14, 2016. doi: 10.3748/wjg.v22.i46.10124
Table 2 Comparison of the FOLFIRINOX and modified FOLFIRINOX trials
ACCORD/PRODIGE trial (FOLFIRINOX)[9]Stein et al[20] Modified FOLFIRINOXMahaseth et al[21] (Modified FOLFIRINOX)Ghorani et al[22] (Modified FOLFIRINOX)
LocationFranceUnited StatesUnited StatesUnited Kingdom
Number of patients342443618
Study designPhase 2-3 ProspectivePhase 2 ProspectivePhase 2 ProspectiveRetrospective
Study designDosing25% reduction in bolus 5-FU and irinotecan dosesNo 5-FU bolusNo 5-FU bolus and 25% reduction in irinotecan doses
Patient and tumor characteristicsMedian age61 years626360
Sex distributionMale (62%)Male (56.8%)Male (56.8%)Male (44.6%)
ECOGPS 0 (37.4%)PS 0 (46%)PS 0 (22%)PS 0 (56.6%)
PS 1 (61.9%)PS 1 (54%)PS 1 (76%)PS 1 (44.4%)
PS 2 (0.6%)PS 2 (1%)
Tumor stageMetastaticMetastaticMetastaticLocally advanced and metastatic
Metastatic sitesLiver (87.6%)Liver (54.1%)
Lung (19.4%)Lung (32.4%)
Peritoneum (19.4%)Peritoneum (37.8%)
Tumor locationHead (39.2%)Head (54.8%)NAHead (566%)
ResponseORR (%)31.635.13047
PR (%)3135.1NA47
SD (%)38.651.5NA23
DCR (%)70.286.6NA80
PFS (mo)6.46.18.57.2
OS (mo)11.110.299.3
1-yr OS (%)48.438NANA
Safety (grade 3-4 toxicities)Neutropenia45.712.230
Febrile N.5.44.105.6
Thrombocytopenia9.19.540
Anemia7.85.40
Fatigue23.612.2135.6
Peripheral neuropathy92.740
Diarrhea12.716.21316.7
Toxic death0.6000
Additional informationPegfilgastrim on each cyclePegfilgastrim on each cyclePegfilgastrim on each cycle