Trial Outcomes & Findings for First-line Metastatic Pancreatic Cancer : FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem (NCT NCT02352337)

Last Updated: 2024-07-10

Results Overview

Progression was defined as radiological progression according to RECIST v1.1 criteria and/or clinical progression according to the investigator. Progression or death (for any reason) was considered if the event occured within the first 6 months since randomization. 6 month scans were 6 month scans with a +/- 1 month window.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

276 participants

Primary outcome timeframe

6 months after randomization

Results posted on

2024-07-10

Participant Flow

276 patients were randomized by 53 centers in France between 12 January 2015 and 28 November 2016. 3 patients withdrew their consent so they were never part on analyses populations.

Participant milestones

Participant milestones
Measure	FOLFIRINOX Every two weeks (maximum of 12 cycles) : Oxaliplatin 85 mg / m2 Day1 in 2 hours - then Irinotecan 180 mg / m2 Day1 in 90 minutes - Folinic acid 400 mg / m2 Day1 in 2 h (during the irinotecan infusion) - 5-FU bolus 400 mg / m² Day1 followed by continuous 5-FU 2400 mg / m2 total over 46 hours FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue	FOLFIRINOX + LV5FU2 in Maintenance Folfirinox during 4 months followed by LV5FU2 maintenance until progression: Folfirinox (as described in arm FOLFIRINOX) LV5FU2 : Folinic acid 400 mg/m² (200 mg/m² if Elvorine), in perfusion over 2 hours the 5FU 400 mg/m² in bolus over 10 mn followed by 5FU 2400 mg/m² in perfusion over 46 hours. FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue LV5FU2: Perfusion: Folinic Acid,5FU Bolus,5FU continue	FIRGEM Alternance of 2 months of FOLFIRI.3 with 2 months of GEMCITABINE: Folfiri.3: Irinotécan 90 mg/m² at day 1 in perfusion over 60 minutes in parralel of folinic acid Folinic acid 400 mg/m² (or 200 mg/m² Elvorine) at day 1 in perfusion over 2 hours 5FU continue 2000 mg/m² over 46 heures then irinotécan at 90 mg/m² (1h) at day 3 when 5U perfusion is over Gemcitabine: 1000 mg/m² in perfusion over 30 mn at day 1,8,15,29,36 and 43 over (1 injection per week during 3 weeks followed with 7 days of rest ) FOLFIRI.3: Perfusion :Irinotecan,Acide folinique ,5FU continue Gemcitabine: Gemcitabine perfusion
Overall Study STARTED	91	92	90
Overall Study COMPLETED	87	91	88
Overall Study NOT COMPLETED	4	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	FOLFIRINOX Every two weeks (maximum of 12 cycles) : Oxaliplatin 85 mg / m2 Day1 in 2 hours - then Irinotecan 180 mg / m2 Day1 in 90 minutes - Folinic acid 400 mg / m2 Day1 in 2 h (during the irinotecan infusion) - 5-FU bolus 400 mg / m² Day1 followed by continuous 5-FU 2400 mg / m2 total over 46 hours FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue	FOLFIRINOX + LV5FU2 in Maintenance Folfirinox during 4 months followed by LV5FU2 maintenance until progression: Folfirinox (as described in arm FOLFIRINOX) LV5FU2 : Folinic acid 400 mg/m² (200 mg/m² if Elvorine), in perfusion over 2 hours the 5FU 400 mg/m² in bolus over 10 mn followed by 5FU 2400 mg/m² in perfusion over 46 hours. FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue LV5FU2: Perfusion: Folinic Acid,5FU Bolus,5FU continue	FIRGEM Alternance of 2 months of FOLFIRI.3 with 2 months of GEMCITABINE: Folfiri.3: Irinotécan 90 mg/m² at day 1 in perfusion over 60 minutes in parralel of folinic acid Folinic acid 400 mg/m² (or 200 mg/m² Elvorine) at day 1 in perfusion over 2 hours 5FU continue 2000 mg/m² over 46 heures then irinotécan at 90 mg/m² (1h) at day 3 when 5U perfusion is over Gemcitabine: 1000 mg/m² in perfusion over 30 mn at day 1,8,15,29,36 and 43 over (1 injection per week during 3 weeks followed with 7 days of rest ) FOLFIRI.3: Perfusion :Irinotecan,Acide folinique ,5FU continue Gemcitabine: Gemcitabine perfusion
Overall Study Patients never treated	4	1	2

Baseline Characteristics

First-line Metastatic Pancreatic Cancer : FOLFIRINOX +/- LV5FU2 in Maintenance Versus Firgem

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FOLFIRINOX n=91 Participants Every two weeks (maximum of 12 cycles) : Oxaliplatin 85 mg / m2 Day1 in 2 hours - then Irinotecan 180 mg / m2 Day1 in 90 minutes - Folinic acid 400 mg / m2 Day1 in 2 h (during the irinotecan infusion) - 5-FU bolus 400 mg / m² Day1 followed by continuous 5-FU 2400 mg / m2 total over 46 hours FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue	FOLFIRINOX + LV5FU2 in Maintenance n=92 Participants Folfirinox during 4 months followed by LV5FU2 maintenance until progression: Folfirinox (as described in arm FOLFIRINOX) LV5FU2 : Folinic acid 400 mg/m² (200 mg/m² if Elvorine), in perfusion over 2 hours the 5FU 400 mg/m² in bolus over 10 mn followed by 5FU 2400 mg/m² in perfusion over 46 hours. FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue LV5FU2: Perfusion: Folinic Acid,5FU Bolus,5FU continue	FIRGEM n=90 Participants Alternance of 2 months of FOLFIRI.3 with 2 months of GEMCITABINE: Folfiri.3: Irinotécan 90 mg/m² at day 1 in perfusion over 60 minutes in parralel of folinic acid Folinic acid 400 mg/m² (or 200 mg/m² Elvorine) at day 1 in perfusion over 2 hours 5FU continue 2000 mg/m² over 46 heures then irinotécan at 90 mg/m² (1h) at day 3 when 5U perfusion is over Gemcitabine: 1000 mg/m² in perfusion over 30 mn at day 1,8,15,29,36 and 43 over (1 injection per week during 3 weeks followed with 7 days of rest ) FOLFIRI.3: Perfusion :Irinotecan,Acide folinique ,5FU continue Gemcitabine: Gemcitabine perfusion	Total n=273 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	51 Participants n=7 Participants	41 Participants n=5 Participants	138 Participants n=4 Participants
Age, Categorical >=65 years	45 Participants n=5 Participants	41 Participants n=7 Participants	49 Participants n=5 Participants	135 Participants n=4 Participants
Age, Continuous	64.55 years n=5 Participants	64.18 years n=7 Participants	65.88 years n=5 Participants	64.81 years n=4 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	34 Participants n=7 Participants	43 Participants n=5 Participants	112 Participants n=4 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	58 Participants n=7 Participants	47 Participants n=5 Participants	161 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	91 Participants n=5 Participants	92 Participants n=7 Participants	90 Participants n=5 Participants	273 Participants n=4 Participants
Region of Enrollment France	91 participants n=5 Participants	92 participants n=7 Participants	90 participants n=5 Participants	273 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months after randomization

Population: The primary endpoint was analysed on the mITT population meaning all the randomized patients with at least one dose of study drug taken

Outcome measures

Outcome measures
Measure	FOLFIRINOX n=87 Participants Every two weeks (maximum of 12 cycles) : Oxaliplatin 85 mg / m2 Day1 in 2 hours - then Irinotecan 180 mg / m2 Day1 in 90 minutes - Folinic acid 400 mg / m2 Day1 in 2 h (during the irinotecan infusion) - 5-FU bolus 400 mg / m² Day1 followed by continuous 5-FU 2400 mg / m2 total over 46 hours FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue	FOLFIRINOX + LV5FU2 in Maintenance n=91 Participants Folfirinox during 4 months followed by LV5FU2 maintenance until progression: Folfirinox (as described in arm FOLFIRINOX) LV5FU2 : Folinic acid 400 mg/m² (200 mg/m² if Elvorine), in perfusion over 2 hours the 5FU 400 mg/m² in bolus over 10 mn followed by 5FU 2400 mg/m² in perfusion over 46 hours. FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue LV5FU2: Perfusion: Folinic Acid,5FU Bolus,5FU continue	FIRGEM n=88 Participants Alternance of 2 months of FOLFIRI.3 with 2 months of GEMCITABINE: Folfiri.3: Irinotécan 90 mg/m² at day 1 in perfusion over 60 minutes in parralel of folinic acid Folinic acid 400 mg/m² (or 200 mg/m² Elvorine) at day 1 in perfusion over 2 hours 5FU continue 2000 mg/m² over 46 heures then irinotécan at 90 mg/m² (1h) at day 3 when 5U perfusion is over Gemcitabine: 1000 mg/m² in perfusion over 30 mn at day 1,8,15,29,36 and 43 over (1 injection per week during 3 weeks followed with 7 days of rest ) FOLFIRI.3: Perfusion :Irinotecan,Acide folinique ,5FU continue Gemcitabine: Gemcitabine perfusion
Percentage of Patients Alive and Without Radiological and/or Clinical Progression 6 Months After the Randomization.	41 Participants	39 Participants	30 Participants

SECONDARY outcome

Timeframe: Up to 3 years after the treatment start

Population: Endpoint was analyzed on the ITT population meaning the patients randomized in the study.

Overall survival was defined as the time from the date of randomization to the patient's death (all causes). For alive patients, the date of last news was taken into account. The analysis was done on the ITT population meaning the patients who have been randomized. Numbers of patients correspond the number of patients randomized in the study.

Outcome measures

Outcome measures
Measure	FOLFIRINOX n=91 Participants Every two weeks (maximum of 12 cycles) : Oxaliplatin 85 mg / m2 Day1 in 2 hours - then Irinotecan 180 mg / m2 Day1 in 90 minutes - Folinic acid 400 mg / m2 Day1 in 2 h (during the irinotecan infusion) - 5-FU bolus 400 mg / m² Day1 followed by continuous 5-FU 2400 mg / m2 total over 46 hours FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue	FOLFIRINOX + LV5FU2 in Maintenance n=92 Participants Folfirinox during 4 months followed by LV5FU2 maintenance until progression: Folfirinox (as described in arm FOLFIRINOX) LV5FU2 : Folinic acid 400 mg/m² (200 mg/m² if Elvorine), in perfusion over 2 hours the 5FU 400 mg/m² in bolus over 10 mn followed by 5FU 2400 mg/m² in perfusion over 46 hours. FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue LV5FU2: Perfusion: Folinic Acid,5FU Bolus,5FU continue	FIRGEM n=90 Participants Alternance of 2 months of FOLFIRI.3 with 2 months of GEMCITABINE: Folfiri.3: Irinotécan 90 mg/m² at day 1 in perfusion over 60 minutes in parralel of folinic acid Folinic acid 400 mg/m² (or 200 mg/m² Elvorine) at day 1 in perfusion over 2 hours 5FU continue 2000 mg/m² over 46 heures then irinotécan at 90 mg/m² (1h) at day 3 when 5U perfusion is over Gemcitabine: 1000 mg/m² in perfusion over 30 mn at day 1,8,15,29,36 and 43 over (1 injection per week during 3 weeks followed with 7 days of rest ) FOLFIRI.3: Perfusion :Irinotecan,Acide folinique ,5FU continue Gemcitabine: Gemcitabine perfusion
Overall Survival (OS)	10.09 months Interval 8.54 to 12.16	11.20 months Interval 9.03 to 13.14	7.34 months Interval 5.72 to 9.49

SECONDARY outcome

Timeframe: up to 12 months after randomization

Population: The analysis was done on the ITT population meaning the patients who have been randomized into the study

It was defined as the time between t randomization and the date of the first radiological progression (RECIST 1.1 criteria) and/or clinical progression according to the investigator or death (whatever the cause is); Patients alive without progression were censored at date of last news .

Outcome measures

Outcome measures
Measure	FOLFIRINOX n=91 Participants Every two weeks (maximum of 12 cycles) : Oxaliplatin 85 mg / m2 Day1 in 2 hours - then Irinotecan 180 mg / m2 Day1 in 90 minutes - Folinic acid 400 mg / m2 Day1 in 2 h (during the irinotecan infusion) - 5-FU bolus 400 mg / m² Day1 followed by continuous 5-FU 2400 mg / m2 total over 46 hours FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue	FOLFIRINOX + LV5FU2 in Maintenance n=92 Participants Folfirinox during 4 months followed by LV5FU2 maintenance until progression: Folfirinox (as described in arm FOLFIRINOX) LV5FU2 : Folinic acid 400 mg/m² (200 mg/m² if Elvorine), in perfusion over 2 hours the 5FU 400 mg/m² in bolus over 10 mn followed by 5FU 2400 mg/m² in perfusion over 46 hours. FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue LV5FU2: Perfusion: Folinic Acid,5FU Bolus,5FU continue	FIRGEM n=90 Participants Alternance of 2 months of FOLFIRI.3 with 2 months of GEMCITABINE: Folfiri.3: Irinotécan 90 mg/m² at day 1 in perfusion over 60 minutes in parralel of folinic acid Folinic acid 400 mg/m² (or 200 mg/m² Elvorine) at day 1 in perfusion over 2 hours 5FU continue 2000 mg/m² over 46 heures then irinotécan at 90 mg/m² (1h) at day 3 when 5U perfusion is over Gemcitabine: 1000 mg/m² in perfusion over 30 mn at day 1,8,15,29,36 and 43 over (1 injection per week during 3 weeks followed with 7 days of rest ) FOLFIRI.3: Perfusion :Irinotecan,Acide folinique ,5FU continue Gemcitabine: Gemcitabine perfusion
Progression-free Survival (PFS)	6.28 months Interval 5.32 to 7.56	5.73 months Interval 5.26 to 7.29	4.50 months Interval 3.48 to 5.72

Adverse Events

FOLFIRINOX

Serious events: 31 serious events

Other events: 88 other events

Deaths: 82 deaths

FOLFIRINOX + LV5FU2 in Maintenance

Serious events: 53 serious events

Other events: 91 other events

Deaths: 80 deaths

FIRGEM

Serious events: 57 serious events

Other events: 87 other events

Deaths: 83 deaths

Serious adverse events

Serious adverse events
Measure	FOLFIRINOX n=88 participants at risk Every two weeks (maximum of 12 cycles) : Oxaliplatin 85 mg / m2 Day1 in 2 hours - then Irinotecan 180 mg / m2 Day1 in 90 minutes - Folinic acid 400 mg / m2 Day1 in 2 h (during the irinotecan infusion) - 5-FU bolus 400 mg / m² Day1 followed by continuous 5-FU 2400 mg / m2 total over 46 hours FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue	FOLFIRINOX + LV5FU2 in Maintenance n=91 participants at risk Folfirinox during 4 months followed by LV5FU2 maintenance until progression: Folfirinox (as described in arm FOLFIRINOX) LV5FU2 : Folinic acid 400 mg/m² (200 mg/m² if Elvorine), in perfusion over 2 hours the 5FU 400 mg/m² in bolus over 10 mn followed by 5FU 2400 mg/m² in perfusion over 46 hours. FOLFIRINOX: Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue LV5FU2: Perfusion: Folinic Acid,5FU Bolus,5FU continue	FIRGEM n=87 participants at risk Alternance of 2 months of FOLFIRI.3 with 2 months of GEMCITABINE: Folfiri.3: Irinotécan 90 mg/m² at day 1 in perfusion over 60 minutes in parralel of folinic acid Folinic acid 400 mg/m² (or 200 mg/m² Elvorine) at day 1 in perfusion over 2 hours 5FU continue 2000 mg/m² over 46 heures then irinotécan at 90 mg/m² (1h) at day 3 when 5U perfusion is over Gemcitabine: 1000 mg/m² in perfusion over 30 mn at day 1,8,15,29,36 and 43 over (1 injection per week during 3 weeks followed with 7 days of rest ) FOLFIRI.3: Perfusion :Irinotecan,Acide folinique ,5FU continue Gemcitabine: Gemcitabine perfusion
Gastrointestinal disorders Diarrhea	6.8% 6/88 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	8.8% 8/91 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	9.2% 8/87 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
Gastrointestinal disorders Abdominal pain	3.4% 3/88 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	11.0% 10/91 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	12.6% 11/87 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
Gastrointestinal disorders Vomiting	10.2% 9/88 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	8.8% 8/91 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	10.3% 9/87 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
Gastrointestinal disorders Naus	2.3% 2/88 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	3.3% 3/91 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	5.7% 5/87 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
Infections and infestations Catheter infection	1.1% 1/88 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	3.3% 3/91 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	2.3% 2/87 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
Infections and infestations Septicemia	2.3% 2/88 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	5.5% 5/91 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	9.2% 8/87 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
Investigations Anemia	3.4% 3/88 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	1.1% 1/91 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	2.3% 2/87 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
Investigations PNN decrease	1.1% 1/88 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	2.2% 2/91 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	3.4% 3/87 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
Metabolism and nutrition disorders Anorexia	2.3% 2/88 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	4.4% 4/91 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	8.0% 7/87 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
General disorders Fatigue	9.1% 8/88 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	17.6% 16/91 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	17.2% 15/87 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.
General disorders Fever	3.4% 3/88 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	4.4% 4/91 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.	3.4% 3/87 • Deaths were assessed up to 3 years but adverse Events were assessed up to 1 year. Adverse events were analyzed on the population of patients who received at leats one dose of treatment and regarding the treatment really received by the patient. One patient randomized in the FIRGEM arm recieved FOLFIRINOX. So, this patient was analyzed in the Folfirinox arm for tolerance For all cause of mortality, the population was the ITT population meaning all patients randomized.

Other adverse events

Additional Information

Karine Le Malicot

Fédération Francophone de Cancérologie Digestive

Phone: +33 3 80 39 34 79

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place