Trial Outcomes & Findings for Efficacy and Safety of Aflibercept in Combination With FOLFIRI Chemotherapy as 1st Line Treatment for Patients With Metastatic Colorectal Cancer (NCT NCT02181556)

Last Updated: 2021-06-07

Results Overview

Progression was evaluated by CT scan, according to RECIST criteria (version 1.1) definition by the investigator. Death was also considered as an event (all causes). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed during the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

6 months

Results posted on

2021-06-07

Participant Flow

41 patients were included by 9 centers between October 2014 and February 2017

Participant milestones

Participant milestones
Measure	FOLFIRI + Aflibercept FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease FOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease Aflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease
Overall Study STARTED	41
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	FOLFIRI + Aflibercept FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease FOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease Aflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FOLFIRI + Aflibercept n=40 Participants FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease FOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease Aflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease
Age, Continuous	64.85 years n=40 Participants
Sex: Female, Male Female	23 Participants n=40 Participants
Sex: Female, Male Male	17 Participants n=40 Participants
Region of Enrollment France	40 participants n=40 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Analyse was done on all the patients included in the study (ITT)

Outcome measures

Outcome measures
Measure	FOLFIRI + Aflibercept n=40 Participants FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease FOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease Aflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease
Rate of Patients Alive and Progression-free 6 Months After Inclusion.	22 Nb of patients alive without progression

SECONDARY outcome

Timeframe: Up to 2 years after the end of the treatment

Overall survival is defined as the time from the date of the patient's inclusion to the patient's death (all causes). For alive patients the date of the latest news is taken into account

Outcome measures

Outcome measures
Measure	FOLFIRI + Aflibercept n=40 Participants FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease FOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease Aflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease
Overall Survival	18.63 Months Interval 14.69 to 30.65

SECONDARY outcome

Timeframe: up to 12 months

The progression-free survival is the time from inclusion to the first radiological progression or death (all causes). For patients alive without progression date of last news will be considered. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions compared the little sum of diameters observed durin the study (NADIR), or a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Outcome measures
Measure	FOLFIRI + Aflibercept n=40 Participants FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease FOLFIRI Protocol: injection of FOLFIRI and Aflibercept every 14 days until progression of disease Aflibercept Injection: injection of FOLFIRI and Aflibercept every 14 days until progression of disease
Progression-free Survival	8.16 Months Interval 6.11 to 10.38

Adverse Events

FOLFIRI and Aflibercept

Serious events: 13 serious events

Other events: 36 other events

Deaths: 25 deaths

Serious adverse events

Serious adverse events
Measure	FOLFIRI and Aflibercept n=40 participants at risk FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease FOLFIRI + Aflibercept: injection of FOLFIRI and Aflibercept every 14 days until progression of disease
Gastrointestinal disorders Abdominal Pain	7.5% 3/40 • Number of events 4 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Anal fistula	2.5% 1/40 • Number of events 1 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Diarrhea	5.0% 2/40 • Number of events 2 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Enterocolitis	2.5% 1/40 • Number of events 1 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Decreased appetite	2.5% 1/40 • Number of events 1 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Intestinal obstruction	2.5% 1/40 • Number of events 1 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Large intestinal haemorrhage	2.5% 1/40 • Number of events 1 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Large intestinal obstruction	2.5% 1/40 • Number of events 1 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Large intestine perforation	2.5% 1/40 • Number of events 1 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Nausea	2.5% 1/40 • Number of events 1 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Small intestinal obstruction	2.5% 1/40 • Number of events 1 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Small intestinal perforation	2.5% 1/40 • Number of events 1 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Vomiting	2.5% 1/40 • Number of events 1 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)

Other adverse events

Other adverse events
Measure	FOLFIRI and Aflibercept n=40 participants at risk FOLFIRI and aflibercept (4 mg/m²) each 14 days until progression of disease FOLFIRI + Aflibercept: injection of FOLFIRI and Aflibercept every 14 days until progression of disease
Gastrointestinal disorders Nausea	5.0% 2/40 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Vomiting	7.5% 3/40 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Diarrhea	12.5% 5/40 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Abdominal Pain	12.5% 5/40 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Mucositis	15.0% 6/40 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Gastrointestinal disorders Colonic perforation	5.0% 2/40 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Vascular disorders Venous TE disorders	17.5% 7/40 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Vascular disorders Hypertension	17.5% 7/40 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Renal and urinary disorders Proteinuria	5.0% 2/40 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Investigations Anemia	5.0% 2/40 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Investigations Leucopenia	5.0% 2/40 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)
Investigations Neutropenia	27.5% 11/40 • Up to the end of treatment, on average of 8 months Toxicities were collected before each cure of treatment up to the end of the treatment. There is no fixed time-frame because of metastatic disease. The study treatment is given until withdrawal of the patients for any reason (Toxicities, progression or any other medical reason)

Additional Information

Mrs Karine Le Malicot, Head of biostatistics

FFCD

Phone: +33 3 80 39.34.79

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place