Trial Outcomes & Findings for Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer (NCT NCT00828672)

Last Updated: 2019-07-10

Results Overview

Dworak tumour regression grades (TRG) were used to assess pathologic response: TRG0=no regression. TRG1=dominant tumor mass with obvious fibrosis and/or vasculopathy; TRG2=dominant fibrotic changes with few tumour cells or groups; TRG3=very few (difficult to find microscopically) tumour cells in fibrotic tissue with or without mucus substance. TRG4=no intact viable tumour cells, only fibrotic mass or presence of mucin lakes without associated malignant cells (total tumour regression). Pathologic assessments of tumour response post chemoradiotherapy as provided by investigators (read by local pathologists on operative specimens) were reviewed centrally for all pts for whom surgical materials were available (centrally reviewed set). The diagnosis of independent central reviewers primed. Pathologic complete response rates (TRG4) are reported (%). Good (TRG3 and TRG4 together) and little (TRG 0,1 and 2) tumour regression rates are summarized. For these 2 last rows, % add to 100.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

4 months

Results posted on

2019-07-10

Participant Flow

Eighty-four patients were included. First patient enrolled: 22-Jun-2009. Last patient enrolled: 29-Sep-2013. Participating sites: UZ Leuven, Erasme Hospital Bruxelles, Cliniques Universitaires St-Luc Bruxelles, AZ St. Lucas Brugge, AZ Groeninge Kortrijk, CHU Sart-Tilman Liege, OLVZ Aalst, H. Hart Ziekenhuis Roeselare, Cl. Saint Elisabeth Namur

Target population was represented by patients with locally advanced rectal cancer (tumour beyond mesorectal fascia (T4) or tumour ≤ 2 mm from mesorectal fascia or T3 tumour \< 5 cm from anal verge by MRI), histologically confirmed. Pts were screened as per incl and excl criteria per protocol. Screening failures were not recorded in the eCRF.

Participant milestones

Participant milestones
Measure	AXE (ARM 1) Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy	AX (ARM 2) Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy
Pre-treatment (Baseline) STARTED	43	41
Pre-treatment (Baseline) COMPLETED	43	41
Pre-treatment (Baseline) NOT COMPLETED	0	0
Study Treatment STARTED	43	41
Study Treatment COMPLETED	41	39
Study Treatment NOT COMPLETED	2	2
Post-surgery (<30 Days) STARTED	41	39
Post-surgery (<30 Days) COMPLETED	41	38
Post-surgery (<30 Days) NOT COMPLETED	0	1
Follow-up STARTED	42	41
Follow-up COMPLETED	42	41
Follow-up NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	AXE (ARM 1) Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy	AX (ARM 2) Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy
Study Treatment Lost to Follow-up	1	0
Study Treatment Adverse Event	0	1
Study Treatment Complete response, no surgery	1	1
Post-surgery (<30 Days) No central review materials	0	1

Baseline Characteristics

Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AXE (ARM 1) n=43 Participants Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy	AX (ARM 2) n=41 Participants Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy	Total n=84 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
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants	59 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
ECOG PS (Performance Status) ECOG PS=0	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants
ECOG PS (Performance Status) ECOG PS=1	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Distance from tumour to anal verge <5cm	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Distance from tumour to anal verge >=5cm	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Distance from tumour to anal verge NA	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Distance to CRM 0mm	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Distance to CRM <2mm	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Distance to CRM >=2mm	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Distance to CRM NA	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Tumour stage T2 (Tumor invades muscularis propria)	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Tumour stage T3 (tumor invades into pericolorectal tissues)	34 Participants n=5 Participants	31 Participants n=7 Participants	65 Participants n=5 Participants
Tumour stage T4 (tumor invades through peritoneum/other organs)	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Nodal stage N0 (no regional lymph node metastase)	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Nodal stage N1 (metastasis in 1-3 regional lymp nodes)	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Nodal stage N2 (metastasis in 4 or more regional lymph nodes)	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Nodal stage Nx (regional nodes cannot be assessed)	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Population: Patients who had undertaken surgery and had pathology materials available for central review (centrally reviewed subset)

Outcome measures

Outcome measures
Measure	AXE (ARM 1) n=41 Participants Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy	AX (ARM 2) n=38 Participants Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy
Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery. Pathological complete response (Dworak TRG=4) %	34 percentage of cases Interval 19.0 to 49.0	11 percentage of cases Interval 0.0 to 21.0
Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery. Good tumour regression (Dworak TRG=3-4) %	41 percentage of cases Interval 26.0 to 57.0	24 percentage of cases Interval 10.0 to 38.0
Pathologic Response at Surgery. Overview of Complete Pathologic Responses, Good and Little Tumour Regression Rates at Surgery. Little tumour regression (Dworak TRG=0-1-2) %	59 percentage of cases Interval 43.0 to 74.0	76 percentage of cases Interval 62.0 to 90.0

SECONDARY outcome

Timeframe: 4 months

Population: Patient in Arm 2 that discontinued chemoradiotherapy due to major toxicity and had surgery off protocol is counted here as well

Histopathologic R0 resection rate was defined as margins histologically negative for tumour involvement after resection. The circumferential resection margin (CRM) is considered to be involved if microscopic tumour is present \<1mm from or at the inked circumferential or radial resection margin. Data on quality of mesorectal excision were expected but not collected consistently.

Outcome measures

Outcome measures
Measure	AXE (ARM 1) n=41 Participants Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy	AX (ARM 2) n=39 Participants Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy
Number of Participants With Histopathologic R0 and Negative CRM Resection Negative resection margins	40 Participants	37 Participants
Number of Participants With Histopathologic R0 and Negative CRM Resection Positive resection margins	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 4 months

Population: Centrally reviewed subset

Outcome measures

Outcome measures
Measure	AXE (ARM 1) n=41 Participants Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy	AX (ARM 2) n=38 Participants Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy
Number of Participants With Pathologic Complete Response at Surgery. Number of Participants With Good or Little Pathological Tumour Regression at Surgery. Complete response, no tumour left Dworak TRG=4	14 Participants	4 Participants
Number of Participants With Pathologic Complete Response at Surgery. Number of Participants With Good or Little Pathological Tumour Regression at Surgery. Good tumour regression TRG=3-4	17 Participants	9 Participants
Number of Participants With Pathologic Complete Response at Surgery. Number of Participants With Good or Little Pathological Tumour Regression at Surgery. No or little tumour regression Dworak TRG=0-1-2	24 Participants	29 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Intent to treat, all registered patients

Baseline tumour measurements were performed within 4 weeks prior to treatment start (RECIST). The same methods of assessment (CT and/or MRI) were used for each measurable lesion at baseline and during follow-up. * Complete Response (CR) is disappearance of all clinical and radiological evidence of tumour (both target and non-target lesions). * Partial Response (PR) is at least a 30% decrease in the sum of LD of target lesions, taking as reference the baseline sum of tumour longest diameters (LD). * Stable Disease (SD) is steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. * Progressive Disease (PD) is at least a 20% increase in the sum of LD of measured lesions taking as references the smallest sum LD recorded since the treatment started. Appearance of new lesions constitutes PD. In exceptional circumstances, unequivocal progression of non-target lesions was considered evidence of PD.

Outcome measures

Outcome measures
Measure	AXE (ARM 1) n=43 Participants Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy	AX (ARM 2) n=41 Participants Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy
Clinical Response Rate CR	3 Participants	5 Participants
Clinical Response Rate PR	24 Participants	17 Participants
Clinical Response Rate SD	9 Participants	13 Participants
Clinical Response Rate PD	0 Participants	1 Participants
Clinical Response Rate NA	7 Participants	5 Participants

SECONDARY outcome

Timeframe: continuous up to 1 year

Population: Intent to treat

Adverse events graded as per NCI CTCAE (US National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0. All Serious Adverse Events occurrences are reported and counts are summarized here; all Adverse Events (all grades) related and not related to study treatment are reported and summarized here; all severe laboratory events (hematology and biochemistry Gr 3 and higher) are reported and summarized here; all severe postoperative complications (Gr 3 and higher) occurred within the first month post surgery are reported and summarized here. See section Adverse events for details.

Outcome measures

Outcome measures
Measure	AXE (ARM 1) n=43 Participants Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy	AX (ARM 2) n=41 Participants Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy
Types and Numbers of Adverse Events - General Overview Serious adverse events	22 counts of events	12 counts of events
Types and Numbers of Adverse Events - General Overview All adverse events	564 counts of events	426 counts of events
Types and Numbers of Adverse Events - General Overview Severe lab events	27 counts of events	16 counts of events
Types and Numbers of Adverse Events - General Overview Post operative complications at 1 month	14 counts of events	9 counts of events

SECONDARY outcome

Timeframe: up to 5 years

Population: Intent to treat (one patient lost to follow-up)

Counts and proportions of patients experiencing recurrence of disease (local and distant).

Outcome measures

Outcome measures
Measure	AXE (ARM 1) n=43 Participants Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy	AX (ARM 2) n=41 Participants Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy
Recurrence Rates and Disease Free Survival Recurred Dec 2017	9 Participants	9 Participants
Recurrence Rates and Disease Free Survival Not recurred Dec 2017	33 Participants	32 Participants
Recurrence Rates and Disease Free Survival Lost to FU	1 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 5 years

Population: Intent to treat in follow up (one patient in Arm 1 lost to follow up).

Counts and proportions of patients deceased (post-study).

Outcome measures

Outcome measures
Measure	AXE (ARM 1) n=43 Participants Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy	AX (ARM 2) n=41 Participants Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy
Death Rates and Overall Survival Deceased (Dec 2017)	6 Participants	7 Participants
Death Rates and Overall Survival Alive (Dec 2017)	36 Participants	34 Participants
Death Rates and Overall Survival Lost to FU	1 Participants	0 Participants

Adverse Events

AXE (ARM 1)

Serious events: 21 serious events

Other events: 18 other events

Deaths: 0 deaths

AX (ARM 2)

Serious events: 12 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Prof. Dr. Eric Van Cutsem

UZ Leuven

Phone: +32 16 34 42 18

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor is an academic institution and not the drug market authorization holder. Participating PIs were selected from other academic institutions. Participating PIs cannot publish full or partial study results before final publication by Sponsor, but they will be nominated as co-authors based on patient accrual at each participating site. Own results can be published afterwards by participant PIs, with the agreement of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	AXE (ARM 1) n=43 participants at risk Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. Oxaliplatin: Administered on days 15,22,29,36 en 43; 50 mg/m2 Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy	AX (ARM 2) n=41 participants at risk Bevacizumab and Capecitabine concurrently with radiotherapy Bevacizumab: Administered on days 1,15,29 and 43 ; 5mg/kg Capecitabine: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy Radiotherapy: Total dose 45Gy
Vascular disorders Lung embolism	0.00% 0/43 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	2.4% 1/41 • Number of events 1 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Nervous system disorders Neuropathy motor	0.00% 0/43 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	2.4% 1/41 • Number of events 1 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Nervous system disorders Seizure	2.3% 1/43 • Number of events 1 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	0.00% 0/41 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
General disorders Fever	7.0% 3/43 • Number of events 4 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	0.00% 0/41 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Psychiatric disorders Depression	0.00% 0/43 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	2.4% 1/41 • Number of events 1 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/43 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	2.4% 1/41 • Number of events 1 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Gastrointestinal disorders Diarrhea	7.0% 3/43 • Number of events 3 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	0.00% 0/41 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Gastrointestinal disorders Fistula	0.00% 0/43 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	2.4% 1/41 • Number of events 1 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Gastrointestinal disorders Leak	4.7% 2/43 • Number of events 2 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	7.3% 3/41 • Number of events 3 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Gastrointestinal disorders Obstruction	4.7% 2/43 • Number of events 2 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	0.00% 0/41 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Gastrointestinal disorders Presacral hematoma	0.00% 0/43 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	2.4% 1/41 • Number of events 1 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Infections and infestations Febrile neutropenia	2.3% 1/43 • Number of events 1 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	0.00% 0/41 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Infections and infestations Septic shock	2.3% 1/43 • Number of events 1 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	0.00% 0/41 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Infections and infestations Urinary tract infection	4.7% 2/43 • Number of events 2 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	2.4% 1/41 • Number of events 1 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Infections and infestations Catheter site infection	2.3% 1/43 • Number of events 1 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	0.00% 0/41 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.
Infections and infestations Wound infection	11.6% 5/43 • Number of events 5 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.	4.9% 2/41 • Number of events 2 • From signature of ICF to 30 days post surgery with follow-up for residual toxicity after this period if applicable All SAE occurences are reported and displayed below. Only Gr 3-4-5 adverse events (serious and non serious) are reported in this report.