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days 1-4, 29-32 and 50-53 and panitumumab on day 1, 15,
29, 50 and 65. The doses were as follows: level -1: 5FU at
400 mg/m
2
/j and panitumumab at 3mg/kg; level 0: 5FU at
600 mg/m
2
/j and panitumumab at 3mg/kg. DLT was
defined by febrile neutropenia, neutropenia grade 4,
thrombocytopenia grade 4 or grade 3 during more than 1
week, GI toxicity grade ≥ 3, dermatitis grade ≥ 4, first part
of treatment non completed (< 75 % doses) according to
CTCAEv4, and assessed until 8 weeks after the completion
of the treatment Tumor evaluation was performed at 8
weeks, 4 months after end of treatment and every 4
months.
Results
Out of 10 pts enrolled in this study between June 2012 and
March 2015, 9 were treated according to the protocol (one
patient was excluded before treatment because the
dosimetric plan did not meet the dosimetric constraints).
Median age was 57.4 years (range: 52.0-71.1). Tumor
characteristics were as follows: T2: one patient; T3: 6; T4:
2; N0: 2 and N+: 7 pts. DLT was observed for the first 3
patients at level 0: febrile neutropenia for one patient,
thrombocytopenia and diarrhea grade 3 for the second
patient and rectitis, cystitis, dermatitis grade 3 for the
third patient. Therefore the protocol was amended to
withdraw one mitomycin injection. Six patients were
treated on level -1. Out of 6 patients, 2 experienced grade
3 toxicities: asthenia and rectitis for one patient and
lymphopenia for the second. Treatment was completed
for all 6 pts. Considering all patients treated at level 0 and
-1, complete response was achieved for 8 pts whereas one
experienced a local recurrence 9 months after the end of
the treatment and went through abomino-perineal
resection. All patients were alive with a median follow-up
of 18 months.
Conclusion
In this phase 1 trial, panitumumab (3 mg/kg), mitomycin
(10 mg/m²) and 5FU (400 mg/m²/day) were considered as
the tolerable and active doses. These are the
recommended doses for the ongoing phase II trial
(EudraCT number: 2011-005436-26).
PO-0703 Bowel dysfunction resulting from different
treatment strategies in patients with rectal cancer.
T. Vuong
1
, A. Garant
2
, S. Devic
3
, A. Kezouth
4
1
Jewish General Hospital - McGill University, Radiation
Oncology,Montreal, Canada
2
McGill University, Radiation Oncology, Montreal,
Canada
3
Jewish General Hospital- McGill University, Radiation
Oncology, Montreal, Canada
4
Jewish General Hospital- McGill University, Statistics-
Epidemiology, Montreal, Canada
Purpose or Objective
For patients with rectal cancer, sphincter preservation
surgery total mesorectal surgery (SPS-TME) is a most
important treatment goal after cure. However, beside the
body image preservation, bowel function is a major
outcome with important impact on quality of life. The Low
Anterior resection syndrome (LARS) is well documented
with bowel frequency, urgency, clustering, stool and gaz
incontinence. A validated LARS questionnaire documented
a 40% of severe LARS score after TME alone and 60% after
pre-operative Radiation (RT) and TME. In this study, we
are proposing to evaluate our population of patients with
ano-rectal cancer with various RT regimens.
Material and Methods
Patients with rectal cancer or anal canal cancer treated
between 2013 - 2015 were recruited in this study. IRB
approved signed consent was obtained with self
administered questionnaires at least in two point times.
Patients with LAR with ileostomy closure for at least 3
months. Patients with anal canal treated with
chemotherapy (CT) and RT and rectal cancer treated with
External beam (EBRT) and high dose rate brachytherapy
(HDRBT) but with no evidence of local recurrence.
Results
Patients and tumor characteristics and LARS scoring
results by treatment regimen are shown in the Table1 and
Figure 1. For the initial 3X4 cross-classified table (3
category-scores: No Lars, Minor Lars, Major Lars, 4
treatment groups: HDRBT-TME, CT-RT-TME , CT-RT (No
surgery), EBRT + HDRBT (No surgery)),we computed the
Fisher exact test .There is independence between the
score category and the treatment group with a p-value of
0.4538. We also considered the Lars score as a continuous
variable and we performed an ANOVA which resulted in a
non-statistical difference between the score means of the
4 treatment groups. Finally to study the severity of the
disease we dichotomized the Lars score into subjects with
Lars score <=26 and those >=27 to construct a new 2X4
table. We found a statistical an overall statistical
difference between the 4 groups with a p-value of
0.0270.Performing a multiple comparison test, an
analogous of a Tukey-type multiple comparison test, we
concluded that there is a statistical difference between
CT-RT and TME and EBRT + HDRBT (No surgery) group,
namely we have more subjects with major Lars in group
CT-XRT + TME than group EBRT-HDRBT (No surgery).
Conclusion
In this study, using the LARS scoring questionnaire, the
favorable functional bowel results (lowest rate of severe
LARS score) in patients treated with EBRT-HDRBT and no
surgery, in the organ preservation approach compared to
standard CT-RT and surgery, support the present efforts in
developping in organ preservation trials for patients with
operable rectal cancer.
PO-0704 Circulating angiogenesis factors predicting
poor chemoradiotherapy outcome in rectal cancer
S. Meltzer
1,2
, L.G. Lyckander
3
, A.H. Ree
1,2
, K.R. Redalen
1
1
Akershus University Hospital, Department of Oncology,
Lørenskog, Norway
2
University of Oslo, Institute of Clinical Medicine, Oslo,
Norway
3
Akershus University Hospital, Department of Pathology,
Lørenskog, Norway
Purpose or Objective
Rapid advances in personalised cancer treatment increase
the demand for early stratification of tumours and their
hosts, which requires easy-to-use, easy-to-interpret
biomarkers to assess tumour phenotypes. In this context,