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P-153Regorafenib in the third-line treatment of metastatic colorectal cancer: a retrospective study of 27 cases

Authors:
  • Medical Oncology Department of Oran Algeria
analysis, patients with hyperglycemia 5-year OS was 73% versus 83% of patients with
normo-glycemia (p ¼0.047 HR: 1.46; 95% CI 1,002 - 2.14). According body-weight,
patients with obesity/overweight 5-year OS was 67% versus 86% of patients with
normo-weight (p ¼0.001 HR: 2.44; 95% CI 1.66-3.59). n Cox-Regre ssion, Obesity/
overweight remained predictive of OS (p ¼0.001 HR: 2.45; 95% CI 1.66-3.61).
Conclusion: The presentstudy demonstrated that hyperglycemia andobesity are main-
tained as a prognostic factorfor recurrence and overallsurvival, reducingdisease-free sur-
vival,and increasing the risk of deathin patients with colon cancerclinical stage I-III.
P150 Perioperative FLOT experience: pathological regression and toxicity
AS
anchez Vegas
1
, A Gil Torralvo
2
, E Fern
andez-Parra
3
, C Robles Barraza
1
, M Rodr
ıguez
de la Borbolla
1
,AL
opez Ladr
on
1
, J Rodr
ıguez Hern
andez
1
, J Fuentes PRadera
1
,
PL
opez
Alvarez
1
, M Chaves
4
1
Valme Hospital, Sevilla, Spain,
2
Valme hospital, Sevilla, Spain,
3
Hospital Nuestra Se~
nora
de Valme, Dos Hermanas, Spain,
4
H Virgen del Roc
ıo, Sevilla, Spain
Introduction: Perioperative fluorouracil/leucovorin (FLOT) treatment improved out-
come for patients with resectable gastric and gastro-oesophageal junction (GEJ) cancer
compared to ECF/ECX. FLOT regimen was associated with toxicity that appea red gen-
erally more favorable and a higher pathologic complete response rate. This analysis
aimed to evaluate the toxicity and tolerability of FLOT treatment in patients at our
institution, operative morbidity, and pathological response.
Methods: We performed a retrospective study of 19 newly diagnosed patients with
resectable gastroesophageal cancer stage cT2 and/or cNþundergoing perioperative
FLOT between July 2017 and October 2018. All adverse events during preoperative/
postoperative were reported using CTCAE v5.0 classification. We analyzed the patho-
logical tumour stage and tumor regression grade was quantified using the Becker
regression criteria.
Results: The median age at diagnosi s was 66 years, 37% (n ¼7) were females and 63%
(n ¼12) males. The proportions of patients with gastric cancer, GEJ and lower oeso-
phagus were 70% (n ¼13), 25% (n ¼5) and 5% (n ¼1), respectively. Seventeen
patients had clinical node-positive disease (90%) and seventeen were T3/T4 clinical
tumour stage (90%). With respect to the Lauren classification, 37% (n ¼7) tumors
were diffuse (86% signet ring cell), 47% (n ¼9) were intestinal, 5% (n ¼1) mixed and
11% (n ¼3) were unclassificable. Performance status (PS) prior to treatment were 0
(n ¼14, 74%) and 1 (n ¼5, 26%). Sixtee n patients (84%) completed 4 preoperative
cycles and three patients (16%) discontinued treatment after 3 cycles because of drug-
related toxicity. Eighteen patients (95%) were able to undergo surgery and (R0) was
achieved in 16 patients (85%) compared with 74% in the AIO-FLOT4 trial.
Pathological regression with FLOT in cT3/T4 patients was detected with a proportion
of postoperative stage ypT0, ypT1, or ypT2 tumours in three patients (18%) contrasted
with 26% in the AIO-FLOT4. Pathological nodal stage ypN0 was reached in five
patients (29%) with clinical node-positive disease compared with 36% in the AIO-
FLOT4. Pathological complete and subtotal regression (Becker 1a or 1b) was reached in
three patients (16%), partial tumor regression (Becker 2) in 9 patients (47%) and no
regression (Becker 3) in 7 patients (37%). Four patients (21%) had postoperative com-
plications. Two patients (11%) did not start postoperative FLOT (1 progressive disease
and 1 treatment-related death). Thirteen patients (68%) completed 4 postoperative
cycles and 3 patients (16%) discontinued postoperative FLOT because of toxic effects.
Twelve patients (63%) had at least one grade 3/4 toxicity. The most common grade 3/4
toxicities were neutropenia (n ¼7, 37%), diarrhoea (n ¼5, 26%), fatigue (n ¼1, 5%)
and nausea/vomiting (n ¼4, 21%). No grade 3/4 cases of neurotoxicity were reported
in our patients. Seven patients (36%) had at least 1 treatment deferral/delay. Eleven
patients (58%) required dose reduction.
Conclusion: Favourable pathological regression with FLOT was consistent in achieving
a pathological complete or partial tumor regression in 63% of patients. Although a
pathological response was detected, downstaging occurred in 18% of patients. FLOT
toxicity was controlled and most of the patients completed the 8 cycles of treatment.
P151 Circulating tumor cells levels correlate with carcinoembryonic
antigen in patients with high-risk colon cancer who experienced
disease progression
E Abdallah
1
, V Souzae Silva
2
, S Aguiar Jr.
1
, R Takahashi
1
, B Flores
1
, A Braun
1
, V Alves
1
,
J Rodr
ıguez Tarazona
3
, L Chinen
1
, C Mello
1
1
A.C. Camargo Cancer Center, S~
ao Paulo, Brazil,
2
A.C.Camargo Cancer Center, S~
ao
Paulo, Brazil,
3
A.C. Camargo Cancer Center , S~
ao Paulo, Brazil
Introduction: Colorectal cancer represents 10% of all cancers diagnosed worldwide,
being the third most diagnosed neoplasm (1.4 million) and the fourth most common
cause of death for cancer (700 000). Circulating tumor cells (CTCs) have been shown to
be a valuable biomarker concerning the prediction of treatment failure and disease pro-
gression. The detection of CTCs in clusters (circulating tumor microemboli CTM)
can be a reliable biomarker of successful transition and colonization of a tumor to a dis-
tant site. Our objective was to explore the importance of CTCs and CTM in blood from
high-risk nonmetastatic colon cancer patients.
Methods: CTCs were enriched using the isolation by size of tumor cells (ISET) filtra-
tion-based method and identified by immunocytochemistry followed by light
microscopy. Here, we evaluated CTCs from the blood of 40 stage II-III high-risk colon
cancer patients at 3 points in time: prior to surgery (baseline), and before and after
adjuvant chemotherapy (1st and 2nd follow-ups, respectively).
Results: The majority of patients were men (55%) and the median age was 59 (33 78)
years. Left colon topography (72.5%) was the most abundant as well as pathological
stage III (85%). CTCs were highly detected and similar among their levels in the 3 time
points (95%, 94.3%, 94.7% of detection, respectively). The median of CTCs levels (per
mL) found at baseline (n ¼40) was 2.4 (0 11. 7), at 1st follow-up (n ¼35) was 1.6 (0
7.3), and at 2nd follow-up (n ¼19) was 2.3 (0 8.0). High levels of CTCs were corre-
lated with CTM presence (P ¼.016). Patients with pathological T (pT) 3-4 had
increased levels (3.0/mL) of CTCs (0 5.3/mL) than those with pT 0-2 (1.5/mL; 0
11.7/mL) (P ¼.109). CTM presence was found in 4 (10%) patients and all of them
belonged to pT3-4 group. The patients were followed for a median of 12.2 months
(95% confidence interval: 8.0 16.3 months), and 5 out of 40 (12.5%) experienced dis-
tant relapse. Analyzing these 5 patients with progressive disease, we found a correlation
between the CTC and carcinoembryonic antigen (CEA) levels at baseline by
Spearman’s rho test (rs ¼0.9; P ¼.037).
Conclusion: These results indicated that CTCs can be useful in cancer management.
CTCs also can prevail in the blood after the total lesion removal and adjuvant chemo-
therapeutic treatment.
P152 A retrospective multicenter study evaluating the efficacy and safety
of irinotecan in patients with advanced gastric cancer: analysis of
Glasgow prognostic score (GPS)
K Harada
1
, S Nakano
2
, S Yuki
2
, K Sawada
3
, T Muranaka
3
, Y Kawamoto
2
, H Nakatsumi
3
,
H Yoshita
4
, T Ando
5
, Y Kobayashi
1
, T Miyagishima
6
, K Hatanaka
7
, A Tanimoto
8
,
A Ishiguro
9
, T Honda
10
, M Dazai
11
, T Sasaki
12
, Y Komatsu
3
1
Department of Medical Oncology, Kushiro Rosai Hospital, Kushiro, Japan,
2
Department of Gastroenterology and Hepatology, Hokkaido University Hospital,
Sapporo, Japan,
3
Division of Cancer Chemotherapy, Hokkaido University Hospital
Cancer Center, Sapporo, Japan,
4
Department of Gastroenterology and Hematology,
Faculty of medicine, University of Toyama, Toyama, Japan, Toyama, Japan,
5
Department of Gastroenterology and Hematology, Faculty of Medicine, University of
Toyama, Toyama, Japan,
6
Department of Internal Medicine, Kushiro Rosai Hospital,
Kushiro, Japan,
7
Department of Gastroenterology, Hakodate Municipal Hospital,
Hakodate, Japan,
8
Department of Medical Oncology, Teine Keijinkai Hospital, Sapporo,
Japan, sapporo, Japan,
9
Department of Medical Oncology, Teine Keijinkai Hospital,
Sapporo, Japan,
10
Division of Clinical Oncology Center, Nagasaki University Hospital,
Nagasaki, Japan,
11
Department of Gastroenterology, Sapporo Medical Center NTT EC,
Sapporo, Japan,
12
8) Department of Internal Medicine, Hokkaido Gastroenterology
Hospital, Sapporo City, Japan
Introduction: It is important to predict prognosis in patients with advanced gastric
cancer receiving chemotherapy. Several studies have reported that Glasgow prognostic
score (GPS), which was based on serum albumin (Alb) and C-reactive protein (CRP),
was associated with poor prognosis in many cancers. However, it is unclear whether
GPS has prognostic value when patients receive irinotecan, which is a key drug of
advanced gastric cancer.
Methods: We conducted a retrospective multicenter study and investigated the associa-
tion between efficacy and GPS in patients who received irinotecan monotherapy
between January 2010 and December 2017. All patients had to receive fluoropyrimidine
and platinum as prior therapy. GPS was identified such that GPS 0 was CRP
1.0 mg/dL and Alb 3.5 g/dL, GPS 1 was CRP >1.0 mg/dL or Alb 1.0 mg/dL and
Alb <3.5 g/dL, and GPS 2 was CRP >1.0 mg/dL and Alb <3.5 g/dL.
Results: There were 174 patients at 8 centers included in this study. The number of
patients with GPS 0/1/2 was 76/56/42, respectively. In GPS 0/1/2 patients, performance
status (0-1/2), treatment line 2nd/3rd or later, and HER2 status were significantly dif-
ferent among them (P <.01). As for safety, there was no significant differe nce amongst
GPS 0/1/2 patients. In GPS 0/1/2 patients, median PFS were 3.7/2.8/2.0 months (P <
.01), median OS were 11.9/7.2/6.7 months (P <.01), respectively. In multivariate anal-
ysis, GPS was associated with shorter PFS (GPS 0 vs 1/0vs 2; HR 1.180/2.378; 95% CI,
0.793-1.758/1.405-4.024; P ¼.414/.001), and shorter OS (GPS 0 vs 1/0vs 2; HR 1.520/
2.529; 95% CI, 1.002-2.305/1.518-4.213; P ¼.049/<.001).
Conclusion: According to this analysis, GPS might be a predictive and pro gnostic fac-
tor for treatment with irinotecan monotherapy in patients with AGC.
P153 Regorafenib in the third-line treatment of metastatic colorectal
cancer: a retrospective study of 27 cases
F Boudinar, B Larbaoui
Medical Oncology Department, EHSO Emir Abdelkader, Oran, Algeria
Introduction: After lung and breast cancer, colorectal cancer represents the third major
cause of cancer-related mortality rate worldwide in terms of frequency. The aim of our
study was to provide an overview of the major epidemiological and clinical characteris -
tics, as well as efficacy and safety of metastatic colorectal cancer (CCRm) treated with
REGORAFENIB in the third line.
Methods: A retrospective study of 27 patients with metastatic colorectal cancer treated
Annals of Oncology abstracts
Volume 30 | Supplement 4 | July 2019 doi:10.1093/annonc/mdz155 | iv41
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_4/mdz155.152/5526397 by guest on 01 August 2019
in a medical oncology department of ORAN cancer center from July 2016 to June 2018
was completed.
Results: We have collected 27 patients with a mean age of 51 years (range 26- 76 years )
with 11 women and 16 men. WHO performance status was 1 in 96% of patients. Rectal
localization occurred in 59 % of cases and colon localization in 40% of cases. Among
the cases, 11% were in pT2N2M1, 62% in pT3N1M1, 25% pT4N1M1. Liver metastasis
occurred in 62%, lung in 37%, and peritoneal carcinomatosis in 25%. K-RAS status
was performed in all patients showing wild type in 55% and mutated Ras in 45%. The
first line of treatment had an average of cycles was 12 (range 3 -25). The second line of
treatment had an average of cycles 10 (range 3-30). The third line of treatment had an
average of cycles was 4 (range 1- 23). The dose of regorafenib was 80 mg in 12%, 120mg
in 48% cases, and 160mg in 28% cases. The therapeutic results were as follows: 10
patients had stability, 6 had progression, 5 patients were lost. There were grade 3 4
adverse events reported, including G3 mucositis in 3%, G3 asthenia in 41%, G3 ano-
rexia in 12%, G3 hand-foot syndrome in 11%, and hepatitic dysfunction in 7%.
Conclusion: Regorafenib was a tolerated drug that was shown to be active in CCRm
pre-treated with chemotherapy in the first or second line. Regorafenib is a new option
for therapy in CCRm.
P154 Correlation between neutrophil/lymphocyte ratio and
postoperative infectious complications after
pancreatoduodenectomy for carcinoma of the pancreas head
L Romano
1
, M Schietroma
2
, A Giuliani
1
, V Vicentini
3
, F Carlei
4
1
University of L’Aquila, L’Aquila, Italy,
2
University of L’Aquila , l’aquila, Italy,
3
Department
of Hepatobiliar-Pancreatic Surgery, St. Salvatore Hospital, L’Aquila, Italy,
4
University of
L’Aquila, l’aquila, Italy
Introduction: Pancreatic ductal adenocarcinomas occur most commonly in the head
of the pancreas. Hence, pancreatoduodenectomy (PD) is the most frequently per-
formed operation for surgical treatment of this disease. Despite the trend toward a
decreasing rate of postoperative mortality, the morbidity rates associated with PD are
still relatively high at 20-65%. Although pancreatic fistula is the most common and
serious complication, infections and wound infections also occur frequently (one-third
of patients who undergo PD). Surgery induces a systemi c inflammatory response
(SIR). A novel inflammatory marker derived from the white cell count (WCC), the
neutrophil-to-lymphocytes ratio (NLR), provides a simple index of the SIR and immu-
nosuppression. Thus, NLR could provide a simple method to identify patients with a
high risk of postoperative complications. In this study, we investigated the potential
correlation between the NLR and the postoperative infectious complications after PD
for carcinoma of the pancreas head.
Methods: From May 2013to January 2019, 62patients were consecutivelyenrolled in this
prospective observational study.Postoperative infectious complications included intra-
abdominal abscess,infected postoperative pancreatic fistula, wound infection, pulmonary,
and urinarytract infection.The incidence of postoperative infectious complications was
monitoredup to the 30th postoperativeday and prospectivelytabulated. Bloodsamples
were collected from all patients beforethe operation and at days1, 3 and 5 post-operation.
Results: Elective PD was associated with an increase in mean NL R from 4.1 to 11.9 (P
<.001). Thirty patients (48.3%) developed at least one predefined complication.
Patients with an NLRR 9.8 on the first postoperative day had a significantly greater
risk of complications (OR 2.18; 95% CI, 1.406-4.022).
Conclusion: The NLR on the first postoperative day is associated with postoperative
infectious complications after PD. This inflammation score based on a readily available
and inexpensive test could potentially be an ideal biomarker of postoperati ve infectious
complications after PD for carcinoma of the pancreas head.
P155 The management of hepatocellular carcinoma: a report of 19 cases
F Boudinar, B Larbaoui
Medical Oncology Department, EHSO Emir Abdelkader, Oran, Algeria
Introduction: Hepatocellular carcinoma (HCC) is the most common malignant liver
tumour. The incidence of this cancer has increased markedly in recent years and is ris-
ing in areas where viral hepatitis is endemic. In Algeria, hepatocellular carcinoma is
rare. The primary objective of this study was to determine the prevalence and epide-
miological profile of hepatocellular carcinoma in patients with chronic liver disease
treated in the medical oncology department.
Methods: We retrospectively conducted this study from October 2014 to October 2018
in the medical oncology department of the Anti-cancer Center of Oran. Nineteen
patients with HCC were included.
Results: In all, 19 patients were recruited; mean age was 54.7 years, range (44-88 years),
73.6% were male, 26.3% were female. The performance status was as follows: OMS1
52.6%, OMS2 36.8%, and OMS3 10.5%. Histological diagnosis was established in 57%
of patients. Ultrasonography and abdominal computed tomography (CT) demon-
strated the presence of hypervascular hepatic lesions (WASH-OUT) in 26% of patients,
one mass in 84%, and multiples nodules in 16%. The risk factors included smoking in
25%, alcohol use in 14%, diabetes in 17.8%, Hepatitis B in 10%, and Hepatitis C in
36.84%. The clinical symptoms were abdominal pain in 79%, HPMG in 42%, SPMG in
21%, VO in 26%, hemorrhage in 10.5%, and icterus in 5%. Patients showed alpha-feto-
protein levels >400 ng in 42%. Thirty-seven percent of patients had CHILD PUGH A,
53% CHILD PUGH B, and 10.5% CHILD PUGH C. BCLC Classification was 10. 5%
ST B and 89.4% ST C. Surgery was performed in 2 patients and systemic treatment per-
formed in 68%. For the 1ST line (SORAFENIB), the average number of cycles was 3
(range 1-10). The dose was 400mg in 2 patients, 600mg in 6 patients, and 800mg in 8
patients. The adverse events were asthenia G2 in 15%, anorexia G2 in 15%, hand-foot
syndrome in 15%, and arterial hypertension in 21%. Evaluation of 8 patients, showed
stability in 6 patients, progression in 2 patients, and death in 2 patients. Median survival
was 13 months.
Conclusion: The prevalence of HCC in patients with chronic liver disease is still very
high in our context. The diagnostic and therapeutic management of HCC is complex
and requires a multidisciplinary approach. It would be necessary to mobilize resources
for prevention and early treatment to control the disease.
P156 Treatment for esophageal and esophagogastric junction cancer
with radical radiotherapy: a single-institution cohort study
M Soce; V Bisof, Z Rakusic, A Misir Krpan, D Stancic-Rokotov, S Sandrk, A Juretic
University Hospital Centre Zagreb, Zagreb, Croatia
Introduction: Esophageal cancer is one of the solid malignant diseases with the worst
prognosis. The five-year overall survival is less than 20% even in more developed coun-
tries. According to the data from the cancer registry for the year 2015, 169 patients have
been diagnosed with this disease in the Republic of Croatia.
Methods: The aim of this non-randomized, retrospective study was to evaluate the sur-
vival rate of patients with esophageal and esophagogastric junction (EGJ) cancers who
were treated with radical radiotherapy in the University Hospital Centre Zagreb
between 2011 and 2018. The excluding criteria were metastatic disease and palliative
radiotherapy. The data was collected from the medical records stored in the hospital
information system.
Results: A total of 77 patients were included in this research; 71 were male (92.2%).
The median follow-up was 4.3 years. Primary radiotherapy was applied in 38 patients
(49.4%). Twenty-eight of them were treated with concomitant chemoradiotherapy
(CRT). Due to comorbidity, 8 patients could not be treated with chemotherapy.
Neoadjuvant CRT was given to 15.5% of patients and adjuvant to 35.1%. In the pri-
mary and neoadjuvant CRT, cisplatin and 5-fluorouracil (5-FU) was used while in the
adjuvant CRT, leucovorin and 5-FU was used. The median age of patients was 61 years
(range 43 85). Squamous cell carcinoma was found in 55.8% of patients, adenocar ci-
noma in 40.3% and 3.9% patients were diagnosed with cancer without further histolo g-
ical differentiation. The most common sites were distal esophageal and EGJ sites
(49.4%), followed by cervical (23.4%) and thoracic (22.1%) site and the cancer over-
took the whole esophagus in 5.1% patients. The majority of patients had advanced dis-
ease (75% stage 3 or 4). The five-year overall survival was 17%. The survival rate was
statistically better in patients with adenocarcinoma than in the patients with squamous
cell carcinoma (31.8% vs 11.3%, P ¼.003). Patients with stage 1 or 2 had better survival
rates than patients with stage 3 or 4, but, this was not statistically significant (45% vs
13%, P ¼.306). There was no difference in the distribution of a disease stage between
the 2 histological subgroups (P ¼.173). Progression of the disease was verified in
70.1% of patients. A locoregional recurrence was found in 29.8% of patients, metastatic
disease in 36.4%, and local recurrence with metastatic disease in 3.9% of patients. The
median progression time was 9.1 months.
Conclusion: The end results are aligned with the data in the literature. To improve
treatments results it is necessary to increase the use of neoadjuvant therapy which can
be accomplished by better utilization of the multidisciplinary team.
P157 Efficacy and safety of FOLFIRI/Aflibercept (FA) in an elderly
population with metastatic colorectal cancer (mCRC) after the
failure of an oxaliplatin-based regimen
N Mart
ınez-Lago
1
, M Carmona Campos
2
, P Gonzalez Villarroel
3
, M Salgado
Fernandez
4
, J De la C
amara G
omez
5
, C Romero Reinoso
6
, A Cousillas Casti~
neiras
7
,
JMe´ndez Me´ndez
8
, Y Vidal Insua
9
, C Reboredo Rendo
1
, M Covela R
ua
10
, G Quintero
Aldana
11
, B Gra~
na Suarez
12
, A Carral Maseda
10
, M Jorge Fernandez
13
, M Pell
on
Augusto
14
, C Grande Ventura
13
, E Gallardo Martin
15
, A Fern
andez Montes
16
,
M Reboredo-Lopez
1
1
University Hospital of A Coru~
na, A Coru~
na, Spain,
2
Hospital Universitario Lucus Agusti,
Lugo, Spain,
3
Hospital
Alvaro Cunqueiro, Vigo, Spain,
4
Complejo Hospitalario
Universitario de Ourense, Orense, Spain,
5
Hospital Arquitecto Marcide, Ferrol, Spain,
6
POVISA, Vigo, Spain,
7
Hospital Provincial de Pontevedra, Pontevedra, Spain,
8
Centro
Oncol
ogico de Galicia, A Coru~
na, Spain,
9
Complejo Universitario De Santiago de
Compostela, santiago de Compostela,, Spain,
10
Hospital Lucus Augusti, Lugo, Spain,
11
Hospital Universitario Lucus Augusti, Lugo, Spain,
12
University Hospital A Coruna, A
Coruna, Spain,
13
Hospital Alvaro Cunqueiro, Vigo, Spain,
14
Hospital Arquitecto Macide,
Ferrol, Spain,
15
Complejo Hospitalario de Pontevedra, pontevedra, Spain,
16
Complexo
Hospitalario Universitario de Ourense, Ourense, Spain
Introduction: Aflibercept (ziv-aflibercept) significantly improves progression-free
(PFS) and overall survival (OS) when added to FOLFIRI, compared with FOLFIRI
abstracts Annals of Oncology
iv42 | Posters Volume 30 | Supplement 4 | July 2019
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