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Annals of Oncology
efficacy benefit of adding docetaxel to CF (cisplatim + 5-fluorouracil) (DCF). DCF is
associated with significant toxicity, making it less tolerable to pts. We modified the
original DCF regimen to reduce its toxicity without decreasing efficacy.
Patients and methods: AGC pts received docetaxel 75 mg/m 2 and cisplatin 75 mg/
m 2 in day2 with leucovorin 50 mg and 5-fluorouracil 500 mg/m 2 (3-hour infusion) in
day 1-3 every 3w (TPF) instead of original DCF (docetaxel 75 mg/m 2 , cisplatin 75
mg/m 2 in day 1 and fluorouracil 750 mg/m 2 in day 1-5 continuous infusion).
Results: 39 CT-naïve pts with AGC were included in our study from Feb2008 to
Dec2010 (20 female, 19 male). ECOG 0/1/2 were10/80/10% pts. ORR was 40% (16/39),
SD – 40% (16/39), PD – 20% (7/39). Median PFS and median OS were evaluated in
38pts and were 5,4m and 9,5m, respectively. Toxicity was moderate. Grade 3 and 4
toxicities included leucopenia – 32,5 and 7,5%, neutropenia – 25 and 40%,
thrombocytopenia – 2,5 and 0% pts, febrile neutropenia -1pt (2,5%); asthenia – 2,5 and
0%, stomatitis – 2,5 and 0%, diarrhea – 12,5 and 0%, vomiting – 0 and 2,5% pts. We
didn’t use G-CSF prophylaxis. There were no deaths and treatment discontinuation due
to toxicity. At present 5 pts are still alive, in three of them distant mts disappeared and
operation became possible. Their survival is 28,5m (without PD), 32.9m with PD over
10m after surgery and 42m with PD over 12m after surgery.
Conclusion: Our data suggest that TPF regimen has the similar efficacy and better
tolerability than the standard DCF. TPF regimen can be safely given in an ambulant
setting.
Disclosure: All authors have declared no conflicts of interest.
761 SECOND-LINE DOCETAXEL (D) IN METASTATIC GASTRIC
CANCER (MGC)
C. Caparello 1 , M. Lencioni 1 , E. Vasile 1 , S. Caponi 1 , S. Santi 2 , M.G. Fabrini 3 ,
L. Ginocchi 1 , M. Lucchesi 1 , S. Ricci 1 , A. Falcone 1
1 Oncologia, Trapianti e Nuove Tecnologie in Medicina, Polo Oncologico -
Azienda Ospedaliero-Universitaria Pisana - Istituto Toscano Tumori, Pisa, ITALY,
2 Department of Gastroenterology, Esophageal Surgery Unit, Tuscany Regional
Referral Center for the Diagnosis and Treatment of Esophageal Disease, Pisa,
Italy, Pisa, ITALY, 3 Division of Radiation Oncology, S. Chiara Pisa Hospital, Pisa,
Italy, Pisa, ITALY
Background: Although second-line chemotherapy with irinotecan or docetaxel
seemed to confer an improvement in overall survival over best supportive care, at
today no standard second-line chemotherapy regimen is approved in MGC.
Methods: The objective of our retrospective analysis was to evaluate the activity of a
second-line taxane-based treatment in MGC patients (pts).
Results: A total of forty-eight pts (M/F 40/8; ECOG PS at second-line treatment 0/1/
2: 23/22/3) were included in the study; median age 67 years (range 38-86). All pts
received a first-line fluoropyrimidine-based chemotherapy; 42 in combination with
platinum compounds (9 received a triplet with anthracyclines and 2 with Herceptin)
and 6 in monochemotherapy. 46 pts were evaluable for analysis: 37 pts received a
docetaxel monochemotherapy (16 weekly, 5 biweekly and 16 three-weekly schedule),
10 a combination of docetaxel with fluorouracil, 1 with cisplatin. Grade 3 or 4
toxicities included: anemia 3 pts, neutropenia 6 pts, diarrhea 1 patient, fatigue,
vomiting and neurotoxicity 1 patient each, stomatitis 2 pts; 13 pts needed a delay of
treatment and 5 a reduction of doses. Among 46 evaluable pts 7 (15.2%) experienced
a partial response, 13(28.3%) a stable disease, 26(56.5%) a progression of disease. 24
pts received a third-line chemotherapy, 21 of these an irinotecan-based treatment.
Median progression-free survival was 4.3 months and median overall survival was 8.6
months from the start of second-line treatment. No significant differences were
found in mPFS, RR and toxicity profile between different treatment schedules. mPFS
seemed to be longer in patients with PS 0 than in patients with PS 1 or 2 (5.4
months versus 2.1 and 0.95 respectively; p = 0.046). No difference in mPFS was
detected according to RR at first-line therapy.
Conclusions: Docetaxel in MGC second-line setting seems to have an encouraging
activity with an acceptable toxicity profile.
Disclosure: All authors have declared no conflicts of interest.
762 THIRD-LINE FOLFIRI IN METASTATIC GASTRIC CANCER
PATIENTS
C. Caparello 1 , E. Vasile 1 , M. Lencioni 1 , M.G. Fabrini 2 , M. Lucchesi 1 , L. Ginocchi 1 ,
S. Caponi 1 , S. Santi 3 , S. Ricci 1 , A. Falcone 1
1 Oncologia, Trapianti e Nuove Tecnologie in Medicina, Polo Oncologico -
Azienda Ospedaliero-Universitaria Pisana - Istituto Toscano Tumori, Pisa, ITALY,
2 Division of Radiation Oncology, S. Chiara Pisa Hospital, Pisa, Italy, Pisa, ITALY,
3 Department of Gastroenterology, Esophageal Surgery Unit, Tuscany Regional
Referral Center for the Diagnosis and Treatment of Esophageal Disease, Pisa,
Italy, Pisa, ITALY
Background: The use of systemic chemotherapy increased median survival of advanced
gastric cancer patients. Besides fluoropyrimidines and platinum compounds, different
active agents such as docetaxel and irinotecan became available giving physicians the
opportunity to administer to patients further lines of treatment. Second-line
chemotherapy with docetaxel or irinotecan showed improved overall survival over best
supportive care. There are many patients progressed after two lines of therapy who
maintain a good performance status that could be evaluated for further treatment.
Methods: The aim of this retrospective analysis was to evaluate the activity of the
combination of 5-fluorouracil/folinic acid and irinotecan (FOLFIRI) as third-line
treatment for metastatic gastric adenocarcinoma patients.
Results: A total of twenty-one patients (M/F 16/5; ECOG Performance Status 0/1: 3/
18) treated between 2009 and 2011 were included in the study; median age was 64
years (range 38-77). All the patients had received first-line fluoropyrimidine plus
platinum compound chemotherapy; in 7 of them a triple-drug combination with
epirubicin was used; one patient with HER-2 positive tumor was treated with
trastuzumab in combination with chemotherapy. All patients had received taxanes in
second-line (docetaxel in 18 and paclitaxel in 3 patients), in 5 cases in association with
5-fluorouracil. A total of 151 cycles of third-line FOLFIRI were administered (median
number 7; range 2-18). Treatment was well tolerated; grade 3 or 4 toxicities included
neutropenia in 3 patients, diarrhea in 3 patients, asthenia and vomiting in 1 patient
each; delay of treatment was required in 9 patients and a reduction of doses only in 3
cases. Among the twenty evaluable patients, two (10%) partial responses and 8 (40%)
stable disease were observed, thus obtaining a disease control in half of patients.
Median duration of response was 7 months. Median progression-free survival was 3.8
months. Median overall survival from the start of third-line treatment was 9.1 months.
Conclusions: FOLFIRI was feasible and showed interesting activity also in third-line
setting of largely pretreated selected metastatic gastric cancer patients.
Disclosure: All authors have declared no conflicts of interest.
763 EPIDEMIOLOGICAL DATA OF PATIENTS WITH GASTRIC
CANCER IN MEXICO
G.C. Ruiz1 , N. Reynoso1 , C. Diaz1 , E.B. Ruiz1 , E. Trejo1 , A. Mohar-Betancourt2 1
Medical Oncology, Instituto Nacional de Cancerologia, Mexico City, MEXICO,
2
Biomedical Research, Instituto Nacional de Cancerología (INCan), Mexico City,
MEXICO
Introduction: The gastric cancer is very common neaplasm in Asia and Central and
SouthAmerica. With large differences among patients diagnosed and treated in
Europe, America and Asia. We present some epidemiological data of patients with
gastric cancer.
Methods: Methodology was analyzed the database of all patients diagnosed of
adenocarcinoma of the stomach from January 1999 to December 2011 served in the
Medical Oncology service.
Results: We identified 1179 patients evaluated by Medical Oncology, these 1130 with
histology adenocarcinoma, 40 with stromal tumor gastro-intestinal, 3 with
leiomiosarcoma, 3 with scamous cell and 3 with neuroendocrine tumor. Of the cases
with adenocarcinoma, 56% were men with a mean age of 55.8 years +/- 13.6 and
44% occured in women with a mean age of 52.2 years +/- 13.4 (p < 0.0001). The
17.5% is presented in patients with 40 years o less. The more common histologic
subtipe is diffuse in 54% versus 30% intestinal y 5% mixed (in 11% nondeterminate).
In patients with diffuse type-adenocarcinoma 88% are poorly
differentiated and 72% with signet ring cells. Gender difference was no observed, but
in relation to age, for patients under 40 years 72% is diffuse versus 40% in over 40
years (p < 0.0001). The location of the tumor is in the stomach in 86% of the cases
versus 14% in the esophago-gastric junction, noting a significant difference in
relation to sex, with 8.6% in women versus 18% in men (p < 0.0001). The stages
were: 33 cases (2.8%) stage I, 34 cases (2.9%) stage II, 103 patients (8.7%) stage III,
194 cases (18.8%) with disease locally advanced, non-surgical and 766 patients
(68.0%) stage IV. Of the patients with stage IV, 18% was confirmed by surgical and
histological findings or T4 or N3, M0 (AJCC 6th edition). The most common sites
of metastases are the peritoneum/ascitis in 58%, liver 26%, retroperitoneal 13%,
ovarian 9.6% and lung 7.3%.
Conclusions: Gastric cancer in Mexico is a serious health problem, is diagnosed in
young patients with poor prognostic factors as the diffuse histological type, poorly
differentiated and signet-ring cells. The location of the tumor in esophago-gastric
junction is more common in men. The diagnosis in made in most patients in
advanced stages (III-IV).
Disclosure: All authors have declared no conflicts of interest.
764 FORTY-ONE CASES OF METASTASIS FROM GASTRIC CANCER
TO THE CENTRAL NERVE SYSTEM: EXPERIENCE AT SINGLE
CENTER
H. Shoji1 , T. Hamaguchi1 , Y. Honma1 , S. Iwasa1 ,K.Kato1 , Y. Yamada2 ,
Y. Shimada1 1
Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, JAPAN,
2
Division of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo,
JAPAN
Background: Metastasis from gastric cancer to the central nerve system (CNS) is a
rare entity, and there is little information available regarding evaluation of these
patients. The purpose of this study was to evaluate the clinical characteristics of
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