Download the ESMO 2012 Abstract Book - Oxford Journals

Results: Frequently reported adverse events (more than 20% of pts.) were
predominantly grade 1 or 2 and included diarrhea (25/36, 69%), polyneuropathy
(17/36, 47%), nausea (17/36, 47%), fatigue (15/36, 42%), neutropenia (13/36, 36%),
abdominal pain (11/36, 31%), hypokalemia (9/36, 25%). Grade 3 and 4 toxicities
included neutropenia (6/36, 17%), diarrhea (3/36, 8%), hypokalemia (3/36, 8%),
anemia in (2/36, 6%), leucopenia (2/36, 6%), thrombocytopenia (1/36, 3%), nausea in
(1/36, 3%). Weight loss Grade 1 was initially documented in 1/36 pts., (3%).
Objective response rate after 3 cycles was available in 25 patients: CR 1/25 (4%), PR
14/25 (56%), SD 8/25 (32%), PD 2/25 (8%). After 6 cycles there were 12 evaluable
patients with CR 2/12 (16.7%), PR 5/12 (41.7%), SD 4/12 (33.3%) and PD 1/12
(8.3%). Median time to progression was 24 weeks, median overall survival was 48
weeks. Progression total was 12/36 (33%).
Conclusions: The combination of oxaliplatin and irinotecan with bevacizumab followed
by docetaxel with bevacizumab is feasible and active in advanced gastric cancer.
Disclosure: All authors have declared no conflicts of interest.
756 CLINICAL OUTCOME OF ADVANCED GASTRIC CANCER (GC)
PATIENTS RECEIVING FIRST-LINE CHEMOTHERAPY
ACCORDING TO TUMOUR HISTOLOGY AND LOCATION
A. Bittoni 1 , M. Scartozzi 1 , R. Giampieri 1 , L. Faloppi 1 , M. Bianconi 1 ,
A. Mandolesi 2 , M. Del Prete 1 , M. Pistelli 2 , I. Bearzi 2 , S. Cascinu 1
1 Clinica di Oncologia Medica, AOU Ospedali Riuniti Ancona Università
Politecnica delle Marche, Ancona, ITALY, 2 Anatomia Patologica, AOU Ospedali
Riuniti Ancona Università Politecnica delle Marche, Ancona, ITALY
Background: In the daily clinical practice GC is considered as a single disease.
However, preliminary data identified distinct subtypes characterized by relevant
differences in epidemiology, carcinogenesis and gene expression profiles. Recently,
a new classification has been proposed, based on Lauren’s histology and on anatomic
tumour location, identifying three subtypes: type 1 (proximal non diffuse GC), type
2 (diffuse GC) and type 3 (distal non diffuse GC). Aim of our analysis was to
compare clinical outcome (in terms of response rate, RR, progression-free survival,
PFS, and overall survival, OS) according to different GC subtypes (1,2,3) in patients
(pts) receiving first-line chemotherapy.
Patients and methods: Advanced GC pts treated with a first-line combination
chemotherapy were included in our analysis. Pts were divided in three subgroups
(type 1, type 2 and type 3) as previously defined.
Results: A total of 202 advanced GC pts were included: most of pts belonged to type
2 (50.5%) and type 3 (40.6%); type 1 included 18 pts (8.9%). The majority of pts
(62%) received a three-drugs chemotherapy combinations including a platinum
derivate, a fluoropyrimidine with the addition of an anthracycline, a taxane or
mytomicin C; the remaining patients received a platinum and fluoropyrimidine
combination. The three pts subgroups resulted comparable for relevant clinical
factors such as ECOG PS, tumour stage, number of metastatic sites, previous surgical
resection, first-line combination and use of second-line treatments; as expected
peritoneal carcinosis was more common in type 2 pts. RR was found to be higher in
type 3 pts (RR = 45.1%) than in type 1 (27.8%) and type 2 (25.5%) (p = 0.017). Type
2 pts presented a shorter PFS (median PFS 5.7 months) compared to type 1, median
PFS = 6.9 months, and type 3, median PFS = 7.8 months (p = 0.0069). These
differences did not translate in statistically significant differences in OS.
Conclusions: Our results suggest that GC subtypes may be important predictors of
benefit from chemotherapy in advanced GC patients. Future clinical trials should
take in account these differences for a better stratification of patients.
Disclosure: All authors have declared no conflicts of interest.
757 A RANDOMIZED, SINGLE CENTER PHASE II TRIAL OF
CAPECITABINE PLUS CISPLATIN VERSUS TS-1 PLUS
CISPLATIN AS FIRST LINE TREATMENT IN PATIENTS WITH
ADVANCED OR METASTATIC GASTRIC CANCER
J. Lee 1 , S.Y. Roh 2 , E. Jeon 1 , S.H. Hong 2 , Y.H. Ko 1 , H.S. Won 1 , H.J. An 1 ,
K.W. Park 3 , J.H. Kim 1 , Y.S. Hong 1
1 Division of Oncology, Department of Internal Medicine, Seoul St. Mary’s
Hospital, Seoul, KOREA, 2 Medical Oncology, Catholic Medical Center, Seoul,
KOREA, 3 Medical Oncology, Fatima Hospital, Daegu, KOREA
Background: Platinum agents and oral fluoropyrimidines are widely used in the
treatment of advanced gastric cancer. This study was aimed to evaluate the efficacy
and safety of two combination regimens (capecitabine plus cisplatin [XP] vs S-1 plus
cisplatin [SP]) in patients with untreated recurrent or metastatic gastric cancer.
Methods: Patients diagnosed as untreated recurrent or metastatic gastric cancer were
randomly assigned to either capecitabine (2500 mg/BSA/day; day 1-14) plus cisplatin
(60 mg/BSA/day; day 1), every 3 weeks or TS-1 (80-120 mg/day; day 1-14) plus
cisplatin (60 mg/BSA/day; day 1), every 3 weeks. Primary end point was overall
response rate (ORR), accessed by RECIST criteria (ver. 1.0). The secondary end point
was progression free survival (PFS), overall survival (OS), and toxicities.
Results: 86 patients were anticipated to be enrolled, but 51 patients were randomized
to XP (25 patients) arm or SP (26 patients) arm because enrollment was slower than
Annals of Oncology
expected. ORR of XP and SP was 52% (13 of 25 assessable patients) vs. 44% (15 of
25 assessable patients), and no significant differences were found (P = 0.778). OS of
XP vs. SP was 10.3 months (95% CI; 4.8-15.8) vs. 12 months (95% CI; 9.5-14.5),
with no differences (P = 0.785). PFS was 4.6 months (95% CI; 4.6-5.2), 4.4 months
(95% CI; 2.2-6.6) each (P = 0.68). The incidence of grade 3-4 neutropenia of XP vs.
SP was 40% vs. 43.2%. There were no febrile neutropenia in XP arm, but 7.7% in SP
arm. Grade 3-4 thrombocytopenia was 12%, 3.8% each. Other grade 3-4 toxicities
were; Nausea (4% vs. 0%), Stomatitis (12% vs. 3.8%), Hand-foot syndrome (16% vs.
0%), Diarrhea (0% vs. 3.8%). Median relative dose intensity of capecitabine vs. TS-1
was 78.7% (range 51.9-116.7%), 87.5% (range 57.1-166.7%).
Conclusion: There were no significant differences in ORR, OS, and PFS between XP
vs. SP arm. The incidence of grade 3-4 neutropenia was similar in both arms, but
thrombocytopenia was relatively more common in XP arm. SP was more tolerable
than XP in non-hematologic toxicities. Considering the usual dosage of capecitabine
in monotherapy is 2500 mg/BSA/day, capecitabine 2500 mg/BSA/day combined with
cisplatin 60 mg/BSA may be overdosed, and higher rate of non-hematologic toxicity
can be explained. Dosage of capecitabine when combined with cisplatin, needs to be
further adjusted for routine use.
Disclosure: All authors have declared no conflicts of interest.
758 FEASIBILITY OF ORAL ADMINISTRATION OF S-1 FOR
ADJUVANT CHEMOTHERAPY OF GASTRIC CANCER; 4-WEEK
S-1 ADMINISTRATION FOLLOWED BY 2-WEEK REST VS.
2-WEEK ADMINISTRATION FOLLOWED BY 1-WEEK REST
T. Yamatsuji 1 , Y. Fujiwara 2 , H. Matsumoto 3 ,S.Hato 4 , T. Namikawa 5 ,
K. Hanazaki 5 , M. Ninomiya 2 , T. Fujiwara 6 , T. Hirai 3 , Y. Naomoto 1
1 Department of General Surgery, Kawasaki Hospital, Kawasaki Medical School,
Okayama, JAPAN, 2 Department of Surgery, Hiroshima City Hospital, Hiroshima,
JAPAN, 3 Digestive Surgery, Kawasaki Medical School, Kurashiki, JAPAN,
4 Depatment of Surgery, Shikoku Cancer Center, Matsuyama, JAPAN,
5 Department of Surgery, Kochi Medical School, Nankoku, JAPAN, 6 Department
of Gastroenterological Surgery, Okayama University Graduate School of
Medicine, Dentistry and Pharmaceutical Sciences, Okayama, JAPAN
Background: In 2006, ACTS-GC study revealed that S-1 is an effective adjuvant
therapy of gastric cancer. Following the study, S-1 is used as the standard treatment
for adjuvant therapy for gastric cancer in Japan. S-1 therapy with 4-week
administration followed by 2-week rest was continued for 6 months in 78%, and 12
months in 66% of the patients. The compliance is the critical problems of the
therapy. Tukuda et al. reported a randomized study of S-1 for adjuvant
chemotherapy of advanced head and neck cancer, showing that the feasibility of
4-week administration followed by 2-week rest for 6 months was 29%, and 2-week
administration followed by 1-week rest was 40%. They claimed that the 2-week
administration followed by 1-week rest seems to be more feasible in adjuvant therapy
of squamous cell carcinoma of the head and neck. There is no study of the feasibility
for S-1 in adjuvant chemotherapy of gastric cancer. Here we conducted a study to
evaluate the feasibility, safety and efficacy of S-1 in adjuvant chemotherapy of gastric
cancer.
Method: The criteria for eligibility were histologically proven gastric cancer of stage
II (excluding T1), IIIA or B with D2 lymph-node dissection. Patients were randomly
assigned to either arm A; S-1 administration for 4 weeks followed by a 2-week rest or
arm B; S-1 administration for 2 weeks followed by a 1-week rest. In each arm, the
therapy was continued for 12 months unless there was any recurrence or severe
adverse event. The primary end point was feasibility. The secondary were the safety
of S-1, relapse-free and overall survival.
Results: We randomly assigned 46 patients to the arm A or B between May 2008
and February 2010. The first interim analysis showed the feasibility of the arm A and
B, those were 83% and 100% in 6 months, 49% and 89% in 12 months respectively.
S-1 administration for 2 weeks followed by a 1-week rest was more feasible in
adjuvant chemotherapy of gastric cancer (P = 0.0046). Adverse events of grade 3 in
the arm A were anorexia (8.0%), nausea (4.0%). There is no event of grade 3 in the
arm B, and no event of grade 4 in both arms. Efficacy of the therapies; relapse-free
survival and overall survival will be reported in the few years.
Conclusion: The schedule of 2-week administration followed by 1-week rest is more
feasible for oral administration of S-1 in adjuvant chemotherapy of gastric cancer.
Disclosure: All authors have declared no conflicts of interest.
760 DOCETAXEL, CISPLATIN, 5-FLUOROURACIL AND
LEUCOVORIN AS FIRST-LINE THERAPY IN ADVANCED
GASTRIC CANCER (AGC)
E. Trusilova, N. Besova, V.A. Gorbunova
Chemotherapy, N.N. Blokhin Russian Cancer Research Center, Moscow,
RUSSIAN FEDERATION
Purpose: AGC is relatively chemosensitive, but a standard chemotherapy (CT)
regimen has yet to emerge, and responses are of short duration. Docetaxel-containing
combinations are new option for pts with AGC. The V325 trial demonstrated the
ix250 | Abstracts Volume 23 | Supplement 9 | September 2012