De Gramont Schedule is a Very Low Toxic and Effective Regimen in Low Performance Status Patients Affected by Metastatic Gastric Cancer: Preliminary Report

Summary Treatment of patients affected by metastatic gastric cancer with low performance status (PS) is a very hard choice. It is mandatory to define a very well-tolerated schedule to be employed in these subgroup of patients. Patients and Methods From June 1999 to December 2001, 21 patients (pts) affected by metastatic gastric cancer with low performance status (≥2 ECOG) were treated with bimonthly “de Gramont” schedule. Treatment was planned to perform 6 courses of chemotherapy for each patient plus other 2-4 if a response had been documented. Results A total of 161 courses of de Gramont schedule was administered to the 21 pts enrolled. We observed 8 PD (38%), 8 SD (38%), 5 objective responses (24% – 2 MR, 3 PR). Duration of objective responses (OR) was 5 months, 3 months for 3 PRs and 2 and 1 months for two MRs respectively. At time of observation (June 2002) median overall survival (OS) was 14 months, median survival from the starting de Gramont schedule was 8 months. Toxicity was very mild: grade 3 leukopenia in 1 pt, grade 1-2 anemia and piastrinopenia in 3 pts, grade 1-2 nausea vomiting in 5 pts, grade 1 diarrhea in 4 pts, grade 3 mucositis in 2 pts. No other side effect was renowned. PS ameliorated in 12 (57%) pts, even if a major response was not noted. Conclusions de Gramont schedule can be safely and effectively employed in metastatic gastric cancer pts with very low performance status.

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Efficacy of Regional Chemotherapy Approach in Peritoneal Metastatic Gastric Cancer

Journal of Clinical Medicine ◽

10.3390/jcm10225322 ◽

2021 ◽

Vol 10 (22) ◽

pp. 5322

Author(s):

Kornelia Aigner ◽

Yogesh Kumar Vashist ◽

Emir Selak ◽

Sabine Gailhofer ◽

Karl Reinhard Aigner

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Median Overall Survival ◽

Metastatic Gastric Cancer ◽

Regional Chemotherapy ◽

Intraarterial Infusion ◽

Flow Perfusion ◽

Advanced Stages ◽

Grade 3 ◽

Upper Abdominal

Peritoneal spread is frequent in gastric cancer (GC) and a palliative condition. After failure to systemic chemotherapy (sCTx) remaining therapeutic options are very limited. We evaluated the feasibility and efficacy of locoregional chemotherapy (RegCTx) in peritoneal metastatic GC. In total, 38 (23 male and 15 female) patients with peritoneal metastatic GC after failure of previous sCTx and unresectable disease were enrolled in this study. Using the hypoxic abdominal stop-flow perfusion, upper abdominal perfusion and intraarterial infusion technique in total 114 cycles with Cisplatin, Adriamycin and Mitomycin C were applied. No significant procedure related toxicity was noticed- especially no Grade 3 or 4 toxicity occurred. With the RegCTx approach a median overall survival of 17.4 months was achieved. Patients who had undergone previously resection of the GC the median overall survival was even better with 23.5 months. RegCTx is a promising, safe and efficient approach in diffuse metastatic GC. The evaluation of RegCTx in the setting of multimodal treatment approach at less advanced stages is also warranted.

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Phase II study of S-1 and biweekly docetaxel combination in advanced or recurrent gastric cancer

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.14031 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 14031-14031

Author(s):

Y. Kakeji ◽

E. Oki ◽

K. Nishida ◽

T. Koga ◽

E. Tokunaga ◽

...

Keyword(s):

Gastric Cancer ◽

Phase Ii ◽

Phase Ii Study ◽

Performance Status ◽

Metastatic Gastric Cancer ◽

Preclinical Study ◽

Current Phase ◽

Tumor Control ◽

Recurrent Gastric Cancer ◽

Grade 3

14031 Background: Docetaxel (TXT) and S-1 are active agents against gastric cancer. A synergistic antitumor effect has been shown in a preclinical study (Takahashi et al., Oncology 2005), and our previous phase I trial demonstrated the safety and tolerability of the combination, and its potent activity. To prospectively evaluate toxicity and efficacy of S-1/ biweekly TXT, we conducted the current phase II study in patients with advanced and recurrent gastric cancer. Methods: Patients (pts) with advanced or recurrent gastric cancer, who have not received any chemotherapy except postoperative chemotherapy (not including S-1 or TXT), were eligible for the trial, and were treated with docetaxel 35 mg/m2 one hour iv infusion on day 1 and 15, and S-1 at a full dose of 80 mg/m2/day for two weeks every four weeks. Results: Thirty-five pts with measurable lesions (RECIST) (10 females, 25 males; performance status [PS] 0/1/2: 23/8/4, age 27–74, differentiated/undifferentiated adenocarcinoma: 19/16) have been enrolled. A total of 113 cycles were administered (median 3, range 1–6), and all pts were assessable for toxicity and efficacy. Grade 3–4 toxicities were: neutropenia in 20.0% (grade 4: 11.4%) of patients, leukocytopenia in 11.4% (grade 4: 0%), anemia in 5.7%, appetite loss in 8.6%, stomatitis in 8.6%, fever in 2.9%, and fatigue in 2.9%. All treatment related toxicities resolved, and no toxic death was reported. Thirteen partial responses (PR) were obtained, resulting in an overall response (OR) rate of 37.1% (95% CI: 0.22–0.55). Thirteen pts (37.5%) had stable disease, and 4 pts (12.5%) progressed. The tumor control rate was 74.3% (95% CI: 0.57–0.88). The median survival time (MST) and time to treatment failure (TTF) were 326 and 75 days, respectively. Conclusions: The combination of S-1/ biweekly TXT is active in advanced or recurrent gastric cancer, and can be given safely with proper management of adverse events even in outpatient clinic. S-1/ biweekly TXT is one of the most effective regimen to control metastatic gastric cancer with less toxicity. No significant financial relationships to disclose.

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Phase II study of irinotecan, 5-fluorouracil (5-FU) and leucovorin combination chemotherapy in taxane and cisplatin-based chemotherapy-refractory metastatic gastric cancer

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.e15599 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. e15599-e15599

Author(s):

J. Yoon ◽

S. Cho ◽

W. Bae ◽

J. Hwang ◽

H. Shim ◽

...

Keyword(s):

Gastric Cancer ◽

Phase Ii ◽

Combination Chemotherapy ◽

Phase Ii Study ◽

Performance Status ◽

Haematological Toxicity ◽

Metastatic Gastric Cancer ◽

High Dose ◽

Ecog Performance Status ◽

Grade 3

e15599 Background: The role of the second line chemotherapy in advanced gastric cancer was not clear, but possibility of prolongation of survival is open question. Irinotecan is promising agents in gastric cancer and this phase II study evaluated the efficacy and safety of combination chemotherapy with irinotecan, high dose of 5-fluorouracil (5-FU) and leucovorin in taxane and cisplatin based chemotherapy refractory metastatic gastric cancer. Methods: Eligible criteria were as followed; histologic confirmed adenocarcinoma of stomach, previously treated with taxane and cisplatin, age≥18, Eastern Clinical Oncology Group (ECOG) performance status of 1 or less, adequate organ function. Irinotecan (150 mg/m2) as a 30-min infusion and leucovorin (200 mg/m2) as a 15-min infusion were given on day 1, followed by 5-FU 400 mg/m2bolus infusion then 5-FU 2,400 mg/m2 as a 48-hour continuous infusion. This cycle was repeated every 2 weeks until disease progression or unacceptable toxicities. Results: Thirty-four patients were enrolled. The median age was 57 years (range 27–73 years), and the ECOG performance status of all patients was 1. All patients were evaluable for safety and survival and twenty seven patients (79.4%) were evaluable for tumor response. The overall response rate was 18.5% (95% CI: 3.9–33.1). The median progression free survival and overall survival were 4.6 (95% CI: 2.4–6.9) and 9.3 months (95% CI: 5.2–13.4), respectively. Greater than grade 3 haematological toxicities were neutropenia in nine (26.5%), febrile neutropenia in one (2.9%) and thrombocytopenia in one patient (2.9%). The major non-haematological toxicity was asthenia, but most of patients showed grade 1 or 2. Greater than grade 3 non- haematological toxicities were elevated AST/ALT in four (11.8%), hyperbilirubinemia in two (5.9%), nausea in two patients (5.9%). Conclusions: This results showed that the combination chemotherapy with irinotecan, 5-FU and leucovorin was well tolerated and active in taxane and cisplatin refractory patients. No significant financial relationships to disclose.

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Phase II Trial of Biweekly Infusional Fluorouracil, Folinic Acid, and Oxaliplatin in Patients With Advanced Gastric Cancer

Journal of Clinical Oncology ◽

10.1200/jco.2004.07.042 ◽

2004 ◽

Vol 22 (4) ◽

pp. 658-663 ◽

Cited By ~ 132

Author(s):

Salah-Eddin Al-Batran ◽

Akin Atmaca ◽

Susanna Hegewisch-Becker ◽

Dirk Jaeger ◽

Sabine Hahnfeld ◽

...

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Folinic Acid ◽

Advanced Gastric Cancer ◽

Intravenous Infusion ◽

Group Performance ◽

Performance Status ◽

Eastern Cooperative Oncology Group ◽

Who Grade ◽

Grade 3

Purpose To evaluate the toxicity and activity of infusional fluorouracil (FU), folinic acid (FA), and oxaliplatin, administered every 2 weeks in patients with metastatic gastric cancer. Patients and Methods Forty-one previously untreated patients with measurable adenocarcinoma of the stomach were eligible for the study. Patients received FU 2.6 g/m2 (24-hour continuous infusion), FA 500 mg/m2 (2-hour intravenous infusion), and oxaliplatin 85 mg/m2 (2-hour intravenous infusion) every 2 weeks for 6 weeks. Treatment was continued until progression of disease was observed. Results All patients were assessable for toxicity and 37 of 41 patients were assessable for response. Patient characteristics were: sex (male, 28; female,13), median age 60 years (range, 20 to 77 years), and median Eastern Cooperative Oncology Group performance status of 1. Response was evaluated every 6 weeks. Of 37 assessable patients, one complete and 15 partial remissions were observed (overall response rate, 43%). Stable disease was observed in 12 patients (32%) and progressive disease in nine patients (24%). The median overall survival was 9.6 months. WHO grade 3 or 4 hematologic toxicities included neutropenia in two patients (4.9%) and thrombocytopenia in one patient (2.4%). Other WHO grade 3 or 4 toxicities included diarrhea in three patients (7.3%) and vomiting in two patients (4.9%). There were no cases of grade 3 peripheral neuropathy and no treatment-related deaths. Conclusion Biweekly fluorouracil, folinic acid, and oxaliplatin is active and well-tolerated in patients with advanced gastric cancer. Response rates, time to progression, and overall survival were comparable to those achieved with other combination chemotherapy regimens, including FOLFOX6, with significantly less toxicity.

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A Pilot Study of Irinotecan Combined with 5-Fluorouracil and Leucovorin for the Treatment of Chinese Patients with Locally Advanced and Metastatic Gastric Cancer

Tumori Journal ◽

10.1177/030089160909500404 ◽

2009 ◽

Vol 95 (4) ◽

pp. 432-437 ◽

Cited By ~ 2

Author(s):

Qiu Li ◽

Jing Chen ◽

Xin Zhao ◽

Xude Yin ◽

Kai Mei ◽

...

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Pilot Study ◽

Partial Response ◽

Locally Advanced ◽

Metastatic Gastric Cancer ◽

Chinese Patients ◽

Grade 3 ◽

Anti Tumor Activity ◽

Comparative Trials

Aims and background The FOLFIRI regimen was evaluated for its anti-tumor activity and toxicity in Chinese patients with locally advanced and metastatic gastric cancer. Methods and study design Treatment consisted of irinotecan, 180 mg/m2 (90-min infusion), leucovorin, 200 mg/m2 (2-h infusion), followed by 5-fluorouracil, 400 mg/m2 (bolus), and then 5-fluorouracil, 600 mg/m2 (22-h continuous infusion) on days 1 and 2, every 14 days. Results Twenty-six patients, of whom 17 were pretreated, were included in the study. Partial response was observed in 9 patients (37.5%). The overall disease control rate was 83.3%. Median progression-free and overall survival was 6.8 and 11.2 months, respectively. Grade 3–4 neutropenia was observed in 6 patients (23.1%) and grade 2–3 diarrhea in 5 (19.2%). No treatment-related deaths occurred. Conclusions The results demonstrate that the FOLFIRI regimen is an active regimen with acceptable toxicity for Chinese patients with advanced and metastatic gastric cancer that merits further investigation in comparative trials.

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Randomized phase II trial comparing the efficacy of standard-dose with high-dose twice-daily thoracic radiotherapy (TRT) in limited disease small-cell lung cancer (LD SCLC).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.9007 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 9007-9007 ◽

Cited By ~ 1

Author(s):

Bjorn Henning Gronberg ◽

Kristin Toftaker Killingberg ◽

Øystein Fløtten ◽

Maria Moksnes Bjaanæs ◽

Tesfaye Madebo ◽

...

Keyword(s):

Overall Survival ◽

Primary Endpoint ◽

Median Overall Survival ◽

Standard Dose ◽

Performance Status ◽

Progression Free Survival ◽

Cranial Irradiation ◽

Prophylactic Cranial Irradiation ◽

High Dose ◽

Grade 3

9007 Background: Concurrent chemoradiotherapy is the standard treatment of LD SCLC. Some patients are cured, but most relapse and better treatment is needed. 45 Gy in 30 fractions BID is the most recommended TRT-schedule. Studies suggest that a higher TRT-dose might prolong survival, but hitherto, this has not been confirmed in randomized trials. We aimed to investigate whether high-dose BID TRT of 60 Gy in 40 fractions was feasible, tolerated, and improved survival. Methods: Patients > 18 years, performance status (PS) 0-2 and confirmed LD SCLC were to receive 4 courses of platinum/etoposide and were randomized to BID TRT of 60 or 45 Gy. Responders were offered prophylactic cranial irradiation of 25-30 Gy. Primary endpoint was 2-year survival; secondary endpoints were toxicity, progression free survival (PFS), and overall survival (OS). To demonstrate a 25% improvement of 2-year survival from 53% to 66% with a one-sided α = .10 and β = .80, 75 patients were required on each arm. Results: Between 2014-2018, 176 patients were enrolled at 22 Scandinavian hospitals. 160 completed TRT per protocol and were eligible for the present analyses (60 Gy: n = 84, 45 Gy: n = 76). Median age was 65, 58% women, 90% PS 0-1. There were no significant differences in grade 3–4 esophagitis (60 Gy: 19%, 45 Gy: 18%, p = .92) or grade 3–4 pneumonitis (60 Gy: 4%, 45 Gy: 0%, p = .10). There was a trend towards more neutropenic infections on the 45 Gy arm (60 Gy: 21%, 45 Gy: 36%, p = .05). There were no significant differences in other grade 3-4 toxicity. Three patients died during the study treatment period (60 Gy: one neutropenic infection and one aortic dissection; 45 Gy: one thrombocytopenic bleeding). There were no statistically significant differences in response rates (60 Gy: 88% [95% CI 81-95], 45 Gy: 85% [95% CI 76-93], p = .52) or median PFS (60 Gy: 20 months [95% CI 11-29], 45 Gy: 14 months [95% CI 10-19], p = .31). Significantly more patients on the 60 Gy arm were alive after 2 years (60 Gy: 73% [95% CI 63-83], 45 Gy: 46% [95% CI 36-60], p = .001), and they had a significantly longer median overall survival (60 Gy: 42 months [95% CI 32-51], 45 Gy: 23 months [95% CI 17-28], HR .63 [95% CI .41-.96], p = .031). Conclusions: LD SCLC patients who received BID TRT of 60 Gy had a statistically significant and numerically substantial benefit in terms of 2-year survival (primary endpoint) and median overall survival compared with those who received BID TRT of 45 Gy. The higher TRT dose did not cause more toxicity than the standard dose. Clinical trial information: NCT02041845.

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Subcutaneous Therapy with Low-Dose Interleukin-2 plus the Neurohormone Melatonin in Metastatic Gastric Cancer Patients with Low Performance Status

Tumori Journal ◽

10.1177/030089169307900606 ◽

1993 ◽

Vol 79 (6) ◽

pp. 401-404 ◽

Cited By ~ 18

Author(s):

Paolo Lissoni ◽

Fernando Brivio ◽

Antonio Ardizzoia ◽

Gabriele Tancini ◽

Sandro Barni

Keyword(s):

Gastric Cancer ◽

Cancer Patients ◽

Low Dose ◽

Tumor Regression ◽

Performance Status ◽

Interleukin 2 ◽

Biological Response ◽

Metastatic Gastric Cancer ◽

Low Performance ◽

Gastric Cancer Patients

Aims and background Patients with disseminated gastric cancer are generally in very bad clinical conditions, which make them not eligible for potentially active polychemotherapies. This justifies the development of less toxic therapies such as the use of biological response modifiers. Unfortunately, IL-2, one of the most promising cytokines, does not seem to be effective in gastric cancer. Our previous studies have shown that the pineal hormone melatonin (MLT) may amplify IL-2 activity, which becomes biologically effective also at very low doses. Based on these considerations, a pilot study was performed with low-dose subcutaneous IL-2 in combination with MLT in metastatic gastric cancer patients with low performance status. Methods The study included 14 patients with metastatic gastric cancer who received IL-2 at a dose of 3 million IU/day at 8.00 p.m. subcutaneously for 6 days/week for 4 weeks. MLT was given orally at a dose of 50 mg/day at 8.00 p.m. every day starting 7 days before IL-2. In patients in whom the disease did not progress, a second cycle was given after a rest period of 21 days. Results A tumor regression was obtained in 3/14 (21 %) patients, complete response in 1 and partial in 2, with a median duration of 13+ months. The disease stabilized in 6/14 (43 %) patients and progressed in the remaining 5 (36 %). Survival was significantly longer in patients with response or stable disease than in those with progression. Toxicity was low in all cases. Conclusions These preliminary results show that the combination on of low-dose subcutaneous IL-2 and the pineal hormone MLT may represent a new well tolerated biotherapy, capable of inducing objective tumor regression also in patients with metastatic gastric cancer and low performance status.

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Palliative Gastrectomy Prolongs Survival of Metastatic Gastric Cancer Patients with Normal Preoperative CEA or CA19-9 Values: A Retrospective Cohort Study

Gastroenterology Research and Practice ◽

10.1155/2016/6846027 ◽

2016 ◽

Vol 2016 ◽

pp. 1-9 ◽

Cited By ~ 2

Author(s):

Chang-Fang Chiu ◽

Horng-Ren Yang ◽

Mei-Due Yang ◽

Long-Bin Jeng ◽

Tse-Yen Yang ◽

...

Keyword(s):

Gastric Cancer ◽

Overall Survival ◽

Prognostic Factors ◽

Cancer Patients ◽

Performance Status ◽

Metastatic Gastric Cancer ◽

Palliative Gastrectomy ◽

Cast Doubt ◽

Gastric Cancer Patients ◽

Univariate Analyses

Background. Palliative gastrectomy has been suggested to improve survival of patients with metastatic gastric cancer, but limitations in study design and availability of robust prognostic factors have cast doubt on the overall merit of this procedure. Methods. The characteristics and clinical outcomes of 173 patients diagnosed between 2008 and 2012 were analyzed to determine the value of palliative gastrectomy and to identify potential prognostic factors. Results. Median overall patient survival was 6.5 months. To attenuate potential selection bias, patients with adequate performance and survival time of ≥ 2 months since diagnosis were included for risk factor analysis (n=137). The median overall survival was longer for patients who were younger than 60 years, had better performance status (8.7 versus 6.4 months, P=0.015), received systemic chemotherapy, or had palliative gastrectomy in univariate analyses. Gastrectomy (P=0.002) remained statistically significant in multivariate analyses. Subgroup analysis showed that patients aged < 60 years, CEA < 5 ng/mL or CA19-9 < 35 U/mL, obtained a survival advantage from palliative gastrectomy. In fact, palliative gastrectomy doubled overall survival for patients who had normal CEA and/or normal CA19-9. Conclusions. Palliative gastrectomy prolongs the survival of metastatic gastric cancer patients with normal CEA and/or CA19-9 level at the time of diagnosis.

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Paclitaxel, oxaliplatin, 5-fluorouracil and leucovorin combination chemotherapy in patients with recurrent or metastatic gastric cancer

Tumori Journal ◽

10.5301/tj.5000665 ◽

2018 ◽

Vol 104 (1) ◽

pp. 22-29

Author(s):

Yan-qin Lan ◽

Ri-ping Wu ◽

Xiao-bing Huang ◽

Xin-li Wang ◽

Dong-ta Zhong ◽

...

Keyword(s):

Gastric Cancer ◽

Combination Chemotherapy ◽

Intravenous Infusion ◽

Median Overall Survival ◽

Objective Response ◽

Metastatic Gastric Cancer ◽

Peripheral Neurotoxicity ◽

Common Grade ◽

Grade 3 ◽

Safe Approach

Purpose: This study evaluated the efficacy and toxicity of combination chemotherapy with paclitaxel, oxaliplatin, 5-fluorouracil and leucovorin (POFL) in patients with recurrent or metastatic gastric cancer. Methods: One hundred and thirty-eight patients with histologically confirmed recurrent or metastatic gastric adenocarcinoma were treated with the POFL regimen: paclitaxel at a dose of 135 mg/m2 as a 3-hour intravenous infusion on day 1, oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 as an intravenous infusion over 2 hours on day 1, followed by 5-fluorouracil 2,400 mg/m2 as an infusion over a 46-hour period on 3 consecutive days, in a 2-week cycle. Results: Twelve patients could not be evaluated for response because of the absence of any measurable lesions or early discontinuation of therapy, so responses were assessed in 126 patients. The overall objective response rate was 56.3% (95% CI, 47.5%-64.9%). The median time to progression was 6.7 months (95% CI, 5.8-7.6 months), and the median overall survival was 12.6 months (95% CI, 11.3-13.9 months). The most common grade 3 and 4 toxicities were neutropenia (50.7%), peripheral neurotoxicity (16.7%) and alopecia (27.5%). Conclusions: Combination chemotherapy with POFL offers a new, active and safe approach to the treatment of recurrent or metastatic gastric cancer.

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A phase I study of sequential administration of S-1 and cisplatin (CDDP) for patients with metastatic gastric cancer (MGC)

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.14101 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 14101-14101

Author(s):

E. Baba ◽

H. Fujishima ◽

H. Kusaba ◽

T. Esaki ◽

H. Ariyama ◽

...

Keyword(s):

Gastric Cancer ◽

Phase I ◽

Dose Level ◽

Phase Ii ◽

Performance Status ◽

Metastatic Gastric Cancer ◽

Sequential Administration ◽

Grade 3

14101 Background: The combination of 5-FU and CDDP has been reported to be active against metastatic gastric cancer (MGC), and great synergy has been shown in vivo and in vitro when 5-FU precedes CDDP. We investigated a sequential combination of S-1 (Tegafur, oxonic acid, CDHP) followed by CDDP for MGC. Methods: In order to determine a maximum tolerated dose (MTD) and recommended phase II dose (RD), we conducted a phase I trial applying increasing doses of oral administration of S-1 (65–80mg/m2) for 21 days and increasing doses of CDDP (60–80mg/m2) on day 22 every 35 days. Pts with metastatic or recurrent gastric cancer, no prior chemotherapy, measurable disease, performance status ECOG less than 3, and adequate organ functions were eligible for the study. Three pts were treated at each dose level with escalation based on toxicity. Fifteen pts were included and evaluated for DLT and MTD. Results: DLT was NCICTC grade 3 anorexia and fatigue in patients treated at the dose level 5 of S-1 80mg/m2 and CDDP 80mg/m2. Other toxicity more than grade 3 was neutropenia (grade 3) and nausea/vomiting (grade 3). Non-hematological toxicities were grade 1/2 and included diarrhea, nausea and stomatitis. There was no treatment-related mortality. The recommended dose was a combination of S-1 80mg/m2 and CDDP 70mg/m2. A tentative median survival was 19.5 months. Conclusions: This sequential S-1 and CDDP administered every 35 days is tolerable and beneficial for patients with MGC, and thus the consequent phase II trial is recommended. A multicenter phase II study is currently under way. No significant financial relationships to disclose.

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