Efficacy of S-1 for Patients with Peritoneal Metastasis of Gastric Cancer

Ishizone, Satoshi; Maruta, Fukuto; Saito, Hiroyasu; Koide, Naoki; Sugiyama, Atsushi; Nakayama, Jun; Miyagawa, Shinichi

doi:10.1159/000096002

Cited by 36 publications

(26 citation statements)

References 38 publications

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“…Although some Phase III trials for metastatic gastric cancer have established standard chemotherapies, some anticancer drugs used in standard therapies, such as cisplatin or irinotecan, can scarcely be administered to gastric cancer patients with peritoneal metastasis, as it is likely to cause serious and sustained toxicity resulting from reduced metabolism and/or excretion (retention in ascites). For these reasons, large-scale trials for gastric cancer with peritoneal metastasis have not been conducted, and a standard chemotherapy regimen in this area has yet to be established (19)(20)(21)(22).…”

Section: Introductionmentioning

confidence: 99%

Randomized Phase III Study of 5-Fluorouracil Continuous Infusion vs. Sequential Methotrexate and 5-Fluorouracil Therapy in Far Advanced Gastric Cancer with Peritoneal Metastasis (JCOG0106)

Shirao

Boku

Yamada

et al. 2013

Japanese Journal of Clinical Oncology

101

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Objective: Owing to the risks of serious and sustained toxicity, anticancer drugs such as cisplatin and irinotecan cannot be readily administered to patients with gastric cancer and severe peritoneal metastasis. Therefore, a standard chemotherapy regimen has yet to be established for these types of patients. This randomized study investigated the utility of sequential methotrexate and 5-fluorouracil therapy vs. 5-fluorouracil continuous infusion for gastric cancer with peritoneal metastasis. Methods: Eligible patients had radiologically confirmed peritoneal metastasis with intestinal stenosis, peritoneal tumor or ascites. Treatment with 5-fluorouracil continuous infusion (800 mg/m 2 /day, ci, d1-5, q4w) or methotrexate and 5-fluorouracil therapy (methotrexate, 100 mg/m 2 , bolus infusion, followed 3 h later by 5-fluorouracil, 600 mg/m 2 , bolus infusion, with leucovorin rescue, q1w) was continued until disease progression or unacceptable toxicity. The projected sample size was 236, providing 80% power to detect a 40% increase in median overall survival in methotrexate and 5-fluorouracil therapy with a one-sided a of 0.05. Results: All 237 randomized patients were included in the primary analysis. The methotrexate and 5-fluorouracil therapy arm was not superior to the 5-fluorouracil continuous infusion arm (median survival time, 9.4 months in the 5-fluorouracil continuous infusion arm, 10.6 months in the methotrexate and 5-fluorouracil therapy arm; hazard ratio, 0.94; 95% confidence interval, 0.72 -1.22; one-sided P ¼ 0.31). Frequencies of Grade 3 or higher neutropenia, Grade 3 or higher anorexia and treatment-related deaths were 0.9, 27.4 and 1.7%, respectively, in the 5-fluorouracil continuous infusion arm, and 31.9, 33.6 and 0.9%, respectively, in the methotrexate and 5-fluorouracil therapy arm. Conclusions: Methotrexate and 5-fluorouracil therapy is not suitable for use as standard therapy for advanced gastric cancer with peritoneal metastasis.

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Section: Introductionmentioning

confidence: 99%

Randomized Phase III Study of 5-Fluorouracil Continuous Infusion vs. Sequential Methotrexate and 5-Fluorouracil Therapy in Far Advanced Gastric Cancer with Peritoneal Metastasis (JCOG0106)

Shirao

Boku

Yamada

et al. 2013

Japanese Journal of Clinical Oncology

101

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“…They also reported that DPD activity in rat liver decreased after 48 h of injection of 5-FU and returned to a normal level after 72 h. Although it can be assumed that the reduced DPD activity after infusion of 5-FU in humans may return to the normal level, this has not been confirmed. Moreover, no studies have investigated the effect of longterm administration of fluoropyrimidines which contain DPD inhibitor, such as UFT and S-1 [16,17] , on DPD activity.…”

Section: Discussionmentioning

confidence: 99%

Dihydropyrimidine Dehydrogenase Activity during Long-Term Adjuvant Treatment with Oral Uracil and Tegafur for Colorectal Cancer

Sadahiro

Suzuki²,

Maeda³

et al. 2007

Chemotherapy

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Background: Dihydropyrimidine dehydrogenase (DPD) is a rate-limiting enzyme for the degradation of 5-fluorouracil. The effect of long-term treatment with oral fluoropyrimidines on DPD activity has not been investigated. This study was conducted to examine changes in DPD activity in peripheral mononuclear cells (PMNC) during long-term treatment with oral uracil and tegafur (UFT) for colorectal cancer. Methods: UFT was administered for 5 consecutive days and not administered the next 2 days for 6 months after surgery. PMNC-DPD activity was measured before and 1, 2, 4 and 6 months after starting UFT administration. Results: In 70 eligible patients, there were no significant variations of PMNC-DPD activity during postoperative administration of UFT for 6 months. Grade 2 or higher adverse events were observed in significantly more patients with low DPD than with high DPD activity (p = 0.018). Conclusion: There were no significant variations of PMNC-DPD activity during the postoperative administration of UFT for 6 months. Low PMNC-DPD activity before UFT treatment was considered to be a predicting factor for toxicity.

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“…In four studies (Lenz et al, 1996;Metzger et al, 1998;Napieralski et al, 2005;Fukuda et al, 2006), patients have received neoadjuvant treatment, which may have altered TS expression, and a treatment-related effect cannot be entirely discounted. Two studies provided insufficient outcome data for effect estimation thus were excluded (Liu et al, 2004;Ishizone et al, 2006). Hence, a total of twenty-four studies with 2,079 patients remained eligible for meta-analysis (Table 1).…”

Section: Eligible Studies and Characteristicsmentioning

confidence: 99%

Predictive V16alue of Thymidylate Synthase Expression in Gastric Cancer: A Systematic Review with Meta-analysis

Hu¹,

Kuang²,

Zeng³

et al. 2012

Asian Pacific Journal of Cancer Prevention

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Efficacy of S-1 for Patients with Peritoneal Metastasis of Gastric Cancer

Cited by 36 publications

References 38 publications

Randomized Phase III Study of 5-Fluorouracil Continuous Infusion vs. Sequential Methotrexate and 5-Fluorouracil Therapy in Far Advanced Gastric Cancer with Peritoneal Metastasis (JCOG0106)

Randomized Phase III Study of 5-Fluorouracil Continuous Infusion vs. Sequential Methotrexate and 5-Fluorouracil Therapy in Far Advanced Gastric Cancer with Peritoneal Metastasis (JCOG0106)

Dihydropyrimidine Dehydrogenase Activity during Long-Term Adjuvant Treatment with Oral Uracil and Tegafur for Colorectal Cancer

Predictive V16alue of Thymidylate Synthase Expression in Gastric Cancer: A Systematic Review with Meta-analysis

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