Comparison of two different S-1 plus cisplatin dosing schedules as first-line chemotherapy for metastatic and/or recurrent gastric cancer: a multicenter, randomized phase III trial (SOS)

Ryu, Min‐Hee; Baba, Eishi; Lee, K.H.; Park, Y.I.; Boku, Narikazu; Hyodo, Ichinosuke; Nam, Byung Ho; Esaki, Taito; Yoo, Changhoon; Ryoo, Baek‐Yeol; Song, Eun-Kee; Cho, S.-H.; Kang, Won Ki; Yang, Shuailong; Zang, Dae Young; Shin, Dong Bok; Park, S.R.; Shinozaki, Kazuo; Takano, Toshimi; Kang, Yoon‐Koo

doi:10.1093/annonc/mdv316

Cited by 44 publications

(27 citation statements)

References 17 publications

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“…This recommended dose is lower than that generally administered to East Asian patients, but corresponds to the S-1 dose commonly recommended for Caucasian patients [25][26][27][28]. The biological basis for this difference in the MTD of S-1 between different ethnic groups may, at least in part, be due to population differences in the genetic polymorphism status of the CYP2A6 gene, the product of which is a Objective response rate (CR ?…”

Section: Discussionmentioning

confidence: 95%

“…The biological basis for this difference in the MTD of S-1 between different ethnic groups may, at least in part, be due to population differences in the genetic polymorphism status of the CYP2A6 gene, the product of which is a Objective response rate (CR ? PR), n (%) 0 0 3 (27) Evaluable for PFS n = 6 n = 4 n = 11 Events, n (%) principal enzyme in relation to the bioactivation of tegafur to 5-FU [25,29,30]. Suggestive of a high potential for tumor control, partial responses to EOS were seen in three (27 %) of 11 evaluable patients in cohort 3, and a further seven patients (64 %) had stable disease, including one patient with an unconfirmed partial response; only one patient (9 %) had progressive disease.…”

Section: Discussionmentioning

confidence: 99%

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Phase I study of orally administered S-1 in combination with epirubicin and oxaliplatin in patients with advanced solid tumors and chemotherapy-naïve advanced or metastatic esophagogastric cancer

et al. 2016

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Background This phase I study investigated the safety and the maximum tolerated dose (MTD) of the oral fluoropyrimidine S-1 when combined with epirubicin and oxaliplatin (EOS). Methods Patients aged C18 years with advanced or metastatic solid tumors were enrolled in a 3 ? 3 design with S-1 dose escalation (two planned cohorts) performed according to the occurrence of dose-limiting toxicity (DLT). On day 1 of each 21-day cycle, patients received epirubicin 50 mg/m 2 followed by oxaliplatin 130 mg/m 2 (maximum 8 cycles) and then S-1 [20 mg/m 2 (cohort 1) or 25 mg/m 2 (cohort 2), twice daily]: first dose, evening of day 1; subsequent administration on days 2-14, twice daily; last dose, morning of day 15 (unlimited number of S-1 cycles). After protocol amendment, enrollment in a third cohort was restricted to patients with chemotherapynaïve advanced or metastatic esophagogastric cancer. Results DLT was reported for two of the five patients in cohort 2, defining 20 mg/m 2 twice daily as the MTD of S-1 combined with epirubicin and oxaliplatin in heavily pretreated patients. Thirteen patients with chemotherapy-naïve advanced or metastatic esophagogastric cancer were subsequently enrolled and treated at an S-1 dose level of 25 mg/m 2 twice daily; no DLTs were reported; median overall survival was 13.1 months. Of the 11 evaluable patients, three (27 %) had partial responses and seven (64 %) had stable disease. The safety profile was in line with expectations. Conclusions The promising activity of EOS (S-1 dose level, 25 mg/m 2 twice daily) and acceptable safety profile support further clinical development of this combination for the first-line treatment of patients with advanced or metastatic esophagogastric cancer.

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Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 99%

Phase I study of orally administered S-1 in combination with epirubicin and oxaliplatin in patients with advanced solid tumors and chemotherapy-naïve advanced or metastatic esophagogastric cancer

et al. 2016

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“…Compared with our study, the 3-weekly treatment regimen resulted in a longer median PFS (7.8 months) but a similar RR (68%) and OS (16 months). In the SOS study comparing 3-weekly and 5-weekly SP therapy, the 3-weekly SP regimen resulted in a longer PFS, similar OS, and a slightly higher toxicity than the 5-weekly SP regimen [15]. Taken together, these results suggest that although PFS may be slightly prolonged with 3-weekly SP threapy plus trastuzumab therapy, 5-weekly SP therapy can be considered to be a comparable combination chemotherapy with trastuzumab in HER2positive advanced GC/EGJC.…”

Section: Discussionmentioning

confidence: 99%

Five-weekly S-1 plus cisplatin therapy combined with trastuzumab therapy in HER2-positive gastric cancer: a phase II trial and biomarker study (WJOG7212G)

et al. 2017

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“…We did not perform a phase I study to determine the dose of cisplatin in the XP regimen for Japanese patients with gastric cancer, so the optimum cisplatin dose remains unclear. We set the cisplatin dose in the current study at 60 mg/m 2 based on the S-1 plus cisplatin (SP) regimen [3, 13] and a previous phase 2 study of XP for gastric cancer [7]. The optimal dose of capecitabine, when administered as a monotherapy, is 1250 mg/m 2 twice daily, on days 1–14, every 3 weeks [14].…”

Section: Discussionmentioning

confidence: 99%

Phase II trial of capecitabine plus modified cisplatin (mXP) as first-line therapy in Japanese patients with metastatic gastric cancer (KSCC1104)

Satake

Iwatsuki

Uenosono

et al. 2016

Cancer Chemother Pharmacol

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PurposeCapecitabine plus cisplatin (XP) is a standard therapy for metastatic gastric cancer (mGC). However, while results from previous phase III trials suggested that the cisplatin dosage should be reduced in Japanese patients, no clinical data exist to support this. Here, we conducted a multicenter study to evaluate the efficacy and safety of modified XP (mXP) in Japanese patients with mGC.MethodsPatients with previously untreated mGC received mXP (cisplatin 60 mg/m2 on day 1 plus capecitabine 1000 mg/m2 twice daily on days 1–14) every 3 weeks. The primary endpoint was the Response Evaluation Criteria in Solid Tumors-confirmed overall response rate (ORR). A sample size of 40 was planned for a threshold ORR of 30% and an expected value of 50%, with a one-sided α of 0.05 and a beta of approximately 0.2.ResultsForty-two patients were enrolled. One patient did not fulfill the eligibility criteria; therefore, a total of 41 patients were assessed. The results were as follows: complete response in 2 patients, partial response in 16, stable disease in 14, progressive disease in 8, and no evaluation in 1. The confirmed ORR was 43.9% (95% confidence interval 28.7–59.1%). The median progression-free survival and median overall survival were 4.6 and 11.3 months, respectively. The most common grade 3 or 4 adverse events were neutropenia (37.5%), anemia (24.4%), anorexia (24.4%), and nausea (12.2%).ConclusionsFirst-line chemotherapy with mXP in Japanese patients with mGC did not reach its primary objective. However, it did show a promising response rate and an acceptable tolerability profile.

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Comparison of two different S-1 plus cisplatin dosing schedules as first-line chemotherapy for metastatic and/or recurrent gastric cancer: a multicenter, randomized phase III trial (SOS)

Abstract: SP3 is superior to SP5 in terms of PFS. However, since the improvement in PFS was only slight and there was no difference in OS, both SP3 and SP5 can be recommended as first-line treatments for patients with advanced GC.

Cited by 44 publications

References 17 publications

Phase I study of orally administered S-1 in combination with epirubicin and oxaliplatin in patients with advanced solid tumors and chemotherapy-naïve advanced or metastatic esophagogastric cancer

Phase I study of orally administered S-1 in combination with epirubicin and oxaliplatin in patients with advanced solid tumors and chemotherapy-naïve advanced or metastatic esophagogastric cancer

Five-weekly S-1 plus cisplatin therapy combined with trastuzumab therapy in HER2-positive gastric cancer: a phase II trial and biomarker study (WJOG7212G)

Phase II trial of capecitabine plus modified cisplatin (mXP) as first-line therapy in Japanese patients with metastatic gastric cancer (KSCC1104)

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