A randomized phase II trial of S-1-oxaliplatin versus capecitabine–oxaliplatin in advanced gastric cancer

Kim, Gun Min; Jeung, Hei Cheul; Rha, Sun Young; Kim, Hyo Song; Jung, Inkyung; Nam, Byung Ho; Lee, Kyung Hee; Chung, Hyun Cheol

doi:10.1016/j.ejca.2011.12.017

Cited by 126 publications

(110 citation statements)

References 28 publications

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“…At the established MTD of SOX, the S-1 dose (70 mg/m 2 ̸day) was lower in our study compared to that used in previous studies (80 mg/m 2 ̸day) (15)(16)(17)(18). At the MTD level, the predominant grade 3̸4 toxicities observed in patients included neutropenia (33.3%), thrombocytopenia (16.7%) and vomiting (16.7%).…”

Section: Discussioncontrasting

confidence: 45%

“…In a phase I̸II study of S-1 and oxaliplatin (fixed at 130 mg̸m 2 ) in AGC, the RD for a phase II study was established as 100 mg/m 2 ; however, the relative dose intensity (RDI) of the S-1̸oxaliplatin regimen became progressively lower over successive chemotherapy cycles (14). Considering that the typical single-agent dose of S-1, which was widely used in Dose-finding study on adjuvant chemotherapy with S-1 plus oxaliplatin for gastric cancer LIN YANG 1* , YI YANG 2* , QIONG QIN 1 , AIPING ZHOU 1 , JIANJUN ZHAO 1 , previous studies (15)(16)(17)(18), was 80 mg̸m 2 ̸day, the highest dose of S-1 in the present study was set at 80 mg̸m 2 ̸day, with the aim of determining the maximum tolerated dose (MTD) of S-1 when administered in combination with oxaliplatin in postoperative GC patients.…”

Section: Introductionmentioning

confidence: 99%

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Dose-finding study on adjuvant chemotherapy with S-1 plus oxaliplatin for gastric cancer

Yang

Qin

et al. 2013

Molecular and Clinical Oncology

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Abstract. Gastric cancer (GC) is the fourth most common type of cancer, accounting for an estimated one million new cases annually worldwide. Locally advanced GC often recurs, even following curative surgical resection. Therefore, there is a need for an effective adjuvant chemotherapy regimen. The aim of this trial was to investigate the maximum tolerated dose (MTD) of S-1 when administered in combination with oxaliplatin in postoperative GC patients. Oxaliplatin was administered at a fixed dose of 130 mg/m 2 on day 1. S-1 was administered from day 1 to 14 of a 3-week cycle and escalated by 10 mg̸m 2 ̸day from 60 to 80 mg/m 2 ̸day. A total of 15 patients were enrolled in this study. No dose-limiting toxicities (DLTs) occurred at level 1 (S-1, 60 mg̸m 2 ; n=3). One case of DLT (grade 3 vomiting) occurred at level 2 (S-1, 70 mg/m 2 ; n= 6), whereas 2 cases of grade 3 vomiting were observed at level 3 (S-1, 80 mg/m 2 ; n=6). Based on these results, the MTD of S-1 was initially determined to be 70 mg̸m 2 . Furthermore, we observed that cytochrome P450 2A6 (CYP2A6) 41349640C>G was associated with severe neutropenia

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Section: Discussioncontrasting

confidence: 45%

Section: Introductionmentioning

confidence: 99%

Dose-finding study on adjuvant chemotherapy with S-1 plus oxaliplatin for gastric cancer

Yang

Qin

et al. 2013

Molecular and Clinical Oncology

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“…In Asian studies, XELOX was associated with an ORR ranging from 42 % to 63 %, a PFS of about 5.8 months, and an OS spanning from 10.8 to 13.3 months [23][24][25][26]. All-grade neurotoxicity was about 60 %, probably because of the higher oxaliplatin dose compared to our study (130 versus 100 mg/m 2 ).…”

Section: Discussionmentioning

confidence: 51%

Docetaxel, oxaliplatin, and capecitabine combination chemotherapy for metastatic gastric cancer

Lauro¹,

Vici²,

Belli³

et al. 2013

Gastric Cancer

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Background The incorporation of docetaxel into the cisplatin and fluorouracil backbone has been demonstrated to be an active combination in metastatic gastric cancer. Nevertheless, this regimen is burdened by nonnegligible toxicity. We hypothesized that replacing cisplatin and fluorouracil with oxaliplatin and capecitabine should be an active and safe option for metastatic gastric cancer patients. Methods In this phase II study, we tested the activity of docetaxel in combination with oxaliplatin and capecitabine (DOC) as a first-line treatment. DOC was administered as follows: docetaxel (60 mg/m 2 ) and oxaliplatin (100 mg/ m 2 ) on day 1, and capecitabine (500 mg/m 2 ) was administered orally twice daily given continuously, with cycles repeated every 3 weeks. The primary endpoint was the overall response rate. Results Forty-eight patients entered the study. All patients had metastatic disease (stage IV). None of the patients had previously received chemotherapy for advanced disease. Performance status was 0, 1, and 2 in 25, 58, and 17 % of patients, respectively; 13 patients (27 %) had adenocarcinoma of the gastroesophageal junction, and 29 patients (60.5 %) had two or more metastatic sites. The overall response rate was 52.1 %. Progression-free survival and overall survival were 6.9 and 12.6 months, respectively. The treatment was well tolerated with no treatmentrelated deaths. The most common grade 3-4 toxicity was neutropenia (41 %). Conclusions DOC is an effective and tolerated first-line treatment, and the lower dose of docetaxel and oxaliplatin used in this study compared with other similar regimens does not seem to hamper the antitumor activity.

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“…6 Both the SOX and CAPOX regimens were equally active and well tolerated in advanced gastric cancer patients. Grades 3/4 neuropathy, nausea, vomiting and asthenia were less frequent with SOX and as anticipated, HFS at any grade was more frequent for CAPOX (SOX = 3 %; CAPOX = 25 %, p=0.001).…”

Section: Established Benefits Of S-1 Confirmed In Western Populationsmentioning

confidence: 99%

“…6 Both the SOX and CAPOX regimens were equally active and well tolerated. A 25 % incidence of all grades of HFS was observed for CAPOX versus only 3.1 % for SOX.…”

mentioning

confidence: 99%

The Need for a New Fluoropyrimidine in Advanced Gastric Cancer Treatment

Cutsem

Sobrero

Yamada

et al. 2012

European Oncology &Amp; Haematology

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Fluoropyrimidines have shown efficacy against a variety of cancers and have evolved into a range of different uses and formulations. These drugs have been tested extensively as monotherapies and as part of numerous different chemotherapy combinations. The efficacy and safety profile of bolus intravenous (IV) 5-fluorouracil (5-FU) has been improved by continuous IV administration. The availability of the first 5-FU oral form in Europe, capecitabine, has added a clear value in terms of convenience for patients, while forcing physicians and nurses to learn how to manage the toxicity profile of this compound. S-1 is a new oral formulation combining a 5-FU prodrug (tegafur) and two targeted modulators of its metabolism (gimeracil and oteracil) preserving the efficacy and improving the safety of the prodrug. S-1 has become the backbone treatment for advanced gastric cancer in Japan since its introduction in 1999. Extensive experience from clinical trials, post-marketing studies and patient registries of over 4,000 patients in Japan show that S-1 has improved measures of survival in advanced gastric cancer and has an acceptable safety profile. S-1 has recently been approved for advanced gastric cancer treatment Following the recent approval of S-1 for use in Western populations after more than 10 years of extensive experience in Japan, the history of the fluoropyrimidines in advanced gastric cancer will be considered, and evidence supporting the use of S-1 from early phases to more recent clinical studies will be reviewed.

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A randomized phase II trial of S-1-oxaliplatin versus capecitabine–oxaliplatin in advanced gastric cancer

Cited by 126 publications

References 28 publications

Dose-finding study on adjuvant chemotherapy with S-1 plus oxaliplatin for gastric cancer

Dose-finding study on adjuvant chemotherapy with S-1 plus oxaliplatin for gastric cancer

Docetaxel, oxaliplatin, and capecitabine combination chemotherapy for metastatic gastric cancer

The Need for a New Fluoropyrimidine in Advanced Gastric Cancer Treatment

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