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Head Office"},{"name":"CReS Kyushu"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Clin Oncol"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Gastrectomy with D2 dissection and adjuvant chemotherapy is the standard treatment for locally advanced gastric cancer (LAGC) in Asia. However, administering chemotherapy with sufficient intensity after gastrectomy is challenging. Several trials demonstrated the efficacy of neoadjuvant chemotherapy (NAC). However, limited studies explored the feasibility of NAC-SOX for older patients with LAGC. This phase II study (KSCC1801) evaluated the safety and efficacy of NAC-SOX in patients with LAGC aged\u2009\u2265\u200970\u00a0years.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Patients received three cycles of SOX\n                      <jats:sub>130<\/jats:sub>\n                      (oxaliplatin 130\u00a0mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      on day 1, oral S-1 40\u201360\u00a0mg twice daily for two weeks every three weeks) as NAC, followed by gastrectomy with lymph node dissection. The primary endpoint was the dose intensity (DI). The secondary endpoints were safety, R0 resection rate, pathological response rate (pRR), overall survival, and relapse-free survival.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The median age of 26 enrolled patients was 74.5\u00a0years. The median DI in NAC-SOX\n                      <jats:sub>130<\/jats:sub>\n                      was 97.2% for S-1 and 98.3% for oxaliplatin. Three cycles of NAC were administered in 25 patients (96.2%), of whom 24 (92.3%) underwent gastrectomy with lymphadenectomy. The R0 resection rate was 92.3% and the pRR (\u2265\u2009grade 1b) was 62.5%. The major adverse events (\u2265\u2009grade 3) were neutropenia (20.0%), thrombocytopenia (11.5%), anorexia (11.5%), nausea (7.7%), and hyponatremia (7.7%). Postoperative complications of abdominal infection, elevated blood amylase, and bacteremia occurred in one patient each. Severe diarrhea and dehydration caused one treatment-related death.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      NAC-SOX\n                      <jats:sub>130<\/jats:sub>\n                      is a feasible therapy for older patients, although systemic management and careful monitoring of adverse events are necessary.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10147-023-02373-3","type":"journal-article","created":{"date-parts":[[2023,6,27]],"date-time":"2023-06-27T02:02:25Z","timestamp":1687831345000},"page":"1166-1175","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Phase II clinical trial to study the safety and efficacy of combined S-1\u2009+\u2009oxaliplatin therapy as neoadjuvant chemotherapy for locally advanced gastric cancer in older patients"],"prefix":"10.1007","volume":"28","author":[{"given":"Mitsuhiko","family":"Ota","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7243-6960","authenticated-orcid":false,"given":"Hiroshi","family":"Saeki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hideo","family":"Uehara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiko","family":"Matsuda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoshi","family":"Tsutsumi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetsuya","family":"Kusumoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisateru","family":"Yasui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasunari","family":"Ubukata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shohei","family":"Yamaguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Orita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoki","family":"Izawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saburo","family":"Kakizoe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mototsugu","family":"Shimokawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoharu","family":"Yoshizumi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihiro","family":"Kakeji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaki","family":"Mori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eiji","family":"Oki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,6,27]]},"reference":[{"key":"2373_CR1","unstructured":"GLOBOCAN database (2020) http:\/\/globocan.iarc.fr\/Default.aspx. 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Head Office. Y. Kakeji has received an honorarium from Taiho Pharmaceutical Co., Ltd. N. Izawa received research grants from Chugai Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Sanofi K.K., Otsuka Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., and honoraria from Taiho Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Bristol-Myers Squibb Co., Chugai Pharmaceutical Co., Ltd., and Daiichi Sankyo Co., Ltd. E. Oki received honoraria from Chugai Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Bayer Yakuhin, Ltd., Eli Lilly Japan K.K., Bristol-Myers Squibb Co., and Takeda Pharmaceutical Co., Ltd. M. Ota received honoraria from Bristol-Myers Squibb Co., Ono Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., and Daiichi Sankyo Co., Ltd. All remaining authors have declared no conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. This study was approved by the Clinical Research Network Fukuoka Certified Review Board (Certification No. CRB7180004). Informed consent to be included in the study, or the equivalent, was obtained from all patients.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Human rights statement and informed consent"}}]}}