Multicenter phase II study of neoadjuvant chemotherapy with S-1 and oxaliplatin for locally advanced gastric cancer (Neo G-SOX PII).

Authors

null

Masato Kondo

Kobe City Medical Center General Hospital, Kobe, Japan

Masato Kondo , Hironaga Satake , Motoko Mizumoto , Akira Miki , Takanori Watanabe , Norimitsu Tanaka , Kenro Hirata , Hiroaki Tanioka , Yoshihiro Okita , Takahisa Kyogoku , Mitsutoshi Tatsumi , Koreatsu Matoba , Shinichi Adachi , Satoshi Kaihara , Hisateru Yasui , Akihito Tsuji

Organizations

Kobe City Medical Center General Hospital, Kobe, Japan, Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan, Department of Surgery, Kobe City Medical Center General Hospital, Kobe, Japan, Department of Surgery, Toyooka Hospital, Toyooka, Japan, Department of Surgery, Himeji Red Cross Hospital, Himeji, Japan, Department of General and Gastroenterological Surgery, Kagawa Prefectural Central Hospital, Kagawa, Japan, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, Medical Oncology, Okayama Rosai Hospital, Okayama, Japan, Nishikobe Medical Center, Kobe, Japan, JCHO Hoshigaoka Medical Center, Hirakata, Japan, Kobe Rosai Hospital, Kobe, Japan, Department of Surgery, Nishinomiya Municipal Central Hospital, Nishinomiya, Japan, Department of Surgury, Kobe City Medical Center General Hospital, Kobe, Japan, Department of Medical Oncology, Kagawa University Hospital, Takamatsu, Japan

Research Funding

No funding received
None

Background: Prognosis for locally advanced gastric cancer (LAGC), such as clinical T4 disease, bulky nodal metastases, type 4 and large type 3 gastric cancer, was not satisfactory even by D2 gastrectomy followed by adjuvant chemotherapy. Neoadjuvant chemotherapy is another promising approach, therefore, we have conducted a phase II study to evaluate the efficacy and safety of the neoadjuvant chemotherapy of S-1 and oxaliplatin (G-SOX) followed by gastrectomy with D2/3 lymph node dissection for LAGC, and the primary endpoint of curative resection rate was met [Miki A, ESMO 2019]. We show longer follow-up data from this study. Methods: Patients with adenocarcinoma of the stomach; clinical T4; clinically resectable gastric cancer of type 4 or large type 3; bulky nodal involvement around major branched arteries to the stomach were enrolled. Patients receive two cycles of neoadjuvant chemotherapy with S-1 (80 mg/m2, p.o., days 1-14 followed by 1 week rest) and oxaliplatin (130 mg/m2 at day 1), followed by D2 or higher surgery with no residual disease. Patients with pathological R0/1 resection received S-1 (80 mg/m2, p.o., days 1-28 followed by 2 week rest) for 1 year as adjuvant chemotherapy. Primary endpoint was curative resection rate. Results: Between August 2015 and March 2017, forty-one patients were in enrolled. Of the patients, 39 patients (95%) completed the two courses of neoadjuvant chemotherapy of G-SOX, 37 (90%) received gastrectomy, and 36 (87.8%) received curative resection (R0/1). Grade 3 or higher toxicities during neoadjuvant chemotherapy of G-SOX were neutropenia (7%), fatigue (7%), diarrhea (5%) and thrombocytopenia (2%). No treatment related deaths were observed. Surgical complications including postoperative complications were observed in 13 patients (35%). Pathological response rate after neoadjuvant G-SOX was 40%. With a median follow-up period of 33.8 months, 3year-relapse free survival and 3year-ovearll survival was 54.3% and 73.1%, respectively. Conclusions: An update analysis confirmed that neoadjuvant chemotherapy of G-SOX is a feasible and might be one of the promising strategies for patients with LAGC. Clinical trial information: UMIN000018661.

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Abstract Details

Meeting

2020 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Esophageal and Gastric Cancer and Other GI Cancers

Track

Esophageal and Gastric Cancer,Other GI Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

UMIN000018661

Citation

J Clin Oncol 38, 2020 (suppl 4; abstr 399)

Abstract #

399

Poster Bd #

F10

Abstract Disclosures