Feasibility and pathological response of TAS-118 + oxaliplatin as perioperative chemotherapy for patients with locally advanced gastric cancer (APOLLO-11).

Authors

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Daisuke Takahari

Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan

Daisuke Takahari , Atsuo Takashima , Takako Eguchi Nakajima , Naoki Ishizuka , Manabu Ohashi , Hitoshi Katai , Shinya Mikami , Keisho Chin , Souya Nunobe , Miki Ito , Takeyuki Wada , Takashi Ogura , Takeshi Sano , Narikazu Boku , Kensei Yamaguchi

Organizations

Department of Gastroenterology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan, Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan, Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan, Department of Clinical Trial Planning and Management, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan, National Cancer Center Hospital, Tokyo, Japan, Department of Gastrointestinal and General Surgery, St. Marianna University School of Medicine, Kawasaki, Japan, Department of Gastroenterological surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan, Department of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan, St. Marianna University School of Medicine, Kawasaki, Japan, Japanese Foundation for Cancer Research Cancer Institute Hospital, Tokyo, Japan, Department of Gastroenterology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan

Research Funding

Pharmaceutical/Biotech Company
Taiho

Background: TAS-118 is a novel oral agent, containing S-1 and leucovorin. In the SOLAR study (NCT02322593), TAS-118 + oxaliplatin (OHP) significantly improved overall survival compared to S-1 + cisplatin for patients (pts) with advanced gastric cancer (GC). We conducted this open-label study to assess feasibility of perioperative adjuvant chemotherapy with TAS-118 + OHP in pts with locally advanced resectable GC with lymph node metastasis. (Clinical trial information: UMIN000024688). Methods: Eligible pts who had histopathologically confirmed GC with clinical T3-4N1-3M0 on image findings (14th Japanese classification of gastric carcinoma), age 20 to 79 years, were enrolled in this study. The protocol treatment consisted of preoperative 4 courses of TAS-118 (80-120 mg/body, days 1-7) + OHP (85 mg/m2, day 1) every 2 weeks, and gastrectomy with D2 lymphadenectomy, followed by postoperative 12 courses of TAS-118 alone (step1) or 8 cycles of TAS-118 + OHP (step2). The primary endpoints were tolerability of preoperative chemotherapy, gastrectomy and postoperative chemotherapy with TAS-118 plus OHP. Here, we report the feasibility of preoperative chemotherapy and gastrectomy, and pathological response. Results: Between December 2016 and April 2018, 45 pts with a median age of 61 years were enrolled. The numbers of pts with T stage (cT3/4a) and those with N stage (cN1/2/3) were 13/32 and 25/17/3, respectively. The completion rate of preoperative chemotherapy and gastrectomy was 88.9% ( 95% CI 78.0-95.5) and 95.6% (95% CI 86.7-99.2). The relative dose intensity of TAS-118 and OHP was 86.0% and 90.6%. During the 4 cycles of preoperative TAS-118 + OHP, 2 pts discontinued the treatment due to adverse event (AE). Major grade 3-4 AEs were diarrhea (17.8%) and neutropenia (8.9%). R0 resection rate was as high as 95.6%. One pts experienced grade 4 postoperative bleeding, but no treatment-related death was reported. pCR was achieved in 6/45 pts (13.3%) and other 7 pts (28.9%) showed near complete regression (<10 % residual tumor cells). Conclusions: Preoperative TAS-118 + OHP followed by D2 gastorectomy was well tolerated and showed promising efficacy. Clinical trial information: 000024688.

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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

000024688

Citation

J Clin Oncol 38, 2020 (suppl 4; abstr 351)

Abstract #

351

Poster Bd #

D6

Abstract Disclosures