Randomized, multicenter, phase III trial to compare S-1 plus docetaxel (DS) with S-1 plus cisplatin (SP) in gastric cancer patients with stage III (POST trial).

Authors

null

Choong-kun Lee

Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea

Choong-kun Lee , Minkyu Jung , Seok Yun Kang , Bong-Seog Kim , Ki Hyang Kim , Kyung Hee Lee , Moon Hee Lee , Dong Bok Shin , Dae Young Zang , Ji Yeong Ahn , Hyoung-Il Kim , Woo Jin Hyung , Sung Hoon Noh , Hyo Song Kim , Hyun Cheol Chung , Sun Young Rha

Organizations

Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea, Department of Internal Medicine, Division of Medical Oncology, Yonsei University College of Medicine, Seoul, South Korea, Ajou University School of Medicine, Suwon, South Korea, Seoul Bohun Hospital, Seoul, South Korea, Busan Paik Hospital, Inje University College of Medicine, Busan, South Korea, Yeungnam University Hospital, Daegu, South Korea, Inha University School of Medicine, Incheon, South Korea, Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea, Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang, South Korea, Department of Surgery, Yonsei University College of Medicine, Seoul, South Korea, Yonsei Cancer Center, Yonsei University Heath System, Seoul, South Korea, Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea

Research Funding

Pharmaceutical/Biotech Company

Background: Even among completely resected gastric cancer patients treated with adjuvant chemotherapy, stage III patients show bad prognosis and somewhat better treatment option is needed. Docetaxel or cisplatin each added to S1 monotherapy showed survival benefits in advanced gastric cancer. Methods: We conducted randomized, multicenter, phase III trial to compare S-1 plus docetaxel (DS) with S1 plus cisplatin (SP) in stage III gastric cancer patients. Gastric cancer patients (AJCC 7th stage III) who had had curative D2 gastrectomy were randomized 1:1 to receive adjuvant chemotherapy of eight 3 week cycles of DS (S-1 70mg/m2/day on day 1-14 plus docetaxel 35mg/m2 on day 1, and day 8) or SP (S-1 70mg/m2/day on day 1-14 plus cisplatin 60mg/m2on day 1). The primary endpoint was 3-year disease-free survival (3Y-DFS). Secondary endpoints include overall survival (OS) and safety. (NCT01283217) Results: As a result of early closure due to slow accrual, 153 patients of planned 290 patients were randomly assigned (75 patients to DS and 78 patients to SP) from 8 institutions for 31 months. The median follow up duration was 15.8 months (range, 0.8 to 36.2 months). There was no difference in DFS (HR, 1.088; 95% CI, 0.589 to 2.01; p=0.787) or OS (HR, 1.621; 95% CI, 0.707 to 3.720; p=0.254) between DS and SP. Most common grade 3 or 4 adverse event was neutropenia (42.7% among DS group and 38.5% among SP group, p=0.351). SP group suffered more grade 3 or 4 anemia (1.3% vs. 11.5%, p=0.037), where grade 3 or 4 hand-foot syndrome (4.1% vs. 0%, p=0.025) and mucositis (10.7% vs. 2.6%, p=0.001) were more common among DS group. Conclusions: Although the trial closed prematurely and had short follow up duration, S-1 plus cisplatin or docetaxel is an effective and tolerable option for patients with stage III advanced gastric cancer patients. Clinical trial information: NCT01283217.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2014 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT01283217

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr 4069)

DOI

10.1200/jco.2014.32.15_suppl.4069

Abstract #

4069

Poster Bd #

156

Abstract Disclosures